SSI Strategy

Regulatory: The Emerging C-Suite Leader

Business EN ↓ 4 episodes

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 i...

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SSI Strategy

Episodes

Why CMC Needs a Seat at the Executive Table 10.06.2026 41:35

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

Regulatory Strategy for Accelerated Programs 30.04.2026 47:14

Murray Abramson, Chief Development Officer at Ascidian, explores what it takes to accelerate drug development in complex settings, particularly in diseases with limited patient populations.

Building the Investor Narrative 27.03.2026 39:50

Rami 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.

From Preclinical to Proof of Concept: FIH Challenges 20.02.2026 39:54

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.