Send us Fan Mail

"The model said so" is not a defense. In the rush to integrate AI into drug discovery, life science companies are sprinting toward a compliance cliff. In this episode, Darshan Kulkarni—pharmacist and FDA regulatory lawyer—strips away the marketing hype to reveal the "messy reality" of AI in regulated environments.

We dive deep into the three pillars of risk that can sink a biotech firm:

• Data Integrity: Why AI scales bad data faster than you can fix it.
• The Ownership Crisis: Why current collaboration agreements aren't ready for probabilistic inventorship.
• The Accountability Gap: Who does the DOJ point to when the algorithm makes a $500M mistake?

If you are an executive or general counsel in the life sciences, this is the briefing you need to hear before your next M&A due diligence or patent filing.

Support the show

www.kulkarnilawfirm.com