Dr. Yong has 11 years of experience at the FDA in the regulation of a broad portfolio of FDA-regulated products, including, but not limited to biological products (cell and gene therapies, TEMPs), human tissues, medical devices, and combination products, and over 25 years of experience in the field of regenerative medicine. She possesses comprehensive regulatory knowledge and experience related to the regulatory framework for human cells, tissues, and cellular- and tissue-based products (HCT/Ps), the Tissue Reference Group (TRG), and medical product classification and jurisdiction, including pre-RFDs and RFDs. Dr. Yong also specializes in HCT/P establishment inspection and regulatory compliance actions as well as advanced manufacturing regulatory frameworks.
As Vice President of Regenerative Medicine and Biologics Quality Regulatory Affairs, Dr. Yong works closely with MCRA’s Regulatory department to manage, develop, and execute regulatory services for tissue establishments, regenerative medicine therapy and device companies. This includes early regulatory strategy, regulatory submissions, analysis, and cross-functional development in the program areas of regenerative medicine therapies, chemistry, manufacturing and controls, advanced manufacturing (CMC), biologics quality, and regulatory compliance.
Dr. Yong received her Ph.D. from the École Polytechnique Fédérale de Lausanne (EPFL) in Bioengineering and Biotechnology with a focus on tissue engineering and biomechanics. She received her Master of Science in Engineering degree in Chemical Engineering and Bachelor of Science in Engineering degrees in Biomedical and Chemical Engineering from Johns Hopkins University.
Prior to joining MCRA in October 2023, Dr. Yong most recently served as an Associate Director for Policy and Chief of the Policy and Special Projects Staff in the Office of Therapeutic Products (OTP) at the US Food and Drug Administration. As the authoritative senior advisor both within and outside OTP, Dr. Yong oversaw regulatory, policy, guidance, and compliance activities for a broad portfolio of products under OTP’s purview: cellular and gene therapies, human tissues, therapeutic vaccines, xenotransplantation products, and devices that produce biological outputs at point of care. Dr. Yong began her regulatory career as a chemistry, manufacturing, and controls (CMC) reviewer specializing in cell therapies, devices, tissue engineered medical products, and combination products, and during her career has participated in all aspects of the regulatory review and oversight of cell and gene therapy products, from pre-submission meetings (INTERACT, pre-INDs, Q-Subs), IND review, BLA review, advisory committees, pre-approval inspection, device review, and guidance development. Other highlights in her career at FDA include CBER designated subject matter expert in Advanced Manufacturing for drugs and biologics, Regenerative Medicine, HCT/Ps for CBER’s Office of Compliance and Biologics Quality, and the Tissue Reference Group. Additional former positions at FDA include Acting Chief of the Cell Therapies Branch, Device and Combination Products Team Lead in CBER, and Lead Reviewer in CDRH for plastic and reconstructive surgical devices, including wound care products and implants.
Overview
Dr. Yong has over a decade of regulatory expertise in a broad portfolio consisting of human tissues and FDA-regulated products, including cell and gene therapies, devices, and combination products. Dr. Yong specializes in the development of early regulatory strategy, regulatory submissions, interacting with the FDA, and is proficient in applying regulatory review experience from multiple Centers across the FDA to create new, innovative solutions to streamline regenerative medicine product regulatory review and advanced manufacturing technology implementation.