Patrick McKenzie (patio11) is joined by Ruxandra Teslo to discuss why drug development keeps getting more expensive despite revolutionary new treatment modalities from GLP-1 agonists to gene therapies. They discuss Eroom’s Law (Moore’s Law in reverse) and Ruxandra's Common Technical Document Project, which aims to build the "Stack Overflow of clinical development" by making regulatory submissions publicly accessible. This will fill a present hole in the education of researchers, lower barriers for small biotechs, and accelerate drug discovery.
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Full transcript available here: https://www.complexsystemspodcast.com/ruxandra-teslo/
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Links:
Eroom's Law (original paper): https://www.nature.com/articles/nrd3681
Ruxandra’s writing: https://www.writingruxandrabio.com/
Ross Rheingans-Yoo on drug development: https://open.spotify.com/episode/4GiO0KYqxJNCIdltCyhN6m?si=2znQniZ3RXKuX8keNcwWtw
Ben Reinhardt on science and development: https://open.spotify.com/episode/0GHegWgLSubYxvATmbWhQu?si=pVCJVITYTqaq65BiST2d0Q
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Timestamps:
(00:00) Intro
(00:56) Challenges in biopharma productivity
(03:12) Understanding clinical development
(04:59) The role of basic science in drug development
(07:39) Clinical development process explained
(09:25) Issues in clinical trials and development
(19:33) The role of information in clinical trials
(20:30) Sponsor: Framer
(21:42) The role of information in clinical trials (continued)
(32:55) Proposed solutions for clinical development
(40:31) Consultant opinions and regulatory documents
(41:28) Streamlining the regulatory process
(43:06) Understanding FDA interactions
(45:35) Building a public library of regulatory documents
(48:18) Encouraging novel approaches in biotech
(50:06) Addressing risk aversion in the industry
(51:52) Analyzing FDA consistency and reviewer heterogeneity
(01:02:15) The importance of courage in professional growth
(01:06:39) Supporting young professionals and catalyzing change
(01:16:14) Wrap
