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Posted on October 27, 2017


Is Right to Try Legislation Really Necessary?

Proponents of the Right to Try Act – namely the public policy group, the Goldwater Institute – say the legislation could help patients get immediate access to potentially life-saving medical treatments that would be considerably faster than the FDA’s current system.

Posted on September 1, 2017


Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub

Many reasons – from investment opportunities to prospects for collaboration – are contributing to Toronto’s growing reputation as a great place for research and development in the life sciences.

Posted on August 10, 2017


One Patient’s Perspective on Clinical Trials

When John Rost was diagnosed with idiopathic pulmonary fibrosis (IPF), a rare lung disease with no known cause characterized by extensive scarring of the tissue, he began to seek out clinical trials – specifically a Phase I trial in IPF – that could help him get faster access to promising new therapies.

Posted on August 8, 2017


Top 6 Most Impactful Tweets from #NIAM17

August is National Immunization Awareness Month (NIAM). So in honour of this, we will be rounding up 6 of the most impactful tweets from #NIAM17 this week to keep you in the loop.

Posted on August 1, 2017


Clinical Trial Operations: 5 Things You’re Probably Doing Wrong

Electronic data capture (EDC) and eSource are becoming increasingly common in modern clinical trials, however both of these tools are rarely integrated with any significant capability, leading to wasted time and resources.

Posted on July 28, 2017


The Top 4 Most Expensive Drugs in the US are Hepatitis C Treatments

In recognition of World Hepatitis Day, let’s take a look at the modern treatments capable of curing patients with hepatitis C.

Posted on July 21, 2017


Top 5 Most Impactful Tweets from #AAIC17

This week, we’ll be rounding up 5 of the most impactful tweets from the Alzheimer’s Association International Conference (AAIC) held in London, England this year. The AAIC is the largest international conference dedicated to furthering Alzheimer’s disease and dementia research, uniting researchers from more than 70 countries across the globe. Here are the highlights from the research presented at the AAIC to keep you in the loop.

Posted on July 17, 2017


Manufacturing Control Strategies: What Pharmaceutical and Biotech Companies Need to Know

Once implemented, a manufacturing control strategy is not only beneficial for pharmaceutical companies to help them avoid product launch delays and quality concerns; patients benefit greatly from being able to rely upon the quality and increased production efficiency of drug products.

Posted on July 6, 2017


We Talk About Patient-Centricity but Are We Actually Listening to Patients?

Buzzwords like ‘patient-centricity’ and ‘personalized medicine’ have been thrown around a lot in the past few years, but these words have little meaning to patients if they’re not being applied in practice. In an effort to better understand the epatient perspective, I spoke with Sarah E. Kucharski, consultant, public speaker and advocate for the patient voice in medicine.

Posted on June 29, 2017


Top 5 Most Impactful Tweets in Biotech During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in biotech to keep you in the loop.

Posted on June 27, 2017


Top 4 Most Impactful Tweets in Drug Safety During the Last Week

This week, we’ll be rounding up 4 of the most impactful tweets in drug safety to keep you in the loop.

Posted on June 22, 2017


5 Reasons Why Animal Health Could be the Next Wave in Biotech

To address the potentially unmet need in the pet health sector, biotech companies focused on developing drugs for companion animals have been popping up in recent years. Zoetis, Kane Biotech, Aratana Therapeutics and Nexvet are just some of the biotechs working towards better medicines, vaccines and diagnostics for cats and dogs.

Posted on June 19, 2017


Top 5 Most Impactful Tweets in Drug Development During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in drug development to keep you in the loop.

Posted on June 12, 2017


Top 4 Most Impactful Tweets in Clinical Trials During the Last Week

This week, we’ll be rounding up 4 of the most impactful tweets in clinical trials to keep you in the loop.

Posted on June 6, 2017


10 Things You Didn’t Know About Food and Beverage Fermentation

A whole host of health claims – from improved digestion to boosted immunity – have been made regarding consumption of fermented foods.

Posted on June 2, 2017


Top 5 Most Impactful Tweets in Medical Devices During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in medical devices, to keep you in the loop.

Posted on June 1, 2017


Understanding the Patient Journey and its Implications for Life Science Companies

Taking the patient’s perspective into account has been an innovative trend in the life sciences sector, with clinical trials increasingly focusing on being more patient-centric, and the healthcare system as a whole moving towards value-based care.

Posted on May 26, 2017


Top 5 Most Impactful Tweets in Food Packaging and Labeling During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in food packaging and labeling, to keep you in the loop.

Posted on May 25, 2017


Highlights from the Bloom Burton & Co. Healthcare Investor Conference 2017

While no investment in a company is a sure-thing, Canadian pharmaceutical, biotech, medical device and diagnostics companies continue to develop and commercialize novel products which bring value to both patients and shareholders. To learn more about the Canadian healthcare sector, and some of the most promising publicly-funded and privately-backed companies, Xtalks attended this year’s Bloom Burton & Co. Healthcare Investor Conference.

Posted on May 19, 2017


Top 5 Most Impactful Tweets in Life Sciences During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in Life Sciences, to keep you in the loop.

Posted on May 16, 2017


Cloud-based Biotech: Managing Data for All Stages of Drug Development

The new wave of targeted, biomarker-based therapies have the potential to be very effective in a small patient population. Since the market for these therapies is smaller than that of blockbuster drugs of years past, biotech companies must make rapid, data-driven decisions regarding the fate of a biologic.

Posted on May 12, 2017


Top 5 Most Impactful Tweets in Healthcare During the Last Week

This week, we’ll be rounding up 5 of the most impactful tweets in healthcare, to keep you in the loop. This week, the passage of the American Health Care Act stirred up many key healthcare influencers to speak out, nurses appreciation week is underway and WHO celebrates the anniversary of the eradication of smallpox.

Posted on May 3, 2017


Which Antioxidant is Right for Your Nutraceutical Product?

For nutraceuticals manufacturers, it’s important to choose a highly-potent antioxidant which is sustainable to produce and can easily be formulated into a number of product forms.

Posted on April 17, 2017


What Medical Device Manufacturers Need to Know Before Developing a Biological Safety Evaluation

Depending on the design and use of a medical device, manufacturers may be required to develop a biological safety evaluation before a device secures regulatory approval. While the main focus of this testing is to assess the biocompatibility of a medical device and the potential risk to the patient, it is imperative that device manufacturers avoid costly and unnecessary testing.

Posted on April 12, 2017


Survey Results Say eConsent Adoption is on the Rise

The State of eConsent 2017 Report released by CRF Health surveyed 100 biotech, pharmaceutical, CRO, and IRB organizations who shared their opinions on Electronic Informed Consent (eConsent) and its ability to produce greater levels of efficiency, effectiveness, and patient engagement in clinical trials.

Posted on April 6, 2017


Ask an Expert: 5 Questions About Regulatory Requirements for Combination Products

The regulatory pathway and corresponding regulatory requirements for combination products can often be unclear and daunting for drug makers and medical device manufacturers.

Posted on March 30, 2017


Cold Chain Considerations for Cell Therapy Clinical Trials

Among the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed. To understand how sponsors can reduce risk and position their product well for commercialization, I sat down with Kristen Franklin, Client Services Manager, Cell Therapy and Amy Hendricks, Project Manager, both from Fisher BioServices.

Posted on March 22, 2017


Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

In response to the growing threat posed by drug counterfeiting, international regulators have begun implementing guidelines aimed at increasing control over the pharmaceutical supply chain. Will these efforts be enough?

Posted on March 14, 2017


The Future of Real-World Evidence

Life Sciences companies are performing advanced analytics, including cohort and predictive analytics, on top of these Real-World Evidence (RWE) data sources to understand the performance of their drugs and devices when used by actual, non-clinical trials patients.

Posted on March 7, 2017


Pharmaceutical Industry Cannibalization: The Launch of Authorized Generics After the Loss of Market Exclusivity

Once a drug begins to reach the end of its patent period, it’s vulnerable to being scooped up by generic drugmakers who seek to develop a copycat version of the medication. Authorized generics are identical to the company’s branded product in terms of both active and inactive excipient ingredients; the only thing missing is the brand name and packaging that comes along with it.

Posted on March 2, 2017


Five Ways to Optimize Capsule Filling Production

If your product’s ideal formulation is a capsule, there a few things you should consider before manufacturing.

Posted on February 21, 2017


Preparing for ICH-GCP E6(R2): A Former GCP Inspector Answers Your Compliance Questions

As this new rule will have an impact on all stakeholders in the clinical trials process – including study sponsors, contract research organizations (CROs), and investigator sites – it’s important that the guidelines are fully understood before GCP inspectors begin implementing them. I had a chance to speak with Gunnar Danielsson, a former GCP Inspector for the Swedish Medical Products Agency and European Medicines Agency, who now helps the industry and academia as an independent consultant.

Posted on February 17, 2017


Adding Value to your Food Products by Adding Live Cultures: Interview with a Probiotic Expert

To better understand how probiotics can be added to food products, and the benefits of probiotic fortification for both food manufacturers and consumers, I spoke with Michael Bush, president of the probiotic research and product development company, Ganeden. With over 20 years of experience in business and a degree in biomedical technology, Bush knows how formulating with functional ingredients like probiotics can help food and beverage companies add value to their products and increase sales.

Posted on February 8, 2017


Dirty Little Secret: How Clean Are Restaurant Tablets?

The digital revolution may well make it easier or more fun to process your order, but these devices shouldn’t be an overlooked source of potential cross-contamination.

Posted on February 2, 2017


5 Ways Mature Material Handling Workflows Can Benefit Your Manufacturing Business

Sometimes inefficiencies in material handling workflows are obvious, however without the right tools to improve these processes, manufacturers could get stuck with a sub-par process. So what defines a mature material handling workflow?

Posted on January 26, 2017


New Frontiers in Drug Discovery: Applying CRISPR/Cas9 Genome Engineering to the Drug Pipeline

For clinical researchers, drug development in a long and arduous process. In speaking with Dr. Anne-Marie Zuurmond, Associate Director of Genome Engineering, Discovery, Charles River Laboratories, I gained a better understanding of how the CRISPR/Cas9 genome editing tool works, and how it could streamline drug discovery.

Posted on January 19, 2017


How Pervasive is Brand Recognition in the Pharmaceutical Industry?

Chances are most consumers have heard of such blockbuster drugs as Viagra, Lipitor and Zoloft, but how much do they know about the companies behind these branded pharmaceuticals? Considering that drugmakers are continually facing tougher competition from the generics market, and US Food and Drug Administration (FDA) new drug approvals have been on the decline, pharmaceutical companies will need to start supporting their brand in order to stay competitive.

Posted on January 12, 2017


Can Automation Reduce the Risk of Product Recalls and Help Food Companies Achieve FSMA Compliance?

Labelling errors on food packaging have become a major problem in recent years, with both the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) issuing recalls due to the presence of undeclared allergens. According to Erik Phillips, US Director of Sales & Business Development, AutoCoding Systems, coding and labelling errors caused by outdated printing systems, as well as human errors in product packaging selection are major causes for this type of product recall.

Posted on January 4, 2017


Meet The App That’s Helping Consumers Manage Food Allergies

With food allergies and changing food preferences on the rise, consumers are paying more attention to ingredients labels on packaged and processed foods. Enter ipiit: The Food Ambassador, an app designed to help consumers identify and avoid products that contain allergens or other ingredients that don’t align with their personal food preferences.

Posted on December 13, 2016


mHealth: Improving Patient Recruitment, Retention and Engagement in Clinical Trials

mHealth technologies – namely mobile apps – have been on the rise in the clinical trials industry for the past few years. But in an industry known to be relatively cautious when it comes to adopting new technology, the early days of mHealth saw few early adopters.

Posted on December 6, 2016


Managing CMC Data for IDMP Compliance: What Pharmaceutical Companies Need To Know Before 2018

By end of 2018, all drugmakers who market their products in Europe will need to report their Chemistry, Manufacturing and Controls (CMC) data in a structured format, compliant with Identification of Medicinal Products (IDMP) standards.

Posted on November 22, 2016


Site Payment Paradigm Shift: Using Electronic Data Capture To Replace Excel

At a recent meeting at the Pharmaceutical Contract Management Group about site payments, pharma sponsors and clinical research organizations (CROs) outlined the complicated and manual process of paying clinical trial sites.

Posted on November 15, 2016


Risk-Based Monitoring, Remote Monitoring and eSource: A Smarter Monitoring Approach for Clinical Trials

Using risk-based monitoring, clinical research associates (CRA) at sites, and Data Quality Scientists (DQS) remotely, are able to focus their efforts on monitoring sites, events and data points which present the greatest risk.

Posted on November 9, 2016


Spotlight on Probiotics: 4 Surprising Product Categories Which Could Benefit from Fortification

Considering the growth potential of probiotics, more and more food companies are incorporating the functional ingredient into their products.

Posted on October 31, 2016


6 Questions about Carbohydrate Conjugates and Targeted Drug Delivery

While antibody-drug conjugates show promise as targeted therapeutics, alternative ligands – such as synthetic carbohydrates – could show better targeting capabilities towards select tissue. To learn more about synthetic carbohydrates and how they can be used for targeted drug delivery, I spoke with Dr. Stewart Campbell, Head of Business Development & Product Management, Carbohydrates, CordenPharma.

Posted on October 17, 2016


Colorectal Cancer: Using RNA-Seq to Identify Molecular Subtypes and Predict Treatment Response

To learn how transcriptional profiling of colorectal cancer subtypes using RNA-Seq can help researchers gain a better understanding of the disease, I spoke to Dr. Enzo Medico, Associate Professor, University of Torino, School of Medicine, Candiolo Cancer Institute.

Posted on October 12, 2016


Pharmacovigilance and Electronic Data Capture: Interview with an Expert

To learn more about how electronic data capture can be used to automate transmission of E2B-formatted serious event reports to the appropriate pharmacovigilance team, I spoke with Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc.

Posted on October 6, 2016


Synthetic Biology Promises On-Demand Biopharmaceuticals In Any Environment

Dr. James J. Collins, Professor in the Department of Biological Engineering at MIT and his colleagues, have developed a freeze-dried, cell-free biomolecular expression system. Highly portable, this technology utilizes all of the transcription and translation machinery – including DNA, RNA, enzymes and ribosomes – found in cells, and applies them to generate biomolecules in a cell-free environment.

Posted on September 28, 2016


Meeting Consumer Demand For Cleaner Food Labels

Packaged foods benefit immensely from artificial ingredients. In recent years however, these artificial and often hard-to-pronounce ingredients have fallen out of favour with consumers, prompting the food industry to simplify their ingredients lists.

Posted on September 21, 2016


Post-Approval Research: Do You Have What It Takes?

Chances are, post-approval research represents a substantial part of a pharmaceutical, biotech, or medical device organization’s annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner?

Posted on September 16, 2016


In an Imperfect World: Strategies for Psychiatric Clinical Trials

Studies involving psychiatry drugs may be uniquely challenging.

Posted on September 12, 2016


Establishing Medical Safety Groups Within a Biotech Startup: 6 Questions for a Medical Safety, Quality and Compliance Expert

I spoke with Dr. Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance from Acerta to discuss issues facing biotech startups when they’re considering establishing a medical safety group.

Posted on September 9, 2016


Examining the Expanding Role of Patient Advocacy Groups

Patient Advocacy groups are playing a larger role in development of drugs to treat cancer and rare diseases.

Posted on September 6, 2016


Insights on Implementing Risk-Based Monitoring: An Interview with François Torche, CEO of CluePoints

I spoke with François Torche, CEO of CluePoints, to learn about challenges and questions that arise when implementing Risk-Based Monitoring.

Posted on August 30, 2016


Getting Serious About Pharmaceutical Serialization: Advice From An Industry Expert

I spoke with Carlos Machado, Serialization Director, US, for Zenith Technologies, to get an expert’s view on what drug manufacturers need to do now in order to prepare to implement a serialization solution.

Posted on August 23, 2016


Did Athletes Use Gene Doping In The 2016 Rio Olympics?

At this year’s 2016 Olympic Games in Rio, athletes faced a battery of doping tests. In light of recent advancements made in the fields of gene therapy and gene editing, officials have now developed a new test to detect potential gene doping among athletes.

Posted on August 12, 2016


AAIC 2016: The Industry Perspective On Alzheimer’s Disease

In order to find out what those in the industry are doing to advance Alzheimer’s disease diagnosis, disease management and treatment options, I spoke to some of the veterans and the newcomers in the space.

Posted on August 4, 2016


AAIC 2016: Highlights In Prevention, Detection And Treatment Of Alzheimer’s Disease

Xtalks attended this year’s Alzheimer’s Association International Conference (AAIC), to get an idea of what advances have been made in Alzheimer’s research, and which companies are helping to support those efforts.

Posted on July 20, 2016


Controversy, Dolly and Two Decades Of Cloning Technology

Twenty years have passed since Dolly the Sheep became the first mammal to be cloned using an adult cell, but what’s become of the technique since?

Posted on July 13, 2016


Polypills: One Pill Fits All?

The most compelling aspect of the polypill is that some researchers think that everyone over the age of 50 should be taking one.

Posted on July 4, 2016


What The FDA's New Nutrition Facts Label Means for Food Manufacturers

While the updated label will help consumers make better choices at the grocery store, the changing regulations could be a nightmare for the sugar industry.

Posted on June 23, 2016


Can Chimeric Pigs Solve Our Human Organ Shortage Crisis?

By exposing pig embryos to human stem cells, it’s hoped that the resulting chimeric animals could grow specific human organs which could be harvested for human transplantation.

Posted on June 16, 2016


The Importance Of Patient-Reported Outcomes In Clinical Trials

While clinical trials may do a good job of assessing a drug or treatment’s efficacy at treating a disease, they often fail to take into account the patients’ experience when participating in a clinical trial.

Posted on June 9, 2016


Advocates’ and Critics’ Perspectives On Creating A Synthetic Human Genome

Last month, over 130 scientists, lawyers, government officials and other prominent individuals from around the world, met at Harvard University for a round-table on the topic of synthetic genomes.

Posted on June 2, 2016


Reducing Human Error In Clinical Trials: Improve Data Entry For More Robust Clinical Trial Data

Here’s a look at some of the most common sources of human error during the course of a clinical trial, and how sponsors and contract research organizations (CROs) can implement proactive measures aimed at reducing these risks, and improving the quality of the resulting clinical trial data.

Posted on May 20, 2016


Trump, Sanders and Clinton: Pharmaceutical Industry’s Friends Or Foe?

While each of their platforms varies when it comes to dealing with drugmakers, all three of the top candidates – Democrats Hillary Clinton and Bernie Sanders, and presumptive Republican nominee, Donald Trump – are siding with public opinion. All three candidates are advocating for increased transparency in the drug pricing process.

Posted on May 13, 2016


5 Ways You Might Be Compromising Your Food Safety Standards

Ignoring any one of these areas can lead a company open to a risk of product contamination, which could lead to failed FDA inspections, product recalls, consumer illness, or worse.

Posted on May 5, 2016


Making The Switch: Continuous Manufacturing vs. Batch Processing of Pharmaceuticals

As many of the issues with contamination occur during the manufacturing process, it’s important that drugmakers implement the best possible production process to limit the risk of recalls and protect consumer safety.

Posted on April 28, 2016


How To Start A Biotech Company On A Dime

While many of the lab tools required will be highly dependent on the type of research you’ll be conducting – such as protein work, human cell culture or animal studies – there are a few gadgets that are almost universally necessary.

Posted on April 22, 2016


Addressing The Challenges Associated With Site Selection For Clinical Trials

In an age of big data and fierce competition for top-performing research centers, some in the industry are urging study teams to take a data-driven approach to site selection.

Posted on April 14, 2016


The Current State Of ClinicalTrials.gov Results Reporting

Despite the legal and ethical requirements, recent research has suggested that most clinical trial results remain unpublished, both in the scientific literature and on ClinicalTrials.gov.

Posted on April 7, 2016


The Surprising Link Between Off-Label Prescribing Practices And Adverse Drug Events

It’s estimated that around 12 to 20 percent of all prescription drugs are prescribed for uses other than those indicated on the label. This has the potential to present a significant risk of adverse drug events in patients, as clinical trials were never conducted to test the safety and efficacy of the pharmaceutical in treating the off-label condition.

Posted on March 31, 2016


CAR-T and Bispecifics: Powerful Immunotherapy With Profound Challenges

Immunotherapy – treatments that harness the power of the body’s own immune system to fight disease – has been widely regarded as a potentially game-changing new tool in the field of oncology.

Posted on March 23, 2016


Six Proposed Changes To The Medicare Part B Drug Payment Model

Here are six things you should know about the proposed changes to Medicare Part B, so you can consider new strategies for demonstrating product value and ensuring your drug will be covered.

Posted on March 16, 2016


FDA Fights Back Against Price Gouging

Faced with public pressure to solve the issue of rising pharmaceutical costs, key groups – including regulators, politicians and private companies – are each approaching the problem from their own perspective.

Posted on March 9, 2016


Pharma, Doctor, Patient: Three Perspectives On The Effects Of Direct-To-Consumer Advertising

While the opinion that pricey DTC ads are at least partially responsible for the rising cost of prescription drugs is widely accepted, other views on the issue are often underrepresented.

Posted on March 3, 2016


Food Fraud: How FSMA Will Hold The Food Industry Accountable For Economically-Motivated Adulteration

As today’s food supply chain is made up of imports from around the world, food fraud – or the economically-motivated intentional adulteration of food products – is an important factor in ensuring food security.

Posted on Feb 24, 2016


5 Ways To Increase Patient-Centricity In Your Clinical Trial Operations

Patient-centricity has become a much-used buzzword by those in the clinical trials industry, but practically-speaking, how can the concept be applied to the average clinical trial site?

Posted on Feb 16, 2016


Preparing For Disaster: 10 Things To Know About Mass Notification Systems and NFPA 72

As facilities specializing in healthcare, pharmaceutical development and clinical trials become increasingly more complex, implementation of a mass notification system has become a necessity.

Posted on Feb 9, 2016


What You Need To Know About The EMA Before Setting Up A Clinical Trial In The EU

With the current trend towards patient-centricity and the drive to establish trial sites where the patients are, pharmaceutical companies and contract research organizations (CRO) are realizing the challenges in understanding international clinical trial regulations, and ensuring compliance.

Posted on Feb 4, 2016


Developing The Zika Vaccine: A Dichotomy Of Optimism and Caution

While multiple pharmaceutical companies have pledged to begin development of a Zika vaccine, the long lead time and regulatory processes associated with vaccine discovery make it unlikely that one will be ready by the end of this year, or the next.

Posted on Jan 28, 2016


Pharmaceutical Packaging: What You’re Doing Wrong

While pharmaceutical manufacturers pay a great deal of attention to ensuring they’re compliant with good manufacturing practices (GMPs) and US Food and Drug Administration (FDA) regulations when manufacturing a drug, pharmaceutical packaging can often be an afterthought.

Posted on Jan 20, 2016


3 Reasons Why Pharma Marketers Are Failing At Social Media

Pharma marketers have historically been much more comfortable with the one-sided conversation of a direct-to-consumer (DTC) ad, but as the industry moves more and more towards patient-centricity, it is becoming necessary for drugmakers to increase engagement with their stakeholders.

Posted on Jan 13, 2016


Martin Shkreli: A Timeline Of Events That Shook Up The Pharmaceutical Industry

While being taken into custody has nothing to do with his pricing decisions as CEO of Turing, the years leading up to the controversy surrounding Daraprim reveals detail about Shkreli’s entry into the pharmaceutical sector, and his contribution to the reputation of greed often conferred upon the pharma industry.

Posted on Dec 15, 2015


Top 5 Pharmaceutical Industry News Stories of 2015

As the 2015 calendar year draws to a close, the Xtalks Blog thought it would be a good idea to explore the top 5 pharmaceutical industry topics of the year, and make predictions on what people in the industry can expect for 2016.

Posted on Dec 3, 2015


Top 2 FDA Issues Affecting Compounding Pharmacies and Outsourcing Facilities

While the FDA has issued guidance on what types of compounding facilities should register under section 503B, many compounding pharmacies are unsure of whether their organization is eligible for exemptions and if those benefits would outweigh the FDA scrutiny. Still other compounders have registered with the agency, but are struggling to comply with stricter regulations.

Posted on Nov 25, 2015


Transparency in Clinical Trials: Why The Industry Isn’t Measuring Up

A recent study conducted by Bioethics International – a not-for-profit organization that keeps tabs on the way pharmaceutical companies develop and market drugs in order to determine the ethics behind these practices – found that many large pharmaceutical companies failed to achieve transparency in their clinical trial results.

Posted on Nov 17, 2015


Is Your Clinical Trial Ready For An FDA Inspection? Surprising Insights Gained From An Interview With An Inspection Trainer

I spoke with Janet E. Holwell, CCRA, CCRA, TIACR clinical research consultant, to understand why many clinical trial professionals dread FDA inspections, and how they can be better prepared to deal with one and its potential aftermath.

Posted on Nov 5, 2015


The FDA Food Safety Modernization Act: Is Your Organization Ready For Compliance?

Since January 2013, the Food and Drug Administration (FDA) has been working towards implementing new rules on food safety, as part of the agency’s Food Safety Modernization Act (FSMA).

Posted on Oct 29, 2015


Virtual Clinical Trials – Can Remote Trials Change The Clinical Trial Landscape?

Virtual clinical trials are a relatively new method of collecting safety and efficacy data from human trial participants.

Posted on Oct 20, 2015


Drug Prices: To Cap or Not To Cap?

Recent price hikes on some new drugs – along with those that were approved by the FDA decades ago – have some asking the question, are these costs justified?

Posted on Oct 13, 2015


Russia & Ukraine Cut Import Taxes, Red Tape for Clinical Trial Supplies

Clinical trial professionals are applauding changes in regulations that make it easier and less expensive to conduct global clinical trials in Russia and Ukraine – two countries whose requirements had been provoking frustration and concern.

Posted on Oct 1, 2015


Transactional Outsourcing and Strategic Partnerships: An Insider’s Perspective

To understand the benefits – and the common challenges – associated with strategic partnerships, I spoke with Richard Fazackerley, Technical Director, Aesica Pharmaceuticals, who will be speaking in more detail about strategic partnerships in a webinar on October 5th.

Posted on Sept 24, 2015


Insights Into The Emerging Health Monitoring Medical Device Market

To get an insider’s perspective on where the health monitoring medical device industry is heading, and how these devices could improve outcomes for clinical trials, I spoke with Deepak Prakash, Global Director of Marketing, Digital Health, for Vancive Medical Technologies.

Posted on Sept 17, 2015

Precision Medicine and the Paradigm Shift In The Development of Novel Cancer Therapies

To further understand how the paradigm shift in cancer research, diagnosis and treatment will affect how drugs are developed and clinical trials are conducted in Canada, I spoke to Dr. Sian Bevan, director of research for the Canadian Cancer Society.

Posted on Sept 9, 2015

Medical Device Innovation: Blurring the Lines Between Medical Necessity and Personal Accessory

As sales of wearable medical monitors rise, and healthy, average consumers increasingly look for high-tech gadgets to monitor their health, device manufacturers are developing technology which can be marketed to both healthy individuals as well as those with specific medical conditions.

Posted on Sept 2, 2015

Recent Medical Applications of 3-D Printing and the Future of Medical Device Manufacture

While the use of 3-D printers in the pharmaceutical industry is still in its infancy, three-dimensional printing technology has been used for other applications such as medical device manufacture and improvements in research tools available for drug testing.

Posted on Aug 26, 2015

Printing Your Prescription: How 3-D Printing Technology is Affecting the Pharmaceutical Industry

In the wake of the FDA’s first approved 3-D printed drug – which happened earlier this year – and the promise of three others in the works, experts are predicting that the future of the pharmaceutical industry lies in the development of printable drug products.

Posted on Aug 19, 2015

Are There Adequate Alternatives to Animal Testing?

Three promising in vitro and in silico technologies including, Modular Immune in vitro Construct (MIMIC), Organ-on-a-Chip and Computer Models of Adverse Drug Reactions, which could reduce the need for animals in research, are reviewed in more detail.

Posted on Aug 12, 2015

Infographic - Medical Device Development in Cardiovascular Disease Clinical Trials

See this infographic to give you an introductory understanding of cardiovascular disease risk, medical device industry involvement and the challenges involved when developing a medical device for a clinical trial.

Posted on July 16, 2015

Which States Are Proactively Using Google Search to Join Clinical Trials?

We used google trends to search some of the most relevant and popular keywords or keyphrases that individuals/healthy volunteers might search when trying to join a clinical trial and collected the results...

Posted on June 30, 2015

Address Your Challenges in Streamlining Clinical Testing Across Global Clinical Trials

During the recent Xtalks webinar, “Implementing a Sound Logistical Strategy to Mitigate Risk and Streamline Clinical Testing Across Global Clinical Trials - A Central Laboratory Perspective,” I outlined several key considerations for conducting clinical testing in challenging locations across the world and explained how 3P logistics principles...

Posted on June 10, 2015

Non-Alcoholic Fatty Liver Disease Epidemic?

The increasing prevalence of nonalcoholic fatty liver disease (NAFLD) and other metabolic syndromes is widespread, likely due to lifestyle factors including diet...

Posted on June 2, 2015

Echolocation Research and Technologies

Echolocation is a highly developed skill for many species, and we are learning more about the ability for humans to acquire this skill and substitute it for vision as a main sense for navigation, and developing more effective electronic mobility aids...

Posted on May 25, 2015

Brief Evolution of Genetic Technologies: Where are we Now?

The field of genetics has become a foundation in all areas of medical research. Technologies to uncover mysteries of life are continuously being developed, but this raises many concerns that require input from all pertinent parties, to move forward with ethical decisions that will benefit society...

Posted on April 20, 2015

The Beginning of Clinical Trials for Gene Silencing in Huntington’s Disease

The first clinical trials for gene silencing in Huntington's disease patients are beginning this year at various sites around the globe...

Posted on April 14, 2015

Personal Genome Service 23andMe – Expands to Drug Development

The personal genome service 23andMe that gives you insight into your own genetics, has faced criticism and FDA hurdles but has officially announced their entrance into drug development. What does this all mean?

Posted on April 6, 2015

Origami DNA Nanobots - Screen Body Health and Kill Cancer Cells

Ido Bachelet and his research team at the Wyss Institute for Biologically Inspired Engineering at Harvard University are making significant progress in the development of robotic devices comprised of folding strands of DNA, aka, DNA nanobots...

Posted on March 31, 2015

Virtually Interactive Medical Research – Wave of the Future?

There have been many exciting announcements this year regarding new technologies launched to accelerate medical research that involve the direct virtual participation of individuals. The latest announcement from Apple has people stirring about the potential of their new software platform, ResearchKit...

Posted on March 23, 2015

Heart on a Chip Technology to Accelerate Drug Development

Dr. Kevin Healy and his research team from the University of California, Berkeley, have microfabricated a 3D tissue construct that recapitulates a minimal organoid structure composed of pulsating human myocardium – essentially, a beating heart-on-a-chip. This cardiovascular microphysiological system has shown to effectively predict the cardiotoxicity of various herat drugs, consistent with pharmacological data on tissue scale references compared to cellular scale studies...

Posted on March 16, 2015

What is Food Fraud and What can be Done about it?

As you are taking a bite of that mouth-watering sandwich you got a great deal on at your corner market, do you ever stop to consider how many ingredients, or how many supply chains, were involved in making it? Do you ever question the quality and nature of your coffee or tea leaves, olive oils or fats, alcoholic beverages, spices or extracts? What about other staples like...

Posted on March 10, 2015

Exploring the Methylome: An Alternative Epigenomics Approach to Capturing Disease Variants

As the genomics information age continues to unfold, high throughput genomic sequencing technologies are becoming increasingly efficient in creating large and complex data sets. Efficient ways to catalogue this data is key to comprehend the dynamic interactions that regulate gene expression and activity through epigenetic processes in normal biology and disease...

Posted on February 20, 2015

How Bad is Food Fraud Today and are we Equipped to Prevent it?

Intentional deception using food for economic gain, or food fraud, has been an ongoing challenge for the food and drink industry since the beginning of time. However, as the global supply chain continues to grow, and becomes more and more complex, so too do the stakes for everyone linked to this chain from manufacturers, retailers, and raw ingredient suppliers to regulators and the consumer....


6 Tips to Overcome Nervousness When Speaking in a Webinar

While there is no instant way to make you a confident speaker, here are some tips to help you exude confidence rather than nervousness, and “fake it, till you make it.”


Top Ten Webinar Production Tips of 2016

As 2016 comes to an end, let's look at some of our best production tips to help elevate your webinar!


A Guide to Following Up on Your Webinar Leads

In this guide, we are happy to share with you some of the unique insights and tips on how to best to conduct your own follow-up.


How to Develop Your Brand’s Unique Value in a Competitive Life Science Marketplace (With Free Worksheet)

How can you cut through the noise of the marketplace?


Webinar Myths: True or False?

How many times have you heard, “I could never host a webinar, it’s too complicated!” or “hosting a webinar will take too much of my time!” In this week’s production tips blog we’ll be debunking some of the myths about hosting webinars.


Webinars - 7 Common Technical Issues to Avoid

In this week’s production tips blog, read more about some common technical issues you can easily avoid when hosting a webinar.

How Your Sales Team Should Be Using Webinars to Their Advantage (& Free Optimizer Template)

Learn why incorporating your sales team within the workflow of your webinars can be beneficial.

Finding the Best Speaker for Your Webinar

In this week’s production tips blog we’ll outline some key points that you should focus on when finding that perfect speaker for your webinar.

5 Ways to Repurpose your Webinar Content

Don't let all that great content go to waste! Here are five ways to repurpose your content to get the most out of your webinar.

Easy Tricks for Hosting a Great Q&A Session

Remember these short helpful tricks, and I’m sure you’ll improve the interactivity of your webinar Q&A session, and be ready for any question headed your way.

Scientifically Proven Ways To WOW Your Attendees

Creating great presentations isn't rocket science. We list out scientifically proven tips on how you can captivate your audience.

Map Your Webinar Content to Stages of the Sales Cycle

As a life science marketer, identifying the buying stage of your prospects is crucial to determining the type of content you should be producing.

Webinar Room

Mistakes to Avoid When Selecting Your Webinar Room

Webinars have gained popularity in recent years partly because of their flexibility when it comes to time and space requirements. One of the key benefits of webinars is the fact that you can not only host, but also participate and watch webinars from anywhere in the world (even your home). In our experience, more and more speakers are working remotely and are able to present webinars while travelling

Live Webinar

Webinars and the Evolving Media Landscape: An Interview with John Hughes, CEO of Honeycomb Worldwide Inc.

This week, I spoke with John Hughes, CEO of Honeycomb Worldwide Inc. Mr. Hughes has seen, first hand, the transition and development of a traditional seminar into an online, interactive business and educational tool.

PowerPoint Design Tips for Your Webinar (With Free Template)

So you’ve compiled all of your slides, graphical data and presenter notes – but your presentation seems to fall flat prior to submission for your upcoming webinar. Here's a brief and easy graphical overview and some tips that can help you jazz up your slide deck!

Why You Should Be Constructing Buyer Personas When Hosting A Webinar (& How To Do It)

The success of your marketing efforts are reflective of how well you know your audience; if you want to optimize your efforts, you’ll need to review your assumptions frequently since a buyer’s wants and needs can change quickly in the life science industry.

Optimize Your Webinar Format to Communicate Your Expertise

In a previous article, we established that the demand for webinars is prevalent, and with the potential for many of your webinar attendees to turn into qualified leads , it is a tool you cannot overlook. Now that you’ve decided to host a webinar, it’s time to decide the format.

11 Speaking Tips for a Remarkable Webinar

Fully captivating your audience is a skill that can be slowly developed from years of experience but you can use the following eleven public speaking tips that will instantly improve your presentation and put you on the right track.

4 Reasons Why Your Audience is Demanding Webinars

Both small enterprises and large organizations are seeing a shift in how individuals consume online content.

A Guide to Webinar Poll Questions – Try These Examples

Learn why you'd want to use poll questions and how to best construct them for your upcoming webinar.

How to Keep Attendees Engaged During Your Webinar

1. Grab the Attendee’s Attention From the Beginning
If you fail to do this at the start of your webinar, you might not be able to reconnect with them again later on in your presentation. Start off with a...

4 Mistakes to Avoid When Creating an Effective Webinar Slide Deck

While there are a lot of points to consider when constructing a slide deck, we've picked out four important points that can get overlooked...

Top 5 Reasons to Host a Webinar

Webinars are not only a more effective alternative to conferences or tradeshows, they will cost your company a lot less money...

Top 10 Most Interactive Webinar Topics for 2015
(Continuing Series - Thinking of Running a Webinar?)

Looking back, we found 10 webinar topics that generated the most interactivity from our audience members. The Q&A sessions for these topics consistently produced an overwhelming number of questions for our presenters to answer, and we believe these trends will likely continue for 2015. Lets take a look...

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