What exactly is CMC, and why is it the backbone of pharmaceutical quality? In this episode, Nicholas sits down with Jeffrey Seres to break down the complexities of Chemistry, Manufacturing, and Controls for early-stage founder-scientists.
From the friction between aggressive VC timelines and operational realities to the future of documentation, we cover the critical gaps in moving from R&D to commercial manufacturing.
Topics covered:
Defining CMC: The control and oversight governing manufacturing quality.
The Strategy Gap: Why rushed timelines destroy CMC strategy and how to mitigate "Time vs. Money" arguments with investors.
Board Composition: Why startups need operational expertise, not just bankers and academics, on their boards.
The Future of Docs: Why putting paper on an iPad isn't true digitization—and why full process automation is the real goal.