
257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1
From Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders by David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
June 2, 2026 · 24 min · Episode 257
About this episode
Milan Tomic discusses the importance of integrating regulatory affairs into drug design based on his 30 years of experience in biotech and GMP manufacturing.
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 comm...
People in this episode
Host: David Brühlmann
Guest: Milan Tomic
Topics covered
- regulatory affairs
- drug design
- biotech
- GMP manufacturing
- process development
Keywords
- regulatory affairs
- drug design
- biotech
- GMP
- process development
- manufacturing
- therapies
Mentioned in this episode
Organizations: Albrem
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