258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2

What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced.This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan’s focus lies in streamlining drug development, from rapid molecule design to building manufacturing infrastructure, all grounded in holistic, systems-level thinking.Topics discussed:Why so many promising programs fail between discovery and the clinic, and how to close this gap through early, iterative design and testing (02:52)The practical advantages and considerations of cell-free protein synthesis for rapid prototyping and testing during development (07:30)How to decide when to deploy cell-free production versus traditional CHO systems (08:29)Recommendations for resource-constrained startups: what to focus on first and why stability and documentation matter most (10:55)Consistent success factors across Milan’s experiences, from government contract projects to launching his own company (13:54)Candid stories of setbacks and lessons—such as the critical importance of safety in development and the impact of overlooked technical details like facility lighting (15:30)The importance of linking drug design decisions to target patient needs and regulatory considerations, thinking holistically, and using target product profiles to guide development (20:22)Smart insight: Perhaps the most powerful takeaway isn’t technical, but personal. Staying curious, open-minded, and deriving enjoyment from the process is vital for sustaining the drive necessary for biotech’s long and often unpredictable journey. The best way to bridge the valley of death in biotech is through rigorous iterative design, early testing of critical attributes, holistic planning, and a relentless commitment to learning.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 SharfsteinEpisodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe LicariEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Milan Tomic:LinkedIn: www.linkedin.com/in/milan-tomic-phdAlbrem Biopharma: www.albrem.comNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show