Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress

By Rachel Sherman, MD, MPH, President of Rachel Sherman Partners, LLC, former Principal Deputy Commissioner of the U.S. Food and Drug Administration

When regulatory challenges obscure the path forward, Dr. Rachel Sherman provides unparalleled clarity. With decades of experience and a deep understanding of both science and law, she helps teams regain direction when they've lost their way.

As a former Principal Deputy Commissioner of the FDA and a highly respected regulatory strategist in biopharma, Dr. Sherman is the expert leaders turn to when a clinical program faces gridlock. She cuts through speculation to leverage science and law with unflinching precision. Her unique ability lies in transforming complex regulatory issues into clear, actionable strategies, especially when the stakes are highest.

Learn more about how Dr. Sherman not only resolves problems but often anticipates and prevents them, knowing precisely when to pivot, escalate, or hold the line.