Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was cited in PYMTS, in “AI Regulation: Global Picture Balances Innovation and Insight.”
Following is an excerpt:
The global artificial intelligence (AI) landscape is undergoing significant shifts as regulators grapple with the technology’s rapid advancements. …
Experts Urge FDA to Strike Balance in AI Regulation
Industry leaders at the RAPS Regulatory Intelligence Conference emphasized the need for a balanced approach in the FDA’s future AI regulations, advocating for flexibility and collaboration over rigid rules, Regulatory News reported Monday (June 10).
Moderated by Chris Whalley, Pfizer’s director of regulatory intelligence, the panel featured attorney Bradley Thompson of law firm Epstein, Becker & Green; Vice President of Pharma Sam Kay of AI-powered health data firm Basil Systems; Director of Global Regulatory Strategy Gopal Abbineni of pharmaceutical firm Bayer; and Head of U.S. Global Regulatory and Scientific Policy at Merck Group Elizabeth Rosenkrands Lange of science and tech firm EMD Serono/Merck. They collectively warned that overly prescriptive regulations could hinder innovation.
The panel stressed the importance of clearly defining AI goals within the pharmaceutical and medical device industries. Bayer’s use of AI was highlighted as an example of integrating AI into medical devices and regulatory intelligence. Merck’s AI tools and pilot projects were also noted, with an emphasis on the need for vendor partnerships due to current technology limitations.
The potential of AI to analyze vast amounts of data pointed to the untapped data that could streamline regulatory processes, Thompson noted.
Opinions on AI’s readiness varied among the panelists.
Some expressed skepticism about AI’s current capabilities and advised against large investments without clear objectives, noting that companies often fail within months due to poor planning. However, others were more optimistic, highlighting AI’s ability to accelerate product development while cautioning that it is just the first step and requires further refinement.
The panel concluded with a consensus that precise goals and strategic investments are crucial for leveraging AI’s full potential in the pharmaceutical and medical device sectors while effectively navigating the regulatory landscape.
