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

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Page 1: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 2: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 3: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 4: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 5: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 6: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 7: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 8: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 9: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 10: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 11: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 12: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 13: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 14: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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Page 15: SAFEGUARDING THE BIOECONOMYnas-sites.org/biotech/files/2016/07/Gigi-Kwik-Gronvall-Presentation.pdf · Gigi Kwik Gronvall, PhD Webex, but located in Baltimore, MD July 21, 2016 1 .

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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