Why CMC Needs a Seat at the Executive Table

Why CMC Needs a Seat at the Executive Table

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 emerging biotechs, manufacturing receives less attention than clinical strategy until a program reaches a critical milestone. By then, the consequences of weak process controls, incomplete assay development, inadequate oversight, or manufacturing variability can be difficult to unwind. CMC-related issues remain one of the most common causes of regulatory delays and complete response letters.   The challenge is not simply technical. CMC decisions influence regulatory strategy, development timelines, investment planning, commercial readiness, and long-term supply. Success depends on understanding what must be built at each stage of development, and recognizing when future manufacturing risks are being created by decisions made today.   Strong CMC organizations are not built by avoiding difficult conversations. They depend on experienced voices willing to challenge assumptions, raise concerns early, and advocate for investments that may not appear urgent until a problem emerges. The most expensive manufacturing mistake is often the one that could have been prevented years earlier.   Ed repeatedly makes the distinction between avoiding mistakes and learning from them. In CMC, learning from mistakes is often the more expensive option. Many of the issues that delay programs can be traced back to risks that were visible much earlier.  What risks are being created today because manufacturing is not yet part of the strategic conversation? Listen to the full episode with Ed Kaye.

Regulatory Strategy for Accelerated Programs

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 in data, patient insight, and regulatory alignment, timelines are built on hope rather than reality. The discussion highlights the importance of early, integrated planning across clinical, regulatory, and CMC functions. Misalignment across these areas is one of the most common reasons accelerated programs fall short, particularly when protocols are built in isolation or timelines are set without grounding in prior experience. Adaptive trial designs can create efficiencies, but they are not a universal solution and must be applied in the context of the disease, modality, endpoints, and available biomarkers. Identifying and continuously reassessing the “source of truth” is critical, meaning grounding decisions in data rather than assumptions. This includes patient needs, enrollment feasibility, regulatory expectations, and operational realities. Successful programs are those that address risks early, create an environment where challenges are surfaced before they become crises, maintain open communication across teams and with regulators, and adapt as new information emerges. A clear tension exists between urgency and rigor. There is a moral imperative to move quickly for patients, but only when speed is supported by scientific rigor, transparency, and a well-grounded development strategy. Hear it in Murray's own words.

Building the Investor Narrative

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 biotech company fundable. Key takeaways: *  Milestones define your valuation, and your credibility. They must be grounded in cross-functional alignment and achievable timelines. * Regulatory leadership is a strategic differentiator. When positioned at the C-suite level, regulatory shapes the development path, anticipates hurdles, and enables efficient, high-quality execution. * Confidence comes from clarity on risk. Transparent, well-articulated risks, and plans to manage them, build far more trust than over-optimized narratives. * Execution is what investors underwrite. Enrollment, data generation, and regulatory sequencing are the true drivers of value inflection. * Experience changes outcomes. Teams that integrate experienced regulatory leadership early are better positioned to deliver on what they promise.   For biotech executives, this highlights the importance of elevating regulatory into a core strategic voice strengthens both the development plan and the investor narrative.   Listen to the episode to hear directly from an investor on what builds and breaks confidence.

From Preclinical to Proof of Concept: FIH 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. letstalk@ssistrategy.com