Gilmore O’Neill, neurologist and CEO of Editas, unpacks what strong regulatory leadership looks like when a biotech is racing toward first-in-human (FIH) and proof of concept.

From Preclinical to Proof of Concept: FIH Challenges

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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From Preclinical to Proof of Concept: FIH Challenges

From Preclinical to Proof of Concept: FIH Challenges