BIO From The Editor and Guest Columns

1. When Pharmaceutical Automation Projects Fail: Averting Disaster Through Risk Assessment 1/25/2021

   Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.

2. Clinical Logistics: Keeping COVID-19 Vaccine, Therapeutic Dev On The Rails 1/22/2021

   With a direct impact on timelines and data quality, transportation for clinical trials patients can make or break in-human studies. The challenge is on full display as hundreds of biopharmas continue their furious development of COVID-19 vaccines and therapeutics.

3. Developing An Automated GxP Workflow Integrated With 21 CFR Part 11 1/22/2021

   The electronic records and electronic signatures (ERES) regulations, 21 CFR Part 11 and EU Annex 11, provide life sciences companies an opportunity to reap the organizational benefits of paperless record-keeping systems. 

4. First In Line: FDA Vs. EMA Biopharma Approval Times 1/20/2021

   The vast majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy, but should they? This article reviews the data from more than 200 new therapeutics approved by the FDA over the past five years to determine if there really is any difference in approval timelines between the FDA and EMA.

5. Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business? 1/20/2021

   In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.

6. Is Your Definition Of Quality Culture The Same As The FDA's? 1/19/2021

   Steven Niedelman and Christina Markus boast more than 70 collective years of pharmaceutical regulatory experience, which will be on full display when they tell you where your quality culture may be falling short at the upcoming FDA/Xavier PharmaLink conference in March. Here’s a sneak peek.

7. Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019 1/18/2021

   In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.

8. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

   One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

9. 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers 1/13/2021

   Amid this opportunity for generic drug makers to capitalize on patent expiration, they’re facing struggles around pricing power. COVID-19 also exposed the fragility of supply chains that were built with economic efficiency rather than resiliency in mind.

10. An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report 1/11/2021

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019.