The Biotech Startups Podcast 🧬 Biosimilars, FDA Risk-Taking & Billion-Dollar Deals | Judy Chou (Part 3/4)
Jan 26, 2026
01:05:01
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“If you want to make money, really follow your passion rather than follow the money, because the money later on will come.”
In this episode of The Biotech Startups Podcast, Dr. Judy Chou shares her journey as employee number one at Tanvex, walking into an empty 50,000 square foot facility and building a biosimilar company from scratch after a close friend’s death from metastatic lung cancer reshaped her understanding of drug access and affordability. She recounts an extraordinary FDA meeting where, as the sole company representative, she fielded questions from 32 regulators and ultimately convinced them to waive all preclinical animal studies, then later took on unexpected responsibility for building three manufacturing suites when multiple VPs were fired. The conversation also follows her move to Medivation, where she scaled technical operations from two people to a global network of over 50 CDMOs and CROs, culminating in a high-stakes bidding war among five pharma giants that ended with Pfizer acquiring Medivation for $14.3 billion, up from a $9 billion market cap just three months earlier.
Key topics covered:
Key topics covered:
- Biosimilars and Access: Why Judy shifted from pure innovation to biosimilars to expand patient access and why availability is as critical as invention.
- From Empty Building to Phase 3: How she built a biosimilar company from scratch, advanced two products into Phase 3 in four years, and navigated a pivotal FDA meeting with 32 reviewers.
- End-to-End Biotech Leadership: Lessons from overseeing R&D, manufacturing build-outs, and global CDMO/CRO networks across Tanvex, Medivation, and Pfizer.
- Passion Over Paycheck: How prioritizing mission over short-term money at key career junctures ultimately benefited both her impact and financial outcomes.
- Culture, M&A, and Big Pharma: Experiences integrating Medivation into Pfizer, helping shape Pfizer’s oncology organization, and later stepping into large-scale leadership at Bayer.​
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Subscribe to the Podcast:
Find our guest, Judy Chou at these links:
Website: https://www.altrubio.com/altrubio/en
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:
​FDA Biosimilars 101: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
FDA Guidance on Biosimilar Development & Approval: https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/biosimilars-guidances
Basics of Phase 3 Clinical Trials: https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/phases
Explainer on Contract Development and Manufacturing Organizations (CDMOs): https://www.excedr.com/blog/contract-manufacturing-organizations
Contract Research Organizations (CROs): https://www.excedr.com/blog/contract-research-organizations
​
Companies, Universities, & People mentioned:
Genentech: https://www.gene.com
Tanvex BioPharma: https://www.tanvex.com
Medivation: https://en.wikipedia.org/wiki/Medivation
​Pfizer: https://www.pfizer.com
​Bayer: https://www.bayer.com
Gilead: https://www.gilead.com
​
David Hung: https://www.linkedin.com/in/davidhungmd/
Timestamps:
00:00 Intro
02:24 Becoming Employee Number One at Tanvex
04:57 Walking Into an Empty 50,000 Square Foot Facility Alone
06:29 Friend's Death from Lung Cancer: Why Biosimilars Matter
09:41 FDA Meeting: 32 Agents, One Scientist, Zero Animal Studies Required
17:05 Learning Every Part of Drug Discovery and Regulatory Process
20:19 Decision to Leave Tanvex Despite IPO Windfall
22:59 Following Passion Over Money: A Golden Timing Lesson
24:53 Joining Medivation and Building Tech Ops from Scratch
31:35 Five Bidders Competing: The $14.3 Billion Pfizer Acquisition
38:59 Bridging East Coast and West Coast Biotech Cultures at Pfizer
39:37 Joining Bayer: Leading 2,000 Employees Across Six Sites
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.