Guest Columns

  1. Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs 7/28/2025

    There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.

  2. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

  3. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  4. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

  5. Here's What Limits AI's Outlook For Replacing Knowledge Workers 7/21/2025

    Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.

  6. How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much 7/21/2025

    In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

  7. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

    Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

  8. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

    The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

  9. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

    Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

  10. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

    Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.