🧬 Pharma Marketing, Compounding, and the GLP-1 Gray Zone | Sabrina Johnson (2/4)

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"Formulation matters. I can put the same active pharmaceutical ingredient in the exact same concentration in 20 different formulations and have 20 different outcomes."

In this episode of The Biotech Startups Podcast, Jon Chee continues his conversation with Sabrina Johnson, President and CEO of DARÉ Bioscience. Sabrina traces her path from a name-tag encounter that led her to Advanced Tissue Sciences to joining Cypress Bioscience in 1998. She unpacks pharmaceutical marketing regulation, the medical-regulatory-legal review process, and the gray zone of compounded GLP-1s — including DARÉ's decision to make its sildenafil cream available via 503B rather than leave women without a validated option.

Key Topics Covered:

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Find our guest, Sabrina Johnson at these links:

LinkedIn: https://www.linkedin.com/in/sabrina-johnson-27799829/ 

Website: https://darebioscience.com/ 

Find our host, Jon Chee, at these links:

LinkedIn: https://www.linkedin.com/in/jonchee/ 

Learn more about Excedr:

LinkedIn: https://www.linkedin.com/company/excedr/ 

Website: https://www.excedr.com 

Intro & Outro Songs Created by OkKyojin, Owned by Excedr:

Website: https://flow.page/kyojin 

Resources & Articles:

Responsible Compounding Could Close the Innovation Gap: https://www.fastcompany.com/91503495/responsible-compounding-could-close-the-innovation-gap 

The Scientist's Guide to Understanding FDA Drug Approval: https://www.excedr.com/blog/fda-drug-approval-process-guide 

503A vs. 503B: A Quick Guide to Compounding Pharmacy Regulations: https://www.thefdagroup.com/blog/503a-vs-503b-compounding-pharmacies 

Hyper Fixed — The Cat Drug Black Market: https://www.hyperfixedpod.com/listen/hyperfixed/the-cat-drug-black-market 

Companies, Universities, & People Mentioned:

Advanced Tissue Sciences: https://www.latimes.com/archives/la-xpm-2002-oct-12-fi-tissue12-story.html 

Cypress Bioscience: https://www.fiercebiotech.com/biotech/cypress-bioscience-agrees-to-be-acquired-by-ramius-llc-and-royalty-pharma-for-6-50-per 

Smith+Nephew: https://www.smith-nephew.com/en-us/ 

Gilead Sciences: https://www.gilead.com/ 

Eli Lilly: https://www.lilly.com/ 

Novo Nordisk: https://www.novonordisk.com/ 

Jay Kranzler (CEO, Cypress Bioscience): https://www.linkedin.com/in/jay-d-kranzler-66b08b12/ 

00:00 Intro

02:41 The Name-Tag Moment That Changed Everything

05:41 Watching ATS Scale from 50 to 250 People

06:31 Partnerships, Public Markets, and Leadership Lessons

07:40 The Medical-Regulatory-Legal Review Process

11:40 GLP-1s and the Direct-to-Consumer Compounding Explosion

13:48 503A vs. 503B: How Compounding Was Designed to Work

18:16 Patient Access vs. Responsible Drug Development

21:10 DARÉ's Sildenafil Cream and Responsible Compounding

23:52 FDA Warning Letters and Where Compounders Cross the Line

24:46 The Cat Drug Black Market

26:43 Outro

The Biotech Startups Podcast gives you a front-row seat to the business and science of building a biotech. Hosted by Jon Chee, CEO of Excedr, the show features honest conversations with founders, execs, and investors about their work, their companies, and how they got there. From scientific breakthroughs to startup lessons, each episode explores what it really takes to grow a life science company—from pre-seed to IPO.