Proactive and Adaptive Risk Management in Biotechnology: Applications to Trans Fats, Synthetic Biology, and Pharmaceuticals
Kenneth Oye, Director of the MIT Program on Emerging Technologies, Associate Professor of Political Science and Engineering Systems at MIT
Friday, May 9, 2014, 3:30pm
This seminar is part of the Jones Seminars on Science, Technology, and Society series.
Proactive and adaptive approaches to risk governance provide a path between precautionary and after-the-fact strategies. Elements of this third way include early engagement with potential risks, targeted research and observation to mitigate uncertainty, and systematic reassessment of practices and policies as information emerges. This talk provides a retrospective worst case case on trans fats to set up current pilot cases on risk governance in synthetic biology and pharmaceuticals.
Transfats: This cautionary tale examines the long lag between 1957-1993 research reports on adverse health effects and 2003-2014 revisions in standards, with a focus on the effects of research funding and assessment on mal-adaptation.
Synthetic Biology: This current case examines US, EU, and transnational adaptive approaches to management of environmental and security risks of synthetic biology, with a focus on the use of multi-stakeholder exercises and directed research to better identify and manage risks.
Pharmaceuticals: This case examines recent US and EU initiatives in adaptive licensing of pharmaceuticals, including FDA provisions for Breakthrough Product Designation and Special Medical Use and EMA Pharmacovigilance legislation and Adaptive Licensing Pilots, with a focus on the use of official and unofficial public-private partnerships to develop proposals for adaptive risk governance.
About the Speaker
Kenneth Oye is Director of the MIT Program on Emerging Technologies (PoET) and Associate Professor of Political Science and Engineering Systems at MIT, with work in international relations and technology policy. He is a PI in the NSF Synthetic Biology Engineering Research Center (SynBERC), a faculty research lead at the MIT Center for Biomedical Innovation, a member of the NRC Board on Global Science and Technology, and a member of the IRGC Scientific Advisory Board. In 2012-2013 he has served as an invited expert with the President’s Council of Advisors on Science and Technology on pharmaceuticals innovation and with the WHO consultation on Dual Use Research of Concern. His books include Cooperation under Anarchy, Economic Discrimination and Political Exchange, and four volumes on American foreign policy. His articles include pieces on adaptive regulation in Technology Forecasting and Social Change, drug licensing in Clinical Pharmacology and Therapeutics, biosecurity in Politics and the Life Sciences, techno-libertarianism in Issues in Science and Technology, with forthcoming pieces on biosecurity in ACS Synthetic Biology and environmental effects of synthetic biology in Journal of Environmental Sciences.