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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:

• From Sales to Therapeutic Marketing: A name-tag moment led Sabrina to Advanced Tissue Sciences and her first exposure to pharmaceutical commercialization.
• The Medical-Regulatory-Legal Review Process: Why every word in a prescription drug piece requires multi-functional sign-off — and why it still holds at DARÉ.
• The GLP-1 Compounding Gray Zone: How compounding expanded beyond its intent and why consumers can't tell compounded from FDA-approved drugs.
• 503A vs. 503B: The regulatory difference between patient-specific pharmacy compounding and outsourcing facilities.
• DARÉ's Sildenafil Cream: How phase-two data led DARÉ to partner with a 503B facility rather than leave women waiting on FDA approval.
• When Demand Outpaces Regulation: From compounded GLP-1s to a Gilead cat drug black market — what happens when need has no sanctioned outlet.

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Subscribe to the Podcast:Apple: https://podcasts.apple.com/us/podcast/the-biotech-startups-podcast/id1679591994 Spotify: https://open.spotify.com/show/2PSL162R2s0zOwU5913Zv4 YouTube: https://www.youtube.com/@thebiotechstartupspodcast Website: https://www.thebiotechstartupspodcast.com/ 
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/ 
Timestamps:00:00 Intro02:41 The Name-Tag Moment That Changed Everything05:41 Watching ATS Scale from 50 to 250 People06:31 Partnerships, Public Markets, and Leadership Lessons07:40 The Medical-Regulatory-Legal Review Process11:40 GLP-1s and the Direct-to-Consumer Compounding Explosion13:48 503A vs. 503B: How Compounding Was Designed to Work18:16 Patient Access vs. Responsible Drug Development21:10 DARÉ's Sildenafil Cream and Responsible Compounding23:52 FDA Warning Letters and Where Compounders Cross the Line24:46 The Cat Drug Black Market26:43 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.