GUEST COLUMNISTS

• 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.

• 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.

• Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

  The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

• Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights

  Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.

• Managing Extractables And Leachables In HPAPI Manufacturing

  These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

• Unlocking Value In Biopharma Operations: A C-Suite Call To Action

  Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.