From Preclinical to proof of Concept: First in Human Challenges

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. [email protected]