5

Strategic Vision and the Way Forward

In the next 5 years, the U.S. Department of Defense (DOD) Biological Threat Reduction Program (BTRP) should encourage, engage, support, and help drive the U.S. government’s development of a durable interagency mechanism that draws on medical, military, diplomatic, scientific/technical, and other expertise to address the full set of biological threats and risks to the deployed U.S. military forces, U.S. interests overseas, and the homeland, seeking to intervene and eliminate, reduce, or mitigate risks at the most opportune and impactful stage of biothreat development. An effective mechanism will have greater geographic flexibility; and will demonstrate better awareness and prevention of threat development, and more timely response; and will partner effectively within DOD, with other U.S. government agencies, and with other nations, international organizations, nongovernmental organizations (NGOs), the private sector, and academia. Likewise, an effective interagency mechanism will avoid unnecessary duplication, identify and close gaps, and explore possible synergies.

CURRENT APPROACHES OF THE BIOLOGICAL THREAT REDUCTION PROGRAM

In the past, Cooperative Threat Reduction (CTR) programs redirected bioweaponeers to peaceful pursuits. As the threats changed, BTRP has helped partners consolidate and secure vulnerable pathogen collections. BTRP has assisted international partners in upgrading high-containment infectious disease laboratories, trained trainers in laboratory safety and security, and helped establish local, national, and regional disease surveillance networks.

The previous chapters have traced the origins and evolution of BTRP at DOD from the original authorizing legislation in 1991 (commonly called the CTR authorizing legislation), to 2018, the 20th anniversary of

the Defense Threat Reduction Agency (DTRA), which is the DOD agency in which BTRP is administratively located. Over those two decades, life sciences advances, biotechnology, and pathogen epidemiology have changed significantly, and call for a new assessment of the biological threats to human, animal, and plant health and the implications for CTR. Several studies describing and assessing CTR programs have been published since their inception, including prior evaluations by the National Academies of Sciences, Engineering, and Medicine. The present report reviews the major developments over the past decade, considers the particular strengths and global connections of BTRP today, develops a new strategic vision for the next 5 to 10 years of BTRP activities, and makes recommendations to enable that vision to be implemented. One constant in this report is the recognition that many of the goals and activities supported by BTRP during the past decade remain relevant today, although there are new dimensions and new concerns that must be addressed. BTRP’s current official mandate is to:

• Consolidate and secure dangerous pathogen collections into central reference laboratories or repositories;
• Improve the safety and security of biological facilities;
• Enhance partner states’ capabilities to detect, diagnose, and report bioterror attacks and potential pandemics;
• Engage scientists with biological weapon-related expertise, wherever they may currently exist, in research that supports force protection, medical countermeasures, diagnostics, and modeling;
• Foster cooperation and collaborative research with partner institutes and scientists to strengthen the joint capacity to rapidly and accurately detect and diagnose high-consequence infectious disease outbreaks and related biothreats, and be prepared to collectively take appropriate action;
• Cooperate with partners to ensure the safety and security of dual-use research of concern; and
• Engage partners across agencies and organizations within and beyond the United States to limit potential threats and risks associated with cyber security.

Goals, Tools, and Approaches for Today and Tomorrow

International engagement is one of the most cost-effective tools available to prevent adverse events rather than to respond to them after they occur. By providing value to host countries’ efforts to diminish their

risk of serious outbreaks, enhance disease surveillance, and increase the speed of response to avert or mitigate their varied consequences, bioengagement also reduces the risk to the deployed U.S. military forces, U.S. citizens living or traveling abroad, and the population in the United States. In this context, the BTRP mission aligns strongly with the National Defense Strategy of 2018.

Based on study of the origins and evolution of BTRP, and changes in the scientific, social, political, and physical environment in which emerging infectious diseases have affected local populations and raise the prospect of regional and global spread, this chapter presents the committee’s perspectives on the critical issues that underlay the development of a new strategic vision for the agency. The intent is to sharpen the program’s focus, facilitate its adaptation to new realities, and better ensure the success of its mission. A set of recommendations designed to enhance the capacity of BTRP to deliver necessary and appropriate support to realize the vision is presented in Chapter 6.

The Changing Context of Biothreats and Biorisks

Biological threats, including natural, accidental, and intentional threats to the United States and its interests overseas, including U.S. allied countries’ military forces and citizens, and the social, political, and physical environments in which they arise, are growing more challenging and at a faster rate than in previous decades. Drone use, targeted assassinations, and breaking of the taboo against the use of chemical weapons are realities. While the taboo against the use of biological weapons has not been breached on a large scale, nature continues to provide less-than-subtle hints of the potential impact of biothreats, and there is documented interest by terrorists in biological weapons. There are examples of probing with chemicals and pharmaceuticals, which prompts the question “What is ‘war’ today?” How can we be prepared for, attribute, and respond to the myriad of potential threats? How can we achieve early warning or even be cognizant of developing threats?

The biodefense and public health communities are now grappling with scenarios in which preparedness and response to disease outbreaks caused by natural or intentional threats, accidental releases, or those arising from scientific advances, are part of a single spectrum of challenges. These challenges affect the United States and global populations at a time when physical distance from the origin of outbreaks no longer provides protection. At the outset of CTR programs, a major goal and metric for

evaluation of impact was to redirect scientists who had participated in state-supported offensive bioweapons programs to peaceful pursuits using their skill sets in new and highly valued ways. While the threat of intentional use of biological weapons by state or non-state entities has not diminished, even if programs the size and scale of the former Soviet biological weapons programs no longer exist, the threat from the widely reported large, multi-country natural events, currently dominates the implementation of the most recent National Strategy for Biosecurity. Furthermore, the origins of outbreaks may be ambiguous because existing tools are often too coarse to definitively attribute them to pathogen evolution in nature or deliberate manipulation in a laboratory.

The boundaries between risk and threat continue to blur and converge at a quickening pace. As the National Biodefense Strategy of 2018 states, the lines between naturally occurring and evolving infectious disease agents, accidents in the course of legitimate research deemed to be justifiable based on careful risk-to-benefit assessment, intentional misuse of biology, and surprises arising from the biotech revolution are becoming less distinct. This suggests the need for strategies to prevent both risks and threats, and to be prepared to act rapidly and effectively when the need arises. The consequences of not planning strategically and acting rapidly and effectively can be great, as in West Africa in 2014–2016, and currently in the Democratic Republic of the Congo (DRC). Naturally occurring disease can seriously destabilize countries and regions, occurring as a “perfect storm” in settings in which civil society is fragmented, authority is fragile, and resources to address emerging outbreaks are limited. Intentional introduction of disease agents can have a similarly destabilizing effect, and may be even more challenging if they have been deliberately modified to be more destructive and/or to resist existing medical countermeasures. At present, the source of modifications at the genetic level may not be readily attributable to evolution in nature or mutation created and introduced in a laboratory, but regardless of source, anticipating problematic settings, improving biosecurity capacity, and building personal relationships between local and U.S. personnel can significantly contribute to reducing the threat of outbreaks.

The Global Consequences of Disease Outbreak

Against the backdrop of ongoing transportation of people and trade in animals and plants, greater access to information, mistrust of authority, dissemination of misinformation and rumor, increasing geopolitical

volatility, corruption, famine, drought, warfare, terrorism, and global migrations of humans escaping violence and persecution or just seeking a better life, there are greater risks of disease outbreaks now than ever before (Coleman, K. et al., 2016). For example, an outbreak of foot-and-mouth disease in the United States would have catastrophic consequences for the multi-billion dollar livestock industry. Hayes (2012) (in USDA, 2013) estimated economic impact of $12.8 billion dollars, annually for 10 years ($128 billion in total). Such threats extend to the U.S. military deployed in areas where these phenomena are present, and are due to the potential of rapid global dissemination of infectious disease, including to the United States.

Greater global connectivity increases the ease of transmission and broadens the reach of infection, which in turn demands faster, more effective response. Given the speed of travel around the globe, an individual in one country with a highly communicable disease can arrive in any other country in approximately 24 hours or less. Outbreak timelines are being compressed and as a result so is the time available to plan and implement an effective response to an outbreak. Improving systems and capacity for biosecurity, especially in unstable or active conflict zones where BTRP would have strategic advantages to engage, can be of critical importance.

Easier access to knowledge relevant to dual-use technologies and tools for previously unimagined biological research and technology capabilities can also set the stage for accidental as well as intentional threats. As noted in Chapter 2, methods for engineering and synthesizing microbial pathogens have already enabled competent molecular biologists to construct viable infectious pathogens simply from genetic sequence information. Digitalization of biology and design of new technologies to manipulate biological materials also challenge current biological governance and oversight structures within and outside the United States. The potential for devastating local impact and secondary global ripple effects of outbreaks is increasing as these advances accelerate.

The Mission Is Growing More Complex for DOD

DOD, including DTRA and BTRP, is aware of these realities. Similarly, it is also aware of technical and political changes in the conduct of conflicts, such as the use of drones for surveillance and combat and advances in biotechnology that permit the acquisition and manipulation of disease agents. While the existing norms, treaties, and other commitments

against the use of biological weapons has not been breached on a large scale in recent decades, there are clear indications that these moderating forces are strained.

How can the United States and the international community be prepared, receive early warnings, or even be cognizant of developing biothreats? What parts of the U.S. government, and which department or entity within the multiple components of government, are capable, prepared, and willing to address these biothreats? As is described in the next section, the committee believes it will take many U.S. government programs working together and with other governments, international organizations, and nongovernmental partners to address these challenges. DOD and BTRP have an essential role to play in that effort.

Support for BTRP Within DOD Will Pay Significant Dividends in Preparedness and Response

DOD has long held essential, interwoven parts of the bioengagement mission, including protection of deployed U.S. military forces and U.S. interests overseas in the event of disruption of critical functions, such as transportation and trade. History informs us that international bioengagement by DOD contributes to military readiness, planning, and force protection important for U.S. national security. For example, the U.S. Army and Navy overseas laboratories provide essential information on endemic infectious diseases and emerging outbreaks and have helped to identify and validate medical countermeasures or prevention strategies. At the same time, they promote and sustain critical professional relationships of trust where they operate, which are necessary for the transparent exchange of information and insight.

BTRP currently plays a distinctive role in DOD’s engagement to reduce biological threats, and can play an even greater role in the future. BTRP establishes critical lines of communication with foreign governments and responsible individuals; supports operational and situational awareness where it can operate; and invests in building capacity that promotes biosecurity, and ultimately provides additional support for security to deployed U.S. military forces, Americans traveling abroad, and the United States itself. BTRP efforts support the host nation as well. The important role BTRP plays is highly effective, particularly relative to its very small portion of the DOD budget.

A Diverse Set of Actors Is Needed to Address the Complex Biothreat Landscape

DOD is not the only or even the central mission holder in an integrated effort to address biological threats. Different parts of the U.S. government, and international and nongovernmental organizations have unique strengths to contribute to the prevention of and/or response to natural, accidental, and intentional biological threats in various contexts. The Centers for Disease Control and Prevention (CDC) and other parts of the Department of Health and Human Services, the Department of State, the U.S. Agency for International Development (USAID), the Department of Agriculture, United Nations agencies, NGOs, the private sector, academic partners, and subject-matter experts more broadly are also critical to enhancing efficiencies and leveraging scarce human and physical resources to reduce the increasing and more complex biothreat landscape.

Multiple organizations with missions related to international biosecurity should work together more effectively to address common challenges to maximize the overall impact of collective efforts. U.S. biosecurity programs seek to work with countries that have special vulnerabilities to security and public health threats, the desire to build capability and capacity to detect, identify, and analyze emerging infectious diseases, and a willingness to cooperate with U.S. and international entities prior to and when incidents occur. There are often multiple organizations with experience working in numerous countries and with their neighbors, on a wide range of biosecurity-related problems.

Consider a hypothetical but plausible situation that could arise in Southeast Asia.

• BTRP has an existing partnership with country A to build laboratory capacity, establish more secure sample libraries, provide training for laboratory and other personnel, sponsor research as part of a larger regional network focused on zoonotic disease, and establish professional and personal relationships and channels of communication.
• USAID is active in the same country and its neighbors (countries B and C), spending more than $100 million per year to improve basic health through delivery of vaccines, promotion of good hygiene, and HIV/AIDS relief, including laboratory testing.
• The National Institutes of Health sponsors joint research on emerging infectious disease with the Ministry of Health in country B, and with a university medical center in country A.

• CDC provides experts who spend months at a time working in country B, helping to improve laboratory practices and upgrade a legacy laboratory to deal with more difficult pathogens.
• Country C has an Institute Pasteur laboratory that participates in the same regional network of researchers on zoonotic diseases with conferences and joint research organized by the EcoHealth Alliance.
• The State Department’s Biological Engagement Program sponsors a nonprofit organization to conduct biosecurity training and upgrades at laboratories in country C.
• Most of these organizations provide information to the World Health Organization (WHO) and participate in regional WHO conferences. As part of its commitment under the Global Health Security Agenda to implement the WHO International Health Regulations (2005), country B is conducting a Joint External Evaluation, while country A is considering doing the same.

In this hypothetical situation there is little or no obvious and unnecessary redundancy, which is good. Likewise, all of these efforts are valuable in and of themselves. Rather than being conceived as a series of separate efforts, though, they could be linked with a coordinated and cooperative strategy to strengthen global health security. Furthermore, the hypothetical situation noted here reflects routine circumstances. Should an outbreak occur in one of these countries, public health and security needs may rapidly change and would increase urgency, and all of the preexisting and additional resources would be needed for an effective response. Preestablished laboratories, pre-deployed protective equipment and preexisting expertise in handling dangerous pathogens, pre-established supply chains, and pre-existing networks of people and their collaborative relationships would be invaluable in rapidly and effectively responding to an emerging infection or epidemic.

Each of these organizations involved in the hypothetical scenario brings unique capabilities, from the expertise in CDC personnel, to the flexible funding of BTRP and logistical capabilities of DOD, the diplomatic relations conducted by State, the strengthened healthcare infrastructure developed and the Disaster Assistance Response Team deployed by USAID, and the decades of collaboration in the Institut Pasteur resulting in enhanced indigenous capability and operation in the country and the region.

As the above hypothetical scenario indicates, DOD’s programs are unique in that they provide a national security focus, while other U.S. government departments and agencies involved in international health

engagement programs are primarily focused on civilian health and biosafety challenges. Moreover, in contrast to the excellent programs of CDC and USAID, the mission of DOD’s programs is first and foremost to support the deployed U.S. military forces and the United States and its interests overseas (Philpott, 2019). By carrying out this function, BTRP engagement programs also directly contribute to U.S. national security by providing early warning and situational awareness. BTRP also indirectly contributes to national security by establishing regular communication around mutually relevant security topics with international scientists and clinicians who have relevant knowledge and tools. Open dialogue among equals builds understanding and promotes individual relationships of trust. Understanding and trust between technically competent individuals, particularly over the long term, contributes further to trust and understanding among leaders in ministries and governments. Where trust exists, transparency increases. BTRP is perfectly placed within DOD to engage with global partners to create the necessary common ground to address biosecurity and biosafety priorities, consistent with the current National Defense Strategy.

While there is no perfect solution to today’s extremely complex global challenges in biosecurity, the committee fully appreciates that BTRP’s engagement program is a critical component of DOD’s mission to protect the nation and its military forces. Because of its knowledge on the ground and its position within DOD, BTRP not only knows, communicates with, and supports, but may also even deploy advanced technologies developed through DOD medical and non-medical biodefense research, development, testing, and evaluation programs (CRS, 2019) necessary for DOD to anticipate, prevent, or respond to an urgent need in times of biological crisis. The next critical health crisis might be one for which BTRP already has existing relationships and partnerships through resources already invested. DOD may be called upon to provide emergency support for a naturally occurring pandemic, or to safely contain and eliminate a biological weapons program in an unstable situation. While the resources of the Office of the Assistant Secretary of Defense for Special Operations/Low-Intensity Conflict (ASD SO/LIC) (Tadjdeh, 2019) will likely continue to be the first place to which the President turns when ordering a DOD response, as in Sierra Leone during the 2014 Ebola outbreak in West Africa, success is predicated on being able to draw on existing relationships and resources already invested in a host country, developed prior to an outbreak, when civilian assets may be overwhelmed.

But resources are limited, and BTRP as well as other partners must address the perennial mandate to produce the best outcome as efficiently as possible. Not only is it right to use funds efficiently and effectively, it is also the way to strengthen BTRP. By building sound working relationships with other U.S. government, NGO, and global networks of experts, BTRP can leverage its resources more effectively and be better attuned to threats, risks, and even successes around the world. BTRP’s common interests in prevention and early engagement with potential partners abroad, albeit viewed through a biosecurity lens, may include epidemiology, genetic engineering, point-of-care or other field-enabled diagnostic methodologies, disease surveillance and secure storage of biological samples, and response, including countermeasure development. Working together on these common interests may be of direct benefit to the host country (whether those partners are from the military or other relevant parts of government) as well as to the United States. Aligning interests, resources, and outcomes can achieve greater effectiveness for all partners and avoid unnecessary duplication of efforts.

The Need to Anticipate, Detect, and Respond Rapidly to Threats

To effectively and efficiently address natural, accidental, and intentional incidents, the U.S. government must be able to anticipate, detect, and, if called upon, respond rapidly to these threats, regardless of their origin as disease outbreaks, including those that arise as a consequence of unanticipated outcomes of life sciences or biotechnology advances. This begins with identifying risk factors, needs, and opportunities. Disease surveillance extends beyond detection of disease outbreaks to noting and responding to the conditions that feed and lead to infectious disease risks and threats. For example, a lack of domestic clinical and research laboratory infrastructure or poor domestic public health capabilities, insecure storage of agents and potentially infectious biological samples, limited training in biosafety procedures in the laboratory or clinical settings, and inadequate numbers of subject-matter experts to prevent and respond to infectious diseases may allow an outbreak to occur where it may have otherwise been preventable. Effective surveillance and improved infrastructure must also be paired with sustained efforts to identify opportunities to act prior to an outbreak.

For example, by building surveillance capacity to identify known and new pathogen threats in nature, it may be possible to prevent outbreaks, or at least to be prepared to efficiently identify and quickly deploy

diagnostics and medical and/or public health countermeasures. The current novel coronavirus outbreak is a case study for rapid response capacity, and a polymerase chain reaction (PCR) test (Corman et al., 2020) was rapidly developed and implemented. Although there are no known proven and safe medical countermeasures, work on a vaccine candidate and screening of therapeutics has begun, even as the usual personal and environmental containment procedures, case identification and contact tracing, screening of travelers, good clinical management practices, and universal precautions are implemented. These efforts can also help to build the partner-country capacity to respond more quickly and more effectively to a bioterror attack resulting in an outbreak. Such efforts could include training, improved infrastructure, partnership with international experts, and access to diagnostics, therapy, and vaccines. Providing help and building country capacity to protect or at least mitigate the impact of an outbreak affecting a local population has a direct effect on protection for deployed U.S. military forces. This is a major benefit of the efforts to assist international partners in upgrading high-containment infectious disease laboratories, to train local trainers in laboratory security and safety, and to help establish local, national, and regional disease surveillance networks. Whether before, during, or after an outbreak, for which BTRP or other DOD programs have been engaged, they have aided partners in consolidating and securing valuable pathogen collections so they may be effectively used to develop countermeasures and reduce the risk that they can be misused. The latter is particularly important because the size of the global workforce with expertise in enormously powerful new biotech capabilities has increased greatly, raising new concerns regarding individual or small-group attempts to create new deadly or drug-resistant strains of pathogens. Advances in science have increased threats in a variety of ways, including the ability to manipulate virulence, and/or create drug and vaccine resistance in a relatively unsophisticated laboratory environment in almost any country. Timely information on such pursuits, gained from a network of trusted international partners, is now more valuable than ever.

Cooperative programs are likely to function most effectively when personal engagement has occurred and the people involved from the relevant agencies and organizations know and trust one another before a biological crisis occurs. Positive examples of such advanced engagement that allowed for rapid response otherwise unavailable include BTRP’s support to the Lassa Fever Ward in Kenema, Sierra Leone (Wilkinson, 2015), including laboratory capacity and training efforts. The pre-existing

program meant that reliable diagnostic platforms were available before the onset of the West African Ebola outbreak beginning in 2014, requiring primarily new primers to adapt PCR technology for the Ebola virus. Similar BTRP engagements before the 2017 outbreak of Marburg disease in Uganda installed laboratory diagnostic equipment at the Uganda Virus Research Institute, the Central Public Health Laboratories, and 15 district laboratories under the Ugandan Ministry of Health, and improved genomic sequencing capabilities and data analyses. These efforts can be credited with reducing the impact of the outbreak and facilitated subsequent DOD engagement.

As previously discussed, the Ebola outbreak in West Africa in 2014–2016 and the ongoing and expanding outbreak in the northeastern regions of the DRC illustrate two new scenarios of “bio-insecurity” and the need for anticipatory thinking. First, in Guinea, Sierra Leone, and Liberia, the legacy of the previous years of civil instability, violence, oppressive government, widespread distrust of authority, and dire poverty contributed to the power of conspiracy theories fueling rumors and mistrust of government and, by extension, international responders. This insecurity and lack of trust contributed to the massive nature of the outbreak, including almost 12,000 Ebola deaths officially registered and the breakdown of the healthcare system and the suspension of routine health services. The ongoing 2018 outbreak in the northeastern provinces of DRC involves an area of continuing unrest, with multiple anti-government armed militias, and major distrust of the government by the local population. As a result, individuals or organizations identified as working with the government, including international health and humanitarian groups, are distrusted by association. These cases illustrate the fact that local insecurity has taken on a new dimension as with the presence of organized armed insurgent groups which are now specifically targeting healthcare and outbreak control initiatives to identify and treat patients, track contacts, and halt the chains of transmission. This local insecurity enables the outbreak to be sustained, grow, and spread, threatening neighbors and, eventually, U.S. interests.

A strategy incorporating the factors of anticipated social and/or environmental instability in determining where and when BTRP should seek to engage with a host country would be a departure from the past, but would address a DOD imperative to protect military servicepersons from health threats in places to which they may be deployed.

Success at anticipating and responding to perceived threats or opportunities is varied and sometimes imprecise. Cases in which it is

feasible to anticipate and identify a specific need, and in which one can, in advance of an incident, identify the specific biosecurity consequences of not engaging are rare. However, there are also cases when analysts know that a high-consequence pathogen is likely to emerge in a country or a region, even if they do not know exactly what it will be and when it will occur. The important counter-threat action in such cases is to establish a flexible capability to detect and respond quickly when something does arise.

BTRP’s resources are relatively small and have been shrinking in recent years (See Appendix B for CBEP/BTRP funding levels from 2007–2020). For geopolitical and epidemiological reasons, BTRP should not engage a state or partner just because it can, but rather engagement should be informed, strategic, and likely to yield benefits. The committee outlines a strategic vision in which strategic, country-level engagements can be pursued. The limited resources that BTRP has at this time make careful selection of engagements even more critical. Likewise, ending aspects of partnership must only be done after careful analysis of options as connections and activities that are well established would have to be rebuilt.

The transportation and communication revolutions have provided the capability of anticipating where the next hot spots most likely may be, and to a greater degree of accuracy than ever before. For BTRP to take a strategic view will require careful articulation of why engagement is required, where it is required, what the specific need is in the context of the local circumstances, and what resources are required—including human resources. The committee asserts that the strategic vision outlined in this report, focusing on improved mechanisms for implementation, can provide an essential framework within which to improve the effectiveness of BTRP.

Geographic and Programmatic Flexibility for BTRP

To the extent that BTRP, together with a range of domestic and international partners, can use its collective abilities to more rapidly and precisely anticipate the location and potential sources of biological threats and opportunities, it will increase its ability to articulate where and why it should engage in a variety of geographical areas and topics. The potential for a greater reduction of risk through earlier and sustained engagement based on trust and shared interests is enabled by the ability to act as soon as human and financial resources will feasibly allow.

Programmatic flexibility is essential for effective and efficient implementation of bioengagement efforts. The time between the anticipation of an incident and its occurrence has shortened due to increased speed of travel and advances in the biological sciences. As a result, there is often insufficient time to seek required determinations to allow BTRP to engage in a geographic region before a situation becomes critical and a response much more expensive—and sometimes less effective—than it would have been years or even months earlier.

There are a number of countries and regions in which such biological engagement programs could make a significant positive difference in local stability and, as a consequence, positively affect U.S. national security, but for which a geographical determination to engage has not yet been made by Congress. A prominent example can be found in Latin America and the Caribbean, where the prevailing view of the determination authority has for years been that, since there is no perceived significant biological or bioterrorist threat, bioengagement through BTRP is not a priority. Yet there are Latin American countries at risk of outbreaks of major emerging infectious diseases, exemplified by the recent increase in incidence of yellow fever, dengue, and Zika viruses. Some Latin American countries also experience political and economic instability. Such factors could have significant adverse implications for rapid and effective action to prevent or mitigate an emerging outbreak that threatens health security for the United States. The Black Sea region is another critical contested area where BTRP could represent the U.S. government and create opportunities to cooperate and enhance biosecurity. BTRP should be enabled to creatively and strategically use all existing authorities and carefully seek to understand needs and opportunities worldwide; this is essential to address current and long-term threats posed by natural, accidental, and intentional biological incidents.

Modern biosciences are increasingly interdisciplinary, dual-use, and rapidly evolving in unknown and unpredictable ways, whereas in the earlier days of CTR bioengagement programs the focus was on a small number of states using industrial-scale methods to make traditional bioweapons that involved a relatively limited sector of biosciences and relevant research. Given this evolving landscape of risks, threats, and opportunities, BTRP should continue to focus on anticipating where bioengagement may be both possible and beneficial to reducing risk. As a result, to remain effective and relevant, BTRP’s engagements must be sufficiently flexible in content and substance. In addition to having flexibility to selectively engage around the world where biorisks and

biothreats are present or can be anticipated to emerge, BTRP would be better-positioned to address the full range of challenges if it also had the scientific expertise within the organization as well as access to external scientific experts to identify new threats that may emerge from unanticipated consequences of cross-disciplinary sciences, some of which could be used for harm.

Because engagements are with humans, not technologies or pathogens, BTRP officials should be proactively communicating with their counterparts in engaged countries and have the flexibility to undertake broadly relevant activities in true partnership with their host-country colleagues. This will invariably result in greater relevance of the program to the needs and priorities of the engaged country and its personnel, and increase the likelihood of success, and thus sustainability, with domestic personnel and resources.

BTRP evaluates progress in its engagements on a regular basis. If this is part of a larger DOD and interagency evaluation of efforts in a country or region, then these evaluations afford opportunities to refine the approach to engagement. This could mean modifying BTRP staffing needs, the composition of partners, revising their roles, creating new networks, and sharing lessons learned and best practices. It may also prompt the interagency or the programs to thoughtfully terminate unproductive partnerships. Overall, a U.S. government-wide strategy and better coordination and communication across U.S. government agencies would be beneficial.

Since it is very difficult to scale the success of BTRP’s engagements, just hiring contractors and providing a project budget will not necessarily lead to proportional gains in success. To allow for the greatest return on the investments made with increased flexibility, BTRP would benefit from an increased number of technical experts in the program. With more technical experts, decisions on how to best support countries to strengthen their capabilities to detect, diagnose, and report on diseases can be more effective. It takes experience to discern what is really required to help a country partner, particularly when there are a variety of requests and solutions offered from multiple directions. Often, suggested solutions come from well-meaning people on all sides, but the solutions need to be scientifically sound to help move missions forward. In other times, prioritization of projects may benefit from scientific knowledge such that sequencing of implementing solutions can be most effective.

Personal Relationships and Networks as the Foundation for Successful Engagement

Connections to people and their institutions are the common thread through all of BTRP’s efforts, whether for biosurveillance, establishing norms, building laboratory capacity, strengthening biosecurity and biosafety rules and practices, or enabling anticipation of threats and rapid, effective response. Threats and risks are much more dynamic than they were during and just after the Cold War. The words of Nobel Laureate Joshua Lederberg, speaking of preventing biological warfare, continue to ring true: “There is no technical solution. It needs an ethical, human, and moral solution. But would an ethical solution appeal to a sociopath?” (Preston, 1998, p. 65) Partners and partner countries are allies in countering threats from state and non-state actors, and while CTR programs have focused on technical solutions for the past 30 years, with some success, it is also clear that human relationships of trust developed through long-term engagements contribute both directly and indirectly to national security, and can even be deterrents to aberrant behavior.

Agreements between trusted peers and colleagues, in addition to strengthening national security through open lines of communication and operational awareness as described above, often enable efforts to improve disease surveillance, enhance the security of repositories of biological agents and clinical specimens, and train research and response teams to work safely in the laboratory and reduce the risk of exposure, across the spectrum from patient care to burial of those who succumb. When an outbreak occurs in a country where BTRP is engaged, whether natural, accidental, or deliberate in origin, such relationships can cut through the chaos of the moment and streamline the rapid implementation of a healthcare and containment response. Together with the ability to secure samples of infectious diseases, this can increase the likelihood that clinical research and trials of medical countermeasures or vaccines can be implemented, including assessment of innovative approaches developed through DOD research and development.

The 2009 National Academy of Sciences report Global Security Engagement: A New Model for Cooperative Threat Reduction encouraged the development of global networks of individuals and organizations with a common interest in biosecurity threat and risk reduction. Whether the source of the biothreat is natural, accidental, or intentional, an interest in collective brainstorming and action focused on complex, shared health-security concerns of importance were encouraged. Such networks can

become a powerful tool for communication, thoughtful partnerships in leadership roles, security, and stability. Multilateral networks at the intergovernmental level allow people to work together, and leverage investments in funding, which, in turn, foster more opportunities for information exchange, development of personal relationships, and appropriate action. One such multilateral forum is the Global Health Security Agenda (GHSA). BTRP has supported some of the biosecurity/biosafety components of GHSA and thereby has extended the impact of its resources, expanded its influence, and promoted an improvement in functional capacity of the involved nations where BTRP is engaged in a strategic manner. In the future, greater engagement with GHSA, as well as similar linkages with other initiatives, such as the Mekong Basin Disease Surveillance consortium (Connecting Organizations for Regional Disease Surveillance, 2019), the Bat Project, and the Alliance for Health Security Cooperation, could continue to extend the influence of BTRP and promote greater efforts toward biosecurity.

Protection of U.S. military forces or other U.S. civilians in a country at risk of an outbreak is enhanced when collaborations and trained healthcare workers are in place before cases are reported, and when local citizens are aware they can benefit from the partnership. A contemporary example of this type of collaboration is that among the Infectious Diseases Institute at Makerere University in Kampala, Uganda, the U.S. Naval Medical Research Center, Walter Reed Army Institute of Research, and the Henry M. Jackson Foundation operating in Fort Portal, Uganda, near the border with DRC, where there is a devastating and continuing outbreak of Ebola since August 2018.

Effective engagement is an iterative process in which clear and honest communication is essential. Long-term success is fostered when key individuals find their counterparts to be not only knowledgeable but also approachable and interested in establishing a personal connection. This not only has implications for leadership, but also for programs’ future successors. As the committee has reviewed BTRP’s experience, we have come to believe that the essential linkages between BTRP and partners abroad require greater involvement of BTRP staff. Bringing more human resources into BTRP itself can allow for selection of professionals based on critical skills necessary to build relationships. Individuals involved at all levels require a set of interpersonal skills that include the ability to listen attentively and understand the needs and thoughts of BTRP leadership, the project managers and implementers, and the partners. BTRP leadership should remain aware of and promote the need to

carefully select, train if necessary, and encourage employees or contractors who demonstrate the diplomatic skills necessary to engage effectively and successfully carry out the program as envisioned.

BTRP professionals should be encouraged to remain in contact with international partners, even informally. The relationships of trust built will not only promote good will, but also allow U.S. partners to understand and more likely to be aware of any significant changes in the situation, good or bad, through communication with its partners. Although there is an emphasis on the development of capabilities among partners in host countries, and on the sustainability of efforts subsequent to the official end of some BTRP programs and projects, trusted relationships built over time through engagement should be maintained and encouraged. Such relationships can be promoted through a host of possible opportunities such as attendance at conferences, participation in regional and global professional networks, and even regular phone and video-conferencing options. Critically, engagement on personal and professional levels should not stop and start along project timelines.

Greater Visibility of the Experience and Expertise within BTRP

As described throughout the report, BTRP has a considerably broad portfolio of bioengagement projects and activities to advance biosecurity across the world as a means of protecting deployed U.S. military forces, U.S. interests overseas, and the homeland. BTRP has gained a great deal of experience and expertise working in a wide range of countries and regions on a host of critical issues. The depth and scope of this experience, however, is not well known within DOD, across the U.S. government including Congress, and among international partners. Likewise, the range of skills and assets that BTRP can contribute to addressing extant and evolving biorisks and biothreats is also not as well-known as it should be. To maximally contribute to U.S. and international efforts to reduce risks from natural, accidental, or intentional outbreaks and other bioincidents, BTRP must be allowed the resources and the platforms to be able to articulate its successes, including through participation in and organization of appropriate international scientific meetings and other modes of global communication. Further, BTRP must be allowed to offer its expertise and resources to other partners within and beyond DOD that may be addressing current or anticipated challenges.

As with any effective partnership, it is desirable to build a strong foundation prior to a time of crisis or stress that may test the durability of

the partnership. BTRP’s relationships within DOD are no exception. BTRP must establish deeper and more effective connections across DOD and regularly engage and inform colleagues of issues of relevance to DOD, so that they can more rapidly come together to form partnerships to take action when necessary. It is imperative to ensure leadership support to advance partnerships as soon as possible. Failure to do so would result in BTRP remaining siloed, and many opportunities to enhance synergies will be missed, potentially leading to lives lost. Particularly, regular open and frank communication must be ongoing between BTRP and combatant commands, ASD SO/LIC, Office of the Assistant Secretary of Defense for Health Affairs, Office of the Under Secretary of Defense for Policy, and other relevant DOD partners. If BTRP can deepen such strategic interactions, including by sharing its successes and available expertise more broadly, it will further strengthen the base of understanding about BTRP and its mission and programs.

Given the complexity of the 21st century risk and threat landscape, DOD, other U.S. government partners, NGOs, academia, and international partners should have the opportunity to draw on the considerable assets that BTRP can offer in support of common security goals, and in which the United States has invested for two decades. Such significant expertise should be included as proactive and responsive efforts to address biothreats.

The number of governmental agencies and organizations from a large number of countries, international organizations, NGOs, and groups from the private sector and academia have created a rich and complex landscape of potential partners around the world, each contributing to the larger effort to reduce the threats and challenges from disease outbreaks and advancing biotechnology. Some of those organizations focus more extensively on scientific research, others on human and animal health. Still others focus on the promises and possible perils of biotechnologies. Taken together, the wide range of people and organizations involved in one or more aspects of countering biological threats requires more diligent awareness of others’ programs and initiatives, their areas of geographic and substantive engagement, and their similarities and differences in goals and objectives among groups and organizations. As a result, to increase the positive outcomes of its work, BTRP must be present and active at meetings and conferences where other potential partners, especially those from host countries, are in attendance. Through such outreach and networking, BTRP can grow its awareness and understanding of others’ work, and increase its opportunities for establishing and maintaining

trusted relationships. Further, by participating actively in such events, the unique set of capabilities, expertise, and assets that BTRP has to contribute can become more widely known around the world.

During the early days of the Nunn-Lugar CTR Program in the former Soviet Union, a small senior advisory group was used very effectively by DTRA, not only to assist with scientific reviews of projects under consideration for U.S. funding, but also, importantly, to advocate for the CTR Program. In these times of reduced funding and a dearth of advocates in Congress for CTR programs, a group of senior experts with relevant experience, could add a robust foundation to BTRP’s efforts. One potentially important contribution of such a group could be helping to link BTRP professionals, BTRP-supported experts, and other partners together through regional and global networks. Annual meetings are one means by which these experts can meet and share experiences working on a daily basis in the laboratories. Participation in science conferences, introduction of experts across regions and/or areas of scientific expertise, and exchanges of scientific publications and visits may also enhance BTRP’s impact.

THE STRATEGIC VISION FOR BTRP

With the rapid pace of change in the biosciences, new biorisks and threats can seemingly develop overnight. Indeed, anticipation and prediction of risks that may emerge from natural occurrences, accidental incidents, or intentional actions may be considered to be an impossible exercise. Yet, building on two decades of experience and expertise by implementing the pillars of the proposed strategic vision articulated in this report, DOD’s BTRP is well poised to seize opportunities prior to events and provide early warning of local and regional biological threats, thereby improving the biosecurity of deployed U.S. military forces and U.S. interests abroad, and strengthening security of the U.S. homeland itself.