Kenneth Oye
Professor of Political Science, Post-Tenure
International relations; science and technology policy; risk governance; biotechnology; information technology.
Biography
Kenneth Oye is a Professor of Political Science (School of Humanities Arts and Social Sciences) and Data Systems and Society (School of Engineering) and Director of the Program on Emerging Technologies (PoET), with work on international relations, political economy and technology policy.
His work in international relations includes Cooperation under Anarchy, Economic Discrimination and Political Exchange, and four “Eagle” monographs on American foreign policy, with advisory work for the Petersen Institute, UNIDO and US Treasury, Commerce and EXIM and the MIT Seminar XXI Program.
His current work in technology policy centers on adaptive management of risks associated with synthetic biology and pharmaceuticals and on equity in health policy, with recent papers in anNature, Science, Clinical Pharmacology and Therapeutics and advisory work with the UN BWC and WHO, NIH NExTRAC, and PCAST.
Professor Oye is the recipient of the Martore Award for Exceptional Educational Contributions (2018) and the Technology Policy Program Faculty Appreciation Award (2003, 2018) in the School of Engineering and the Levitan Award for Excellence in Teaching (2011) and the Graduate Council Teaching Award in the School of Humanities, Arts and Social Sciences.
Before coming to MIT, Professor Oye taught at Harvard University, the University of California, Princeton University and Swarthmore College. He holds a BA in Economics and Political Science from Swarthmore College with Highest Honors and a Ph.D in Political Science from Harvard University with the Chase Dissertation Prize.
Research
My work divides into studies on international relations (IR) and technology policy. My books in IR include Cooperation under Anarchy, Economic Discrimination and Political Exchange and four Eagle symposia on American foreign policy. In the last decade, I have become known for my work on adaptive regulation of rapidly changing technologies, with papers on synthetic biology and pharmaceuticals in Nature, Science, Clinical Pharmacology and Therapeutics (CP&T) and other journals. The detailed research narrative below describes how my theories on cooperation, externalities management and adaptive strategy developed in IR now provide a foundation for my current work in technology policy.
International Relations
As a student and young faculty member during an era of Cold War crises, military interventions, and economic distress, I turned from engineering to political science and economics. My IR work provided a theoretical basis for addressing problems of that time and continues to be used by IR scholars. When I returned to engineering topics, these works, originally developed within IR/IPE, have provided an analytic basis for my research on adaptive regulation in technology policy.
1. Cooperation under Anarchy (1985) developed a theoretical foundation for realization of mutual interests in the absence of centralized authority, with applications to security and economic affairs. “Explaining the End of the Cold War: Morphological and Behavioral Adaptations to the Nuclear Peace” (1995) moved beyond a game theoretic frame to emphasize the role of evolving ideas and interests in ending the Cold War. I have applied theories on realization of mutual interests in work with AFSC, US agencies and the UN and in biotechnology policy. I structured synthetic biology and pharmaceuticals workshops using theories from Cooperation under Anarchy, with emphasis on cultivating expectations of continuing interaction.
2. Economic Discrimination and Political Exchange (1993) offered insights into the internalization of policy externalities through ad hoc negotiation and formal international regimes, with retrospective cases on trade, financial and monetary affairs in the 1930s and 1980s. My chapter on “The Logic of Contingent Action” examined the welfare reducing properties of extortion, the welfare enhancing properties of explanation and the mixed effects on global welfare of exchange, placing limits on claims on the virtues of ad hoc approaches. “Conflict and Cooperation in Government Export Financing” (with Evans) (IIE 2001) and work for Treasury/Commerce/EXIM applied theories on regimes and ad hoc exchange to analyze violations of OECD export credit disciplines. I am now applying theories on regulation of policy externalities to environmental and security implications of synthetic biology.
3. Eagle Entangled (1979), Eagle Defiant (1983), Eagle Resurgent (1987), Eagle in a New World (1991) offered contemporaneous assessments of Carter, Reagan and Bush foreign policies. My lead chapters also developed a general argument on the limits of doctrinal approaches and benefits of adaptive strategies under conditions of uncertainty, complexity and resource constraints. Carter policy is a cautionary tale on adaptive management. The common (unfair) view of Carter as “flipflopping, incoherent, unstable” underscores the perils of pursuing adaptive policies. My current work on adaptive regulation uses the frame developed in Eagle Entangled, albeit with attention to preserving legitimacy while planning for adaptation.
Techonology Policy
At MIT, my research applications changed even as I retained my theories on adaptive foreign policy and cooperative externalities management. President Charles Vest often spoke of the responsibility of technologists to understand and shape consequences of technologies they create. I worked with many MIT colleagues to act on President Vest’s charge. I joined with nuclear engineer Tatsujiro Suzuki and Gene Skolnikoff to study plutonium reprocessing and proliferation risks ("International Responses to Japanese Plutonium Programs," 1995). I worked with combustion engineers Janos Beer and Adel Sarofim to reduce environmental burdens of coal combustion in China (“Co-Benefits of Climate Policy,” 2004; “A Proposed Industrial Boiler Efficiency Program in Shanxi” 1999). These studies differed from most technology policy work by engaging with interests and institutions that precluded adoption of first best policies from a purely technological perspective.
These projects also underscored the need for institutionalized research and education on implications of technologies. In 2004, historian Merritt Roe Smith, engineers Dan Hastings and Dava Newman and I secured an NSF IGERT to create the Program on Emerging Technologies (PoET). Initially, PoET studied the auto, laser, and GPS to better assess the effects of technologies and evaluate forecasting methods. Our retrospective studies found that the record of forecasting was bad, that intrinsic uncertainty, material interests, and psychological biases were dispositive sources of failure, and that popular fixes would not improve results. PoET ultimately took forecasting failure as a given and worked to improve capacity for adaptation and self-correction. My current projects may be seen as experiments in adaptive regulation, intended to affect policy and in so doing to elicit reactions that provide insights into political process.
1. Theoretical Foundations on Adaptive Regulation and Risk Governance: Three papers provide a framework for the application of adaptive approaches to technology policy. "Self-Interest and Environmental Management" (Oye and Maxwell, in Keohane and Ostrom, 1995) suggests that Stiglerian situations, where regulations confer concentrated tangible benefits on the regulated, commonly give rise to NGO/business pro-regulatory coalitions. Olsonian situations, with regulatory benefits diffused across the many and costs concentrated on the few, are associated with conventional collective action problems and under-provision of regulations. “The Precautionary Principle and International Conflict over Domestic Regulation: Mitigating Uncertainty and Improving Adaptive Capacity,” (2005) lays out essentials of adaptive regulation and suggests that commitments to modify policies as information evolves may facilitate agreements by ameliorating up-front conflicts. “Planned Adaptation in Risk Regulation” (with McCray and Petersen, 2010) makes the case for adaptive regulation, suggesting that old rules should be revised in light of evolving policy experience and scientific knowledge. The article also underscores the difficulty of acting on adaptive principles, with only 5 out of 32 U.S. programs exhibiting properties of “planned adaptation.”
2. Applications in Biotechnology: Synthetic biology debates are marked by the complexity of biotechnology, unstable understandings and deep suspicions of evidence on benefits and risks, and inherited rules and institutions that do not mesh with evolving technologies. My work with PoET, NSF SynBERC and iGEM has served as a platform for developing adaptive approaches to addressing concerns over synthetic biology.
a. Traditional Work: A three paper cluster provided a baseline for policy work. In terms of research methods and presentational form, these papers most resemble conventional political science. “The Intellectual Commons and Property in Synthetic Biology” (with Wellhausen, 2009) treats the political economy of intellectual property rights. “Synthetic Biology and the Future of Biosecurity,” (with Mukunda & Mohr, 2009), evaluates security implications of synthetic biology, with emphasis on how diffusion of methods and advances in the power methods are undercutting existing security regimes. “Proactive and Adaptive Governance of Emerging Risks” (IRGC, 2012) describes and evaluates national policies, international regimes and transnational voluntary arrangements that govern synthetic biology risks.
b. Experimental Work: I have been using “trials” to identify risks, policy gaps, and sources of resistance.
First, I designed five workshops on environmental effects of synthetic biology using principles from Cooperation under Anarchy, with emphasis on fostering ongoing interaction across real actors from government, industry, and civil society (not role playing students). The exercises used real (not hypothetical) applications, including arsenic biosensors, algae fuel production, yeast based drug production, organoids for testing drugs, nitrogen fixating non-legumes and gene drives. The results were encouraging, with convergence on areas of concern, specification of areas of uncertainty, and definition of research to fill knowledge gaps. See “Shaping Ecological Risk Research for Synthetic Biology” (Kuiken et al, 2014; “Creating a Research Agenda for Ecological Implications of Synthetic Biology” (2014).
Second, I chair safety committees for the Broad Institute Bio-Foundry and iGEM. These activities provide early warnings on potential safety and security problems, testbeds for testing ways of addressing risks, and venues for evaluating propositions on how private and public actors may come to see an interest in providing public goods. For example, when the iGEM safety committee flagged a problem with unscreened parts in the iGEM registry, we engaged with SGI-DNA to provide the collective good of screening 20000 parts for organism of origin and function. When the iGEM safety committee flagged a problem with widespread ignorance of biosecurity and biosafety risks and weaknesses in institutional reviews, we partnered with Public Health Canada and the UN to test guidelines that were under development for official use. See “Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management” (with McNamara et al 2014).
c. Publications as Probes: I have used articles in Science and Nature to draw attention to potential risks and policy gaps and elicit responses. “On Regulating Gene Drives” (Oye, Esvelt et al 2014) treated issues associated with editing the genetic commons. By raising the odds of inheritance of introduced genetic elements from 50 to 99+ percent, gene drives have the potential to control vector borne diseases like malaria and Zika, suppress invasive species, and alter herbicide/insecticide resistance. Gene drives also have uncertain environmental, safety and security effects. My team evaluated effects, flagged sources of uncertainty, recommended technical safeguards and identified policy gaps. The resulting Policy Forum triggered ongoing reviews by UNBWC, NAS, NSABB, and the National Intelligence Board. “Regulate Home Brew Opiates” (with Lawson and Bubela, 2015) treated issues associated with development of yeast strains to convert glucose to morphine. In 2015, John Dueber of UC Berkeley asked me to assemble a team to address security and health implications of his soon-to-be-published work on opiate synthesis. The resulting policy piece examined how an opiate producing yeast strain might affect licit and illicit opiate markets, proposed technical safeguards to reduce the spread of such strains, and identified policy gaps. The article triggered reviews by domestic regulators and law enforcement and the International Expert Group on Biosecurity Regulation and sparked a larger academic and policy debate on the advantages and costs of early engagement with potential risks of biotechnologies.
d. Commentary for Policy Makers: The research above provided a basis for a response to a request for comment from the White House OSTP. “On Revision of the Coordinated Framework for the Regulation of Biotechnology” is a White Paper prepared for consideration by the Biotechnology Working Group, U.S. Emerging Technologies Interagency Policy Coordinating Committee (2016) and a National Academy panel.
3. Applications in Pharmaceuticals: My collection of articles on adaptive approaches to pharmaceuticals policy is the result of collaboration with the MIT Center for Biomedical Innovation, Hans-Georg Eichler of the European Medicines Agency (EMA) and Harry Selker of Tufts Medical. I was interested in applying ideas on adaptive regulation in drug licensing, where the safety and effectiveness of drugs in use often differs from projections based on confounder cleansed RCTs. Eichler’s proposals for staggered approval had features in common with my proposals for planned adaptation. We joined forces.
a. Eichler and I wrote “Adaptive Licensing” (CP&T 2013) and assembled a coalition of sponsors, payers and regulators as co-authors. Adaptive licensing attenuates data requirements from RCTs, restricts initial use to patient populations for whom benefits offset uncertainty, and strengthens updating based on drugs in use. When critics suggested that adaptive licensing was incompatible with existing statutes, I organized a workshop with current and former counsels for FDA, EMA, Health Canada, HSA Singapore, CMS and NHS. Adaptive licensing was consistent with existing statutes in all except Canada, which changed its governing statute two years later. See “Legal Foundations of Adaptive Licensing” (Oye et al, CP&T 2013).
b. Access to drugs requires reimbursement as well as licensing, and payers are demanding better evidence on effectiveness of drugs as a condition of reimbursement. I worked with Selker on a paper to exploit regulatory and data infrastructure developed for adaptive licensing to generate data on drug effectiveness. See "Proposal for Integrated E2E Clinical Trials," (Selker, Oye et al, CP&T 2014). Adaptive management of benefits and risks requires effective access to health data. I organized a research team on data access issues, including curation, standardization and causal inference; and policy issues on intellectual property rights, privacy and consent. A summary was published as "Fostering Innovation by Improving Health Data Access and Utilization" (Oye et al, CP&T 2015).
c. I organized an OECD panel on EU and US licensing and reimbursement policies, summarized in “Managing Uncertainty in Drug Development and Use” (IRGC 2015). I wrote an updated version for the EU Parliament “Pharmaceuticals Licensing and Reimbursement in the EU and US” (2016) and am writing a version including Japanese, Korean and Chinese drug licensing. This last paper will address the failure of firms to conduct after-market studies, a problem rightly flagged by critics of adaptive pathways. In conventional approvals, where after-market studies may limit a broad initial target population, firms often default on commitments. Conversely, under adaptive pathways, where studies may widen a narrow initial target population, firms have a material interest in honoring commitments.
Integrating IPE and Technology Policy
This new project inserts work above into the field of IPE. Externalities cases are drawn from synthetic biology, nuclear fuel cycle, and internet. Informed consent cases are drawn from drug licensing, dietary guidelines, and product safety. While the theoretical frames follow from my game theoretic work on realization of mutual interests and my microeconomic work on internalization of externalities, I cannot reconcile conventional assumptions on preference formation and influence with my practical experience in technology policy. Political economists typically derive (stable) actor interests using simple factor models. In technology policy (less stable) actor preferences are often based on complex projections of interests across outcomes. Political economists typically focus on micro-political processes of influence, with emphasis on exchanges of material resources for political acts. In technology policy, influence is often exercised by control of information access and interpretation. These differences will be brought out clearly, with an assessment of implications for the study of classic IPE issues in trade, financial and monetary affairs.
Recent Publications
2017 “On Sources and Implications of Accelerating Innovation in Bioechnology: U.S. Opportunities and Challenges,” Testimony for the U.S.-China Economic and Security Review Commission, March 16, 2017. 12 pp.
2016 “Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan,” Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM and Pearson M, Clinical Pharmacology & Therapeutics Volume 100 Number 6 December 2016. Received 26 July 2016; accepted 28 August 2016; advance online publication 12 September 2016, doi: 10.1002/cpt505.
2016 “On Revision of the Coordinated Framework for the Regulation of Biotechnology,” A White Paper Prepared for Consideration by the Biotechnology Working Group, U.S. Emerging Technologies Interagency Policy Coordinating Committee, Kenneth A. Oye, Jane Maunsell, Shlomiya Bar-Yam Lightfoot, Kevin Esvelt, Nicholas Short, Caroline Liu, Samuel Weiss Evans, Todd Kuiken, Jeantine Lunshof, Yusuke Mori and Megan Palmer, March 22. 21 pages.
2015 "The Next Frontier: Fostering Innovation by Improving Health Data Access and Utilization" Oye, KA, Jain G, Amador, M, Arnout R, Brown, JS, Crown W, Ferguson, J, Pezalla, E, Rassen JA, Selker JP, Trusheim, M and Hirsch G, Clinical Pharmacology & Therapeutics. 98 (5) Nov 5, pp 515-521.
2015 “Regulate Home Brew Opiates,” (with JC Lawson and T Bubela), Nature. 521 (7552), May 21, pp.281-283.
2014 “Regulating Gene Drives,” (with Kevin Esvelt, Evan Appleton, Flaminia Catteruccia, George Church, Todd Kuiken, Shlomiya Bar-Yam Lightfoot, Julie McNamara, Andrea Smidler, James Collins), Science. 345 (6197), 8 August, pp. 626-628.
2014 “A Proposal for Integrated Efficacy-to-Effectiveness (E2E Clinical Trials.” (with H.P. Selker), Clinical Pharmacology & Therapeutics, 95 2, pp. 147-153.
2014 “Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management.” (with J McNamara, S Bar-Yam Lightfoot, K Drinkwater, E Appleton) ACS Synthetic Biology. 3 (12) December, pp. 983-985.
2014 “Shaping Ecological Risk Research for Synthetic Biology.” (with T. Kuiken, G. Dana, D. Rajeski), Journal of Environmental Studies and Sciences. 4:191-199.
2013 “Legal Foundations of Adaptive Licensing.” (with L.G. Baird, A. Chia, S. Hocking, P.B. Hutt, D. Lee, L. Norwalk, V. Salvatore), Clinical Pharmacology & Therapeutics, 94 3, pp. 309-311.
2013 “Summary Report of the Meeting to Discuss Data Needs and Testing Methods for Assessing the Safety of Environmental Introduction of Synthetically Designed Algae for Biofuel Production,” A Joint Workshop of the Woodrow Wilson Center, the MIT Program on Emerging Technologies and the U.S. Environmental Protection Agency, PA December 14, 2012, 21 pages.
2012 “Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval,” (with H Eichler et al), Nature Clinical Pharmacology & Therapeutics, March 2012, DOI 10.1038/clpt.2011.345, pp. 426-437.
2010 “Planned Adaptation in Risk Regulation: An Initial Survey of United State Environmental, Health, and Safety Regulation,” ( with Lawrence McCray Arthur C. Petersen), Technological Forecasting and Social Change, Volume 77, Issue 6, pp. 951-959.
Teaching
| 17.430 | International Relations Research Seminar |
| 17.310/IDS.412/STS.482 | Science, Technology & Public Policy (Graduate) |
| 17.309/IDS.055/STS.082 | Science, Technology & Public Policy (Undergraduate) |
News
Biography
Kenneth Oye is a Professor of Political Science (School of Humanities Arts and Social Sciences) and Data Systems and Society (School of Engineering) and Director of the Program on Emerging Technologies (PoET), with work on international relations, political economy and technology policy.
His work in international relations includes Cooperation under Anarchy, Economic Discrimination and Political Exchange, and four “Eagle” monographs on American foreign policy, with advisory work for the Petersen Institute, UNIDO and US Treasury, Commerce and EXIM and the MIT Seminar XXI Program.
His current work in technology policy centers on adaptive management of risks associated with synthetic biology and pharmaceuticals and on equity in health policy, with recent papers in anNature, Science, Clinical Pharmacology and Therapeutics and advisory work with the UN BWC and WHO, NIH NExTRAC, and PCAST.
Professor Oye is the recipient of the Martore Award for Exceptional Educational Contributions (2018) and the Technology Policy Program Faculty Appreciation Award (2003, 2018) in the School of Engineering and the Levitan Award for Excellence in Teaching (2011) and the Graduate Council Teaching Award in the School of Humanities, Arts and Social Sciences.
Before coming to MIT, Professor Oye taught at Harvard University, the University of California, Princeton University and Swarthmore College. He holds a BA in Economics and Political Science from Swarthmore College with Highest Honors and a Ph.D in Political Science from Harvard University with the Chase Dissertation Prize.
Research
My work divides into studies on international relations (IR) and technology policy. My books in IR include Cooperation under Anarchy, Economic Discrimination and Political Exchange and four Eagle symposia on American foreign policy. In the last decade, I have become known for my work on adaptive regulation of rapidly changing technologies, with papers on synthetic biology and pharmaceuticals in Nature, Science, Clinical Pharmacology and Therapeutics (CP&T) and other journals. The detailed research narrative below describes how my theories on cooperation, externalities management and adaptive strategy developed in IR now provide a foundation for my current work in technology policy.
International Relations
As a student and young faculty member during an era of Cold War crises, military interventions, and economic distress, I turned from engineering to political science and economics. My IR work provided a theoretical basis for addressing problems of that time and continues to be used by IR scholars. When I returned to engineering topics, these works, originally developed within IR/IPE, have provided an analytic basis for my research on adaptive regulation in technology policy.
1. Cooperation under Anarchy (1985) developed a theoretical foundation for realization of mutual interests in the absence of centralized authority, with applications to security and economic affairs. “Explaining the End of the Cold War: Morphological and Behavioral Adaptations to the Nuclear Peace” (1995) moved beyond a game theoretic frame to emphasize the role of evolving ideas and interests in ending the Cold War. I have applied theories on realization of mutual interests in work with AFSC, US agencies and the UN and in biotechnology policy. I structured synthetic biology and pharmaceuticals workshops using theories from Cooperation under Anarchy, with emphasis on cultivating expectations of continuing interaction.
2. Economic Discrimination and Political Exchange (1993) offered insights into the internalization of policy externalities through ad hoc negotiation and formal international regimes, with retrospective cases on trade, financial and monetary affairs in the 1930s and 1980s. My chapter on “The Logic of Contingent Action” examined the welfare reducing properties of extortion, the welfare enhancing properties of explanation and the mixed effects on global welfare of exchange, placing limits on claims on the virtues of ad hoc approaches. “Conflict and Cooperation in Government Export Financing” (with Evans) (IIE 2001) and work for Treasury/Commerce/EXIM applied theories on regimes and ad hoc exchange to analyze violations of OECD export credit disciplines. I am now applying theories on regulation of policy externalities to environmental and security implications of synthetic biology.
3. Eagle Entangled (1979), Eagle Defiant (1983), Eagle Resurgent (1987), Eagle in a New World (1991) offered contemporaneous assessments of Carter, Reagan and Bush foreign policies. My lead chapters also developed a general argument on the limits of doctrinal approaches and benefits of adaptive strategies under conditions of uncertainty, complexity and resource constraints. Carter policy is a cautionary tale on adaptive management. The common (unfair) view of Carter as “flipflopping, incoherent, unstable” underscores the perils of pursuing adaptive policies. My current work on adaptive regulation uses the frame developed in Eagle Entangled, albeit with attention to preserving legitimacy while planning for adaptation.
Techonology Policy
At MIT, my research applications changed even as I retained my theories on adaptive foreign policy and cooperative externalities management. President Charles Vest often spoke of the responsibility of technologists to understand and shape consequences of technologies they create. I worked with many MIT colleagues to act on President Vest’s charge. I joined with nuclear engineer Tatsujiro Suzuki and Gene Skolnikoff to study plutonium reprocessing and proliferation risks ("International Responses to Japanese Plutonium Programs," 1995). I worked with combustion engineers Janos Beer and Adel Sarofim to reduce environmental burdens of coal combustion in China (“Co-Benefits of Climate Policy,” 2004; “A Proposed Industrial Boiler Efficiency Program in Shanxi” 1999). These studies differed from most technology policy work by engaging with interests and institutions that precluded adoption of first best policies from a purely technological perspective.
These projects also underscored the need for institutionalized research and education on implications of technologies. In 2004, historian Merritt Roe Smith, engineers Dan Hastings and Dava Newman and I secured an NSF IGERT to create the Program on Emerging Technologies (PoET). Initially, PoET studied the auto, laser, and GPS to better assess the effects of technologies and evaluate forecasting methods. Our retrospective studies found that the record of forecasting was bad, that intrinsic uncertainty, material interests, and psychological biases were dispositive sources of failure, and that popular fixes would not improve results. PoET ultimately took forecasting failure as a given and worked to improve capacity for adaptation and self-correction. My current projects may be seen as experiments in adaptive regulation, intended to affect policy and in so doing to elicit reactions that provide insights into political process.
1. Theoretical Foundations on Adaptive Regulation and Risk Governance: Three papers provide a framework for the application of adaptive approaches to technology policy. "Self-Interest and Environmental Management" (Oye and Maxwell, in Keohane and Ostrom, 1995) suggests that Stiglerian situations, where regulations confer concentrated tangible benefits on the regulated, commonly give rise to NGO/business pro-regulatory coalitions. Olsonian situations, with regulatory benefits diffused across the many and costs concentrated on the few, are associated with conventional collective action problems and under-provision of regulations. “The Precautionary Principle and International Conflict over Domestic Regulation: Mitigating Uncertainty and Improving Adaptive Capacity,” (2005) lays out essentials of adaptive regulation and suggests that commitments to modify policies as information evolves may facilitate agreements by ameliorating up-front conflicts. “Planned Adaptation in Risk Regulation” (with McCray and Petersen, 2010) makes the case for adaptive regulation, suggesting that old rules should be revised in light of evolving policy experience and scientific knowledge. The article also underscores the difficulty of acting on adaptive principles, with only 5 out of 32 U.S. programs exhibiting properties of “planned adaptation.”
2. Applications in Biotechnology: Synthetic biology debates are marked by the complexity of biotechnology, unstable understandings and deep suspicions of evidence on benefits and risks, and inherited rules and institutions that do not mesh with evolving technologies. My work with PoET, NSF SynBERC and iGEM has served as a platform for developing adaptive approaches to addressing concerns over synthetic biology.
a. Traditional Work: A three paper cluster provided a baseline for policy work. In terms of research methods and presentational form, these papers most resemble conventional political science. “The Intellectual Commons and Property in Synthetic Biology” (with Wellhausen, 2009) treats the political economy of intellectual property rights. “Synthetic Biology and the Future of Biosecurity,” (with Mukunda & Mohr, 2009), evaluates security implications of synthetic biology, with emphasis on how diffusion of methods and advances in the power methods are undercutting existing security regimes. “Proactive and Adaptive Governance of Emerging Risks” (IRGC, 2012) describes and evaluates national policies, international regimes and transnational voluntary arrangements that govern synthetic biology risks.
b. Experimental Work: I have been using “trials” to identify risks, policy gaps, and sources of resistance.
First, I designed five workshops on environmental effects of synthetic biology using principles from Cooperation under Anarchy, with emphasis on fostering ongoing interaction across real actors from government, industry, and civil society (not role playing students). The exercises used real (not hypothetical) applications, including arsenic biosensors, algae fuel production, yeast based drug production, organoids for testing drugs, nitrogen fixating non-legumes and gene drives. The results were encouraging, with convergence on areas of concern, specification of areas of uncertainty, and definition of research to fill knowledge gaps. See “Shaping Ecological Risk Research for Synthetic Biology” (Kuiken et al, 2014; “Creating a Research Agenda for Ecological Implications of Synthetic Biology” (2014).
Second, I chair safety committees for the Broad Institute Bio-Foundry and iGEM. These activities provide early warnings on potential safety and security problems, testbeds for testing ways of addressing risks, and venues for evaluating propositions on how private and public actors may come to see an interest in providing public goods. For example, when the iGEM safety committee flagged a problem with unscreened parts in the iGEM registry, we engaged with SGI-DNA to provide the collective good of screening 20000 parts for organism of origin and function. When the iGEM safety committee flagged a problem with widespread ignorance of biosecurity and biosafety risks and weaknesses in institutional reviews, we partnered with Public Health Canada and the UN to test guidelines that were under development for official use. See “Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management” (with McNamara et al 2014).
c. Publications as Probes: I have used articles in Science and Nature to draw attention to potential risks and policy gaps and elicit responses. “On Regulating Gene Drives” (Oye, Esvelt et al 2014) treated issues associated with editing the genetic commons. By raising the odds of inheritance of introduced genetic elements from 50 to 99+ percent, gene drives have the potential to control vector borne diseases like malaria and Zika, suppress invasive species, and alter herbicide/insecticide resistance. Gene drives also have uncertain environmental, safety and security effects. My team evaluated effects, flagged sources of uncertainty, recommended technical safeguards and identified policy gaps. The resulting Policy Forum triggered ongoing reviews by UNBWC, NAS, NSABB, and the National Intelligence Board. “Regulate Home Brew Opiates” (with Lawson and Bubela, 2015) treated issues associated with development of yeast strains to convert glucose to morphine. In 2015, John Dueber of UC Berkeley asked me to assemble a team to address security and health implications of his soon-to-be-published work on opiate synthesis. The resulting policy piece examined how an opiate producing yeast strain might affect licit and illicit opiate markets, proposed technical safeguards to reduce the spread of such strains, and identified policy gaps. The article triggered reviews by domestic regulators and law enforcement and the International Expert Group on Biosecurity Regulation and sparked a larger academic and policy debate on the advantages and costs of early engagement with potential risks of biotechnologies.
d. Commentary for Policy Makers: The research above provided a basis for a response to a request for comment from the White House OSTP. “On Revision of the Coordinated Framework for the Regulation of Biotechnology” is a White Paper prepared for consideration by the Biotechnology Working Group, U.S. Emerging Technologies Interagency Policy Coordinating Committee (2016) and a National Academy panel.
3. Applications in Pharmaceuticals: My collection of articles on adaptive approaches to pharmaceuticals policy is the result of collaboration with the MIT Center for Biomedical Innovation, Hans-Georg Eichler of the European Medicines Agency (EMA) and Harry Selker of Tufts Medical. I was interested in applying ideas on adaptive regulation in drug licensing, where the safety and effectiveness of drugs in use often differs from projections based on confounder cleansed RCTs. Eichler’s proposals for staggered approval had features in common with my proposals for planned adaptation. We joined forces.
a. Eichler and I wrote “Adaptive Licensing” (CP&T 2013) and assembled a coalition of sponsors, payers and regulators as co-authors. Adaptive licensing attenuates data requirements from RCTs, restricts initial use to patient populations for whom benefits offset uncertainty, and strengthens updating based on drugs in use. When critics suggested that adaptive licensing was incompatible with existing statutes, I organized a workshop with current and former counsels for FDA, EMA, Health Canada, HSA Singapore, CMS and NHS. Adaptive licensing was consistent with existing statutes in all except Canada, which changed its governing statute two years later. See “Legal Foundations of Adaptive Licensing” (Oye et al, CP&T 2013).
b. Access to drugs requires reimbursement as well as licensing, and payers are demanding better evidence on effectiveness of drugs as a condition of reimbursement. I worked with Selker on a paper to exploit regulatory and data infrastructure developed for adaptive licensing to generate data on drug effectiveness. See "Proposal for Integrated E2E Clinical Trials," (Selker, Oye et al, CP&T 2014). Adaptive management of benefits and risks requires effective access to health data. I organized a research team on data access issues, including curation, standardization and causal inference; and policy issues on intellectual property rights, privacy and consent. A summary was published as "Fostering Innovation by Improving Health Data Access and Utilization" (Oye et al, CP&T 2015).
c. I organized an OECD panel on EU and US licensing and reimbursement policies, summarized in “Managing Uncertainty in Drug Development and Use” (IRGC 2015). I wrote an updated version for the EU Parliament “Pharmaceuticals Licensing and Reimbursement in the EU and US” (2016) and am writing a version including Japanese, Korean and Chinese drug licensing. This last paper will address the failure of firms to conduct after-market studies, a problem rightly flagged by critics of adaptive pathways. In conventional approvals, where after-market studies may limit a broad initial target population, firms often default on commitments. Conversely, under adaptive pathways, where studies may widen a narrow initial target population, firms have a material interest in honoring commitments.
Integrating IPE and Technology Policy
This new project inserts work above into the field of IPE. Externalities cases are drawn from synthetic biology, nuclear fuel cycle, and internet. Informed consent cases are drawn from drug licensing, dietary guidelines, and product safety. While the theoretical frames follow from my game theoretic work on realization of mutual interests and my microeconomic work on internalization of externalities, I cannot reconcile conventional assumptions on preference formation and influence with my practical experience in technology policy. Political economists typically derive (stable) actor interests using simple factor models. In technology policy (less stable) actor preferences are often based on complex projections of interests across outcomes. Political economists typically focus on micro-political processes of influence, with emphasis on exchanges of material resources for political acts. In technology policy, influence is often exercised by control of information access and interpretation. These differences will be brought out clearly, with an assessment of implications for the study of classic IPE issues in trade, financial and monetary affairs.
Recent Publications
2017 “On Sources and Implications of Accelerating Innovation in Bioechnology: U.S. Opportunities and Challenges,” Testimony for the U.S.-China Economic and Security Review Commission, March 16, 2017. 12 pp.
2016 “Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan,” Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM and Pearson M, Clinical Pharmacology & Therapeutics Volume 100 Number 6 December 2016. Received 26 July 2016; accepted 28 August 2016; advance online publication 12 September 2016, doi: 10.1002/cpt505.
2016 “On Revision of the Coordinated Framework for the Regulation of Biotechnology,” A White Paper Prepared for Consideration by the Biotechnology Working Group, U.S. Emerging Technologies Interagency Policy Coordinating Committee, Kenneth A. Oye, Jane Maunsell, Shlomiya Bar-Yam Lightfoot, Kevin Esvelt, Nicholas Short, Caroline Liu, Samuel Weiss Evans, Todd Kuiken, Jeantine Lunshof, Yusuke Mori and Megan Palmer, March 22. 21 pages.
2015 "The Next Frontier: Fostering Innovation by Improving Health Data Access and Utilization" Oye, KA, Jain G, Amador, M, Arnout R, Brown, JS, Crown W, Ferguson, J, Pezalla, E, Rassen JA, Selker JP, Trusheim, M and Hirsch G, Clinical Pharmacology & Therapeutics. 98 (5) Nov 5, pp 515-521.
2015 “Regulate Home Brew Opiates,” (with JC Lawson and T Bubela), Nature. 521 (7552), May 21, pp.281-283.
2014 “Regulating Gene Drives,” (with Kevin Esvelt, Evan Appleton, Flaminia Catteruccia, George Church, Todd Kuiken, Shlomiya Bar-Yam Lightfoot, Julie McNamara, Andrea Smidler, James Collins), Science. 345 (6197), 8 August, pp. 626-628.
2014 “A Proposal for Integrated Efficacy-to-Effectiveness (E2E Clinical Trials.” (with H.P. Selker), Clinical Pharmacology & Therapeutics, 95 2, pp. 147-153.
2014 “Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management.” (with J McNamara, S Bar-Yam Lightfoot, K Drinkwater, E Appleton) ACS Synthetic Biology. 3 (12) December, pp. 983-985.
2014 “Shaping Ecological Risk Research for Synthetic Biology.” (with T. Kuiken, G. Dana, D. Rajeski), Journal of Environmental Studies and Sciences. 4:191-199.
2013 “Legal Foundations of Adaptive Licensing.” (with L.G. Baird, A. Chia, S. Hocking, P.B. Hutt, D. Lee, L. Norwalk, V. Salvatore), Clinical Pharmacology & Therapeutics, 94 3, pp. 309-311.
2013 “Summary Report of the Meeting to Discuss Data Needs and Testing Methods for Assessing the Safety of Environmental Introduction of Synthetically Designed Algae for Biofuel Production,” A Joint Workshop of the Woodrow Wilson Center, the MIT Program on Emerging Technologies and the U.S. Environmental Protection Agency, PA December 14, 2012, 21 pages.
2012 “Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval,” (with H Eichler et al), Nature Clinical Pharmacology & Therapeutics, March 2012, DOI 10.1038/clpt.2011.345, pp. 426-437.
2010 “Planned Adaptation in Risk Regulation: An Initial Survey of United State Environmental, Health, and Safety Regulation,” ( with Lawrence McCray Arthur C. Petersen), Technological Forecasting and Social Change, Volume 77, Issue 6, pp. 951-959.
Teaching
| 17.430 | International Relations Research Seminar |
| 17.310/IDS.412/STS.482 | Science, Technology & Public Policy (Graduate) |
| 17.309/IDS.055/STS.082 | Science, Technology & Public Policy (Undergraduate) |