Regulatory Paths: 505(b)(2) and Label Change Challenges

How can AI really help advance medicine? Should patients and care teams be seeking second opinions from LLMs? This week, Reid and Aria sit down with physician-scientist Dr. David Fajgenbaum, who repurposes existing drugs to save lives—including his own. David shares his journey from receiving last rites as a young medical student to co-founding Every Cure, a nonprofit using AI to come up with ways existing drugs can be repurposed to treat every disease and every patient possible. On this special episode, filmed live in New York City, David, Reid, and Aria explore the circuit of hope, action, and impact that drives medical discovery; the technical and ethical challenges around accelerating AI in healthcare; “agent optimization” as the new “search engine optimization;” and what a future of faster diagnoses and treatment could look like. The result is a conversation about resilience, innovation, and unlocking cures that are already within our reach.

For more info on the podcast and transcripts of all the episodes, visit https://www.possible.fm/podcast/ 

Topics:

3:00 - Hellos and intros

3:29 - A promise to his mother and the origin of AMF

6:23 - From grief support to medical school

9:18 - Near-death experiences and founding a research network

14:38 - What kept David going at death’s door

16:19 - Discovering a potential treatment and testing it on himself

19:42 - Why drug repurposing is a faster, cheaper complement to drug discovery

22:14 - Co-founding Every Cure and scaling discovery with AI

25:20 - Demo: Building MATRIX and how the algorithm makes predictions

28:41 - Breast cancer and Lidocaine as a case study

30:07 - Why human review is essential in AI for medicine

34:08 - Car exhaust fumes example and FDA pathways

37:31 - Reid’s surprise million-dollar donation for Every Cure compute

39:24 - What AI can unlock across healthcare

41:46 - Building an impact team to close the repurposing loop

47:32 - Improving systemic incentives for generics

54:58 - FDA approval pathways and label change challenges

57:21 - Three life-saving repurposing stories

1:02:20 - Rapid-fire questions

Select mentions: 

Hidden Potential by Adam Grant

Chasing My Cure by Dr. David Fajgenbaum

Every Cure 

David’s TED Talk: https://youtu.be/sb34MfJjurc?si=GcVleWHZuJ9MqLgS

Manas AI

Possible is an award-winning podcast that sketches out the brightest version of the future—and what it will take to get there. Most of all, it asks: what if, in the future, everything breaks humanity's way? Tune in for grounded and speculative takes on how technology—and, in particular, AI—is inspiring change and transforming the future. Hosted by Reid Hoffman and Aria Finger, each episode features an interview with an ambitious builder or deep thinker on a topic, from art to geopolitics and from healthcare to education. These conversations also showcase another kind of guest: AI. Each episode seeks to enhance and advance our discussion about what humanity could possibly get right if we leverage technology—and our collective effort—effectively.