AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development – FDA Watch
In part two of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers’ data integrity operations and in inspections; how AI could play a part in product applications; and much more.
Access Arnold & Porter’s survey on AI adoption in life sciences here.
About Our Guests
Howard Sklamberg
Howard is a partner at Arnold & Porter. Before entering private practice, Howard held a variety of roles at FDA from 2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement.
Eva Temkin
Eva is a partner at Arnold & Porter. Eva has extensive experience with the unique issues facing biological products, including cell and gene therapies, in addition to drugs and devices. During her tenure at FDA, Eva served as the agency’s lead for development and implementation of therapeutic biologics and biosimilars policy.
Marko Topalovic
Marko leads the AI team at Clario, which recently acquired ArtiQ, where he was the founder and CEO. Joining forces with Clario, Marko said, was a pivotal moment because of the integration of ArtiQ’s technology into Clario’s portfolio. Marko noted that the integration not only enhances the quality and efficiency of spirometry data analysis “but also marks a sizable step toward minimizing the patient burden and improving trial outcomes.”
FDA Watch Podcast 