Inside the CMC Black Box: A Deep Dive with Reza Oliyai

 

🎙️ Episode Title:

Inside the CMC Black Box: A Deep Dive with Reza Oliyai

🧾 Show Notes:

What exactly is CMC — and why is it behind more FDA rejections than any other category?

In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Reza Oliyai, former SVP of Pharmaceutical & Biologics Operations at Gilead Sciences, and now Founder & CEO of Oliyai Consulting, to demystify the world of Chemistry, Manufacturing, and Controls (CMC).

With over three decades of experience and a role in advancing 200+ drug candidates and 27 product launches, Reza offers a front-row seat to what goes wrong — and right — in the drug development journey.

🔍 In this episode, we explore:

• What CMC really means — and why the "controls" part is most overlooked

• Why 74% of FDA complete response letters involve CMC issues

• The pitfalls of the “Phase 1 mentality” in late-stage development

• AI in CMC: helpful tool or overhyped distraction?

• How to evaluate CDMO partners (and why big pharma’s pick might be your wrong fit)

• The evolving geopolitical landscape and its impact on global manufacturing

• What startups, investors, and boards need to understand about CMC before it’s too late

• Career advice: what it takes to lead in this increasingly complex field

🧠 Key Quote:

“CMC is a black box to most executives. That’s a problem. Because it’s also the number one reason drugs get delayed.” — Dr. Reza Oliyai

Whether you're in manufacturing, regulatory, executive leadership, or just trying to understand what actually gets a drug to market — this episode is a must-listen.

🔗 Resources & Mentions:

• Oliyai Consulting

• Reza Oliyai on LinkedIn

• FDA’s recent publication of Complete Response Letters

👤 About Our Guest:

Dr. Reza Oliyai is a globally recognized leader in pharmaceutical operations, with deep expertise across small molecules, biologics, ADCs, peptides, siRNA, and more. After 28 years at Gilead Sciences, he now advises over 100 organizations worldwide through his firm, Oliyai Consulting.