Janet Goldberg is a Senior Regulatory Health Project Manager for Rare Diseases in FDA’s Center for Biologics Evaluation and Research (CBER), which regulates cell and gene therapies, vaccines, and blood products. Janet has more than two decades of experience providing strategic counseling and expert advice on complex legal, legislative, and policy matters impacting federal programs, including FDA and other HHS agencies. Earlier in her career, she was a litigator in private legal practice. In addition to being an attorney, Janet completed graduate studies in science and epidemiology.

Dr. Sandra “Sandy” Retzky is the Director of the Office of Orphan Product Development at FDA. Sandy joined the Agency in 2016. Sandy initially trained as a pharmacist. She is also a physician with board certification in Obstetrics and Gynecology and fellowship training in Urogynecology. After practicing medicine for many years, Sandy received an MBA degree from the Wharton School at the University of Pennsylvania and worked in the pharmaceutical and biotech industries for more than a decade. In 2010, Sandy transitioned to a career in public health. To make the change, she obtained an MPH degree from Johns Hopkins Bloomberg School of Public Health in 2011 and a J.D. degree from Widener University in 2014.

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination products. As Assistant Director – Injection Devices at FDA, she managed reviewers and set technical and regulatory expectations for combination products and drug delivery devices. Before FDA, Rumi worked in R&D for a number of years at Genentech and AstraZeneca. She holds a Bachelor’s in Chemistry and Chemical Biology and a Masters in Material Science Engineering from Cornell University.