GUEST COLUMNISTS

• FDA Priority Voucher Program Submissions Window Opens On New Website

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

• Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs

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

• 5 Best Practices For Improving AI Literacy In A GxP Environment

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

• AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies

  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.

• All Of Us Need To Be Rooting For The FDA

  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.

• Here's What Limits AI's Outlook For Replacing Knowledge Workers

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

• How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much

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

• Tales From The Trenches: Developing Potency Assays Outside Big Pharma

  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.