Episode Details
Back to Episodes257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1
Description
The gap between a “drug” and a true “product” is where many therapies fail.
Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful commercialization.
Topics discussed:
- Milan’s path from curiosity-driven research in molecular biology to biotech industry leadership (05:24)
- The importance of integrating work-life factors into career decisions, and balancing scientific depth with operational and business responsibilities (08:22)
- The unexpected role that salesmanship plays for scientists moving into entrepreneurship (10:40)
- Lessons from transitioning between scientific disciplines, including dealing with setbacks like unpublished graduate work (12:57)
- How curiosity led Milan to oversee the redesign of a 2,000-liter GMP manufacturing facility (16:16)
- Key advice for scientists on process design and scaling up, especially for those involved in CMC (20:18)
Smart insight: A promising molecule isn’t enough—successful drug development requires designing early for scalability, GMP compliance, and real patient need. Companies that align science with manufacturability and market fit are far better positioned to advance, attract investors, and secure partners.
If you enjoyed this episode you might also like listening to:
- Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)
- Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
- Episodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari
- Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann
Connect with Milan Tomic:
LinkedIn: www.linkedin.com/in/milan-tomic-phd
Albrem Biopharma: www.albrem.com
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