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Pharmaceutical Webinars - Archived

The pharmaceutical webinars listed here are recordings of past events. Simply register, for free, for any webinar by clicking the download archive button on each webinar page. There are a wide range of topics covered under “pharma” - from research and development in pharma (learn about drug discovery and drug development), the product approval process for pharmaceuticals (learn submission efforts for FDA, EMA and more), best practices for marketing top pharmaceutical products, to learning how to navigate the world of emerging markets and the clinical trials process. If “pharmaceuticals” is to broad a term, don’t forget, you can search our webinar catalog using the search bar, or, if you’re looking for something more specific browse through our other topics.

  Synopsis Webinar Title Date

LifeScience - Join the speakers as they discuss an approach to evidence-generation strategies in drug and medical device development that enables integrated teams to develop and implement targeted and effective value propositions
Paul Just, PharmD, Senior Principal, Medical Device Health Economics, Commercialisation & Outcomes, ICON
Sarah Clifford, PhD, Senior Principal, Clinical Outcomes Assessments, Commercialisation & Outcomes, ICON
Linking Evidence and Value Strategies with the Right Stakeholder Oct 13, 2017

LifeScience - This webinar will discuss adaptive designs and focus on strategies for achieving additional objectives through the inclusion of biomarker evaluation in Phase 1/2 clinical trial design
Speakers: David R. McIlwain, PhD, Scientific and Medical Affairs Subject Matter Expert, WCCT Global
Kalyan Ghosh, Vice President, Biostatistics, WCCT Global
Adaptive Trial Design and Incorporation of Biomarkers to Maximize Achievable Objectives in Early Phase Clinical Studies Oct 13, 2017

LifeScience - In this webinar, the speaker will consider strategies for timely patient recruitment and retention for Alzheimer's clinical trials and discuss guidelines for, and technologies to support patient recruitment
Speaker: William A Holt, DO, Executive Director, Scientific Affairs, Neurosciences, PRA Health Sciences
Tactics for Successful Patient Recruitment in Alzheimer's Clinical Studies Sep 21, 2017

LifeScience -  Osteoarthritis (OA) occurs as the cartilage on the end of bones wears down and most often affects the hands, knees, hips, and spine - though it can damage any joint in the body.
Speaker: Michael Kuss, Vice President, Strategic Development, Analgesia, Premier Research
Chronic Pain: Conducting Clinical Trials in Osteoarthritis Sep 19, 2017

LifeScience -  In this session, you will learn about Systech’s ability to create trusted uniqueness in every product, and how this idea is central to a modern approach to brand protection
Speaker: Jim Sinisgalli, Director of Product Management and Brand Protection, Systech
Why Making Every Product Truly Unique is the Key to Modern Brand Protection Sep 6, 2017

LifeScience - This webinar will provide the audience with a general explanation of how CROs can support biologics testing, ranging from product release and stability to in-depth structural elucidation and degradation pathway studies
Speaker: Min Zhao, Ph.D., Director, Analytical Services for Biologic Product - CMC Services, Frontage Laboratories, Inc.
Outsourcing Analytical Testing for Biologics from a CRO Point of View Aug 31, 2017

LifeScience - In this webinar, the speakers will discuss how pediatric considerations fit into the overall drug development program and make recommendations for addressing issues from both a practical and scientific perspective
Speakers: Jean-Francois Marier, Senior Vice President Canada, Consulting Services Certara
Barry Mangum, Founder and CEO, Paidion Research
Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs Aug 16, 2017

LifeScience - This webinar featuring one of the US’s foremost cancer researchers as the speaker, will discuss cancer as a chronic disease and how researching cancer under this new archetype is adjusting the way in which clinical oncology trials are conducted and how cancer patients are treated
Speaker: Professor Lee Schwartzberg MD, FACP, Executive Director, West Cancer Center; Scientific Leader, George Clinical
Cancer as a Chronic Disease: The Past, the Present and the Future of Cancer Research Aug 8, 2017


LifeScience - Through a case study with PTC Therapeutics, the speakers will discuss the challenges of entering a new disease area for the first time, the balance of achieving the right size global organization to meet the customer population and the considerations for proceeding independently with a global launch rather than partnering
Speakers: Mark Rothera, Chief Commercial Officer, PTC Therapeutics
Ned Kitfield, Vice President, Charles River Associates
Into the Great Wide Open: PTC’s Transformation & Global Journey to Bring Patients a First Ever Rare Disease Therapy Jul 31, 2017

LifeScience -  This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency
Speakers: Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica, Inc.
Justin Hunt, Director, CTMS Implementation Services, Bioclinica, Inc.
Outsourcing to CROs? The Top 5 Reasons to Consider Bringing CTMS and Quality Management/RBM Systems in House Jul 27, 2017

LifeScience -  In this webinar, Dr. Tom Snowden will demonstrate why model reduction methods are a potent and necessary tool in the modeler’s arsenal, can be applied to QSP models, and used to extract scientific and business insights from complex models
Speaker: Tom Snowden, Research Scientist, Certara
Using Model Reduction to Bridge the Quality Systems Pharmacology-Pharmacometrics Divide Jul 26, 2017

LifeScience - This webinar will share both design and methodology guidance in Non-GLP Toxicology studies in both NHPs and rodent models
Speakers: Dr. Keefe Chng, Chief Scientific Officer and Site Head, Crown Bioscience Louisiana (CBLA, Inc.)
Dr. Judith Gorski, Global Director of Scientific Engagement, Crown Bioscience Inc.
How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology Jul 26, 2017

LifeScience -  Learn how a combined EDC and eSource solution improves the quality of clinical data and reduces the time to actionable insights
Speakers: Richard Young, VP, Vault EDC, Veeva
Hugo Cervantes, VP, Vault EDC, Veeva
EDC and eSource: Combined for Better Data and Faster Insights Jul 25, 2017

LifeScience -  This webinar will include case studies of how market authorization holders and CROs are becoming partners of choice in the ever changing world of pharmacovigilance outsourcing
Speakers: Sukrit Singh, Associate Director, CRM, Bioclinica, Inc.
Dr. Ayesha Hussain, Associate Director, CRM, Bioclinica, Inc.
Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned Jul 25, 2017

LifeScience -  Learning points include implementing an effective manufacturing control strategy and the benefits when designed in a cross-divisional approach
Speaker: Steve Murray, Principal Consultant, Werum IT Solutions America, Inc.
Data Integrity and the Manufacturing Control Strategy for Life Sciences Manufacturers Jul 19, 2017

LifeScience - Celerion scientists will share key learnings gained from engagement with multiple biosimilar programs for approval in the US and EU
Speakers:René Wuttke, Bioanalytical Principal Investigator, Celerion
David Goblot, Principal Scientist, Protocol Design and Development, Celerion
Biosimilar Development: Lessons Learned from Early Clinical Studies Jul 18, 2017

LifeScience - In this webinar, the speaker will present vascular and neural complications in rodent models of obesity and type 2 diabetes. Specifically, he will present the characterization of peripheral neuropathy in translational animal models such as the ZDSD rat
Speaker: Dr. Mark Yorek, Professor of Medicine, University of Iowa and Associate Chief of Staff, Iowa City VA
Vascular and Neural Complications in Rodent Models of Obesity and Type 2 Diabetes Jul 12, 2017

LifeScience - This webinar will discuss the Quality by Design process as it relates to logistics and evaluate its benefits
Speaker: Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport
Integrating Equipment Design, Logistics Processes and Real-Time Informatics: The Arrival of QbD in Pharmaceutical Logistic Jul 11, 2017

LifeScience - The speakers will share insight into how their joint, consultative approach to drug development can help in understanding the absorption and clearance characteristics of a drug substance and how these properties will influence dose prediction and selection of an appropriate formulation strategy
Speakers: Robert Harris, PhD, CChem, FRSC, Chief Technical Officer, Juniper Pharma Services
Graham Trevitt, PhD, Director (DMPK Consultancy, Modelling and Simulation), XenoGesis
The Importance of Dose Prediction for Early Drug Development Jul 6, 2017

LifeScience - The speaker will share his experiences in developing PCI’s serialization technology platform, along with developing and executing PCI’s strategy for supplying commercial serialized products to domestic and emerging markets across the globe
Speaker: Ian Parsonage, Senior Director, Global Serialization Services (Global Engineering), PCI Pharma Services
Pharmaceutical Serialization – Best Practices for Global Commercial Supply in an Evolving Market Jun 29, 2017

LifeScience - In this webinar, speakers will demonstrate live the power of real-time clinical data insights and analytics, and what this means for clinical trial conduct and for clinical trial management activities
Speakers: Stephanie Langouet, Vice President, Data & Analytics, Cmed
Jon Carter, Product Manager, Cmed
What Can Real-time Insights and Analytics Achieve for Your Clinical Trials? Jun 28, 2017

LifeScience - Definiens has developed quantitative methods to analyze the CT images and diagnostic pathology of patients, associating these measurements with outcomes
Speaker: Eugene J. Koay, MD, PhD, Assistant Professor, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center
Imaging-based Subtypes of Pancreatic Cancer Jun 26, 2017

LifeScience - Pharmaceutical manufacturers are scrambling to meet Serialization deadlines, most notably in the USA and EU, and many have already. But even when you serialize, the reality of product diversion still exists. How can we leverage your serialization investment to combat ever-increasing product diversion?
Speaker: Joe Lipari, Director of Cloud Products, Systech International
Serialized? Yes. But are Products Still Being Diverted? Jun 21, 2017

LifeScience - During this webinar, the speaker will describe Evotec’s medicinal chemistry and drug discovery philosophy
Speaker: Dr. Craig Johnstone, EVP, Global Head of Chemistry and Directeur General, Evotec France
Medicinal Chemistry Excellence – Efficient and Innovative Solutions for Superior Preclinical Candidates Jun 20, 2017

LifeScience - This webinar will examine the use of targeted clinical strategies are as a critical step towards improving success rates
Speakers: Dr. Richard K. Harrison, Chief Scientific Officer, Clarivate Analytics
Gavin Coney, Head of Clinical Products, Clarivate Analytics
Dr. Lee Lancashire, Principal Research Scientist, Clarivate Analytics
The Evolving Utilization of Specific Biomarker Roles Within Trial Design Jun 15, 2017

LifeScience - Find out how the use of information technology for drug safety has evolved over the last decade in line with changing demands from the business
Speakers Andrew Mitchell, Director of Life Sciences, Synchronoss
Kapil Kedia, Founder & CEO, SyNRG Solutions Technologies
Pharmacovigilance Oversight – Best Practices for Safety IT Jun 14, 2017

LifeScience - In this practical, guidance-filled webinar, the speakers will review the ICH E6 R2 guidelines and provide insights and tips to help map the road to compliance
Speakers Steven Whittaker, Executive Director, Avoca Quality Consortium, Senior Consultant, The Avoca Group
Ellen Kelso, Senior Consultant, The Avoca Group
Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica
ICH E6 R2 - Guidance and road map of tools for navigating the regulatory landscape Jun 14, 2017

LifeScience - This webinar will appeal to scientists involved in the development of generic drugs, particularly those considered complex generics because of their formulation or method of delivery
Speakers from Malvern Instruments:
Dr. Paul Kippax, Director of Product Management - Morphology
Dr. Anne Virden, Technical Support Supervisor - Analytical Imaging and Laser Diffraction
Dr. Katy Langley, Associate Product Manager - Analytical Imaging
Complex Generics: Physicochemical Characterization Analysis for Deformulation and In Vitro Bioequivalence Studies Jun 13, 2017

LifeScience - See how drug safety teams can use dynamic visual analytics to uncover safety issues earlier
Speakers: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
James (Jamie) Powers, Director of Real World Evidence and Data Science, PerkinElmer Informatics
Uncover Pharmacovigilance Insights with Data Discovery and Active Surveillance Jun 12, 2017

LifeScience - This webinar will focus on specific pharmaceutical case study examples, with a focus on the Seeq software application
Speakers: Lisa J. Graham, Ph.D., P.E., CEO and Founder, Alkemy Innovation Inc.
Brian Crandall, Analytics Engineer, Seeq
Pharmaceutical Case Studies Illustrating Data Analytics Strategies
Extracting the Most Value from Your Data Assets
Jun 12, 2017

LifeScience - This webinar will provide insight on the advantages of prefilled syringes and cartridges, including the various differentiators of the most commonly used syringe platforms – presterilized and bulk. Issues such as customization in packaging materials and production steps, challenges for dealing with complex compounds such as silicone sensitivity, reduced particle load and more are reviewed and solutions discussed.
Speaker: Kevin Joseph Wrigley, Product & Service Manager, Vetter Pharma International GmbH
Self-Administration Injection Systems – A Change in Market Trends Requires a Rethinking of Your Compounds Packaging Jun 8, 2017

LifeSciences - Coming from a both a CRO and clinical pharmacology unit perspective, WCCT Global offers insight into the five qualities that are most indicative of a high-performing, optimized Phase 1 clinical pharmacology unit
Speaker: Jon Rojas, CEO, WCCT Global
5 Qualities to Consider When Selecting Clinical Pharmacology Units for Early Drug Development Jun 6, 2017

LifeSciences - Topics include key challenges to improve cost-efficiency in orphan drugs clinical development, regulatory evolution in the review process of Orphan Drugs, and what role multi-stakeholder collaboration in rare disease research plays in improving clinical trials cost-efficiency
Speakers: Carlos R. Camozzi, MD, Chief Medical Officer, Simbec-Orion Group
Fabrice Chartier, PhD, Chief Operating Officer, Simbec-Orion Group
Rare Disease & Orphan Drug Development: Cost-Efficient Trial Design to Minimize Cash Burn Jun 1, 2017

LifeSciences -  Promising approaches in immuno-oncology drug development include checkpoint inhibitors, antibody drug conjugates, autologous cellular immunotherapy, and oncolytic viruses. This webinar will explore each of these, along with challenges in researching these compounds and recommendations to improve your odds of success.
Speakers: Nina Baluja, Senior Medical Director, Medical Services, Premier Research
Luke Gill, Executive Director, Oncology, Strategic Development, Premier Research
Expanding the Potential of Immuno-Oncology Therapies May 23, 2017

LifeSciences -  During this seminar the spakers will showcase actual pharmaceutical-ozone treatment results along with residues and reaction kinetics as well as how to determine required capacity and full scale implementation
Speakers: John Lindam, Ozonetech
Ramnath Lakshmanan, PhD, Ozonetech
Complete Treatment and Removal of Pharmaceutical Residues Using High Efficiency Ozone Systems May 23, 2017

LifeSciences -  In this webinar, Charles River's scientists take a look at some of the complementary approaches to HTS from a chemist’s perspective and how these strategies have been successfully applied to real drug discovery programs at Charles River for Charles River's partners
Speaker: Sam Mann, MChem, PhD, Principal Scientist, Medicinal Chemistry, Charles River Laboratories
Alternatives to HTS – Hit-finding Approaches in the Medicinal Chemist’s Arsenal May 18, 2017

LifeSciences - In this live webinar, the speakers will outline both the importance of a coherent endpoint strategy as well as the importance of leveraging scientific leadership early-on in trial design
Speakers: Professor Christine Jenkins, Scientific Leader – Respiratory, George Clinical
Dr. Marisa Petersen, Associate Director, CEO, George Clinical
Respiratory Endpoints, Scientific Leadership and the Asia-Pacific Region May 16, 2017

LifeSciences - This webinar will discuss the role and relevance of cognitive endpoints in clinical trials to accelerate our understanding of cognitive dysfunction related to cancer and cancer treatments
Speaker: Jeffrey S. Wefel, PhD, ABPP, Section Chief and Associate Professor, Section of Neuropsychology, Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center
The ABCs of Assessing Cognition in Oncology Clinical Trials: Applications, Benefits, and Considerations May 16, 2017

LifeSciences - Through quantitative analysis of IHC images, effective biomarkers can be predictors of disease prognosis and immune response of various immunotherapies.
Speaker: Belma Dogdas, PhD, Associate Principal Scientist, Merck, Inc.
Quantitative Immunohistochemistry for Development of Predictive Biomarkers in Oncology Clinical Trials May 10, 2017

LifeSciences - Learn how Covance and Global Specimen Solutions, Inc. can bring new insights to your research, using a fully-outsourced SaaS platform designed from the ground up to accommodate not just a few trials’ worth of data, but entire pipelines for rich answers in real time
Speaker: Amelia Warner, PharmD, RPh, CEO andFounder, Global Specimen Solutions, Inc.
Turning Biorepositories into Translational Science Treasure Troves: The Value of Uniquely Complete Data Sets May 4, 2017

LifeSciences - Attend this webinar to get up to speed with serialization regulations quickly and effectively for long term compliance & success
Speakers: Carlos Machado, Serialization Director, SEA Vision US
Paolo Landriani, Product Manager, SEA Vision Italy
Serialization for Late Starters – With Live Industry Research Results May 2, 2017

LifeSciences - Viewers will learn how technological innovation can be applied to late phase research studies and how the smart application of that technology can enhance use of real world data (RWD) assets
Speakers: Michael Cook, MSc, MSPH, PhD, Principal, Epidemiology, ICON Commercialisation & Outcomes
Bill Row, MBA, MS, Divisional Principal, Real World Evidence, ICON Commercialisation & Outcomes
Technology Solutions for Late Phase Research: Optimising Real World Data Assets May 1, 2017

LifeSciences - This webinar will provide viewers with insight into how to develop a successful patient journey analysis that will yield actionable insights
Speakers: Lou Brooks, Vice President, Commercial Consulting, Optum
Shelli Field, Principal Consultant, Commercial Consulting, Optum
A Holistic Understanding of the Patient Journey Using Multiple Data Sources Apr 27, 2017

LifeSciences - In this webinar, the speakers will discuss 3D Biology technology and the application of this novel approach in the study 75 lung cancer FFPE samples
Speakers: A. McGarry Houghton, MD, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center
Joseph M. Beechem, PhD, Senior Vice President of Research and Development, NanoString Technologies
Enabling Multi-Analyte Analysis of Lung Cancer FFPE Samples with 3D Biology™ Technology Apr 27, 2017

LifeSciences -  Understand factors the presenters believe medical device sponsors should consider when developing or using embloic protection devices in clinical trials
Speakers: Alan B. Lumsden, MD, ChB, RVT, FACS, Medical Director, Medical Metrics
Zsolt Garami, MD, Director of Vascular Imaging, Medical Metrics
Richelle Massey Senior Director, Project Management, Medical Device & Diagnostic Division, Novella Clinical
Clinical Trial Considerations in Cerebral Protection for TAVR Patients Apr 26, 2017

LifeSciences - The webinar will focus on specific analytical test solutions for Type II Diabetes that enable the creation of high quality laboratory data sets which in turn enable an accurate and efficient assessment of the test compound
Speakers: Andrew Roche, Ph.D., Scientific Director, Global Validation, Scientific Affairs, ICON
Martin Benson, Ph.D., Senior Director and Global Lead, Cardiometabolic Drug Development Services
Addressing the Challenges of Type II Diabetes Global Clinical Trials via Use of High Quality Laboratory Solutions Apr 26, 2017

LifeSciences -  The webinar will discuss the implications of the results and highlight key insights for sponsors and CROs to optimize their investigative site management practices
Speakers: Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts CSDD
Beth Harper, President, Clinical Performance Partners
Patricia Smith, Business Architect, goBalto
New Tufts CSDD Study on End-to-End Site Identification Through Startup Apr 25, 2017

LifeSciences - Whether your organization is just starting to consider eConsent or looking to expand adoption company-wide, learn about what others in the industry are currently thinking about the informed consent process
Speakers: Sam Sather, Quality and Regulatory, TrialConsent, CRF Health
Naor Chazan, Director of Marketing, CRF Health
Electronic Informed Consent: 2017 Industry Survey Results Apr 20, 2017

LifeSciences -  This webinar will discuss noninvasive ways to assess NASH using imaging, including proton density fat fraction (PDFF), T1 relaxometry, Magnetic resonance elastography (MRE) and the latest advances in MRE and how they can be used to assess inflammation.
Speakers: Richard L. Ehman, M.D., Professor of Radiology, Blanche R. & Richard J. Erlanger Professor of Medical Research, Mayo Clinic; President and CEO, Resoundant, Inc.
Jonathan Riek, Vice President, Ph.D., Musculoskeletal and Metabolic Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Assessing NASH: Discover the Non-invasive Techniques Apr 13, 2017

LifeSciences -  This webinar provides a timely update on new industry expectations of eCOA technologies
Speaker: Mike Hughes, Senior Director, eCOA Solutions, YPrime
The Modernization of eCOA Technology for Clinical Trials Apr 13, 2017

LifeSciences - This webinar will take an in-depth look at CRO oversight and risk management best practice, delving into the gaps in oversight processes, the causes of these gaps and how to successfully address them
Speakers: Julie Peacock, Client Services, Comprehend
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-time Apr 12, 2017

LifeSciences - In this webinar, the importance of an integrated development of both the spray dried intermediate (SDI) and the formulation, is highlighted
Speakers: João Henriques, MSc, Team Leader, Hovione
Pedro Valente, PhD, Scientist, Hovione
Formulating Amorphous Solid Dispersions: Bridging Particle Engineering and Formulation Apr 6, 2017

LifeSciences -  In this webinar, the speakers will discuss their experience with the regulatory and product development processes for combination products to show you how to navigate regulatory complexities
Speakers: Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences
Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act Apr 5, 2017

LifeSciences -  This series explores proven ways to develop go/no-go insights faster so clinical development teams can get submission-ready faster, reduce the risk of a rejected submission or potential market withdrawal, and optimize data provisioning, aggregation and review
Speaker: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
Predict and Act on Site Risks With Data-Driven Insights
Part 2 of Series "Four Steps to Shorten Your Clinical Trials with Informatics"
Apr 4, 2017

LifeSciences -  Key elements of this webinar will include the importance of natural history information in rare disease research, the difference between registry and natural history studies, and how to design and conduct a registry or natural history study
Speakers: Angi Robinson, Executive Director, Pediatrics & Rare Disease, Premier Research
Juliet Moritz, Executive Director, Rare Disease & General Medicine, Premier Research
Natural History vs. Registry Studies in Rare Disease Apr 4, 2017

LifeSciences - The purpose of this webinar is to evaluate and discuss the methodological approaches outlined in the guidance and highlight several key areas that may warrant further consideration when designing and planning for such studies
Speakers: Dr. Jack E. Henningfield, PhD, Vice President, Research, Health Policy, Abuse Liability, PinneyAssociates
Dr. David J. Heal, PhD, DSc, FRSC, FBPhS, Executive Director, RenaSci Ltd.
Dr. Beatrice Setnik, PhD, Vice President, Scientific Affairs, INC Research, Early Phase
The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review Mar 30, 2017

LifeSciences - This webinar will examine the clinical and pathogenetic aspects of the disease and the characteristics of clinical trials that seek to address this genetic condition
Speakers: Howard Welgus, Executive Medical Director, Dermatology, Premier Research
Ted Trafford, Managing Director, Probity Medical Research
Treatment of Psoriasis: Improvements Through Clinical Trials Mar 29, 2017

LifeSciences -  Can technology really streamline processes, make the research team more efficient, improve patient safety, and get to the end result of the research faster?
Speakers: Graham Belgrave, Chief Operations Officer, Cmed
Sammie Rivera, Senior Client Services Manager, Cmed
Jon Carter, Product Manager, Cmed
David Holloway, Global Head of Commercial Operations, Cmed
How to Improve the Speed and Efficiency of Your Clinical Trials Mar 28, 2017

LifeSciences -  In this webinar, PerkinElmer and AMRI will present a case study wherein High-Performance Computing (HPC) was leveraged for ultimate performance in image and data analysis of High Content Screening experiments
Speakers: Seungtaek Lee, Product Manager, PerkinElmer Informatics
James LaRocque, Senior Research Scientist II, Lead Discovery, Albany Molecular Research Inc. (AMRI)
High Performance Computing for High Content Screening - A Case Study Mar 28, 2017

LifeSciences - This webinar will explore how having a Medical Information role, supported by appropriate technology, can provide valuable customer and competitor intelligence and improve safety and quality reporting
Speakers: Jayne Packham, Director, Jayne Packham Consultancy
Syed Saad Rahman, Head of Product Management, Techsol Corporation
Strategies and Technology to Provide a Superior Medical Information Service Integrated with Safety and Quality Mar 23, 2017

LifeSciences - Join the speaker as he discusses a layered and holistic approach to brand protection. This webinar topic includes serialization, as well as additional measures that can be taken through global inspectors, overt and covert packaging modifications, and an emerging ability for authentication using cloud technologies and smart devices.
Speaker: Jim Sinisgalli, Director of Product Management and Brand Protection, Systech
Will Serialization Compliance Alone Protect Your Brand? Mar 22, 2017

LifeSciences - This presentation will explore how exponential growth in the variety of real world data sources and their quick adoption across functional business units is necessitating the need for the standardization of real world data and analytics platforms
Speakers: Robert Collins, Senior Life Sciences Industry Consultant, SAS
Ari Yacobi, Chief Data Scientist, Knowledgent
Institutionalizing Real-World Evidence Across Your Organization Mar 22, 2017

LifeSciences - While PD-L1 by immunohistochemistry has been successfully employed as a companion diagnostic for several therapies across a handful of indications, PD-L1 is only one potential biomarker for showing a predictive response. As more combination therapies are examined, more informative markers will need to guide when and how a treatment or combinations of treatment should be considered.
Speaker: Gina Wallar, PhD, MPH, Division Vice President for Pharma Services Sales, NeoGenomics, Inc.
Evaluation of the Tumor Microenvironment Using Image Analysis for Clinical Trials Mar 21, 2017

LifeSciences - This webinar will provide tips not only for quick, pain-free implementation as you’re assessing your DSCSA compliance readiness today, but will also help you lay a solid foundation for your serialized workflow that will provide benefits for many years to come
Speakers: Tim Donelon, Director of Quality and Validation, Verify Brand
Haris Kamal, Senior Vice President, Verify Brand
Scott Pugh, Solution Architect, Verify Brand
Assess Your Compliance Readiness: Tips for DSCSA Implementation – Faster, Easier and Done Right Mar 15, 2017

LifeSciences - This webinar follows a previous session from December 2016 on preparing for ICH-GCP E6(R2) at investigator sites by addressing questions practitioners now have as they prepare for future GCP audits and inspections conducted in accordance with these revised guidelines
Speakers: Andrew Mitchell, Director of Life Sciences, Intralinks
Dan Sfera, The Clinical Trials Guru
Gunnar Danielsson, DGD Consulting
ICH-GCP E6(R2) – Live Q&A with GCP Inspector and Investigator Site Perspectives Mar 15, 2017

LifeSciences - This webinar will address the necessity of serialization from market compliance to business supply, covering all aspects from line choice and regulation approach to management of data and related products
Speaker: Mario R. Scigliano, Serialization & Automation Manager, Corden Pharma Latina S.p.A.
From Market Compliance to Business Supply: The Necessity For Serialization Mar 8, 2017

LifeSciences -The speaker will demonstrate how pharmaceutical manufacturers can benefit from desiccant dehumidification solutions regardless of the local climatic conditions
Speaker: Martin Ginty, Industry Manager, Pharmaceutical, Munters GmbH
Are Humidity Fluctuations Compromising Your Capsule Quality? Mar 7, 2017

LifeSciences - This talk will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process
Speaker: Richard Kotz, Senior Medical Research Scientist, Biostatistics, NAMSA
Designing an Effective Clinical Trial Mar 7, 2017

LifeSciences - This webinar will help viewers comprehend regulatory requirements, understand the steps in preparing a successful Integrated Summaries project from a timelines and cost perspective and have a better idea of the deliverables they should expect from their CRO
Speakers: Mark Paul, Senior VP North America, CROS NT
Caroline Terrill, Director of Statistical Programming, CROS NT
Gail Head, Senior Medical Writer, CROS NT
Integrated Summaries – Tips for Meeting the Challenges Faced by Sponsors Feb 28, 2017

LifeSciences - New regulatory pathways and processes are expediting the translation of novel therapies to the bedside, and understanding these options helps ensure availability of more new treatments while minimizing delays
Speakers: Peter Larson, Senior Medical Director, Hematology-Oncology, Premier Research
Colin Hayward, Chief Medical Officer, Premier Research
From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments Feb 28, 2017

LifeSciences - Learn how technological advances are helping to best support the mid-study change process
Speaker: Rich Davies, Executive Director of Business Solutions, OmniComm Systems
Mid-Study Changes: Keeping Your Clinical Trial on Track with EDC Feb 23, 2017

LifeSciences - This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success
Speakers: Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Medical Device Regulation: Finding Your Path to Success Feb 14, 2017

LifeSciences - In this webinar, the presenter will consider issues associated with the application of cognitive tests to guide decision making about the safety and efficacy of drugs in both the chronic and acute stages of schizophrenia
Speaker: Paul Maruff, Chief Science Officer, Cogstate
Increasing the Precision of Cognitive Endpoints in Schizophrenia Clinical Trials Feb 9, 2017

LifeSciences - This webcast discusses how medical monitors can leverage guided visual analytics to find and act on the right issues quickly without sifting through mounds of clinical data
Speaker: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
Propel Medical Review with Guided Analytics
Part 1 of Series "Four Steps to Shorten Your Clinical Trials with Informatics"
Feb 7, 2017

LifeSciences -  This webinar will focus on the utilization of CRISPR/Cas9 technology in drug discovery, with an emphasis on generation of in vitro models for high-throughput screening, and creating new mouse models
Speaker: Anne-Marie Zuurmond, Ph.D., Associate Director of Genome Engineering Director, Charles River Laboratories
Vertical Integration of CRISPR/Cas9 Genome Engineering in Drug Discovery Feb 2, 2017

LifeSciences -  The speaker will discuss the importance of scientific leadership in the trial design process and throughout trial delivery, and examine the challenges of trial design in the Asia-Pacific along with the region's many opportunities for all phases of clinical studies
Speaker: Professor Vlado Perkovic, MBBS PhD FRACP FASN, Director, George Clinical, Executive Director, The George Institute, Australia
Trial Design and Scientific Leadership: How to Boost Patient Recruitment in Asia and Around the World Jan 31, 2017

LifeSciences - In this third webinar, the speaker will discuss the challenges of serialisation and how serialisation capability could be developed to address future needs
Speaker: Catherine Kay, Operations Director, Aesica Pharmaceuticals
Webinar Series: Routes to Address the Real Challenges in Serialisation
Part 3: Pharmaceutical Serialisation – Opportunities and Aggregation in the Future
Jan 31, 2017

LifeSciences - The scope of this webinar is to describe some predictive tools and methodologies that can be used to support process/product development and scale-up activities
Speakers: Márcio Temtem, Associate Director, Particle Design and Formulation Development, Hovione
João Vicente, Team Leader, Particle Engineering and Solubility Enhancement, Hovione
Development by Design: Hovione’s Approach to Spray Drying Process Development Jan 31, 2017

LifeSciences - As cancer treatments become more focused on personalized care for the patient, understanding the intricacies of immuno-oncology becomes increasingly important. Join our speakers who will outline how to manage the complexity of these studies and ways to maintain a successful partnership with your CRO.
Speakers: Megan Liles, Director, Project Management, Chiltern
Lynn Donald, Project Director, Chiltern
Operational Excellence in Immuno-Oncology Clinical Trials Jan 26, 2017

LifeSciences - This webinar will discuss the use of ligand-observed NMR techniques for rapid and efficient fragment screening of viral targets.
Speaker: Douglas R. Davies, Senior Manager of Structural Biology, Beryllium Discovery Corp.
Rapid and Efficient Fragment Screening of Influenza and Ebola Viral Targets to Enable Novel Drug Discovery Jan 24, 2017

LifeSciences - Part 2 of this series discuss will discuss serial numbers and the corresponding details of Aesica's serialisation solution
Speaker: Ralf Liedke, PhD, IT Director Germany, Aesica Pharmaceuticals
Webinar Series: Routes to Address the Real Challenges in Serialisation
Part 2: Serialisation Data Integration – Drug Safety, Security and The Whole IT Picture
Jan 24, 2017

LifeSciences -  This webinar will focus on data integration, which brings to life risks that are not apparent when examining data from one source alone
Speakers: Andy Lawton, Advisor, Risk Based Approach Ltd.
Pankaj Manon, CTO, ThoughtSphere
Bridging the Clinical Data Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management Jan 19, 2017

LifeSciences - This session provides insight into managing and operationalizing various aspects of clinical trials as well as identifying challenges and the technology based solutions needed to overcome them.
Speaker: Kelly Knowles, PMP, Director, Client Services, Bracket
The Future of IRT is in Your Hands – Leveraging Mobile Technology to Bring Clinical IRT into the 21st Century Jan 18, 2017

LifeSciences - In this first part of the series the speaker will discuss the industry's preparedness for serialisation legislation and Aesica's serialisation solution, from concept to delivery
Speaker: Christian Groß, Manager Packaging Technology and Project Manager Serialisation, Aesica Pharmaceuticals
Webinar Series: Routes to Address the Real Challenges in Serialisation
Part 1: Pharmaceutical Serialisation – The Challenges We, As a CDMO, Are Facing
Jan 17, 2017

LifeSciences -  This webinar will address emerging trends in clinical trial methodology for orphan disease drug development
Speakers from Worldwide Clinical Trials:
Michael Murphy, MD, PhD, Chief Medical and Scientific Officer
Josie Measures, Vice President Biostatistical Operations
Lorna Graham, BSc, MSc, Associate Director, Project Management, Evidence
Barbara Zupancic, Director, Global Patient Recruitment and Retention
Necessity is the Mother of Invention: The Impetus for Observational Research in Orphan Drug Development Dec 7, 2016

LifeSciences -  The presentation represents the team effort of groups at DEFINIENS and MedImmune and was recently presented at the SITC conference
Speaker: Sonja Althammer, Bioinformatics Team Lead, Definiens
Late Breaking Data from the Society for Immunotherapy of Cancer 2016 Dec 6, 2016

LifeSciences -  This webinar will discuss the findings from a commissioned study conducted by Forrester Consulting on behalf of Attivio surveying 112 life sciences experts involved with data analytics and visualization regarding current challenges such as too many data sets, unstandardized formats, multiple data sources (many outside the firewall), and lack of business-friendly analytics
Speakers: Rowan Curran, Analyst, Application Development & Delivery Professionals
Brendon Kellner, Presales Consultant, PerkinElmer
Four Reasons You’re Not Harnessing Big Data for R&D Dec 6, 2016

LifeSciences -  Developing and executing a sales enablement strategy is critical to keep sales teams competitive and relevant in the rapidly evolving healthcare landscape
Speakers: Jeff Gaus, Chief Executive Officer, Prolifiq Software
Vrahram Kadkhodaian, Chief Commercial Officer, Prolifiq Software
Best Practices to Create an Effective and Scalable Sales Enablement Strategy in Life Sciences Dec 1, 2016

LifeSciences - Global financial management is more important than ever and given sizable site payment allocations, you now can gain greater transparency and timely, accurate disbursement
Speakers: Victoria Moore, FCCA, Executive Director, Global Business Finance, INC Research
Shaun Williams, Director, Investigator Payments, INC Research
Marcus Thornton, Principal, Platform Adoption, Medidata
Nina Pruitt, Senior Director, Global Product Marketing, Medidata
Site Payment Paradigm Shift: Say Goodbye to Excel Nov 30, 2016

LifeSciences -  The spaeker will outline many of the opportunities that exist when conducting clinical trials, such as the SAVE trial (one of the largest obstructive sleep apnea medical device trials ever undertaken), in Asia and debunk a lot of the misconceptions that exist for sponsors who have operated in the traditional clinical trial markets of the USA and Europe
Speakers: Professor Craig Anderson, Executive Director, The George Institute, China, and Senior Director, Neurological & Mental Health Division
Emma Field, Project Manager, George Clinical, A division of The George Institute for Global Health
The Scientific Leadership Model: An Innovative Approach to Clinical Trial Leadership, Design and Delivery Nov 28, 2016

LifeSciences -  The speakers will demonstrate the functionality of by encapsia™ and how "Smart Monitoring" improves the quality, speed and cost of clinical trials
Speakers: Graham Belgrave, Chief Operations Officer, Cmed
Jon Carter, Product Manager, Cmed
Risk-Based Monitoring, Remote Monitoring and eSource: The Unattainable Trilogy of Monitoring? Nov 22, 2016

LifeSciences -  This webinar is aimed at informing scientists considering the use of immunohistochemistry (IHC) as a readout for target and biomarker validation
Speaker: Nicola Tonge, Histology Manager & Immunohistochemistry Specialist, Epistem
The Use of Immunohistochemistry in Target and Biomarker Validation Nov 21, 2016

LifeSciences - In this webinar, the speakers will provide an overview of the current status of surrogates for overall survival in oncology
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Dr. Everardo Saad, Senior Medical Expert, IDDI
Current Status of Surrogates for Survival in Cancer Trials Nov 17, 2016

LifeSciences -  The speakers will we will discuss considerations for multi-sponsor registries from a variety of stakeholder perspectives: manufacturer/sponsor, CRO, patients/healthcare providers
Speakers: Bill Row, MBA, MSm, Vice President, INC Research
Dr. Jessica Albano, PhD, MPH, Senior Director, Epidemiology, INC Research
Dr. Susan Sinclair, PhD, MPH, Associate Professor, UNCW College of Health and Human Services, and Sr. Advisor, INC Research
Navigating Multi-Sponsor Registries: The Journey to Success Nov 17, 2016

LifeSciences -  Extensive prior studies have shown strong positive effects for targets and negative effects for acquirers but, they’ve have focused on measuring value creation from individual deals, not a firm’s overall programs of activity and performance over longer time periods
Speaker: Guy Henninger, Senior Life Sciences Executive, Intralinks
Biopharma Deal Making: Lessons Learnt from Cass Business School’s Study of Strategic Deals and Corporate Portfolio Management Nov 15, 2016

LifeSciences -  Viewers will learn about best practices for personalized neoantigen vaccine development
Speakers: Erin Newburn, MS, PhD, Manager, Field Application Scientist, Personalis, Inc.
Christelle Johnson, MS, PhD, Field Application Scientist, Personalis, Inc.
Shifting the Cancer Vaccine Paradigm: NGS Best Practices for Developing Personalized Neoantigen Vaccines Nov 15, 2016

LifeSciences -  This webinar will privide a wide-ranging examination of strategies that can help ensure a successful trial
Speakers: Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier Research
Carol M. Gaines, M.D., Senior Medical Director, Premier Research
Todd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research
Neurodegenerative Disease Research: Steps to a Successful Clinical Trial Nov 15, 2016

LifeSciences - In this webinar, the speakers will share recent data and discuss recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient’s voice in cancer care
David Thompson, PhD, Senior Vice President, Real-World Evidence, inVentiv Health
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health
Heather Gartman, Managing Director, Patient Engagement Practice Lead, inVentiv Health
Kelly E. White, Director, Managed Markets Research, inVentiv Health
Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes Nov 10, 2016

LifeSciences - This webinar will discuss the collection of E/L data that are useful and relevant to risk assessment
Kevin Connor, Ph.D., DABT,, Study Director, Toxikon Corporation
Toxicological Risk Assessment Based on Extractable/Leachable (E/L) Data: Benefits and Limitations Nov 9, 2016

LifeSciences - The speaker will discuss how iQue Screener can maximize the chances of finding therapeutic leads by screening more clones in a shorter time, while using less reagents
Andrea Gorlani, Scientist, ModiQuest Research
Thomas Duensing, Chief Technology Officer, IntelliCyt Corporation
A High Throughput Multiparametric Approach to Identifying Biologically Relevant Target Antibodies Nov 7, 2016

LifeSciences - Learn how clinical supplies professionals are working behind the scenes to bring these complex devices through clinical development
Speakers: Shawn Regits, Process Engineering Manager, Fisher Clinical Services
Guido Hunkeler, Director Engineering & Automation, Fisher Clinical Services
Key Tips to Sharpen Your Clinical Trial Packaging Strategy for Prefilled Syringes Nov 3, 2016

LifeSciences - The presenters will discuss how pharmacogenetics can be integrated in clinical trials.
Lynn R. Webster, M.D., F.A.C.P.M., F.A.S.A.M., Vice President of Scientific Affairs, PRA Health Sciences
Michael Marschler, MS, Director of Safety and Risk Management PRA Health Sciences
Pharmacogenetics in Pain Management and the Use of Pharmacogenomics Methodologies in the Pharmacovigilance Evaluation of Medicinal Products Oct 31, 2016

LifeSciences -  Topics include scientific and clinical research insights on the principles of BOLD fMRI and its application as a clinical tool and drug development biomarker, design of an fMRI study, and an overview of the challenges and limitations of performing fMRI evaluation under an Investigational New Drug Application for drug development
Speakers: Maria Laura Blefari, PhD, Biomedical Engineer, WorldCare Clinical
Mykol Larvie, MD, PhD, Physician, Department of Radiology, Director of Molecular Neuroimaging, Massachusetts General Hospital
Functional Brain Imaging Using MRI: An Emerging Tool for Drug Development and Clinical Trials Oct 28, 2016

LifeSciences -  This webinar will showcase the results of Comprehend’s 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship
Speakers: Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert
Matt McKinney, Clinical Intelligence Expert, Comprehend Systems
ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight Oct 27, 2016

LifeSciences - Pharmaceutical and life sciences companies are under constant pressure to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance. In this webinar, Esko will present 6 examples of what good looks like in the world of pharma packaging and labeling management.
Speaker: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
Packaging and Labeling Management Best Practices in Pharma Oct 27, 2016

LifeSciences -  Data visualization and analytics is only the beginning of a holistic RBM program. The speaker will show how PerkinElmer puts the principles of actionable and adaptive RBM to work in an enhanced RBM offering.
Speaker: George H. Johnson IV, SCPM, Senior Consultant Clinical, Services Lead for Risk Based Monitoring and Data Provisioning, PerkinElmer Informatics
Actionable & Adaptive RBM: PerkinElmer’s Comprehensive Approach to Risk-Based Monitoring Oct 26, 2016

LifeSciences -  This webinar will assist medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation
Speaker: Michael Brady, MS, PhD , Director of Microbiology Services, Toxikon Corporation
Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations Oct 26, 2016

LifeSciences - This webinar discusses developing a methodology and minimum standards for migrating instruments that would be applicable to any device
Speakers: Dr. Wilhelm Muehlhausen, Head of Innovation, ICON
Kai Langel, Director Patient Solutions, eClinicalHealth
Helen Marson-Smith, Outcomes Researcher, Clinical Outcomes Assessment, ICON
Bring Your Own Device (BYOD) eCOA – Instrument Validation Methodology Oct 26, 2016

LifeSciences - This webinar will examine transformative applications in observational studies and pragmatic clinical trials
Speakers: Jim Carroll, Vice President, Real World Evidence, ICON
Rob Sambrook, Divisional Principal, Epidemiology, ICON
Meeting Evidentiary Needs with Electronic Health Records Oct 25, 2016

LifeSciences -  The webinar includes case studies and discussion of the advantages of continuous processing in general, shortcomings associated with the current batch manufacturing processes and limitations observed in continuous processors today
Speakers: Dr. Babu Padmanabhan, Managing Director and Chief Knowledge Officer, STEERLife
Mr. Indu Bhushan, Chief Technical Officer, STEERLife
Novel Continuous Activated Granulation Oct 21, 2016

LifeSciences -  This webinar will discuss recent technological advances that have illuminated promising new approaches for immunogen design, vaccine delivery and vaccination
Speaker: Christos J. Petropoulos, PhD, Chief Scientific Officer, Monogram Biosciences, and Vice President, LabCorp
Leveraging Technological Advances to Overcome the Challenges of HIV Vaccine Development Oct 20, 2016

LifeSciences -  In this presentation, the speakers will discuss key findings of a customer use case that involved an SSI impact assessment for a chemical and protein substance according to the latest ISO Implementation Guideline (March 2016)
Speakers: Louise Petersen, Senior Consultant and ISO IDMP SME, NNIT
Jacob Ekstrøm, Advanced Business Consultant, Life Sciences Industry, NNIT
Will Your CMC Data be IDMP e-Submission Ready by 2018?
How to Bring Structure to Substance Information by Leveraging ISO 11238 Compliance with NNIT Substance Registration System
Oct 19, 2016

LifeSciences - Colorectal Cancer (CRC) is a heterogeneous disease, with variable molecular pathogenesis, natural history and response to treatments. Therefore it is important to exploit all available molecular information to enable personalized management of the disease.
Speaker: Enzo Medico, MD, PhD, Associate Professor, University of Torino, School of Medicine, Candiolo Cancer Institute
RNA-Seq in Colorectal Cancer Defines Neoplastic and Stromal Features Impacting Future Treatments Oct 19, 2015

LifeSciences - Comprehensive analysis of target expression and key proteins of cancer pathways as well as their modifications (e.g., phosphorylation) can provide a much more detailed (and more predictive) picture of the individual tumor biology.
Speaker: Prof. Dr. med. Hartmut Juhl, Founder and CEO, Indivumed GmbH and IndivuTest GmbH (Hamburg)
Tissue Collection Standards Determine the Future of Precision Medicine Oct 18, 2016

LifeSciences - This webinar will discuss the market access and reimbursement challenges around cell and gene therapies
Speaker: David Pruce, Principal, Pricing & Market Access, ICON
Market Access Hurdles for Cell and Gene Therapies: Managing Evidence to Enhance Market Adoption Oct 14, 2016

LifeSciences - Hear from industry experts how to implement an automated process for EDC to PV via E2B
Speakers: Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc.
Dr. Marc Zittartz, Chief Quality Officer, pharmasol
What You Need to Know About Electronic Data Capture, Serious Adverse Events, E2B and Pharmacovigilance Systems Oct 13, 2016

LifeSciences - In response to changes in the pharmaceutical market, CMOs and CDMOs must provide new service models that accelerate drug development times for drugs made for smaller patient populations. This webinar will describe a service model that integrates new technologies for aseptic fill-finish with upstream and downstream support services.
Speakers: Brent Lieffers, Senior Director of Operations, Singota Solutions
John Harmer, Director of Sales, Vanrx Pharmasystems
Re-thinking Aseptic Filling - Innovations for Pharma’s Challenging Requirements Oct 5, 2016

LifeSciences - This webinar will help organizations evaluate how their structure and processes will be affected with the pending adoption of revisions the ICH Guideline for Good Clinical Practice (E6 R2) that primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting
Speaker: Kristin Mauri, MBA, Senior Director, Global Consulting, eHealth Solutions, Bioclinica
What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management? Oct 5, 2016

LifeSciences -  This webinar will address the spectrum of immunotherapy development considerations and their implications for drug developers
Speaker: Steven M. Anderson, PhD, Senior Vice President, Chief Scientific Officer, Covance
The Role of Biomarkers and Companion / Complementary Diagnostics in Immuno-Oncology Trials Oct 5, 2016

LifeSciences - This webinar will present a streamlined enrichment method based on Molecular Inversion Probes and will elaborate on how its fast workflow and other refinements can simplify the variant discovery and validation process
Speaker: Michael Brockman, PhD, Manager of Research Informatics, Roche Sequencing
Rapid and Accurate Variant Detection with the HEAT-Seq Target Enrichment System, a New Method Using Advanced Molecular Inversion Probes Sep 30, 2016

LifeSciences - This webinar will explore the critical role and impact of RWE on product life-cycle management from concept through post-launch
Speakers: Dr. Mike Eaddy, PharmD, PhD, Vice President, Real-World Evidence Generation, Xcenda
Patricia Wolfangel, Vice President, Market Access Consulting & Communications, Xcenda
Real World Evidence: What Does It Mean for Your Commercialization Plans? Sep 29, 2016

LifeSciences - Overcoming the challenges in the NAFLD/NASH race to the market will not only benefit the pharmaceutical and biotech industry to bring new therapies to market, but will ensure that the millions of NAFLD/NASH patients are treated or cured of this chronic liver disease
Speakers: Sabina Paglialunga, PhD, Metabolic and Pharmacodynamic Specialist, Celerion
Rafiq Islam, MS, Senior Director, Bioanalytical Services, Celerion
NAFLD/NASH – Race to the Market: Strategies and Tactics to Address Unmet Needs Sep 28, 2016

LifeSciences - The speaker will review the application was first evaluated in GlaxoSmithKline’s DMPK bioanalytical labs, and discuss current studies and evaluations looking at establishing best practice recommendations for the collection and freezing of pre-clinical and clinical samples, to ensure the best possible uniformity of analyte distribution for frozen aliquotting.
Speaker: Glenn Smith, Independent Scientific Consultant for CryoXtract, and Former Section Manager of the DMPK bioanalytical labs at GlaxoSmithKline Inc. in Research Triangle Park, NC
Automated Frozen Sample Aliquotting: Improving Bioanalytical Assay Results for Labile Molecules Sep 27, 2016

LifeSciences -  The speaker will present Taconic’s experience in using CRISPR/Cas9 to edit the mouse genome and how the use of this technology has changed the way mouse models are being generated
Speaker: Jochen Welcker, PhD, Director of Molecular Biology and Scientific Development, Taconic Biosciences
The Evolution of CRISPR/Cas9 in Mouse Model Generation: From Constitutive Gene Knock-out to Full Gene Replacement Sep 22, 2016

LifeSciences - The webinar will examine factors that produce a therapeutic effect which erodes the efficacy signal of a potential treatment, with particular focus on study design considerations, site factors, subject selection and eligibility, and data surveillance
Speakers: Krista Armstrong, PhD, Vice President, Strategic Development, Premier Research
Susan Kozauer, MD, Senior Medical Director, Psychiatry, Premier Research
Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinical Trials Sep 20, 2016

LifeSciences - Join a panel of experts from Zenith Technologies and SEA Vision, plus guest speaker Terry Crawford, Serialization Technical Manager at GSK, as they discuss the pharmaceutical latest track and trace regulations and timelines. A current case study will be included. Overcoming the Challenges of Implementing Serialization Across a Diverse Pharmaceutical Manufacturing Environment Sep 20, 2016

LifeSciences - The speaker will takes us along a journey with lessons learnt from both an organizational and personal perspective
Speaker: Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance, Acerta (a majority owned company of AstraZeneca)
Drug Safety in a Startup Biotech Sep 15, 2016

LifeSciences - This webinar reviews the history of patient advocacy groups in advancing clinical research and examines the evolution of their role in light of recent and pending legislative and regulatory changes in the United States and European Union
Speakers: Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Susan Stein, MPH, CEO & President, Connexion Healthcare, and Board Member, Global Genes
The Powerful and Evolving Role of Patient Advocacy Groups in Orphan Drug Development Sep 14, 2016

LifeSciences - The webinar, will focus on specific pharmaceutical case study examples that illustrate how to drive innovation through an enhanced data strategy
Speakers: Lisa J. Graham, Ph.D., P.E., CEO and Founder, Alkemy Innovation Inc.
Brian Crandall, Analytics Engineer, Seeq
Pharmaceutical Case Studies that Illustrate a Data Strategy for Developing Better Medicines Sep 13, 2016

LifeSciences - This session details best practices for onboarding RBM that have been gained through implementation involving smaller and larger BioPharma sponsors and CROs
Speakers: Francois Torche, Chief Executive Officer, CluePoints
Craig Serra, Senior Director, Data Management BPO, Clinical Sciences and Operations, Pfizer
Removing the “Risk” in Risk-Based Monitoring
What We Have Learnt in the Last 4 Years from the Practical Implementation of RBM
Sep 12, 2016

LifeSciences -  The panel of speakers from Almac will utilise their experience to guide attendees through the EU orphan drug launch process, from submitting Marketing Application (MA) to final distribution of drug product to the end-user
Speakers: David McCoubrey, Senior Regulatory Affairs Scientist / Orla Hartnett, Qualified Person / Michael Rooney, Senior Business Support Manager / Emma Jordan, Distribution Manager
Key Considerations for a Successful EU Orphan Drug Launch Sep 8, 2016

LifeSciences -  The webinar will demonstrate and explain how a joint, consultative approach to drug development developed by Juniper Pharma Services and XenoGesis can help pharma companies take their compound through to clinic in a seamless, rapid and cost-effective way
Speakers: Robert Harris, PhD, CChem, FRSC, Chief Technical Officer, Juniper Pharma Services
Richard Weaver PhD, FRSC, Founder and Managing Director, XenoGesis
An Integrated Bio-Pharmaceutics Approach for Effective Drug Development Sep 8, 2016

- 李振亚 博士, CST中国及亚太区学术经理
- 裴华东 教授, 研究员、博士生导师 DNA损伤应答研究课题组组长, 中国国家蛋白科学研究中心
利用前沿蛋白质组技术,解读肿瘤发生关键信号通路及进行新分子靶标鉴定 Aug 31, 2016

LifeSciences -  The presentation will include a brief history of the microbiome in research, a discussion of health standards and host interaction with the gut flora, care and use of gnotobiotic and germ-free models and a review of current studies involving the microbiome
Speaker: Jennifer Phelan, Product Manager, Taconic Biosciences
Intro to the Microbiome Aug 25, 2016

LifeSciences -  The speakers will discuss the growing range of imaging modalities and analysis methods that are available for use in your clinical trials during oncology drug development
Speakers: Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research (Cardiocore & VirtualScopics)
Edward Ashton, Ph.D, Vice President, Oncology Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Advanced Imaging in Oncology Aug 24, 2016

LifeSciences -  Flexible multiplex testing platforms can provide both targeted and broad respiratory testing
Marilyn Mitchell, MT(ASCP)MS, Supervisor, Microbiology Laboratory, Community Regional Medical Center
Robin Chamberland, Ph.D., Assistant Professor, Department of Pathology, Director of Microbiology Laboratory, Medical Director of Molecular Microbiology, Saint Louis University Hospital
Flexible Testing for Respiratory Pathogens: Cost-Effectiveness and Impact on Clinician Ordering Patterns Aug 23, 2016

LifeSciences - Learn how Quintiles uses TrialOne® to eliminate unnecessary duplication of data, reduce the opportunity for transcription errors, promote real-time entry of electronic source data during subject visits and ensure the accuracy and completeness of data
Speakers: Roman Laddach, Director of Early Phase Consulting, OmniComm Systems, Inc.
Sara Rothermich, Clinical Lead Manager, Quintiles
Early Phase Clinic’s Real World Experience with Clinic Automation Aug 18, 2016

LifeSciences -  Topics include how a modern application platform can deliver automation, control, data accuracy and on-demand operational transparency in critical initial trial phases
Speakers: Michael Calluori, Sr. Business Analyst BPM, Sanofi
Pramod Sachdeva, Managing Director and Founder, Princeton Blue
Evi Cohen, Global Practice Leader, Life Sciences, Appian
Avoid Patent Eclipse – Accelerate Your Study Start Up and Tracking Aug 17, 2016

LifeSciences - In this webinar, the speaker will discuss upcoming changes in global drug safety regulatory requirements and will demonstrate how Bioclinica's drug safety regulatory intelligence tool, RITrace, can improve efficiencies and help you remain compliant
Speaker: Nicole Baker, EEA QPPV, Director Drug Safety, Bioclinica, Inc.
Using the Cloud to Meet Pharmacovigilance Requirements and Maintain Global Compliance Aug 10, 2016

LifeSciences -  Join the webinar to learn more about the consequences of poor forecasting, the difficulties of reforecasting with manual systems, the complexities that make forecasting so challenging, and how technology that is purpose-built for clinical trials can help CROs and Sponsors forecast more effectively and accurately
Speakers: Jay Trepanier, Senior VP and General Manager, Bioclinica Financial Lifecycle Solutions
James Sacchetta, Manager, Technical Operations, Premier Research
Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines Aug 3, 2016

LifeSciences - In this webinar, the speakers will discuss in detail the digital health market and the tremendous positive impact it can have for clinical research right now and in the coming years
Speakers: Ken Light, EVP of Transformation and Professional Services, OmniComm Systems
Jennifer Plumer, Pharma/CRO Lead, Validic
Digital Health and the Emerging Vital Role of EDC Jul 28, 2016

LifeSciences - This session will focus on the keys to finding a good sponsor/CRO match for your clinical research
Speakers: Cassie Jacobson, Clinical Research Strategy Director, 3M, Critical & Chronic Care Solutions Division
Katie Schaaf, Director, Strategic Partnerships, NAMSA
Ensuring a Successful Collaboration between Sponsors and CROs Jul 27, 2016

LifeSciences -  This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process
Speakers: Adelina Lear, BA, Strategic Account Executive, ICON Language Services
Diane Wild, MSc, Consultant
Linguistic Validation – When Google Translate Just Isn’t Enough Jul 26, 2016

LifeSciences - End-to-end safety solutions need to encompass the required service, product and technology components in order to stand up to the challenges
Speaker: Francois Audibert, Vice President, Global Consulting Practice, Bioclinica, Inc.
Finding the Right End-to-End Safety Solution for Your Needs Jul 21, 2016

LifeSciences -  Viewers will learn about the PACC component tests, challenges to implementation and possible solutions, plus possible alternative component measures
Speakers: Paul Maruff, Chief Science Officer, Cogstate
Edward Bartolic, Senior Science Director, Cogstate
The Preclinical Alzheimer Cognitive Composite (PACC): From Theory to Practical Application in Global Clinical Trials Jul 20, 2016

LifeSciences -  In this webinar, te speakers will discuss examples of identified data quality concerns coming from CNS clinical trials and the impact of their presence on study outcomes
Speakers: Alan Kott, MUDr, Clinical Vice President and Practice Lead, Data Analytics, Bracket
David G. Daniel, MD, Senior Vice President and Chief Medical Officer, Bracket, and Professor of Psychiatry, George Washington University
Disruptive Innovations in Data Analytics in CNS Clinical Trials Jul 20, 2016

LifeSciences - Histological phenotypes generally play an essential role in diagnostics, but in particular in oncology there is a growing need for selecting the right patients for the right treatments based on information derived from tissue slides
Speakers: Dr. Ralf Huss, Chief Medical Officer, Definiens AG
Alan Jerusalmi, PhD, Global Head of Professional Services, Definiens Inc.
Integrated Tissue Phenomics® and Big Data for Biomarker Discovery and Test Development Jul 19, 2016

LifeSciences - In this webinar, the presenter will show how pharmaceutical packaging and labelling complexity occurs, what the consequences are of inaction, most importantly, what pharmaceutical companies can do to reduce and manage the process
Speaker: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
How to Manage Pharma Packaging Complexity Jul 19, 2016

LifeSciences - While post-approval research is evolving rapidly, and these studies are becoming far more complex, our knowledge in implementing and conducting such studies has not evolved with the same pace
Speaker: Kirsten Colling, Senior Director Global Operations, Bioclinica Post-Approval Research
Conducting Post-Approval Research Requires a Unique Mindset and Specialized Infrastructure. Do You Have What it Takes? Jul 14, 2016

LifeSciencesPart 1: Robust Assay Development for Multiplex qPCR and SNP Genotyping in Miniaturized Volumes on a High-Throughput Instrument, Presented by Luke Linz, Ph.D. Laboratory Operations Manager, LGC Douglas Scientific
Part 2: Digital PCR as a Tool to Support the Molecular Diagnosis of Infectious Diseases, Presented by Jim Huggett, Ph.D. Principal Scientist, Nucleic Acid Research, LGC, and Senior Lecturer, Analytical Microbiology, University of Surrey
Pushing the Limits of PCR: Considerations for Assay Development in High-Throughput qPCR and Digital PCR Platforms Jul 13, 2016

LifeSciences - During this webinar, the speakers will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan
Speakers: Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical
Ofir Moreno, Vice President of R&D, MEI Pharma, Inc.
First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines Jul 12, 2016

LifeSciences - While this webinar will focus primarily on important laboratory issues when developing clinical trials involving multiple myeloma, many of the issues to be discussed are also relevant to the other plasma cell dyscrasias
Speakers: Marc Golightly, PhD, SI (ASCP), Professor of Pathology, Stony Brook University, and Consultant, ICON Laboratory Services
Domenica Gandini, MD PhD, Medical Director, ICON Clinical Research
Learn about Laboratory Considerations when Developing Multiple Myeloma Trials Jun 30, 2016

LifeSciences - This webinar will present various aspects of hemocompatibility testing: selection of tests, identification of what devices need to be tested and what part of the device needs testing
Speaker: Franck Grall, PharmD, PhD, Department head, In Vitro Services, Toxikon Corporation
Hemocompatibility: Preclinical Biological Evaluation of Medical Devices for Interaction with Blood June 29, 2016

LifeSciences - Immuno-oncology and transplantation medicine share the medical need for robust, immune cell-based biomarkers extracted from tissue biopsies. In an interdisciplinary approach, the Tissue Phenomics® methodology is applied to mine clinically annotated image data.
Speakers: Prof. Dr. med. Friedrich Feuerhake, Consultant in Neuropathology and Head of Digital Pathology Group, Hanover Medical School, Germany
Dr. Ralf Schönmeyer, Senior Research Scientist, Definiens AG
Tissue Phenomics® at Work for Immuno-Oncology and Transplantation Medicine Jun 27, 2016

LifeSciences - This webinar will introduce the concept of diet-induced obesity models, including preferred mouse strains as well as resistant strains and compare to other models of diabetes and metabolic syndrome
Speaker: Jennifer Phelan, Product Manager, Taconic Biosciences
DIO 101: Diet-induced Obesity in Mice Jun 23, 2016

LifeSciences - In this webinar Bachem's amyloid peptides, inhibitors and labelled secretase substrates that are widely used in the research of Alzheimer’s disease will be presented
Violeta Jordan, Global Director of Product Management, Bachem
Peptides in Alzheimer's Research Jun 22, 2016

LifeSciences - In Using a case study approach, webinar participants will learn more about developing Observer-Reported Outcomes Measures and implementing them in clinical studies
Speakers: Beverly Romero, MA, Senior Outcomes Researcher, ICON Clinical Outcomes Assessment
Emuella Flood, Senior Principal, ICON Clinical Outcomes Assessment
Developing an Observer-Reported Outcomes Measure (ObsRO): Best Practices, Challenges, and Solutions Jun 22, 2016

LifeSciences - Topics include a review of the benefits and considerations related to pursuing accelerated approval, advice on how to access the applicable expedited program, and effectively interact with the Agency, following the regulatory pathway most expeditiously
Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health
Carolyn Finkle, MSc, Senior Vice President, Regulatory Affairs, inVentiv Health
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health
Pursuing Accelerated Approval in Oncology Indications: Is your Asset the Right Candidate? Jun 16, 2016

LifeSciences - This webinar will guide you through BioTelemetry Research’s exclusive offering, EvriBeat, an advanced method for assessing cardiac safety in early human trials
Speaker: Daniel B. Goodman, MD, Vice President and Medical Director, BioTelemetry Research
EvriBeat – Dynamic Electrocardiography Jun 15, 2016

LifeSciences - This webinar will provide an overview of the screening process from assay development through to the final data package by exploring examples of successful high throughput screening programs conducted at Charles River Laboratories
Speakers: David Cronk, CBiol, MSB, Director, Hit Discovery, Charles River Laboratories, Early Discovery, Chesterford Research Park, Saffron Walden, UK
Victoria Wong, PhD, Senior Principal Scientist, Pfizer
High Throughput Screening: An Insider’s Guide to Outsourcing Jun 14, 2016

LifeSciences - This webinar is aimed at informing end-users involved in preclinical drug screening (discovery and development) of the models and techniques available to elucidate the causes and consequences of GI toxicities and pathologies
Speaker: Cath Booth, PhD, Co-founder and Managing Director, Contract Research Services, Epistem
Pre-clinical Models of Intestinal Toxicity Jun 10, 2016

LifeSciences - With a real-time healthcare system and the use of RFID-enabled solutions, imagine the possibilities that exist when all assets in your healthcare facility are connected
Speakers: Mark Van Sumeren, Managing Director, Health Industry Advisor, LLC
Joe Pleshek, CEO & President, Terso Solutions, Inc.
Improving the Operations and Delivery of Care through the Real-time Healthcare System Jun 9, 2016

LifeSciences - Join us for this webinar to learn how to deal with the above mentioned challenges in R&D procurement and employ a strategic buying approach
Speakers: Gurdeep S. Rooprai, Global Client Partner, Life Sciences Practice, Infosys Limited
Shubham Tripathi, Client Parter (Americas) - Source to Pay, EdgeVerve Systems (Infosys Limited)
Reduce R&D Costs by Simplifying Procurement: Enhance Efficiency, Increase Compliance and Save Costs Jun 8, 2016

LifeSciences - Understanding existing resources, financial aid, and incentives is important for any orphan product developer. This webinar will describe support offerings available through global regulatory agencies and examine pending initiatives affecting orphan drug clinical development.
Speakers: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research<
No Opportunity Unturned: Optimizing Orphan Drug Development June 1, 2016

LifeSciences - This case study details how one successful Clinical Operations team automated their next generation risk and centralized monitoring program
Speakers: Ken Wu, ClinOps Consultant and Expert
Matt McKinney, Continuous Quality Solution Expert, Comprehend Systems
How One Clinical Operations Team Returned 100% of Studies to Within Risk Threshold: A Next Generation Monitoring Case Study May 26, 2016

LifeSciences - The presenters will share guidance as provided in the AMCP Format in regard to special content considerations as well as logistical considerations with regard to AMCP dossiers
Speakers: Evelyn Sarnes, PharmD, MPH, Senior Director Medical Communications, Xcenda
Kim Boswell, MD, Director, Medical Communications, Xcenda
Academy of Managed Care Pharmacy (AMCP) Format Update, Version 4.0: Practical Implications for AMCP Dossiers May 26, 2016

LifeSciences - Learn about what you need to know to make the best decisions for your clinic and intended parents when planning an operational strategy for both storage and shipping of reproductive materials, domestically and internationally
Speakers: Tamie Joeckel, Senior Vice President of Client Services, Cryoport
Shannon Curiel, Director of Sales, Reproductive Medicine, Cryoport
Optimize Your IVF Clinic Operations: Facilitating Growth Through Cold Chain Management May 25, 2016

LifeSciences - This webinar, featuring a panel of experts from LZ Lifescience and FDA consultant Robert Lewis of IHL Consulting, aims to help life science companies reduce the risk of getting 483 observations and warning letters in 2016 and beyond Mitigate the Risk of Receiving FDA 483 Observations, Leading to Warning Letters – Your Guide to a Preventative Approach May 24 2016

LifeSciences - The webinar aims to help sponsors conducting oncology trials in Asia navigate the maze of trial logistics, local regulatory requirements and cultural differences to ensure success
Speakers: Dr. John Moller, Chief Operating Officer - Asia, Novotech
Andrea Jeffrey, Senior Project Manager, Novotech
Chin Wee Tan, Clinical Operations Manager - Singapore, Novotech
Navigating Oncology Trials in Asia: How a Regional CRO can Deliver on a Global Project May 19, 2016

LifeSciences - This webinar will examine how investigating biologic effects of combination treatments can be conducted with an in vitro phenotypic profiling platform, using rheumatoid arthritis combination treatments as an example
Speaker: Ernest Choy, MD, FRCP, Head of Rheumatology, Section of Rheumatology, Institute of Infection and Immunity, Cardiff University, Cardiff, United Kingdom
System Investigation of Biologic Effects of Rheumatoid Arthritis Treatments using Phenotypic Profiling May 18, 2016

LifeSciences - This webinar will showcase studies and metrics from two experts in drug delivery and drug product optimisation, illustrating the applications and benefits for a range of drug formulations
Speakers: John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical
Kieran Crowley, Senior Scientific Director, Quotient Clinical
How to Reduce the Time and Cost for Optimizing Drug Product Formulations with RapidFACT® (Rapid formulation Development And Clinical Testing) May 16, 2016

LifeSciences - Join this webinar and consider the potential of collaborative partnerships between academicians, clinical investigators and contract research organizations in delivering new therapies for patients with diabetic nephropathy
Speakers: George L. Bakris , MD, Hon. DSc, F.A.S.H, F.A.S.N., F.A.H.A., Professor of Medicine, Director, ASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL
Michael D. Cressman, D.O., Senior Medical Director, Covance
Jennifer Ennis, MD, Medical Director, Litholink Corporation, A LabCorp Company
Applying Advanced Informatics to Accelerate Drug Development in Diabetic Nephropathy May 6, 2016

LifeSciences - In this webinar, buyers and users of clinical trial software will learn how to assess current technology options with the goal of streamlining the management of data for clinical trials
Speaker: Patrick Smith, Product Manager, DATATRAK
A Buyer and Users Guide to Clinical Trial Software May 5, 2016

LifeSciences - This webinar explores challenges smaller companies should consider when embarking on immunotherapy studies
Speakers: Andrew Zupnick, Ph.D., Vice President, Oncology Strategy, Novella Clinical
Julia Lawrence, D.O., Senior Medical Director, Novella Clinical
Mastering Oncology Immunotherapy Clinical Trials: The Smaller Biopharmaceutical Perspective May 5, 2016

LifeSciences - Understanding and mastering the FDA's Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling is the first step in getting new, reusable devices into the US marketplace
Speaker: Steven Elliott, Director, Quality Control and Sterility Assurance, NAMSA
Reusable Medical Devices – Getting Market Clearance in the United States May 4, 2016

LifeSciences - The presentation includes a discussion of known or suspected mechanisms that mediate protection elicited by very different licensed vaccines: MMRV (anti-Measles, -Mumps, -Rubella and -Varicella), Pertussis (anti-whooping cough), and the recently introduced anti-serogroup B meningococcal vaccines
Speaker: Rolando Pajon, PhD , Vaccine Validation Scientist, Vaccine and Novel Immunotherapeutic Laboratory Solutions, Covance
Immunological Mechanisms of Vaccine-elicited Protection: Licensed Vaccines Apr 28, 2016

LifeSciences - The speakers will discuss how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape
Speakers: Pradeep Nathan, MA, PhD, MRACI, CChem, FCP, Vice President Neuroscience Scientific Strategy Lead and Head, Neuroscience Center of Innovation, inVentiv Health
Kenton H. Zavitz, PhD, Director of Clinical Affairs , Cambridge Cognition, Ltd.
Assessing Cognitive Safety of Drugs in Clinical Development Apr 28, 2016

LifeSciences - This webinar looks to highlight some of the major challenges of PV in early phase clinical trials and what can be done to overcome them
Speaker: Tom Nichols, Senior Director, Pharmacovigilance, Quanticate
The Challenges of Pharmacovigilance in Early Phase Clinical Trials

Apr 27, 2016

LifeSciences - This webinar will help viewers understand better the industry’s current inspection challenges and for a demo of a pioneering fully integrated label management software solution with a print inspection hardware
Speakers: Warren Stacey, SVP of Sales, PRISYM ID
Phil Dray, Senior Test and Validation Engineer, PRISYM ID
Craig Jones, VP Enterprise Sales Engineering, PRISYM ID
Medical Device Labels: Using Integrated Vision to Achieve 100% FDA Compliance Apr 6, 2016

LifeSciences - There are two major categories of safety monitoring: “Clinical” which refers to safety monitoring of clinical trials and “Post-marketing”, safety monitoring of situations following approval and marketing, other than directly associated with clinical trials
Speaker: Margaret McCulloch, M.D. , Medical Doctor, Ashfield Pharmacovigilance
The Differences Between Clinical and Post Market Medical Reviews Mar 30, 2016

LifeSciences - This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions adopted by various authors and research consortia on how to best design and conduct these trials, including a review of pending legislation — the 21st Century Cures Act — and how it might affect rare oncology research if passed
Speakers: Sachin Kulkarni, Executive Director, Strategic Development, Oncology & General Medicine, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Rare Oncology Research in the 21st Century Mar 29, 2016

LifeSciences - This webinar will focus on what’s known about the proposed Medicare Part B drug payment model and what the implications are for pharmaceutical manufacturers
Speakers: Amanda Forys, MSPH, Director, Reimbursement Policy Insights, Xcenda
Jennifer Snow, MPH, Director of Health Policy, Xcenda
Part B Drug Payment Change: Understanding the Implications for Pharma Mar 28, 2016

LifeSciences - To seek explanation for the variability of opioid response is one of many important facets in easing the burden of chronic pain upon our society, as is understanding the heritability of pain
Speaker: Dr. Lynn Webster, MD, Vice President, Scientific Affairs, PRA Health Sciences, and Past President, American Academy of Pain Medicine
Personalized Medicine: Genetic Testing for Predicting Opioid Response Mar 22, 2016

LifeSciences - This presentation will focus on spray drying process development and will cover spray-drying equipment and scale-up of from the bench to pilot scale
Speaker: Jon Scrafford, Manager, Process Engineering, Pharmatek
Spray Dried Dispersion Process Development Mar, 10, 2016

LifeSciences - Topics include data driven formulation development and spray dried dispersions formulation development for early phase clinical studies
Speakers: Bryan Knox, Senior Director of Pharmaceutics, Pharmatek
Nathan Barksdale, Senior Scientist, Pharmatek
Product Development Strategies for Poorly Soluble Compounds Mar 3, 2016

LifeSciences - The speaker will examine the requirements listed in MEDDEV 2.7.1 rev. 3 while focusing on the global benefits of the Clinical Evaluation report for an individual's product’s path to market
Speaker: Sandra Welch, Director of Clinical Research Services, NAMSA
The Global Value for Clinical Evaluation Reports in Medical Device Studies Feb 29, 2016

LifeSciences - This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process
Speakers: Paul Hallenbeck, Executive Director, Drug Development Strategy, Oncology, Premier Research
Luke Gill, Executive Director Clinical Development Planning, Premier Research
Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials Feb 24, 2016

LifeSciences - The speakers will discuss the best practices for justification, validation, and implementation of the Verigene Respiratory Pathogens Flex Test, Verigene Gram-Positive and Gram-Negative Blood Culture Tests, and Verigene Enteric Pathogens Test.
Kevin McNabb, Ph.D., MT(ASCP), Director of Microbiology, Immunology and Molecular Testing, Department of Pathology and Laboratory Services, New Hanover Regional Medical Center
Susan Sable, MT (ASCP), Manager, Microbiology and Molecular Department, Meridian Health at Jersey Shore University Medical Center
Kevin Alby, Ph.D., Assistant Professor of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania
Justification, Validation, and Implementation: Best Practices for Multiplex Molecular Infectious Disease Tests Feb 24, 2016

LifeSciences - Effective miRNA profiling calls for reproducible, sensitive and specific tools with turn-around times fast enough to support investigations into what can be a rapidly changing disease progression and treatment environment
Speaker: Simon Baker PhD, Global R&D Director, Bioline Reagents Ltd
MicroRNA Profiling Using a Rapid and Highly Sensitive qPCR Feb 18, 2016

LifeSciences - The speakers will discuss examples, implementation, features and benefits of an integrated approach to reduce recalls from pharmaceutical packaging errors
Speakers: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
Arpad Lehoczki, Senior Account Executive, Global Vision
Minimize the Risk of Recalls - The Cost of Poor Pharmaceutical Packaging Management Feb 18, 2016

LifeSciences - This webinar will review the principles, opportunities, complexities, and risks of data sharing, and discuss future perspectives, including full access to all data, including biomarker and –omic data, access to analysis code for reproducible research, involvement of principal investigators in the research process, and access to data from academic trials
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Frank Rockhold, PhD, Senior Vice President, Safety and Pharmacovigilance, GlaxoSmithKline
Patient-Level Data Sharing in Clinical Research Feb 16, 2016

LifeSciences - This webinar will outline some of the 2015 Avoca Quality Consortium research around sponsor and CRO perceptions of quality in protocol design, effectiveness in identifying concerns from the patient perspective, and share some key factors identified that impede quality in protocols
Speakers: Jennifer Byrne, CEO, PMG Research, Inc.
JoAnn Muir, Head of Clinical QA Vendor Oversight, Novartis Pharmaceutical
Kenneth Getz, Director and Associate Professor, Tufts CSDD
Tomasz Sablinski, M.D., Ph.D., Founder, Transparency Life Sciences
Jeremy Gilbert, VP, Life Science Ventures, Patients Like Me
Moderator: Denise Calaprice-Whitty, Ph.D., Senior Consultant, The Avoca Group, Inc.
Protocol Quality: Challenges and Opportunities for Patient Centricity in Protocol Design and Execution Feb 11, 2016

LifeSciences - This webinar discusses Data Sciences Analytics and the new Analytics Paradigm from an overall industry perspective along with a discussion of the MaxisIT Common Services Analytics Framework and Data Sciences Analytics Workbench functionality and how the it is used to oversee the presentation and availability of data that will support and drive Data Sciences initiatives across the Health Care & Life Sciences industries, including Predictive Analytics
Speakers: Patrick Zbyszewski, Executive Director of Project and Data Management, Onconova Therapeutics
Vipul Kashyap, Ph.D., Head, Product Strategy and Management, MaxisIT
Data Sciences – The New Analytics Paradigm Feb 10, 2016

LifeSciences - A ClinOps team goes beyond simple CRA monitoring by implementing new generation Portfolio Monitoring to increase speed, lower study cost and risk. Their solution: A single system with powerful data aggregation, monitoring, collaboration and analytic capabilities to actively manage enrollment funnels, patient compliance, and site productivity across systems and studies.
Speakers: Ken Wu, former Clinical Operations Executive at Scios
Jud Gardner, CTO and Co-Founder, Comprehend Systems
Next Generation Centralized and Risk Monitoring Jan 28, 2016

LifeSciences - This presentation will discuss the three sins and provide absolution methods on how to be a successful GMP Executive
Speaker: Troy Fugate, Vice President, Compliance Insight, Inc.
The Three Sins of GMP Executives Jan 27, 2016

LifeSciences - Dr. Murphy will discuss the findings from a recent evaluation made by Charles River Laboratories regarding the responsiveness of several syngeneic murine tumor models to antibody-based, immune checkpoint inhibitor therapeutics targeting CTLA-4 and PD-1, and detail the benefits of a multidisciplinary approach to cancer immunotherapy efficacy study design and execution
Speaker: Joseph Murphy, Ph.D., Director of R&D, Oncology, Charles River Laboratories
Cancer Immunotherapy: Advancing and Accelerating Discovery Programs Jan 25, 2016

LifeSciences - This webinar will highlight the challenges of emerging and re-emerging infectious diseases such as MTB, HIV, MRSA, and Ebola
Speakers: Stephen Mortlock, DSc, Global Infectious Diseases and Microbiology Liaison, Heston, UK, Q2 Solutions, a Quintiles Quest Joint Venture
Ayaskant Pany, MD, Director, Medical Laboratory, Central Laboratories South Africa, Q2 Solutions, a Quintiles Quest Joint Venture
Sorika van Niekerk, MSc Medical Microbiology, UP, SA, Senior Director / General Manager, Central Laboratories South Africa, Q2 Solutions, a Quintiles Quest Joint Venture
Combating Emerging and Re-emerging Infectious Diseases in Clinical Trials by Harnessing Innovative Technologies Jan 20, 2016

LifeSciences - This webinar will examine the opportunities for improvement introduced by RBM invite evaluation of a new pattern of interaction between clinical development teams and ERBs, and provide recommendations to industry, ERBs and other stakeholders
Speakers: Andy Lawton, Global Head, Biometrics and Data Management, Boehringer Ingelheim Ltd.
Ellen Kelso, Executive Director Strategic Development, Chesapeake IRB
Risk-Based Monitoring and The IRB: Convergence and Opportunities Dec 17, 2015

LifeSciences - Opening sites in countries where clinical trials are uncommon requires detailed knowledge of the host countries and the complex regulations they may impose, along with thorough site training in protocol and good clinical practices
Speakers: Alison Sampson, Senior Project Director, Premier Research
Hanna Wide, MSc, Project Manager, Premier Research
Rare Disease Research: Conducting Clinical Trials Where the Patients Are Dec 15, 2015

LifeSciences - This discussion is built around the most pressing issues affecting the Compounding Pharmacy/ Outsourcing Industry
Speaker: Doyle Smith, Compliance Specialist, Compliance Insight, Inc.
FDA Expectations for 503B Outsourcing Facilities Dec 11, 2015

LifeSciences - This webinar will explore important areas of early preparation in vaccine studies
Speakers: Lynlee Burton, Director of Project Delivery, Vaccines, PRA Health Sciences
Jeff Rosen, Medical Director and Founder, Clinical Research of South Florida (CRSF)
Vaccine Studies – Operationalize before you Finalize Dec 11, 2015

LifeSciences - The webinar will focus on how these frameworks are currently perceived through sharing of comprehensive survey data from oncologists and payers
Speakers: Doug Neely, CMPE, MHA, Senior Director, Xcenda
Lisa Bloudek, PharmD, MS, Assistant Director, Xcenda
Oncology in the Era of Value Frameworks: Perspectives from Payers and Oncologists & Implications for Product Planning Dec 10, 2015

LifeSciences - The purpose of this webinar is to simplify the regulatory submission process, which is a source of difficulty largely unmitigated by available technologies today
Speaker: Patrick Smith, Technical Marketing Writer, DATATRAK
Simplifying the Clinical Trial Regulatory Submission Process Dec 9, 2015

LifeSciences - This webinar will provide a unique insight into human abuse potential studies and their diverse challenges, notably from the perspective of the study subject.
Speakers: Dr. Beatrice Setnik, Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Pierre Geoffroy, Vice President, Early Phase, INC Research
Clinical Challenges in the Abuse Potential Assessment of CNS-Active Drugs: Investigator Perspectives with a Special Commentary from a Study Volunteer Dec 9, 2015

LifeSciences - This webinar will focus on how the HCV RNA polymerase replicates the HCV RNA genome starting with basic biology continuing through Beryllium's structural mechanistic studies with native substrates and nucleotide analog inhibitors such as sofosbuvir
Speaker: Thomas E. Edwards, Vice President of Structural Biology, Beryllium Discovery Corp.
Structural Basis for HCV RNA Replication and Inhibition by Sofosbuvir Dec 8, 2015

LifeSciences - The purpose of this webinar is to share the results of the IQ-CSRC study, discuss what it will take to obtain a waiver for the TQT study and to which extent there is a remaining role for TQT studies
Speaker: Dr. Borje Darpo, Chief Scientific Officer, iCardiac Technologies
Dr. Emanuel DeNoia, Medical Director, ICON Early Phase Services
Learn About FDA Waivers for TQT Studies
How Early Precision QT™ for Cardiac Safety Testing Can Elevate Drug Development and Lower Study Costs
Dec 8, 2015

LifeSciences - The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process
Speakers: Steve Pondell, Vice President of CMC, ESSA Pharmaceuticals
Jennifer Stanek, Director in Global Regulatory Affairs CMC, Takeda
Dan Weissmueller, Director of Quality, Regis Technologies
Success Factors in Your Investigational New Drug (IND) Filing Dec 4, 2015

LifeSciences - This presentation will describe a method for manufacturing glycosylated peptides and proteins via chemical synthesis
Speaker: Michael F. Haller, Ph.D., Board Advisor, GlyTech, Inc.
Chemical Synthesis of Glycosylated Peptides and Proteins Improves Drug Properties Dec 2, 2015

LifeSciences - This webinar will present a bird’s eye view highlighting a Phase I study with mid-level complexities and showcase lessons learned from the speakers' experiences, highlighting how building the database structure utilizing CDASH standards minimizes the gap with SDTM format
Speakers: Jonathan Zimmerman, Senior Clinical Data Manager, FMD K&L Inc.
Yuguang Zhao, MS, Vice President, Statistical Programming, FMD K&L Inc.
Utilizing a Collaborative Approach to Create Efficiencies with CDISC – CDASH Standards Nov 19, 2015

LifeSciences - In adaptive design trials, the importance of careful design, meticulous planning, and rigorous ethical review cannot be overemphasized
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Jennifer Nezzer, Director of Biostatistics, Premier Research
Ethical Considerations in Adaptive Design Clinical Trials Nov 19, 2015

LifeSciences - This webinar will discuss the challenges and the importance of NAb assays and a well thought out immunogenicity strategy in drug development to assess and mitigate risk
Speaker: Paul W. Rhyne, Ph.D., Scientific Director, Q2 Solutions, a Quintiles Quest Joint Venture
Strategies for Effective Neutralizing Cell Based Assays in Early Immunogenicity Risk Assessment Nov 18, 2015

LifeSciences - Industry leaders are now adopting ‘best of breed’ applications in the eClinical stack to speed the development of needed therapies to patients
Speakers: Vittoria Sparacio, Head of Clinical Documentation, GSK Pharmaceuticals
Scott McCulloch, Principal Consultant, SMClinical Limited
Barry Milton, Director of Client Engagement, goBalto
Ready to Start Your Clinical Trial? Think Again. Nov 16, 2015

LifeSciences - This webinar is aimed at improving the end-users’ understanding of pre-clinical in vivo inflammatory bowel disease (IBD) models, addressing issues associated with the various models currently available
Speaker: Dr. James Wilson, Principal Scientist, Epistem
Pre-clinical Inflammatory Bowel Disease (IBD) Models Nov 13, 2015

LifeSciences - Charles River has characterized numerous cell-based and animal models of lung fibrosis. In this webinar, the speakers will describe the pharmacological characterization of these models, including biomarker profile, histopathological and imaging-based readouts.
Speakers: Dr. Alan Young, PhD, Business Development Manager, Respiratory Pharmacology, Charles River
Dr. Jeroen DeGroot, PhD, Director of Cell Biology, Charles River
Dr. Vince Russell, PhD, Senior Director of Pharmacology, Discovery Services, Charles River
Disease Relevant In Vitro and In Vivo Models for Lung Fibrosis Nov 12, 2015

LifeSciences - Learn about optimal clinical trial patient recruitment planning and execution
Speaker: Dr. Ute Simon, Head, Clinical Research, Novartis Pharma GmbH
Dr. Nils Drews, Chief Medical Officer, Clariness
Optimizing Clinical Trial Patient Recruitment from Lessons Learned: From the Burning House to Strategic Collaboration Nov 12, 2015

LifeSciences - Dr.Harder will present the Tissue Phenomics methodology to discover new tissue-based diagnostics using image and clinical data from prostate cancer patients with similar pathologies and known clinical outcome
Speaker: Nathalie Harder, PhD, Research Scientist, Definiens AG
How to Discover Powerful Tissue-Based Prognostic Biomarkers for the Benefit of Individual Patients Nov 11, 2015

LifeSciences - The presentation will include three examples of how regain control of your pharmaceutical packaging supply chain
Speaker: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
Brieann Beckner, Director of Pre-Sales Brand Owner, Esko
Gain Control of Your Packaging Supply Chain Nov 10, 2015

LifeSciences - Wipro and OmniComm Systems have developed an integrated system that connects EHR and the research systems to ease and simplify EDC data capture process supporting clinical research to enable faster completion of study, reduce the cost of development
Speakers: Rao Teki, PhD, Global Head, Pharma R&D Innovation Solutions Group, Wipro
Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.
NexGen eSource: EHR-EDC Integration - Clinical Data as a Service - The Game Changer Nov 10, 2015

LifeSciences - Premier Research has developed a proprietary Pediatric Certificate Training Program to train our employees on core competencies and considerations in the development and conduct of pediatric studies
Speakers: Alison Sampson, Senior Project Director, Premier Research
Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Pediatric Trial Certification: A Platform for Success Nov 9, 2015

LifeSciences - This webinar will provide an overview of the independent endpoint adjudication process with a focus on understanding what is necessary to operationalize an endpoint committee
Speakers: Richard Walovitch, PhD, President, WorldCare Clinical
Glenn Bubley, MD, Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center
An Overview and Guide to Clinical Trial Endpoint Adjudication Nov 9, 2015

LifeSciences - In order to generate reliable immune monitoring data that will help us determine the safety and efficacy of the therapeutic intervention approach from a global study, highly standardized methods to collect, process and prepare patient samples need to be implemented
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Translational Biomarkers Solutions, Covance
Recent Advances in Immune Monitoring Nov 5, 2015

LifeSciences - This webinar summarizes key aspects of evaluating safety and efficacy in studies of immune checkpoint inhibitors and describes operational strategies that support successful trial execution and regulatory approval
Speakers: Thomas Moehler, MD, PhD, Vice President, Medical & Scientific Affairs, Hematology/Oncology, inVentiv Health
Cheryl Askew, PhD, Senior Director, Program Delivery, Hematology/Oncology, inVentiv Health
Jessica Lee, PhD, Senior Engagement Manager, Campbell Alliance (an inVentiv Health Company
Immuno-Oncology Clinical Trials: Best Practices for Clinical Development of Immunotherapies Nov 4, 2015

LifeSciences - Topics include "Deciphering the Molecular Pathology of Alzheimer’s Disease" and " The Use of Highly Validated Antibodies to Study Neurodegenerative Disease"
Speakers: Li-Huei Tsai, Ph. D, Picower Professor of Neuroscience, The Picower Institute for Learning and Memory, Broad Institute, Senior Associate Member, Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology
Raphael Rozenfeld, Ph.D, Development Scientist, Cell Signaling Technology
Immunolabeling for Neurodegenerative Diseases Oct 28, 2015

LifeSciences - Dr. Lappalainen will present an overview of what medications have been developed for addictive disorder, what study end-points were used, and what operational challenges companies may face when developing medications for addictive disorders
Speaker: Jaakko Lappalainen, MD, PhD, Executive Director, Global Drug Development, Neuroscience at Premier Research
Challenges in Medication Development for Addictions Oct 28, 2015

LifeSciences - The speakers will discuss a menu of genomic tests developed to supplement many endpoints for complex clinical trials, including a Comprehensive Cancer Panel (Q2 Solutions CCP), HLA typing, exome sequencing and pan-cancer immune-profiling, to set the stage for more precise and individualized therapeutics, also known as precision medicine
Speakers: Patrice Hugo, Ph.D., Chief Scientific Officer, Q2 Solutions, a Quintiles Quest Joint Venture
Victor Weigman, Ph.D., Associate Director, Translational Genomics, Q2 Solutions, a Quintiles Quest Joint Venture
Precision Medicine: Shifting from One Drug for All Trials to Targeted Therapy Trials Oct 28, 2015

LifeSciences - The presenters will discuss the use of the SeqCap EZ MedExome Target Enrichment Kit from Roche and other methods at Yale Center for Genome Analysis (YCGA)
Speakers: Shrikant M. Mane, PhD, Director, Yale Center for Genome Analysis
Michael Brockman, PhD, Manager of Research Informatics, Roche NimbleGen
Applying a New Exome Sequencing Method in Medical and Translational Research Oct 23, 2015

LifeSciences - Learn about the latest trends and key factors to consider when choosing and implementing a Medical Information Systems
Speakers: Jayne Packham, Director, Jayne Packham Consultancy
Syed Saad Rahman, Head of Product Management, Techsol Corporation
Larry J. Davis, Pharm.D., VP, Dohmen Life Science Services
Thomas Barton, Director of Business Process, Dohmen Life Science Services
Joe Pierce, Founder & CEO, End Point Technologies
Understanding Next Generation Medical Information Technology Oct 23, 2015

LifeSciences - The speakers will present an approach to forecasting enrollment in oncology trials, sharing a case study with predicted vs. actual results
Speakers: Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health
JB Flinders, MPH, MBA, Director, Feasibility & Clinical Informatics, InVentiv Health
Taking the Guesswork Out of Feasibility Assessment in Oncology Clinical Trials Oct 22, 2015

LifeSciences - This webinar will cover new technologies and study management strategies for both viral and bacteriological infectious disease trials.
Speakers: Chris Petropoulos, Ph.D., CSO of Monogram Biosciences and Vice President, Laboratory Corporation of America
Pritty Patel, M.S, MBA, Global Director of Microbiology, Vaccines and Novel Immunotherapies, Covance Laboratories
The Prescription for an Efficient Infectious Disease Clinical Trial: Rich Science & Seamless Operations Oct 21, 2015

LifeSciences - Learn from industry experts as they delve into the journey from CDASH to SDTM and beyond...
Speakers: Neil Vivian, Senior Director of Business Solutions, OmniComm Systems
Ed Chappell, Consultancy Team Lead, Formedix
The Journey to Study Data Tabulation Model and Beyond Oct 21, 2015

LifeSciences - Quanterix and Myriad RBM are working together to use ultrasensitive, high quality immunoassay services that offer drug developers an unparalleled approach to clinical research
Speakers: Mark Roskey, Ph.D., VP/GM, Applications and Reagents, Quanterix
Dominic Eisinger, Ph.D., Vice President of Sales and Marketing, Myriad RBM
Detecting the Undetectable: Development & Validation of Ultrasensitive Simoa-based Immunoassay Services Oct 20, 2015

LifeSciences - The purpose of this webinar is to provide an educational forum to discuss current issues and applications associated with the analysis of large molecules in biological matrices
Speakers: Binodh DeSilva, Executive Director, Immunochemistry and Biomarker Development, Bristol-Myer Squibb Company
Valerie Leesch, Associate Scientific Director, WIL Research
Theresa J. Goletz, PhD, Founder, Theresa Goletz Consulting
Elizabeth Groeber, Director, Bioanalytical Chemistry, WIL Research
Moderator: Andy Vick, Vice President, Analytical Services, WIL Research
Emerging Trends in Large Molecule Bioanalysis Oct 19, 2015

LifeSciences - This webinar will explore what’s happening in the payer space today, the impetus for this change, and the potential outlook of the health insurance landscape in the future
Speakers: Cathy Carroll, PhD, MA, MBA, BSPharm, Senior Director of Managed Markets/Market Access, Commercial Consulting, Xcenda
Nina Ohara, PharmD, MBA, MS, RPh, Director, Commercial Client Strategy Team, Xcenda
Insurance Megamergers: How Will They Impact Manufacturers’ Commercialization Strategy? Oct 15, 2015

LifeSciences - The speakers will present the design and results of an early development program focused on a new molecule CORT125134, which is in development for the treatment of Cushing’s syndrome and certain cancers, as well as further cases studies illustrating the applications and benefits of Enabled-FIH
Speakers: Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical
Hazel Hunt, VP of Research, Corcept Therapeutics
Accelerating Timelines from Candidate Selection to Proof-Of-Concept with Enabled-FIH® Programs Oct 14, 2015

LifeSciences - This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products
Speaker: Eileen C. Nieto, CQA, Compliance Specialist, Compliance Insight, Inc.
Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions Oct 14, 2015

LifeSciences - Examples of signal detection through a multi-tiered approach will be provided, the roles of key players in the process will be introduced and the speaker will explore how the outcomes of signal detection and tending influence Benefit Risk assessments
Speaker: Robin Williams, B.S., CMC, Senior Safety Scientist, Drug Safety Alliance / Ashfield Pharmacovigilance
Insight into Detection & Management of Safety Signals Oct 9, 2015

LifeSciences - Learn through case studies how to effectively address the challenges across a product's lifecycle, despite the increasing demand for Real World Evidence (RWE) generation
Speaker: Alex Exuzides, PhD, Director, Health Economics & Epidemiology, ICON Commercialisation & Outcomes
Building the Evidence Generation Roadmap: The Role of Real World Data in Drug Development Oct 7, 2015

LifeSciences - The speaker  will discuss exosome composition, different sources of RNA in biofluids, isolation approcahes and clinical applications of exosome biomarkers.
Speaker: Dr. Johan Skog, Chief Scientific Officer and Founding Scientist, Exosome Diagnostics
Exosome RNA for Biomarker Development Oct 6, 2015

LifeSciences - The speaker will discuss the regulation of colorants in medical devices and present solutions to many of these challenges, therefore preparing you for the attainment of a successful regulatory submission
Speaker: John Iannone, Program Manager/Technical Specialist, Extractables/Leachables & Special Studies, Toxikon Corporation
Colorants in Devices: Successfully Integrated Strategies towards Regulatory Approval Oct 6, 2015

LifeSciences - The presenter will draw on his industry experience to provide an example of how a strategic alliance can help form an end to end solution that will reduce the complexity of drug/device development and accelerate the route to market
Speaker: Richard Fazackerley, Technical Director, Aesica Pharmaceuticals
Using Strategic Partnership for Value Creation from Early Stage Development to Manufacture Oct 5, 2015

LifeSciences - This webinar explores the pragmatic solution of accessing clinical research talent and creating an avenue for developing CRAs through a comprehensive training program
Speakers: John Avender, Associate Director, Clinical Performance, inVentiv Health Clinical
Michael L. Jimmink, Vice President, Strategic Resourcing, inVentiv Health Clinical
Joe Mills, Senior Director - Global Recruitment Center, inVentiv Health Clinical
Talent Management Solutions to the CRA Shortage: Investing in a Global Talent Pool Oct 1, 2015

LifeSciences - This webinar will showcase studies and metrics from industry experts and users of RapidFACT®, illustrating the applications and benefits when developing enabled drug formulations
Speakers: John McDermott, Director, Drug Product Optimization, Quotient Clinical
Gábor Heltovics, CEO, Druggability Technologies
Overcoming the Challenge of Poorly Soluble Drugs – How to Optimize Enabled Drug Products with Rapid Formulation Development and Clinical Testing (RapidFACT®) Sept 30, 2015

LifeSciences - A case study will be included in the presentation
Speaker: David F. Fischer, Senior Director of Biology for BioFocus, a Charles River company, and Site Head of Charles River Leiden, the Netherlands
Phenotypic Screening – Complex and Disease-Relevant Human Primary Cell Assays Sept 28, 2015

LifeSciences - This webinar will review the merits of employing LC-HRMS using case studies and examples to illustrate how HRMS can be employed in environmental fate and metabolism studies to answer both scientific and regulatory questions
Speakers: James Schmidt, Senior Scientific Advisor, ABC Laboratories
Tom Fleischmann, Ph.D., Director Metabolism, PTRL West – Evans Analytical Group
The Use of High Resolution Accurate Mass Spectrometry in Environmental Fate and Metabolism Studies Sept 22, 2015


LifeSciences - In this session, specific case study examples will be used to explore all these key topics. Learn best practices for site selection, including the possible need to over recruit sites for Phase IV trials
Speaker: Alexandra Adams, Ph.D Dip.Clin.Sci. Hon FICR, Director, Late Phase, Chiltern
Best Practice Approaches in Executing Post Approval Programs Sept 17, 2015


LifeSciences - In this case study, the speakers will show the power of using a novel combination of machine learning algorithms with a systems biology based approach for identifying genes and the subsequent exonic regions driving prognosis for patients with lung squamous cell carcinoma (SQCC)
Speakers: Scott Marshall, Ph.D., Managing Director, Analytics, Precision for Medicine
Jared Kohler, Ph.D., Managing Director, Analytics, Precision for Medicine
Tobias Guennel, Ph.D., Principal, Analytics, Precision for Medicine
Applying Systems Biology and Predictive Genomic Analytics on Patients with Lung Squamous Cell Carcinoma and RNA-Seq Gene Expression Sept 14, 2015


LifeSciences - This webinar will demonstrate the properties of the ideal data and analytics ecosystem for value-based drug development with a real example
Speaker: Jamie Powers, DrPH, Principal Consultant & Practice Lead, SAS Health and Life Sciences
Accelerate Value-Based Drug Development Using Real World Data and Predictive Analytics Sept 11, 2015

LifeSciences - This webinar provides a framework to assist pharmaceutical, biotechnology and/or medical device companies in the development of a risk based monitoring plan that will define the various risks and steps needed to implement a risk-based monitoring strategy
Speakers: Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK
Tim Lyons, Vice President, Product Development and Operations, DATATRAK
Rob Nichols, Chief Commercial Officer, Algorics
Risk Based Monitoring Adoption Simplified Sept 10, 2015

LifeSciences - The speaker will share ideas and practical examples on innovative approaches to antibacterial discovery to meet the augmented needs of the market and to tackle antibacterial resistance issues
Speaker: Antonio Felici, PhD, Senior Manager, Head of Microbiology, Aptuit Center for Drug Discovery & Development – Verona, Italy
Driving Innovation back into Antibacterial Discovery Sept 2, 2015

LifeSciences - Quanterix and Myriad RBM are working together to use ultrasensitive, high quality immunoassay services that offer drug developers an unparalleled approach to clinical research
Speakers: James P. Mapes, Ph.D., Chief Scientific Officer, Myriad RBM
Mark Roskey, VP/GM, Applications and Reagents, Quanterix
Detecting the Undetectable: Development & Validation of Ultrasensitive Simoa-based Immunoassay Services Aug 25, 2015


LifeSciences - This presentation on the new EU clinical trials regulation will identify what’s happening with the regulation that governs clinical trials in Europe
Speaker: Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs, SynteractHCR
The New EU Clinical Trials Regulation: What You Need to Know Before 2016 Jul 23, 2015

LifeSciences - This webinar is intended to provide the scientific community with information on new approaches for quick and effective frozen sample processing for experimental applications
Speaker: Luca Lambertini, PhD, MSc, MPH, Assistant Professor of Preventive Medicine and Obstetrics, Gynecology and Reproductive Science (OB/GYN), Icahn School of Medicine at Mount Sinai
Eliminating Freeze-thaw Cycles: Advances in Frozen Biospecimen Integrity Utilization Jul 22, 2015
LifeSciences - The identification and quantification of post-translationally modified peptides will be discussed, as well as multiplexed quantitative ubiquitylome analysis utilizing ubiquitin remnant immunoprecipitation, nLC-MS/MS, andiIsobaric labels
Speakers: Matthew P. Stokes, PhD, Principal Scientist, Proteomics Group, Cell Signaling Technology, Inc.
Christopher Michael Rose, Postdoctoral Research Fellow, Gygi Lab Harvard Medical School
Post Translational Modification: Antibody Enrichment for Mass Spectrometry Based Proteomics Jul 15, 2015


LifeSciences - This free webinar aims to describe novel medical imaging approaches and methodologies to help sponsors maximize clinical trial efficiency along the development pathway.
Speakers: Sandra Chica, MD, VP of Medical Imaging, BioTelemetry Inc.
Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research
Medical Imaging: Maximizing Efficacy and Safety in Oncology Clinical Trials Jun 24, 2015


LifeSciences - In this free webinar, the speakers will explore what we believe are the driving factors of change toward that future, hoping that it will be suitable to a broad audience of stakeholders in cancer clinical trials.
Speakers: Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA
Dr. Everardo Saad, Senior Medical Expert, IDDI
What is the Future of Cancer Clinical Trials? Jun 22, 2015
LifeSciences - This webinar will discuss how risk based monitoring can be used to leverage common clinical data sources, advanced statistical methodologies and cutting-edge visualizations for your central nervous system clinical trials.
Speakers: Michael Phillips, Director, Product Innovation, ICON plc
Gerard Conway, Director, Data Analytics, PerkinElmer Informatics
Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials Jun 11, 2015
LifeSciences - The speaker will discuss clinical supply strategies for Investigator Initiated Trials, including an extensive analysis of the study protocols
Speaker: Helen Underwood, Director of Strategic Customer Relationships, Fisher Clinical Services
How Clinical Supply Teams can Respond to the Growth in Investigator Initiated Trials Jun 9, 2015
LifeSciences Viewers will learn how to reduce cycle times and late stage attrition rates while managing the ethical considerations that are at the heart of everything
Speakers: Cheng Gang Greg Wei, Ph.D., Research Fellow, SynteractHCR
Zoran Antonijevic, Senior Director, Strategic Consulting, Cytel, Chair of the Adaptive Design Scientific Working Group at DIA
Adaptive Trial Design in Clinical Trials: What You Need to Know June 4, 2015
LifeSciences The speaker will present on important factors to consider when performing a ChIP assay, including use of highly validated antibodies, optimized protocols and reagents, and the advantages of using enzyme-based chromatin digestion over sonication-based chromatin fragmentation
Speaker: Sayura Aoyagi, PhD, Antibody Validation Scientist, Cell Signaling Technology
Epigenetic Analysis Using Highly Validated Antibodies and Optimized ChIP Assays May 27, 2015
LifeSciences - This webinar will discuss the rationale for including functional assessments in repeat-dose toxicology studies, how the data can be used for more impactful risk assessments, and the potential for more relevant clinical biomarker strategies
Speakers: Brian R. Berridge, DVM, PhD, DACVP, Director and Head of WW Animal Research Strategy in the Office of Animal Welfare, Ethics and Strategy, GlaxoSmithKline
Jonathan Heyen, M.S., D.A.B.T., Senior Principal Scientist - Safety Pharmacology Department, Pfizer La Jolla
Structural and Functional Endpoints in Repeat-Dose Toxicity Cardiovascular Risk Assessments and the Use of In Vivo Physiologic Monitoring May 20, 2015
LifeSciences - This presentation focuses on the regulatory aspects of bringing therapies for rare diseases to the market
Speakers: Nach Dave, Director, Regulatory Affairs, Premier Research
Carol Huntington, Associate Director, Regulatory Affairs Europe, Premier Research
Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape May 19, 2015
LifeSciences - This webinar will review strategies for accessing the expression profiles of mRNA, lncRNA, and miRNA in both solid tissues and liquid biopsies, and describe the application of human micronome profiling in liquid biopsies to the development of an early minimally invasive biomarker for detection of early stage acetaminophen poisoning in patients
Speakers: Eric Lader, Senior Director of Product Development, QIAGEN
James Dear, Senior Clinical Lecturer in Clinical Pharmacology, Royal Infirmary of Edinburgh/Edinburgh University
RNA Biomarker Development: From Sample to Insight May 13, 2015
Life Sciences - This webinar will include a discussion about the variety of inhalation exposure applications currently being used in research, identifying the need for better inhalation exposure tools, plus an introduction of DSI’s 14-Port Inhalation Tower and All-in-One Tower Controller
Speakers: Michael Girand, Principal Applications Engineer, Data Sciences International (DSI)
Aileen House, Sr. Scientist, In Vivo Pharmacology – Cardiovascular Department, Merck & Co Pharmaceuticals
Inhalation Exposure Systems for Aerosol Delivery Advancements: Perspective from a Bench Scientist Apr 30, 2015
Life Sciences - This webinar will discuss the factors effecting absorption and bio-availability, how the candidate properties from discovery effect the formulation development and how the formulation chemist can adopt particular bio-enhancement strategies to make compounds drugable
Speaker: Dr. Flavio Fabiani, Senior Manager, Formulation and Material Science Group, Pharmaceutical & Preclinical Development, Aptuit Center for Drug Discovery & Development, Verona – Italy
Bioenhancement of Poorly Water Soluble Drugs: Challenges and Opportunities for Drug Development Apr 22, 2015
Life Sciences - This learn how OmniComm and Mortara use the bi-directional communication between Mortara ECG devices and the TrialOne® eSource system to automatically transmit information between the two, and how the implementation of direct data capture is able to improve clinical trial data quality and availability
Speakers: Mark Mentzer, Vice President of Strategic Partnerships, Mortara Instrument
Michelle King, Director, Early Phase Consulting, OmniComm Systems, Inc.
Improving ECG Data Quality and Availability: Automatic Transmission of Data from Devices into eSource Systems Apr 21, 2015
This webinar will discuss glucose clamping as a method for quantifying insulin resistance and secretion, outlining methods used, including algorithm controlled clamping, and all its inherent benefits
Speakers: Dariush Elahi, PhD, Director of Metabolic Research, Early Phase Services, ICON plc
Dennis Ruff, MD, Vice President, Medical Director, Early Phase Services, ICON plc
Glucose Clamping in Humans: Establishing Early Proof-of-Concept in the Development of Diabetes Interventions Apr 9, 2015
While the technology is advancing at a rapid rate, users are hampered by the lack of official regulatory guidance documents regarding the validation of flow cytometric instruments and methods
Speakers: Virginia M. Litwin, PhD, Principal Scientist in Hematology/Flow Cytometry, Covance
Lisa Green, MS, Manager of Flow Cytometry, Covance
Linsen Du, PhD, Lead Scientist, Flow Cytometry/Hematology, Covance
Evolution of Flow Cytometry Guidelines for Drug Development and Clinical Testing Apr 8, 2015
The speakers will discuss strategies for maximizing the value vigilance of your established product
Speakers: Matthew McKeever, M.D., FAAP, VP and Global Head, Safety Knowledge and Reporting, Medical Safety, Aggregate Reporting, Benefit Risk Management and Regulatory Reporting, Quintiles
James C. Walker, CEO and Founder, Octagon Research Solutions, Inc.
Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products Apr 2, 2015
This webinar is intended to help Oncology drug developers explore Biomarkers in the design of clinical trials
Speakers: Kamala Maddali, DVM, PhD, Director of Scientific Development, Quest Diagnostics Clinical Trials
Arturo Anguiano, MD, FFACMG, International Medical Director – Medical Affairs, Quest Diagnostics
Frederick K. Racke, M.D.,Ph.D., Medical Director, Hematopathology and Coagulation, Quest Diagnostics Nichols Institute
Emerging Role of Biomarkers in Improving the Success Rate of Early Oncology Drug Development Mar 31, 2015
Understand key lessons learned through years of experience using RBM procedures and processes to get to a global, scalable approach, proven to deliver higher efficiencies with improved data quality and patient safety
Speakers: Yvonne Barnes, Senior Director, Clinical Operations, Quintiles
Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles
Risk-based Monitoring Requires Changes to Leverage Data Insights Mar 31, 2015
The talk will highlight the reasons for the development of the service and give some details on the potential benefits to biopharma. Almac have developed a service to enable biomarker studies to be carried out retrospectively in trials where there was not one in place from the start.
Speakers: Dr. Peter Kerr, Head of Project Management & Product Development, Almac Diagnostics
Kinga Wojciechowska, Project Manager - Ethics/Tissue Collection, Almac Diagnostics
Retrospective Sample Collection
Sample Access and Profiling for Biomarker Discovery to Help Rescue or Reposition your Drug
Mar 25, 2015
Quintiles experts will discuss practices that will help emerging biopharma companies design smarter trials to put their products on a more predictable path to success
Speakers: Seth Berry, PharmD, Director, Clinical Pharmacokinetic / Pharmacodynamic Modeling & Simulation, Quintiles
Laura Marquis, Vice President and Global Head, Emerging Biopharma, Quintiles
Cara Willoughby, Senior Director, Infosario Design Delivery Lead, Quintiles
Emerging Biopharma: Designing Smarter, More Predictable Clinical Trials Mar 25, 2015
The speaker will discuss best practices for patient recruitment and retention for pediatric clinical studies
Speaker: Nikki Fink, Director, Patient Access and Retention Services, PRA Health Sciences
Pediatric Clinical Trials: Patient Recruitment and Retention Best Practices Mar 23, 2015
This webinar will focus on showing how the ASAP approach can very well fit into different stages of a product development, shortening product development time and strengthening relevant key decisions
Speaker: Dr. Piero De Filippis, Stability Manager, Pharmaceutical & Preclinical Development, Aptuit Center for Drug Discovery & Development, Verona – Italy
Accelerated Stability Assessment Program (ASAP) to Improve Product Development Mar 19, 2015
This webinar offers risk mitigation strategies for clinical supply professionals and those in key functional adjacencies
Speaker: Susan Diehl, Project Manager, Fisher Clinical Services
How to Avoid Breaking the Blind in Clinical Trials Mar 18, 2015
The speaker will present a new approach: MethylC-Capture Sequencing (MCC-Seq), for customizable and cost-effective sequencing of disease or tissue-targeted functional methylomes that simultaneously provides information on genetic variation
Speaker: Dr. Elin Grundberg, Assistant Professor of Human Genetics, McGill University
Characterization of Functional Methylomes by Next-Generation Capture Sequencing Identifies Novel Disease Associated Variants Mar 13, 2015
This webinar will discuss new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program
Speakers: Judith Newmark, PhD, Program Manager, Pharmacology/Toxicology/Ocular, Toxikon Corporation
Franck Grall, PharmD, PhD, Director, Cellular and Molecular Toxicology, Toxikon Corporation
Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing Mar 12, 2015
This webinar will focus primarily on rare disease programs, as well as ultra rare disease programs
Speakers: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Patricia Nowowieski, Head, Global Clinical Operations, Cambridge, Alexion Pharmaceuticals
Mallory Bissett, Associate Director, Global Clinical Operations, Alexion Pharmaceuticals
Rare Disease Studies: How to Run Successful Programs Mar 11, 2015
In this webinar, the speakers will use their compiled and individual data to outline and review the pharmaceutical market from the vantage point of chemical molecules and present an overview of the API market
Speakers: Dr. Matthew Moorcroft, VP of Global Marketing and Communications, Cambrex
Dr. Jan Ramakers, Director, Jan Ramakers Fine Chemical Consulting Group
Resurgence of the Small Molecule API Market - An Industry Primer Mar 5, 2015
This webinar will discuss how rapid molecular stool pathogen diagnostic testing may minimize the burden of diarrheal illness throughout the entire hospital and to healthcare providers worldwide
Speakers: David Peaper, MD, PhD, Assistant Professor of Laboratory Medicine, Yale School of Medicine; Director of Clinical Microbiology Laboratory, Yale-New Haven Hospital; and Director of Virology Reference Laboratory, VA Connecticut Healthcare System
Marilyn Mitchell, MT(ASCP)MS, Microbiology Supervisor, Community Regional Medical Center, Fresno, California
Molecular Testing for GI Pathogens: Cost-Effectiveness, Clinical Impact and Lab Implementation Feb 18, 2015
This interactive webinar will review practical strategies, solutions and examples for keeping medical device supply chains responsive, aligned and optimized for today's changing landscape
Speakers: Dave Bode, Vice President, Health Care Solutions, DSC Logistics
Jeff Willis, Group General Manager - Health Care, DSC Logistics
Value Creation in the Medical Device Supply Chain: Strategies and Case Studies Feb 17, 2015
In this scientific webinar, Caprion and Medicago will describe how the production of Virus-Like Particle (VLP)-based vaccines using plant-based transient expression technology has particular advantages for accelerating both the development of new vaccines and the scaling-up of production for deployment in affected areas
Speakers: Jean-Francois Poulin, PhD, MBA, Senior Principal Scientist and Business Development Liaison, Caprion/IMMUNECARTA Services
Stéphane Pillet, PhD, , Scientifique immunologie / Scientist Immunology, Medicago Inc.
Multiparametric Flow Cytometry Analysis of Cell-mediated Immunity in Clinical Trials: A Case-study Using Plant-derived Virus-like Particles (VLP) in Influenza Vaccines Feb 17, 2015
This presentation describes how Bend Research has created an integrated lab environment that capitalizes on the MAST platform to collect high density data sets for on-line analysis and predictive model generation
Speakers: Clint Pepper, Ph.D., Director, Bend Research, a division of Capsugel Dosage Form Solutions
Jeffrey Breit, Ph.D., Director, Bend Research, division of Capsugel Dosage Form Solutions
Moderator: David Lyon, Ph.D., Sr. Vice President of Research, Bend Research, a division of Capsugel Dosage Form Solution
Bioprocess Design and Operation: Enhanced Bioreactor Observability and Process Guidance Feb 10, 2015
This interactive webinar will look at changing the conversation from one of engagement to collaboration with both patients and patient influencers
Speakers: Amy Parke, VP Integrated Marketing Communications, Ashfield Healthcare Communications
Nareda Mills BScN, RN, AE-C, VP, Nursing Services, Ashfield Healthcare
Navigating the Optimal Patient Journey to Treatment Success Feb 5, 2015
Viewers will take away vital new perspectives and tools that can be used to achieve the levels of accelerated clinical and commercial development and cooperation that are critical to success in today’s environment
Speakers: Jeff Trotter, President, Continuum Clinical
Neil Weisman, Executive Vice President, Patient Recruitment, Continuum Clinical
Jeff Kent, Senior Vice President, Medical Affairs and Health Outcomes, Horizon Pharma
Elaine Ferguson, Executive Vice President, Medical Communications, Continuum Clinical
Optimizing Late-Stage Clinical and Commercial Development: The Benefits and Challenges of Bridging the Gap Feb 3, 2015
The speakers will discuss proven approaches to address these challenges through patient and caregiver engagement with the help of qualified oncology nurse educators, MSL’s and even specialized pharmaceutical reps engaging providers
Speakers: Susie Newton, RN, MS, AOCN, AOCNS, Senior Director, Health Management Solutions, Quintiles
Cheryl Fowler, BN, RN, National Director, Hematology Clinical Nurse Educators
Nicole Korak, MSN, FNP, National Director, Oncology Clinical Nurse Educators
Oral Oncology Therapies: Meeting New Patient Adherence Challenges Jan 27, 2015
This webinar will provide insight into these questions by reviewing the methods involved in collecting abuse potential data during CNS drug development and current regulatory thinking on NMEs and ADFs
Speaker: Kerri A. Schoedel, PhD, Director and Co-founder, Altreos Research Partners, Inc.
Understanding the Clinical Assessment of Abuse Potential during CNS Drug Development Jan 14, 2015
In this webinar, three unique case studies will be presented that demonstrate how IHC-based assays have been used to advance basic research and preclinical studies in diabetes, immuno-oncology, and oncology
Speakers: Anindita Bhoumik, M.S., Scientist, R&D, ViaCyte, Inc.
Jeff Dzubay, Ph.D., Field Application Scientist, Definiens
Douglas Bowman, Associate Scientific Fellow, Takeda Pharmaceuticals International Co.
Best Practices in IHC-based Tissue Image Analysis for Immuno-oncology, Oncology, and Diabetes Jan 14, 2015
Join the webinar to discover future trends, assess available options, and implement an eClinical system that works best for your organization's particular business requirements
Speakers: Eldin Rammell, Managing Director and Principal Consultant, Rammell Consulting
Rob Wynden, VP of Technology and Engineering, goBalto
Best Practices for Leveraging eClinical Systems for Study Startup Dec 17/14
The speakers will present the various types of clinical networks that are available (Europe and the US) and the functions that they are able to provide
Speakers: Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Charles A. Thompson, MD, FAPP, Global Lead, Pediatric Center of Excellence, Pfizer
Pediatric Clinical Networks, Pharma and CROs Working Together for Success in Pediatric Clinical Trials Dec 16/14
The challenge of and need for developing more sensitive clinical outcomes, and ensuring that they are administered and scored properly will be presented
Speakers: Veronika Logovinsky, M.D., Ph.D., Executive Director, Eisai Inc., Neuroscience & General Medicine
David Miller, M.D., Clinical Vice President, Bracket
Enhancing Confidence in Alzheimer's Disease Clinical Trial Outcomes: Composite Measures and In-Study Quality Programs Dec 11/14
This presentation discusses the translation process, needs, requirements, review cycles, and regulations surrounding the use of eCOA in clinical studies and the need for linguistic validation
Speakers: Colleen Chulis, Global Director of Linguistic Validation, TransPerfect
Brielle Sydor, Account Executive of Linguistic Validation, TransPerfect
Jane Carter, Program Director, CRF Health
Translation of eCOA in Global Studies – Challenges & Solutions Dec 10/14
The purpose of this webinar is to provide information to Pharmaceutical Researchers and Flow Core Staff Scientists on how this new method is employed and why it is of value to them in their daily work
Speaker: Mark Edinger, Global Scientific Director, Quintiles
A New Method for Standardizing Quantitative Flow Cytometry Dec 10/14
This webinar will explore data monitoring committees (DMC) best practices that have emerged over the past 25 years
Speaker: Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA
Data Monitoring Committees for Today and Tomorrow Dec 8/14
As the paradigm shift in drug development continues to drive unsustainable costs, biopharmaceutical companies must lift the veil on true sponsor vs. CRO operating costs
Speakers: Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts University
Samir Shah, Chief Operating Officer of Strategic Solutions division, PRA Health Sciences
Pharma’s Productivity Challenge – Unraveling the Mystery of True Sponsor and CRO Operating Cost Comparisons Dec 8/14
This program is focused on the development of experimental nucleoside analogues containing locked nucleic acids for the treatment of HCV and will highlight the problems nucleoside chemists face when working to develop new antiviral drugs
Dr.Nigel Allanson, Group Leader, Peakdale Molecular
Dr. Mark Betson, Group Leader, Peakdale Molecular
Dr. Steve Moore, Lead Chemist, Peakdale Molecular
Sugar Modified Nucleosides and Nucleotides - The Synthesis of Anti-Viral Drugs Dec 4/14
This webinar will discuss how FUJIFILM Diosynth Biotechnologies’ cell line development and upstream process development platforms have been modified and optimized to develop customized, reliable manufacturing processes
Speakers: Alison Porter, PhD, Head of Mammalian Cell Culture R&D, FUJIFILM Diosynth Biotechnologies, Billingham, UK
Stewart McNaull, PhD, Director, Development and Technical Services, FUJIFILM Diosynth Biotechnologes USA Inc.
From Gene to Manufacturing: Application of Efficient Cell Line Development Strategies to Deliver Reliable, High Quality Biomanufacturing Processes Dec 3/14
The speaker will discuss the emerging field of companion diagnostics with focus on its importance in clinical trial design and how drug / companion diagnostic co-development is rapidly changing the drug development process
Speaker: Mark Roberts, PhD, Director, Diagnostics Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 5: Accelerating Drug Development through Companion Diagnostic Co-Development
Dec 3/14 (APAC live broadcast)
Recent Standardization and harmonization of methodologies across multicenter allergy and respiratory trials with induced sputum biomarkers as a primary outcome
Speakers: Graham Clarke, PhD, Senior Director and Head of Respiratory & Inflammation, Quintiles Early Clinical Development
Neil Alexis, PhD, Professor, Department of Pediatrics, Division of Allergy Immunology Rheumatology and Infectious Disease, University of North Carolina at Chapel Hill
Improving the Quality of Allergy and Respiratory Clinical Research Using Induced Sputum Biomarkers Dec 2/14
The presenters will share lessons learned, critical partnerships, permitting, tax and VAT implications, local labor considerations and other pertinent topics associated with execution of a successful project in a new environment
Speakers: Doug Tom Hendricks, Vice President, Fluor Industrial Services
Rob Bollenback, Project Director, Fluor Industrial Services
Stuart Mosby, Project Director, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 4: Designing and Building Production Facilities in New Markets
Nov 24/14
Hear TransCelerate and Medidata discuss the results of a data-driven analysis on the relative effectiveness of SDV—which will be published in the November 2014 issue of Therapeutic Innovation & Regulatory Science (TIRS), the official journal of DIA—as well as learn how to turn the findings into real-world practice
Speakers: Stephen Young, Principal Engagement Consultant, Medidata
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Mark Travers, Vice President, Head of Clinical Study Units, Sanofi
TransCelerate and Medidata Discuss SDV ​Findings and Application to Risk-Based Monitoring Nov 17/14
Hear industry experts offering key insights which will help you gain a better understanding of the opportunities and challenges when conducting vaccines studies within Latin America
Speakers: Valeria Staffolani, Associate Medical Director, Quintiles Pediatric Center of Excellence
Mauro Martinelli, DEmerging Markets Specialist, Quintiles
Vaccine Trials in Latin America – Insight and Opportunities Nov 13/14
The speakers will present a novel targeted RNA sequencing method and elaborate on experiences with targeted RNA sequencing that overcomes many of the standard RNA-Seq limitations and achieves unprecedented read coverage, sensitivity and resolution.
Speakers: Timothy R. Mercer, PhD, Lab Head - Transcriptomic Research, The Garvan Institute of Medical Research, Australia
John Tan, PhD., Senior Scientist – Sequence Capture, Roche NimbleGen
Discover More in Transcriptome Research with the Unprecedented Read Coverage, Sensitivity and Resolution of Targeted RNA Sequencing Nov 12/14
The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata
Marcus Thornton,Senior Director, CTMS, Medidata
Streamlining the Site Budgeting and Payment Process Nov 11/14
This webinar will outline the background and evolution of the role. It will show how the role of MSL both complements and exceeds that of traditional sales representatives – demonstrating the key differences between these two roles
Speakers: James Cornwall, PhD, Regional Head, New Business Ventures, Quintiles AA
Jill Morjaria, MSc B Pharm, Regional Lead, Quintiles AA
Evolving Role of the Medical Field-force in Asia-Pacific Nov 11/14 (APAC live broadcast)
The presenter will discuss definitions for bound residues and NER, explanations for their formation, regulatory approaches and guidance, and review case studies of experimental approaches and analytical techniques employed to answer both scientific and regulatory questions
Speaker: James Schmidt, Senior Scientific Advisor, ABC Laboratories
Strategies for Bound and Non-Extractable Residues in Laboratory Environmental Fate Studies Nov 6/14
Learn how optimized study design dramatically decreases excessive cost, waste and subject burden, the positive effect of streamlined protocols on downstream operational execution, and the benefits of a facilitated design and review process
Speaker: Jason Attanucci, Global Director, Study and Protocol Design, Medidata
Focusing Resources on the Science of Study Design Nov 6/14
The presenter will examine the growth of pre-filled syringes, the factors contributing to this growth, and the key role technological advances in syringe assembly and labeling are playing in this expanding area
Speaker: Pamela Osborne, Senior Clinical Supply Chain Manager, Fisher Clinical Services
Pre-Filled Syringes in Clinical Trials Nov 6/14
As R&D expenditures in Asia-Pac continue to increase, Dr. Gries’ presentation will examine the five ways to maximize molecule value and will provide practical advice on reaching your proof-of-concept milestones
Speaker: Jean-Michel Gries, PharmD PhD MBA FCP, VP & GM, Early Clinical Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 4: Strategies and Operations for Early Clinical Development
Nov 4/14
qPCR experts describe their experience overcoming challenges to assay design for diverse applications. The BHQplus® probe format presents a compact oligo design offering enhanced specificity for the detection of challenging target sequences and discrimination of sequence variations.
Speakers: James C. Willey George Isaac Professor for Cancer Research, University of Toledo Health Sciences Campus, Consultant for Accugenomics, Inc.
Cassie Keppel Laboratory Operations Manager, Douglas Scientific
Probe-based qPCR Approaches for Detection of SNPs and Validation of Molecular Diagnostics Oct 30/14
This webinar will examine three key benefits of electronic clinical outcome assessments: reduced data variance, increased patient compliance and reduced site monitoring costs
Speakers: Elisabeth Kurkimilis, Senior Manager of Clinical Operations, Celgene Corporation
Valdo Arnera, MD, General Manager Europe, PHT Corporation
Benefits and ROI of eCOA Data Collection in Clinical Trials Oct 30/14
As biopharmaceutical companies increasingly seek to achieve global patient access, there is a need to develop PV procedures and systems that go beyond the strict confines of safety signal detection to provide for proactive benefit/risk management and optimized oversight
Speakers: Brian Guza , VP of Infosario Safety, Quintiles
Annette Williams , Senior Director, Pharmacovigilance Services, Lifecycle Safety , Quintiles
Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology Oct 29/14
The speakers will present data and lessons drawn from risk based monitoring of 12 global schizophrenia trials involving over 80000 visits
Speakers: Alan Kott, MUDr, Senior Manager Data Analytics, Bracket
David G. Daniel, M.D., Senior Vice President and Chief Medical Officer, Bracket
Risk-Based Monitoring in Global Schizophrenia Trials: A 360 Degree View Oct 28/14
The presenters will follow an imaginary high-value, temperature-sensitive healthcare shipment from the moment the products are loaded into your trucks for delivery
Speakers: Douglas Braund, Manager, Security, FedEx Custom Critical
Chris Swearingen, Marketing Manager, SenseAware, powered by FedEx
Identifying and Preventing Security Vulnerabilities and Temperatrue Excursions in Your Clinical Supply Chain Oct 23/14
There is great excitement in the pharmaceutical and oncology fields as drugs targeting immune checkpoint proteins promise to truly restore immune anti-tumor activity to broad patient populations across many indications
Speakers: Chris Learn PhD, PMP, Senior Clinical Project Manager , Quintiles
Brad Smith, PhD, VP of Translational Medicine, Quintiles
Eric Groves, MD, PhD, VP, Center for Integrated Drug Development, Quintiles
Seizing the Future in Oncology: Improving the Clinical Development of Immunotherapies Oct 23/14
This webinar will review the technical advantages of extrusion and spheronization, xxcipient selection for the extrusion process, examples of process equipment available in the industry, specifically at Xcelience, and dosage form examples
Speaker: Jeff Williamson, Manager, Pre-Formulation and Formulation Development, Xcelience
Exploring the Extrusion and Spheronization Process Oct 21/14
Presentation will include a case study where a sponsor found sites in a highly competitive therapeutic area, with a number of competing ongoing studies, and successfully rescued their study
Speakers: William Turnbull, Local Study Leader, AstraZeneca
Kirsty Kwiatkowski, Director, Feasibility and Site Identification, DrugDev
Jim DiCesare, Vice President, Contract & Regulatory Services, DrugDev
S.O.S. – Best Practices for Finding, Engaging and Activating Investigators on a Rescue Study Oct 21/14
The presenters will explore and showcase how Cambrex can manage your API life cycle through innovation, process and cost improvements, to meet you API development needs and help you move your products quickly to market
Speakers: Jonathan Knight, VP of New Product Development, Cambrex
Margus Eek, Head of R&D, Cambrex Tallinn
Lars Eklund, Technical Lead, Cambrex
Managing the API Life Cycle: Cambrex Innovation, Process and Cost Improvement Oct 16/14
Knowledge created from holistic clinical trial insights are improving efficiency in clinical development through timely, integrated data, enabling the identification of potential issues faster than previously possible – but changes are required in how we integrate processes and change roles
Speakers: Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles
Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles
The Evolving Role of Data Management in Risk-Based Monitoring Oct 16/14
This webinar attempts to highlight the last development of REACH including testing strategy and tips and tricks to more efficiently and successfully use QSAR and read across in REACH registrations
Speakers: Erwin Annys, Director REACH/Chemicals Policy, CEFIC
Marie-Elène Boivin, Head of Regulatory Affairs, WIL Research
Tatiana Netzeva, Senior Scientific Officer, Computational Assessment and Dissemination Unit, ECHA
REACH: Suggestions, Tips and Tricks for Effective Testing Strategies Oct 15/14
This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission
Speaker: Glenn E. Petrie, Ph.D., Senior Scientific Advisor, ABC Laboratories
The Critical Role of CMC in Your IND Submission Oct 15/14
The session will include a hands-on workshop using a simple ITC tool requiring no technical experience
Speaker: Marie Maxime Hubert, M.Sc., Health Economics and Outcomes Research Manager, JSS Medical Research
Indirect Treatment Comparisons and Network Meta-analyses for Managers and Directors: Concept & Application Using a Non-technical, User-friendly Tool Oct 14/14
Topics include clinical data challenges when outsourcing trials to CROs, capturing data from EDC, CTMS, Electronic patient reported outcomes, Electronic health records, and actionable analytics that are possible once the data is captured and aggregated
Speakers: Greg Caressi, Senior Vice President, Healthcare & Life Sciences, Frost & Sullivan
Hunter Walker, Chief Technology Officer, Atlantic Research Group
Ben McGraw, Senior Vice President, Strategy & Marketing, Comprehend Systems
Partnering with the Right CRO to Complement Clinical Data Analytics Oct 10/14
This interactive webinar will review how to manage various working relationships while being aware of the challenges with co employment
Speakers: Wendy Wolf, Senior VP, Commercial & Clinical Operations, Ashfield Healthcare
Vicki Alston, Director, Human Resources, Ashfield Healthcare
Co-employment: Get the Best of a Flexible Partnership with the Strategic Benefits of Outsourcing Oct 7/14
This webinar will focus on newer patient recruitment techniques that can be implemented much earlier in the process
Speakers: Chris Frega, Sr. Director & Head of Global Feasibility and Patient Recruitment, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Bernadette Tosti, Director Business Development, Health Engagement and Communications, Quintiles
The Right Start: Optimizing Trial Recruitment Through Earlier Planning and Patient Identification Oct 2/14
In today’s monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx, an inVentiv Health company
Using a Clinical Quality Risk Management (QRM) Process to Implement Risk-Based Monitoring: Concepts and Case Study Oct 1/14
Discussion of the current clinical trial regulatory scenario in India and the many aspects involved in conducting clinical trials in this region
Speaker: Dr. Renu Razdan, Chief Operating Officer, Max Neeman International
Clinical Trials in India: Approval Process Sep 26/14
The webinar will discuss eBR as a key functionality for MES in the pharmaceutical Industry
Speaker: Andrew Whytock, Business Development Manager MES & Life Sciences, Siemens AG - Industry Sector
Discover Paperless Manufacturing with Electronic Batch Records (eBR) Sep 26/14
This session will provide latest information concerning mAb placental transfer and put into perspective the relevance of using these animal models during the development of antibody-like biotherapeutics
Speakers: Edward Marsden, Associate Director and Head of Reproductive and Developmental Toxicology, WIL Research
Eddie Sloter, Associate Director of Developmental and Reproductive Toxicology, WIL Research
John DeSesso, Principal Scientist and Office Director in Exponent’s Center for Toxicology and Mechanistic Biology, Exponent
Don Stump, Vice President, Nonclinical Safety Science, WIL Research
Comparative Placental Transfer of Biologics: Preclinical Alternatives to the Nonhuman Primate Sep 24/14
Using real-world examples, the presenter will provide an overview of Tissue Phenomics™ and how the platform supports improved biomarker discovery on through to clinical diagnostic assay commercialization
Speakers: Thomas Nifong, MD, Executive Vice President, Diagnostic Tests, Definiens
Tissue Phenomics™: From Biomarker Discovery to Clinical Diagnostic Assay Commercialization Sep 23/14
The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata Solutions
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
Streamlining the Site Budgeting and Payment Process Sep 23/14
This webinar will provide best practice approaches fo decision making regarding the identification and mitigation of operational risk, and optimization of positive opportunities
Speakers: Coleen Glessner, Vice President, Clinical Trials Process & Quality Pfizer Inc.
Brian W. Hagen, Ph.D., Managing Director, Decision Empowerment Institute
Ann Meeker O'Connell, Senior Director, Clinical Strategy Strategic Development QA, Janssen Research & Development LLC
Steve Whitaker, Executive Director, The Avoca Quality Consortium The Avoca Group
Clinical Trial Risk Management Using Decision Analytics Sep 23/14
This webinar will benefit agriculture or model organism researchers, as well as scientists working on any genomes less well-annotated than human or mouse
Speaker: Mick Watson, Head of Bioinformatics, Edinburgh Genomics, University of Edinburgh
Efficient Identification of Protein-Coding Variants in a Model Organism through Exome Sequencing Sep 17/14
Join the presenter for insight on the current German requirements, recent trends in price negotiations, and future direction for the AMNOG assessment
Speaker: Thomas Mittendorf, MBA, PhD, Vice President and Managing Director, Herescon GmbH, an AmerisourceBergen company
AMNOG – German Regulation in the Past, Present and Future Sep 17/14
Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 3: Transitioning from Bench into Clinical Phase
Sep 17/14
This presentation will visit current guidelines and also discuss subjects such as when should I study forced degradation
Speaker: Harley Everett Wilcox, Senior Scientific Advisor, ABC Laboratories
Analytical Methods: What Makes Them “Suitable” Can Be Subtle Sep 16/14
The process of signal detection (Signal Generation, Signal Strengthening, Signal Assessment and Signal Follow-Up) can generate more signals than true signals. Consequently, methods for ranking signals for further evaluation are required.
Speaker: Declan O’Rourke, MVB DipM MBA FRCVS, Ortec Consultancy, UK
Signal Detection & Trending in Veterinary Pharmacovigilance Sep 15/14
Now that both regulators and the industry alike have had almost two years of experience evolving the expectations of how PBRERs should be written and assessed, biopharmaceutical companies must create streamlined processes that will allow them to develop consistent standards for meaningful benefit-risk assessments
Speakers: Dominique Coleman, Director, Safety Aggregate Reporting and Analytics (SARA), Quintiles
Carrie Messina, Safety Aggregate Reporting Manager for the SARA group, Quintiles
Top Five Best Practices for Developing Your Periodic Benefit Risk Evaluation Report (PBRER) Sep 11/14
This webinar will delve into patient self-reporting, examining the use of paper and ePRO by phase and therapeutic area, and examining the projected use of patient-direct data
Speaker: Anne Zielinski, Global Lead for the Patient Engagement, Medidata Solutions
The Voice of the Patient in Clinical Trials: Hearing It, Understanding It Sep 10/14
During this webinar, the presenter will discuss the opportunities and challenges and provide tips on how to achieve success in running clinical trials in China
Speaker: Ianne Loh, General Manager, Fisher Clinical Services, China
China – Land of Opportunities & Challenges for the Clinical Research Industry Sep 10/14
This presentation will address regulatory trends and how to design a phase-appropriate E&L program
Speaker: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Are Extractable and Leachables Going Phase-Appropriate? Sep 4/14
This webinar will explore the benefits, challenges and methodologies for using POD and Protocol Pooling philosophies
Speaker: Joseph G. Iacobucci,Vice-President, Clinical Supplies, Xcelience
Protocol Pooling & Point of Distribution (POD) Clinical Labeling Sep 3/14
The speakers will provide an examination of the Conceptual Design process and Cost Evaluation of capacity, single-use vs. multi-use operations, redundancy, planned expansion and modularity
Speakers: Carrier Li, Director in Global Asset Planning, Amgen
Bob Allen, Senior Director, Facilities Integration, Fluor Industrial Services
Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 3: Defining Low Cost in Your Solution for Future Facilities
Aug 26/14
Through this webinar viewers will have a much more comprehensive understanding of the types of biological questions and problems RNA-Seq can address fully or be a key aid in addressing, and those it cannot
Speaker: Wendell Jones, PhD, Global Head, Genomic Bioinformatics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 5: The Evolution of RNA-Sequencing
Aug 22/14
The objective of this webinar is to review types of datasets commonly used in this field, discuss potential pros & cons of each type depending on research question, and identify other key considerations
Speaker: Pamela Landsman-Blumberg, MPH, DrPH, Director, Xcenda
Leveraging ‘Big Data’ - Methodological Considerations in Health Services Research Aug 21/14
Gain an understanding of ways to make the most of your early clinical development -- from efficiently conducting studies to providing dependable model predictions to optimize the overall process
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD Modeling & Simulation, & Center for Statistics in Pharmaceutical Drug Development, Quintiles
Professor Tim Mant, FRCP FFPM, Vice President, Medical Research and Principal Investigator, Quintiles
Best Practices for Optimizing Dose Escalation in First in Human Studies Aug 6/14
The presenters will share examples of delivering effective programs that achieved greater resource efficiencies and improved data quality nearly twofold better than industry benchmarks
Speakers: Teresa Lamantia, Vice President, Strategic Operations Quintiles
Alexandra Massoud, Director of Clinical Operations, Quintiles
Implementing Risk-based Monitoring, Using Oncology Examples Jul 31/14
This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speaker: Kim Robasky, PhD, Associate Director, Bioinformatics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 4: Sources of Error and the Role of Replicates in Next Generation Sequencing (NGS)
Jul 25/14
The presenters will discuss time response modeling for Rheumatoid Arthritis (RA) and similar indications based on a number of biologic agents that they have studied
Speakers: Russell Reeve, PhD, Senior Biostatistics Director, Center for Statistics in Drug Development, Quintiles
Niti Goel, MD, Senior Medical Director & Global Head, Rheumatology Center of Excellence, Quintiles
Time Response Modeling in Rheumatoid Arthritis and Other Autoimmune Indications Jul 23/14
This In this webinar, learn about a novel mass spectrometer-based approach that can speed detection and quantitation while achieving the required specificity and sensitivity—and how multiple reaction monitoring (MRM) techniques can be effectively applied to CMC-related development activities
Speakers: John Anders, Ph.D., Senior Scientific Advisor, ABC Laboratories
Rowel Tobias, Ph.D., Senior Scientist, Protein Chemistry ABC Laboratories
Novel MS Techniques Speed Detection of Biopharmaceutical Product and Process Impurities Jul 22/14
The increase in adoption of rapid sepsis diagnostic tests has been driven, in large part, by clinical studies that have captured the clinical and economic impact of these tests. This webinar will look at a few of these studies and discuss the design, execution and clinical and/or economic outcomes achieved in each.
Speakers: Michael Saubolle, Ph.D., D(ABMM), F(AAM), F(IDSA), Medical Director, Infectious Diseases Division Laboratory Sciences of Arizona/Banner Health, Clinical Associate Professor of Medicine, University of Arizona College of Medicine
Bert Lopansri, M.D, Associate Professor of Medicine, Division of Infectious Diseases , Intermountain Medical Center
Each Hour Counts: The Clinical and Economic Case for Rapid Sepsis Diagnostics Jul 17/14
This A case-study approach will be used to demonstrate how quickly evolving data can affect timelines and impact HEOR initiatives
Speakers: Jay Jackson, PharmD, MPH ,Vice-President, GHEOR Xcenda
Kasia Puto, PharmD, MBA, BCOP, BCPS, Associate Director, Xcenda
Breakthrough Therapy Designation: Oncology Lessons Jul 16/14
The aim of this webinar is to enable the end-user to select the best model and study design for their research
Speaker: Dr. James Wilson, Principal Scientist, Epistem
Pre-clinical Inflammatory Bowel Disease (IBD) Models Jul 10/14
This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Wendy Stewart, Vice President, Integrated Site Start Up, Quintiles
Sam Searcy, Associate Contracts Services Director, Global Regulatory Start Up, Quintiles
Accelerated Start-Up: The Right Start to Trial Success July 10/14
This webinar will describe the Translational Pharmaceutics™ platform and present Enabled-First-in-Human case studies to illustrate how it has been applied in early stage pharmaceutical drug development programs
Speakers: Alyson Connor, Director, Exploratory Clinical Pharmacology, Quotient Clinical
Phil Collis, VP, Clinical Development, Biocryst Pharmaceuticals
Enabled-First-in-Human™ – Accelerating Your Programs into Clinic and Through to Proof of Concept (PoC) Jul 9/14
This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.
John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation
Colorants in Devices: Integrated Strategies Toward Regulatory Approval Jul 8/14
Join ACM Global Central Lab and Pharm-Olam to learn the key considerations in working with outsourced partners in minimizing study start-up times, processing times and in optimizing work efficiencies
Speakers: Mark Engelhart, Chief Commercial Officer, ACM Global Central Laboratory
Jerry Boxall, Managing Director, ACM Europe and Asia ACM Global Central Laboratory
Dr. Yamin “Mo” Khan, Executive VP of Global Clinical Development Pharm-Olam International
Successful Management of Global Studies in Emerging Markets – Key Considerations from the CRO and Central Laboratory Perspective Jun 30/14
Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your pharmaceutical drug development success
Speaker: William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 2: Starting with the End in Mind: Regulatory Strategy from the Beginning
Jun 26/14
During this presentation, you will discover how the Target Product Profile (TPP) process can provide your company with a clear advantage in early clinical development, leading to the greatest possibility of approval and successful product launch
Speaker: Kimberly Hunsicker, MSN, CRNP, MBA, Vice President, Medical Device and Diagnostics, Premier Research
Target Product Profile Guiding Cross-functional Strategies for Medical Device and Diagnostic Organizations Jun 26/14
This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speaker: Vic Weigman, PhD, Associate Director of Translational Genomics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 3: Exome Sequencing and Analysis: Considerations for Sample Input, Capture Techniques and Pipelines related to Variant Detection
Jun 25/14
This webinar focuses on the relationship between Infinity Pharmaceuticals and INC Research as a case study in how Pharma and CROs can successfully make this transition
Speakers: Maria Makarovskaya, Clinical Outsourcing Lead, Infinity Pharmaceuticals
David Burnham, Vice President, Strategic Alliances INC Research
Innovation in Strategic Alliances: Moving from Transactional Outsourcing to a Partnership Jun 25/14
This webinar will explore the impact of clinical labels design and execution on the patient and site experience
Speaker: Kevin Shea, Label Program Director, Clintrak Clinical Labeling LLC., Part of Thermo Fisher Scientific
Clinical Labels: Keeping the Patient & Site in Mind June 17/14
The presentation will provide a discussion of operational challenges that are of key importance in adaptive trials with illlustrations using an actual phase I trial in oncology
Speakers: Marc Buyse, Sc.D., Founder and Chairman, IDDI
Linda Danielson, Chief Operating Officer, IDDI
Implementing Adaptive Trials: Operational Considerations June 12/14
Viewers will learn Industry-wide monitoring trends from the annual monitorforhire.com survey, how monitors spend their time on-site to support activities like recruitment and training, and a methodology for triggered monitoring visit schedules
Speakers: Scott Freedman, President, Founder, monitorforhire.com
Mauro Citterio, Director of R&D and Industrialization, Plastiape S.p.A.
The Role of the Monitor in a Risk-Based Monitoring Program June 12/14
In this webinar, the speakers will examine how Cambrex works with large, mid-size, emerging and niche pharmaceutical companies to meet their changing small molecule needs and bring their products to market quickly
Speakers: Joe Nettleton, VP of Operations and Site Director, Cambrex Charles City
Bjarne Sandberg, Managing Director, Cambrex Karlskoga
Quality, Speed, Flexibility and Customer Focus in API Manufacturing: An Introduction of Cambrex through Customer Case Studies June 11/14
Topics address include the neuropsychiatric tests required for demonstrating safety and tolerability in neuropsychiatric clinical trials, cognitive and functional endpoints that are relevant clinically and for regulatory purposes, and options that are available and affordable in the marketplace
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Matthew T. Healy, Senior Manager, Clinical Management, Premier Research
Measuring How Well Subjects Know and Do in Neuropsychiatric Clinical Trials Jun 10/14
This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speakers: Sarah Bacus, PhD, Senior VP and Chief Scientific Officer, Translational R&D Oncology, Quintiles
Jeff Fitzgerald, Director, Personalized Medicine Integration, EA | Quintiles
Genomic Know-How® Webinar Series
Part 2: Targeted Oncology Biomarker Solutions in the Elucidation of Inflammatory Breast Cancer Mechanisms
May 28/14
This webinar will explore the relationship between dry powder inhalers and hard capsules, how to match them together to give good powder aerosolization and delivery of the active ingredient deep into the lungs
Speakers: Brian E. Jones, Scientific Advisor, Qualicaps Europe S.A., Alcobendas (Madrid), Spain
Mauro Citterio, Director of R&D and Industrialization, Plastiape S.p.A.
Pulmonary Drug Delivery, Hard Capsules and Dry Powder Inhalers: Solving Development Challenges May 22/14
This talk will focus on lessons learned and applied to the standardization of global clinical trials and reducing variability in Anatomic Pathology and Histology (APH) services supporting global clinical trials
Speakers: Paul Kirchgraber, MD, MBA, FCAP, Vice President, Global Testing Services, Medical & Technical Affairs, General Manager of the Americas, Covance Central Laboratory
Steven G. Brodie, PhD, FACMG, Director of Molecular Genetics and Cytogenetics, NeoGenomics Laboratories
Harmonization of Anatomic Pathology and Histology services in Support of Global Oncology Clinical Trials May 21/14
This webinar focuses on the importance of consistent quality practices for management of veterinary pharmacovigilance, particularly, adverse event data
Speaker: Renee Helms, DVM, Director, PV Operations, Drug Safety Alliance, Inc.
Minimizing Negative Impact of Dirty Data in Veterinary Pharmacovigilance May 15/14
Viewers Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your pharmaceutical drug development success
Speaker: Eric Lang, MD, VP, Molecule Development Group, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 1: Integrated Approach for Successful Drug Development
May 13/14
Viewers will learn about the advantages of continuous glucose monitoring and the new possibilities DSI’s solution enables for diabetes and metabolic disease research
Speaker: Bob Brockway, Director of Advanced Market Research, Data Science International (DSI)
Continuous Glucose Monitoring Applications in Rodents May 13/14
This session includes a regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process
Speaker: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Rare Disease Trials: The Beginning, the Middle and the End May 12/14
In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementation of an Automated SUSAR System May 8/14
This webinar is intended to provide a better understanding of Rheumatoid Arthritis (RA) and new targets and pathways for developing new and potentially more effective RA, from more personalized approaches to RA drug development in the near-term future, to the critical next steps that could improve your company’s probability of successfully developing and commercializing new RA treatments
Speakers: Prof. Iain B. McInnes, Muirhead Professor of Medicine, Director of the Institute of Infection, Immunity and Inflammation, University of Glasgow, UK
Mary Katherine (MK) Farmer, MD, Senior Medical Director & Rheumatology Therapeutic Strategy Lead, Quintiles
Rheumatoid Arthritis – Biomarkers and Other New Advances in Drug Development May 7/14
This webinar will provide insight on how PhosphoScout® technology utilizes quantitative mass spectrometry and bioinformatics to investigate and signaling pathways and mechanisms on a global scale
Speaker: Henrik Daub, PhD, Senior Vice President, Science & Technology, Evotec
Quantitative Phosphoproteomics to Support the Discovery and Development of Kinase-selective Drugs May 7/14
This webinar will include a discussion of the current missing data landscape, how missing data can be prevented, the framework for handling missing data known as multiple imputation, and examples of how multiple imputation can provide reasonable approaches to analysing missing data
Speakers: Michael O’Kelly, Ph.D, Senior Director, Centre for Statistics in Drug Development (CSDD), Innovation, Quintiles
Jessica Cooper, Clinical Project Manager, Quintiles
Ilya Lipkovich, Ph.D., Senior Director, Center for Statistics in Drug Development (CSDD), Innovation, Quintiles
Handling & Preventing Missing Data: Improving Clinical Trial Data Credibility May 2/14
The key to successful implementation starts with identifying what type of strategy your study needs
Speaker: Donna Hanson, Director, Global Feasibility and Patient Recruitment, Advanced Clinical
How to Determine and Build an Effective Patient Recruitment and Retention Strategy Apr 30/14
This presentation reviews some of the elements that go into decision making for outsourcing pharmacovigilance work especially for off shore projects
Speaker: Angela Pitwood, Vice President, IPM Safety Services
Cracking the Code…
To Successfully Outsourcing Pharmacovigilance Activites
Apr 30/14
The presenters will share the rationale behind the development of this flexible targeted bisulfite sequencing tool and how it has been applied in methylation research
Speakers:Daniel Burgess, PhD, Group Leader – Sequence Capture, Roche NimbleGen
Nathan Springer, PhD, Professor, University of Minnesota
Discover Epigenomic Variation with a Flexible Targeted Bisulfite Sequencing Method Apr 29/14
This webinar is intended to help genomic researchers better understand technical hurdles in the analysis of FFPE-derived RNA
Speaker: Patrick Hurban, PhD, Global Head of Genomic Research and Development, EA | Quintiles
Genomic Know-How® Webinar Series Part 1: Best Practices for Obtaining RNA Sequencing Data from Formalin-fixed Paraffin-embedded (FFPE) Samples Apr 25/14
The presenter will provide insights on how to address these challenges, updates on regulatory requirements and examples of new technology that can assist with monitoring and compliance
Speaker: Euan Douglas, Global Project Director, Fisher Clinical Services
Extreme Transportation Challenges Apr 23/14
This webinar will focus on an introduction and overview of Antibody Drug Conjugates, and the development of a mechanistic PK/PD model for preclinical-to-clinical translation of ADCs
Speaker: Dhaval Shah, PhD, MS Pharmaceutics, Assistant Professor, Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York
Using PK/PD Modeling for Antibody Drug Conjugate Translation Apr 23/14
This webinar will explore the current state of eCOA and the future offered by BYOD, while highlighting some of the issues that need to be addressed to move the industry forward
Speaker: Paul O’Donohoe, Director of Health Outcomes, CRF Health
What's Next in eCOA? Psychometric Validation and BYOD Apr 17/14
The focus of the presentation will be on introducing an emerging process-development methodology that is based on applying novel and existing bioreactor monitoring technologies to existing bioreactor processes, coupled with applied mathematics and data-integration techniques across disciplines
Speakers: Jeff Breitm Ph.D., Director, Bend Research Inc.
Brandon Downey, Technical Group Leader, Bend Research Inc.
A Multi-Disciplinary Approach to Optimize and Redefine Bioreactor Operations: Leveraging Coupled Bioreactor Analytics, Automated Sampling, and Applied Mathematics to Improve Productivity & Product Quality Apr 16/14
The presentation will discuss when a HAL study will likely be required and how a HAL study is conducted
Speaker: Dr. Lynn Webster, Vice President of Scientific Affairs, PRA, and President, American Academy of Pain Medicine

Human Abuse Liability Role in NDAs
Apr 15/14
Find out how sponsors, CMOs and their integral partners are successfully using active units to support global clinical and commercial supply chain with industry best practices.
Speakers: James Klingelhoefer, Business Development Manager, World Courier
Tony Mistretta, Distribution Manager, Almac Clinical Services
Global Clinical and Commercial Supply Chain: Protecting Bulk Product with Active Temperature Controlled Systems Apr 8/14
Learn about the complexities and challenges in producing SDTM datasets, as well as groundbreaking new technology that allows SDTM datasets to be generated directly from an EDC system
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Albert Chau, CStat CSci, Senior Director, Data Science, SCRI Development Innovations
Automating the Production of SDTM Datasets Apr 2/14
Five considerations are discussed to optimize the budget impact analysis’ methodology
Speaker: Marie Maxime Hubert, M.Sc., Manager, Health Economics and Outcomes Research, JSS Medical Research Inc.
Pharmacoeconomics: Five Simple and Effective Ways to Optimize Budget Impact Analyses and Obtain Drug Reimbursement Apr 1/14
This is part two of a four-part series that presents the tools and methods used to identify and quantify Production Capacity at a Facility/Site/Enterprise level
Speakers: Jim Robertson, Senior Director, Facilities Integration, Fluor Industrial Services
Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services
Tim McNeill, Director of Technology, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 2: Unlocking High Volumes of Production Capacity & Increasing Enterprise Level Output
Mar 27/14
This webinar will examine how an eISF can improve site performance and audit readiness, as well as enable a remote monitoring strategy that significantly reduces the amount of on-site monitoring visits
Speaker: Kevin McNulty, Product Marketing Director, Intralinks
Leveraging a Single Source of Truth to Improve Site-Sponsor Collaboration from Site Activation to Study Close Out Mar 27/14
Through case examples the speakers will discuss ways to accelerate enrollment across the continuum of protocol development to activation
Speakers: Martin Lee, M.D., Vice President, Investigator Relations, PRA
Gretchen Goller, MSW , Sr. Director, Patient Access and Retention Services, PRA

A Comprehensive Approach to Accelerating Clinical Trial Enrollment
Mar 26/14
This webinar will provide a regulatory perspective on what is expected from an independent and objective assessment of clinical data
Speakers: Marc Buyse, Founder, IDDI and CluePoints
Francois Torche, CEO, CluePoints

Risk-Based Monitoring & Central Statistical Monitoring
Mar 25/14
The aim of this webinar will be to convey the importance of considering differing ages/ stages of development of children when designing and conducting clinical trials, and how doing so can contribute to successful well-designed pediatric studies
Speakers: Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Susanne Schmidt, MD, PhD, Director Medical Affairs, Premier Research

The Aspects of Clinical Development Related to the ICH E11 Categories of Children: Preterm Neonates, Term Neonates, Infants and Toddlers, Children and Adolescents
Mar 24/14
Speaking from years of experience, the presenters will share insights they have gained through years of deploying risk-based monitoring principals and procedures from a variety of therapeutic studies on a global scale
Speakers: Martin Giblin, Vice President, Clinical Data Management, Quintiles
Teresa Lamantia, Vice President, Strategic Operations, Quintiles
Risk-based Monitoring: Using Centralized Data Surveillance to Evolve Data Review and Site Engagement Mar 20/14
Dr. Moulis will discuss how Merrimack Pharmaceutical has devised a method of IHC assay design that increases the chance of finding the optimal cutpoint of biomarker expression and maximizing the chance of success for companion diagnostic use
Speaker: Sharon Moulis, Ph.D., Principal Scientist and Director of the Human Tissues Laboratory, Merrimack Pharmaceuticals
IHC Assays for Companion Diagnostic Use: Standardization Methods that Maximize Success Mar 18/14
This webinar will focus on APAC, including a review of the new GVP guideline by EMA & its impact, the challenges of complying with changing country regulations for patient data collection, and an overview of the major achievements of PvPI
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur
Pharmacovigilance in APAC: An Update and Focus on India (PvPI) Mar 13/14
In this webinar, you will learn what an employer can do with baseline testing
Speaker: MaryRose Cusimano-Reaston, Ph.D., Founder and Chief Science Officer, Emerge Diagnostics
The Sunshine Act: CMS Mandatory Reporting Requirements and Baseline Testing Mar 12/14
The presenters will discuss scientific and ethical imperatives associated with the use of animals in experiments and testing, and examine burgeoning alternatives to animal research
Speakers: Aysha Akhtar, Fellow, Oxford Centre for Animal Ethics, and Medical Officer, Food and Drug Administration
Dr. Toby Gill, Independent Nanotechnology Professional, UK
Alternatives to Animal Testing Methods Feb 27/14
The presenters have used whole-genome bisulfite sequencing (WGBS) to profile dozens of primary tumors from The Cancer Genome Atlas (TCGA) project, and found that DNA methylation changes occur within lineage-specific and cancer-specific chromatin states
Speakers: Ben Berman, Ph.D., Assistant Professor, Division of Bioinformatics, Department of Preventive Medicine, University of Southern California
Ramesh Vaidyanathan, Ph.D., Associate Director of Research and Development, Epicentre
Using Whole-genome Bisulfite Sequencing to Understand Chromatin State Changes in Cancer Feb 26/14
This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars
Part 2 : Regulatory Perspective

Feb 20/14

This webinar will review the benefits of leveraging a secure collaboration platform to ensure distribution of patient safety documents to sites and other parties across the globe, while reducing notification time from days to hours
Speaker: Martin K. Grant, Senior Program Manager Life Sciences, Intralinks
Informing the Investigator: Reduce Liability Risk and Improve Patient Safety through Automated SUSAR Processing Feb 20/14
The presenters will share data demonstrating how our workflow will help you achieve greater molecular complexity with minimal DNA sample input or with FFPE DNA, hence maximizing variant discovery with your precious samples
Speakers: Maryke Appel, PhD, Technical Director Kapa Biosystems
Daniel Burgess, PhD, Group Leader Sequence Capture, Roche NimbleGen
Unleash the Potential of your DNA Samples with an Optimized Target Enrichment Workflow for Next-Generation Sequencing Feb 5/14
During this webinar, the speakers discuss preclinical and clinical perspectives on how to use increasingly intricate and sophisticated procedures for intravenous injection or infusion, and new ideas on attending to animal welfare
Speakers: Stéphane Milano, Chief Scientific Officer, WIL Research – Europe
Edward Marsden, Associate Director, WIL Research – Europe
Tim Vanderveen, Vice President, Center for Safety and Clinical Excellence
Intravenous Infusion: From Preclinical Challenge to Clinical Reality Feb 5/14
The Sunshine Act compliance requirements in the context of the present regulatory environment, enforcement, penalties for failure to comply, and potential unintended consequences, both good and bad, will be discussed
Speakers: Gary Yingling, BS, MS, JD., Partner, Morgan Lewis, Washington DC
The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? Jan 29/14
This webinar will discuss adaptive designs for phase I, phase II and phase III clinical trials in oncology
Speakers: Marc Buyse, Sc.D, Founder and Chairman, IDDI
Tomasz Burzykowski, PhD, VP of Research, IDDI
Everardo Saad, MD, Scientific Director and Chairman, Dendrix, Senior Oncology Consultant, IDDI
Pros and Cons of Adaptive Designs: A Leisurely Conversation Between a Clinician and Two Statisticians Jan 14/14
This webinar will focus on cardiovascular pressure sensing and relevant performance specifications to ensure integrity of your data
Speaker: R. Dustan (Dusty) Sarazan DVM, PhD, Vice President & Chief Scientific Officer, Data Science International (DSI)
A Review of Cardiovascular Pressure Sensing and Relevant Performance Specifications to Ensure Data Integrity Jan 8/14
The presenters will discuss the theory and application of quality systems and their foundations with measurable outcomes to achieve successful design and implementation of meaningful QMS
Speakers: Pierre Deschamps, C.M., Ad. E., Adjunct Professor, Faculty of Law, McGill University
Marianne Vanderwel, MEng, MSc, Director, Human Research Protection Program, IRB Services
Quality Management in Clinical Research: A Matter of Human Rights Dec 18/13
During this webinar, the presenters will explore how mHealth technology can be used to reduce overall clinical development cost, while increasing subject and investigator satisfaction, retention, and engagement
Speakers: Andy Lee, Deputy Head of Clinical Sciences and Operations, Sanofi
Glen De Vries, President, Medidata Solutions
Randy Spaulding, Founder and President, Spaulding Clinical Research, LLC
Patient-Centric Technology for Better Trial Outcomes Dec 13/13
This webinar will provide insight into key genomic concepts and technologies that have shaped our contemporary understanding of the biology, treatment, and drug development opportunities in oncology
Speakers: Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology, Quintiles
Jeff Fitzgerald, Product Specialist Director, Global Laboratory Solutions, Quintiles
Catching Up with the Genomic Era in Oncology: Key Considerations for Incorporating Genomics into Oncology Drug Development Dec 13/13
In this webinar, you will learn how Metamark Genetics developed a new prognostic test using image analysis for early stage prostate cancer based on tissue samples: ProMark
Speakers: Thomas Nifong, M.D., Senior Vice President of Clinical Labs, Metamark Genetics
Thomas Colarusso, Vice President, Business Development Tissue Diagnostics, Definiens
ProMark: Lessons Learned in Launching a Prognostic Test Based on Tissue Image Analysis Dec 10/13
Learn about the details of the candidate identification, assay development, testing and results, beginning with the derivation of the initial list of candidates, to the identification of the five blood-based proteins, which together constitute the biomarker panel used in the commercial protein expression test, developed by Caprion Proteomics in collaboration with Integrated Diagnostics (InDi)
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
A Blood-Based Proteomic Classifier for the Molecular Characterization of Pulmonary Nodules:
A Case Study in the Discovery and Validation of a Molecular Diagnostic Using Caprion’s Technology Platform
Dec 9/13
This webinar will outline the methodology and conduct of safety benefit-risk assessments for post-marketed products
Speaker: Mary Mease, RPH, MPH, Senior Director, Risk Management, Quintiles
Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications Dec 6/13
The presenters will examine MCIDs and different types of PROs that are available for respiratory diseases and review case studies of successful demonstrations of product value in respiratory programs
Speakers: Dr. Chad Gwaltney , Senior Director, Consulting Services, ERT
Dr. Kai-Michael Beeh , Founder and Medical Director, insaf Respiratory Research Institute Wiesbaden
Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with Patient-Reported Outcomes (PROs) Dec 4/13
A discussion of current trends and insights by the presenters
Speakers: Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA, and member of Gedeon Richter Group
Dr. Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited

Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends

Dec 4/13

The presenters will discuss the primary drivers of site costs, the correlation and impact of study complexity, plus case studies highlighting the benefits of better study planning
Speakers: Stella Stergiopoulos, Project Manager, Tufts Center of the Study of Drug Developtment (CSDD)
Vic DeSario, Director, Trial Planning Solutions, Medidata Solutions
Data-driven Site Negotiations: Fast Track to Fair Market Value (FMV) Nov 25/13
In this webinar, Dr. Eisinger will describe the development and validation of a multiplex panel of biomarkers for quantifying the commitment, onset, and induction of apoptosis by the intrinsic pathway in tumor tissue samples
Speaker: Dominic Eisinger, PhD, Director of Strategic Development, Myriad RBM
Quantitative Profiling of the Intrinsic Pathway of Apoptosis in Tumor Tissue using Myriad RBM’s Multiplex ApoptosisMAP™ Nov 22/13
This webinar will discuss the latest advances in AD research and explain how central laboratories can contribute to the progress in the battle against this disease by supporting clinical trials through quality testing
Speaker: Tatiana Souslova, M.Sc., Ph.D., Principal Scientist, ACM Global Central Laboratory
Past, Present and Future: The Role of Central Laboratories in Alzheimer’s Disease Research Nov 21/13
This webinar will highlight a solutions-based approach to filling large panels for complex trials, while incorporating special populations in a high volume environment
Speakers: Ingrid Holmes, Senior Director, Clinical Operations, Algorithme Pharma
Petra Hillebrand, Vice President, Integrated Services, Altasciences
Early Stage Recruitment Strategies for Complex Trials & Special Populations: How to Deliver Full Panels On-Time Nov 21/13
The seminar will address the tools used to define and examine facility critical path production, methods of identification of high value/low impact bottlenecks and the tools used to evaluate and present multi-year variable production volumes with hierarchically organized production improvement solutions
Speakers: Craig Sandstrom, PhD, Director of Process Engineering, Fluor Corporation
Tim McNeill, Director of Technology, Fluor Industrial Services
Jim Humphries, Vice President, Performance Technology, Fluor Corporation
Maximizing Production Capacity for Growth
Part 1: Finding 5% through Facility Optimization
Nov 21/13
This third webinar of the series will focus on the data analysis questions related to clinical outcome assessment in multinational clinical trials
Speaker: Antoine Regnault, PhD, MSc, MA , Research Director, Mapi HEOR & Strategic Market Access - France
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 3: Quantitative Approaches for Clinical Outcome Assessment in a Cross-cultural Context
Nov 20/13
The presenter shares his experience and recommendations for optimizing clinical programs through a flexible approach
Speaker: Michael McNear, RPh, Global Head, Clinical Supply Optimization Services, Fisher Clinical Services
Why Flexibility Matters in Your Clinical Supply Chain Nov 20/13
This webinar provides an overview of the key benefits of hard capsules liquid-fill encapsulation with a focus on practical applications, case studies and coating technologies
Speakers: Jakob Mettler, Marketing Manager, Tillotts Pharma AG
Brian E. Jones, Scientific Advisor, Qualicaps Europe S.A., Alcobendas (Madrid), Spain
Claudio Scialdone, Contract Services & Business Development Senior Manager, Tillotts Pharma AG
Discovering the Power of Capsules and Liquid Filling Technology Nov 19/13
In this webinar, the presenters will discuss ways to develop targeted strategies with the potential to increase enrollment rates and reduce lost to follow-up
Speakers: Tracy Stewart, MBA, Associate Director, Patient Recruitment, Quintiles
Scott Oakes, PhD, Associate Clinical Project Management Director, Cardiovascular and Metabolic Therapeutic Area, Quintiles
Erica Caveney, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Quintiles
Bernadette Tosti, Manager, Market Development, Quintiles Communications, Quintiles
Best Practices in Patient Recruitment and Retention for Diabetes Trials Nov 18/13
Designing and implementing an extractables and leachables program can save significant time/cost in development and potentially avoid pitfalls, which may increase time to market
Speaker: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Understanding and Implementing Effective Extractable and Leachable Programs Nov 15/13
An open dialog explaining the changes occurring now, and what the future looks like, for clinical product development
Speaker: Dan White, Vice President, Global Operations, Quintiles
The Next-Generation of Risk-based Monitoring Nov 15/13
This program will present a systematic approach to the risk assessment of clinical trials, using methodologies that have been accepted by regulatory authorities as the basis for approvals in other healthcare categories and in other industries
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx International, an inVentiv Health Business
Risk Assessment: Laying the Foundation for RBM Nov 14/13
Learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning
Speaker: Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management PRA
Challenges with Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them Nov 13/13
This webinar will address in more detail the advantages of globalization as well as the best practices for overcoming the challenges
Speakers: Garth Tierney, Executive Vice President, Asia/Pacific, INC Research
Silvia Zieher, President, Clinical Development and Latin America Operations, INC Research
Globalizing Clinical Trials to Include Emerging Markets Nov 12/13
In this webinar, an overview of the market environment along with the key operational, logistical, and regulatory aspects of conducting clinical trials in China and other Asian countries will be discussed
Speakers: Li Yan, MD, PhD, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets, Merck
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Current Trends for Conducting Clinical Trials in China Nov 12/13
This webinar will discuss factors critical to success in the design and execution of pediatric clinical trials
Speaker: Alison Sampson, Senior Project Director, Premier Research
Successful Pediatric Studies: Key Study Design and Operational Considerations Nov 11/13
This presentation will focus on the use of RNA aptamers for developing cancer diagnostics and treatments
Speakers: Paolo Serafini, Ph.D., Assistant Professor of Microbiology & Immunology, University of Miami, Miller School of Medicine
Samir Iqbal, Ph.D., Assistant Professor Electrical Engineering and Bioengineering (Courtesy), Nanotechnology Research and Education Center, University of Texas at Arlington
Justin Dassie, Ph.D., Post-Doctoral Research Fellow, University of Iowa
RNA Aptamers: A New Paradigm in Cancer Diagnosis and Treatment Nov 7/13
This webinar focuses on Covance's experience with in vitro assays to demonstrate pharmacological similarity between biologics and biosimilars
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Biomarker Center of Excellence, Covance
Biomarker Challenges in Biosimilar Drug Development Nov 6/13
This presentation reviews the background and drivers for making the decision - when to outsource pharmacovigilance work. There are several schools of thought on how best to handle safety data as well
Speaker: Angela Pitwood, Vice President, IPM Safety Services, a division of IndiPharm, Inc.
Outsourcing in Pharmacovigilance Nov 5/13
Join our speakers for an in-depth look at challenges and proven strategies to develop and implement post-approval risk management procedures
Speakers: Mazhar Thakur, MD, MBA, MAMM, Senior Director, Safety and Risk Management, PRA
Agnes Rivaille, Scientific Affairs Director, Late Phase Services, PRA
Risk Minimization/Mitigation in the Post-Marketing Arena: Regulatory Landscape, Strategy and Effectiveness Nov 4/13
The presenter will share his thoughts and discuss the importance of having an independent Medical Affairs Strategy that is aligned with business objectives
Speaker: Ramin Farhood, PharmD, MBA, Senior Director, Global Head Medical Affairs Operations, Baxter BioScience

The Evolving Role of Global Medical Affairs

Nov 1/13

The talk will outline the steps taken to transform a complex natural product with poor ‘druggability’ features into an orally available agent suitable for clinical investigations
Speakers: Mike Peel, Ph.D., Executive Director Discovery Research, SCYNEXIS, Inc.
James Balkovec, Ph.D., Principal and Owner, ChemTract LLC
Drug Discovery using Natural Products – Optimization Studies of Inhibitors of Glucan Synthesis as Anti-Fungal Agents Oct 31/13
This presentation will focus on the rationale for selecting varioius technologies enabling the progression of compounds that require bioavailability enhancement to achieve target absorption
Speaker: David Vodak, Ph.D, Vice President of Chemistry, Bend Research Inc.
Technology Selection for Enhancing Bioavailability Oct 30/13
This webinar will focus on Covance's experience in standardization of methods for microparticle isolation from preclinical and clinical samples, as well as recent findings from microparticle analyses in disease models of Oncology and Cardiovascular/Metabolic Disease
Speaker: Katherine T. Landschulz , PhD, Manager, Biomarker Center of Excellence, Covance
Microparticles and Applications in Assays and Endpoints Oct 29/13
In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementing an Automated SUSAR Reporting System Oct 24/13
This webinar will cover the concepts involved in using metadata to improve the efficiency of data transformation programming. We will also see a case study of a large portfolio of work that has implemented these concepts to great success
Speaker: Keith Hibbetts, Manager, Statistical Programming, inVentiv Health Clinical
Using Metadata for Data Transformation: How Your Specifications Can Serve You Oct 24/13
This diabetes webinar will provide an overview of advanced data mining and software applications that can be used to understand the implications of various protocol entrance criteria
Speakers: Claudia de Oliveira, MD, PhD, MPH, Associate Medical Director, Cardiovascular and Metabolic Therapeutic Delivery Unit , Quintiles
Denise Messer, MA, Senior Project Manager, Clinical Analytics and Simulations, Quintiles
Erica Caveney, MD, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Cardiovascular & Metabolic Therapeutic Delivery Unit, Quintiles
Bruce Basson, MS, Associate Director, Clinical Planning & Design, Quintiles
Improve Protocol Designs for Diabetes Trials Using Predictive Techniques Oct 23/13
Discover the flexibility and efficiencies offered through an FSP partnership
Speaker: Bryan Haas, Pharm.D., Vice President, Functional Service Partnerships, PPD
FSP Answered: How New Partnership Models are Shaping Client-Provider Relationships Oct 22/13
The need for leaner, faster and cost effective clinical trials demands more attention on where to target enrollment and Latin America can  play a key role this regard
Speakers: Mauro Martinelli, Emerging Markets Specialist, Quintiles
Jose Emilio, Associate Director, Clinical Operations, Quintiles
The Clinical Research Landscape in Latin America Oct 21/13
In this presentation, the advantages and challenges of applying NMR in these new areas will be discussed
Speakers: Darryl LeBlanc, Ph.D., NMR Spectroscopist, Manager - Analytical Services, SCYNEXIS, Inc.
Allan R. Moorman , Ph.D., Founder, Alta Vetta Pharmaceutical Consulting
Determining Relative Response Factors of Impurities by NMR & Developing GMP NMR Methods – Expanding the Role of NMR beyond Structure Identification Oct 18/13
Learn how RFID enabled smart rooms can eliminate shrinkage, automate reordering processes, simplify inventory reconciliation and financial accounting, and eliminate manual inventory checkouts to return researchers and lab tech’s back to their bench more quickly
Speaker: Keith Hoffman, Director of Marketing, Terso Solutions, Inc.
Improving Efficiency in Research and Clinical Labs with RFID Smart Rooms Oct 18/13
Learn how to customize a cost-effective communications mix that is continually monitored and updated across multiple channels, including sales reps, so that you can drive prescription growth at any point in your commercial lifecycle – from launch to loss of exclusivity
Speaker: Peter Dussias, Executive Director, Integrated Channel Management Services, Quintiles
Maximize your Physician Reach and Optimize your Spend with Integrated Channel Management Oct 17/13
The webinar will examine the automation of NGS library preparation using different chemistries and its applications
Speakers: Dr. Oleg V Evgrafov, Associate Professor, University of Southern California
Susan Lee, Senior Application Specialist, Hamilton Robotics
Automation Solutions for NGS Sample Preparation Oct 16/13
During this webinar leaders in agricultural research will share their research using Roche’s sequence capture technology for genotyping by sequencing in wheat, barley and maize
Speakers: Patrick Schnable, PhD, Distinguished Professor and Director, Center for Plant Genomics, Iowa State University
Eduard Akhunov, PhD, Associate Professor – Department of Plant Pathology, Kansas State University
Nils Stein, PhD, Group Leader Research, Leibniz Institute of Plant Genetics and Crop Plant Research (IPK), Gatersleben, Germany
Efficient SNP Discovery for Crop Genomes through Exome Sequencing Oct 16/13
During this presentation, you will learn how to establish the best and most cost-effective approach to a cleaning, disinfection and monitoring program
Speakers: Harolyn M. Clow, M.S., SM (NRCM), Manager, Pharmaceutical Microbiology, Eurofins Lancaster Laboratories
Anthony J. Langione, Senior Chemist, Method Development & Validation, Eurofins Lancaster Laboratories
Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies Oct 10/13
During the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care.
Speaker: Mark Travers, VP, Head of Clinical Study Units, Sanofi-Aventis

Risk-Based Monitoring

Oct 10/13

The speaker will discuss the emerging field of companion diagnostics with focus on its importance in clinical trial design and how pharmaceutical drug / companion diagnostic co-development is rapidly changing the pharmaceutical  development process
Speaker: Mark Roberts, PhD, Director, Diagnostics Development, Covance
Accelerating Drug Development through Drug & Companion Diagnostic Co-Development Oct 9/13
A discussion of the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps progressive guidance in the world on the inclusion of women in clinical trials, plus insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative
Speaker: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Mr. Zach Halinan, Director of Patient Communication and Engagement Programs, Center for Information and Study on Clinical Research Participation
Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations Oct 7/13
This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with a sponsor to develop methods that compare the surrogate matrix and surrogate analyte approaches for the analysis of five amino acids in human plasma: alanine, valine, methionine, leucine and isoleucine
Speaker: Barry R. Jones, Ph.D., Assistant Research Investigator, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Better Methods for Novel Biomarkers Series:
LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches
Oct 3/13
In this webinar, the speakers will focus on the use and quality of COA translations, the importance of linguistic validation and how to assess the reliability of its process
Speakers: Axelle Nadjar, Key Account Director – Linguistic Validation, Mapi
Caroline Anfray, Business Development Director – Linguistic Validation, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 2: Maximizing Cross-cultural Equivalence of PRO Measures: The Linguistic Validation Methodology
Oct 3/13
The speaker will present a unique cooperation between IMS GrantPlan and Greenphire’s eClinical GPS that delivers powerful reporting and analytics on costs throughout a clinical trial, allowing you to stay informed as never before
Speakers: Sam Whitaker, CEO, Greenphire
John Humphreys, Senior Product Manager, IMS Health
Investigator Payments: Handling the Entire Process from Initial Budget to Payment Reconciliation Sep 30/13
The presenters will share their views of the most recent FDA guidance and explain its impact on clinical development
Speakers: Dan White, Vice President, Global Operations, Quintiles
Dan Ballard, Senior Director, Data Quality, Quintiles
FDA Guidance on Risk-based Monitoring while Improving Data Quality Sep 30/13
During this webinar you will learn how planning can help avoid costly delays and quality issues, ultimately saving you time and setting you off on the right path to a successful dossier filing and registration
Speakers: Terry Weber Sosa, Vice President, NAMR Biostatistics, Quintiles
Laurie Henricks, Senior Director, Head of North America Regulatory Affairs, Quintiles
Planning for Success: Early Opportunities to Set the Course for Successful Global Marketing Authorization Sep 26/13
During this webinar, Cubist Pharmaceuticals and CluePoints will explore how sponsors are harnessing the power of Central Statistical Monitoring (CSM) to improve data quality and de-risk their studies
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Kostia Franklin, Senior Manager, Clinical Data Management, Cubist Pharmaceuticals
Risk-Based Monitoring Improves Data Quality – It’s A Fact! Sep 25/13
The implementation of innovative technology tools that make INC Researcg's SDM approach a viable option for improving efficiency in clinical trials will be discussed, as well as how life science companies can use technology to implement a strategic monitoring program
Speakers: Jill Collins, Senior Director, Clinical Innovation, INC Research
Stephen Young, Senior Product Director, Medidata Solutions
Reduce Site Monitoring Costs with a Strategic Approach Sep 25/13
The case-reports presented will include a discussion of the tools used to comprehensively monitor antigen-specific T cells and evaluation of the immunostimulatory and suppressive compartments
Speaker: Yoav Peretz, Ph.D, Senior Principal Scientist, Caprion/IMMUNECARTA Services
Revealing Relationships Between the Clinical and Immunological Response in Vaccination Trials Sep 24/13
This webinar will demonstrate how selecting the right EDC can help ensure project success and return on investment
Speaker: Toby Odenheim, MBA, Director, Clinical Technology Services, SynteractHCR, United States
Selecting the Right Electronic Data Capture (EDC) Platform Sep 23/13
The presentation will include valid examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing
Speakers: Jan Verelst, M.Sc. Chemical Engineering, International Business Development Manager for Life Sciences, Siemens
Kjell Francois, Ph.D., Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT
PAT/QbD – Keeping an Eye on Your Quality Sep 18/13
In vitro pharmacological profiling, testing compounds in select panels of assays like SafetyScreen, play an increasingly important role in reducing pharmaceutical related safety attrition
Speaker: Gonzalo Castillo, Ph.D., Technical Director, Eurofins Panlabs
In Vitro Safety Screening for Clinical Liabilities Sep 17/13
This webinar will explore the role of life cycle management and our observations and experiences as they relate to “what’s worked” and “what hasn’t"
Speakers: Keith Ruark, Vice President, AVOS Consulting (an INC Research business)
Bridget Martell, President, BAM Consulting
Life Cycle Management of Biopharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice Sep 17/13
This webinar and panel discussion focuses on new ways to design biomarker driven trials and access the right patients, as well as demonstrate the power of the Total Cancer Care data warehouse, featuring participation from Millennium Pharmaceuticals
Speakers: Kyle Kuvalanka, MBA, VP, Strategy and Business Development, Millennium Pharmaceuticals
William (Bill) Trepicchio, PhD, Senior Director, Translational Medicine, Millennium Pharmaceuticals
William Dalton, PhD, MD, CEO, M2Gen and Director, Personalized Medicine Institute at Moffitt Cancer Center
Frank Makosiej, PharmD, Executive Director, Operations, Strategy and Planning, Covance
Enhanced Strategies for Design and Execution of Biomarker-driven Oncology Trials Sep 12/13
During this webinar the presenters will discuss the wide array of scalable dosage form technologies available, matching technology strengths with API properties, and bringing all of the choices together through biological modeling
Speakers: Chris Craig, Director, Dosage Form Product Development, Bend Research Inc.
Brett Caldwell, Ph.D., Director, Formulation Science, Bend Research Inc.
Rational Design Of Modified Release Dosage Forms: From Pharmacokinetic Targets Through Technology Selection Sep 12/13
This second webinar in the series will examine market access related issues in Japan, South Korea and Taiwan including the ongoing healthcare reform and its implication on access
Speaker: Chia Wen Lee, Head of Emerging Markets Access, Biogen Idec

Evolving Market Access in the APAC Region: The Pharmaceutical Market in Japan, South Korea and Taiwan

Sep 6/13

A discussion of platforms, platform selection and migration, optimising tests for FFPE tissue, clinical delivery for trial enrichment, and development routes for companion diagnostics
Speaker: Dr. Austin Tanney, Scientific Liaison Manager, Almac
Optimizing Assays from FFPE for Biomarker Strategies Sep 4/13
Improving Development of antibacterial and antifungal agents remains an important priority in the pharmaceutical research industry
Speaker: Lynn Miesel, Ph. D., Global Technical Director, Infectious Disease and Microbiology, Eurofins Panlabs
Anti-Infective Services for Drug Discovery and Development Aug 15/13
Improving management of CRE’s and other antibiotic-resistant BSI’s with rapid molecular diagnostics
Speakers: Karen C. Carroll, M.D., Professor of Pathology and Medicine, Johns Hopkins University School of Medicine
Blake W. Buchan, PhD, Assistant Professor of Pathology, Medical College of Wisconsin, Associate Director, Clinical Microbiology Dynacare Laboratory
Debra A. Goff, PharmD, FFCP, Clinical Associate Professor, The Ohio State University College of Pharmacy, Infectious Diseases Specialist, The Ohio State Medical Center
Each Hour Counts: Improving Management of CRE’s and Other Antibiotic-Resistant BSI’s with Rapid Molecular Diagnostics Aug 14/13
An overview of clinically relevant assays for ultrasensitive endocrine clinical trial testing services will be discussed
Speakers: Walt Chandler, PhD, Executive Director of Endocrine Sciences, LabCorp
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Advancements in Endocrine Testing – Case Studies and Solutions for Clinical Trials Aug 7/13
This webinar will explain the similarities and differences that exist for device and pharmaceutical studies in the US and EU and the nuances of study conduct
Speakers: Kimberly D. Hunsicker, MSN, CRNP, MBA, Vice President, Global Medical Devices & Diagnostics, Premier Research
Victoria Cavendish, BSc(Hons), MPhil, PhD, PGDipPH, MICR, CSci, Senior Director, Devices, Premier Research
Medical Device and Drug Research: Similarities and Differences Jul 30/13
This webinar will focus on the regulatory requirements and expectancies for the conduct of studies to support the scheduling of new chemical entities
Speaker: Mary Jeanne Kallman, Ph.D., Director of Nonclinical Neuroscience, Covance
Addressing Scientific and Regulatory Challenges for Abuse Liability Studies Jul 26/13
The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

Jul 25/13

The presentation will include valid examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing
Speakers: Pamela Bruen, Life Sciences Industry Manager, USA, Siemens
John Klaas, Corporate Account Manager, Siemens
Dr. Kjell Francois, Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT
PAT/QbD – Keeping an Eye on Your Quality Jul 23/13
The best practices for applying quantitative and qualitative information to develop study strategies, from feasibility through patient recruitment will be discussed
Speakers: Michelle Archibald, Senor Director, Site & Patient Strategies, Quintiles
Nicole Turner, Associate Director, Global Feasibility, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Mark Brown, Vice President of Strategic Site Intelligence and Feasibility, Quintiles
DOs and DON’Ts of Study Start-Up: Best Practices to Improve Efficiency and Meet/Exceed Timelines Jul 23/13
The panel will explain how safety and therapeutic medics, biostatisticians, data management experts and operations gurus apply risk-based thinking before a trial begins
Speakers: Rick Sax, M.D., Senior Vice President, Integrated Clinical Services, Quintiles
Dan White, Vice President, Global Operations, Quintiles
Risk-based Thinking: The Success of Risk-based Monitoring Begins with Risk-based Thinking Jul 19/13
This webinar will explore the roles of DSMBs and IRBs in particular and examine how they are involved in ensuring patient safety in pediatric trials, the unique considerations in developing DSMBs for pediatric populations, how regulatory guidance is driving change for DSMBs and IRBs and how to best work with each other and sponsors to ensure the highest degree of safety for patients and the best quality of research and data
Speakers: Jeffrey Cooper: Vice President Global Consulting at WIRB Copernicus Group IRB
Amy Professor Philip Walson, MD Board Certified in Paediatrics, Clinical Pharmacology and Medical Toxicology; Visiting Professor, Department of Laboratory Medicine at Georg-August-University Medical School, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Pediatric Safety Monitoring: Role of IRBs and DSMBs Jul 18/13
Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Angi Robinson, Executive Director, Scientific Account Leader, Premier Research
Charlene Sanders, Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in the US Jul 16/13
This webinar will feature a case study on Heparin-induced thrombocytopenia (HIT) antibodies developed in response to heparin, and its low molecular weight analogues using the SQI Diagnostics’ platform
Speakers: Jaymie R. Sawyer, Ph.D., Vice-President, Research and Development, SQI Diagnostics
Robert Massé, Ph.D., Vice-President, Large Molecule Bioanalysis, Algorithme Pharma
A Multiplexed Approach for Immunogenicity Assessment Using the New SQiDlite™ System: Case Study Analysis Jul 11/13
This webinar will cover mapping SDTM specifications during study design, describe the benefits of having an SDTM database available during study conduct and the final datasets within 24 hours of database lock, and provide a brief overview of the technology that provides these capabilities
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Prashanthi Vunnava, Senior SAS Programmer, Alkermes, Plc.
SDTM in Real Time – A Case Study: Initial Datasets by First Patient In; Final Datasets Within 24 Hours of Study Lock Jul 11/13
This webinar will discuss approaches used at Bend Research to design, assay, and manufacture spray-dried powder formulations containing proteins and nucleic acids
Speakers: Jeff Breit, Ph.D., Director of Inhalation Technology, Bend Research Inc.
Devon DuBose, Senior Research Engineer, Bend Research Inc.
Vaccine and Biotherapeutic Formulation Development and Manufacture Using Spray-Drying Jul 10/13
This webinar will encompass the three key steps that maximize cross-cultural equivalence of scales assessing patient benefit and safety in international research
Speakers: Benoit Arnould, PhD, Senior Director, Mapi
Nicola Germain, MA, Senior Research Associate, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 1: Cross-cultural Qualitative Research for Simultaneous Scale Development
Jul 2/13
This presentation will examine recent changes in Indian clinical trial regulations, iImmediate and long term impacts, an foreseeable opportunities
Speaker: Dr. Josemund Menezes, MBBS, Regional Director, Clinical Development (Asia-Pacific), Sanofi Pasteur

Adhering Navigating the Dynamic Indian Clinical Trial Landscape

Jun 28/13

This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with our sponsors to develop quantitative methods for biomarkers and biotherapeutics by adapting the immunoprecipitation methodologies of ELISA with the specificity and robustness of LCMS to achieve sensitivity that is comparable to ELISA but with the specificity of LCMS
Speaker: Gary Schultz Ph.D., Director, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Quantitative Analysis of Biomarkers with the Specificity and Robustness of Liquid Chromatography/Mass Spectrometry (LC/MS) and the Sensitivity of ELISA Jun 27/13
This presentation will explore optimization and validation strategies for flow cytometry assays, as well as highlight assays used at MPI Research on GLP toxicology and drug discovery studies
Speaker: Brandon Zeigler, PhD, research scientist, MPI Research
Practical Uses for Flow Cytometry in Toxicology Studies Within a GLP Environment Jun 25/13
This webinar will examine the need for more oversight in pharmaceutical advertising and promotion, and review the basic regulations and guiding principles
Speaker: Moulakshi (Mou) Roychowdhury, PharmD, JD, Director of Regulatory Affairs – Global Advertising & Labeling, Forest Laboratories

Drug Advertising and Promotion Labeling: FDA Regulations

Jun 21/13

Learn how to optimize your product launch by first understanding and addressing the needs of all your key stakeholders and then organizing all the launch activities
Speaker: Troy Hampton, MBA, Senior Director, Global Market Access and Commercialization, Quintiles
Optimize Your Product Launch in a Multi-Stakeholder Environment Jun 20/13
In this webinar, animal models of pain to explore the efficacy of novel new pharmaceutical candidates will be summarized to include acute, inflammatory and chronic pain conditions
Speakers: Linda Hedley, Global CNS Technical Director, Eurofins Panlabs
Tamara King, Ph.D., Assistant Professor, College of Osteopathic Medicine and Center for Excellence in the Neurosciences, University of New England
Translational Animal Models of Pain Jun 19/13
This webinar will provide an overview of clinical outsourcing in the MENA (Middle East and North Africa) and APAC (Asia-Pacific) regions and will provide considerations for programs of development
Speaker: Larry Ajuwon, (former) Senior Outsourcing Manager, Genzyme Europe, the Netherlands

Clinical Development, Contracts and Outsourcing in MENA & APAC

Jun 19/13

This webinar will explore the direction clinical research is headed and the role innovation plays in its new course
Speakers: Jamie Macdonald, Chief Executive Officer, INC Research
Amy Kissam, Executive Director, Integrated Clinical Processes, INC Research
John Whitaker, Ph.D., Senior Vice President, Clinical Innovation, INC Research
Clinical Process Innovation: Driving Predictability in Clinical Development through Innovation Jun 18/13
In this webinar the issue of adherence to asthma medication in both clinical trials and the real world will be explored, including measurement of adherence, data interpretation, regulatory implications, and the challenges of generalizing study data to routine clinical practice
Speakers: Liam Heaney, Clinical Professor and Consultant, Queen's University. Belfast, UK
Peter Summerfield, VP, Global TAH Respiratory, Global Product Development, PPD
Rav Seeruthun, MRCGP, MFPM, Senior Director, Global Late Stage Research, PPD
Adherence in Asthma: Comparing Clinical Trials to the "Real-World" Jun 14/13
This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP) and Risk Evaluation and Risk Evaluation and Mitigation Strategies (REMS) for EU and US submissions
Speaker: Amy Sun MD, Ph.D., FACP, Director of Clinical Risk Management, Merck

Drug Safety & Risk Management

Jun 14/13

This webinar will discuss the benefits of partnering with an academic medical center and will feature case studies for successful biomarker discovery, biomarker development and companion diagnostics co-development
Speakers: Steve Groshong, MD, PhD, Pathology Division Chief, National Jewish Health
Preveen Ramamoorthy, PhD, Molecular Diagnostics Laboratory Director, National Jewish Health
Leveraging an Academic-Industry Partnership for Commercial Success Jun 13/13
A discussion of the core principles, best practices and steps that must be taken in order to optimize the selection of the diagnostic testing to support the trial protocol
Speaker panel from ACM Global Central Laboratory: Mark Engelhart, Chief Commercial Officer
Kathleen Murray, Executive Director, Scientific Affairs
Suzanne Dale, PhD, D(ABMM), Director of Microbiology and Molecular Diagnostics
Endpoint Based Protocol Development: A Central Laboratory Perspective + Microbiology Case Study Jun 12/13
This webinar will discuss ways in which we can ensure “distribution readiness” by having a real understanding of the pre-FPI planning and preparation as well as country rollout post approval
Speaker: Elizabeth Gallagher, Director Global Logistics, Fisher Clinical Services
Ensuring Distribution Readiness Before FPI: A Simple Guide to De-Risking Jun 12/13
This session will give an in-depth examination of Central Statistical Monitoring (CSM)
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Removing the Risk in Risk-Based Monitoring – A Practical and Proven Approach to Implementing Central Statistical Monitoring Jun 10/13
This webinar will explore how biopharma can use information technology to bring pharmaceuticals to market faster, better, and cheaper
Speaker: Thomas Grundstrom, Vice President & Global Head, Integrated Processes and Technologies, Quintiles Infosario
Mark Gorton, Senior Director of Information Technology, Quintiles
Accelerating Drug Development by Harnessing Technology Jun 7/13
A discussion of the clinical research scenario in S.E. Asia including market opportunity, registration, new regulatory and safety guidelines
Speakers: Dr. Shariq Anwar, Head of Operations, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
S.E. Asia Drug/Device Update: Market Potential and Regulatory Environment Jun 6/13
The webinar will examine the objectives of PMOS and Phase IV studies, possible designs, benefits, disadvantages and challenges
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post-Marketing Observation Studies (PMOS) and Phase IV Studies Jun 5/13
The speakers will discuss the disposition challenges required to guide lead optimization, predict in vivo activity in animal models, and identify any species-dependent variables that may impact the likely human clinical dose
Speakers: Steve Wring, Ph.D., Director of Drug Metabolism and Pharmacokinetics, SCYNEXIS, Inc.
Tom von Geldern, Ph.D., Pharma/Biotech Consultant, Embedded Consulting
DMPK for Targeted Tissue Delivery: Solutions for the Most Challenging Part of Outsourcing Jun 4/13
Understand the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and additional regulations for the conduction of clinical trials
Speaker: Jeremy Lim, Pharm.D., Fellow, Clinical Development, Novartis Pharmaceuticals Corporation

Adhering to Good Clinical Practice: An Overview of Clinical Trials

May 31/13

LifeSciences The presentation will include a discussion of a suite of techniques developed at UCSF/HHMI based on ribosome profiling (deep sequencing of ribosome protected fragments) that dramatically expand our ability to follow translation in vivo
Speakers: Jonathan Weissman, Ph.D., HHMI Investigator, UCSF/HHMI Nicholas Ingolia, Ph.D., Principal Investigator, Carnegie Institution for Science
Scott Kuersten, Ph.D., Staff Scientist, Epicentre, an Illumina Company
Monitoring Protein Synthesis One Codon at a Time Through Ribosome Profiling May 30/13
LifeSciences In this webinar, the presenter will review how an effective collaboration between client and service provider can be achieved in outsourcing pharmaceutical development
Speakers: Torkel Gren, PhD, Director, Recipharm
Development of an Innovative Microtablet Dosage Form May 30/13
LifeSciences This talk will discuss the use of computational biology tools to ensure high-quality genomics when used as part of the QC process
Speaker: Sergey Stepaniants, Ph.D., Head of Computational Biology, Genomics Laboratory, Covance
Impacting Clinical and Preclinical Decisions: Computational Analysis of Complex Genomics Data Sets May 29/13
LifeSciences In this webinar the presenter will discuss best practices for optimizing design to improve success rates and deliver more cost effective and timely clinical programs
Speaker: Dan Frederic L. Sax, M.D., Global Head, Center for Integrated Drug Development, Quintiles
Optimizing Trial Outcomes through Computer Assisted Design May 28/13
LifeSciences This webinar focuses on OncoPanelTM,, a collection of 240 genomically and histologically diverse cancer cell lines, that providesmultiplexed high-content imaging analysis of therapeutics in oncology
Speakers: O. Jameel Shah, Ph.D, Principal Scientist and Group Leader, Oncology, Eurofins Panlabs
Jonathan Crane, Ph.D., Senior Scientist, Oncology and Cell Biology, Eurofins Panlabs
Predictive Biomarker Discovery for Oncology Small-Molecules and Biologics May 22/13
LifeSciences Learn strategies for establishing an extractables study design, allowing for a detailed risk assessment
Speakers: Thomas C. Lehman, Ph.D., Manager, Method Development and Validation, Eurofins Lancaster Laboratories, Inc.
Erica J. Tullo, Ph.D., Senior Chemist, Method Development and Validation, Eurofins Lancaster Laboratories, Inc.
Paolo Pescio, Medical Devices & Toxicology Manager, Eurofins Biolab
Best Practices for Conducting Extractable and Leachable Studies May 22/13
LifeSciences Learn how Caprion applies its label-free mass spectrometry-based proteomics platform to successfully identify tissue-specific protein biomarkers that can be used to follow disease progression in human blood
Speaker: Eustache Paramithiotis, Ph.D., Senior Director, Molecular and Cell Biology, Caprion
Discovery of Circulating Protein Biomarkers by Analysis of the Tissue Secretome May 21/13
LifeSciences An in-depth look at the challenges and solutions in conducting biosimilar trials
Speaker: Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA
Challenges and Solutions in Conducting Biosimilar Trials May 15/13
LifeSciences Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Susan Tansey, MD, Medical Director, Paediatrics, Premier Research
Susan Bhatti, PhD, Executive Director European Regulatory Affairs and Medical Writing, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in Europe May 14/13
A discussion of the latest developments in nanotechnology including a case study of a targeted therapeutic developed with the use of nanotechnology
Speakers: Dr. Toby Gill, Independent Nanotechnology Professional, UK
Dr. Jeff Hrkach, Senior Vice President of Technology, Research and Development, BIND Biosciences

Nanotechnologies in Bioscience: Targeted Therapeutics & Drug Development

May 10/13

LifeSciences Translating the Preclinical Pharmacology of the Select TLR8 Agonist VTX-2337, into Clinical Activity using the Myriad RBM MAP Inflammation Panel
Speaker: Dr. Gregory N Dietsch, Ph.D., DABT, Vice President of Research, VentiRx Pharmaceuticals
Translating Preclinical Pharmacology to Clinical Activity May 2/13
LifeSciences In this webinar, Quintiles will share recent research insights and real experiences using a modernized approach to risk-based monitoring
Speakers: Dan White, Quintiles, Vice President, Global Operations, Quintiles
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: Deployment Insights and Lessons Learned Apr 30/13
LifeSciences An in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA
Speaker: Thijs van Iersel, M.D., Senior Director of Scientific Affairs, PRA, Early Development Services, The Netherlands
Risk Assessment and Risk Mitigation in Phase I Trials in High Risk Compounds: A Continuously Developing Process Apr 25/13
LifeSciences This webinar will break down the issues related to the implementation and tracking of a risk-based monitoring program through the utilization of site quality management as well as the process and organizational challenges of adopting site quality management and centralized monitoring
Speakers: Steve Young, Senior Product Director, Medidata Solutions
Laurie Halloran, President, Halloran Consulting Group
Site Quality Management to Optimize Risk-Based and Centralized Monitoring Apr 23/13
LifeSciences Forward-thinking companies are now looking to the cutting edge in supply chain technology: sensor-based logistics (SBL). During this webinar, you will be provided with five questions to get ahead of the SBL trend and things to consider when getting a program off the ground
Speakers: Richard W. Horan, Vice President, Support Operations, med fusion
Chris Swearingen, Marketing Manager, FedEx
Sensor-Based Logistics for Life Science Supply Chains Apr 22/13
LifeSciences This webinar will provide insight into current approaches and issues in co-developing novel oncology therapeutics and diagnostics
Speakers: Brad Smith, Ph.D., Vice President, Translational Medicine, Center for Integrated Drug Development, Quintiles
Eric Faulkner, MPH, Director, Global Market Access – Diagnostics / Personalized Medicine, Quintiles
Drug-Diagnostic Co-Development Strategies for Oncology: Critical Aspects of Development and Launching an Oncology Companion Diagnostic Apr 19/13
This first webinar in the series will examine market access related issues in China, including the ongoing healthcare reform in China and its implication on access
Speaker: Chia Wen Lee, Head of Emerging Markets Access, Biogen Idec

Evolving Market Access in the APAC Region: The Pharmaceutical Market in China

Apr 18/13

The speaker will examine the move in the pharma/biotech industry to the adoption and implementation of Lean Six Sigma
Speaker: Rodrigo Crispim, Hub Unit Manager, Regional Clinical Operations Office, Bristol-Myers Squibb

Serialization Best Practices for Lean Six Sigma in Clinical Development and R&D

Apr 17/13

LifeSciences This webinar will focus on lead optimization pharmacology and toxicology and a fail fast strategy that many companies are using
Speaker: Shawn Heidel, D.V.M., Ph.D., Executive Director, Global Discovery Pharmacology & Toxicology, Covance
A “Fail Fast” Strategy for Lead Optimization Pharmacology and Toxicology Apr 16/13
LifeSciences During this webinar, the speakers will discuss how Fujifilm Diosynth Biotechnologies has provided manufacturing flexibility under accelerated timelines on a cost-effective basis and how they compared process and product quality data for single use systems vs. stainless steel reactors, critical factors to consider when selecting the elements of the final (1000L) manufacturing train

Speakers: Stewart McNaull, Section Leader, Upstream Process Development, Fujifilm Diosynth Biotechnologies, RTP, NC, USA
Bo Kara, Director of Science & Technology, Fujifilm Diosynth Biotechnologies, Billingham, UK

Achieving Optimal Performance From Single Use Platforms: Elegant Process Design To Achieve Efficient and Economic Operational Flexibility in Multi-product GMP Facilities Mar 27/13
LifeSciences The speakers will evaluate the quality of clinical trials being conducted in Russia / Ukraine compared to Western Europe, Eastern Europe and other Emerging Markets based on the results of recent FDA inspections conducted at clinical trial sites in these regions
Speakers: David Passov, MBA Senior Vice President, Eastern Europe, ClinStar, A PRA Company
Stanislav Gneushev, MD, MRQA, Director, Quality Assurance, ClinStar, A PRA Company
An Evaluation of Clinical Trial Quality in Russia / Ukraine Compared to Western Europe, Eastern Europe and Other Emerging Markets Mar 22/13
LifeSciences During this presentation, you will learn current strategies and best practices for comparator product testing
Speakers: Nathan T. Whitford, M.B.A., Manager, Chemistry and Site Operations, Eurofins Lancaster Laboratories, Inc.
Jutta Wagner, Head of Project Management Manufacturing, Fisher Clinical Services
Chrissy Leslie, Manager, Pharmaceutical Product Testing, Eurofins Lancaster Laboratories, Inc.
Effective Strategies for Managing Comparator Product Testing Mar 20/13
LifeSciences The speaker will present an overview of LabCorp's HCV capabilities, and discuss ongoing and future HCV assay development activities, such as the implementation of next generation sequencing platforms for minor variant detection
Speaker: Christos Petropoulos, PhD, Chief Scientific Officer, Monogram Biosciences, a LabCorp Company
Comprehensive Global Testing Solutions for HCV Novel Therapeutics in Clinical Development Mar 13/13
LifeSciences This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global
Challenges and Opportunities in Risk-based Approach to Monitoring Mar 12/13
LifeSciences This webinar will provide an overview of the basics of model based pharmaceutical development and its practical applications in selecting the right dose and population, optimizing trial, program, and portfolio design, and quantitative decision making through computer modeling and simulation
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation, Quintiles
Russell Reeve, PhD, Senior Strategic Biostatistics Director, Quintiles
Model-Based Drug Development (MBDD) 101: A Primer on MBDD and Its Benefits Feb 28/13
Join our speaker from Bristol-Myers Squibb, one of the first companies to understand the multiple benefits of item level serialization, as he examines serialization and its use in fighting counterfeit pharmaceuticals.
Speaker: Daljeet Sahni, AD EDO Engineering, Global Supply Chain, Bristol-Myers Squibb

Serialization in Pharmaceuticals

Feb 27/13

LifeSciences This third webinar in our series will focus on how conducting clinical trials in Russia can help cut the cost of clinical research
Speakers: Sergei Varshavsky, MD, PhD, Sr. VP, Global Strategy, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 3 - Cutting the Cost of Clinical Research: The Solution Comes from Russia
Feb 25/13
In this webinar, Dr. Speers will describe the AAHRPP accreditation process, the value of accreditation and why sites and IRBs should seek accreditation, and demonstrate that research protection and quality are responsibilities of those at the highest level at the site
Speaker: Marjorie A. Speers, Ph.D., President and CEO, AAHRPP

Human Research Protection and Understanding the Landscape of AAHRPP Accreditation

Feb 20/13

LifeSciences In this webinar, our expert shares a case study for a biological pharmaceutical product that required re-development of both the bioassay method for potency, as well as an improved process for extracting the pharmaceutical product from a carrier so that the potency of the final pharmaceutical product could be reproducibly measured
Speaker: Peter Wunderli, Ph.D., associate director, biopharmaceutical services, PPD, cGMP laboratory
Developing Robust Potency Assays for Validation: A Case Study Feb 19/13
LifeSciences In this webinar we will discuss best practices for using data to objectively assess the best fit countries and associated sites for particular trials
Speakers: Chris Frega, Sr. Director and Head of Global Feasibility, Quintiles
Tom Larrichio, Senior Director, Strategic Site Intelligence, Quintiles
Country and Site Selection: Optimizing Protocol Planning Decisions by Leveraging Data Through Custom Algorithms Feb 13/13
LifeSciences A strategy to achieve a better assessment of QT liability early in the pharmaceutical development cycle, at lower cost, will be discussed by the experts in this webinar
Speakers: Dr. Jay Mason, Chief Medical Officer, Spaulding Clinical Research
Dr. Charles Benson, Eli Lilly and Company and E14 Implementation Working Group Member
Moderator: Daniel Selness, Sr. VP and GM of Clinical Research, Spaulding Clinical Research
Farewell to TQT Studies? Feb 7/13
This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

Jan 30/13

LifeSciences Dr. Klein will discuss Health Canada’s approach and stringent infectious disease requirements for Phase 1 clincal trials. Dr. Larouche will discuss the practical dimensions of the problem, and what must be done at the clinic level, over and above regulatory requirements.
Speakers: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Dr. Richard Larouche, BPharm, MD, Director, Medical Affairs, Early Stage Development, Pharmanet/i3
Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered Jan 18/13
The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight into the regulatory pathway for biosimilar and biobetter registration
Speaker: Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc.

FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013

Jan 16/13

LifeSciences This webinar will address the various clinical, regulatory (US & EU) and commercialization strategies that may be implemented in the development of products to treat rare diseases and orphan indications
Speaker: William C. Maier, PhD, Chief Scientific Officer, REGISTRAT-MAPI
Clinical, Regulatory and Commercialization Strategies for Rare Diseases Jan 15/13
LifeSciences Learn how to dramatically enhance the value derived from outsourcing, without additional expense
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Thomas J. Wilson, Vice President of Quality, Synta Pharmaceuticals Corp.
Best Practices for Outsourcing Drug Development: The Human Elements of a Successful Relationship Jan 14/13
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Clark Williard, Executive Director, Mass Spectrometry Operations, PharmaNet/i3
Application of GC/MS/MS in Monitoring Steriods as a Pharmacokinetic and Pharmacological Biomarker Dec 17/12
LifeSciences This webinar will provide insight into some of the current issues in progressing oncology compounds from the pre-clinical arena through early clinical development in humans, with specific focus on three areas of early oncology research that can make or break these critical first-in-man studies
Speakers: Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology Therapeutic Area, Quintiles
Eric Groves, MD, PhD, Vice President, Center for Integrated Drug Development, Quintiles
Chris Learn, PhD, PMP, Senior Clinical Project Manager, Quintiles
Maximizing Quality and Efficiency of Go/No Go Decisions in Early Oncology Development Dec 14/12
LifeSciences Understand the role of Next Generation Sequencing in personalized medicine, how to identify various genomic alterations in rapid time, and how Next Generation Sequencing can help stratify patient populations
Speaker: Anup Madan, Ph.D., Director of Sequencing, Covance
Personalized Medicine Through Integrated Next Generation Sequencing Dec 12/12
LifeSciences In this webinar we will discuss how evidence generated for regulatory purposes can be useful for CER
Speakers: Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy
Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America
Comparative Effectiveness Research – The Role of Evidence Synthesis and Non-randomized Real World Studies Dec 11/12
LifeSciences During this session we will explore ways to minimize the variability in pain studies and methods for increasing the chances of showing a therapeutic effect for the study medication being tested
Speaker: Michael Kuss, Vice President, Analgesia, Premier Research
Managing Variability in Pain Studies Dec 10/12
LifeSciences This presentation will explore requisite study designs and detail the procedures routinely employed in support of scientific and regulatory best practices in assessing auditory safety
Speakers: Matthew Abernathy, MS, Associate Scientist, MPI Research
Rachel Tapp, BS, LATG, Study Director, MPI Research
What’d You Say? Understanding Nonclinical Auditory Safety Evaluations Dec 7/12
LifeSciences This presentation will review the potential clinical applications of Vectra DA in the management of RA, with a specific focus on findings from recent studies presented at the Annual Rheumatology Meeting held in DC
Speaker: Eric Sasso, MD, Vice President Medical and Scientific Affairs Crescendo Bioscience
Clinical Applications of Vectra™ DA: Review of Recent Study Findings Dec 4/12
LifeSciences This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.
Speakers: Carolyn Finkle, Vice President, Global Regulatory Consulting, Catalent Pharma Solutions
Vincy Abraham, Senior Manager, Bioanalytics Catalent Pharma Solutions
Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges Nov 30/12
LifeSciences This presentation will provide an overview of cell based potency assays, including current regulatory expectations as well as trends within the industry
Speakers: Weihong Wang, Ph.D., manager of Molecular and Cell Biology Services, Eurofins Lancaster Laboratories
Darren Kamikura, Ph.D., Research Scientist, Eli Lilly and Co
Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory Nov 15/12
LifeSciences This webinar discusses evolution and the current landscape of pediatric clinical research networks, selecting and engaging with the right network for your pediatric trial, and enhancing your pediatric clinical research process while fostering high-quality, ethical research on medicines for use in children
Speakers: Brian Smith, MD, MPH, MHS, Associate Professor of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute
Peter Clayton, BSc, MB, ChB, MD, MRCP, FRCPCH, Professor of Child Health, Director NIHR Greater Manchester, Lancashire & South Cumbria (GMLC) Medicines for Children Local Research Network, Associate Director, Greater Manchester Comprehensive Local Research Network
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
The Role of Research Networks in Pediatric Clinical Trials Nov 13/12
LifeSciences In this webinar we will present and discuss some tools that Emerald Bio uses for the expression and crystallization of membrane proteins
Speaker: James Fairman, Ph.D., Group Leader, Membrane Protein Crystallography, Emerald Bio
Tools for the Expression and Crystallization of Membrane Proteins Nov 12/12
LifeSciences Post Ap­proval Clinical and Epidemio­logical Studies (PACES) that in­clude Phase IV and Post Mar­keting Observational Studies (PMOS) have evolved into an integral and essential phase of the pharmaceutical develop­ment life cycle with implications that have comparable weight to that of the Phase II and III registrational studies. Join Dr. John Sampalis for a live discussion.
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post Approval Clinical Epidemiological Studies (PACES) Nov 12/12
LifeSciences In this final webinar of our series, we will look at (i) when we should start preparing for database lock, (ii) what can/will go wrong, (iii) how we can minimize/correct issues and (iv) what checklists everyone should have in their repertoire to ensure success.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Homestretch – Don’t Let the Timelines Slip Nov 9/12
LifeSciences Our speaker will discuss the enormous value and practical considerations of including Russia in your global clinical study planning from the outset, and at a minimum, in your risk management and contingency planning
Speakers: Richard Koenig, Vice President of Operations, ClinStar,
Alina Tatarenko, MD, Senior Project Manager, ClinStar
Including Russia and Ukraine in Your Risk Management and Rescue Study Plans Nov 8/12
LifeSciences During this webinar, you’ll get practical guidance from CMC experts on a stepwise approach to determining if, what type, and how much extractables/leachables data may be required to address the regulatory concerns
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Ken M. Wong, M.Sc., Senior Scientist, Center for Extractables and Leachables, Merck & Co.
Supply Chain Changes in Phase III/Post-Commercialization: Regulatory Considerations for Container/Closure Systems Nov 6/12
LifeSciences This webinar will focus on the key aspects of monitoring for the development of renal toxicities and the issues in conducting clinical trials in patients with both recognized and unrecognized kidney disease
Speaker: Lynda Szczech, MD, MSCE, FASN, FNKF, Medical Director, Pharmacovigilance, PPD, LLC
Kidney Safety in Clinical Trial Design: Recognizing the Complexities and Avoiding the Pitfalls Nov 2/12
LifeSciences This webinar will discuss a number of methodologies to facilitate the assessment of potential development risks including safety and immunogenicity, stability, aggregation and low productivity
Speaker: Noel Smith, Ph.D., Senior Scientist, Lonza Applied Protein Services, Lonza Biologics plc
Developability: Reducing the Risk of Failure of Biotherapeutic Candidates Oct 23/12
LifeSciences This webinar will provide insight into the various regulations which direct pediatric diabetes drug development for registration globally
Speakers: Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles
Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles
Robin Huff, PhD, Sr. Director, Global Pediatric Regulatory Strategy Lead, Quintiles
Moderator: Rick Turner, PhD, Sr. Scientific Director, Corporate Communications, Quintiles
DIABETES DRUG DEVELOPMENT: A Perspective on Pediatric Indication Planning Oct 19/12
LifeSciences This webinar presents an overview of some of the key components involved in developing products related to the application of biomarkers earlier in the pharmaceutical development pipeline
Speakers: Tim Davison , B. Math, Ph.D., VP, Bioinformatics and Biostatistics, Almac Diagnostics
Susan Farragher, Operations Manager, Almac Diagnostics
Developing and Applying Biomarkers in Early Phase Clinical Trials

Oct 18/12

LifeSciences The webinar will examine operational and analytical considerations for early detection of potential organ toxicity
Speakers from ACM Global Central Laboratory:
Mark Engelhart, Chief Commercial Officer
Andrew Botham, PhD, Research & Development Manager
Maria-Magdalena Patru, MD, PhD, Scientific Affairs Medical Liaison
Drug-Induced Organ Toxicity (DIOT): The Early Detection and Management of Elevated Biomarkers to Ensure Patient Safety Oct 17/12
LifeSciences The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging the three elements of people, process and technology
Speakers: Thomas Grundstrom, Vice President, Integrated Processes and Technologies and Global Head, Quintiles Infosario®
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: The Future Roles of People, Process & Technology Oct 15/12
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Brigitte Pellerin, Senior Bioanalytical Project Manager, PharmaNet/i3
Reduce Filing Time - Fast Turnaround of Innovator and BE First-to-File Analysis Oct 15/12
LifeSciences This second webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia and Kazakhstan, and the upcoming trends in this market
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 2 - Conducting Cinical Trials in Russia and Kazakhstan
Oct 12/12
LifeSciences During this webinar, you’ll get practical guidance from CMC experts on how to avoid the most common development hiccups and E&L pitfalls related to container/closure selection and regulatory requirements
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Allan R. Moorman, Ph.D., President and Chief Operating Officer, Alta Vetta Pharmaceutical Consulting
You Have Received Extractables Information From Your Container/Closure Manufacturer. Now What? Oct 10/12
LifeSciences This webinar will present rationale for a dedicated study start-up process which lends to a decrease in cycle times, higher quality pre-study site assessments, and improved study start up metrics
Speakers: Brett Barber, Senior Director, Strategic Sourcing, PharmaNet/i3
Nicole Baker, Director, Strategic Resourcing, PharmaNet/i3
Lisa Rhiner, Clinical Study Lead, PharmaNet/i3
Innovative Solutions Designed to Improve Operational Capacity, Efficiency, and Effectiveness in Clinical Monitoring Oct 4/12
LifeSciences This webinar will provide a review of current adnexal mass management practices, including improvements in patient care with the addition of recently cleared blood tests, and the criteria necessary for utility of blood tests when used to identify potential ovarian malignancy
Speaker: Michael D. Randell, MD, FACOG, Department of Obstetrics and Gynecology, Northside Hospital, Atlanta, Georgia
OVA1 & Managing Adnexal Masses Oct 2/12
LifeSciences An examination of why Asia-Pac excels as a region for strategic clinical data management / medical writing base in which to achieve savings in cost and time investment
Speakers: Koteshwar Govind, Head of Data Management, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
Global Data Management & Medical Writing: The Asia-Pac Advantage

Sep 26/12

LifeSciences This presentation addresses the challenges of analytical method development that is required for physicochemical characterization
Speakers: Robert J. Duff, Ph.D., manager, Biopharmaceutical Services, Lancaster Laboratories
Lieza M. Danan-Leon, Ph.D., principal scientist, Biochemistry, Lancaster Laboratories
Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis Sep 25/12
LifeSciences This webinar will provide best practice insights into dose selection for First in Human (FIH) dose escalation studies to mitigate risk and optimize the value of your early clinical data
Speaker Panel from Quintiles: Eleanor A. Lisbon MD, MPH, CPI, Senior Medical Research Director, Early Clinical Development
Professor Tim Mant, Vice President, Medical Research and Principal Investigator
Steve Lowes, PhD, Vice President, Scientific, Advion Bioanalytical Labs
N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation
EARLY CLINICAL INSIGHTS: Best Practices for Optimizing Dose Escalation in FIH Studies Sep 24/12
LifeSciences In this webinar, case studies will be presented to demonstrate how advanced immune monitoring tools have been used to gain insight on the proportion of major lymphocyte subsets, their response to various stimuli and their activation versus exhaustion status.
Speaker: Yoav Peretz Ph.D., Principal Scientist, Caprion/IMMUNECARTA Services
PD-1 and the Immune Exhaustion Paradigm: Immune Profiling tools for Drug Discovery and Clinical Monitoring Sep 20/12
LifeSciences This webinar will encompass key spray-dried dispersion (SDD) aspects that enhance and sustain in vivo drug solubility, and how these attributes are preserved during downstream solid dosage form formulation and process development
Speakers: Randy Wald, R.Ph., Senior Research Fellow, Bend Research Inc.
Chris Craig, Research Fellow, Bend Research Inc.
Using Amorphous Spray-Dried Dispersions to Develop Oral Solid Dosage Forms Sep 19/12
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Chris Beaver, Director, Immunochemistry and Cell Biology Operations, PharmaNet/i3
Immunogenicity Testing Considerations for Biosimilar Drug Development Sep 17/12
LifeSciences The presentation give an overview of the advantages of conducting clinical trials in emerging markets, an analysis of the importance of start-up timelines in the decision-making process when selecting geographies for a global clinical trial, and a review of the regulatory challenges that can be anticipated when starting up a trial in Russia
Speakers: Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
Richard Koenig, Vice President of Operations, ClinStar
Study Start-up: A Comparison Across Emerging Markets Sep 13/12
LifeSciences A discussion of the  fundamental principles of preclinical modeling in cancer and the specific roles that imaging can play in improving the predictive power for clinical success, formulating a new standard for pharmaceutical development, with particular reference to gliomas as case studies
Speakers: Jim Dougherty, MD, General Partner, Arcus Ventures, and former Deputy Physician-in Chief for Clinical Affairs a Memorial Sloan-Kettering Cancer Center (MSKCC)
Dick Leopold, PhD, VP, R&D, Molecular Imaging Inc.
John L. Chunta, PhD, Senior Imaging Scientist, Molecular Imaging Inc.
Driving Translational Imaging to a Drug Industry Standard: Case Studies in Glioblastoma and Other Clinically Predictive Cancer Models Sep 12/12
LifeSciences The session will address key regulatory expectations and the role of ethics committees in pediatric development
Speakers: Daniel Brasseur, MD, PhD, Chairman of the EU Paediatric Committee (PDCO)
Petra B. Knupfer, MD, MBA, Managing Director of the Ethics Committee, Medical Association of Baden-Württemberg, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development Sep 11/12
LifeSciences In this 3rd of 4 webinars, we look at the impact of one or more protocol amendment(s) on the study database and the EDC team and how changes can be implemented smoothly and with minimal effect on the ongoing study
Speaker: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change Sep 10/12
LifeSciences Although the Guidance remains in draft form, it is clear that the key elements of the Final Guidance will likely be retained. Some sponsors and CROs have already begun to adopt a risk-based approach, but the key questions around operationalizing the Guidance and its implications to all pharmaceutical development stakeholders remain. The discussion will include perceptions from the legal and regulatory perspective, recent initiatives at the highest levels to integrate a risk-based approach to clinical trial monitoring, and practical implementation aspects of risk based monitoring.
Speakers: - Mr. Gary Yingling, BS, MS, JD, Partner, K&L Gates, Washington DC
- Nicholas Alp, PhD, BM BCh, FRCP, DM, Vice President, Scientific Council, ICON plc, and Hon. Consultant Cardiologist, Oxford University Hospitals NHS Trust
- Anick Duchesne, BSc, DSA, Senior Director, CRA Management - North America, ICON plc
A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE Sep 6/12
LifeSciences This presentation will focus on Orbis Biosciences’ patented Precision Particle Fabrication technology and its ability to develop novel oral formulations of both new and existing pharmaceuticals.
Speaker: Cory Berkland, PhD, Chief Scientific Officer, Orbis Biosciences, Inc.
Improving Oral Dosage Formulations: Microencapsulation for Controlled and Immediate Release Jul 24/12
LifeSciences This webinar will discuss the Covance LC-MS based in vivo target occupancy capabilities and discuss the advantages of using this approach in a preclinical pharmaceutical discovery arena.
Speakers: Patrick L. Love, B.S., Staff Scientist and Supervisor, Receptor Occupancy/In Vivo Pharmacology, Discovery and Translational Services, Covance
Sally Old, Ph.D., Site Leader, Alnwick, Covance
John Batchelor, M.Sc., Head of Toxicology, Alnwick, Covance
Determining Target Occupancy using LC-MS: Advantages and Application to a Preclinical Drug Discovery Paradigm Jun 28/12
LifeSciences This webinar will review models available for assessing anti-inflammatory activity in vivo then focus on imaging technologies, for discovery screening and for translatable biomarkers as applied in inflammation models
Speakers: James Mobley, Ph.D., Founder and CSO, Sunapten Therapeutics, Inc.
Patrick McConville, Ph.D., COO, CSO and Co-founder, Molecular Imaging Inc.
Advances in Inflammation Models and Associated Drug Evaluation: Improved Assessment Using Imaging Biomarkers Jun 26/12
LifeSciences In this 2nd of 4 webinars, the speakers highlight the typical problems associated with the initial stage and present several tips and solutions to addressing them at the start, while showing how technology can play an integral part in coordination, control and communication
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: Bringing the Team Together Jun 8/12
LifeSciences This webinar will discuss compounding at the clinic’s pharmacy as a means to accelerate development and minimize CMC development resources
Speakers: William Schachtner, associate director, small molecule and inhalation product testing services, cGMP laboratory, PPD
Eugene McNally, Ph.D., executive director, global CM&C, global regulatory affairs, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 4: Accelerating to Phase I Clinical Trials for All Dosage Forms
Jun 7/12
LifeSciences Learn how Caprion accelerates validation of biomarkers, diagnostics, and toxicology profiles using MRM technology. A variety of sample types and applications will be covered, including plasma proteins, immune response, toxicology, and tissue-specific panels
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
New Solutions for Highly Multiplexed Protein Assays via MRM Jun 4/12
LifeSciences In this 1st of 4 webinars, the speakers will provide insight into the unique needs of Biotech/Biopharma companies from both the Sponsor and Technology/Services providers (CROs) perspectives. Subsequent webinars will focus on case studies, specific challenges and solutions.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Unique Needs of Biotech/Biopharma May 30/12
LifeSciences This presentation will discuss a unique system called Isolation Liquid Chromatography with Mass Spectrometry (Iso-LCMS), a two-dimensional HPLC system coupled to MS that allows for one-step mass analysis of peaks in MS-incompatible mobile phases
Speaker: David J. Sherlock, Senior Research Scientist, cGMP Laboratory, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 3: Impurity Identification Using Two Dimensional LCMS
May 24/12
LifeSciences This webinar will further explore the challenges that we face in the industry today due to the globalization of clinical trials and the increased penetration of less developed countries
Speaker: Rognvald Lamb, Distribution & Logistics, Fisher Clinical Services
Evaluating Challenges with Clinical Trial Supply Logistics in the Less Developed World May 22/12
LifeSciences The speakers will discuss the benefits of conducting clinical trials in Russia and parts of Eastern Europe compared to other emerging markets, address many of the questions and concerns Sponsors have about logistics, and introduce five keys to successfully managing clinical trial logistics in this region
Speakers: David Passov, CEO, ClinStar
Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
5 Keys to Successful Clinical Trial Logistics in Russia, Ukraine and Belarus May 17/12
LifeSciences This presentation will include a brief background on the development & validation of Vectra DA delivered by Dr. David Chernoff, followed by a patient case study discussion led by Dr. Alvin Wells highlighting the application of Vectra DA in clinical practice
Speakers: Alvin Wells, MD, PhD, Director, Rheumatology and Immunotherapy Center
David Chernoff, MD, Chief Medical Officer, Crescendo Bioscience®, Inc.
Clinical Applications of Vectra™ DA, a Multi-Biomarker Blood Test for Rheumatoid Arthritis Disease Activity May 15/12
LifeSciences Learn types of analytical methods requiring verification, what is required to demonstrate that methods can be run successfully in a laboratory, actions to take when method is found not suitable for intended purpose, approaches for qualification for non-compendial products, and how to track performance of execution of standard compendia methods with the laboratory
Speakers: Pauline McGregor, Ph.D., CChem, MRSC, PMcG Consulting
Travis Emig, Director, Pharmaceutical Chemistry, Lancaster Laboratories
Kimberly Rhoades, Manager, Pharmaceutical Raw Materials, Lancaster Laboratories
Terry Schuck, Principal Chemist/Group Leader, Pharmaceutical Raw Materials, Lancaster Laboratories
Efficient and Effective Approaches to Managing Raw Material Methods May 15/12

This presentation will address: the importance of E&L for patient and product safety, a well-planned and thorough E&L study design for the entire pharmaceutical development and manufacturing process, and the types of E&L evaluations that are being performed for dosage forms other than just orally-inhaled and nasal products and which will help prevent delays in regulatory approvals
Speakers: Derek Wood, laboratory manager, cGMP laboratory, PPD
Istvan Kovac, Ph.D., senior research scientist, cGMP laboratory, PPD
Contributor: Xiaochun Yu, Ph.D., principal scientist, cGMP laboratory, PPD

Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 2: Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval
May 10/12
BusinessStrategy This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Clinical Research in India – Regulatory Environment May 9/12

This presentation will outline important aspects of the spray-drying process and highlight formulation and process parameters that dictate a scalable, stable, and efficacious inhalable pharmaceutical product
Speakers: Jeff Breit, Ph.D., Director of Inhalation Technologies, Bend Research Inc.
Devon DuBose, Senior Research Engineer, Bend Research Inc.

Engineered Particles for Inhaled Biotherapeutics: Considerations in Process and Formulation May 3/12

The panel, representing both big pharma, and small biotech, and will speak from deep experience about the likely intended and unintended consequences of the new guidance
Speakers: Jack Corman, President, IRB SERVICES
Nestor Nituch, Director Clinical Research, Bristol-Myers Squibb Canada (retired)
Terri Hinkley, RN, BScN, MBA, CCRC, Director, Clinical Operations, Helix BioPharma
Ronald Fehst, President, Ronald Fehst Research Consultants

New FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs May 1/12

This presentation will address strategies and the analytical testing considerations that help speed the process for getting a follow-on biological product to market
Speakers: William Bakewell, Ph.D., associate director, biopharmaceutical services PPD, cGMP laboratory
Steven Becht, Ph.D., research and development senior research scientist PPD, cGMP laboratory

Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 1: Strategies to Speed Follow-on Biologicals to Market
Apr 26/12
LifeSciences This webinar will address advances in the development of pharmaceuticals to treat respiratory diseases with a focus on new technologies that enrich data collected early in clinical research
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Professor J. Stuart Elborn, MD, FRCP, Professor of Respiratory Medicine, Queen's University of Belfast
Stephen Smith, MB BCh BAO, MRCGP, Diploma Pharmaceutical Medicine, Principal Investigator, Celerion
Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases Apr 24/12
LifeSciences The presentation will focus on how sponsors evaluate bids from CROs and provide you with some practical tips on how to improve your proposals
Speaker: Leif Kjetil Skjæveland, Partner, Xait
CROs/CMOs – How Does a Sponsor Evaluate Your Bid? Apr 17/12
LifeSciences Case studies will be presented to illustrate the unique benefits of Tandem Labs targeted proteomics service, as well as the unique challenges associated with the technique, the role of bioinformatics, and optimization of sample preparation
Speaker: Bob Xiong, Ph.D., Associate Lab Director, Tandem Labs
Targeted Bioanalytical Proteomics by LC-MS/MS Apr 11/12

This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design
Speakers: Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac Safety Services
J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular Safety
Jared Schettler, MS, Associate Director, Quintiles Phase I Biostatistics

EARLY CLINICAL INSIGHTS: The Case for Early Cardiac Safety Data & Modeling Apr 10/12
LifeSciences This webinar will examine the new EU legislation and its impact on the pharmacovigilance practice of regulators and the pharmaceutical industry in years 2012-2016
Speaker: Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent
EU Pharmacovigilance Change Readiness 2012 Apr 4/12
BusinessStrategy This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Donald Swankie, MBA, Vice President, USA
Asia-Pac Clinical Research – Regulatory Environment Mar 28/12
LifeSciences This in-depth webinar will focus on current global trends in sample management
Moderator: Pinar Gencturk, Managing Editor, 20/20 Pharma
Speakers: Steve Sweeney, Head of Clinical Technologies, Southern Infinity Pharmaceuticals, Inc.
Cathy Michael, Senior Director - Comprehensive Solutions, Biostorage Technologies, Inc.
Comprehensive Sample Management: Leveraging an Onsite Model to Maximize Research and Minimize Costs Mar 22/12
LifeSciences This presentation will address current strategies for evaluating and mitigating the risk of contamination by adventitious agents
Speakers: Jeri Ann Boose, Ph.D., Director, Biopharmaceutical Services, Lancaster Laboratories
Hans Katherine Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories
Yuling Li, Ph.D., fellow, BioPharmaceutical Development, MedImmune
Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products Mar 21/12
LifeSciences This webinar will provide an overview of simulation modeling and how it can be used to improve clinical development efforts, including enhancing choice of target population, powering, and operational feasibility, as well as understanding performance in real-world settings
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes Inc.
Simulation Modeling for Optimizing Design of Clinical Trials and Registries Mar 20/12
LifeSciences This webinar will address the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Raymond Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion
Michael E. Placke, PhD, DABT, Senior Vice President and General Manager, Ricerca Biosciences

Challenges in Early Comparability Assessment of Biosimilars
Mar 20/12
LifeSciences This first webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia, the clinical studies cycle, regulatory environment, and impact of the new pharmaceutical Law in Russia on the clinical trials
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 1 - Russia: Understanding the Regulatory Environment, Challenges & Benefits
Mar 13/12
LifeSciences Our speakers will discuss interventional observational studies, including different types of data that can be collected, different country regulations and approval processes, and setting up and running international real-world observational studies
Speakers: Dr. William Maier, Chief Scientific Offier & VP Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Sarah Rosen, Global Project Director, Registrat-Mapi
International Real World Post-marketing Studies that Involve Patient Intervention Mar 12/12
LifeSciences The purpose of this presentation is to discuss how DART capabilities have been introduced into an established toxicology laboratory at Southern Research, in compliance with Good Laboratory Practices (GLP)
Speakers: Stephen B. Harris, Ph.D., Fellow, ATS, President, Stephen B. Harris Group
Eve Mylchreest, Ph.D., Program Leader, Developmental and Reproductive Toxicology (DART), Southern Research
Kellye K. Daniels, Ph.D., D.A.B.T., Director, Toxicology and Pathology Services Department, Southern Research
Successful Introduction of GLP-compliant Reproductive Toxicology Programs Feb 28/12
LifeSciences The speaker panel will discuss key elements for clinical research in pediatric patients from the point of view of the research site and the investigator
Speakers: Ginger Steinhilber RN.MS. CCRC, Clinical Research Manager, Children’s Hospital of Michigan and Wayne State University
John van den Anker, MD, Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center (Washington, DC)
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Perspectives on Pediatric Trials from Investigative Sites Feb 14/12
LifeSciences In this presentation, the principles of applying the melt extrusion technology in the development of high-energy materials and solid dispersion systems will be discussed, along with some of the issues in the successful development of melt-extruded products. Strategies to overcome such issues will be presented by using case histories.
Speakers: Abu T. M. Serajuddin, Ph.D., Professor, Dept of Pharmaceutical Sciences, College of Pharmacy & Allied Health Professions, St. John's University
Hans Maeir, Head Formulation Scientist, Catalent Pharma Solutions
Michael Valazza, Catalent Pharma Solutions
Irena McGuffy, Manager, Softgel Formulation, Catalent Pharma Solutions
Applied Drug Delivery: Hot Melt Extrusion and Optidose Technology Feb 8/12
LifeSciences The presentation will include an overview of the FDA’s Animal Rule followed by an example end-user case study
Speakers: Peter Silvera, Ph.D., Program Leader for the Animal Models and Vaccine Program, Southern Research
Michael G. Murray, Ph.D., Director, Department of Infectious Disease, Southern Research
The FDA Animal Rule – Successful Submission of Animal Efficacy Studies Feb 7/12
LifeSciences Topics include a discussion of different models available to commercialisation, IVD and Regulated Laboratory Developed Test (LDT), scalable commercialization pathways, and strategies to reduce CDx development timelines by up to 12 months. Recent case studies with FDA submissions will also be cited to demonstrate a different approach.
Speaker: Alan Wookey, Executive Director, Companion Diagnostics, LabCorp
Companion Diagnostics (CDx): Accelerating the Path to Commercialization Feb 1/12
LifeSciences This webinar will explore the challenges in clinical supply chain strategy and discuss how to develop the appropriate risk profile
Speaker: Jim Benkendorf, General Manager, Fisher Clinical Services
Optimizing Clinical Supplies When Facing Drug and Resource Constraints Jan 30/12
LifeSciences Learn how to effectively navigate the challenges of conducting clinical trials in Russia and parts of Eastern Europe (EE) and successfully include these emerging markets in rescue trials and as an integral part of your initial study plans
Speaker: David Passov, CEO, ClinStar
Include Russia and Eastern Europe for Successful Clinical Trials Jan 24/12
LifeSciences An examination of the complex process of translating biomarkers into clinically applicable tests and their use in clinical trials
Speakers: Dr. Peter Kerr, Product Development Team Manager, Almac
Dr. Stephen Moore, Product Development Team Manager, Almac
Translating Pre-clinical Markers to Validated Assays and Their Application to Clinical Trials for the Pharma Industry Jan 19/12
LifeSciences The aim of this webinar is to present an overview of molecular imaging technologies, including the multiple imaging modalities and radiotracers available. Examples of preclinical imaging studies will be applied to illustrate how molecular imaging can advance preclinical drug discovery and development.
Speakers: Stephen Lokitz, Ph.D., Medical Physicist, PET Imaging Center, Biomedical Research Foundation of Northwest Louisiana
J. Michael Mathis, Ph.D., Professor and Director, Small Animal Imaging Facility, LSU Health Sciences Center
Novel Uses of In Vivo Molecular Imaging in Pre-clinical Drug Development Dec 13/11
LifeSciences This presentation will, through the use of actual illustrations, demonstrate some of the pitfalls encountered in early phase pediatric clinical pharmacology studies and by doing so, provide direction on how they might be avoided in the design and conduct of future studies
Speakers: Gregory L. Kearns, PharmD, PhD, Marion Merrell Dow/ Missouri Chair in Pediatric Medial Research
Dr. Alexander Cvetkovich Muntañola, Senior Director Clinical Development, INC Research
Pediatric Clinical Trials - Lessons Learned the Hard Way Dec 13/11
LifeSciences This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities
Speakers: Greg Koski, PhD, MD, Senior Scientist, James Mongan Institute for Health Policy, Associate Professor of Anesthesia, Harvard Medical School, Associate Editor, Journal for Empirical Research on Human Research Ethics
Jack Corman, B.Sc, B.Ed, President and Founder, Institutional Review Board Services
Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign! Dec 12/11
LifeSciences A discussion of how an integrated pharmaceutical development perspective will allow biopharmaceutical developers to bring biosimilars to market quickly
Speakers: Tom Fritz, Managing Partner, Swiftwater Group LLC
Tom Stover, Ph.D., Associate Principal, Swiftwater Group LLC
Developing Biosimilars in the US – The Dawn of a New Era? Nov 16/11
LifeSciences The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials
Speakers: Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research Unit
Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB
Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study Oct 18/11
LifeSciences This webinar will address scientific and practical aspects of formulation selection and process design relative to early- and late-stage pharmaceutical development
Speakers: Dana Settell, Director of Engineering, Late Stage Programs, Bend Research Inc.
Corey Bloom, Director, Formulation Science, Bend Research Inc.
Spray Dried Dispersions: Robust Formulation and Science of Scale from Preclinical to Launch Sep 29/11
LifeSciences A look at the current status and future of oral Vitamin D3 analogs; main biopharmaceutical, physico-chemical and industrial hurdles to the development of appropriate drug delivery systems; and preferred pharmaceutical delivery systems for Vit D3 analogs
Speakers: Hector F. DeLuca, Professor Emeritus, Department of Biochemistry, University of Wisconsin-Madison
Julien Meissonnier, Director, Research and Development, Catalent Pharma Solutions
Applied Drug Delivery: Options for Vitamin D Analogs Sep 27/11
LifeSciences This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions
Speakers: Dr. William Maier, Vice-President, Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Dr. Paula Thompson, Senior Epidemiologist, Registrat-Mapi
Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success Sep 23/11
LifeSciences The presentation will focus on how sponsors evaluate bids from CROs and provide you with some practical tips on how to improve your proposals
Speaker: Leif Kjetil Skjæveland, Partner, Xait
CROs/CMOs – How Does a Sponsor Evaluate Your Bid? Sep 19/11
LifeSciences This webinar for Clinical Trial Supply professionals,  will help you plan ahead in order to reduce the risk involved in Cold Chain management practices
Speakers: Brian S. Hilton, Product Manager, Almac Clinical Services
Anthony Mistretta, Distribution Manager, Almac Clinical Services
Cold Chain Capabilities – Packaging, Labeling and Distribution Solutions for Your Organization Sep 8/11
LifeSciences This webinar will discuss dry granulation/roller compaction technologies, including the advantages/disadvantages of dry granulation over wet granulation
Speaker: Theodore S. Koontz, Director Operations, Xcelience
Introduction and Technical Notes for Dry Granulation – Roller Compaction Jun 22/11
LifeSciences This program will provide an overview and key lessons in leveraging India as a strategic venue for research as well as post market approval in a country of 1.3 Billion
Speaker panel from Max Neeman International: Ajoy Kumar, MD, CEO, Renu Razdan, COO, and Donald Swankie, MBA, VP, USA
Clinical Research in India – Potential & Challenges Jun 15/11
LifeSciences This webinar will review the requirements and practical considerations around preparation and parametric release of pharmaceuticals in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed.
Speakers: Staci McDonald, PharmD, Senior Director, Scientific Clinical Operations, Celerion
Stuart Best, PhD, Senior Director of Operations, Xceleron
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies Jun 8/11
LifeSciences During this webinar, the speaker will introduce a unique web-based solution for gaining rapid insight into temperature-sensitive shipments in clinical trials
Speaker: Shirley Attryde, Product Manager, STEMS, Almac
Improving Insight and Increasing Control of Temperature-Sensitive Supplies in Clinical Trial Jun 1/11
LifeSciences Our speaker panel from Swiftwater Group LLC will discuss what works and what doesn’t in dealing with vendors, whether the vendors are CROs, CMOs, Quality Assurance/Control Consultants, or Bioanalytical vendors
Speakers: Tom Fritz, Managing Partner / Chris Seifarth, Associate Partner / Agnes Cobbum, Associate Principal /William J. Miller, Ph.D., Senior Manager
Managing Vendors: Tips and Tricks for Pharma and Biotech Companies to Get What You Need While Cutting Costs May 18/11
LifeSciences Celerion's clinical pharmacology scientists will describe recent trends in adaptive designs, highlight areas where innovative approaches resulted in more robust clinical study results and discuss the challenges sometimes faced with these designs
Speakers: Michelle L. Combs, PhD, Vice President, Clinical Pharmacology Sciences
Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design May 17/11
LifeSciences Reduce the reporting burden on sites, sponsors, CROs and review boards while raising the bar on providing real protection of the subjects participating in clinical trials
Speaker: Glenn Veit, JD, CIP, Chairperson, Copernicus Group IRB
Safety Reporting to the Institutional Review Board (IRB): Understanding Recent Guidance May 4/11
LifeSciences Panel discussion with Celerion’s experienced physicians describing their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the audience will learn about changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric, ophthalmologic and cardiovascular adverse effects as well as assessing risk for ocular toxicity in humans.
Key Presenter: William Wheeler, M.D., Therapeutic Area Lead-Cardiovascular (Chair)
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments Apr 28/11
LifeSciences This webinar will discuss using amorphous dispersions as a platform technology to rapidly formulate compounds as respirable dry powders for preclinical evaluation
Speakers: Dan Dobry, Vice President Engineering, Bend Research Inc.
Dr. David T. Vodak, Vice President Chemistry, Bend Research Inc.
Dana M. Settell, Director of Business Development, Bend Research Inc.
Dextran-Based Amorphous Dispersions as a Platform Technology in Preclinical Screening for Inhaled Dry Powders Apr 27/11
LifeSciences The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Apr 21/11
LifeSciences Join this webinar and learn how some of the major challenges of biomarker discovery can be addressed in an integrated manner, how to discover and select the biomarker models most suitable for independent validation, and the importance of functional analysis as an essential component of biomarker discovery
Speakers: Max Bylesjo, Ph.D., Bioinformatics Team Leader, Almac
Nicolas Goffard, Ph.D, Bioinformatics Scientist, Almac
An Integrated Approach to Biomarker Discovery Mar 28/11
LifeSciences This webinar will address strategies for expediting small molecule oral dosage formulations to Phase I studies, strategies to overcome challenges associated with poorly soluble compounds, technical considerations for liquid in capsule formulations, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Strategies for Expediting Small Molecule Oral Dosage Formulations to Phase I Studies Mar 23/11
Legal This webinar will explore the utilization of fit-for-purpose strategies in the discovery and development of solid-state forms of pharmaceutical substances and highlight how these strategies impact cost, speed, and risk
Speakers: Joanna Bis, Principal Scientist, Catalent Pharma Solutions
Pingyun (PY) Chen, Manager, Optiform™ Technologies, Catalent Pharma Solutions
David Igo, Director, Optiform™ Technologies, Catalent Pharma Solutions
Fit-for-Purpose Strategies for Solid-form Discovery and Development Jan 26/11
LifeSciences This webinar discusses some of the most pertinent changes to regulations regarding compounds coming to approval since the implementation of ICH E14 by the FDA in 2005.
Speakers:  Joy Olbertz, Ph.D., PharmD., Clinical Site Director, Celerion
William Wheeler, M.D., Therapeutic Area Lead Cardiovascular, Celerion
The Need for Speed: Science and Innovation Driving Efficient, Cost Effective QT Assessment Oct 26/10
LifeSciences In this webinar, Celerion partners with Xceleron to discuss how Accelerator Mass Spectrometry (AMS), through measurement of ultra low levels of drug-associated radioactivity, can enrich the information gathered from early clinical studies
Speakers:  J. Fred Pritchard, Ph.D.,Vice President, Drug Development Services, Celerion
Jeremy Hague, BSc, Senior Director, Strategic Development, Xceleron Ltd.
The Need for Speed: Enriching Early Clinical Studies for Better Data, Faster Oct 7/10
LifeSciences QbD extends beyond formulation and process development. On-going monitoring of the manufacturing process, a vigorous continuous improvement program and commitment to quality are critical to maintain the success of a QbD program.
Speaker: Dr. Tahir Nazir, Manager, Formulation Development, Pharmaceutical Development Services, Patheon UK Limited
Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture Oct 1/10
LifeSciences Our speaker panel from Almac will utilise their experience in the industry to explore the various mechanisms and techniques currently available in the marketplace to promote successful clinical trial supply capsule manufacture and over-encapsulation. They will also discuss key GMP challenges that need to be overcome in order to ensure product quality and study result integrity.
Speakers: Dr. Colin Lorimer, Senior Formulation Scientist
James Hurst, Analytical Support Manager
Michael Rainey, Production Manager
Richard Shannon, Head of Business Development (Europe)
Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials Sept 24/10
LifeSciences A discussion of the potential of biopharmaceutical products including differentiating the risk associated with internal attributes of the drug from the risk derived from external factors, a guideline to selecting the best methods to analyze and characterize antibodies, and recommendations on a risk-based sampling strategy and representative clinical case studies describing the importance of immunogenicity testing not only during clinical trials but also after the pharmaceutical is commercialized
Speaker: Ana T. Menendez, Ph.D., Senior Director of Biotechnology, Catalent Pharma Solutions
Strategic Considerations For A Successful Immunogenicity Program Sept 17/10
LifeSciences This webinar will explore what clinical delivery alliances are and the value alliance partnership models bring to the pharmaceutical development process from both the sponsor and CRO perspective
Speakers: Tim Dietlin, Vice President of Alliance Development, INC Research
David Gillogly, Global Head, Clinical Contracting and Category Management, Novartis
The Value of Strategic Alliances vs. Transactional CRO-Sponsor Relationships Sept 15/10
LifeSciences The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Sept 9/10
LifeSciences QbD extends beyond formulation and process development. On-going monitoring of the manufacturing process, a vigorous continuous improvement program and commitment to quality are critical to maintain the success of a QbD program.
Speaker: Kwok Chow, Ph.D., Senior Director Global Pharmaceutical Development Technology and Alliances, Patheon
Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture June 17/10
LifeSciences This talk will explore how steps in the generation of mammalian cell lines were optimized to make a process more efficient and outline certain risks that were taken to improve timelines and throughput
Speaker: Gregory T. Bleck, Ph.D., Senior Director of Cell Line Engineering, Catalent Pharma Solutions
Characteristics of an Effective Mammalian Cell Line Generation Process for Bio-Pharmaceutical Production May 25/10
LifeSciences This talk will introduce 3 new technologies which could revolutionize the formulation world and how you approach your product's development and life-cycle management
Speakers: Emma Mickley, Ph.D., Director of Business Development, R5 Pharmaceuticals
Richard Johnson, Ph.D., Managing Director, Upperton Limited
Marcel de Matas, Ph.D., Scientific Manager, Lena Nanoceutics
Steffen Mittwich, Dipl. Wi.-Ing., CEO, Atacama Labs
Rob Lammens, Ph.D., CTO, Atacama Labs
Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture May 12/10
LifeSciences Supplier Management, Improving Supplier Oversight and Product Quality Outcomes
Speakers: John C. (Jack) Garvey, Principal, Compliance Architects ®
Peter Miller, Senior Partner, Dynamic Compliance Solutions, Inc.
Enforcement Risk Reduction Approaches for FDA-Regulated Manufacturers Apr 28/10
LifeSciences This webinar will cover 3 key topics: Beyond 30 Parameters in Single Cells with Mass Cytometry, Mass Cytometry (Equipment and Reagents - how does it work?), and Mass Cytometry Methods
Speakers: Scott D. Tanner, President - Dmitry R. Bandura, Director - Olga I. Ornatsky, Director - DVS Sciences, Inc.
Massively Multi-parameter Single Cell Analysis by Mass Cytometry Apr 15/10
LifeSciences This presentation provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission
Speaker: Alan D. Hendricker, Ph.D., Principal Scientist, Catalent Pharma Solutions
Leachables and Extractables: Regulatory Context Mar 18/10
LifeSciences This webinar will introduce the utility of SharePoint for clinical trial operations and will present the application of SharePoint to two specific areas: clinical trial management and investigator portals. Viewers will learn how they can use technology to manage their clinical operational data to collect more timely information and to make more informed decisions.
Speakers: Les Jordan, CTO, Life Sciences Industry Unit, Microsoft
Bob Webber, President & CEO, TranSenda
Greg Cohee, Director, eClinical Services, Pharmica Consulting
Perspectives on Utilizing Microsoft SharePoint to Improve Clinical Trial Operations Mar 4/10
LifeSciences This webinar will address considerations for prototype formulation development, formulation options for phase I studies, a prototype formulation approach, strategies to overcome poorly soluble compounds, liquid in capsule, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Options for Speed to Phase I Studies Jan 21/10
LifeSciences This webinar will address the principles and practices of stability studies in the pharmaceutical development process, discuss the framework of the FDA cGMP guidelines as expressed in 21CFR 211 which will help pharmaceutical analysts to understand the process, and provide a comprehensive review of the ICH and WHO stability guidelines and discuss the strategy used in stability protocols design to support global registration
Speakers: Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions
Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions
Stability Studies in Pharmaceutical Development Nov 20/09
LifeSciences An in-depth look at the most effective strategies for planning and implementing this new breed of trials.
Speaker: Judith Quinlan, Vice President, Adaptive Trials, Cytel Inc.
Real-time Clinical Trial Decision Making: Reaching the correct decisions - at the earliest time point - in the most efficient way Nov 18/09
LifeSciences Learn how to organize, analyze, and visualize chemical and biological data quickly and efficiently, enhancing efficiency and productivity
Speaker: Brian Masek, Ph.D., Product Manager and Lead Scientist, Tripos International
Strategies for Merging and Analyzing Chemical and Biological Data for Effective Compound Prioritization Decisions Nov 16/09
LifeSciences Join our webcast as we discuss paperless clinical trials, covering the initiatives, the progress and what we have learned along the way
Speakers: Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting
Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks
The Journey Toward Paperless Clinical Trials Nov 5/09
LifeSciences This webinar will focus on the importance of self-emulsification (dispersion) and lipolysis (digestion) properties for achieving acceptable “in-vivo” performance of lipid-based formulations
Speakers: Dr. Jean Cuiné, Fellow Project Leader, Novartis Pharma AG
Julien Meissonnier, Director, R&D and Technical Services, Catalent Pharma Solutions
Sarah Dr. Jeffrey Browne, Technical Director, Pharmaceutical Softgel Business Development, Catalent Pharma Solutions
Norman Stroud, Director, Technology Development, Catalent Pharma Solutions
Unlocking the Therapeutic Potential of BCS Type II & IV Compounds: Oral Lipid-based Drug Delivery Sep 23/09
LifeSciences The webinar will focus on improving preclinical studies by combining MDS Pharma Services' 40 years of experience and insight in safety pharmacology and toxicology, with innovative technology and processes that improve study data and provide greater animal welfare. Presentations will highlight key challenges, best practices and methodologies.
Speakers: Dr. Stéphane Milano, Vice President, Drug Safety Assessment, MDS Pharma Services
Paul Barrow, Director of Toxicology, MDS Pharma Services
Sarah Merrett, Lean Sigma Black Belt, MDS Pharma Services
Advances Insight and Innovation: Novel Approaches to Safety Pharmacology and Toxicology in the 21st Century June 23/09
LifeSciences Learn about how pharmaceutical development strategies are changing to keep pace with these discoveries
Speakers: Jeffrey Settleman, Ph.D., Laurel Schwartz Professor of Oncology, Scientific Director, Massachusetts General Hospital Cancer Center
Christine O’Day, Ph.D., Technical Director, In Vitro Pharmacology, MDS Pharma Services
Dan Rhodes, Ph.D., CEO, Compendia Bioscience
Advances in Oncology Drug Development: Linking Drug Response Phenotypes to Multiplex Molecular Signatures June 18/09
LifeSciences This web-based training class is geared to clinical program managers, clinical trial managers and directors of clinical trials to expand their understanding and to learn the intricacies involved in managing the Central Lab component of clinical trials through the APOLLO:RDA™
Speaker: Jennifer Trudel, Training Manager, MDS Pharma Services
Quality On Time™ results with APOLLO:RDA™ (Remote Data Access) Apr 23/09
LifeSciences Through case studies this webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize pharmaceutical development
Speakers: JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services, Pharsight Corporation
Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services, Pharsight Corporation
Combining Technology and PK/PD Expertise to Optimize Drug Development: A New Era for Collaborative Environments in Translational Medicine Apr 22/09
LifeSciences This program is intended for clinical research and regulatory affairs professionals who are responsible for or impact their organizations’ efforts applied to clinical trial patient recruitment and retention and/or study site performance
Speaker: Tony L. Hursey, MPH, Vice President, Cardiology & Endocrinology, MMG
Perspectives on Patient Recruitment: Site and Patient Awareness Items and Participant Insurance Coverage Apr 21/09
LifeSciences This webinar will feature an examination of the current status of the hemagglutination inhibition assay (HAI) as a surrogate test for evaluating serological status to influenza, both vaccines and natural infection
Speaker: Keith A. Gottlieb, PhD, Principal Scientist, Clinical Trials Department, Focus Diagnostics, Inc.
Influenza Options: HAI and Beyond Apr 14/09
LifeSciences A panel discussion of a flexible, cost effective approach for today's R&D and clinical supply leaders that accounts for the complexity of the global distribution of the clinical trial supplies
Speakers: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates
Martin Page, General Manager, Catalent Pharma Solutions
Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions
Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions
Meeting the Challenges of Global Clinical Supply Chain Management Jan 27/09
LifeSciences This presentation will address the recent regulatory initiatives in the U.S. and Europe and how safety registries can effectively be used as part of a risk management, riskMAP, or REMS program strategy
Speaker: Richard Gliklich, MD, President, Outcome
From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements Nov 6/08
LifeSciences Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis
Speakers: William Wheeler, MD, FACC, Global Medical Director, Centralized Cardiac Services, MDS Pharma Services
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Nathan S. Teuscher, PhD, Director, PK/PD, MDS Pharma Services
Joy Olbertz, PharmD, PhD, Director, Cardiac Safety Services, MDS Pharma Services
Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis Nov 5/08
LifeSciences Find out in an exclusive webcast that brings together CROs and investigative sites to share their experiences managing study start-ups online
Speakers: Lee Ferrell, Director, Site Start Up, Quintiles, Inc.
Adam McFarland, ECMP, Business Systems Specialist, Copernicus Group IRB
Dave Espenshade, Vice President of Life Sciences, IntraLinks, Inc.
Site Activation: How to Reduce Costs and Shorten Study Start-up Time Oct 29/08
LifeSciences Learn about science-driven strategies for a successful First-in-Human trial
Speakers: Todd Johnson, MD, Senior Vice President, Early Stage Development, MDS Pharma Services
Robert F. Butz, PhD, Vice President, Medical & Scientific Affairs, Biovail
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Gaetano Morelli, MD, Senior Director, Global Medical Affairs, MDS Pharma Services
First- In-Human Studies: Science-Driven Strategies Oct 23/08
LifeSciences A guide through current multi-site and web marketing trends in the pharmacy space and the steps you need to map out your future WCM success
Speakers: Kevin Adkisson, Director of Software Sales, Crown Partners LLC
Rob Alfieri, Strategic Consultant, Crown Partners LLC
Andrew Zupfer, Senior WCM Product Manager, Crown Partners LLC
Web Content Management for Pharma Marketing -- Leveraging the Present, Mapping the Future Feb 21/08
LifeSciences The key challenge areas associated with serializing distribution processes and best practices learned from the front line with early adopters
Speakers: Ann Grackin, Mangaging Director, Supply Chain Risk (RISC) Consulting, Marsh Advisors
John DiPalo, Senior Vice President, Product Development, Acsis
Mike Lipton, Director of Strategy for RIFD/Supply Chain Management, SAP Labs
James Dowden, Director, Distribution Services, Hoffman La-Roche
Best Practices for Serialized Distribution in Support of ePedigree Compliance Jan 31/08
LifeSciences A panel dicussion of the ethical marketing practices in the Pharmaceutical and Biotech industries
Speaker: Wesley Wheeler, President, Valeant Pharmaceuticals
Dr. John F. Kamp, Executive Director, Coalition for Healthcare Communication
Denis Arnold, Director of the Center for Applied and Professional Ethics, The University of Tennessee
Gene Guselli, Co-founder, President, CEO, InfoMedics, Inc.
Ethical Marketing to Improve the Public’s Perception of the Pharmaceutical and Biotech Industry Sep 24/07
LifeSciences Benefits of the Clinical Investigator Management Process System (CIMPS)
Speaker panel from CTMG, Inc. led by Anton Usala, M.D., CEO & Medical Director
CIMPS—A GMP Approach to Physician Site Management Enabling Clinical Trial Success (Regardless of PI Experience) Sep 19/07
LifeSciences Learn how to get better visibility into your data and improve your understanding of industry trends and drivers to improve overall company ROI
Speakers: George Foldes, Senior Business Analyst, Aspreva Pharmaceuticals
Christopher-Paul Milne, D.V.M., M.P.H., J.D., Associate Director, Tufts Center For The Study Of Drug Development
Tim Knutson, Area Manager, Applix
Better Understanding Industry Trends and Drivers in the Pharma and Biotech Industries through the use of Performance Management (PM) Technology Aug 22/07
LifeSciences This Adaptive Dose-Ranging Studies: an Evaluation with Recommendations from the PhRMA Working Group
Speaker: Dr. Jose Pinheiro, Director Biostatistics, Senior Modeler, Pharmacology Modeling and Simulation, Novartis Pharmaceutical
Adaptive Clinical Trials: Improving the Efficacy of Dose Finding Trials June 28/07
LifeSciences This The team from CRG will present three simple solutions to accelerating trial completion
Speakers: Lynn. S. Bachrach, President and CEO, CRG
Harry Bachrach, Principal and CFO, CRG
Vicky Rochford, Senior Vice President, CRG
Three Simple Solutions to Accelerating Trial Completion June 19/07
LifeSciences A case study that will include a discussion of site selection and recruitment strategies, the importance of patient advocacy support, regional differences and participant expectations, acknowledge and address barriers to participation & moral concerns, and retention strategies
Speakers: Lisa A. Ward, MPH Clinical Research Manager, Genzyme Corporation
Gail Adinamis, President, CEO, Clinical Resource Network, Inc.
Patient Retention in Orphan Drug Studies June 8/07
LifeSciences Current insights into the differences between Phase I versus Phases II-III and Phase IV cardiac safety testing. Discussion will also include common ECG collection practices at sites versus best practices, the impact of the TQT on Phase III programs, ECG data considerations beyond QTc, and how implementation of best practices ensures data quality and consistency and reduces data evaluation time.
Speaker: Jeffrey S. Litwin, M.D., F.A.C.C., Executive Vice -President, Chief Medical Officer, eResearchTechnology, Inc
Best Practices in Cardiac Safety Data Collection Before and After the Thorough QT Trial June 7/07
LifeSciences The collaboration of pharmaceutical, medical devices, and diagnostic testing companies in order to create innovative ways to administer pharmaceuticals and increase patent lengths
Speaker: Wesley Wheeler, President, Valeant Pharmaceuticals
Alternative Methods of Drug Delivery June 4/07
LifeSciences Current insights into the ICH guidance and practical implications for implementation of the TQT
Speaker: Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.
ICH-E14 Two Years Later - Trends in Design & Conduct of a Thorough ECG Trial (TET) May 31/07
LifeSciences Exploring cost- effective ways of maintaining integrity of biological and pharmaceutical products during transportation
Speaker: Clifford H. Harze, Consultant, C H Harze Pharmaceutical Distribution Consultant LLC
Distribution of Biopharma Products Feb 28/07
LifeSciences Exploring the first stage implementation results of Pfizer’s RFID Pilot Program
Speaker: Peggy Staver, Director of Trade Product Integrity, Pfizer
RFID for Pharma Feb 2/07
LifeSciences Anti- Counterfeiting Drug Strategies
Speakers: Mr. Eshetu Wondemagegnehu Technical Officer & Focal Person for Counterfeit Drugs, Quality Assurance & Safety Medicines Essential Drugs and Medicines Policy World Health Organization
Dr. Peter Rost, VP, Marketing, Endocrine Care, Pfizer. (Dr. Rost speaks as a private citizen and does not represent Pfizer in his talk.)
Anti-Counterfeiting Drug Strategies Dec 10/04

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