Regulatory Scientist Dr. Heather Hatcher will present on Regenerative Medicine and Advanced Therapies (RMATs) during a session at the Food & Drug Law Institute virtual event, Introduction to Biologics and Biosimilars Law and Regulation. The event, taking place completely virtually this year, will be held on October 14-16. Sessions at the conference will explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products, and attendees will learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation.
Dr. Hatcher’s session will focus on how FDA regulates new regenerative medicine products and advanced therapies, such as gene therapies, stem cell therapies, and immunotherapies, and she will be presenting on Wednesday, October 14th.
Heather Hatcher, Ph.D. is a Regulatory Scientist in the Winston Salem, N.C. office, and her extensive background as a basic and clinical research scientist, as well as Regulatory Affairs, has enabled her to effectively guide clients through the complex FDA regulatory landscape. Dr. Hatcher previously worked in academic research and research administration at Wake Forest Baptist Medical Center for 12 years and her 20+ year research career spans a number of fields including endocrinology, cancer biology and regenerative medicine; and her research has been published in numerous peer-reviewed journals.