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...

Author

SSI Strategy

Episodes

Why CMC Needs a Seat at the Executive Table 09.06.2026 41:35

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...

Regulatory Strategy for Accelerated Programs 30.04.2026 47:14

In this episode of Regulatory: The Emerging C-Suite Leader podcast, our hosts Debra Webster and Trevor Mill sit down with Murray Abramson, Chief Development Officer at Ascidian, to explore what it takes to accelerate drug development in complex settings, particularly in diseases with limited patient populations. Acceleration is often misunderstood. It is not about speed alone. Without a foundation...

Building the Investor Narrative 27.03.2026 39:50

Investor confidence is built on credible milestones and the ability to deliver on them. This episode features Rami Rahal , an investor at a leading biotech investment firm with a background spanning genetic research, drug discovery, and successful program development through approval. Having operated on both the development and investment sides, he brings a rare, practical lens on what makes a bio...

From Preclinical to Proof of Concept: FIH Challenges 19.02.2026 39:54

In our first episode of Regulatory: The Emerging C-Suite Leader , Debra and Trevor sit down with Gilmore O’Neill—neurologist and CEO of Editas—to unpack what strong regulatory leadership looks like when a biotech is racing toward first-in-human (FIH) and proof of concept. Gilmore argues that early regulatory engagement is not an adversarial exercise. It’s a long-term, science-led relationship buil...