Biosecurity
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Abstract: International cooperation has long been founded on the idea that securing a common factual understanding of things in the world is a prerequisite for deciding how to act in concert. However, in recent decades the very possibility of such agreement on the facts has come under attack both empirically, through persistent technical controversies around issues such as climate change and crop biotechnology, and theoretically, from demonstrations that facts and norms are co-produced to build alternate, coexisting worlds. The divergent self-understandings of these worlds, in which epistemic and normative order are interdependent, cannot be bridged by simply insisting on a singular “reality” that must be accepted by all.

In this talk, I use the longue durée case of international biotech regulation to suggest a different basis for long-term cooperation. Using epistemic subsidiarity rather than harmonization as the basis for making progress, I suggest how biotechnology risks might be handled in three regimes of subsidiarity: coexistence, cosmopolitanism, and constitutionalism. The advantages and limits of each regime will be exemplified and reflected upon.

Speaker bio: Sheila Jasanoff is Pforzheimer Professor of Science and Technology Studies at the Harvard Kennedy School. A pioneer in her field, she has authored more than 120 articles and chapters and is author or editor of more than 15 books, including The Fifth Branch, Science at the Bar, Designs on Nature, and The Ethics of Invention. Her work explores the role of science and technology in the law, politics, and policy of modern democracies. She founded and directs the STS Program at Harvard; previously, she was founding chair of the STS Department at Cornell. She has held distinguished visiting appointments at leading universities in Europe, Asia, Australia, and the US. Jasanoff served on the AAAS Board of Directors and as President of the Society for Social Studies of Science. She is a member of the Council on Foreign Relations. Her honors include a Guggenheim Fellowship, an Ehrenkreuz from the Government of Austria, membership in the Royal Danish Academy, and the Humboldt Foundation’s Reimar-Lüst award. She holds AB, JD, and PhD degrees from Harvard, and honorary doctorates from the Universities of Twente and Liège.

Sheila Jasanoff Professor of Science and Technology Studies Harvard University's Kennedy School of Government
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Abstract: Against a backdrop of emerging and reemerging infectious diseases of natural origin, fueled by changes in land use and global climate, there is an ongoing revolution in the life sciences with growing empowerment of the individual to decipher, genetically alter, and manufacture living things. In addition to widely-touted potential benefits, these events and developments pose challenges and risks of profound harm to humans and the rest of the planet. Yet, the United States and most other nations have failed to respond with a strategic plan, sustained resources, coherent leadership, critical self-assessment, and accountability. Why is this? A selected history of recent naturally-occurring disease outbreaks and advances in the life sciences that create new risks of potential misuse will be offered, differing perspectives from the science and policy communities described, and some of the efforts to address these challenges summarized. Forward-looking proposals for efforts to mitigate risk in the life sciences will be discussed.

Speaker Bio: David A. Relman, M.D., is the Thomas C. and Joan M. Merigan Professor in Medicine, and Microbiology & Immunology at Stanford University, and Chief of Infectious Diseases at the Veterans Affairs Palo Alto Health Care System. He is also Senior Fellow at the Freeman Spogli Institute for International Studies (FSI), and served as science co-director at the Center for International Security and Cooperation from 2013-2017. He is currently director of a new Biosecurity Initiative at FSI.

Relman identified several historically important and novel microbial disease agents, and was an early pioneer in the modern study of the human indigenous microbiota (microbiome). His lab group currently examines human microbial community assembly, and community stability and resilience.

Among policy-relevant activities, Relman is currently a member of the Intelligence Community Studies Board at the National Academies of Science (NAS), served as vice-chair of the NAS Committee that reviewed the science performed for the FBI 2001 Anthrax Letters investigation, and was a member of the National Science Advisory Board on Biosecurity. He was elected to the National Academy of Medicine in 2011. 

CISAC
Stanford University
Encina Hall, E209
Stanford, CA 94305-6165

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Senior Fellow at the Freeman Spogli Institute for International Studies
Thomas C. and Joan M. Merigan Professor
Professor of Medicine
Professor of Microbiology and Immunology
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David A. Relman, M.D., is the Thomas C. and Joan M. Merigan Professor in the Departments of Medicine, and of Microbiology and Immunology at Stanford University, and Chief of Infectious Diseases at the Veterans Affairs Palo Alto Health Care System in Palo Alto, California. He is also Senior Fellow at the Freeman Spogli Institute for International Studies (FSI) at Stanford, and served as science co-director at the Center for International Security and Cooperation at Stanford from 2013-2017. He is currently director of a new Biosecurity Initiative at FSI.

Relman was an early pioneer in the modern study of the human indigenous microbiota. Most recently, his work has focused on human microbial community assembly, and community stability and resilience in the face of disturbance. Ecological theory and predictions are tested in clinical studies with multiple approaches for characterizing the human microbiome. Previous work included the development of molecular methods for identifying novel microbial pathogens, and the subsequent identification of several historically important microbial disease agents. One of his papers was selected as “one of the 50 most important publications of the past century” by the American Society for Microbiology.

Dr. Relman received an S.B. (Biology) from MIT, M.D. from Harvard Medical School, and joined the faculty at Stanford in 1994. He served as vice-chair of the NAS Committee that reviewed the science performed as part of the FBI investigation of the 2001 Anthrax Letters, as a member of the National Science Advisory Board on Biosecurity, and as President of the Infectious Diseases Society of America. He is currently a member of the Intelligence Community Studies Board and the Committee on Science, Technology and the Law, both at the National Academies of Science. He has received an NIH Pioneer Award, an NIH Transformative Research Award, and was elected a member of the National Academy of Medicine in 2011.

Stanford Health Policy Affiliate
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Department of Medicine; CISAC, Stanford University
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Abstract: The threat of biological catastrophes-- stemming from natural, accidental or intentional causes-- looms ever larger as populations urbanize, global temperatures rise, and the access to biological weapons spreads. In fact, climate change and the increasing ease with which biological weapons may be obtained represent two significant threats to public health. As these threats materialize, they test nations’ resources, capabilities, and strength. Through an examination of the policy and scientific challenges posed by weaponized biological agents as well as by the growing public health risks stemming from climate change impacts, key gaps in bio-preparedness emerge. Bio-preparedness efforts, nationally and globally, do not currently keep pace with emerging biological risks. Will the scientific and policy communities find common ground to move the global health agenda forward through prevention, detection, and response?

Speaker Bio: Alice Hill is a Research Fellow at the Hoover Institution at Stanford University.  She previously served at the White House as Special Assistant to President Barack Obama and Senior Director for Resilience Policy on the National Security Council.  Hill led the creation of national policy regarding catastrophic risk, including the impacts of climate change and biological threats.

Hill previously served as Senior Counselor to the Secretary of the Department of Homeland Security (DHS).  She headed the DHS Biological Leadership group and led development of Department strategies and policies regarding catastrophic biological and chemical incidents, ranging from pandemics to weapons of mass destruction.  Hill also founded and was the first Chair of the Blue Campaign, an internationally recognized anti-human trafficking campaign.

Earlier in her career, Hill has served as a supervising judge on the Los Angeles Superior Court and as chief of the white-collar crime unit in the Los Angeles US Attorney’s Office.

She is a frequent speaker and has been quoted in the NY Times, Washington Post, and Los Angeles Times, among other publications. She has appeared on CBS, NPR, and MSNBC and her commentary has been published in Newsweek, LawFare, The Hill, and other media.  She has received numerous awards and commendations, including the Department of Justice’s highest award for legal accomplishment, Harvard’s Meta-Leader of the Year Award, and the San Fernando Valley Bar’s Judge of the Year.

Alice Hill Research Fellow Hoover Institution, Stanford University
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The Johns Hopkins Center for Health Security has formulated an encompassing working definition of global catastrophic biological risks (GCBRs) that reflects diverse sources of risk and mechanisms of damage. The authors draw on their definition to highlight some important considerations for understanding and addressing GCBRs.

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Health Security
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Megan Palmer
David Relman
Bruce C. Tiu
Amy S. Weissenbach
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The fact that biological weapons have never been used—at least in recent history—is not sufficient reason to dismiss concerns that terrorists or nations could acquire and use dangerous pathogens as weapons. The ongoing discussion about gain-of-function experiments should take this very real prospect more seriously.

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Wiley Online Library
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Thomas V Inglesby
David Relman
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According to the WHO, dual use research of concern (DURC) is “life sciences research that is intended for benefit, but which might easily be misapplied to do harm”. Recent studies, particularly those on influenza viruses, have led to renewed attention on DURC, as there is an ongoing debate over whether the benefits of gain‐of‐function (GOF) experiments that result in an increase in the transmission and/or pathogenicity of potential pandemic pathogens (PPPs) are outweighed by concerns over biosecurity and biosafety. In this Viewpoint article, proponents and opponents of GOF experiments discuss the benefits and risks associated with these studies, as well as the implications of the current debate for the scientific community and the general public, and suggest how the current discussion should move forward.

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Nature Reviews Microbiology
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W. Paul Duprex
Ron A. M. Fouchier
Michael J. Imperiale
Marc Lipsitch
David Relman
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Abstract: High-security organizations around the world face devastating threats from insiders—trusted employees with access to sensitive information, facilities, and materials. From Edward Snowden to the Fort Hood shooter to the theft of nuclear materials, the threat from insiders is on the front page and at the top of the policy agenda. Insider Threats offers detailed case studies of insider disasters across a range of different types of institutions, from biological research laboratories, to nuclear power plants, to the U.S. Army. Matthew Bunn and Scott D. Sagan outline cognitive and organizational biases that lead organizations to downplay the insider threat, and they synthesize "worst practices" from these past mistakes, offering lessons that will be valuable for any organization with high security and a lot to lose.

About the Speakers: Matthew Bunn is a Professor of Practice at Harvard University's John F. Kennedy School of Government. His research interests include nuclear theft and terrorism; nuclear proliferation and measures to control it; the future of nuclear energy and its fuel cycle; and policies to promote innovation in energy technologies. Before joining the Kennedy School in January 1997, he served for three years as an adviser to the Office of Science and Technology Policy, where he played a major role in U.S. policies related to the control and disposition of weapons-usable nuclear materials in the United States and the former Soviet Union, and directed a secret study for President Clinton on security for nuclear materials in Russia.

Scott S. Sagan is the Caroline S.G. Munro Professor of Political Science, the Mimi and Peter Haas University Fellow in Undergraduate Education, and Senior Fellow at the Center for International Security and Cooperation and the Freeman Spogli Institute at Stanford University. He also serves as Project Chair for the American Academy of Arts and Sciences’ Initiative on New Dilemmas in Ethics, Technology, and War. Before joining the Stanford faculty, Sagan was a lecturer in the Department of Government at Harvard University. From 1984 to 1985, he served as special assistant to the director of the Organization of the Joint Chiefs of Staff in the Pentagon. Sagan has also served as a consultant to the office of the Secretary of Defense and at the Sandia National Laboratory and the Los Alamos National Laboratory. 

Amy Zegart is is co-director of CISAC and Professor of Political Science, by courtesy. She is also the Davies Family Senior Fellow at the Hoover Institution. 

Before coming to Stanford in 2011, Zegart served as professor of public policy at UCLA’s Luskin School of Public Affairs and as a fellow at the Burkle Center for International Relations. Her research examines the organization of American national security agencies and their effectiveness. She is the author of two award-winning books. Flawed by Design, which chronicles the development of the Central Intelligence Agency, Joint Chiefs of Staff, and National Security Council, won the highest national dissertation award in political science. Spying Blind, which examines why American intelligence agencies failed to adapt to the terrorist threat before 9/11, won the National Academy of Public Administration’s Brownlow Book Award. She has also published in International Security, Political Science Quarterly, and other leading academic journals. She serves on the editorial boards of Terrorism and Political Violence and Intelligence and National Security. Her most recent book is Eyes on Spies: Congress and the United States Intelligence Community.
 
Zegart was featured by the National Journal as one of the ten most influential experts in intelligence reform. 

- The book, Insider Threats, will be available for purchase at the event -

CISAC
Stanford University
Encina Hall, E202
Stanford, CA 94305-6165

(650) 725-2715 (650) 723-0089
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The Caroline S.G. Munro Professor of Political Science
The Bass University Fellow in Undergraduate Education  
Senior Fellow, Freeman Spogli Institute for International Studies
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Scott D. Sagan is Co-Director and Senior Fellow at the Center for International Security and Cooperation, the Caroline S.G. Munro Professor of Political Science, and the Bass University Fellow in Undergraduate Education at Stanford University. He also serves as Co-Chair of the American Academy of Arts and Sciences’ Committee on International Security Studies. Before joining the Stanford faculty, Sagan was a lecturer in the Department of Government at Harvard University and served as special assistant to the director of the Organization of the Joint Chiefs of Staff in the Pentagon.

Sagan is the author of Moving Targets: Nuclear Strategy and National Security (Princeton University Press, 1989); The Limits of Safety: Organizations, Accidents, and Nuclear Weapons (Princeton University Press, 1993); and, with co-author Kenneth N. Waltz, The Spread of Nuclear Weapons: An Enduring Debate (W.W. Norton, 2012). He is the co-editor of Insider Threats (Cornell University Press, 2017) with Matthew Bunn; and co-editor of The Fragile Balance of Terror (Cornell University Press, 2022) with Vipin Narang. Sagan was also the guest editor of a two-volume special issue of DaedalusEthics, Technology, and War (Fall 2016) and The Changing Rules of War (Winter 2017).

Recent publications include “Kettles of Hawks: Public Opinion on the Nuclear Taboo and Noncombatant Immunity in the United States, United Kingdom, France, and Israel”, with Janina Dill and Benjamin A. Valentino in Security Studies (February 2022); “The Rule of Law and the Role of Strategy in U.S. Nuclear Doctrine” with Allen S. Weiner in International Security (Spring 2021); “Does the Noncombatant Immunity Norm Have Stopping Power?” with Benjamin A. Valentino in International Security (Fall 2020); and “Just War and Unjust Soldiers: American Public Opinion on the Moral Equality of Combatants” and “On Reciprocity, Revenge, and Replication: A Rejoinder to Walzer, McMahan, and Keohane” with Benjamin A. Valentino in Ethics & International Affairs (Winter 2019).

In 2022, Sagan was awarded Thérèse Delpech Memorial Award from the Carnegie Endowment for International Peace at their International Nuclear Policy Conference. In 2017, he received the International Studies Association’s Susan Strange Award which recognizes the scholar whose “singular intellect, assertiveness, and insight most challenge conventional wisdom and intellectual and organizational complacency" in the international studies community. Sagan was also the recipient of the National Academy of Sciences William and Katherine Estes Award in 2015, for his work addressing the risks of nuclear weapons and the causes of nuclear proliferation. The award, which is granted triennially, recognizes “research in any field of cognitive or behavioral science that advances understanding of issues relating to the risk of nuclear war.” In 2013, Sagan received the International Studies Association's International Security Studies Section Distinguished Scholar Award. He has also won four teaching awards: Stanford’s 1998-99 Dean’s Award for Distinguished Teaching; Stanford's 1996 Hoagland Prize for Undergraduate Teaching; the International Studies Association’s 2008 Innovative Teaching Award; and the Monterey Institute for International Studies’ Nonproliferation Education Award in 2009.     

Co-director of the Center for International Security and Cooperation
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Stanford University
Matthew Bunn Professor of Practice; Co-Principal Investigator, Project on Managing the Atom Belfer Center, Harvard Kennedy School

CISAC
Stanford University
Encina Hall, E216
Stanford, CA 94305-6165

(650) 725-9754 (650) 723-0089
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Senior Fellow at the Freeman Spogli Institute for International Studies
Morris Arnold and Nona Jean Cox Senior Fellow at the Hoover Institution
Professor, by courtesy, of Political Science
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PhD

Amy Zegart is a senior fellow at the Freeman Spogli Institute for International Studies, the Morris Arnold and Nona Jean Cox Senior Fellow at the Hoover Institution, and Professor of Political Science by courtesy at Stanford University. She is also a contributing writer at The Atlantic. The author of five books, Zegart is an internationally recognized expert in U.S. intelligence, emerging technologies, and global political risk management.

Her award-winning research includes the leading academic study of intelligence failures before 9/11 — Spying Blind: The CIA, the FBI, and the Origins of 9/11 (Princeton, 2007). Her most recent book is the bestseller Spies, Lies, and Algorithms: The History and Future of American Intelligence (Princeton, 2022), which was nominated by Princeton University Press for the Pulitzer Prize. She also co-authored Political Risk: How Businesses and Organizations Can Anticipate Global Insecurity, with Condoleezza Rice (Twelve, 2018) and co-edited Bytes, Bombs, and Spies: The Strategic Dimensions of Offensive Cyber Operations with Herbert Lin (Brookings, 2019). Her op-eds and essays have appeared in Foreign Affairs, Politico, the New York Times, Washington Post, and Wall Street Journal

Zegart has advised senior officials about intelligence and foreign policy for more than two decades. She served on the National Security Council staff, as a presidential campaign foreign policy advisor, and has testified before the House and Senate Intelligence committees. 

In addition to her research and teaching, she led Stanford’s Center for International Security and Cooperation, founded the Stanford Cyber Policy Program, and served as chief academic officer of the Hoover Institution. Before coming to Stanford, she was Professor of Public Policy at UCLA and a McKinsey & Company consultant.

She is the recipient of a Fullbright Fellowship, the American Political Science Association's Leonard D. White Dissertation Prize, and research grants from the Carnegie Corporation of New York, the Hewlett Foundation, the Smith Richardson Foundation, and the National Science Foundation.

A native of Louisville, Kentucky, Zegart received an AB in East Asian studies, magna cum laude, from Harvard and a PhD in political science from Stanford. She serves on the board of directors of the council on Foreign Relations, Kratos Defense & Secretary Solutions (KTOS), and the American Funds/Capital Group.

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In this new articleMegan Palmer, a senior research scholar at the Center for International Security and Cooperation, talks about the different ways that the FBI is collaborating with the biotech community in order to be prepared to respond to an emerging biological threat. One of them is by reaching out to student bioengineers at programs like the International Genetically Engineered Machine (iGEM) Competition. The purpose of that event is to demonstrate how synthetic biology can be used to address pressing global issues.

As the article states, whether it’s an accidental outbreak or a biological attack, the FBI seeks to create a culture of trust and transparency with the biotech community. Palmer discussed this topic recently at the Biofabricate conference for synthetic biology and design in New York City.

As Palmer noted, biological attacks are a historical reality. In 1984, cult members poisoned patrons of 10 salad bars in Oregon with salmonella, sickening more than 750 people. And in 2001 shortly after the 9/11 attacks, anthrax spores that were mailed to newsrooms and government offices killed five people. While other incidents may have simply failed, it seems prudent to prepare for future attacks that could be even more deadlier.

Enter the FBI's foreay into the biotech community. Collaboartion between the public and private sectors is increasing in this area. As Palmer said, examples exist of iGEM students acting as "white hat biohackers" to help biotech companies detect weaknesses in their systems that  all in collaboration with the FBI, Palmer says. 

“There’s the overall sense that the government has acknowledged that it is not necessarily the center of influence in technological development,” Palmer told the publication. “We’re going to start seeing many more examples of partnerships between the government and the private sector where you wouldn't have necessarily expected them before. People should be willing to give them a chance.” 

To Palmer, the key to the collaboration is open communication. She reports progress with the FBI and biotech community on this front. Palmer herself asks the FBI questions about its involvement and interest in biotech dangers. So far, they have “been willing to have more of those conversations,” she said. The true test will come when the relationship is finally tested by what Palmer describes as a “triggering event,” either a situation where there is reason to believe a biotech has occurred or one in which the FBI is prying a bit too much into the lives of biologists. Palmer said that if the relationship doesn’t withstand this type of challenge, the trust between the FBI and the community would weaken, and communication would break down.

Follow CISAC on Twitter at @StanfordCISAC and on Facebook at www.facebook.com/StanfordCISAC.

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Abstract: DNA synthesis providers form the primary biosecurity safety net for the synthetic biology industry. Twist’s silicon-based DNA synthesis platform allows for synthesis of 2-3 orders of magnitude more DNA in the same footprint as traditional methods. This poses a challenge to existing labor-intensive biosecurity screening practices as recommended by US government guidance. Can the technical and regulatory environments adapt to lower the cost and increase throughput of screening while maintaining or even improving detection accuracy? This talk will provide an overview of current best practices, review technical gaps in existing regulatory guidance and suggest possible improvements to help continue to power the rapid scientific and economic development of synthetic biology.

About the Speaker: James Diggans leads the Bioinformatics and Biosecurity group at Twist Bioscience, a DNA synthesis company based in San Francisco, CA. The group develops algorithms and predictive models and builds large-scale distributed computing systems supporting Twist’s next generation synthesis technology, including biosecurity and export control screening systems. He currently represents Twist’s membership to the International Gene Synthesis Consortium and to the US Department of Commerce/BIS Materials Technical Advisory Committee.

Dr. Diggans received his PhD from George Mason University and previously led the computational biology group at MITRE, designing software-defined biosensors and battlefield chem/bio sensor fusion systems. He has also worked in molecular diagnostics spending five years building and validating machine learning algorithms for cancer detection from tissue biopsy. 

Encina Hall, 2nd floor

James Diggans Senior Manager, Bioinformatics and Biosecurity |Twist Bioscience
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Clifton B. Parker
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Biosecurity leaders gathered at Stanford this week to offer new ideas and perspectives on a wide range of issues critical to societal health.

The conference, “Emerging Leaders in Biosecurity,” began Sept. 13 with a trip to Lawrence Livermore National Laboratory in the East Bay. The second day featured a series of panel discussions on the Stanford campus. The fellows, chosen by the UPMC Center for Health Security, hailed from a wide array of backgrounds, including biological science, medicine, policy, the military, law, public health and the private sector.

Biosecurity and its relationship to global health is a key issue for Stanford’s Center for International Security and Cooperation (CISAC), which hosted and helped organize the conference along with the sponsoring UPMC Center. The conference was sponsored by the Defense Threat Reduction Agency and the emerging leaders program run by the UPMC. 

With rapid advances in technology and science, biosecurity is increasingly focused on how harmful biological agents could become national security threats and risks.

‘A changing world’

David Relman, co-director of CISAC, addressed the fellows on Wednesday with remarks on the origins of CISAC’s involvement in biosecurity. Relman, a professor in the departments of medicine, and microbiology and immunology, later served as a panelist in a discussion on biosecurity and national and international policy.

Megan Palmer, a fellow and CISAC senior research scholar on biosecurity, panel moderator and organizer of the conference, described the program as one that “brings together some of the most talented and committed rising leaders from multiple organizations and disciplines critical to national and international biosecurity.”

She noted, “Stanford's biosecurity programs are focused on developing strategies for biosecurity in a changing world. Today we face complex biosecurity challenging ranging from emerging infectious diseases, intentional misuse of biotechnology, and potential accidents and unintentional consequences of our increasing ability to manipulate living systems.”

At the same time, biotechnology continues to be an important and growing part of the global economy, Palmer said. “Our scholarship and engagement work seeks to developing new ways to think about and act in this changing environment.”

Research focus

Through the “emerging leaders” program, fellows deepen their expertise in biosecurity, build leadership skills, and forge networks of lasting professional relationships, she added.

The two-day conference included talks on threat awareness, biodetection, a “viral storm” exercise, bioengineering research, computational biology and national security, biosecurity and national and international policy, the evolving biotechnology field, among other topics.

Stanford participants and speakers included CISAC’s William Perry, the former secretary of defense; Drew Endy, a Stanford associate professor of bioengineering; Tim Stearns, chair of the biology department; Milana Trounce, clinical associate professor of emergency medicine; and Manu Prakash, assistant professor of bioengineering.

CISAC activity in biosecurity includes research on:

  • Risks in misusing the emerging life sciences;
  • Social and political factors behind drug-resistant antibiotics, leading to an tight pipeline for new drugs;
  • Examining the ethical responsibilities of scientists in this field and the needs for regulation;
  • Anticipating and pre-empting the misuse of biotechnology by people with the intent to do harm.

Matthew Watson, a senior analyst for the UPMC Center, said, “It is difficult to imagine a more fitting venue for the fall Emerging Leaders in Biosecurity workshop than Stanford. Few institutions can bring together this array of world class talent, including leaders from national security, the life sciences, and the private sector.”

Back in February, the UPMC Center for Health Security chose its 2016 fellows and launched the program with a Washington, D.C. workshop in March.

 

 

 

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