Contributing Editors

1. FDA FY2019 Warning Letter Trends: A Closer Look At Drug Product Manufacturers 2/28/2020

   This is the second article in a two-part series reviewing the FDA’s GMP drug warning letters from FY2019. Part 1 provided a high-level overview of the FY2019 data, including trends since FY2013. In Part 2, we take a deeper dive into the types of drug product manufacturers that received warning letters and their locations.
   
    

2. Another "Partnership" Sob Story: A Dear John Letter To Biotech Landlords 2/26/2020

   The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.

3. The 5 Pillars Of Clinical Trial Material Management 2/25/2020

   Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.

4. 3 CMC Mistakes That Could Cost You Billions 2/24/2020

   The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.

5. U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report 2/21/2020

   Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

6. Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers 2/17/2020

   Implementing online water bioburden analyzer (OWBA) technology often includes laboratory microorganism challenge testing to verify that the instrument is suitable for its intended use. This requires the end user to select microorganisms for testing and successfully create quantifiable suspensions of these microorganisms for OWBA analysis. While this would seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

7. Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk 2/14/2020

   The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to high levels of nitrosamine impurities have once again put the spotlight on sourcing strategies and the globalization of the pharmaceutical supply chain. Learn how the Johari Window model can help minimize risk and shrink the unknown risks inherent in any complex manufacturing supply chain.

8. Valentine’s Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go 2/12/2020

   We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?

9. What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know 2/10/2020

   Rates of investment in the microbiome category are increasing as both venture capital firms like Seventure and pharmaceutical companies like Johnson & Johnson and Takeda make significant investments and establish partnerships with a variety of start-ups that are commercializing novel offerings in the microbiome space.

10. FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark? 2/7/2020

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.