Jae Kim

Partner at DLA Piper

Speaker

Jae Kim is a Partner in the Philadelphia and Washington D.C. offices of DLA Piper. Her Food and Drug Administration (FDA) practice is primarily focused on regulatory compliance, enforcement, and transactional matters. She frequently advises clients in the pharmaceutical, advanced therapeutics, device, and digital health industries.

She has extensive transactional experience as an FDA subject matter specialist and routinely leads regulatory due diligence projects on significant transactions. Jae routinely advises on the drafting and negotiation of various contracts, including supply agreements, quality agreements, and clinical trial agreements.

Jae also has deep experience in navigating complex regulatory requirements for food and beverage, cosmetics, hemp CBD, and dietary supplements as well as other products and services that are regulated by the U.S. Department of Agriculture (USDA), the Alcohol Tax and Trade Bureau (TTB) and state liquor authorities, the Drug Enforcement Administration (DEA), Centers for Medicare & Medicaid (CMS) and state clinical laboratory agencies, and the Consumer Product Safety Commission (CSPC).

Her knowledge and unique experience across various industries and sectors are invaluable for clients who are seeking to launch products that intersect with two or more product categories, especially when they need strategic advice on how to best position novel products to achieve their business goals. She counsels companies in regulated industries on issues that arise throughout the product life cycle, from product development to postmarket compliance.

Jae is one of the leaders of AAPEX, the Firm's Asian American Pacific Islander Resource Group. Outside the office, she is actively involved in the regulatory community, including the Food and Drug Law Institute (FDLI) and Women in Bio.