Guest Columns
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Choosing The Best Regulatory Pathway For Microbiome Products
4/10/2020
There is a regulatory grey area between healthcare and consumer health products, often causing confusion for brands entering this space. The microbiome is one area that is bringing new challenges, because much of the science supporting microbiome product claims are very new and remain unproven in many cases.
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Harmonious Harmonization: How To Get Quality System Alignment Right
4/8/2020
This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.
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Do We Need Comparative Clinical Efficacy Testing For Biosimilars?
4/7/2020
This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.
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Clinical Study Risk Management During The COVID-19 Pandemic
4/6/2020
While COVID-19 has proven to be an extremely trying obstacle for the life science community, it is crucial for organizations to not only focus on the short-term impacts of COVID-19 but on developing a long-term plan of action for how we return to business once the pandemic subsides.
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Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions
4/6/2020
Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.
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Stand By To Stand By: Organizational Contingency Planning
4/6/2020
The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.
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COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain
4/6/2020
During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need.
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EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications
4/3/2020
While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.
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What Pharma Can Learn From A Parent Turned Patient Advocate
4/2/2020
I am humbled and honored to introduce you to Andrew McFadyen — founder of the Isaac Foundation. Andrew is a husband, a father, and an advocate who tirelessly works to advance actionable dialogue around access, care, and policy for patients with rare diseases. Recently, I had the opportunity to chat with Andrew about the unique challenges that patients and their families face when dealing with serious illness and how we may better serve their needs.
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Implementing Data Quality By Design For Improved Data Integrity
4/1/2020
We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.