The Peter Attia Drive · Podcast summary
#409 ‒ Inside modern drug development: the science, economics, and regulatory hurdles behind bringing new medicines to patients | Lloyd Klickstein, M.D., Ph.D.
Dr. Lloyd Klickstein, a physician-scientist and drug developer, reveals the intricate science, economics, and regulatory challenges behind modern drug development, using the muscle and obesity drug Bimagrumab as a case study.
Listen on the show ↗Key takeaways
- 🧬Drug discovery begins by identifying unmet medical needs, focusing on transformative rather than incremental therapies.6:37
- 🛡️Patent strategies include multiple filings on composition, formulation, manufacturing, and use to extend exclusivity and protect investments.20:42
- 📉Measuring falls in elderly patients using accelerometers was ineffective, highlighting challenges in clinical endpoint assessment.34:16
- 💊Biologics like monoclonal antibodies are favored for targets requiring very high binding affinity, which small molecules struggle to achieve.48:14
- 🐭In mice, blocking myostatin and activin receptors dramatically increases muscle mass and strength, but human gains are more modest.1:00:22
- 💰Developing a drug through IND-enabling studies and phase one costs around $20–30 million, with much higher costs in later phases.1:09:44
Chapters
- 0:00🎙️ Introduction and Background
- 6:00🔬 Drug Discovery Foundations
- 12:00💉 Drug Modalities and Patents
- 23:00💪 Bimagrumab Development
- 33:00🧪 Clinical Trials and Challenges
- 42:00💼 Commercial and Regulatory Landscape
- 50:00📊 BELIEVE Study and Obesity Focus
- 1:02:00🔮 Future Directions and Prevention
The digest
From Physician Scientist to Drug Developer
Dr. Lloyd Klickstein began his career as a rheumatologist and NIH-funded basic scientist at Harvard Medical School and Brigham and Women's Hospital. He transitioned into industry over 20 years ago, joining Novartis where he helped pioneer translational medicine and led the new indication discovery unit. Today, as CEO of Coslap Therapeutics, Klickstein offers a unique perspective on drug development from early discovery through clinical trials and commercialization.
Keep reading in The Digest
The full 3-minute article, 8 more sections, and every new episode from The Peter Attia Drive and the creators you follow.
- The Black Box of Drug Discovery
- Drug Modalities and Intellectual Property
- The Journey of Bimagrumab: Targeting Muscle Loss
- Clinical Trials and Challenges in Measuring Outcomes
- From Novartis to Versantis and Eli Lilly
- Regulatory and Economic Realities
- The Future of Drug Development and Prevention
- Key Takeaways
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