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Regulatory: The Emerging C-Suite Leader
Regulatory: The Emerging C-Suite Leader episodes
- Why CMC Needs a Seat at the Executive TableEdward Kaye, CEO of Aurora Therapeutics, discusses why CMC is often one of the most consequential and underestimated areas of drug development.42 min
- Regulatory Strategy for Accelerated ProgramsMurray Abramson, Chief Development Officer at Ascidian, explores what it takes to accelerate drug development in complex settings, particularly in diseases with limited patient populations.48 min
- Building the Investor NarrativeRami Rahal, an investor at a leading biotech investment firm with a background spanning genetic research, brings a practical lens on what makes a biotech company fundable.40 min
- From Preclinical to Proof of Concept: FIH ChallengesGilmore 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.40 min
About Regulatory: The Emerging C-Suite Leader
From the publisher's feed
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.