Synthetic Biology
The trademark of PoET work on synthetic biology is to use practical work on risks associated with applications of synthetic biology as test beds for research on risk governance and policy recommendation.
A. Environmental Testbed
NSF commissioned PoET and the Woodrow Wilson Center to identify environmental effects of synthetic biology, flag sources of uncertainty over effects and generate a research agenda to address critical sources of uncertainty. The project is supported jointly by three units within NSF, the Division of Cellular and Molecular Biology, the Division of Environmental Biology, and the Engineering Directorate. In 2013-2014, the research agenda was developed through consultations among synthetic biologists, evolutionary biologists, regulators, civil society and firms. January 2014 workshops used four applications of synthetic biology as prompts: endonuclease gene drives for editing genomes of populations of plants and animals in the wild (Wyss Institute); nitrogen fixation in non-legumes (MIT Synthetic Biology Center); luminescent Arabidopsis (Kickstarter Glowing Plants); and bioremediation and waste treatment in copper mining (Universal Biomining). Key policy relevant gaps in knowledge were identified, with emphasis on interaction across fitness, volutionary stability and gene transfer. Outputs include a 30 page monograph “Creating a Research Agenda for Ecological Implications of Synthetic Biology,” with forthcoming articles on “Shaping Ecological Risk Research for Synthetic Biology” in Journal of Environmental Studies and Sciences and on “Regulating Gene Drives” in Science.
B. Security and Safety Testbed
PoET worked with the International Genetically Engineered Machine Competition (iGEM), the UN Biological Weapons Convention Implementation Support Unit, Public Health Canada and SGI DNA to screen over 200 iGEM team projects, train iGEM faculty and students on safety and security practices and screen over 20000 parts in the Standard Registry of Biological Parts. This work provided a research side benefit, as project screening provided an empirical basis for characterizing cross-national differences in safety practices and identifying gaps in international agreements and national regulations that govern transfer of biological materials and as parts screening provided an empirical basis for evaluating the need for development of international standards for characterizing the function of biological parts as well as organisms of origin. "Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management" is forthcoming in ACS Synthetic Biology.
Pharmaceuticals
2013-2014 work with the MIT Center for Biomedical Innovation (CBI) and Tufts University Medical School focused on reform of systems for evaluating safety, efficacy, and cost effectiveness of pharmaceuticals. This project integrates PoET research on adaptive environmental, health and safety regulation under conditions of uncertainty and complexity and proposals from senior leaders of the European Medicines Agency, FDA and Health Canada on progressive licensing of drugs. A highlight was publication of "A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials" by H P Selker, K A Oye et al, in Clinical Pharmacology & Therapeutics. To address demands of papers and providers, the paper recommends ways of moving more rapidly from conventional trial based information on safety and efficacy of drugs to the evaluation of the effectiveness of drugs in use. Research on “Adaptive Licensing: Evolving Regulation to Enable Precision Medicine” at Molecular Tri-Con.
Dietary Standards - Transfats
At times, technologies applied to address problems produce adverse side effects. PoET has been developing a body of cases to better understand how to improve the detection of such adverse effects and the adjustment of policies to take account of emerging information. Lawrence McCray and Kenneth Oye produced a case study on the long lag between research on adverse effects of transfats from 1957-1975 and 1989-91 and adjustments in FDA policies on labels in 2003 and safety in 2013-2014. The case study was a highlight of symposia at University College London, EPFL and the University of Illinois.
Click here for a list of Working Papers