Sidley is pleased to host FDLI’s Introduction to Biologics and Biosimilars Law and Regulation course on October 1–2, 2019, at Sidley’s office in Washington, D.C. Emily Marden, counsel in Sidley’s Food and Drug Regulatory group, will teach the Regenerative Medicine and Advanced Therapies (RMATs) session on October 1 at 11:00 a.m. Emily has deep experience with the regulatory and strategic issues raised by novel genetic technologies, including applications of gene therapy and genome editing in human therapeutic products, animal drugs, foods, and agricultural crops, as well as in emerging science and regulatory pathways in the food, agriculture, biopharmaceutical and biotech arenas.
The two-day course, which is geared to both new legal and regulatory professionals, as well as seasoned practitioners, will focus on the regulation of biological products, including biotechnology-derived therapeutic proteins, human tissue, gene and cell products. The course will also cover abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals and time for Q&A will be provided.
Speakers: Emily Marden
