Featured Pharma Online Editorial

1. 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.

2. New Plug-And-Play Guidances: Computerized Systems Validation And Audit Trail Requirements 10/18/2021

   A plug-and-play approach can significantly impact how we design, build, and operate biopharmaceutical facilities. Yet, with such a new and innovative development, there are many challenges for industry to adopt the approach. This article summarizes two recently released BioPhorum standards:_ Plug-And-Play Computerized Systems Validation Strategy_ and _Plug-And-Play Audit Trail Requirements_.

3. 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.

4. 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.

5. 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.

6. 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.

7. Cell And Gene Therapies: Solving Six Challenges 9/20/2021

   This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

8. CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward 9/17/2021

   In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.

9. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

   Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

10. Biotech Patenting: 4 Tips & Personal Experiences 9/13/2021

    When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.