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SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-  · PDF file Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 . OUTLINE

Feb 04, 2020

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  • SAFEGUARDING THE BIOECONOMY Webinar for the NAS Committee: Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System

    Gigi Kwik Gronvall, PhD

    Webex, but located in Baltimore, MD

    July 21, 2016

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  • OUTLINE

     Describe the major categories of risk that can stem from synthetic biology and other emerging biotechnologies.

     Focus on US competitiveness in synthetic biology

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  • 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 (from syntheticbiology.org)

     Interdisciplinary

     Aims to make biology easier to engineer

     Applies to tools as well as the field

     What is happening as a result:

     Industrialization

     Personalization

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  • INDUSTRIALIZATION OF BIOLOGY

     Replacing chemical engineering processes, or resource- intense harvesting from nature

     Typically large, multidisciplinary teams

     Funded by big businesses and nations

     Examples in tires, adhesives, flavorings, cosmetics, mining, pharmaceuticals

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  • PERSONALIZATION OF BIOLOGY

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     Tools are accessible and increasingly powerful.

     iGEM

     DIY Bio

     Applications may be personally and immediately relevant.

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  •  Many pathways for misuse that do not rely on synthetic biology, affecting people or agriculture

     Misuse does not require pathogen access (and regulatory system is largely built on access control)

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    RISK 1: DELIBERATE USE FOR HARM

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  • RISK 2: CONSEQUENTIAL ACCIDENT

     Many of the same effects as deliberate use, plus outrage (as seen by rxns to inactivated anthrax… forgotten smallpox vials…)

     Outside the laboratory concerns: gene drives, remediation, agriculture

     Major concern about gain-of-function influenza research

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  • RISK 3: MISUSE OF BIOLOGICAL INFORMATION

     Information about biodefense/classified material or experiments becomes revealed.

     Using information about a leader’s DNA for political purposes or embarrassment.

     Identity protection or clandestine activity gets harder.

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  •  Peer competition or politically blocked.

     Consequences are not only that the benefits won’t be realized, but that there will not be as strong a role in governance.

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    RISK 4: THAT THE TECHNOLOGY WILL NOT BE FULLY PURSUED

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  • THE RISKS OF THE US FALLING BEHIND

     Field of synthetic biology was pioneered in the US, and the US is currently the leader.

     China, India, UK and other nations have specific synthetic biology roadmaps for development;

     Mounting concern that the competitive position of the US life sciences is diminishing.

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  • ECONOMIC EFFECTS

     Fidelity Investments describes synthetic biology as ‘‘the defining technology of next century’’ for global investments.

     In 2012, the World Economic Forum ranked synthetic biology as the second key technology for the 21st century, after informatics.

     According to BCC research, a market analysis company, the synthetic biology market reached nearly $2.1 billion in 2012 and $2.7 billion in 2013. They expect the market to grow to $11.8 billion in 2018 with a compound annual growth rate of 34.4% over a 5-year period from 2013 to 2018. 11

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  • ECONOMIC EFFECTS = NATIONAL SECURITY CONSEQUENCES

    ‘‘In addition to being a key measure of power and influence in its own right, [a strong economy] underwrites our military strength and diplomatic influence. A strong economy, combined with a prominent US presence in the global financial system, creates opportunities to advance our security.”

    -- US National Security Strategy (2015)

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  • GOVERNANCE EFFECTS

     “Rules of the road” often developed by technological leaders, scientists at the cutting edge.

     Examples:

     Asilomar

     DNA synthesis guidelines

     Gene drives

     Germline editing

     Examples to come….??? (new products, de-extinction, ???)

     Self-governance is absolutely not perfect

     If US scientists, policymakers, and institutions would like to have a say, they need to be at the forefront.

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  • US FALLING BEHIND

     NIH: there has been an ‘‘erosion of the competitive position of the U.S. life sciences industry over the past decade.” (2015)

     China will overtake the US in R&D spending by 2020, overtook the number of doctoral degrees awarded in the natural sciences and engineering by 2007.

     UK investing £200 million for research and the creation of several synthetic biology research groups across the country

     DoD report: ‘‘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.” (2015)

     iGEM competition: few wins, ‘‘in part because of a lack of laboratory facilities’’ and other support. 14

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  • WHAT TO DO

     Measures that boost competitiveness (stable research funding, workforce development, STEM education, incentives for biotech, automatic green cards for PhDs who receive their PhD in a US university)

     Maintain position on GMOs: it’s the product that needs to be regulated, not the method used to create it.

     The industrialization of biology is happening– if the US wants to benefit, we need to be in the game.

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  • THANK YOU!

    [email protected]

    443-573-3304

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    mailto:[email protected] mailto:[email protected] mailto:[email protected]

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