AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences – FDA Watch
In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm’s Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus. Together, they discuss Arnold & Porter’s recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in developing AI policy given budget and personnel cuts; concerns surrounding AI and protecting IP; and much more.
Access Arnold & Porter’s survey on AI adoption in life sciences here.
About Our Guests
Dan Kracov
Dan is Chair of Arnold & Porter’s Global Life Sciences Industry group, which was honored by Law360 in 2020 and 2022 as a “Life Sciences Practice Group of the Year.” For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and many others.
Abeba Habtemariam
Abeba is a Partner at Arnold & Porter, where she advises life sciences companies on a range of regulatory, compliance, and legislative matters, with a particular focus on counseling pharmaceutical and medical device manufacturers on compliance with the Federal Food, Drug, and Cosmetic Act. She routinely advises clients on the regulation of medical device software and healthcare IT, premarket approval and clearance strategies, promotional review matters, and cGMP compliance.
Ethan Dabbs
As a core member of the Health Care practice, Ethan leads Boston Consulting Group’s biopharma work in North America. In addition, he serves as the firm’s Northeast System lead. He is an expert in biopharma strategy and operations, including commercialization, marketing, positioning, segmentation, product launch, market access and pricing, field force effectiveness, clinical operations, medical affairs, and field-based medicine.
Lauren Silvis
Lauren serves as Senior Vice President of External Affairs at Tempus. She oversees regulatory, public policy, government affairs, and strategic communications. She has served as Senior Advisor at the Department of Health and Human Services, Chief of Staff at the FDA and Deputy Center Director for Policy in the FDA’s Center for Devices and Radiological Health.
FDA Watch Podcast 