Agenda

The way FDA evaluates clinical evidence is undergoing significant modernization, and the implications for women's health development are substantial. Real-time access to trial data, the expanding role of real-world evidence, and the emergence of AI-enabled tools in trial design and safety monitoring are reshaping how sponsors plan, execute, and engage with the Agency across the product lifecycle.

For a category long defined by underrepresentation in trials, fragmented real-world datasets, and economic barriers to investment, these shifts create new opportunities to improve the efficiency, quality, and relevance of evidence generation.

In this session, Dr. Mallika Mundkur, former Deputy Chief Medical Officer at the U.S. Food and Drug Administration, offers an independent perspective informed by senior leadership experience at FDA helping drive and shape the Agency's modernization of regulatory science and advancing its approach to real-time review of clinical trials. Dr. Mundkur will provide a candid assessment of where the modernization of clinical evidence generation and regulatory review is headed, the opportunities and practical challenges that lie ahead, and how sponsors can best prepare for an increasingly data-driven and continuously learning regulatory environment. The discussion will explore the growing role of real-time review, real-world evidence, and AI-enabled tools in clinical development and regulatory decision-making, offering attendees strategic insights into the future direction of evidence generation and regulatory science.