Complex Systems with Patrick McKenzie (patio11)

From molecule to medicine, with Ross Rheingans-Yoo

Oct 31, 2024

01:27:14

Snipd AI

In this discussion, Ross Rheingans-Yoo, an expert in drug development, delves into the complexities of drug approval processes, revealing systemic inefficiencies and the evolving landscape of clinical trials. He reflects on historical events like the thalidomide crisis and how they shaped FDA policy, while also highlighting the impact of the AIDS epidemic and COVID-19 on accelerated approvals. Ross shares his innovative work in rescuing abandoned drugs and emphasizes the need for integrating technology into medicine to enhance patient care and streamline drug development.

AI Summary

AI Chapters

Episode notes

Podcast summary created with Snipd AI

Quick takeaways

The intricate journey of drug development starts in academic labs, requiring navigation through various approval processes before reaching patients.

Pharmaceutical companies face significant economic pressures, necessitating drugs to generate substantial revenue during their patent life for project viability.

Optimizing patient recruitment strategies in clinical trials is crucial for enhancing trial efficacy and overall drug development timelines.

Deep dives

The Journey of Drug Development

Drug development typically begins in a university lab, where researchers explore the properties of molecules with potential medical benefits. When a drug advances beyond the early investigative stages, it passes through a university's tech transfer office and is spun out into a startup company that seeks venture capital funding. This company then undertakes preclinical studies in animals, followed by an Investigational New Drug (IND) application to the FDA, which must be approved before human trials can commence. This entire process, from academic research to regulatory approval, illustrates the intricate path that a new drug must navigate before reaching patients.

Intro

3min

Navigating Drug Development

14min

Streamlining Clinical Trials: Overcoming Inefficiencies

5min

Navigating Drug Development and Trials

24min

Navigating Pharmaceutical Development Challenges and Advanced Market Commitments

2min

Navigating Accelerated Drug Approval

30min

Navigating Clinical Trial Design

8min

Innovative Synergies Between Tech and Medicine

3min

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.

–

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

–

Sponsors: Manifold Markets | Check

Manifold is my favorite prediction market platform, making it easy to bet on anything from elections to crypto drama. Get started with a bonus at https://manifold.markets/complexsystems when you spend $20. Play money markets open to anyone; cash prizes only available to U.S. residents of at least 18 years of age. Terms and conditions apply.

Check is the leading payroll infrastructure provider and pioneer of embedded payroll. Check makes it easy for any SaaS platform to build a payroll business, and already powers 60+ popular platforms. Head to checkhq.com/complex and tell them patio11 sent you.

–

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/

–

Twitter:
@patio11
@_rossry

–
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

–

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

Get the Snipd
podcast app

Unlock the knowledge in podcasts with the podcast player of the future.

AI-powered
podcast player

Listen to all your favourite podcasts with AI-powered features

Discover
highlights

Listen to the best highlights from the podcasts you love and dive into the full episode

Save any
moment

Hear something you like? Tap your headphones to save it with AI-generated key takeaways

Share
& Export