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1、Building Strong Biosafety and Biosecurity into the Expanding US BioeconomyMeeting report on a 10 January 2023 public-private roundtable organized by the Johns Hopkins Center for Health SecurityFebruary 28,2023Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|iiJohns Hopkins

2、Center for Health Security Project TeamAurelia Attal-Juncqua,MScFellow,Johns Hopkins Center for Health Security Thomas V.Inglesby,MDDirector,Johns Hopkins Center for Health SecurityMatthew E.WalshPhD Student,Johns Hopkins Bloomberg School of Public Health Gigi Kwik Gronvall,PhD Senior Scholar,Johns

3、Hopkins Center for Health SecurityAcknowledgementsWe would like to express our gratitude to all the participants in the meeting.The authors would like to thank Alyson Browett,Julia Cizek,Cagla Giray,and Prarthana Vasudevan for their editing,design,and publication support;and Andrea Lapp and Rachael

4、Brown for organization and logistics support of the meeting.The views expressed in this publication and/or made by meeting attendees do not necessarily reflect the official views of the US Government or the Johns Hopkins Center for Health Security.Suggested citation:Attal-Juncqua A,Inglesby TV,Walsh

5、 ME,Gronvall GK.Roundtable on the Biosafety and Biosecurity Aspects of the Bioeconomy.Baltimore,MD:Johns Hopkins Center for Health Security;2023.2023 The Johns Hopkins University.All rights reservedBuilding Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|iiiContentsSummary.4Introdu

6、ction.4Context and Scope of the Biosafety and Biosecurity Innovation Initiative.5The Biosafety and Biosecurity Innovation Initiative.5Defining Biosafety and Biosecurity.6Supporting Applied Biosafety Research and Incentivizing and Enhancing Biosafety Practices.7Funding for Applied Biosafety Research.

7、7Financial Incentives and Support.8Risk Identification and Risk Assessment Frameworks.9Biosafety Workforce Investments.9Supporting Biosecurity Innovation.9Risk Prioritization.10Risk Characterization and Quantification.10National Security Intelligence.10Bioattribution Technology.11Mitigating Risks As

8、sociated with Biological Data and Intellectual Property Theft.11Assessing,Anticipating and Mitigating Threats,Risks,and Potential Vulnerabilities to the US Bioeconomy.11Balancing Global Partnerships and US Economic Competitiveness.11Protecting and Expanding Domestic Biomanufacturing Supply Chain and

9、 Infrastructure.12Mitigating Adversarial Information Campaigns.13Future Bioeconomy Planning.14Data and Biobanks.14Public-Private Partnerships.14Academic Partnerships and Collaboration.15Making MCM Programs More Sustainable.15Bioeconomy Coordinating Body.15Prioritization of Biosecurity and Biosafety

10、in Federal Budgets.16Regulatory Landscape.16Conclusion.16References.17Appendix A:Participant List.18Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|4SummaryOn January 10,2023,the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health convened an

11、in-person,not-for-attribution meeting of experts and practitioners from government,academia,and the private sector to discuss the US Biosafety&Biosecurity Innovation Initiative launched as part of a September 2022 Executive Order titled,“Advancing Biotechnology and Biomanufacturing Innovation for a

12、Sustainable,Safe,and Secure American Bioeconomy.”The meeting focused on priority actions and efforts needed to enhance biosafety and biosecurity throughout the biotechnology research and development(R&D)and biomanufacturing lifecycles,while maximizing potential societal benefits,as well as safeguard

13、ing and boosting US national competitiveness.This report describes discussion on these topics undertaken by the experts who attended the meeting.IntroductionOn September 12,2022,President Joe Biden issued Executive Order(EO)14081,“Advancing Biotechnology and Biomanufacturing Innovation for a Sustain

14、able,Safe,and Secure American Bioeconomy,”which launched a National Biotechnology and Biomanufacturing Initiative involving a“whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health,climate change,energy,food security,agriculture,supply chain

15、 resilience,and national and economic security.”1 The bioeconomy previously has been defined as any“economic activity that is driven by research and innovation in the life sciences and biotechnology,and that is enabled by technological advances in engineering and in computing and information science

16、s.”2 EO 14081 also launched the new Biosafety and Biosecurity Innovation Initiative,which requires agencies funding,conducting,or sponsoring life sciences research to“prioritize investments in applied biosafety research and innovations in biosecurity to reduce biological risk during the biotechnolog

17、y R&D and biomanufacturing lifecycles,as well as incentivize and improve biosafety and biosecurity best practices.”As part of the Biosafety and Biosecurity Innovation Initiative,the Secretary of the Department of Health&Human Services(HHS)and the Secretary of the Department of Homeland Security(DHS)

18、,in coordination with agencies that fund,conduct,or sponsor life sciences research,must produce an implementation plan for biosafety and biosecurity for the bioeconomy within 180 days of the EOs issuance.In December 2022,the White House issued a public Request For Information(RFI)pertaining to the b

19、roader EO that included specific questions on how to reduce risks to the bioeconomy by advancing biosafety and biosecurity.3 On January 10,2023,the Johns Hopkins Center for Health Security convened an in-person,not-for-attribution meeting to discuss the Biosafety and Biosecurity Innovation Initiativ

20、e.The meeting focused on priority actions and efforts needed to enhance biosafety and biosecurity throughout the biotechnology R&D and biomanufacturing Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|5lifecycles,while maximizing potential societal benefits as well as safeg

21、uarding and boosting US national competitiveness.The purpose of the meeting was to respond to many critical questions posed by the RFI and to provide the National Institutes of Health(NIH),the National Security Council(NSC),the Office of Science and Technology(OSTP),and other US government(USG)stake

22、holders an opportunity to obtain information and viewpoints from subject matter experts on the development of the Biosafety and Biosecurity Innovation Initiative implementation plan.The meeting also was an opportunity for USG stakeholders to describe the context and scope of the Biosafety and Biosec

23、urity Innovation Initiative.During discussions in the morning session,experts shared their insights on several questions pertaining to supporting applied biosafety research,incentivizing biosafety practices,and supporting biosecurity innovation,while afternoon discussions focused on assessing and mi

24、tigating other potential threats to the bioeconomy,as well as future bioeconomy planning.The meeting featured participation from members of government,academia,and industry,including subject matter experts from a range of disciplines and sectors:biosafety,biosecurity,biodefense,biotechnology,synthet

25、ic biology,global health,and public health.A non-exhaustive list of meeting participants is included in Appendix A.The Johns Hopkins Center for Health Security did not attempt to reach expert consensus on the topics discussed.This document is a synthesis of insights presented by one or more experts

26、during the meeting.Context and Scope of the Biosafety and Biosecurity Innovation InitiativeThe Biosafety and Biosecurity Innovation InitiativeUSG representatives opened the meeting by framing the Biosafety and Biosecurity Innovation Initiative within current national bioeconomy policy and goals.The

27、White House,through EO 14081,aims to drive federal investments that will define US biotechnology leadership,realize the promise of biology in transforming the US economy,and help tackle major societal challenges such as climate change,energy security,food security,future pandemics,and supply chain r

28、esiliency.USG stakeholders outlined how current efforts to expand the US bioeconomy are critical to safeguarding US leadership,economic competitiveness,and national security,and how these efforts are coming at a defining inflection point in the industrys trajectory.While currently valued at US$1 tri

29、llion dollars,the US bioeconomy is predicted to grow globally to more than US$30 trillion dollars over the next 20 years.4 The new National Biotechnology and Biomanufacturing Initiativealong with legislative actions such as the recent CHIPS and Science Act of 2022will help the US attain its goal of

30、revolutionizing the manufacturing industry to advance biotechnology.5 Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|6Rapid advances in the fields of biotechnology and biomanufacturing bring new risks,as new advances challenge the regulatory and biosafety frameworks desig

31、ned for earlier biotechnology products.USG stakeholders emphasized the importance of ensuring that new technologies be developed in tandem with new advances in biosecurity and biosafety to both ensure the safety and security of specific products and to safeguard public trust in the bioeconomy if a s

32、afety or security incident were to occur.USG participants described the Biosafety and Biosecurity Innovation Initiative as a whole-of-government endeavor aimed at better understanding risks and vulnerabilities and helping to establish national norms and standards for biosafety and biosecurity,as wel

33、l as promoting those norms at the international level.Coordinated by the NIH,the Biosafety and Biosecurity Innovation Initiative will focus comprehensively on the bioeconomy sector,including innovations in the fields of medicine,energy,environment,material sciences,and agriculture.Ultimately,the aim

34、 of the Biosafety and Biosecurity Innovation Initiative is to build upon existing biosafety and security systems,while identifying ways to further incentivize best practices in biotechnology and biomanufacturing domestically and internationally.USG stakeholders explained that the development of an i

35、mplementation plan,as prescribed in the EO,is a critical next step in launching the Biosafety and Biosecurity Innovation Initiative.Defining Biosafety and Biosecurity Meeting participants underscored the importance of defining biosecurity and biosafety in the context of the bioeconomy.One expert not

36、ed that the National Institute of Standards and Technology(NIST)published a bioeconomy lexicon that defines biosafety as“practices,controls,and containment infrastructure that reduce the risk of unintentional exposure to,contamination with,release of,or harm from pathogens,toxins,and biological mate

37、rials,”and biosecurity as“security measures designed to prevent the loss,theft,misuse,diversion,unauthorized possession or material introduction,or intentional release of pathogens,toxins,biological materials,and related information and/or technology.”6 There was general agreement among participants

38、 that these definitions need to be expanded to fully capture the breadth of risks associated with rapid advances in biotechnology R&D.Applied biosafety research has focused on pathogens and laboratory containment techniques;however,participants recognized that the definition must be explicitly expan

39、ded to include environmental biosafety,such as upstream controls like DNA watermarking.Similarly,participants noted that biotech advances are occurring rapidly,with some companies and research teams already creating whole new organisms.They agreed it is critical to ensure that stakeholders think abo

40、ut biosecurity broadly,considering not only the context of dual use research in which the methodologies,materials,or results could be used to cause harm but all potential adversarial action intended to create harm using biological systems or data.Building Strong Biosafety and Biosecurity into the Ex

41、panding US Bioeconomy|7Supporting Applied Biosafety Research and Incentivizing and Enhancing Biosafety PracticesSupporting applied biosafety research and developing and maintaining strong biosafety systems to reduce risks while maximizing societal benefits throughout the biotechnology and biomanufac

42、turing lifecycle should be a strategic interest of the United States.Discussions during this session focused on identifying actions and priority investments for the US government to strengthen its support of applied biosafety research and to further incentivize and enhance biosafety practices at hom

43、e and abroad.Participants were asked to discuss what role the US government should play in advancing biosafety practices,oversight,and coordination,beyond federally funded research.Experts were also asked to examine how industry and academia might best participate in this work and how other nations

44、are investing in biosafety-related efforts.Funding for Applied Biosafety ResearchParticipants generally agreed that federal funding should be made available for applied biosafety research,both in the laboratory setting as well as in the development of biomanufacturing and biotechnology products.Seve

45、ral experts noted that federal funding mechanisms are not usually available for biosafety studies,in contrast to other occupational health risks,and without dedicated research studies and the systematic collection of data,determining principles for biosafety can rely too much on anecdote and past ex

46、periences,which do not necessarily take into consideration the development of new technologies.As the biotechnology products of the future pose new potential safety and security risks,research into how to characterize and mitigate concerns while allowing technology development to proceed requires de

47、dicated funding.There was general agreement that studies identifying opportunities for biosafety research regarding novel products should characterize the capital cost and ease of adoption of biosafety investments,including those that can be undertaken by nontraditional,noninstitutional actors,such

48、as do-it-yourself(DIY)labs and small start-ups.For example,automation,like most biosafety investments,requires significant upfront financing;cost-benefit analyses that could justify these investments depend on biosafety data from analysis and study.Some participants suggested that the US government

49、should fund research to better understand where,when,and how accidents happen to delineate the processes that would benefit from automation or other biosafety-enhancing practices.Several experts highlighted this lack of data pertaining to biosafety incidents as a clear barrier toward the broader int

50、egration of biosafety practices in biotech and biomanufacturing processes.One participant suggested greater adoption of anonymous reporting systems to increase incident reporting rates by lowering the barriers that may be linked to fears of punitive culturesadmitting a mistake or being seen as incom

51、petentdisclosure,litigation,or other legal concerns.Other participants noted these anonymous systems have been under consideration for many years,Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|8but significant barriers to and concerns surrounding implementation and usage

52、persist.Some experts posited that the US government should work with industry and academia to identify new ways of gathering biosafety data,including funding students to undertake graduate-level research comparing laboratory practices as a part of their degree program.Another participant suggested t

53、hat the US Department of Commerce could use its legal authority to mandate that companies respond to biosafety incident surveys,under penalty of law,as one way to gather additional and systematic biosafety data.Participants also noted that research into biosafety practices should incorporate behavio

54、ral,social,and organizational sciences studies that look at how to create and promote a biosafety culture across the life sciences industry.This was considered especially important by participants in the context of increasingly democratized access to biotechnology and growing biotechnological social

55、 movements,such as DIY biology or other individual-or community-led biotechnological work.Experts agreed that it is critical to ensure the inclusion of this broader network of biotech actors in efforts to expand biosafety practices to further mitigate the possible ripple effect a single incident in

56、a limited DIY context may have on the entire biotech ecosystemfor example,an accident in that setting may prompt regulatory action that does not meaningfully improve biosafety but may negatively impact the US bioeconomy.Financial Incentives and SupportWith the US government striving to increase inve

57、stments in biotechnology and biomanufacturing,there was consensus among participants that it is increasingly critical for grant recipients to keep biosafety top of mind.Some experts suggested that federal agencies that fund or sponsor life science research could enhance biosafety and biosecurity pra

58、ctices by incorporating and requiring documentation of biosafety and biosecurity steps in research reporting for federal funding.Another expert noted that,as was done with the Human Genome Project,a specific percentage of federal funding could be dedicated for other important research goals,in this

59、case biosafety,biosecurity,sustainability,and responsible conduct of research.Another meeting participant suggested insurance companies could begin applying financial incentives to biosafety risk mitigation.Insurance industry assessment of biological risks could motivate both public and private sect

60、or stakeholders to develop and implement safety protocols in order to reduce their insurance premiums.There was general agreement,however,that the dearth of data on biosafety-related incidents and applied biosafety research was a hurdle to insurance companies in this field.Finally,some meeting atten

61、dees noted that the upfront cost associated with both biosafety risk pattern identification research and biosafety infrastructure(eg,automation)may be financially punitive or unaffordable for many research laboratories,start-ups,and smaller private labs.One participant suggested that USG investments

62、 or grants could help industry bridge these financial gaps to help expand biosafety research and infrastructure on the scale necessary to render safer advances in the US bioeconomy.Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|9Risk Identification and Risk Assessment Fra

63、meworks Some participants said USG regulators and partners should prioritize the development of biosafety and biosecurity risk assessment frameworks as they are developing bioeconomy R&D efforts.The pace at which biotechnology and biomanufacturing are evolving requires nimble risk assessment framewo

64、rks that can be adapted to entirely new classes of bioproducts and that can assess risks to humans,animals,and the environment.Meeting participants agreed that in the context of an expanding bioeconomy,the US must move away from a pathogen-based risk definition and toward contextual risk assessments

65、 that include the potential scale and impact(eg,environmental or laboratory spill,etc.).One participant stated that these new risk assessments should consider the capacities needed for implementation and how to tailor them to different needs and environments,if they are to become economically and cu

66、lturally viable international standards.Biosafety Workforce InvestmentsMost participants agreed there is very little investment in the development of a biosafety-specific workforce.One expert emphasized that there are no graduate programs focused on biosafety research and practice and,to this day,bi

67、osafety has been more anecdotal with no sustained funding to fully develop biosafety as a viable professional field.7There was general agreement that the US government should prioritize investments needed to kickstart the development of a well-trained and diverse domestic biosafety workforce.Some ex

68、perts suggested the US government should consider investing in and/or providing tax credit incentives to help bring industry and learning institutions together to increase the number of biosafety professionals through the support of certification programs,degrees,graduate research grants,competition

69、s(eg,iGEM or similar),and/or other training curricula in a variety of educational settings(eg,community colleges,Historically Black Colleges and Universities,Tribal Colleges and Universities,Hispanic Serving Institutions,4-year institutions,and others).Another participant noted that major investment

70、s in the field of synthetic biology have been madefostering a growing new generation of leadersand suggested that these efforts be captured and analyzed to inform playbooks that could be applied to supporting the development of a broader biosafety and biosecurity workforce.Supporting Biosecurity Inn

71、ovation Accelerating the identification,development,and implementation of innovative technologies and approaches that enhance the capacity of the national biosecurity system to manage biosecurity risks is critical to safeguard and boost US national security and competitiveness.Discussions during thi

72、s session focused on identifying actions and priority investments the US government could make to strengthen its support of biosecurity innovation.Participants were also asked to explore how the Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|10US government could enhance

73、its collaboration with industry,universities,and other research entities and consider how other nations might be investing in this space.Risk PrioritizationSome experts noted that USG stakeholders could take an active role in defining both the type and scale of harms that are seen as most concerning

74、 by developing a biosecurity risks priorities list(eg,uncontrolled spread of biological agent in humans,animals,or the environment versus localized and contained incident;population level genetic data theft versus individual data theft).Such a list could help set priorities for current biosecurity i

75、nnovation efforts.Risk Characterization and Quantification There was general agreement among participants that certain innovative technologies under developmentsuch as technologies that can be embedded in bio-enabled products,like kill switches or genetic controlsare engineering solutions for proble

76、ms that are not yet characterized.Biotech and biomanufacturing applications are increasingly moving out of traditional laboratory settings,and several experts suggested the US government fund studies to measure the impact of these new bio-enabled products on individuals and the environment.Some expe

77、rts suggested the US government partner with the private sector and academia to invest in infrastructure needed for environmental monitoring and surveillance systems to characterize“normal”background environments and pick up specific genetic signals.Such systems could help to determine how newly eng

78、ineered biological products or organisms behave and interact with their environments.One expert stated that US policymakers should outline plans and timescales over which these monitoring systems ought to be built and streamline ways to set up the aggregation of reporting and surveillance data natio

79、nwide.There are logistical and technical challenges to building such broad-ranging monitoring systems without fully knowing the type of signal to screen for,and past lessons should be identified and studied(eg,from wastewater surveillance systems).One expert suggested that policymakers use tabletop

80、or simulation exercises to outline the steps to take if a concerning signal is identified during a surveillance activity and determine preparedness and response investments needed to mitigate new biosecurity risks.National Security IntelligenceThe US Intelligence Community has deep experience analyz

81、ing and profiling potential malevolent actors and threats to the US and its economy.Some experts suggested USG stakeholders responsible for identifying biosecurity threats work to ensure they are utilizing this expertise to help outline possible malevolent actors who could threaten the bioeconomy an

82、d identify their capabilities.In addition,the US government can partner with academia to fund research programs that study national security threats to the bioeconomy.These types of investment would help safeguard US competitiveness and protect national security.Building Strong Biosafety and Biosecu

83、rity into the Expanding US Bioeconomy|11Bioattribution TechnologySome participants singled out bioattributionthe ability to accurately determine who is responsible for a biological incidentas a critical biosecurity hurdle.Attribution could ensure that those responsible for actions that may cause har

84、m are held accountable and deter future threats,including actions that harm the competitiveness of US life sciences programs within the government,private sector,or academia.Attribution depends on multiple tools and methods,which may include the use of leading scientific techniques and access to dat

85、a sets,public health information,and law enforcement tools and approaches.Tools to detect evidence of bioengineering are already under development,such as in the Intelligence Advanced Research Projects Activity(IARPA)Finding Engineering-Linked Indicators project,FELIX,which seeks to use experimental

86、 and computational tools to augment biodetection and biosurveillance capabilities.8 Most experts agreed that the US government should play a more active role in expanding attribution-related programs like these.Mitigating Risks Associated with Biological Data and Intellectual Property TheftSome part

87、icipants recommended that the US government collaborate with private sector stakeholders to better understand the risks associated with the theft of biological data or intellectual property(IP)to industry,the environment,or the public,and to identify what role the government should play in mitigatin

88、g such risks.IP theft and other cybersecurity concerns are critical risks to industry,but young companies and start-ups often lack the funds to build protective cybersecurity infrastructure.Federal agencies could partner with US-based companies to help protect materials,methods,algorithms,code base,

89、and other trade secrets behind transformative modern biology.Assessing,Anticipating,and Mitigating Threats,Risks,and Potential Vulnerabilities to the US BioeconomySafeguarding the US bioeconomy is critical to protecting US economic competitiveness and national security.In this session,discussions fo

90、cused on how to anticipate and mitigate foreign adversaries and strategic competitors that use legal and illegal means to acquire US technologies and data,including biological data.Participants were asked to examine threats and risks to the US bioeconomy and explore approaches the US government shou

91、ld take to proactively assess,anticipate,and mitigate these potential vulnerabilities.Experts were also asked to consider how to leverage stakeholder capabilities during their discussion.Balancing Global Partnerships and US Economic Competitiveness According to the White House,“global industry is on

92、 the cusp of an industrial revolution powered by biotechnology.and other countries are positioning themselves Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|12to become the worlds resource for biotechnology solutions and product.”9 Many other countries are investing in th

93、eir bioeconomysuch as Singapore,Taiwan,South Korea,and Malaysiaand pouring significant effort and funding into new biotech and biomanufacturing programs.Certain biotechnologies have advanced rapidly in sub-Saharan Africa(eg,mRNA platforms,sequencing technologies),though in some cases these technolog

94、ies come with service contracts that require the use of Chinese infrastructure.Some participants noted that the US government use its“soft biological power”and offer its expertise and support to countries that are in the process of developing systems and infrastructure to support their bioeconomies.

95、Several experts noted that USG stakeholders should continue to engage internationally and recognize the important issues of equitable access to technologies,equipment,and genetic materials.Some participants suggested the US and its nongovernmental partners collaborate on ways to strengthen internati

96、onal engagement mechanisms and bolster scientific and diplomatic relationships through international sample-sharing programs,scientific and academic exchanges,and other Track 2 diplomacy efforts.As part of furthering international engagement,one participant proposed that the US should reassess its s

97、tance pertaining to the Convention on Biological Diversity and the associated Nagoya Protocol,which provides a framework that helps researchers access genetic resources for biotechnology research,development,and other activities,in return for a fair share of any benefits from their use.In addition,t

98、here was general agreement that the US should work toward international biosafety and biosecurity norms and federal agencies should enhance international collaboration on issues related to biotechnology,biomanufacturing,safety,and security.Specifically,most attendees recommended that USG stakeholder

99、s identify and collaborate with international leaders in biosafety and biosecurity and leverage these partnerships to create and disseminate shared international norms,reinforce unified messages countering mis/disinformation that threaten the industry,and protect the bioeconomy at home and abroad.Fi

100、nding,recognizing,and crediting like-minded champions around the world was considered critical in the long term to foster and elevate emerging leaders,integrate and protect supply chains with allies,and ultimately develop a shared understanding of what it means to be a responsible actor in biotechno

101、logy and biomanufacturing.Protecting and Expanding Domestic Biomanufacturing Supply Chain and Infrastructure Participants discussed how building up domestic biomanufacturing infrastructure could mitigate risks associated with supply chain vulnerabilities and the loss of critical or promising IP.One

102、expert noted that the White House recently issued an executive order(EO 14083)elaborating on key US industries requiring heightened regulatory scrutiny from the Committee on Foreign Investment in the United States(CFIUS).Specifically,the EO issues guidance to CFIUS so that its review of internationa

103、l investments and acquisitions continues to be adaptable and responsive to new national Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|13security demands.10 Some participants suggested that CFIUS and other government stakeholders partner with industry to review biotech an

104、d biomanufacturing supply chain vulnerabilities and identify weak nodes that could be targeted by foreign adversaries.Availability and affordability of feedstock,rare earth minerals,and active pharmaceutical ingredients were identified during the meeting as significant weak points in the present US

105、biomanufacturing infrastructure.Several participants also noted that the US government should fund systematic studies across the entire biomanufacturing landscape to identify the critical bioreachable ingredients(ie,critical ingredients that can be made with biological processes)necessary to maintai

106、n functioning and resilient biotech supply chains and protect the US bioeconomy.There was general agreement that the US biomanufacturing complex must be able to manufacture biological products domestically and at commodity scale to remain competitive.Fragilities in the bio-based supply chain put com

107、panies and their assets at risk and ultimately threaten the US bioeconomy.Some experts recommended that federal agencies continue to fund and champion governmental initiatives,such as the Bioindustrial Manufacturing and Design Ecosystem(BioMADE),to fill that investment gap.Most participants agreed t

108、hat,at this inflection point for the US bioeconomy,the US government should be more intentional with its industrial policy and how it prioritizes biotech and biomanufacturing.Importantly,experts noted that the US should avoid past mistakes,such as those made with semiconductors,and limit overrelianc

109、e on foreign production for its critical industrial needs.Other experts noted that,from a national security perspective,IP and academic brain trust loss via the acquisition of smaller start-ups by foreign companies or adversaries is also a major risk and vulnerability to the US bioeconomy.They sugge

110、sted the White House consider issuing an additional EO with guidance to CFIUS that specifically focuses on the biotech and biomanufacturing industry and calls for the analysis and aggregation of data pertaining to these acquisitions to better understand and predict those that will pose a risk,what r

111、isks might be acceptable,and which technologies ought to be protected from a national security and competitiveness standpoint.Mitigating Adversarial Information Campaigns Several meeting attendees acknowledged the security and economic risks associated with adversarial information campaigns that may

112、 sour public sentiment and threaten the overall promise of the bioeconomy.Some experts recommended that federal agencies fund additional research to better understand how to identify and combat viral information campaigns and how these impact the industry,for example by stifling investments and mark

113、et opportunities for new biological products.One participant suggested that the US government also fund studies aimed at better understanding the post-pandemic publics perceptions of scientists and healthcare professionals to tease out some lessons learned.This type of research could help document h

114、ow public sentiment and government leaders align,or not,with science,Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|14scientists,and the prospect of new biotechnology,and how negative perceptions might be used by US adversaries.Future Bioeconomy PlanningDiscussions during

115、 the final session focused on identifying important issues not raised by the RFI but that USG stakeholders should consider as priority investments or actions in bioeconomy planning policy.Participants were also asked to identify current strengths and weaknesses of the US bioeconomy,and what policy,r

116、egulatory,and/or legislative instruments might need to be used to address challenges and gaps over the next decade.Data and BiobanksDomestic biobanking capacity was identified as a key weakness of the US bioeconomy.Indeed,several participants noted that other countries were quickly outpacing the US

117、with their investments in biobanking infrastructure for human,animal,plant,and microbial biological material.They suggested the US government increase investment aimed at enabling US-based storage of such materials,including genetic information.The evolution of diverse,comprehensive biobanks,and the

118、 associated sharing capabilities,could revolutionize biotech and biological research and enable the US to become the go-to public resource for reference genomes for the global bioeconomy.Public-Private Partnerships There was general agreement among participants that the USs long history of effective

119、 public-private partnerships(PPPs)is a key strength of the US bioeconomy.Some experts suggested that lessons learned from previous PPPs be captured in order to identify how such partnerships help accelerate certain USG goals.Other participants noted that USG agencies should explore and expand new op

120、portunities for biotech-or biomanufacturing-related PPPs,especially for projects pertaining to biosafety and biosecurity innovation and building more resilient biological supply chains.Existing programs and partnership that were singled out by experts as examples included:BioMADE:Department of Defen

121、se(DoD)funded nonprofit created by the Engineering Biology Research Consortium(ERBC)to enable collaboration through memberships with non-USG partners to accelerate the DoDs biotechnology modernization goals via a new Manufacturing Innovation Institute(MII).Traveler Genomic Surveillance program(TGS):

122、A partnership among the Centers for Disease Control and Prevention(CDC)and the companies Gingko BioWorks and XpresCheck that works to fill gaps in disease surveillance by testing travelers and airplane wastewater to detect SARS-CoV-2 variants.The program is unique in that the CDC is not merely subco

123、ntracting certain aspects of its work but truly partnering with the companies on day-to-day challenges,allowing for more flexible and fluid responses to real-time needs.Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|15Several participants noted that while the US governmen

124、t may want to engage in PPPs to leverage private sector capabilities and speed up certain USG goals,this type of partnership can be hindered and slowed down by lengthy and bureaucratic government contracting processes.Other experts identified cost-sharing as another potential barrier to PPPs,specifi

125、cally for smaller biotech start-ups that make up a significant portion of the bioeconomy.Academic Partnerships and CollaborationMost participants agreed that the US bioeconomy is strong now because of decades of academic investments but that it risks falling behind other countries in terms of invest

126、ment rates,a potential hurdle to continuing its growth at a similar historical pace.Several participants recommended USG agencies further boost their current investments and partnerships with universities and other academic centers.Other experts suggested federal agencies also work to identify and o

127、utline capabilities available within the US academic network and find ways to effectively leverage such experience to achieve US bioeconomy and biomanufacturing goals.One participant noted that in the early days of the COVID-19 pandemic,the US experienced severe testing and diagnostic challenges and

128、 bottlenecks.By concentrating testing responsibility to a single national laboratory,the US government ignored academias wealth of know-how.Universities throughout the US had diagnostics capabilities and assays,often developed with federal funding,that remained untapped until later in the crisis but

129、 that could have been used to more rapidly expand domestic testing capacity.Some experts agreed that US agencies responsible for funding academic research partners should identify ways to better maintain their networks of resources,experts,and university partnerships after grants conclude in order t

130、o facilitate and speed-up collaborations in times of necessity or crisis.Making MCM Programs More SustainableUSG-funded medical countermeasure(MCM)research and development programs often suffer from sustainability challenges post-crisis.One participant suggested the government should act as a depend

131、able market maker to ensure the continuity and maintenance of critical MCM infrastructure and research(eg,mRNA technology platforms and manufacturing capacities).Bioeconomy Coordinating BodySeveral participants noted the challenges USG stakeholders face engaging on biosecurity issues with various ag

132、encies within the federal government,as they all have different cultures,missions,and incentives.One expert suggested that stakeholders create a single coordinating body across the government to streamline USG policy,lexicon,and overarching goals,which also could serve as an information resource to

133、interested parties.This coordinating body could be used to improve external communication and provide transparency to non-USG stakeholders in the private sector and academia.Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|16Prioritization of Biosecurity and Biosafety in Fe

134、deral BudgetsParticipants generally agreed that biosafety and biosecurity historically have not been prioritized in government funding,both during legislative appropriations and within the Office of Management and Budget(OMB)processes.To help identify clear short-and long-term budget needs,a partici

135、pant recommended USG stakeholders publicly define their biosecurity and biosafety goals for the next decade and outline key milestones and incremental steps necessary to achieve those goals.Examples included developing biosafety research and implementation plans for new biotechnologies that are mean

136、t to be used outside the laboratory;growing a biosafety workforce that can meet the demands of future biotechnologies;or preventing the theft of biological IP or life sciences infrastructure with negative consequences to the US bioeconomy.Similarly,another participant suggested that USG officials an

137、d their partners come together to define the desired overarching goals for the entire US bioeconomy and create a matching priority list of biosafety and biosecurity harms that must be avoided or mitigated.The publication of these two lists as interconnected entities would elevate biosafety and biose

138、curity concerns in discussions with federal budget and appropriations administrators.Regulatory Landscape Several participants noted that overreactive or inflexible regulatory measures may threaten the growth of the bioeconomy as well as US leadership and competitiveness in the field over the long t

139、erm.To mitigate those risks,some experts suggested that USG stakeholders work closely with industry to build a deeper rapport,knowledge,and understanding of the products and technologies under development.ConclusionThis meeting was held by the Johns Hopkins Center for Health Security to solicit expe

140、rt insights,summarized in this document,to inform the development of the USG-led Biosafety and Biosecurity Innovation Initiative implementation plan.The Initiative is an important step toward modernizing,streamlining,and strengthening the US biosafety and biosecurity policy apparatus at home and abr

141、oad.These efforts aim to enhance biosafety and biosecurity throughout the biotechnology R&D and biomanufacturing lifecycles,while maximizing potential societal benefits,as well as safeguarding and boosting US national competitiveness.Implementation of the recommendations of experts herein would real

142、ize meaningful reductions to the evolving biosafety and biosecurity risks in the context of rapidly advancing R&D.Building Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|17References1.Executive Office of the President.Executive Order 14081 of September 12,2022:Advancing Biotechnol

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145、egister.gov/d/.Hodgson A,Alper J,Maxon ME.The US Bioeconomy:Charting a Course for a Resilient and Competitive Future.New York,New York:Schmidt Futures;2022.Accessed January 31,2023.https:/doi.org/10.55879/d2hrs7zwc5.The White House.FACT SHEET:CHIPS and Science Act Will Lower Costs,Create

146、Jobs,Strengthen Supply Chains,and Counter China.Published August 9,2022.Accessed January 31,2023.https:/www.whitehouse.gov/briefing-room/statements-releases/2022/08/09/fact-sheet-chips-and-science-act-will-lower-costs-create-jobs-strengthen-supply-chains-and-counter-china/6.National Institute of Sta

147、ndards and Technology.NIST Bioeconomy Lexicon.Updated December 9,2022.Accessed January 31,2023.https:/www.nist.gov/bioscience/nist-bioeconomy-lexicon7.Gronvall GK.A Biosafety Agenda to Spur Biotechnology Development and Prevent Accidents.Health Secur.February 1,2017.doi:10.1089/hs.2016.00958.Intelli

148、gence Advanced Research Projects Activity.FELIX:Finding Engineering-Linked Indicators.Updated November 1,2022.Accessed January 31,2023.https:/www.iarpa.gov/research-programs/felix9.The White House.FACT SHEET:President Biden to Launch a National Biotechnology and Biomanufacturing Initiative.Published

149、 September 12,2022.Accessed January 31,2023.https:/www.whitehouse.gov/briefing-room/statements-releases/2022/09/12/fact-sheet-president-biden-to-launch-a-national-biotechnology-and-biomanufacturing-initiative/10.Executive Office of the President.Executive Order 14083 of September 15,2022:Ensuring Ro

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151、my|18Appendix A:Participant ListAdejare(Jay)Atanda,DMD,DrPH,MPHPolicy Advisor and AAAS STPF FellowStrategy,Plans,and Policy(SPP)Directorate(CW-5)Countering Weapons of Mass DestructionUS Department of Homeland SecurityAdejare.Atandahq.dhs.govAurelia Attal-Juncqua,MScFellowJohns Hopkins Center for Hea

152、lth Securityaattalj1jhu.eduAndrew Bremer,PhDProgram OfficerNational Academies of Sciences,Engineering,and Medicineabremernas.eduMichael Callahan,MD,DTM&H(UK),MSPHDirector,Clinical TranslationVaccine&Immunotherapy Center Massachusetts General HospitalMVCALLAHANmgh.harvard.eduKitty Cardwell,PhDProfess

153、orInstitute of Biosecurity and Microbial Forensics,Oklahoma State Universitykitty.cardwellokstate.eduGenevieve Croft,PhDProgram ScientistSchmidt FRyan Donohue,PhDHealth Science Policy AnalystNIHryan.donohuenih.govGerald Epstein,PhDDistinguished FellowNational Defense Universitygerald.l.epstein.civnd

154、u.eduAmer Fayad,PhDNational Program Leader National Institute of Food and AgricultureUS Department of Agricultureamer.fayadusda.govAmanda Field,PhDHealth Science Policy AnalystNIHamanda.fieldnih.govJulie Fischer,PhDTechnical Director for Global HealthCRDF Globaljfischercrdfglobal.orgRobert W.Fisher,

155、PhDSenior Advisor for CBRN and Pandemic InfluenzaOffice of Counterterrorism and Emerging Threats(OCET)Office of the Chief Scientist,Office of the CommissionerUS Food and Drug Administrationrobert.fisherfda.hhs.govKatie Gibson,PhDSenior Biotechnology AdvisorOffice of the Undersecretary of Defense(Res

156、earch&Engineering)kathleen.m.gibson4.ctrmail.milGigi Gronvall,PhDSenior ScholarJohns Hopkins Center for Health Securityggronvalljhu.eduAlessandra HollandInternational Trade Administrationalessandra.hollandtrade.govBuilding Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|19Lloyd P.H

157、ough,PhD,PMPLead,Hazard Awareness&Characterization Technology CenterDHS/S&T/OSE/TCDLloyd.Houghhq.dhs.govMichael Imperiale,PhDArthur F.Thurnau ProfessorUniversity of Michiganimperialumich.eduThomas V.Inglesby,MDDirectorJohns Hopkins Center for Health Securitytinglesbyjhu.eduMark Kazmierczak,PhDDirect

158、or,Biosafety,Biosecurity&Emerging TechnologiesGryphon SYong-Bee Lim,PhDDeputy Director,Nolan Center on Strategic WeaponsThe Council on Strategic Risksylimcsrisks.orgMonique Mansoura,PhDExecutive Director,Global Health SecurityMITREmmansouramitre.orgJessica McCormick-Ell,PhDDirector,Division of Occup

159、ational Health and SafetyNIHjessica.mccormick-ellnih.govMichael Montague,PhDSenior ScholarJohns Hopkins Center for Health Securitymichael.montaguejhu.eduKevin OConnell,PhDSenior Vice President,TechnologyIn-Q-Telkoconnelliqt.orgMegan Palmer,PhDExecutive Director of Bio Policy&Leadership Initiatives,A

160、djunct Professor of BioengineeringStanford Universitymjpalmerstanford.eduDana Perkins,PhDSenior Science AdvisorASPRUS Department of Health and Human Servicesdana.perkinshhs.govBrian Renda,PhDAssociate Director,Business DevelopmentGinkgo Bioworks,IMichelle Rozo,PhDErin Sorrell,PhDAssistant ProfessorG

161、eorgetown University(now with Johns Hopkins Center for Health Security)esorrelljhu.eduCDR Cody ThorntonDirector,Security and Assurance(soon to be Security and Intelligence)HCORE,ASPRUS Department of Health and Human Services Cody.Thorntonhhs.govAlexander Titus,PhDVice President of StrategyColossal B

162、iosciencesalexanderbioeconomy.xyzBuilding Strong Biosafety and Biosecurity into the Expanding US Bioeconomy|20Matthew E.WalshPhD StudentJohns Hopkins Center for Health Securitymwalsh52jhu.eduMatt WatsonLead Bioeconomy AnalystMITREmwatsonmitre.orgCari Young,ScMActing Director,Division of Biosafety,Biosecurity,and Emerging Biotechnology PolicyOffice of Science PolicyNIHcaroline.youngnih.gov700 E.Pratt Street,Suite 900Baltimore,MD 21202Tel:443-573-3304Fax:443-573-3305centerhealthsecurityjhu.educenterforhealthsecurity.org