Edward Kaye, CEO of Aurora Therapeutics, discusses why CMC is often one of the most consequential and underestimated areas of drug development.

Why CMC Needs a Seat at the Executive Table

Welcome to Regulatory: The Emerging C-Suite Leader — the podcast where regulatory isn’t just a checklist. It’s leadership. 

Hosted by Debra Aub Webster and Trevor Mill — two of our Chief Regulatory Officers — this show goes behind the scenes of biotech’s highest-stakes decisions. From FDA meetings that define the future of a company to global strategies that set the pace for clinical success, we explore how regulatory thinking becomes strategic advantage. 

Each episode features candid conversations with seasoned leaders who’ve navigated accelerated programs, first-in-human trials, and critical inflection points. These are the lessons you won’t find in a training deck. 

If you're a biotech executive, investor, or regulatory leader, this podcast is for you. 

Because regulatory affairs isn’t just about approval — it’s about direction.

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Science

Life Sciences

Welcome to Regulatory: The Emerging C-Suite Leader — the podcast where regulatory isn’t just a checklist. It’s leadership. Hosted by Debra Aub Webster and Trevor Mill — two of our Chief Regulatory Officers — this show goes behind the scenes of biotech’s highest-stakes decisions. From FDA meetings that define the future of a company to global strategies that set the pace for clinical success, we explore how regulatory thinking becomes strategic advantage. Each episode features candid conversations with seasoned leaders who’ve navigated accelerated programs, first-in-human trials, and critical inflection points. These are the lessons you won’t find in a training deck. If you're a biotech executive, investor, or regulatory leader, this podcast is for you. Because regulatory affairs isn’t just about approval — it’s about direction.

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Why CMC Needs a Seat at the Executive Table

Why CMC Needs a Seat at the Executive Table