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Biodefense in the Age of Synthetic Biology – Tom Slezak

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Biodefense in the Age of Synthetic Biology – Tom Slezak

  1. 1. Biodefense in the Age of Synthetic Biology Tom Slezak, KPATH Scientific, LLC (Committee Member) Catalyst Workshop February 22, 2020 (Report released in June 2018)
  2. 2. Committee Michael Imperiale, Ph.D. (Chair) University of Michigan Charles Haas, Ph.D. Drexel University Patrick Boyle, Ph.D. Ginkgo Bioworks Joseph Kanabrocki, Ph.D. University of Chicago Peter A. Carr, Ph.D. MIT Lincoln Laboratory Kara Morgan, Ph.D. Quant Policy Strategies, LLC Douglas Densmore, Ph.D. Boston University Kristala Jones Prather, Ph.D. Massachusetts Institute of Technology Diane DiEuliis, Ph.D. National Defense University Jill Taylor, Ph.D. New York State Department of Health Andrew Ellington, Ph.D. University of Texas Thomas R. Slezak, M.S. Lawrence Livermore National Laboratory Gigi Kwik Gronvall, Ph.D. John Hopkins Bloomberg School of Public Health National Academies Staff Marilee Shelton Davenport, Ph.D. Study Director Katherine Bowman, Ph.D., Sr. Program Officer Jenna Ogilvie, Research Associate Jarrett Nguyen, Senior Program Assistant
  3. 3. Report’s Task 1. Develop a strategic framework to guide assessment of security vulnerabilities associated with advances in biotechnology, with emphasis on synthetic biology: • What are security concerns on the horizon? • What are time frames of development of these concerns? • What are potential options for mitigating these concerns? 2. Use the framework to assess a set of synthetic biology- enabled capabilities (Report sponsored by the U.S. Department of Defense's Chemical and Biological Defense Program)
  4. 4. Framework for evaluating security concerns
  5. 5. Analysis of Potential Capabilities Assessed 12 capabilities related to: • Synthesis and modification of pathogens • Production of chemicals, biochemicals and toxins • Modulation of human physiology
  6. 6. Biotechnology in the age of synthetic biology expands the landscape of potential defense concerns Ongoing strategies for chemical and biological defense remain relevant in the age of synthetic biology Also need approaches to account for the broader capabilities enabled by synthetic biology, now and into the future Overarching Recommendation
  7. 7. Relative Concern of Capabilities Assessed
  8. 8. Pathogens Synthetic biology is expected to: • expand the range of what could be produced • decrease the amount of time required • expand the range of actors Creation and manipulation of pathogens is facilitated by increasingly accessible technologies and starting materials, including DNA sequences in public databases. A wide range of pathogen characteristics could be explored as part of such efforts.
  9. 9. Chemicals, Biochemicals, and Toxins Synthetic biology: • blurs the line between chemical and biological weapons High potency molecules that can be produced through simple genetic pathways are of greatest concern, as they could conceivably be developed with modest resources and organizational footprint.
  10. 10. Through synthetic biology: • may be possible to modulate human physiology in novel ways These include physiological changes that differ from the typical effects of known pathogens and chemical agents. Synthetic biology expands the landscape by potentially allowing the delivery of biochemicals by a biological agent, and by potentially allowing the engineering of the microbiome or immune system. While unlikely today, these types of manipulations may become more feasible as knowledge of complex systems grows. Modulation of Human Physiology
  11. 11. Bottlenecks and Barriers Some malicious applications may not seem plausible now but could become achievable if certain barriers are overcome. It is important to continue to monitor advances in biotechnology that may lower these barriers. Barriers include: • Knowledge barriers, as is the case for building a novel pathogen • Technological barriers, as in engineering complex biosynthetic pathways into bacteria or re-creating known bacterial pathogens
  12. 12. Convergent technologies from outside of synthetic biology may assist in overcoming some of the barriers in areas such as production, fidelity and testing, delivery, targeting – Gene therapy – Nanotechnology – Automation – Additive manufacturing – Health informatics Related Developments May Impact Ability to Use Synthetic Biology-Enabled Weapons
  13. 13. Synthetic Biology Poses Mitigation Challenges Many traditional approaches to biological and chemical defense preparedness will be relevant to synthetic biology. But synthetic biology also presents new challenges • The potential unpredictability related to how a synthetic biology- enabled weapon could manifest creates an added challenge to monitoring and detection • Range of strategies needed to prepare and respond • Continue exploring strategies that are applicable to a wide range of chemical and biodefense threats • Evaluate the infrastructure that informs population-based surveillance, identification, and notification of both natural and purposeful health threats • Consider strategies that manage emerging risk better than current agent-based lists and access control approaches
  14. 14. Exploration Areas: Potential Opportunities to Advance Mitigation Capabilities • Developing capabilities to detect unusual ways in which a synthetic biology-enabled weapon may manifest • Harnessing computational approaches for mitigation • Leveraging synthetic biology to advance detection, therapeutics, vaccines, and other medical countermeasures
  15. 15. More Information synbiodefense@nas.edu Download report and 4-page brief: http://nas-sites.org/dels/studies/strategies- for-identifying-and-addressing- vulnerabilities-posed-by-synthetic-biology/ Staff Marilee Shelton-Davenport, PhD; Study Director mshelton@nas.edu Katherine Bowman, PhD; Board on Life Sciences kbowman@nas.edu
  16. 16. Discussion Question: • Consider both bio-error and bio-terror. • Consider what we don’t know about the organisms we are manipulating. What assumptions about safety might turn out to be incorrect? How might YOUR work be affected by an increased understanding of potential Synthetic Biology risks?

Editor's Notes

  • New report released by the U.S. National Academies of Sciences, Engineering, and Medicine in June 2018
  • Highlight that committee has expertise in a number of areas –

    Various areas of synthetic biology; microbiology; data analytics and biodesign software; public health; technical forecasting and threat assessment; biosafety and biosecurity
  • This is a streamlined SOT. The full task is in the report. (Report is not be a threat assessment)
    To assist the U.S. Department of Defense's Chemical and Biological Defense Program (CBDP), The National Academies of Sciences, Engineering, and Medicine will appoint an ad hoc committee to address the changing nature of the biodefense threat in the age of synthetic biology. Specifically, the focus of the study will be the manipulation of biological functions, systems, or microorganisms resulting in the production of a disease-causing agents or toxins. The study will be conducted in two primary phases. Initially, the committee will develop a strategic framework to guide an assessment of the potential security vulnerabilities related to advances in biology and biotechnology, with a particular emphasis on synthetic biology.
    The framework will focus on how to address the following three questions: What are the possible security concerns with regard to synthetic biology that are on the horizon? What are the time frames of development of these concerns? What are our options for mitigating these potential concerns? The committee will publish a brief interim, public report outlining the developed framework. This framework will not be a threat assessment, but rather, will focus on ways to identify scientific developments to enable opportunities that have the potential to mitigate threats posed by synthetic biology in the near-, mid-, and long-term, with the specific time frames defined by the committee. The framework will lay out how best to consider the trajectory of scientific advances, identify potential areas of vulnerability and predict promising mitigation opportunities.

    In Phase 2 of the study, the committee refined its strategic framework and used the framework to generate an assessment of vulnerabilities posed by synthetic biology.
     
    The report is currently in security review with DOD. It will be briefed to DOD and partner agencies, to interested congressional committees, and disseminated to the public including the synthetic biology communities once it has cleared security review

    Phase 3: After the study portion is completed and the final report is released, the committee will organize a classified workshop to present its findings to the biodefense community and selected members of the synthetic biology community and contribute to the biodefense community's discussion of potential vulnerabilities and mitigation options. A brief proceedings will be prepared by a rapporteur to capture the discussion at the workshop. The brief proceedings will not contain any consensus finding or recommendations of the committee.
  • The committee acknowledges the tremendous value of synthetic biology to a number of societal goals but made no attempt to compare the size or nature of those benefits with the potential risks. It is not the intent of the committee or study sponsor to in any way imply that research efforts that use synthetic biology approaches should be curtailed.

    Benefits of Synthetic Biology
     
    The field of synthetic biology opens tremendous possibilities for the application of biotechnology to improve human well-being, as well as the health of animals, plants, and the environment. Such applications hold substantial economic potential. For example, annual U.S. revenues from genetically engineered plants and microbes are estimated to exceed $300 billion, and industrial biotechnology (the use of biological components to generate industrial products) is estimated to account for more than $115 billion in annual U.S. revenues. New applications for biotechnology, particularly those driven by innovation in synthetic biology, are expected to further grow the size and reach of the bioeconomy (White House 2012).
    Often looked to as a means of producing products that would otherwise be difficult to obtain, synthetic biology has already led to new ways of producing pharmaceuticals including opioids and the anti-malarial drug artemisinin. There are significant ongoing efforts to engineer microorganisms to produce fuels, act as detection devices, and clean up toxic spills. Synthetic biology is also seen as a potential means to grow organs for transplant, manipulate the microbiome, and even produce cosmetics. In addition to such application-driven goals, synthetic biology is also advancing the reach and role of science in society by inspiring more people to engage in biological experimentation, such as through the International Genetically Engineered Machine (iGEM) competition or by engaging with community laboratories. This broad array of applications and implications suggests that the potential benefits of synthetic biology are limited only by human creativity and imagination.
  • The framework developed by the report is shown here. Is a qualitative framework. Note the four factors that go into the analysis and sub-areas. Report appendix also includes illustrative questions that analysts, experts and other can ask themselves to help articulate the issues and form the assessment


    Analysis of these elements feeds into the overall assessment of the level of concern for a synthetic biology capability.

    Note that the report’s framework is not intended as a rigid checklist. Also is not a formal threat assessment because committee did not access or assess information on specific actors or their intent (although others could incorporate such information)
  • Report applies the framework to an assessment of relative levels of concern associated with synthetic biology enabled capabilities in these 3 general areas
  • This report hopefully contributes to DoD and partner agencies ability to understand, assess and prepare for the capabilities that synthetic biology enables
  • This figure provides the report’s assessment of relative concern associated with the capabilities assessed

    Figure - Relative ranking of concerns related to the synthetic biology-enabled capabilities analyzed. At the present time, capabilities toward the top warrant a relatively high level of concern while capabilities toward the bottom warrant a relatively low level of concern.

    Out of Scope - Comparing risks related to synthetic biology to other types of threats

  • For the capabilities discussed in the report, The report identifies a number of bottlenecks and barriers…. These areas provide ones that could be monitored for developments that overcome current constraints and may enable new advances

    This next slide shows the ones identified with pathogen capabilities…..
  • Summary of how selected examples of convergent technologies may affect challenges of effecting an attack using a synthetic biology-enabled weapon. Shading indicates which attribute each example aligns with most closely.


    While factors such as scale-up, stability, fidelity, and delivery are likely to continue to pose barriers to the weaponization of biological agents, a number of technological developments could create synergies with synthetic biology capabilities that allow malicious actors to overcome these barriers.

    examples of convergent technologies at various stages of development may help reduce barriers in various aspects of weaponization.

    It will be important to monitor future developments in these and other areas to identify and assess vulnerabilities that could facilitate bioweapons development. Such developments might result in significant raising of the level of concern related to the synthetic biology-enabled capabilities examined in this study

  • General Observations
    Classical public health measures such as the disease surveillance system are critical to effective mitigation of attacks caused by agents created with synthetic biology. However, synthetic biology provides opportunities to engineer around current system and cases are likely to arise in which the current infrastructure will be insufficient and thus needing enhancement.
    Biological and chemical defense strategies that are nimble, as well as adaptable to a wide range of threats, are needed because of rapid rates of technological change and uncertainty about which approaches an adversary might pursue.
    Prevention and Deterrence
    Risk management strategies based on defined lists of biological agents, such as the Federal Select Agent Program Select Agents and Toxins list, will be insufficient for managing risks arising from the application of synthetic biology. Similarly, while measures to control access to physical materials such as synthetic nucleic acids and microbial strains have merits, such approaches will not be effective in mitigating all types of synthetic biology-enabled attacks. Appropriate preparation for these challenges is needed.

    Recognition and Attribution
    The development of more flexible, untargeted, and multi-modal detection technologies such as next-generation sequencing and mass spectrometry analysis will facilitate improved identification capabilities for synthetic biology derived agents.
    The development of epidemiological methods (e.g., surveillance and data collection) that would strengthen the ability to detect unusual symptoms or aberrant patterns of disease will be useful.
    Consequence Management
    Computer-based approaches may provide a number of tools to support the prevention, detection, attribution, and consequence mitigation of threats posed by synthetic biology. Such approaches represent an area for further exploration.
    Beneficial applications of synthetic biology for countermeasure research and development are expected to provide an opportunity to address concerns raised by synthetic biology, when accompanied by corresponding efforts to facilitate the entire development process, including regulatory considerations.
  • Developing capabilities to detect unusual ways in which a synthetic biology-enabled weapon may manifest. For consequence management, expanding the development of epidemiological methods (e.g., surveillance and data collection) would strengthen the ability to detect unusual symptoms or aberrant patterns of disease. Enhancing epidemiological methods will have an additional benefit of strengthening the ability to respond to natural disease outbreaks.
     
    Harnessing computational approaches for mitigation. The role of computational approaches for prevention, detection, control, and attribution will become more important with the increasing reliance of synthetic biology on computational design and computational infrastructure.
    Leveraging synthetic biology to advance detection, therapeutics, vaccines, and other medical countermeasures. Taking advantage of beneficial applications of synthetic biology for countermeasure research and development is expected to prove valuable, along with corresponding efforts to facilitate the entire development process, including regulatory considerations.
     
    REMINDER: A comprehensive, in-depth review of strengths and weaknesses in current U.S. or international programs was outside the scope of this study; as such, this report does not offer a full analysis of mitigation capabilities and makes no recommendations pertaining to mitigation priorities.

    A comprehensive, in-depth review of strengths and weaknesses in current U.S. or international programs was outside the scope of this study; as such, this report does not offer a full analysis of mitigation capabilities and makes no recommendations pertaining to mitigation priorities. The following observations indicate areas in which additional attention could help address some of the challenges posed by synthetic biology.
  • What could possibly go wrong? How could you tell if someone in your lab/company was conducting rogue research?

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