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2018 Annual Meeting of the Council of Sponsoring Institutions
Gigi Kwik Gronvall, PhD
Associate Professor, Johns Hopkins Bloomberg School of Public
Senior Scholar, Johns Hopkins Center for Health Security

Published in: Government & Nonprofit
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  1. 1. JohnsHopkinsCenterforHealthSecurity SYNTHETIC BIOLOGY: SAFETY, SECURITY, AND PROMISE Gigi Kwik Gronvall, PhD Associate Professor, Johns Hopkins Bloomberg School of Public Health Senior Scholar, Johns Hopkins Center for Health Security ORAU, Oak Ridge, TN March 7, 2018
  2. 2. JohnsHopkinsCenterforHealthSecurity WHAT IS SYNTHETIC BIOLOGY? The design and construction of new biological parts, devices, and systems and the re-design of existing, natural biological systems for useful purposes. ( • Convergence of engineering, biology, chemistry • Applies to tools as well as the field • Aims to make biology easier to engineer 2
  3. 3. JohnsHopkinsCenterforHealthSecurity A SYNTHETIC BIOLOGY FUTURE — Ushering in 2 major changes in science, with different implications for policy, security, and regulation, as well as different actors involved. ¢ Industrialization ¢Personalization and individual control — Acceleration of the field yields the potential for consequential research and policy options for public health. 3
  4. 4. JohnsHopkinsCenterforHealthSecurity INDUSTRIALIZATION ¢ Replacing chemical engineering processes, or resource- intense harvesting from nature ¢ Examples in tires, adhesives, flavorings, cosmetics, mining, pharmaceuticals ¢ Typically large, multidisciplinary teams ¢ Funded by big businesses and nations ¢ Global synthetic biology market: $2.7 billion in 2013. Expected to grow to $11.8 billion in 2018 4
  5. 5. JohnsHopkinsCenterforHealthSecurity ¢ Tools are accessible and increasingly powerful — CRISPR — Synthesis and sequencing ¢ Applications may be personally and immediately relevant — iGEM and DIY Bio 5
  6. 6. JohnsHopkinsCenterforHealthSecurity IGEM 6 5,600 participants across 42 countries
  7. 7. ON SECURITY 7
  8. 8. JohnsHopkinsCenterforHealthSecurity DELIBERATE MISUSE (I.E. BIOLOGICAL WEAPONS DEVELOPMENT) ¢ There are many biosecurity vulnerabilities with ordinary microbiology-- synthetic biology adds to them. However: ¢ Misuse may not require pathogen access (and biosecurity regulatory system is largely built on access control). 8
  9. 9. JohnsHopkinsCenterforHealthSecurity 9 Key Points: • This is the primary means for US biosecurity regulation • Requires individual clearance from DOJ, institutional approval • Should not be considered the only law enforcement tool for biological agents. • Challenged by synthetic biology and also nature.
  10. 10. JohnsHopkinsCenterforHealthSecurity REGULATED PATHOGENS: EVERYWHERE YOU LOOK 10
  11. 11. JohnsHopkinsCenterforHealthSecurity 11 ¢ “nobody anticipated that… advances in genome sequencing and genome synthesis would render substantial portions of [variola] accessible to anyone with an internet connection and access to a DNA synthesizer.” ¢ – World Health Organization (2010)
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  13. 13. JohnsHopkinsCenterforHealthSecurity ACTIONS TO DIMINISH RISKS Misuse cannot be categorically prevented– this is one of the reasons why norms against biological weapons development are so important. ¢ BWC and UNSCR1540 ¢ Screen gene synthesis orders (this is already done). But: — What can the government do to facilitate screening? (technically, diplomatically, financially) — Which method of screening is most influential– customer screening or sequence screening? ¢ Engage with the community of practitioners, working internationally. Who is available to call if there is a problem? ¢ Are US scientists engaged enough in the world and educated about risks to be able to raise alarms about misuse? ¢ Actions that affect the legitimate scientific community (measures re: dual-use research of concern) ¢ Prepare to respond. 13
  14. 14. JohnsHopkinsCenterforHealthSecurity 14
  15. 15. JohnsHopkinsCenterforHealthSecurity THE PROBLEM OF DUAL-USE RESEARCH ¢ Dual use: advances that lower the barriers to misuse ¢ Dual use research of concern: “Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” ¢ Conundrum: Legitimate scientific inquiry, often with medical benefits, and not everyone sees the risks and benefits in the same way. 15
  16. 16. JohnsHopkinsCenterforHealthSecurity 16
  17. 17. JohnsHopkinsCenterforHealthSecurity SCIENTIFIC ACTIVITIES WHICH MAY LEAD TO DURC ¢ Enhance the harmful consequences of a biological agent or toxin. ¢ Disrupt immunity or the effectiveness of an immunization without clinical and/or agricultural justification. ¢ Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies. ¢ Increase the stability , transmissibility, or the ability to disseminate a biological agent or toxin. ¢ Alter the host range or tropism of a biological agent or toxin. ¢ Enhance the susceptibility of a host population. ¢ Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent. 17
  18. 18. JohnsHopkinsCenterforHealthSecurity THERE IS LITTLE CONSENSUS ABOUT THE THREAT 18
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  20. 20. JohnsHopkinsCenterforHealthSecurity THERE IS STRONG INTEREST IN MANAGING DUAL USE RESEARCH ¢ Yet: Misuse by whom and to what degree? ¢ Dual use research of concern can be identified, but can the risks and benefits be truly quantified? — More likely they will be experiment-dependent, context- dependent, and time-dependent — Not all nations will balance the risks and benefits the same way — Consensus will remain difficult, particularly as experts view the threat differently ¢ Can any more be done than raising awareness? 20
  21. 21. ON SAFETY 21
  22. 22. JohnsHopkinsCenterforHealthSecurity BIOSAFETY CONCERNS OF SYNTHETIC BIOLOGY ¢ Not associated with any accidents to date ¢ Categories for concern: — “outside the laboratory” applications — Experience of practitioners — General concern that biosciences could lead to bioerrors 22
  23. 23. JohnsHopkinsCenterforHealthSecurity NEED FOR MORE DATA Need for more data to inform biosafety policy; very little research into biosafety research practices and equipment is being funded or performed. ¢ Procedural studies (such as the proper protocols to inactivate anthrax spores, studies to determine which equipment works best for a given protocol, and which personal protective equipment (PPE) works best to protect ¢ Behavioral studies and human reliability studies to be done to best instill a safety culture in the laboratory, to develop the best training material ¢ Laboratory inspections that are geared towards improving safety over time, and to promote safe practices in routinized biological laboratory environments. ¢ Comparative studies are needed for practices, engineering, laboratory set-ups, and equipment. 23
  24. 24. JohnsHopkinsCenterforHealthSecurity INTERNATIONAL: WHAT IS THE SOVEREIGN OBLIGATION FOR SAFETY? ¢ No news ≠ good news ¢ Worldwide, there is a wide divergence of the quality and quantity of biosafety regulations. Pathogens which could result in a consequential laboratory accident are not adequately addressed by publicly available regulations. ¢ There is a gap related to the biosafety and governance of pathogens that have increased potential to initiate an outbreak outside a laboratory with the potential to spread nationally or internationally, or lead to a pandemic. ¢ There is a need for international norms for biosafety, and political prioritization. 24
  26. 26. JohnsHopkinsCenterforHealthSecurity NATIONAL CONSIDERATIONS ¢ Synthetic biology born in the US, but other nations are investing heavily. — China, India, UK have synthetic biology roadmaps — BGI — Few barriers to entrance ¢ NIH: “erosion of the competitive position of the US life sciences industry over the past decade.” — China will overtake US in R&D spending by 2020 — Giving into nonsense: Anti-GMO marketing campaigns are cynical, erode public support, and are also counter-factual 26
  27. 27. JohnsHopkinsCenterforHealthSecurity DEPARTMENT OF DEFENSE ¢ “There are few highly-experienced program managers in the Department, few leading scientists, and even fewer individuals in uniform with deep knowledge of the [synthetic biology] field. The lack of uniformed expertise is particularly troubling.” 27
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  29. 29. JohnsHopkinsCenterforHealthSecurity WHY DOES IT MATTER? ¢ For the economy ¢ For our nation’s security: — NSS 2015:“A strong economy, combined with a prominent US presence in the global financial system, creates opportunities to advance our security.” — DoD applications ¢ Lost opportunities in early governance and direction of synthetic biology applications; scientists at the leading edge are setting norms and expectations — Germline edits– “designer babies” — Gene drives– to eradicate mosquitoes — De-extinction — What will be next? 29
  30. 30. JohnsHopkinsCenterforHealthSecurity WHAT CAN BE DONE? . The US should pursue maintain competitiveness in S&T, including in synthetic biology. — Fund basic research with minimal fluctuations from year to year; — Fund STEM educational initiatives; — Institute financial incentives to discourage synthetic biology companies and other biotechnology companies from locating offshore; — Develop the workforce through training programs; — Ensure that women are targeted for advancement in STEM fields; and — Encourage foreign students who receive their PhDs in the US in technical areas to stay in the US, by receiving green cards enabling them to work here. — Specific to US leadership in synthetic biology, the US should give more support to university iGEM teams (including their mentors), to help them succeed. 30
  31. 31. JohnsHopkinsCenterforHealthSecurity 2. The US should continue to support a regulatory philosophy that focuses on the end product, which has proven beneficial to innovation, and not a “precautionary” European model. The regulatory system for biotechnology in the US should continue to be based on sound science, and should not be politically driven. 3. The US should ensure that products made in synthetic biology are appropriately regulated and overseen. Emerging biosciences are likely to increase the gaps in regulation, and these gaps can sow distrust (e.g. glowing plants). 4. Support science, and scientists. 31
  32. 32. JohnsHopkinsCenterforHealthSecurity THANK YOU!! 32