Uploaded December 2024 | Updated September 2026, 1 week ago
Join host William Barrier for a thought-provoking discussion with Jonathan Helfgott on the evolving role of Artificial Intelligence and Machine Learning in the development of medical products and how these technologies intersect with regulatory science.
Helfgott will discuss how AI/ML is shaping drug and device development, clinical trials, and the regulatory review process. The session will provide insights into both the current applications and future potential of AI/ML within the regulatory landscape, with a focus on challenges and opportunities for industry stakeholders.
Jonathan Helfgott is a Senior Lecturer and Program Coordinator at Johns Hopkins University in the MS in Regulatory Science program. Outside of Johns Hopkins, Helfgott is the executive director of global regulatory/clinical affairs and market access at Stage 2 Innovations. Prior to joining Stage 2 Innovations, Helfgott was the associate director for risk science within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research.
Interested in learning more about regulatory science and innovation? Explore the JHU MS in Regulatory Science program as well as the JHU Master of Biotechnology Enterprise and Entrepreneurship:
https://advanced.jhu.edu/academics/graduate/ms-regulatory-science/
https://advanced.jhu.edu/academics/graduate/master-biotechnology-enterprise-entrepreneurship/
Join host William Barrier for a thought-provoking discussion with Jonathan Helfgott on the evolving role of Artificial Intelligence and Machine Learning in the development of medical products and how these technologies intersect with regulatory science.
Helfgott will discuss how AI/ML is shaping drug and device development, clinical trials, and the regulatory review process. The session will provide insights into both the current applications and future potential of AI/ML within the regulatory landscape, with a focus on challenges and opportunities for industry stakeholders.
Jonathan Helfgott is a Senior Lecturer and Program Coordinator at Johns Hopkins University in the MS in Regulatory Science program. Outside of Johns Hopkins, Helfgott is the executive director of global regulatory/clinical affairs and market access at Stage 2 Innovations. Prior to joining Stage 2 Innovations, Helfgott was the associate director for risk science within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research.
Interested in learning more about regulatory science and innovation? Explore the JHU MS in Regulatory Science program as well as the JHU Master of Biotechnology Enterprise and Entrepreneurship:
https://advanced.jhu.edu/academics/graduate/ms-regulatory-science/
https://advanced.jhu.edu/academics/graduate/master-biotechnology-enterprise-entrepreneurship/
