Guest Columns

1. 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.

2. 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.

3. 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. 

4. 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.

    

5. 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.

6. 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.

7. Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies 3/31/2020

   One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

8. Which Biosimilar Companies Will Thrive In 2025? 3/31/2020

   Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.

9. Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update 3/26/2020

   This article compares aspects of the biosimilar development pipeline and related market evolution over the past seven years, since 2013, including what has and hasn’t changed.

10. COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain 3/26/2020

    To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.