Industry Battlecard
Pharma
FDA 21 CFR Part 11, GxP, and trade-secret exposure. A leaked compound structure is irreversible IP loss.
Shadow AI risk
R&D and medical affairs paste proprietary compound data, trial results, and patient narratives into AI tools.
Common use cases
- · Literature review
- · Trial protocol drafting
- · Medical writing
- · Regulatory submissions
Compliance impact
21 CFR Part 11
GxP
FDA AI/ML guidance
Conversation starter
"Pharma IP leakage to public LLMs is uninsurable. How is your CISO measuring it right now?"
Discovery questions
- ·Do you have a sanctioned LLM for R&D?
- ·How are you handling AI in GxP-validated systems?
- ·What's your stance on Copilot in regulated workflows?
Recommended collateral
- Pharma Battlecard
- GxP + LLM Whitepaper