Show Notes
Part 3 of 4 of our series with Judy Chou, President and CEO of AltruBio.
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:
- 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.
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
Organizations & People
- 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/




.png)