Janice M. Soreth, MD Former Associate Commissioner, FDA With more than twenty-five years of public health experience, Dr. Soreth has served in senior roles, including as the Food and Drug Administration’s Director of Anti-Infectives, U.S. Liaison to the European Medicines Agency, and FDA Associate Commissioner for Special Medical Programs. She has championed drug development with the patient in mind, encouraging Target Product Profiles, fostering communication between regulators and industry, promoting harmonized regulatory standards and mutual recognition agreements, and facilitating new product development. Since leaving government service, Dr. Soreth has served on corporate boards and advised companies and non-profits on the clinical and strategic programs needed to develop new therapeutics. She has special expertise in reviewing clinical trial designs, ensuring the trials are rigorously crafted to pass regulatory scrutiny and enhance the informativeness of global health clinical trials. As a clinician, she served in the U.S. Public Health Service in Micronesia, and as a general internist with Kaiser Permanente. She continues her clinical practice by volunteering in medically underserved areas. Dr. Soreth received a B.A. in biology summa cum laude from Temple University, and an M.D. from the University of Pittsburgh. She trained in internal medicine at the George Washington University Hospital and is a Diplomate of the American Board of Internal Medicine.