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In the fall of 2010, the U.S. National Academies (consisting of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council) and the Russian Academy of Sciences (in cooperation with the Russian Academy of Medical Sciences and the Russian Academy of Agricultural Sciences) initiated a joint study of U.S.-Russian bilateral engagement in the biological sciences and biotechnology (hereinafter collectively referred to as bioengagement). The U.S. Department of State and the Russian Academy of Sciences provided support for the study. The academies established a joint committee of 12 leading scientists from the two countries to assess bioengagement activities since 1996 and to provide recommendations as to collaborative efforts in the near future. The principal conclusions and recommendations of the study are set forth in this summary and are elaborated in the complete report.

Shared health, agricultural, and environmental interests of the United States and Russia, together with common security concerns, involve activities of national and international interest spread over vast ecological landscapes that cover 34 percent of the land surface of the northern hemisphere. The countries have two of the world’s largest scientific work forces, skilled in virtually all aspects of the life sciences. Their specialists have repeatedly demonstrated how bioengagement can advance science, contribute to economic and social progress, and promote international security. Many of these scientists have developed long-term professional and personal relationships across the ocean that have helped advance their scientific capabilities and broaden their global perspectives. The two countries are now well positioned to capitalize on joint achievements of the



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Summary In the fall of 2010, the U.S. National Academies (consisting of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council) and the Russian Academy of Sci- ences (in cooperation with the Russian Academy of Medical Sciences and the Russian Academy of Agricultural Sciences) initiated a joint study of U.S.-Russian bilateral engagement in the biological sciences and biotechnology (hereinafter collectively referred to as bioengagement). The U.S. Department of State and the Russian Academy of Sciences provided support for the study. The academies established a joint committee of 12 leading scientists from the two countries to assess bioengagement activities since 1996 and to provide recommendations as to collaborative efforts in the near future. The principal conclusions and recom- mendations of the study are set forth in this summary and are elaborated in the complete report. Shared health, agricultural, and environmental interests of the United States and Russia, together with common security concerns, involve activities of national and international interest spread over vast ecological landscapes that cover 34 percent of the land surface of the northern hemisphere. The countries have two of the world’s largest scientific work forces, skilled in virtually all aspects of the life sciences. Their specialists have repeatedly demonstrated how bioengagement can advance science, contribute to economic and social progress, and promote international security. Many of these scientists have developed long- term professional and personal relationships across the ocean that have helped advance their scientific capabilities and broaden their global perspectives. The two countries are now well positioned to capitalize on joint achievements of the 1

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2 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY past while pursuing emerging bioengagement opportunities that can continue to benefit both countries. Looking to the future, the Russian government is in the process of terminat- ing Russia’s involvement in the Cooperative Threat Reduction Program admin- istered by the U.S. Department of Defense (often referred to as the Nunn-Lugar Program), the foreign assistance efforts of the U.S. Agency for International Development, and the activities of the International Science and Technology Center. These three programs have provided important pillars of U.S.-Russian bioengagement efforts for many years. But during the past several years the U.S. government has significantly reduced financial support for bioengagement through these and other channels in favor of competing budget priorities. Despite the foregoing developments, the committee responsible for this report considers that the case is strong for expanding U.S.-Russian bioengage- ment, even in the face of budget stringency by both governments. The stakes are significant, the established base for collaboration is unprecedented, and many of the potential payoffs from future joint efforts are clear. The broad-ranging assess- ment in this report of lessons learned and of future collaboration opportunities should help ensure that the governments and the scientific leaders in both coun- tries now give adequate attention to the many dimensions of and rewards from U.S.-Russian bioengagement. BIOENGAGEMENT IN THE LATE 1990s AND EARLY 2000s Following the splintering of the Soviet Union into 15 independent states, officials in Washington, Brussels, and other western capitals, in cooperation with Russian government counterparts, launched a number of bilateral and multilateral programs to help limit internal and external brain drains of Russian scientists whose salaries were no longer adequate for meeting even minimal needs. A par- ticular concern was the possibility that Russian scientists with important nuclear, biological, chemical, or aerospace skills who were facing difficult economic problems might accept financial support from nefarious sources interested in using Russian expertise for dangerous purposes. At the same time, scientists in the West, as well as their colleagues in Russia, were apprehensive that without an infusion of financial resources from abroad, civilian-oriented capabilities of Rus- sia’s scientific institutions that were of international significance would decline and eventually be lost. In a few years, bioengagement reached unprecedented heights. The U.S. government provided substantial financing. Russian institutions that were inter- ested in bioengagement provided important matching resources along with their extensive knowledge base. Since the mid-1990s, U.S. and Russian organizations have invested more than $1 billion in bioengagement, with the U.S. side cover- ing most of the direct costs. The Russian side has covered many of the indirect expenses, such as costs of utilities, facility improvements, program management

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SUMMARY 3 and documentation, and other overhead expenses, as well as provided most of the scientific expertise. Much of the funding and expertise has been linked to (a) proliferation concerns of both countries and (b) health components of the U.S. foreign assistance program. Bioengagement had a profound effect in preserving important segments of the research infrastructure of Russia during times of severe economic difficulties. Thousands of Russian life scientists who participated in joint projects had new opportunities to contribute to (a) advancement of science, (b) applications of sci- entific findings leading to better and cheaper products and improved services that help meet the needs of the population, and (c) assessments of important health, agricultural, and environmental issues of regional and global significance. At the same time, hundreds of American scientists have benefited from collaborations with Russian colleagues whose expertise, experience, and access to territories, facilities, and data banks had been little known outside Russia. REVITALIZATION OF RUSSIA’S CAPABILITIES Currently, Russia is reshaping its scientific infrastructure. Several hundred Russian biology-oriented research laboratories are now well equipped and staffed to work at an international level. Many more health, agricultural, and environ- mental facilities provide updated services with broad-ranging benefits for impor- tant segments of the population. Russian scientific publications in internationally accredited journals, while still very limited in number, are commanding increased scientific interest. At the same time, emigration of outstanding young Russian scientists in recent years has been a serious loss that limits Russia’s scientific capabilities. Today a new generation of well-educated young professionals with up-to-date skills and interests is slowly filling important gaps in the availability of technical personnel in the country. In most areas of the biological sciences and biotechnology, the United States is technologically more advanced than Russia. Also, scientists working in U.S. facilities, with broad access to modern equipment and to skilled technical support staffs, are generally able to work more efficiently than counterparts in Russia. This gap arises not only because science is better financed in the United States than in Russia but also because U.S. scientists have more experience in managing research activities that yield results suitable for application in a market economy. Substantial financial support of U.S. science also (a) helps ensure stability of the technical workforce and (b) provides broad opportunities for international connectivity of scientific centers. Moreover, in the United States there has been a consistent focus on strengthening basic research capabilities. In this regard, an important U.S. priority has been providing opportunities for scientists in the early stages of their careers to become important participants in exploring unfolding fields of science.

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4 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY In a number of subfields, Russian scientists are making contributions at the forefront of the life sciences. Russian achievements, when coupled with U.S. strengths, often offer important synergistic effects in advancing capabilities of both countries to work effectively in these subfields, such as enhancing under- standing of the characteristics of the influenza A/H5N1 virus. When projects focus on conditions in specific geographical environments, each country has unique experience that combined may offer remarkable scientific insights that would not otherwise be possible. IMPACTS OF BIOENGAGEMENT The investments of the United States and Russia in bioengagement during the past 15 years are paying off in important ways. Communications between counterparts have been commonplace, addressing not only the details of joint projects but also broader professional interests. As a result, the development of unique research approaches has been frequent, and research findings of joint efforts have been significant. At times, working together has dramatically reduced preconceived suspicions about the possibility of inappropriate intentions of the leaders of previously closed scientific facilities in the two countries. Transparency and insights as to accomplishments and future plans have increased greatly. It is important for both countries and for the advancement of science more broadly that the personal relationships that have led to openness and confidence building over the years be maintained. Significant public- and private-sector organizations in the two countries are now well positioned for and interested in intensifying research collaboration that would benefit both countries. Also, following a long period of hesitation, a few entrepreneurial investors in the two countries have taken initial steps to develop joint commercial opportunities in the biotechnology marketplace. Of particular significance has been “working together” in the development of effective approaches for (a) ensuring biosafety when handling dangerous patho- gens, (b) improving disease surveillance capabilities, (c) reducing the prevalence of agricultural pests and pathogens, and (d) assessing and reducing environmental problems. American and Russian colleagues are now well prepared to continue their cooperative efforts more effectively than during their initial pioneering expe- riences. The likely positive impacts of collaboration certainly deserve appropriate recognition by the two governments in their policy and budget decisions affecting bioengagement. At the policy level, the U.S.-Russia Bilateral Presidential Commission estab- lished in 2009 has provided an important mechanism for encouraging political support of new bioengagement initiatives, as well as for coordinating and facili- tating ongoing collaborative programs.

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SUMMARY 5 NEW RUSSIAN INVESTMENTS As previously noted, during the past several years, there has been a steady decline in the extent of bioengagement. The United States has shifted much of its financial resources from programs centered in Russia to programs sited in other areas of the world. The Russian government has only slowly followed through on long-standing commitments to share more fully the direct costs of bioengagement activities that benefit both countries. Meanwhile, the Russian government has initiated a number of new programs, with mandates for international outreach. One priority area is the biomedical field. The other priorities are nuclear, space, information, and energy technolo- gies. Activities of special interest are the following: • The Skolkovo Foundation is supporting the establishment of a flag- ship high-technology education-research complex headquartered near Moscow, which is being designed with the participation of the Massachusetts Institute of Technology. • The Skolkovo Foundation also provides research and development grants in the five priority areas listed above, primarily to Russian companies, with occasional involvement of Russian institutes and universities working with international partners. These partners receive tax exemptions, customs privileges, and other incentives that encourage their participation. • Rusnano, which is supported by the Russian government, is providing grants and contracts to Russian companies and also at times to institutes and universities for activities that are designed to lead to near-term commercialization of nanobiotechnologies, drawing on the experience of the United States and other countries when considered appropriate. • Russian government-supported venture funds are investing in U.S.-based start-up and established companies, including biotech companies, which in turn will engage both commercial and research organizations based in Russia. • The Kurchatov Institute of Atomic Energy, heralded as the country’s first national laboratory, is expanding its new nanobiology facilities and is seeking relationships with U.S. organizations with common interests. • In April 2012, the Russian government issued a broad decree calling for establishment of a framework for a national biomedical program (Pharma 2020), although the funding to carry out this program has been uncertain. It is too soon to assess the importance and impact of these recent activi- ties, which are oriented to promoting Russian scientific and economic interests, including expansion of opportunities for international cooperation. The new types of Russian investments in biomedical activities are planned to reach levels in the tens of millions of dollars annually, and investments are beginning. A number of Russia’s leading scientists, including well-known biologists, are participating in

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6 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY the programs. Significantly, the political support of the Russian government for these activities during the next several years seems reasonably assured, which should provide Russia with opportunities to leverage its own investments through international collaboration. These and other biology-related outreach initiatives of the Russian govern- ment emphasize biomedical applications, with most of the government funding provided to companies, including state-owned companies, and to applied research laboratories and service organizations. The basic research capabilities of the country—particularly the capabilities of laboratories that are organizationally linked to the Russian science academies, universities, and research branches of several ministries—also need strengthening, with international collaboration an important mechanism to achieve upgraded capabilities. Leading Russian biolo- gists recognize that a strong and broad basic science infrastructure is essential for development of new drugs, vaccines, and other medical products. But there are skeptics in both Russia and the United States who are not convinced that a broadening of basic research in Russia, in and of itself, will contribute in a sig- nificant manner to the “return” on investments made by the Russian government. Several less ambitious Russian government initiatives have recently been directed toward strengthening research at universities. They include (a) the des- ignation of 29 elite universities as “research universities,” with access to special governmental funding, including several universities with well-developed pro- grams in the life sciences and (b) 79 megagrants of $5 million each over 3 years for establishing new research laboratories within the universities. These labora- tories are to be led by internationally respected scientists from within Russia and from abroad. However, relatively few of the initiatives targeted on universities have been directed to the life sciences thus far. In short, in Russia’s efforts to improve contributions of the life sciences to economic and social progress, the government has not given adequate priority to strengthening basic research capabilities. To be economically competitive in the long run, public- and private-sector organizations involved in manufacturing and in providing services need a steady infusion of novel ideas and new talent from the nation’s basic science and higher education institutions. The traditional focus by the U.S. government on U.S. universities that support the life sciences is now paying off, both in basic and applied science. Meanwhile, Russia continues the important task of strengthening its medical education and applied research com- plexes. Thus, both countries can gain from one another through bioengagement, although the approach should be tailored to the specific interests and capabilities of the participating institutions. Of special interest in both countries is nurturing the capabilities of young scientists. Many highly creative young Russian life scientists are now remaining in Russia, where some are attracted by financial incentives offered by emerging and expanding biotech companies. Such newly minted industrial researchers are becoming very focused on near-term applications of existing technologies. This

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SUMMARY 7 orientation is understandable. But comparable applications of the talents of young scientists in searching for fundamentally new approaches are also important, and the government should strongly support their research activities. Meanwhile, many U.S. and other western organizations are hesitant to become financially involved in the new biotechnology activities in Russia. A long history of problems in ensuring a business-friendly environment in Russia that provides appropriate protection for financial investments from abroad does not fade easily from memory. Fortunately, Russian partners with good understanding of the importance of responsible handling of international investments are now emerging; and U.S. institutions should be alert to bioengagement opportunities that will avoid difficulties of the past. Also of significance are Russian capabilities in the life sciences that are not directed to biomedical applications. Hundreds of well-respected university and academy centers direct their attention to basic issues in the agricultural and environmental sciences, often on skimpy budgets. In recent years, opportunities for cooperation in these fields have been manyfold with considerable payoffs for the participants. They continue to deserve attention by organizations in the two countries that have access to funds for outreach programs. THE FUTURE OF BIOENGAGEMENT Against a background of declining U.S. financial support for bioengage- ment programs, strengthened capabilities of Russian institutions to be effective partners, and greater Russian government interest in biotechnology, increased support for future bioengagement deserves careful consideration. Common sci- entific interests, complementary activities under different but related geographical circumstances, and unprecedented experience of specialists from the two coun- tries in effectively working together for more than a decade are unrivaled. They provide compelling reasons for revitalizing bioengagement activities that include, but extend beyond, a biomedical focus. The committee responsible for this report concludes that it is clearly in the interest of the United States and Russia for the governments to support a robust bioengagement program, involving both government and private- sector institutions and initiatives. The likelihood of achieving high-value pay- offs from carefully designed and well-implemented programs is high. A continued decline in financial support of bioengagement would be a serious mistake, one that should be reversed through joint action of the two governments. Indicators of success range from joint scientific publications to new trade opportunities to enhanced transparency. Also, of considerable importance is the establishment of lasting personal relationships among scientists with common interests in the responsible use of science for social and economic betterment. Most of the recent bioengagement programs supported by the two govern- ments have achieved their short-term objectives and have set the stage for follow-

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8 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY on activities. These achievements include (a) strengthened physical security, and particularly biosafety measures, surrounding biological materials of concern; (b) improved protection of the population from the spread of infectious diseases; (c) enhanced agricultural productivity; and (d) upgraded approaches to preservation of ecological resources. Also, the increasing interest of the two governments in working together to encourage private-sector initiatives has been important in encouraging the long-term evolution of a market economy in Russia. The two governments have decided to terminate most security-driven bioen- gagement activities, and particularly the enhancement of physical protection of biological materials in Russia, given the strengthened capabilities of the coun- try to address its own internal security concerns. However, the governments recognize that the prevention of proliferation has many dimensions, including providing scientists with defense-related backgrounds with the skills and oppor- tunities to pursue stable civilian-oriented career tracks. Joint programs often indirectly enhance biosecurity, while advancing science. Such programs also can (a) emphasize responsible science when dealing with uncertain technologies in fields such as synthetic biology, (b) encourage greater emphasis on bioethics, and (c) strengthen biosafety. In these areas, U.S. and Russian institutions can and should continue to demonstrate how bioengagement contributes to biosecurity. (For the purposes of this report, biosafety is defined as: “Prevention of exposure to harmful biological agents and measures taken to this end.” Biosecurity is defined as: “A complex of measures that include biosafety, while also providing for physical safekeeping of biomaterials and for prevention of inappropriate use of biomaterials.”) No other countries have moved forward from such a pervasive past of sus- picion and conflicting objectives than those that characterized U.S.-Russian rela- tions in the early 1990s to an era of confidence and mutuality of program goals that have characterized the U.S.-Russian relationship in recent years. Thus, the committee’s first recommendation is that the two governments support and expand ongoing bioengagement activities that have clearly demonstrated significant scientific and related benefits for both countries. Currently active cooperative programs are quite limited, funded at a level that supports about 20 percent of the range of activities that were under way a few years ago. Some programs may require modifications, particularly those that were justified in the first instance by their potential to redirect former defense scientists to civilian activities. The best incentive for introducing modifications of past approaches is the likelihood of future funding opportunities that encourage such modifications. In short, a revitalized approach is needed and should be actively pursued. Second, the committee recommends that the two governments establish a jointly financed new research fund, under the direction of an independent board of directors, with its members appointed by the two governments. The fund should have small offices embedded in existing institutions in both

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SUMMARY 9 countries, thereby avoiding the complications of establishing new legal enti- ties. The fund should enable American and Russian scientists from interested institutions to join in designing and carrying out projects that enhance important components of the research and development cycle, with special emphasis on basic research activities. This emphasis can provide specialists in both countries access to achievements in the other country that are in the formative stage. Their assessments of developments can best be carried out during onsite discussions and collaboration. In short, each project supported by the fund should be of scientific inter- est to and implemented by researchers in both countries working together. To attract both well-established and young scientists and to build lasting networks of researchers with common interests, most projects—selected on the basis of carefully structured peer reviews—should be relatively large (e.g., up to $2 mil- lion for 3-year projects) and involve scientists from several institutions. Each side should commit to joint funding; and the financial resources should be disbursed in a coordinated manner, with 50 percent of the overall funds to collaborating institutions in each country, although the division of funding will undoubtedly vary with specific needs from project to project. Given the breadth of the life sciences and the demonstrated capabilities of the United States and Russia to cooperate effectively in many areas, the annual launch of 15–20 projects over a period of 5 years could effectively engage a num- ber of key laboratories and specialists in important scientific relationships. Highly visible, easily understood, and long-term impacts would be important goals for the projects. Successful efforts very likely would attract additional follow-on sup- port from other national and international sources. Such sources would include, for example, the previously identified new outreach initiatives being developed by the Russian government and the currently latent international interests of the U.S. private sector in research investments in Russia. Among the topics that are suitable for joint investigations are the following: • Development of novel therapeutics, diagnostics, drugs, and vaccines. • Improvements in disease surveillance and monitoring techniques. • Introduction of new approaches and techniques in synthetic biology. • Understanding and curtailment of negative influences on animal health and latent zoonotic diseases. • Measures to control plant diseases. • Understanding and preservation of biodiversity. • Research with dangerous pathogens requiring specialized biocontain- ment facilities and highly experienced staff capabilities. The committee’s third recommendation is that the two governments continue their efforts to reduce the impediments to cooperation. At the top

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10 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY of the list of persistent problems are the difficulties in obtaining appropriate visas for cooperative activities in a timely manner. Current efforts of the two govern- ments to improve the visa situation should continue. Other potential impediments to cooperation relate to tax and customs aspects of joint projects, restrictions on international shipments of biological materials, intellectual property rights associated with joint projects, and compliance with export control requirements.