Redefining Every Stage of Investment (RESI) Seed to Exit

講演者：: Geoff Fatzinger, Vice President, Regulatory Strategy, Certara

開催場所: Maynard 1

Early regulatory planning can transform an IND/CTA program from a fragmented set of activities into a focused, credible, and fundable development pathway. This session will outline best practices across nonclinical, CMC, First-in-Human (FIH) clinical design, and regulatory strategy, with a special emphasis on how early regulatory alignment drives integration and accelerates decision making. We will highlight some common pitfalls on the pathway to IND/CTA and attendees will gain actionable approaches to building an optimal regulatory strategy that meets business objectives, enabling a more predictable and efficient path to First-in-Human studies.