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 built on trust. He explains why sponsors should proactively surface and address real, probable, and possible risks—and how transparent risk discussions can reduce delays, strengthen credibility, and improve decision-making. The conversation also connects regulatory strategy to the integrated development plan: start with the target product profile, work backward to define the questions you must answer (clinical, CMC and beyond), and engage the right regulators at the right time to clarify uncertainties early.
The episode closes with a CEO’s perspective on what they want from a regulatory leader: a problem-solving mindset, rigorous “why” thinking, and the willingness to challenge assumptions early—because the truth will surface either way, and it’s better to find it first.
Approaching FIH or a major health authority interaction and need senior regulatory leadership in the room?
SSI provides executive-level regulatory leadership to help you clarify the path, pressure-test the risks, and keep milestones moving. Let’s talk. letstalk@ssistrategy.com
What is Regulatory: The Emerging C-Suite Leader?
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.