Dr. Lisa Jenkins is the VP of Regulatory Strategy and Content Development at Virtual Regulatory Solutions, a company designed to assist small companies develop, register, and maintain drug, biologic, device, and generic applications. Dr. Jenkins has 15+ years of experience in the life sciences industry, and specializes in eCTD submissions management, adaptive clinical trial design, biomarkers, product labeling, and risk management planning. Dr. Jenkins serves as the Deputy Editor of TIRS.

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional RCTs, and addressing how intersecting regulatory, legal, and policy approaches influence strategy and innovation. With over two decades of experience in private practice, at FDA, and in industry, where she has led regulatory policy at several international biopharmaceutical companies, she brings a holistic, cross-cutting perspective to lifecycle issues from R&D and regulatory review through commercialization.