Abstract: Biotechnology is rapidly diffusing globally. Efficient methods for reading, writing, and editing genetic information, producing genetic diversity, and selecting for traits are becoming widely available. New communities of practice are gaining the power to act on timescales and geographies that fall outside current systems of oversight. Governments and scientific communities alike are struggling to respond appropriately.

Recent controversies have brought these issues to light: “gain-of-function” research may risk causing the very pandemics it aims to help mitigate; the development of “gene drives” may drastically alter ecosystems; and crowd-funded “CRISPR kits” are giving decentralized communities access to powerful new tools. Meanwhile, a series of accidents at the nation’s premier biological labs, and recent struggles in responses to Ebola and Zika are raising concerns about the capacity to respond to biological threats regardless of their cause – accidental, deliberate or naturally occurring. The lack of mechanisms to assess the benefits and risks of advances in biotechnology has prompted reactive and blunt policy solutions including scientific and government-lead research moratoriums.

This presentation will review recent developments and discuss improved strategies for preparing for emerging biological risks. It will highlight key needs and opportunities in leadership, oversight and learning to mature our institutions to tackle long-term governance challenges.

About the Speaker: Dr. Megan J. Palmer is a Senior Research Scholar and William J. Perry Fellow in International Security at the Center for International Security and Cooperation (CISAC) at Stanford University. She leads a research program focused on risk governance in biotechnology and other emerging technologies. Dr. Palmer is also an investigator of the multi-university Synthetic Biology Engineering Research Center (Synberc), where for the last 5 years she served as Deputy Director of its policy-related research program, and led projects in safety and security, property rights, and community organization and governance. She was previously a research scientist at the California Center for Quantitative Bioscience at UC Berkeley, and an affiliate of Lawrence Berkeley National Labs.

Dr. Palmer has created and led many programs aimed at developing and promoting best practices and policies for the responsible development of biotechnology. She founded and serves as Executive Director of the Synthetic Biology Leadership Excellence Accelerator Program (LEAP), an international fellowship program in responsible biotechnology leadership. She also leads programs in safety and responsible innovation for the international Genetically Engineered Machine (iGEM) competition. Dr. Palmer advises a diversity of organizations on their approach to policy issues in biotechnology, including serving on the board of the synthetic biology program of the Joint Genomics Institute (JGI)

Dr. Palmer holds a Ph.D. in Biological Engineering from MIT, and was a postdoctoral scholar in the Bioengineering Department at Stanford University, when she first became a CISAC affiliate. She received a B.Sc.E. in Engineering Chemistry from Queen’s University, Canada.

Abstract: Industry, medical centers, academics and patient advocates have come together to create common standards for the representation and exchange of genomics information for both research and clinical use in The Global Alliance for Genomics and Health. Now GA4GH involves hundreds of organizations and individuals worldwide. The open source projects of our Data Working Group welcome participation by all individuals and organizations.

About the Speaker: David Haussler develops new statistical and algorithmic methods to explore the molecular function, evolution, and disease process in the human genome, integrating comparative and high-throughput genomics data to study gene structure, function, and regulation. As a collaborator on the international Human Genome Project, his team posted the first publicly available computational assembly of the human genome sequence. His team subsequently developed the UCSC Genome Browser, a web-based tool that is used extensively in biomedical research. He built the CGHub database to hold NCI’s cancer genome data, co-founded the Genome 10K project so science can learn from other vertebrate genomes, co-founded the Treehouse Childhood Cancer Project to enable international comparison of childhood cancer genomes, and is a co-founder of the Global Alliance for Genomics and Health (GA4GH), a coalition of the top research, health care, and disease advocacy organizations.

Haussler is a member of the National Academy of Sciences and the American Academy of Arts and Sciences and a fellow of AAAS and AAAI. He has won a number of awards, including the 2014 Dan David Prize, 2011 Weldon Memorial prize for application of mathematics and statistics to biology, 2009 ASHG Curt Stern Award in Human Genetics, and the 2008 Senior Scientist Accomplishment Award from the International Society for Computational Biology, the 2006 Dickson Prize for Science from Carnegie Mellon University, and the 2003 ACM/AAAI Allen Newell Award in Artificial Intelligence.

Abstract: Technological and social forces are allowing the growth of science outside a professionalized context.  The Internet, mobile devices, and public availability of big data are technological facilitators of “citizen science”, in part through enabling data sharing, analysis, and communication.  These technological changes now allow the entire scientific process, from funding and development of a research agenda, to conduct, analysis and dissemination and application of findings, to take place without the involvement of any science professionals or research-related institutions.  However, most ethical and regulatory frameworks for biomedical science arose from concepts of obligations of professionals and (largely not-for-profit) institutions.  We will discuss current examples of “citizen science” in biology and clinical research, and the ethical and policy implications.

About the Speaker: Mildred Cho is a Professor in the Division of Medical Genetics of the Department of Pediatrics at Stanford University, Associate Director of the Stanford Center for Biomedical Ethics, and Director of the Center for Integration of Research on Genetics and Ethics. She received her B.S. in Biology in 1984 from the Massachusetts Institute of Technology and her Ph.D. in 1992 from the Stanford University Department of Pharmacology.  Her post-doctoral training was in Health Policy as a Pew Fellow at the Institute for Health Policy Studies at the University of California, San Francisco and at the Palo Alto VA Center for Health Care Evaluation.  She is a member of international and national advisory boards, including for Genome Canada, the March of Dimes, and the Board of Reviewing Editors of Science magazine.  Her current research projects examine ethical and social issues in research on the human genome and microbiome, synthetic biology and genome editing, and the ethics at the intersection of clinical practice and research.  

Abstract: Faster evolving technologies, new peer adversaries, and the increased role of non-government entities changes how we think about decisions to develop and adopt new technology. Uncertainties about technology “shelf life,” adversary intentions, and dual uses of technology complicate these decisions. This seminar will discuss the use of mathematical models and optimization methods to provide insight on technology policy issues. These issues include: balancing risk and affordability during technology research and development; timing technology adoption; and understanding adversary responses to new technologies. Examples will be discussed from offensive cyber operations and synthetic biology. We will conclude by discussing implications for how policy analysts and policy makers think about technology and security.

About the Speaker: Philip Keller is a National Defense Science and Engineering Graduate Fellow at Stanford. He is completing his PhD in Management Science & Engineering. He studies technology policy problems posed by new technologies. His research is highly interdisciplinary, drawing on methods from engineering risk and decision analysis, game theory, and operations research. His professional experience includes conducting studies and analysis for the Department of Defense and the Department of Homeland Security at RAND and the Homeland Security Studies and Analysis Institute. Previous study topics include unmanned aircraft operations; nuclear terrorism; offensive cyber operations; and military force structure. Philip holds a BS in Mathematics and an MS in Defense and Strategic Studies.

Abstract: Biotechnology is in a transition from artisanal tools and methods to computer-controlled, high-throughput systems that allow research and development at industrial scale. This digitization is also radically reducing technical and economic barriers, empowering a new generation of young designers to do bioengineering on par with major companies but at a fraction of the cost, and prompting a re-think of the entire industry, including business models, intellectual property, ethics and biosecurity. This shift has the potential to disrupt R&D on a global scale. This lecture provides an overview of the issues and opportunities.

About the Speaker: Autodesk Distinguished Researcher Andrew Hessel is spearheading the development of tools and processes that facilitate the computer-aided design and computer-aided manufacture of living creatures and systems. As a 2015-2016 AAAS-Lemelson Invention Ambassador, he also encourages others to explore invention and innovation in biological engineering. Andrew is active in the iGEM and DIYbio (do-it-yourself) communities and frequently works with students and young entrepreneurs to guide their career and business development efforts. He has given hundreds of invited talks on synthetic biology to groups that include hollywood movie producers, the United Nations, and the FBI.

Abstract: The threat of biological attack on the people of the United States and the world, whether intentional, natural or accidental, is of growing concern, both in spite of and because of significant technological advances over the past four decades. As a global leader, the United States needs a comprehensive policy approach for managing future attacks, which incorporates technologic elements from rapid detection through appropriate response. American and international responses to recent infectious disease outbreaks such as anthrax (intentional, accidental), H5N1 influenza (natural) and ebola (natural) have managed to contain these events ‐ with the paradoxical effect on policy makers, both political and administrative, of relief (“missed that bullet”, “we must be doing this right”), rather than serving as wake‐up calls. A challenge in merging technological solutions into policy lies in the rapid advances across the multiple sciences. Translation of these ongoing technologic advances for policy leaders is an essential element in effective policy development. Incorporation of technologic solutions into biosecurity policy construction, combined with motivated leadership, has the potential for enhancing future national and global responses to unprecedented biological attacks.

About the Speaker: Patrick J. Scannon, M.D., Ph.D. is XOMA's Company Founder, Executive Vice President, Chief Scientific Officer and a member of its Board of Directors. Since 1980, Dr. Scannon has directed the Company's product identification, evaluation and clinical testing programs for novel therapeutic monoclonal antibodies and proteins against infectious, oncologic, metabolic and immunologic diseases. As Chief Scientific Officer, he leads evaluations for new therapeutic antibody identification and discovery programs. 

Dr. Scannon holds a Ph.D. in organic chemistry from the University of California, Berkeley and an M.D. from the Medical College of Georgia. He completed his medical internship and residency in internal medicine at the Letterman Army Medical Center in San Francisco. A board-certified internist, Dr. Scannon is also a member of the American College of Physicians. He is the inventor or co-inventor of several issued U.S. patents, and has published numerous scientific abstracts and papers.

Dr. Scannon has served as a member of the Research Committee for Infectious Diseases Society of America (IDSA), the National Biodefense Science Board (NBSB, a federal advisory board for the Department of Health and Human Services), the chair of the Chem/Bio Warfare Defense Panel for the Defense Threat Reduction Agency (DTRA) and a member of the Defense Sciences Research Council (DSRC, a research board for Defense Advanced Research Projects Agency (DARPA)). He has served as a Trustee of the University of California Berkeley Foundation and as a member of the University of California Berkeley Chancellor's Community Advisory Board. Dr. Scannon is currently on the Board of Directors of Pain Therapeutics, Inc.