EXECUTIVE DIRECTOR, US LEAD, GLOBAL REGULATORY POLICY, MERCK
Rockville, Maryland, United States
Alexis Reisin Miller leads the U.S. regulatory policy team at Merck & Co., Inc. Alexis has advised a range of innovative biopharmaceutical industry players over her career of over 20 years, helping clients speed development and approval of new therapies. She held similar roles at Sanofi and Eisai, leading U.S. policy, and also was a Regulatory Counsel to the Office of Regulatory Policy at FDA’s Center for Drugs. Some of Alexis’ areas of focus have included: identifying and leveraging flexibilities in regulatory pathways and assessments, advancing regulatory science related to substantial evidence determinations, rare disease and pediatric drug development, patient-informed drug development and benefit-risk, regulation of digital health tools, advertising and promotion, labeling/ eLabeling, and harnessing digital technologies to inform strategy and health authority interactions. Her work over the past years includes a focus on helping ensure that patient input points are considered holistically, throughout the drug development timeline, and that tools to advance the efficiency of patient outcomes and input are supported through the regulatory, legislative, and policy processes. Prior to her in-house policy roles, Alexis worked as both an associate and as a partner in the FDA regulatory practice group at Morgan Lewis, counseling clients on regulatory legal, compliance, and policy matters.
1:45 PM - 2:45 PM (PDT)
Tuesday, June 14
Complex Innovative Design - What’s in a Name? A Global Perspective on the Changing Design Landscape for Clinical Trials and What That Means for Developers
Complex Innovative Design – what’s in a name? A global perspective on the changing…