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.

CDR Lei Xu, MD, PhD, serves as the Acting Director of Office of Orphan Products Development (OOPD), Office of Chief Medical Officer (OCMO), the Office of Commissioner, FDA. She began her FDA career in 2009 as a primary clinical reviewer in the Center for Biologics Evaluation and Research (CBER), later advancing to Branch Chief, where she oversaw approval decisions for 12 CBER products. In early 2024, she joined OOPD as a primary reviewer, and in November 2025, she became the Acting Director overseeing OOPD’s congressionally mandated programs and other activities that support and advance the development and evaluation of new treatments for rare diseases.

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.