257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

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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