Date: Thursday, September 15, 2016

Location: University of California Berkeley, Bancroft Hotel – map

Program:

The University of California Berkeley’s Center to Advance Science in Policy and Regulation (CASPR) together with the Center for Science, Technology, Medicine and Society (CSTMS) and co-sponsors the Innovative Genomics Initiative (IGI) and the Forum for Collaborative HIV Research will host a Workshop on Advancing Science for Policy through Interdisciplinary Research in Regulation (ASPIRR). This workshop is supported by the National Science Foundation’s Science of Science and Innovation Policy Program.

The workshop will bring together leading experts from multiple disciplines and research areas to examine innovative approaches to incorporating science into the policymaking and regulatory processes for emerging technologies. Each panel will be made of people from different sectors and will be designed to focus on three domain areas: (1) drug, device and diagnostic development; (2) climate change mitigation and (3) nanoscale technology R&D. The objective of this conference is to stimulate joint research in regulatory science and to coordinate efforts of scholars in diverse disciplines with practitioners and policymakers across the United States and internationally.

Confirmed Panelists include:

• Christopher Ansell, Professor of Political Science, UC Berkeley, and U.S. editor of Public Administration: An International Quarterly
• Nabajyoti Barkakati, Ph.D. Chief Technologist, U.S. Government Accountability Office (GAO)
• Jacob Corn, PhD, Scientific Director, Innovative Genomics Initiative (IGI)
• Jason Delborne, Associate Professor, Department of Forestry and Environmental Resources & Genetic Engineering and Society Faculty Cluster, North Carolina State University
• Jonas Meckling, Assistant Professor, Energy and Environmental Policy, UC Berkeley
• Dáithí Stone, Research Scientist, Computational Chemistry, Materials & Climate Group, Lawrence Berkeley Lab
  

  Agenda:

Statement of Need

Recent scientific and technological breakthroughs — ranging from new precision techniques for engineering the human genome to advances in the application of nanotechnology to a spectrum of new domains in healthcare, materials and energy — have the potential to transform our ability to prevent, diagnose and treat disease; achieve energy sustainability; and overhaul industrial production processes. As science and engineering advances, identifying appropriate questions and marshaling data to make decisions about the applications and accompanying risks of these innovations is a moving target. Standards setting, evaluation and approval processes must evolve in concert with the technologies to ensure that novel products emerge and can be used when they will be most valuable. For emerging technologies to realize their full potential, governance mechanisms must be responsive and address cross-cutting issues to ensure safe and effective products and environments. The scientific enterprise, technology and manufacturing industry that bring novel inventions to the market and the public will benefit from a responsive regulatory regime that attends to both future uncertainties and innovation.

These new scientific tools, technologies, and approaches form what we call regulatory science: the science of developing tools, standards and approaches to assess the safety, efficacy, quality and performance of emerging technologies across multiple domains. A contemporary accounting of regulation involves a wide range of tools and mechanisms beyond legislation. Codes, standards, contracts, grants, and economic incentives like tax credits all shape the ebb and flow of the scientific and engineering enterprise and its influence in the market and on society. These tools may be deployed by a host of institutions and actors, all with different levels of jurisdiction inside and outside of governments (through independent institutions), or result from the interaction of hybrid mechanisms, such as co-regulation, self-regulation or even ‘meta’ regulation, where the state’s regulatory bodies oversee others.

Workshop Organization

Panel 1: Standards for Regulation of Innovative Technologies

Key Readings

Blackstock, Jason J., and Jane C.S. Long. The Politics of Geoengineering. Science 29 Jan 2010: Vol. 327, Issue 5965, pp. 527 DOI: 10.1126/science.1183877

Gilad, Sharon. It runs in the family: Meta-regulation and its siblings. Regulation & Governance (2010) 4, 485–506. doi:10.1111/j.1748-5991.2010.01090.x
Hamburg, Margaret A. FDA’s Approach to Regulation of Products of Nanotechnology. Science 336, no. 6079 (April 20, 2012): 299–300. doi:10.1126/science.1205441.

Marchant, Gary E., and Douglas J. Sylvester. Transnational Models for Regulation of Nanotechnology. The Journal of Law, Medicine & Ethics 34.4 (2006): 714–725.

Panel 2: Locus of Regulation (level, sector, type)

Key Readings

Barben, Daniel, et al., Anticipatory Governance of Nanotechnology: Foresight, Engagement, and Integration. In The Handbook of Science and Technology Studies, Third Edition. The MIT Press: Cambridge, MA.

Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct, Board on Life Sciences, Division on Earth and Life Studies, & National Academies of Sciences, Engineering, and Medicine. (2016). Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. Washington, D.C.: National Academies Press. Retrieved from http://www.nap.edu/catalog/23405

Delborne, Jason, Jen Schneider, Ravtosh Bal, Susan Cozzens, and Richard Worthington. Policy pathways, policy networks, and citizen deliberation: Disseminating the results of World Wide Views on Global Warming in the USA. Science and Public Policy (2013) 40 (3): 378-392. doi: 10.1093/scipol/scs124

Meckling, Jonas and Steffen Jenner. Varieties of market based policy Instrument choice in climate policy. Journal Environmental Politics. 2016. 25 (5): 853-874.
http://dx.doi.org/10.1080/09644016.2016.1168062

Panel 3: Scientific Authority in Regulation

Key Readings

Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman S, Barratt R, Rocca M, Hills I, Woodcock J. Catalyzing the Critical Path Initiative: FDA’s Progress in Drug Development Activities. Clin Pharmacol Ther 2015; 97(3).

Selin, Cynthia, Kelly Campbell Rawlings, Kathryn de Ridder-Vignone, Jathan Sadowski and Carlo Altamirano Allende, Gretchen Gano, Sarah R. Davies, David H. Guston. Experiments in engagement: Designing public engagement with science and technology for capacity building doi:10.1177/0963662515620970

To accomplish this objective, this agenda-setting conference will address three cross-cutting topics:

• Regulation of Emerging Technologies

• Framing Authoritative Science for Policy and Regulatory Decisions

• Identifying Appropriate Loci of Regulatory Oversight: Centralized (National); Decentralized (State/Local); or Private (Self-Regulation and Enforcement Litigation)

These three topics will be explored across the domains and in concert with researchers in:

• Healthcare – Drug/Device Innovation

• Environmental Regulation for both Ecosystem Integrity and Human Health

• Nanoscale Materials Innovation and Commercialization

Our inquiry will extend conventional discourse on regulatory science confined to domain concerns or to developing standards setting and legislative mechanisms to address boundary spanning institutional, economic, social and political contexts operative in framing the representation of sound science in public discourse and debate.

FAQs

What are my transport/parking options getting to the event?
Attendant parking is available immediately adjacent to the Hotel.

Where can I contact the organizer with any questions?
For more information about this event, email aspirr@berkeley.edu.

Leadership Team

Arthur L Reingold, MD / PI
Professor and Division Head, Epidemiology
UC Berkeley School of Public Health

Ann Keller, PhD / Co-PI
Associate Professor, Health Policy & Management
UC Berkeley School of Public Health

Ken Taymor, JD
Executive Director, Center to Advance Science in Policy & Regulation
UC Berkeley School of Public

Gretchen Gano, PhD

Associate Director of Research
Center for Science, Technology, Medicine & Society (CSTMS)

Marsha Fenner
Program Director
Innovative Genomics Initiative (IGI)

Veronica Miller, PhD
Executive Director
Forum for Collaborative HIV Research (the Forum)

This workshop is supported by the National Science Foundation’s Science of Science and Innovation Policy Program Award #1561413