Contributing Editors

1. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

   In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

2. 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.

3. Cell & Gene Therapies: A Roadmap To Solving 6 Challenges Over The Next Decades 9/20/2021

   This past year has seen remarkable progress in the growth of cell and gene therapies. Advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell & gene therapies will be available for a range of diseases and uses. However, the pathway ahead will need planning. This article reviews six major issues affecting the cell & gene therapy space and provides recommendations for companies to be successful.

4. 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.

5. 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.

6. 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.

7. FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History 9/10/2021

   On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.

8. Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing 9/8/2021

   Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

9. How To Find & Manage Biotech Consultants Effectively 9/6/2021

   The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

10. What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?