Clinical data may determine whether a therapy works. Manufacturing determines whether patients ever receive it.

In this episode of Regulatory: The Emerging C-Suite Leader, hosts Trevor and Debra speak with Edward Kaye, CEO of Aurora Therapeutics, about why Chemistry, Manufacturing and Controls (CMC) is often one of the most consequential, and underestimated, areas of drug development.

For many emerging biotechs, manufacturing receives less attention than clinical strategy until a program reaches a critical milestone. By then, the consequences of weak process controls, incomplete assay development, inadequate oversight, or manufacturing variability can be difficult to unwind. CMC-related issues remain one of the most common causes of regulatory delays and complete response letters.

The challenge is not simply technical. CMC decisions influence regulatory strategy, development timelines, investment planning, commercial readiness, and long-term supply. Success depends on understanding what must be built at each stage of development, and recognizing when future manufacturing risks are being created by decisions made today.

Strong CMC organizations are not built by avoiding difficult conversations. They depend on experienced voices willing to challenge assumptions, raise concerns early, and advocate for investments that may not appear urgent until a problem emerges. The most expensive manufacturing mistake is often the one that could have been prevented years earlier.

Ed repeatedly makes the distinction between avoiding mistakes and learning from them. In CMC, learning from mistakes is often the more expensive option. Many of the issues that delay programs can be traced back to risks that were visible much earlier.

What risks are being created today because manufacturing is not yet part of the strategic conversation? Listen to the full episode with Ed Kaye.