3

Diffusion of Life Sciences
Research Capacity and Applications

Chapter 3 addresses the second of the major trends considered by the committee: the increasing diffusion of life sciences research and its implications for the Biological and Toxin Weapons Convention (BWC). The chapter first examines the growing diffusion of research capacity and applications around the globe, illustrated by the rise in international research collaboration, and briefly discusses some of the specific developments enabling these collaborations. It then presents two examples of how the BWC can take advantage of global diffusion to enhance the effective implementation of the treaty. The final section of the chapter discusses a different sort of diffusion: the increasing ability to carry out life sciences research outside traditional institutional settings.

3.1 GLOBAL R&D CAPACITY AND INTERNATIONAL
COLLABORATIONS IN SCIENTIFIC RESEARCH

3.1.1 The Growth of International S&T Collaboration

The increasingly widespread access and ease of use of communications technologies, combined with the growing availability of resources to support research (see Section 3.1.2), support the continuing expansion of global research capacity and an ever larger number of international collaborations in science and technology (S&T). Workshop presentations illustrated how global capacity in the life sciences has become; examples included studies at the International Livestock Research Institute (ILRI) in Kenya on Rift Valley fever (de Villiers, 2010) and at the Centre for Systems



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3 Diffusion of Life Sciences Research Capacity and Applications C hapter 3 addresses the second of the major trends considered by the committee: the increasing diffusion of life sciences research and its implications for the Biological and Toxin Weapons Conven- tion (BWC). The chapter first examines the growing diffusion of research capacity and applications around the globe, illustrated by the rise in inter- national research collaboration, and briefly discusses some of the specific developments enabling these collaborations. It then presents two exam - ples of how the BWC can take advantage of global diffusion to enhance the effective implementation of the treaty. The final section of the chapter discusses a different sort of diffusion: the increasing ability to carry out life sciences research outside traditional institutional settings. 3.1 GLOBAL R&D CAPACITY AND INTERNATIONAL COLLABORATIONS IN SCIENTIFIC RESEARCH 3.1.1 The Growth of International S&T Collaboration The increasingly widespread access and ease of use of communica- tions technologies, combined with the growing availability of resources to support research (see Section 3.1.2), support the continuing expansion of global research capacity and an ever larger number of international collaborations in science and technology (S&T). Workshop presentations illustrated how global capacity in the life sciences has become; examples included studies at the International Livestock Research Institute (ILRI) in Kenya on Rift Valley fever (de Villiers, 2010) and at the Centre for Systems 59

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60 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION and Synthetic Biology at the University of Kerala, which organized the first synthetic biology conference in India and created a wiki to encour- age information sharing among Indian laboratories engaged in synthetic biology research (Dhar, 2010). Data from studies in the United States and the United Kingdom (Adams et al., 2007; NSB, 2010; Royal Society, 2011b) indicate that the number of international collaborations, as measured by jointly authored scientific papers, continues to increase; in 2008 more than one-third of scientific articles included authors from more than one country (Royal Society, 2011b). Although the absolute numbers of scientific papers remain highest for the United States and scientifically developed coun - tries in Europe, countries such as China and India are experiencing par- ticularly rapid growth in output. A recent report comparing the number and growth rate of collaboratively authored papers among a sample of six countries (United States, United Kingdom, France, Germany, China, and India) over two time periods—1996 to 2000 and 2001 to 2005 found that, in all cases, more jointly authored papers were released in 2001-2005 than in 1996-2000. Although there were higher total numbers of papers from the United States and European countries, the rate of increase in joint papers was highest for China and India (Adams et al., 2007). A recent analysis by the U.S. National Science Foundation similarly observed that U.S. and European Union researchers’ “com - bined world share of published articles decreased steadily from 69% in 1995 to 59% in 2008 as Asia’s output increased. In little more than a decade, Asia’s world article share expanded from 14% to 23%” (NSB, 2010). The additional observation that, as a general pattern, “collabo - ration usually creates an increase in the indexed bibliometric impact” of a journal article, such as through an increased number of citations (Adams et al., 2007), suggests that collaborative research is producing valuable science. The workshop also highlighted that international S&T collaborations are occurring not only among researchers in scientifically developed coun- tries and between researchers in developed and developing countries (sometimes referred to as North-South collaboration). The impressive growth of scientific capacity among countries once considered “develop- ing” has enabled collaborations among regional networks and increasingly among scientists (South-South collaboration) (Hassan, 2007; Royal Society, 2011b; Sáenz et al., 2010; Thorsteinsdóttir et al., 2010; WHO, 2009). The growing numbers of such regional and South-South collaborations appear to be an important trend that is expected to continue (UNESCO, 2010). Examples of effective international and regional collaborations pre- sented at the workshop included multi-partner genomic sequencing efforts (de Villiers, 2010; Pitt, 2010b), the global Human Genome Organi -

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61 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS zation (HUGO),1 and related initiatives like the Pan Asian SNP Consor- tium (HUGO Pan-Asian SNP Consortium, 2009; Sudoyo, 2010). The SNP Consortium links scientists in 11 Asian countries in efforts to catalogue regional human genetic variation, fosters the exchange of knowledge among partner countries, and enables knowledge transfer from more scientifically advanced countries to partner countries seeking to increase their scientific capacity. The three additional examples described briefly below underscore the growing role that regional and South-South collaborations are playing in S&T and emphasize how truly global life sciences research has become: • Cooperation between Cuba and Brazil in Biotechnology: The Finlay Institute in Cuba and the Immunobiological Technology Institute (Bio-Manguinhos) of the Oswaldo Cruz Foundation in Brazil part- nered to develop and manufacture a meningitis vaccine for distri- bution in Africa, building on the scientific expertise both countries have in biotechnology. Reportedly, “between 2007 and 2009, some 19 million doses were produced and distributed in Burkina Faso, Ethiopia, Mali and Nigeria. The vaccine’s price is much lower than on the international market and lower than would be possible without Cuba-Brazil cooperation” (Sáenz et al., 2010) • Pan-African Cooperation in Health: The African Network for Drugs and Diagnostics Innovation (ANDI) was recently established as a partnership among national African organizations, the African Development Bank, and the World Health Organization “to pro- mote and sustain African-led health product innovation to address African public health needs through efficient use of local knowl- edge, assembly of research networks, and building of capacity to support economic development” (http://www.andi-africa.org/). The ANDI initiative will support projects undertaken by networks of research centers, provide an information technology and data - base backbone, and support the purchase of advanced laboratory equipment such as nuclear magnetic resonance (NMR) and mass spectrometry instruments (WHO, 2009). The project will tap into and help connect existing R&D capacity in a variety of centers within Africa (see Figure 3.1). 1 HUGO, created in 1998 as part of the earliest planning for the Human Genome Project, promotes international coordination and collaboration in the study of the human genome. It has grown from an initial membership of 42 scientists from 17 countries to more than 1,200 members from 69 countries. See HUGO website at http://www.hugo-international. org/aboutus.php.

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62 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION FIGURE 3.1 Distribution of R&D capacity in Africa based on analysis of journal articles from 2004-2008 having corresponding authors located in Africa. The size of the circles correlates with the numbers of published articles. SOURCE: Nwaka et al. (2010). • Cooperation among India, Brazil, and South Africa (IBSA): Although health and health-related biotechnology is clearly an area of active international collaboration, it is by no means the only scientific one. IBSA was established in 2003 as a trilateral partnership between the governments of India, Brazil, and South Africa. Within this frame- work, a variety of cooperative S&T activities have been fostered. The IBSA nanotechnology initiative, for example, is a partnership between the ministries of science and technology of the coun - tries that undertake nanotechnology-based projects in the areas of advanced materials, energy, health and water, and human-capacity building. The initiative has conducted several nanotechnology schools, including one on health applications of nanotechnology (held in November 2009 in South Africa) and one on sensor appli- cations of advanced materials (held in November 2010 in India) (http://www.ibsa-nano.igcar.gov.in/).

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63 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS As these examples illustrate, there can be multiple motivations for life sciences researchers to engage in international collaborations beyond joint publications. Regional and South-South collaborations, for example, may involve alignment of shared research needs and priorities (e.g., in seek - ing treatments for diseases endemic to a particular region, but rare else - where), opportunities to bring together complementary types of expertise in “South-South partnerships that synergize strengths and bolster com - petitiveness” (Thorsteinsdóttir et al., 2010), or information sharing by scientifically advanced countries in the South to support capacity building in partner counties (Hassan, 2007). Ideally, all partners in a given collabo - ration benefit, and one of the strongest incentives seems to be a desire to work with the best people and facilities in a particular field. As a recent analysis of international S&T collaborations noted: Collaboration enhances the quality of scientific research, improves the efficiency and effectiveness of that research, and is increasingly neces - sary, as the scale of both budgets and research challenges grow. However, the primary driver of most collaboration is the scientists themselves. In developing their research and finding answers, scientists are seeking to work with the best people, institutions and equipment which comple - ment their research, wherever they may be. (Royal Society, 2011b:6) The value of international collaboration is not limited to academic research, as the Cuba-Brazil vaccine development example shows. Indus- try also participates and benefits. As an examination of collaborations by biotechnology companies in six developing countries concluded: Collaboration between firms in the North and South can also facilitate access to strategic knowledge and resources. This flow of resources is not solely North to South, with developed countries being the providers of knowledge; developing countries have been increasing their expertise in this field and possess other resources, such as indigenous materials, important for health biotech development. Furthermore, South-North collaboration can open firms’ access to each other’s markets. For devel- oping countries, it can be key to gain access to the rich markets in the North, but market opportunities are also flourishing in the South. (Melon et al., 2009:229) 3.1.2 Availability of Resources to Support Collaboration Investments and Support for S&T As mentioned in Chapter 1, advances in the life sciences are expected to yield great benefits for health, economic growth and well-being, and the environment. For many countries, they are a key element of invest-

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64 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION ments in S&T as part of national strategies for development. As early as 1992, Agenda 21 from the United Nations Conference on Environment and Development forecasted that: By itself, biotechnology cannot resolve all the fundamental problems of environment and development, so expectations need to be tempered by realism. Nevertheless, it promises to make a significant contribution in enabling the development of, for example, better health care, enhanced food security through sustainable agricultural practices, improved sup- plies of potable water, more efficient industrial development processes for transforming raw materials, support for sustainable methods of afforesta- tion and reforestation, and detoxification of hazardous wastes. (United Nations Conference on Environment and Development, 1992:223) More recently, in 2009 the Organisation for Economic Co-operation and Development (OECD) released a major study on the potential contri- butions of a “bioeconomy” in 2030, which it defined as “a world where biotechnology contributes to a significant share of economic output. The emerging bioeconomy is likely to involve three elements: the use of advanced knowledge of genes and complex cell processes to develop new processes and products, the use of renewable biomass and efficient bio- processes to support sustainable production, and the integration of bio - technology knowledge and applications across sectors” (OECD, 2009:8). For developing countries, one of the key conclusions from the UNESCO Science Report 2010 is worth quoting at length: [T]he increase in the stock of “world knowledge”, as epitomized by new digital technologies and discoveries in life sciences or nanotechnolo- gies, is creating fantastic opportunities for emerging nations to attain higher levels of social welfare and productivity. It is in this sense that the old notion of a technological gap can today be considered a blessing for those economies possessing sufficient absorptive capacity and ef - ficiency to enable them to exploit their “advantage of relative backward - ness”. Countries lagging behind can grow faster than the early leaders of technology by building on the backlog of unexploited technology and benefiting from lower risks. They are already managing to leapfrog over the expensive investment in infrastructure that mobilized the finances of developed countries in the 20th century, thanks to the development of wireless telecommunications and wireless education (via satellites, etc), wireless energy (windmills, solar panels, etc) and wireless health (tele- medicine, portable medical scanners, etc). (UNESCO, 2010:25) Moreover, the substantial trend over the past decade or more by multinational corporations to diversify their research and development facilities beyond their traditional bases in the West (Zanatta and Queiroz, 2007), combined with the growth of significant industries in countries

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65 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS such as India and China that are investing in the West (UNESCO, 2010) provides another significant driver for the development of life sciences capacity. AstraZeneca, for example, has research facilities in Shanghai, China, and Bangalore, India.2 The effects of these commercial drivers on particular areas of life sciences research are discussed in Chapter 2 and examined more generally in Chapter 5. Significant challenges remain to making this potential globally avail- able, and the financial crisis of 2008 and its continuing perturbations have slowed progress for some (UNESCO, 2010). Numerous reports from inter- national and regional organizations recognize the challenges and offer les- sons and strategies for overcoming them (see, for example, InterAcademy Council, 2004; Juma and Serageldin, 2007). Efforts to take advantage of S&T to support development and improved well-being can be expected to con- tinue to provide a powerful impetus for the diffusion of research capacity. Access to Computational and Data Resources As discussed in Chapter 2, the availability of large amounts of data storage capacity and powerful computational resources supports many of the S&T developments surveyed at the workshop, particularly in the omics fields and in systems and synthetic biology (see Section 2.1). Access to computational resources continues to expand as the underlying infra - structure is put in place worldwide. The ILRI research project on Rift Valley fever described by Dr. de Villiers will generate large amounts of sample meta-data in parallel with the storage of the samples themselves in a biobank (De Villiers, 2010). The project plans to take advantage of the possibilities offered by the completed installation of high-speed fiber- optic cables along the east coast of Africa. The East Africa Submarine Cable System (EASSy), completed in 2010, currently provides 4.72 tera- bits per second network capacity (http://www.eassy.org/); additional regional bandwidth is now provided by the East African Marine System (TEAMS) and SEACOM cables completed in 2009, as well as by national cable infrastructure. These networks will enable the project to use distrib - uted computing (see Section 2.2.2), providing capacity equivalent to the largest supercomputers. Availability of Sophisticated Kits, Reagents, and Commercial Services Global research capacity in the life sciences is also enabled by the commercial availability of kits, reagents, and services to conduct scien - 2 Further information may be found at http://www.astrazeneca.com/Research/our- global-reach.

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66 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION tific protocols for cutting-edge research. A large number of multinational suppliers produce kits containing reagents, enzymes, and step-by-step instructions to conduct many of the basic laboratory techniques a life sciences researcher might use, including nucleic acid and protein expres- sion, purification, detection, and analysis.3 Commercial services are also available for tasks like sequencing, DNA and protein synthesis, micro- array construction, mass spectrometry analysis, and others. The avail - ability of smaller, more automated, and easier to use bioinstrumentation also facilitates the performance of laboratory research. In addition to commercial high throughput sequencing services, for example, benchtop DNA sequencers are now available for use within individual laboratories. These tools, which can help increase the speed and efficiency of labora - tory research, are available to scientists worldwide, although direct com - mercial suppliers largely remain clustered in Europe, North America, and parts of Asia. Qualifying Comments: Continuing Limits on Access and Availability Although life sciences research capacity is now globally distributed in a very real sense, a variety of barriers remain for scientists in developing countries (InterAcademy Council, 2004). One example, as discussed in Chapter 2, is access to the Internet and other communications technolo - gies, which facilitates global scientific collaboration. Despite continued growth in usage, however, this access remains uneven.4 A recent report from the Royal Society in the United Kingdom found, for example, that “access to the net is growing very rapidly in some middle-income devel - oping countries, such as South Korea (where access is almost universal) and Brazil. But it is rising only very slowly in low-income countries: 0.06% of the population in low-income countries had access to the web in 1997, rising to 6% 10 years later” (Royal Society, 2011b). However, the same report also noted that statistics on access among the general population of a country are not the entire picture, because “scientists are one community who are most likely to have good access. More troublesome for research- ers is internet bandwidth which may be limited, or infrastructure issues which may hinder the ability to communicate effectively. For example, 3 Major life sciences supply companies include Invitrogen (http://www.invitrogen. com), Promega (http://www.promega.com), Qiagen (http://www.qiagen.com), Ambion (http://www.ambion.com), Clontech (http://www.clontech.com), Sigma-Aldrich (http:// www.sigmaaldrich.com), Roche Applied Science (http://www.roche-applied-science.com), Affymetrix (http://www.affymetrix.com), and many others. 4 As noted by participants in a 2009 workshop on the use of online resources for education about biosecurity issues, it is not just developing countries that suffer from uneven access to the Internet. Substantial parts of the rural United States, for example, either do not have access to the Internet or have only very basic services (NRC, 2011a).

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67 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS power cuts are frequent in many universities across Africa and the inter- net connection speed is low” (Royal Society, 2011b). As noted above, direct suppliers of commercial life sciences kits, tools, and services largely remain clustered in Europe, North America, and parts of Asia, although networks of local distributors may exist. In addition to the financial cost of ordering from commercial suppliers, researchers in areas of the developing world may still experience challenges associated with regulations and shipping times. A detailed discussion of these forces is beyond the committee’s task. A major purpose of this section has been to highlight the increasingly global nature of current life sciences research and the growing role of regional and South-South scientific collaborations, while recognizing that advanced S&T capacity is not yet evenly distrib- uted worldwide. 3.1.3 Discussion and Implications The diffusion of research capacity and its applications is directly rel - evant to two articles of the BWC: • Article III, which states: “Each State Party to this Convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of this Convention.” (United Nations, 2011:2)5 • Article X, which states: “(1) The States Parties to this Convention undertake to facilitate, and have the right to participate in, the full- est possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. Parties to the Convention in a position to do so shall also cooperate in contributing individu - ally or together with other States or international organizations to the further development and application of scientific discoveries in the field of bacteriology (biology) for prevention of disease, or for other peaceful purposes. (2) This Convention shall be imple- mented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention or international cooperation in the field of peaceful bacteriologi - cal (biological) activities, including the international exchange of 5 “The Second, Third, Fourth and Sixth Review Conferences affirmed that Article III is sufficiently comprehensive to cover any recipient whatsoever at the international, national or sub-national levels. [VI.III.8, IV.III.1, III.III.1, II.III.1].” (United Nations, 2007:6)

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68 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION bacteriological (biological) and toxins and equipment for the pro- cessing, use or production of bacteriological (biological) agents and toxins for peaceful purposes in accordance with the provisions of the Convention.” (United Nations, 2011:3) The relationship between Article III and Article X has been the source of debate since the BWC’s entry into force; the list of common understand- ings achieved at various review conferences reflects the continuing effort to find a satisfactory mix of policies to address both aspects of this com - mon disarmament bargain.6 The debates have sharpened since the early 1990s, when the Australia Group expanded its focus from chemical weap- ons to include biological weapons and placed export controls on certain dual use biological equipment and a number of pathogens and toxins. 7 The Chemical Weapons Convention and the Nuclear Non-Proliferation Treaty contain similar provisions and debates, but the pervasively dual nature of life sciences research discussed in Chapter 1 makes this problem particularly difficult for the BWC.8 The continuing, rapid diffusion of research capacity and knowledge poses a profound challenge to those aspects of nonproliferation policy that rely on controlling access to knowledge, materials, and technolo- gies. Given that there is little hope of reversing this trend—and multiple reasons beyond the commitments in Article X to see it as positive and 6 For example, with slightly different wording the Second, Third, Fourth, and Sixth Review Conferences all “noted States Parties should not use the provisions of this Article to impose restrictions and/or limitations on transfers for purposes consistent with the objectives and provisions of the Convention of scientific knowledge, technology, equipment and materials under Article X. [VI.III.10, IV.III.4, III.III.2, II.III.2]” (ibid., p. 7). 7 “The Australia Group (AG) is an informal forum of countries which, through the har- monisation of export controls, seeks to ensure that exports do not contribute to the develop - ment of chemical or biological weapons. Coordination of national export control measures assists Australia Group participants to fulfill their obligations under the Chemical Weapons Convention and the Biological and Toxin Weapons Convention to the fullest extent pos - sible” (Australia Group, http://www.australiagroup.net/en/index.html, accessed October 20, 2011). The AG membership currently includes 40 countries as well as the European Commission. 8 Chemical and nuclear weapons also involve dual use technologies; one distinguishing feature of biological weapons is that the dual use relationship is deeper and more extensive than in these other fields. For biological weapons, it is much harder to identify S&T that is primarily “weapons relevant” or primarily “legitimate.” The issue of scaling up is even more important; for CW, agent quantity can play a key role in distinguishing between offensive and defensive intentions (the definition of CW refers to consistency of types and quantities of toxic chemicals with regard to permitted purposes); in BW that is less relevant given the nature of biological agents, including self-replicating organisms, and the different scenarios of hostile use, some of which require relatively small quantities.

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69 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS beneficial9—this argues for at least two important findings. First, it sug- gests the importance of continuing attention to monitoring and assessing the diffusion to try to anticipate the potential negative consequences and of strengthening the capacity of States Parties to address them, for exam - ple through their Article IV commitments to national implementation. Second, it underscores the potential for a much larger number of States Parties to contribute to the implementation of the convention, for example by expanding global public health and disease surveillance capabilities, or by playing leadership roles in capacity building in their regions. The next two sections of the chapter provide examples of this second finding in more detail. 3.2 DISEASE SURVEILLANCE AND RESPONSE SYSTEMS: A RESEARCH AREA THAT EXEMPLIFIES GLOBAL LIFE SCIENCES CAPACITY AND INTERNATIONAL COLLABORATION RELEVANT TO THE BWC 3.2.1 Introduction In 2007 the World Health Report from the World Health Organization (WHO) warned Today’s highly mobile, interdependent and interconnected world pro- vides myriad opportunities for the rapid spread of infectious diseases … Infectious diseases are now spreading geographically much faster than at any time in history. It is estimated that 2.1 billion airline passengers travelled in 2006; an outbreak or epidemic in any one part of the world is only a few hours away from becoming an imminent threat somewhere else … Infectious diseases are not only spreading faster, they appear to be emerging more quickly than ever before. Since the 1970s, newly emerging diseases have been identified at the unprecedented rate of one or more per year. There are now nearly 40 diseases that were unknown a generation ago. In addition, during the last five years, WHO has verified more than 1100 epidemic events worldwide. (WHO, 2007b:x) Becaause major parts of the public health response to infectious dis - eases are the same whether the origins of an incidents are natural, unin - tentional, or deliberate, as Dr. Raymond Lin of the Singapore National Public Health Laboratory noted at the workshop, “Preparedness for natu - 9 See, for example, the discussions of advances in research in Section 2.1 and their potential applications for health, the environment, and economic growth. For a more general discus - sion, see NRC (2009b) and OECD (2009).

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70 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION rally occurring infectious disease outbreaks equals preparedness for bio - threat events” (Lin, 2010). A critical area in which life sciences S&T is contributing to the opera - tion of the BWC is thus in the development of systems for the surveil- lance, detection, and identification of diseases in human, animal, and plant communities. It also includes the development of vaccines and medical countermeasures to prevent and respond to outbreaks of human and animal diseases and the development of appropriate pesticides or rapid if not preemptive development of genetically resistant cultivars for plant diseases. This is a major example of how, over the years, the States Parties to the BWC have increasingly recognized the importance of using multiple means and methods to support the implementation of the treaty in addition to the regulatory aspects of disarmament and nonproliferation exemplified in Article IV. 10 This approach is commonly referred to as the “web of prevention.”11 Because diseases do not recognize national borders, such systems greatly benefit from international cooperation. And because many emerg- ing diseases arise in regions such as Southeast Asia, Africa, and Latin America (Jones et al., 2008), the ability to draw on global scientific capac - ity also contributes significantly to the field. Diseases of concern are not limited to human illnesses; agricultural systems also remain vulnerable to devastating disease outbreaks (NRC, 2002). Vulnerabilities in agricultural systems exist because of both local- scale and global movement of people, animals, and goods, as well as the increasing prevalence of large-scale monoculture farming (Jeger, 2010). An agricultural disease outbreak can produce significant economic impacts and commercial implications even if the pathogen is present only in low numbers. For example, 53 countries banned the import of U.S. beef fol- lowing the first detection in 2003 of bovine spongiform encephalopathy (BSE), or mad cow disease, in the United States, causing the beef industry estimated losses of several billion dollars in 2004 (CDC, 2004; Coffey et al., 2005). Although the BSE case was not due to a biological weapons attack and many markets gradually reopened, the potential economic 10 Prevention for human, animal, or plant health, for example, is distinct from the range of other political, military, and technical measures that States Parties may take to prevent an intentional biological attack. 11 The International Committee of the Red Cross coined the phrase as part of its 2004 initiative on “Biotechnology, Weapons, and Humanity”; more information is available at http://www.icrc.org/eng/resources/documents/misc/5vdj7s.htm. Also see Rappert and McLeish (2007).

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71 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS consequences of an incident are clear.12 Only limited plant and animal dis- ease surveillance and identification systems currently exist (for example, monitoring of sentinel plants), and lack of funding has remained a chal - lenge in this area. 3.2.2 Improving Disease Surveillance International collaboration on the development of integrated and multidimensional disease surveillance systems provides clear benefits for understanding and monitoring human, animal, and plant diseases whether they are natural outbreaks, unintentional releases such as patho- gen escape from a laboratory, or intentional exposures (Jeger, 2010; Lin, 2010). A variety of clinical and epidemiological monitoring tools can be used as part of surveillance systems, including testing relevant sentinel sites, screening blood samples from particular groups, or analyzing data from disease-specific Internet searches and Twitter postings to help esti - mate the prevalence of an infection (Lin, 2010). Communications systems are also important to rapidly share information about disease incidents. 13 The program of annual meetings of experts and States Parties—the intersessional process—undertaken by the BWC States Parties in 2002 has provided the basis for the growing attention to the role that global health security plays in supporting the BWC regime. The annual meetings in 2004 and 2009 were devoted to global health topics, and the United Nations website for the meetings contains materials related to dozens 12 An example from plant pathology would be Karnal bunt of wheat caused by Tilletia indica. The United States was free of this disease until it showed up on wheat in Arizona in 1996 and later in Texas and California. Nearly all countries that import wheat from the United States had and still have quarantine against introduction of this pathogen, whether on wheat for seed or food. Immediately, a $5 billion U.S. wheat export industry was in jeopardy as wheat-importing countries turned to Australia, Argentina, and Canada for their wheat. In response, the U.S. Department of Agriculture implemented a policy whereby wheat-producing states were surveyed and declared Karnal bunt free, state by state, for the export market, while wheat from states with the pathogen was dedicated for domestic use only. Karnal bunt is actually a minor disease of wheat, and the designation of T indica as a quarantined pathogen has been political and not based on science. Nevertheless, the vulner- ability of the U.S. wheat industry remains (Bonde et al., 1997). 13 An initiative from the nongovernmental community that preceded—and served as a model for—current intergovernmental efforts, the International Society for Infectious Diseases operates ProMed-mail, which provides reports on emerging infectious disease outbreaks online as well as through an email listserv and also operates region-specific notifications for areas such as Africa, the former Soviet Union, and Southeast Asia (http:// www.promedmail.org/).

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72 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION of presentations and other events.14 The WHO, the World Organization for Animal Health (OIE), and the United Nations Food and Agriculture Organization (FAO) all made presentations at the 2009 meeting of experts. One of the outcomes from the meetings has been increasing connections between the BWC and the WHO, especially with regard to the implemen- tation of the International Health Regulations (IHRs) adopted in 2005, because improved capacities to monitor and report disease outbreaks serve the goals of both regimes.15 OIE’s participation in the intersessional meetings reflects increasing international attention to the connections between human and animal dis- eases. The WHO, OIE, and FAO are partners in the Global Early Warning and Response System (GLEWS), launched in 2006, which is a joint system that builds on the added value of combining and coordi - nating the alert and response mechanisms of OIE, FAO and WHO for the international community and stakeholders to assist in prediction, prevention and control of animal disease threats, including zoonoses, through sharing of information, epidemiological analysis and joint field missions to assess and control the outbreak, whenever needed. (http:// www.glews.net/) The growing emphasis on public health can be controversial. There continue to be concerns about the “securitization of health” by drawing 14 See http://www.unog.ch/80256EE600585943/(httpPages)/04FBBDD6315AC720C125 7180004B1B2F?OpenDocument. In 2004, the focus was “strengthening and broadening na - tional and international institutional efforts and existing mechanisms for the surveillance, detection, diagnosis and combating of infectious diseases affecting humans, animals, and plants; and in 2009 it was enhancing international cooperation, assistance and exchange in biological sciences and technology for peaceful purposes, promoting capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases: (1) for States Parties in need of assistance, identifying requirements and requests for capacity enhancement; and (2) from States Parties in a position to do so, and international organiza - tions, opportunities for providing assistance related to these fields.” 15 “The International Health Regulations (IHR) are an international legal instrument that is binding on 194 countries across the globe, including all the Member States of WHO. Their aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. … The IHR, which entered into force on 15 June 2007, require countries to report certain disease outbreaks and public health events to WHO. Building on the unique experience of WHO in global disease surveillance, alert and response, the IHR define the rights and obligations of countries to report public health events, and establish a number of procedures that WHO must follow in its work to uphold global public health security. The IHR also require countries to strengthen their existing capacities for public health surveillance and response. WHO is working closely with countries and partners to provide technical guidance and support to mobilize the re - sources needed to implement the new rules in an effective and timely manner. Timely and open reporting of public health events will help make the world more secure” (WHO, What Are the IHR?, http://www.who.int/features/qa/39/en/index.html).

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73 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS the WHO and the IHR into the realm of biosecurity (Kelle, 2006; Tucker, 2005).16 On the other hand, participants in the meetings hosted by the BWC ISU and key States Parties to prepare for the Review Conference tended to emphasize the perceived benefits to viewing cooperation on disease surveillance via Article X (China, Canada, and BWC ISU, 2010; Indonesia, Norway, and BWC ISU, 2010), as do a number of national strategy docu- ments (see, for example, White House, 2009a). 3.2.3 Laboratory Analysis and Response Capabilities As discussed in Chapter 2, advances in technologies such as biosen - sors (Section 2.1.7), along with other forms of epidemiological monitoring (Jeger, 2010; Kurochkin, 2010; Lin, 2010; Resnick, 2010), help build the essential components of an effective public health system. In addition to clinical and epidemiological monitoring to detect a disease outbreak, laboratory analyses are a valuable part of the disease surveillance and response system to identify and characterize the pathogen in more detail (Lin, 2010; Murch, 2010). Particular genetic mutations of a pathogen may be associated with greater virulence or with antimicrobial drug resistance, for example. Genetic sequencing and other laboratory studies may help to identify particular changes to be monitored. Human, animal, and plant pathogens evolve as they spread, and scientific approaches can help trace the likely movement of pathogen strains over time and location. A closely related field, bioforensics, which uses scientific tools to help identify the origin of a particular pathogen and thus has the potential to support the investigation of natural disease outbreaks or potential bioweapons incidents as well as to contribute to the global network of national and international public health disease surveillance labs, is discussed in the next section. The increased attention to global health security has included a sig- nificant expansion of laboratory capacity in many parts of the world, in part to support research and in part to enable identification of outbreaks close to the source. The increase in the number of laboratories working with highly dangerous pathogens has sparked concerns about safety and security. The 2007 World Health Report warned: As activities related to infectious disease surveillance and laboratory research have increased in recent years, so too has the potential for out- breaks associated with the accidental release of infectious agents. Breaches in biosafety measures are often responsible for these accidents. At the same time, opportunities for malicious releases of dangerous pathogens, 16A review of this debate in the context of the development of biosecurity as an issue may be found in Koblentz (2010).

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74 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION once unthinkable, have become a reality, as shown by the anthrax letters in the United States of America in 2001. (WHO, 2007b:xi) The most recent edition of the WHO’s Biosafety Manual, published in 2004, discusses biosecurity for the first time (WHO, 2004). The WHO’s 2006 Biorisk Management: Laboratory Biosecurity Guidance provides guidance to member states for developing national approaches that can “strike a balance” between traditional biosafety and more recent security concerns (WHO, 2006:1).17 And a 2010 report offers guidance on measures to address the risks of laboratory accidents or potential deliberate misuse “within the context of promoting and harnessing the power of the life sciences to improve health for all people” (WHO, 2010:1). In 2008, the European Committee for Standardization (CEN) pub- lished its International Laboratory Biorisk Management Standard, which seeks “to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities” (CEN, 2008:8). The recent rapid growth of national and regional biosafety associations is intended to develop the capacity to implement and sustain high standards for laboratory safety and security.18 In addition, a number of important initiatives focused specifically on security by national governments, regional organizations, and international partnerships are bringing substantial resources to bear to improve safety and security at laboratories around the world, along with more general public health capacity-building for surveillance and diagnosis.19 Examples include the U.S. National Strategy for Countering Biological Threats (White House, 2009a) and the programs to implement it, the European Commission’s CBRN Centres of Excellence, and the G8 Global Partnership Against the Spread of Weapons and Materials of Mass Destruction.20 17 The most recent edition of the Biosafety in Microbiological and Biomedical Laboratories from the U.S. National Institutes of Health, another widely used reference document, also added a discussion of laboratory biosecurity (CDC/NIH, 2007). 18 Additional information may be found at the website of the International Federation of Biosafety Associations (IFBA) at http://www.internationalbiosafety.org/english/index. asp. 19 The U.S. national strategy may be found at http://www.whitehouse.gov/sites/default/ files/National_Strategy_for_Countering_BioThreats.pdf. Information about the Centres of Excellence may be found at http://www.cbrn-coe.eu/. The 2011 report on the G8 Global Partnership may be found at http://www.g20-g8.com/g8-g20/g8/english/the-2011- s ummit/declarations-and-reports/appendices/report-on-the-g8-global-partnership- angainst-the.1353.html. 20 For more information see, for example, the Biosecurity Engagement Program of the U.S. Department of State at http://www.bepstate.net/, the Centres of Excellence at http://www. cbrn-coe.eu/, and the G8 Global Partnership at http://www.canadainternational.gc.ca/g8/ summit-sommet/2003/mass-destruction-massive.aspx?view=d.

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75 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS Although disease monitoring and surveillance is critically impor- tant, a workshop participant eloquently noted that “surveillance without response is nothing but the quantification of misery.” Immunological research to develop vaccines and medical countermeasures helps to pro- vide a capability to respond to identified outbreaks, and some of the recent advances are discussed in Section 2.1.3. The field also benefits directly from collaborative international scientific research as shown in Figure 3.2. The sizes of the circles on the figure represent numbers of jointly authored scientific papers in the field of vaccine development, while the lines represent co-author linkages. Although the United States and Europe are heavily represented, the map indicates that countries like Brazil, South Africa, India, China, and Thailand show nodes of significant involvement as well. In the area of animal diseases, a very recent global initiative may contribute to the research capacity to better understand some of these diseases. The Global Strategic Alliances for the Coordination of Research on the Major Infectious Diseases of Animals and Zoonoses (STAR-IDAZ) will include multiple partner counties and will be coordinated by the U.K. Department for Environment, Food and Rural Affairs (Defra) with the goal of improving information sharing, research coordination, and priority setting (http://www.star-idaz.net/). FIGURE 3.2 Patterns of international, multi-author journal publications in the field of vaccine development. SOURCE: Ilchmann et al. (2011), reprinted with permission from the Harvard Sussex Program. Figure 3-2 low-res, bitmapped

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76 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION 3.2.4 Discussion and Implications The combination of tools including sensors, forensics and other labo- ratory investigations, epidemiological monitoring, and vaccine research— and its increasingly global distribution—contribute to the development of effective disease detection, investigation, and response systems. The spe- cific tools and capabilities needed to investigate a disease outbreak will be scenario dependent, and it remains difficult to provide real-time awareness using surveillance networks. However, these multiple tools can provide a network of complementary support including general detection or rapid screening to flag a likely outbreak, specific diagnosis and more detailed characterization of the pathogen, and potential treatments that can be deployed to protect at-risk populations. Global travel and trade and the potential commercial as well as health implications of disease outbreaks highlight vulnerabilities in the system and also emphasize the important role of international cooperation in disease monitoring and response. 3.3 MICROBIAL FORENSICS: AN OPPORTUNITY TO TAKE ADVANTAGE OF GROWING INTERNATIONAL S&T CAPACITY TO SUPPORT THE BWC One of the fundamental components of any investigation of alleged hostile use of biological agents, whether by states or non-state actors, will be scientific analysis to support efforts at attribution. Science may not offer definitive solutions for all scenarios, but it often plays a special role in supporting other aspects of an investigation. The investigation of the 2001 anthrax mailings in the United States highlighted the role of micro- bial forensics in support of pathogen identification and attribution and served as a driver for the development of new microbial forensics tools and approaches (Connell, 2010; NRC, 2011b). Contrary to the images from popular media, however, microbial forensics is in the early stages of development and faces substantial chal - lenges that involve fundamental scientific questions. Dr. Randall Murch of the Virginia Polytechnic Institute and State University noted in his workshop presentation that many of the tools employed to investigate the anthrax strains are unique to that case and that only limited foren - sic systems have been worked out for other pathogens of interest. As a result, anthrax remains almost a unique case for which detailed forensics approaches are currently possible (Murch, 2010). Gaps in the development of microbial forensics that were identified during the discussions included a lack of common approaches and standards, as well as a lack of agree - ment on proper sample storage to prevent contamination. Given the controversies likely to surround any investigation of alleged use, there could be substantial advantages to building capacity

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77 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS in microbial forensics via international collaborations that engage the broader scientific community. The goal would be to create a shared techni- cal understanding of the possibilities—and limitations—of the scientific basis for microbial forensic analysis. Because many of the challenges are also important questions for the life sciences and related disciplines more generally, these collaborations could engage the very best scientific talent across a range of fields. The diffusion of research capacity described in this chapter means that the effort could be genuinely international from the beginning. Such collaborations would complement work already being done by government agencies and scientists in a number of countries, and could build connections between this work and the contributions to be made by the wider scientific community. Examples of some of the science questions identified by Dr. Murch and carried into the workshop discussions include: • How can systematics and genomics be reconciled to provide pre- cise, consistent, and robust approaches to identifying and charac - terizing sources of microorganisms that can be used as biothreat agents? • How could microbial systems be sampled to effectively address forensic questions? • What are the “big leaps” in physico-chemical methodology and technology development that are needed for microbial forensics and what would be gained from them? • What is the optimal and most adaptive combination of genomic and physico-chemical methods to achieve maximal forensic exploi- tation for current and future biothreat agents? • What is the most robust statistical approach for defining and com - municating certainty/uncertainty for microbial samples from known and questioned sources? • What computational and bioinformatics tools are needed to sup- port microbial forensics and what strategic approach could be developed to achieve them? • What science has yet to be developed to distinguish among natu- ral, deliberate, and unintentional outbreaks, and how can the time to doing so be reduced? In addition to supporting investigations of alleged hostile uses of biological agents, advances in technology to support microbial forensics could be potentially applied to further the development of biosurveillance and detection systems. The challenge of building capacity for micro- bial forensics presents one opportunity to take advantage of life sciences research from around the world to support the work of the BWC.

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78 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION 3.4 DOING LIFE SCIENCES RESEARCH OUTSIDE TRADITIONAL INSTITUTIONS The abundance of kits and commercial services now associated with modern life sciences research discussed in Section 3.1.2 above, coupled with excitement about the possibilities of discovery in rapidly advancing S&T, supports another important form of diffusion: enabling individuals and groups to do research outside traditional research institutions. In some cases these are trained scientists taking advantage of commercial kits and services, as well as the availability of secondhand equipment, to build their own laboratories and conduct experiments (Carlson, 2005). In other cases these are individuals who are undertaking research without having the detailed biological or mechanistic understanding previously required in the life sciences. Innovative approaches to engaging students in hands-on research early in their studies are another example. Although there are important differences among the cases, they are all frequently included in discussions of “amateur,” “garage,” or “do-it-yourself” (DIY) biology (Ledford, 2010; Penders, 2011). 3.4.1 Engaging Students: The International Genetically Engineered Machines (iGEM) Competition The creation of registries of biological “parts” (sequences of DNA that can be combined in a straightforward manner to ultimately perform par- ticular biological functions),21 a key goal for one portion of the synthetic biology community, also raises the possibility that steps used in traditional genetic engineering and molecular biology are becoming more standard- ized and easier to accomplish. iGEM, which began at the Massachusetts Institute of Technology (MIT) in 2003, provides teams of undergraduate students with an assortment of standard parts to use to design new biolog- ical systems; the competition has recently added a division for high school teams.22 The 2010 competition included 130 groups from more than 29 countries, including 5 teams from countries in Latin America and Africa. Projects in 2010 included the modification of biosynthetic pathways (Slo - venia); the creation of a “Virus Construction Kit” of components for adeno- associated virus (AAV)-based viral gene therapy (Freiburg, Germany); and the creation of a bacterial diagnostic biosensor designed to respond as a population to a particular viral infection (WITS, South Africa). Reflecting the growing global participation, the 2011 competition will begin with 21 The Registry of Standard Biological Parts, used by the iGEM competition, is available online, as “part of the Synthetic Biology community’s efforts to make biology easier to en - gineer” (http://partsregistry.org/). 22 More information is available on the iGem website at http://ung.igem.org.

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79 DIFFUSION OF LIFE SCIENCES RESEARCH CAPACITY AND APPLICATIONS regional competitions in Europe, Asia, and the Americas in October, fol- lowed by the Worldwide Championship in November at MIT. 3.4.2 DIY Bio Just as the iGEM competition arises out of the synthetic biology com- munity, much of the excitement within and around the amateur biol- ogy community has also come to be linked with the ability to manipu- late DNA and with the synthetic biology goal of making biology easier to engineer.23 The website Diybio.org (http://diybio.org/) lists local groups of amateur biologists in a variety of major cities, primarily in the United States and Europe, although groups are also listed in India and Singa- pore. These local groups may offer community lab space to help facili- tate hands-on experiments (e.g., Genspace in New York [http://genspace. org/] or BioCurious in California [http://biocurious.org/]), or offer training to help people get started. Some DIY biologists also construct or purchase their own inexpensive versions of equipment for perform- ing common laboratory tasks such as electrophoresis or thermal cycling, and information and videos are available online (Ledford, 2010). See, for example, Teklalabs (http://www.teklalabs.org/about/) and Singular- ity Hub (http://singularityhub.com/2010/08/03/making-the-modern- do-it-yourself-biology-laboratory-video/). It is not yet clear how widespread truly amateur biology has become, but it seems reasonable to expect that this trend will grow in the future. This underscores the need to understand how training and know-how are propagated and cultures of safety are developed in such noninstitutional environments. How does one identify and reach out to those who may operate unaware of (or indifferent to) government regula- tory frameworks, which is the typical province of the BWC? 3.4.3 Discussion and Implications Improving the understanding of and excitement for life sciences among the public can be seen as advantageous, because scientific research relies on public trust and public funding and because policies to address a range of issues require public engagement. It is obviously important from a safety and security as well as an educational standpoint that students and amateur/DIY biologists are able to safely conduct their experiments and that they are able to understand possible risks and ethi- cal considerations. 23 In the same manner that synthetic biologists have adopted electrical engineering and computer science terminology (referring to DNA as the “software” of life for example), some in the amateur biology community refer to themselves as “biohackers.”

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80 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION iGEM requires teams to answer safety-related questions about their proposed projects as part of their application for the competition, and judges are to consider the answers in assessing the proposals. The website includes references to various international, regional, and national policies and regulations related to biosafety. The potential for intentional misuse of research results is also addressed. The website includes references to the BWC as the key international legal agreement and to resources related to responsible conduct as well as national guidelines and regulations.24 Dr. Piers Millet from the BWC’s Implementation Support Unit serves as an iGEM judge and resource, and in 2010 a U.S.-French team received a special safety and security award for its development of screening soft - ware to identify whether DNA parts in the iGEM Standard Registry of Parts came from pathogens or toxins.25 According to its website, “One motivation for establishing DIYbio. org in advance of widespread amateur activity in the life sciences is to create a framework for best practices worldwide,” including resources on biosafety and norms of ethics and practice (http://diybio.org/safety). In the United States, the American Association for the Advancement of Sci - ence is working with the Federal Bureau of Investigation (FBI) on a series of outreach activities to the amateur biology community. The meetings, which began in 2009, include researchers, FBI and other government offi- cials, and members of the amateur biology community (AAAS, 2011). The FBI also has an active outreach program to U.S. iGEM teams. Life sciences knowledge and research capacity continue to become more available to communities who operate outside of traditional settings. However, although commercial kits and services and other advances such as standardized DNA parts provide efficiencies and ease-of-use, when it comes to less highly trained practitioners, it is important to note that suc- cessful achievement of experimental goals generally relies on more than these products. Valuable knowledge and skills are also acquired through experience, and the importance of having these additional levels of knowl- edge increases with the complexity of the research projects undertaken. 24 For example, the iGEM website contains a box suggesting that “as a participant in iGEM, there are three things you can do right now to help us secure our science: • nclude something in your project description and presentations that demonstrates that I you have thought about how others could misuse your work • Contribute to community discussions on what needs to go into a code against the use of our science for hostile purposes (see A Community Response) • Look into what security provisions, such as laws and regulations, are already in place in your country (see Working within the Law).” 25 More information is available at http://2010.igem.org/Security.