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 to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding diversity & inclusion into R&D, and protection of innovation despite impact of other laws on regulatory strategy. Alexis' work in the industry spans over 20 years, across regulatory and legal functions, including FDA's Office of Reg Policy in CDER, and work at an international law firm as both an associate and partner advising a range of regulated industry clients on FDA, FTC, CPSC, and other regulatory, legal, and commercial issues.