Industry Insights

  1. Navigating The Complexities Of NK Cell Therapy Development 7/30/2025

    Deloitte's Amit Agarwal and Ashraf Husain share expert insights on how NK cell therapy developers can overcome manufacturing, supply chain, and commercialization challenges to successfully scale these promising therapies.

  2. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

    The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

  3. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.