Featured Pharma Online Editorial

1. Regulatory Intelligence: It’s More Than Just Compliance 12/3/2021

   Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.

2. Can Real-World Evidence Transform Healthcare? FDA Indicates Yes 11/19/2021

   Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

3. Juno v. Kite Case Implications For Functionally Claimed Biological Compositions 11/12/2021

   The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?

4. Marks Took On FDA Vaccine Leadership Position – What Happens Now? 11/2/2021

   Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.

5. Updated Orange Book/Biologic Patent Study: Key Learnings 10/20/2021

   Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.

6. Computerized Systems Validation And Audit Trail Requirements 10/18/2021

   A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption  challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.

7. A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk 10/6/2021

   In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

8. A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I 10/4/2021

   This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.

9. Is The FDA About To Reclassify Your Drug Product As A Device? 9/27/2021

   Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.

10. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.