Guest Columns

1. 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.

2. An Analysis Of FDA’s Recently Issued Gene Therapy Guidances 2/20/2020

   The FDA has finalized six draft guidance documents intended to serve as part of a modern, comprehensive framework for how the agency will help advance the field of gene therapy. At the same time, it issued a new draft guidance on determining “sameness” of gene therapy products for the purposes of orphan drug designation/exclusivity. This article highlights key changes made in each of the final guidances and also reviews the new draft guidance.

3. Management 4.0: Putting Pharmaceutical Companies On The Path To Agile 2/20/2020

   In Part 1 of this three-part article series, we defined how Agile evolved and how it began to be successfully implemented across multiple industries, including pharmaceutical manufacturing. Part 2 discussed the building blocks needed to bring agility to the project world. Here in the third and final article, we show how to implement this change through a new style of management.

4. Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development 2/18/2020

   For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.

5. 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.

6. 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.

7. Valentine’s Day Heartbreak: Let Go Of Your (Underperforming) CMO Partner 2/12/2020

   What should you do if your CMO has a deteriorating plant that directly impacts your production or personnel turnover that creates an environment of never-ending deviations and senseless retraining?

8. What Is the Current State Of BREXIT, And What Happens Next? 2/12/2020

   It's official: The United Kingdom is headed out of the European Union. Now begins a transition period, during which the trade relationship between the UK and EU will be decided, and both the European MDR and the CTR are set to take effect. 

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.