Industry Insights

1. Your Medical Device Software Will Need Updated — Better Plan For It Now 8/6/2018

   Medical devices released into the market are part of an evolving software and security ecosystem in which new vulnerabilities are discovered or introduced all the time. The FDA's Medical Device Safety Action Plan outlines evolving expectations for the medical device industry, including expectations for secure updates.

2. Biosimilar Discounting & Contracting: What Can The U.S. Learn From Europe? 3/14/2018

   In this two-part series, we will consider multiple facets of the EU’s influence on biosimilar adoption. Part 1 will focus on payer coverage of biosimilars and the role of discounting and contracting. Part 2 will highlight the effects of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

3. Serialization In Practice: How Manufacturers Can Ensure Compliance 10/2/2017

   Pharmaceutical manufacturers cannot limit responsibility for DSCSA compliance to just the engineers and operators involved in processing and packaging.

4. The FDA, Device Cybersecurity, And What To Expect In 2019 1/7/2019

    The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?

5. How Much Do You Really Know About Your CDMO’s Equipment (And How Much Should You)? 2/19/2019

   The first article in this series discussed the physical elements of facility design that sponsors look for in contract development and manufacturing organizations’ (CDMOs) manufacturing facilities. 

6. 3 Good Reasons To Never Fall In Love With A Molecule 6/6/2018

   In my 2016 book about drug development, Nesiritide,¹ I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.

7. Best Practices For Handling Potent APIs 7/7/2015

   This article addresses the issue of how to overcome the industry challenge of handling highly potent APIs using advanced technologies and techniques that can provide a solution.

8. Risks And Challenges Of Having Multiple Products In Your Pipeline 12/22/2015

   As cell therapy companies tackle multiple products in their pipelines and move them from basic research into development and production, the risks and challenges of developing multiple products become clear.

9. Integrating Risk Management Into Your QMS — An Essential Toolkit 6/11/2018

   Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.

10. What Is Shelf Life Testing Of A Pharmaceutical Product? 6/4/2015

    Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.