SAPA Data Science Community
2025 October Webinar
AI in Drug & Device Development: Navigating FDA’s New Regulatory Landscape
HIGHLIGHTS
Artificial Intelligence (AI) is reshaping the landscape of drug and medical device development at an unprecedented pace. Its integration into clinical trials, product design, and regulatory submissions has the potential to accelerate innovation while enhancing precision and efficiency, yet it also raises concerns about “overrushing” that could compromise safety. Recognizing both the promise and the risks of these technological advances, the FDA has taken an active role in guiding the evolution of this field. In late 2024 and early 2025, the FDA released a series of groundbreaking guidelines on the application of AI and Machine Learning (ML) in drug development, medical device innovation, and regulatory processes. These publications set a pivotal momentum in the industry, reflecting the agency’s intent to foster innovation while maintaining rigorous oversight. This seminar will explore the key developments in this evolving regulatory framework, discuss compliance trends from both industry and agency perspectives, and provide practical recommendations for stakeholders navigating the AI-driven future. Participants will gain valuable insights into aligning development strategies with regulatory expectations and preparing for AI-enhanced submissions.
SPEAKER
Ran He, PhD, JD
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Founder and Lawyer,
THC Lawyers
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Dr. Ran He is a lawyer licensed in the United States (NY and CA) and Canada and the Founder of THC Lawyers, a fast-growing international law firm with offices in Manhattan, Silicon Valley, Toronto and Vancouver. Dr. He has extensive experience in technology law, capital markets and venture consulting, and commercial litigation. Dr. He has successfully represented global pharmaceutical companies, NASDAQ-listed corporations, Chinese state-owned enterprises (SOEs), Chinese listing companies, and other high-profile clients in complex commercial and IP transactions and disputes across North America.
Dr. He is particularly skilled in advising companies in the biomedical and technology sectors. His practice extends beyond legal representation, as he provides strategic consultation to established and start-up companies, with a special focus on innovation and capital market. Dr. He brings a unique perspective on the intersection of technology, law, and business to his clients.
Dr. He is a frequent speaker at industry-leading conferences, and teaches at law school and business school. Before becoming a lawyer, Dr. He earned a Ph.D. in Biochemistry and Molecular Biology from the Chinese Academy of Sciences, and completed a post-doctoral fellowship at Johns Hopkins School of Medicine in drug development.
ABOUT US
Data science and AI are hot trending topics in many industry. The aim of SAPA Data Science community is to bring together researchers, young professionals, educators, and experts into one place, provide learning and collaboration platform for data science related topics, and drive the personal growth and career development of members.
Join us on the 2nd Tuesday of every other month from 8:00 PM to 9:30 PM for complimentary educational seminars and discussions on practical data science applications. Stay tuned for upcoming topics and activities!
