Episode Details

In this episode, Patrick McKenzie (patio11) is joined by Ross Rheingans-Yoo to discuss drug development and clinical trials. Ross breaks down how drugs progress from academic research through FDA approval, the challenging economics, and the many systemic inefficiencies in the current approval process. Patrick and Ross discuss historical cases like the thalidomide crisis that shaped FDA policy, the evolution of accelerated approvals during the AIDS epidemic, and lessons from COVID-19 trials. Ross shares his current work rescuing abandoned promising drugs from bankruptcy.

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Full transcript available here: https://www.complexsystemspodcast.com/episodes/drug-development-ross-rheingans-yoo/ 

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Links:

• Ross' newsletter: https://essays.soletta.vc 
• Ross' blog post on drug development costs: https://blog.rossry.net/100x/
• Ross' blog post on lessons from thalidomide https://blog.rossry.net/thalidomide/ 

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Twitter:
@patio11
@_rossry

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Timestamps:
(00:00) Intro

(02:28) Ross’ career transition to drug development

(03:12) The drug development process

(06:22) Clinical trials and FDA approval

(11:48) Challenges in clinical trials

(14:50) Case study: COVID-19 trials

(18:00) Sponsors: Manifold Markets | Check

(19:55) Pharmaceutical economics

(38:13) Rare diseases and regulatory strategies

(45:18) Advanced market commitments explained

(45:54) Operation warp speed and its impact

(47:45) How to get accelerated approvals

(52:49) The thalidomide tragedy and its legacy

(01:03:17) Modern regulatory challenges and patient advocacy

(01:07:14) Reviving abandoned drugs

(01:12:06) Innovative approaches to drug trials

(01:24:26) The future of pharmaceutical development

(01:26:34) Wrap

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Complex Systems is part of the Turpentine podcast network. Turpentine also has a social network for top founders and execs: https://www.turpentinenetwork.com/