AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization – FDA Watch
In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI’s impact on advertising and promotion; what “AI washing” is and why it’s important to distinguish real AI innovation from marketing hype; FDA’s first AI-assisted scientific review pilot; and much more.
Access Arnold & Porter’s survey on AI adoption in life sciences here.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Philip Desjardins
Philip Desjardins brings nearly two decades of experience working with the FDA Center for Devices and Radiological Health and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. His comprehensive insights into the intricacies of the FDA’s operational framework and regulatory expectations and broad knowledge of the MedTech ecosystem position Phil as a leading authority on MedTech regulatory affairs and compliance. He has consistently delivered successful outcomes to a broad spectrum of clients, from emergent biotech startups to established global healthcare giants.
As CDRH Associate Director for Policy, Phil was key in formulating the FDA’s current policies on medical devices and drug-device combinations, including legislation, regulations, and enforcement actions. He helped develop and implement CDRH policies in the MedTech space on clinical trials and audits. As Regulatory Counsel, Phil advised FDA leaders on the legal implications of potential compliance actions, pending litigation, enforcing post-market regulatory requirements, and responses to congressional inquiries.
Phil rejoined the firm’s Life Sciences & Healthcare Regulatory practice after serving as counsel earlier in his career.
Mahnu Davar
Mahnu Davar co-chairs the Life Sciences & Healthcare Regulatory practice and is a trusted partner to lawyers, compliance officers, regulatory professionals, and business executives across the life sciences industry. Mahnu counsels clients on mission-critical FDA, CLIA, fraud and abuse, and state licensing regulatory matters, including compliance program development and management. He routinely assists multinational companies with sensitive internal investigations, regulatory inspections, product quality and safety issues, data integrity concerns, and government enforcement matters. He frequently assists medical technology and diagnostics clients with product classification, clearance/approval, and commercial strategy issues.
Mahnu’s clients include biotechnology startups, non-profit research institutions, major clinical laboratories, and some of the world’s largest pharmaceutical and medical technology companies in the oncology, ophthalmology, and pain care spaces. His practical, interdisciplinary approach to counseling is informed by prior secondments in the legal departments of major life sciences companies where he has acted as the lead commercial lawyer for several blockbuster biopharma and surgical product franchises. Mahnu is an Adjunct Professor at Penn Law School, a Fellow of the Salzburg Seminar, and a former Fulbright Scholar to India.
Dr. William Maisel
Dr. William Maisel is a board-certified cardiologist and Vice President and Senior Medical Officer at Intuitive Surgical. He previously served as Chief Medical Officer and Director, Office of Product Evaluation and Quality at the FDA Center for Devices and Radiological Health for many years where he was responsible for the agency’s premarket, post-market, and compliance programs.
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