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Drug Development Webinars - Archived

The term drug development can be used to describe a wide range of processess from drug discovery through to clinincal trials. As such, we've curated a wide range of webinars on this page covered under the term, drug development - from phenotypic screening and PK/PD modeling to quantitative profiling and next-generation sequencing for the drug development process. The drug development 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. If drug development 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 different, browse through our other topics.

  Synopsis Webinar Title Date

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 -  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 - 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 - 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 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 - 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 - 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 -  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 - 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 - This webinar will focus on some of the challenges faced in executing a complex global oncology trial
Speakers: Amy Franke, Senior Director, Strategy and Planning, Covance
Bridget (Fitzsimmons) Weeks, Director, Project Management (Oncology), Covance
Montessa Lizaso, RN, Senior Data Analyst, Strategy and Planning (Oncology), Covance
Implementing Basket/Bucket and Umbrella Designs: What You Need to Know for Global Oncology Trials May 8, 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 - 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 - 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 -  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 provide an overview of the current use and potential of HTA as a component of clinical trials aimed at regulatory approval of novel agents in various medical fields, including the general concept of HTA and cost-effectiveness in healthcare
Speakers: Everardo Saad, MD, Senior Medical Expert, IDDI
Oriana Ciani, PhD, Postdoctoral Research Fellow, University of Exeter Medical School; Research and Teaching Fellow, Centre for Research on Health and Social Care Management (CeRGAS), Bocconi University, Milan
Rod Taylor, MSc, PhD, Professor of Health Services Research, University of Exeter Medical School; Director, Exeter Clinical Trials Unit; Senior Investigator, National Institute for Health Research (NIHR), UK
Incorporating Health Technology Assessment (HTA) in Clinical Trials Feb 22, 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 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 - 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 -  Discussion topics include risk factors for disease progression, the detection, assessment and monitoring of DILI in NASH patients, and the strategic framework of applying a seamless adaptive design in a NASH development program
Speakers: Arun Sanyal, MD, Professor of Medicine and Chairman of Gastroenterology Division, Virginia Commonwealth University School of Medicine
Claudia Filozof, MD, PhD Executive, Medical Director in CVM/ER Therapeutic Area, Covance
Arie Regev, MD, Head of the Safety Advisory Hub, Eli Lilly and Company
Tammy McIver, MSc, CStat, Senior Manager, Biostatistics and Statistical Programming, Covance
Hot Topics in Non-Alcoholic Steatohepatitis (NASH) Nov 29, 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 - 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 - 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 -  The webinar will offer practical advice on employing the right mobile strategies to increase patient engagement and support smarter decisions based on larger, better data streams
Speakers: Matt Kibby, President, BBK Worldwide
Lewis Millen, Operational Intelligence Leader, Roche Products Limited
Harnessing the Power of mHealth for New, Better Data and Improved Patient Engagement Oct 28, 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 -  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 - 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 - 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 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 - 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 - This webinar will give an overview of endpoint assessment as it relates to RECIST, irRC, and clinical benefit in the setting of cancer immunotherapy
Speakers: Klaus Noever, MD, Senior Director of Medical Affairs, WorldCare Clinical, LLC
Ryan J. Sullivan, MD, Assistant in Medicine, MGH Cancer Center, Massachusetts General Hospital, and Assistant Professor, Medicine, Harvard Medical School
Tumor Burden and Clinical Benefit Assessment in Immunotherapy Clinical Trials Sep 19, 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 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 -  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

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 - In this webinar, the speakers will challenge the view that the expected benefits from new drugs are generally sufficient to forgo randomization to a standard-of-care arm
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Everardo Saad, Senior Medical Expert, IDDI
Personalized Cancer Medicine Needs Randomized Trials Jun 24, 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 - 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 webinar will highlight unique attributes of SOMAmers but also discuss similarities between aptamers and antibodies from the standpoints of and target protein recognition and shape complementarity
Speaker: Douglas R. Davies, Senior Manager of Structural Biology, Beryllium Discovery Corp.
The Aptamer: An Alternative to the Antibody for Research and Therapeutic Development May 31, 2016

LifeSciences - This presentation will discuss what level of Validation is required at the different stages of the pharmaceutical product development lifecycle
Speaker: Troy Fugate, Vice President, Compliance Insight, Inc.
When Does Validation Start? May 20, 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 - 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 - 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 - Learn about how the largest molecular diagnostic clinical laboratory in the world can help identify molecular characteristics linked to complex disease states and drug response phenotypes to improve drug development and help deliver the promise of precision medicine
Speaker: Patrick M. Burke, Ph.D., Executive Vice President, Emerging Products, Myriad Genetics
Enabling Precision Medicine with Complex Companion Diagnostic Tools Apr 25, 2016

LifeSciences - This webinar will examine past design issues, current techniques to raise standards and new technology which will aid future understanding
Speaker: Philip Lake, PhD, Executive Director of Scientific Affairs, Respiratory, Chiltern
Jan De Backer, PhD, CEO, Fluidda
An Illustration of Challenges in Respiratory Drug Development Apr 19, 2016

LifeSciences - This free webinar examines the nuances of successfully conducting hematological oncology clinical trials
Speakers: Chris Smyth, PhD, MBA, Managing Director, European & Asian Operations, Novella Clinical
Richard Gams, MD, Chief Scientific Officer, Novella Clinical
Achieving Effective Haematological Oncology Clinical Trials Apr 14, 2016

LifeSciences - Discussion topics include how hematological patient-derived xenograft (PDX) models are established, why hematological PDX models are more translational than cell line-derived models, and can be employed in drug discovery and development
Speakers:Julia Schueler, Department Head, In Vivo Tumor Biology, Oncotest GmbH
Megan MacBride , Associate Director, Product Management, Taconic Biosciences
Patient-derived Xenografts of Hematological Malignancies: Model Systems for Drug Development and Tumor Biology Research Apr 14, 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 - 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 - 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 - 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 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 - 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 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 - Roche NimbleGen has designed a panel to capture 6.5 Mb of DNA, targeting over 300 hdCNVs and non-exonic PGx content
Speakers: Dr. Brendan J. Keating, Assistant Professor of Pediatrics and Surgery, Perelman School of Medicine, University of Pennsylvania
Targeted Sequencing as a Tool to Understand the Genetic Basis of Transplant Rejection Nov 17, 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 - This webinar will discuss the assessment of cognitive function throughout the development of drugs for both CNS and non-CNS indications
Speaker: Kenton Zavitz, PhD, Director of Clinical Affairs, Cambridge Cognition
Leveraging Cognitive Measures in Clinical Trials Oct 30, 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 - 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 - 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 - The speakers  will revisit the central dogma of molecular biology with respect to single-cell DNA-RNA co-analysis, and cell heterogeneity.
Speakers: Rong Fan, Ph.D., Associate Professor of Biomedical Engineering, Yale University
Ioanna Andreou, Ph.D., Senior Scientist, QIAGEN
Revisiting the Central Dogma of Molecular Biology at the Genome Scale and in Single Cells Oct 20, 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 - This webinar will focus on the analytical validation of in-vitro diagnostic devices, the process through which one gains assurance that the data delivered by in-vitro diagnostic devices are ‘reliably correct’, the prerequisite for in-vitro diagnostic devices' clinical use
Speakers: Elisabeth (Els) Coart, PhD, Senior Research Biostatistician, IDDI
Hugo Vanderstichele, PhD, Co-Founder and Director Assay Development, ADx NeuroSciences
From Biomarker to In-Vitro (Companion) Diagnostic Device:
How to Design and Conduct Efficient Analytical Validation Studies in Accordance with CLSI Guidelines
Oct 19, 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 - With an increasing number of biomarkers and, often, limited availability of biopsy material, there is a growing need for multiplexed assays for both research and clinical purposes
Speaker: Matthew R. Silver, Ph.D, Principal Scientist, Translational Assays, Cell Signaling Technology
Analysis of Immune Checkpoint Control Protein Co-expression in Breast and Ovarian Cancer Using Novel Rabbit Monoclonal Antibodies and Multiplex IHC Oct 7, 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 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 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 focus on two important aspects of Data Monitoring Committees: Set-up and communications
Speakers: Angela McPartlane, Associate Director of the DMC Unit, PRA Health Sciences
Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Data Monitoring Committees: Simple Solutions for Critical Issues Sept 25, 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
Speakers: Beth A. Lage, RAC,, Associate Director of Strategic Global Labeling for Medical Products, Baxter Healthcare Corporation
Griha L. Mangru, Labeling Strategist, Global Labeling Management Team, Pfizer
Boris Jankowski, Director of Solutions Architecture, Sciformix
Craig Trautman, CEO, Intagras
Optimizing Your Global Labeling Operations: An Expert Panel Discussion Sept 22, 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 - 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 - 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 - During the webinar, the presenters will describe a targeted sequencing workflow that combines Roche NimbleGen’s SeqCap EZ enrichment technology with Pacific Biosciences’ SMRT Sequencing to provide a more comprehensive view of variants and haplotype information over multi-kilobase, contiguous region.
Speakers: Dr. Lawrence Hon, Senior Manager, Bioinformatics, Pacific Biosciences
Dr. Denise Raterman, R&D Scientist, Sequence Capture, Roche NimbleGen
Long Genomic DNA Fragment Capture and SMRT Sequencing Enables Accurate Phasing of Cancer and HLA Loci Jun 30, 2015

LifeSciences - In this webinar, the successful development and commercialization of companion diagnostics (CDx) will be discussed by experts from Covance and LabCorp.
Speakers: Mark Roberts, Ph.D., Director of Diagnostics Development, Covance
Alan Wookey, Associate Vice President and Executive Director of Companion Diagnostics, Covance
Pathway Considerations to CDx Development and Commercialization Jun 30, 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 - The presenters will discuss new solutions and strategies for streamlined glycosylation analysis
Speakers: Alicia Bielik, PhD, Product Manager, Glycobiology, New England Biolabs
Paula Magnelli, PhD, Scientist, Glycobiology, New England Biolabs
Improved Methods for Structural Characterization of Therapeutic Proteins Jun 19, 2015


LifeSciences - This webinar aims to help attendees understand the epidemiology and health burden of Non-Alcoholic Steatohepatitis and present contemporary information on new preclinical models that can support drug development for NASH.
Speakers: Claudia Filozof, MD, PhD, Senior Medical Director, Cardiovascular/Metabolic, Covance
Arun Sanyal, MD, Executive Director, Education Core, Center for Clinical and Translational Research, Virginia Commonwealth University
Richard Williams, PhD, JD, Senior Director, Global Regulatory Strategy, Covance
Non-Alcoholic Steatohepatitis (NASH): Preclinical and Clinical Development and Progress Toward Regulatory Approval Pathways Jun 17, 2015
LifeSciences - In contrast to traditional antibody-based methodologies, such as ELISA and Western blot, mass spectrometry can provide more detailed characterization and quantitation of individual host cell proteins (HCP) and other protein impurities, without affinity-based bias
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
Comprehensive Identification and Quantification of Host Cell Proteins by Mass Spectrometry Jun 8, 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 - The speakers will discuss trends in continuous ecg monitoring and the implications for clinical trials of both medical device and therapies for cardiovascular, hematologic, metabolic and cns diseases, with an emphasis on atrial fibrillation and other arrhythmias
Speakers: Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research
Wayne M. Derkac, MD, Vice President of Medical Affairs, BioTelemetry Inc.
Evaluation of Atrial Fibrillation and Other Arrhythmias within Clinical Trials and Clinical Practice Apr 28, 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
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
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
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
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 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
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 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
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)
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
LifeSciences - 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 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
LifeSciences - 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
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 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
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
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
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
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 July 10/14
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: 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
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 will demonstrate how image analysis technology, such as Definiens, is particularly well suited to objectively characterize the tumor microenvironment and show how Definiens is being used by the Society for Immunotherapy of Cancer (SITC)-led global immunoscore initiative, that seeks to validate the immunoscore as a prognostic biomarker for patients with colon cancer
Speakers: Bernard A. Fox, Ph.D., Endowed Chair and Chief, Laboratory of Molecular and Tumor Immunology, at the Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Cancer Center
Carlo B. Bifulco, M.D., Director of Molecular Pathology and Pathology Informatics at the Providence Regional Laboratory and Director of Translational Molecular Pathology at the Earle A. Chiles Research Institute
The Immunoscore and Immunoprofile: Assessing Anti-Cancer Immunity as a Biomarker to Stratify Patients for Clinical Trials May 29/14
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 provide insight into Evotec’s approach to phenotypic screening for hit ID in the context of complex & novel biological systems
Speakers: Mark Slack, PhD, Vice President, In Vitro Pharmacology, Evotec
Stefan Müller, PhD, Head of Chemical Biology, Evotec
Integrated Phenotypic Screening and Target Deconvolution for Accelerated Drug Discovery May 21/14
Viewers 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: 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
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 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
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
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 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 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 Dec 5/14
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 short, 40 minute webinar viewers will learn about how the Archimedes Model was applied by Eli Lilly and Company to prioritize early stage compounds for development
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes, Inc.
Market Access and Pipeline Development – How Healthcare Modeling Can Make a Difference Nov 22/13
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 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
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
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
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
Accelerating Drug Development through Drug & Companion Diagnostic Co-Development Oct 9/13
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
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
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

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 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 explore how biopharma can use information technology to bring drugs 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
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
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 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 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
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 This fourth webinar in our series will focus on the regulatory aspects of conducting clinical trials in Russia
Speakers: Yuri Afonchikov, MD, PhD, Vice President, Regulatory Affairs, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 4 - Regulatory Affairs: The Key to Russia
Apr 10/13
LifeSciences This webinar will provide an overview of the basics of model based drug 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
LifeSciences In this webinar, our expert shares a case study for a biological drug product that required re-development of both the bioassay method for potency, as well as an improved process for extracting the drug product from a carrier so that the potency of the final drug 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 A strategy to achieve a better assessment of QT liability early in the drug 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
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 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 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 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 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 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 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 drug 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 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 drug 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

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 drug 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
LifeSciences This webinar will address advances in the development of drugs 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 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
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 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 webinar will review the requirements and practical considerations around preparation and parametric release of drug 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
Healthcare In this webinar David Eddy, MD. PhD. will demonstrate ARCHeS Innovator, a software as a service (SaaS) that enables researchers and decision makers to use many of the capabilities of the Archimedes Model over the web
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
DEMO: ARCHeS Innovator May 31/11
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 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 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 drug 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
Healthcare Archimedes has created a web application which enables anyone to analyze and share simulation datasets produced by the Archimedes Model. During this webinar Dr. David Eddy will show why the Outcomes Analyzer is essential for anyone interested in understanding future health and cost issues and especially recommended for those interested in cardiovascular risk, obesity, and diabetes complications.
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
DEMO: The Archimedes Outcomes Analyzer Oct 28/10
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
Healthcare In this webinar Dr. Eddy will describe and illustrate data sources and methods for deriving equations for physiological pathways and the occurrence of diseases, as well as methods for validating the equations
Speaker:David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
Healthcare Modeling Part 5: How the Archimedes Model Works – Derivation of Equations Oct 6/10
LifeSciences This webinar will explore what clinical delivery alliances are and the value alliance partnership models bring to the drug 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 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 address the principles and practices of stability studies in the drug 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 Learn about how drug 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 Through case studies this webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug 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 How should manufacturers retool to navigate reimbursement planning in this brave new world?
Speakers: DrEric Faulkner, MPH, Senior Director, Market Access and Reimbursement, RTI Health Solutions, and Executive Director, Genomics Biotech Institute, National Association of Managed Care Physicians
Allan Jay Kogan, MD, Vice President and Regional Medical Director, CIGNA
Jayson S. Slotnick, Associate, Hogan & Hartson LLP
Reimbursement Planning: Reverse Engineering Drug Development to Meet Changing Payer Requirements Mar 10/09

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