GUEST COLUMNISTS

• Valentine’s Day Heartbreak: Let Go Of Your (Underperforming) CMO Partner

  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?

• What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know

  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.

• FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?

  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.

• The 10 Phases Of An Effective CAPA

  Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

• New FDA Draft Guidance: Qualification Process For Drug Development Tools

  Pharmatech Associates' Bikash Chatterjee on FDA-issued draft guidance on the qualification process for drug development tools (DDTs), including biomarkers for clinical trial enrichment, outcome assessments to evaluate clinical benefit, and an animal models for efficacy testing of medical countermeasures.

• The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter

  This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

• Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away

  Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

• An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report

  To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle.