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10

Recommendations for Future Bioengagement

The Introduction of this report underscores the difficulty in estimating direct and indirect costs of public and private investments in bioengagement activities. While estimates are far from precise, they clearly indicate that annual investments of the two countries in bioengagement decreased from more than $100 million a decade ago to less than $25 million in 2011. Many important bioengagement collaborations have terminated, and significant opportunities for pursuing innovative joint efforts have been lost. This chapter recommends appropriate investments that will revitalize bioengagement while advancing broad-ranging interests of both countries.

Some bilateral programs described in Chapters 2, 3, 4, and 5 and in the appendixes will probably continue to receive financial support by the two governments and by the private sector, without the need for new advocacy efforts (e.g., cooperation in surveillance and reporting of infectious diseases that cross international borders, and responses to market demands for express diagnostic tools). However, many other programs based on important mutual interests in bioengagement will be terminated or may not even begin if governmental funding for bilateral activities continues to decrease.

The overall level of bioengagement activities is determined by many individual decisions of a wide variety of funding and implementing organizations in the two countries. Each organization has its own priorities and financial constraints, and the criteria in selecting projects for support vary across funding organizations. Projects advocated by different organizations simply do not compete one-against-another in practice.

Thus, the committee is not in a position to select specific programs that deserve priority in competition with other bilateral or international programs.



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10 Recommendations for Future Bioengagement The Introduction of this report underscores the difficulty in estimating direct and indirect costs of public and private investments in bioengagement activities. While estimates are far from precise, they clearly indicate that annual investments of the two countries in bioengagement decreased from more than $100 million a decade ago to less than $25 million in 2011. Many important bioengagement col- laborations have terminated, and significant opportunities for pursuing innovative joint efforts have been lost. This chapter recommends appropriate investments that will revitalize bioengagement while advancing broad-ranging interests of both countries. Some bilateral programs described in Chapters 2, 3, 4, and 5 and in the appendixes will probably continue to receive financial support by the two gov- ernments and by the private sector, without the need for new advocacy efforts (e.g., cooperation in surveillance and reporting of infectious diseases that cross international borders, and responses to market demands for express diagnostic tools). However, many other programs based on important mutual interests in bioengagement will be terminated or may not even begin if governmental funding for bilateral activities continues to decrease. The overall level of bioengagement activities is determined by many individ- ual decisions of a wide variety of funding and implementing organizations in the two countries. Each organization has its own priorities and financial constraints, and the criteria in selecting projects for support vary across funding organiza- tions. Projects advocated by different organizations simply do not compete one- against-another in practice. Thus, the committee is not in a position to select specific programs that deserve priority in competition with other bilateral or international programs. 115

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116 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY However, the committee has identified promising areas of research for consid- eration by governments and the private sector as priorities for collaboration. Then action-oriented political decisions, supported with financial commitments, at senior levels of the two governments are needed to implement recommended approaches, if the uniqueness of the U.S.-Russian relationship in the life sciences is to be maintained. THREE RECOMMENDATIONS Given the benefits from U.S.-Russian bioengagement activities that have been repeatedly recorded in recent years, the committee recommends continu- ation and, to the extent possible, expansion of U.S.-Russian programs that have been considered by the sponsors and the participants in the two countries to have been successes and hold promise for even more fruitful rewards in the future. Much of the focus will probably be on themes wherein Russian strengths are recognized internationally as complementing capabilities of the United States, which is the global leader in many fields. The current portfolio of current bioengagement projects includes only a few activities directed primarily to nonproliferation or science-infrastructure enhance- ment in Russia, the main emphasis when bioengagement was on the rise in the early 2000s. The several activities that are currently directed to these objectives are devoted in large measure to transferring U.S. experience to Russian institu- tions that are rapidly accepting the responsibility and financial burden for their own activities. At the same time, however, there is increased appreciation in both countries of the importance of strengthening public health and agriculture production systems on a broad basis for not only achieving health and food goals but also contributing to achievement of security and environmental objectives. Most projects that are currently in place are intended to meet goals of the future without clinging to outdated objectives of the past. Such forward-looking projects deserve special attention as the overall character of the U.S.-Russian relationship continues to evolve. Second, the committee recommends establishment of a bilateral research fund to enable highly qualified specialists in the two countries to join together in new collaborative endeavors at the leading edge of the life sciences. The emphasis is on strengthening basic research, which is essential in providing the ideas and skills for eventually taking scientific achievements to the public- and private- sector markets. In each country, strong research capabilities should undergird development of biotechnology efforts that are internationally competitive and in time should become self-supporting. Many highly qualified research institutions in the two countries have demonstrated their capabilities to be stable and reliable focal points for productive bioengagement. The new fund, which would build on these capabilities, is discussed later in this chapter. Illustrative research areas that are particularly attractive for collaboration are identified.

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RECOMMENDATIONS FOR FUTURE BIOENGAGEMENT 117 Third, earlier chapters have identified both (a) steps that can facilitate imple- mentation of joint programs and (b) difficulties that continue to inhibit effective collaboration. Thus, the committee recommends that the two governments continue their efforts to reduce the impediments to cooperation. In previous chapters, the problems associated with visas, taxes, customs, intellectual property rights, export control, financial accountability, lack of trans- parency, and other common difficulties were discussed. The time and resources lost in coping with administrative issues should be minimized. The Science and Technology Working Group of the Bilateral Presidential Commission should continue to focus on improving policies of the two countries that reduce admin- istrative complications of joint scientific efforts. ELABORATION OF PROPOSAL FOR A NEW BILATERAL RESEARCH FUND The committee recommends that the two governments establish the new research fund under the direction of an independent board of directors, with its members appointed by the two governments (e.g., perhaps five established scien- tists from each country who would be ineligible to compete for project awards by virtue of their membership on the board). The fund should have small offices in both countries, hosted by respected scientific organizations in the countries that have existing authorities to award research grants, thereby eliminating the need to establish new legal entities, at least at the outset of activities. The fund should encourage American and Russian scientists from interested research institutions to jointly design projects that enhance important components of the research and development cycle, with special emphasis on basic research activities of national and global importance. (Appendix F.4 identifies other international efforts to provide funding mechanisms that were considered.) The committee is not in a position to determine the most appropriate host organizations in Russia or the United States where the offices of the fund would be embedded. The two governments must weigh a number of organizational and financial issues in making such determinations. Also of importance will be the views of the scientists and others who are selected to lead the fund. The emphasis on basic research is important, given the current trends in Russia to invest an excessively large proportion of available resources for life science initiatives into applied research and development activities with the pos- sibility of near-term payoffs (e.g., policies of Rusnano). Thus, the significance of the proposed fund as a complement to other unfolding opportunities that stress biotechnology is clear. In the long run, the basic research component of activities in both countries will be essential in advancing biotechnology. Each project supported by the new fund should be of scientific interest to researchers in both countries. To attract leading scientists and to help build last- ing networks of scientists with common interests, most projects—selected on the

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118 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY basis of carefully structured peer reviews—should be relatively large (e.g., up to $2 million for 3-year projects). At times, clusters of small projects focused on related objectives might be bundled as a single project. Each side should com- mit to equal funding; and they should then disburse their financial resources in a coordinated manner, with about 50 percent of the overall funds directed to col- laborating institutions in each country. The division of funding responsibilities for individual projects will undoubtedly vary. The fund should have a project development component. Scientists, and particularly young investigators, who have good ideas but not strong existing connections with colleagues in the other country might be awarded small travel grants on a competitive basis. They would then have an opportunity to interact with potential partners and, if appropriate, develop with colleagues proposals for consideration by the fund. This get-acquainted approach has been quite useful in the development of linkages in the past. Among the criteria that should be considered in selecting recipients of research awards are the following: • Uniqueness of the combined capabilities of the Russian and U.S. scien- tists to address technical issues that are important in achieving both national and global scientific objectives. • Involvement of scientists in international cooperation during the early stages of their careers, thereby increasing the likelihood that successful coopera- tion will be continued for a lengthy period. • Contribution of the research in demonstrating how a culture of respon- sible science should pervade many global research activities, with particular attention to conservation of biological resources and to mitigation of concerns over inappropriate use of sensitive technologies. Given the breadth of the life sciences, the annual launch of 15–20 projects over a period of 5 years would engage a number of key laboratories and special- ists in a number of important and rapidly developing scientific relationships. Highly visible and easily understood outcomes would be the goal for each proj- ect. Successful efforts would in some cases attract additional follow-on support from other national and international sources. Such sources would include, for example, the previously identified new outreach initiatives being developed by the Russian government, such as the Skolkovo initiative, and currently latent interests of the U.S. private sector in research and manufacturing investments in Russia. Among the topics that could be considered for joint investigations are the following: • Novel therapeutics, diagnostics, and vaccines. Examples are multidrug- resistant tuberculosis therapies, rapid and inexpensive point-of-care diagnostics

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RECOMMENDATIONS FOR FUTURE BIOENGAGEMENT 119 for both common and rare but devastating diseases, inexpensive and reliable water and food quality testing, viral therapeutics, and stem cell therapies. • New preparations and drugs for combating cancer, together with new methods for diagnosis and treatment of cancer. • Improvements in disease surveillance and monitoring techniques of priority interest to the two countries. Examples are molecular and genetic studies of influenza, viral infections linked to oncology diseases, respiratory infections, intestinal illnesses, and vector-borne diseases. • New approaches and techniques in synthetic biology. Examples are investigations of genome, proteome, and metabolic pathways; development of improved diagnostic tools; and studies of chemical and protein synthesis. • Animal health and latent zoonotic diseases. Examples are avian influ- enza, porcine reproductive and respiratory syndrome, African swine fever, and foot-and-mouth disease. • Plant resilience. Examples are control of potato blight and soybean and wheat diseases; adapted cultivars for alfalfa and grapes; protection against inva- sive weeds; and genetic modifications to reduce disease susceptibility. • Understanding and preservation of biodiversity. Examples are catalog- ing and analyzing plant, animal, and microbial biodiversity in contaminated and pristine ecological regions, including regions distant from large urban centers. • Research with highly dangerous pathogens requiring specialized bio- containment facilities and highly experienced staff capabilities. Examples are investigations of Ebola, Marburg, and variola viruses of special interest to the governments. • Development of medical software. Examples are improved telemedicine methodologies, and upgrading of medical database technology and transfer. • Investigations of antidotes to counter adverse health and ecological aspects of organophosphorous compounds used in pesticides and herbicides. Each award could involve not only two lead laboratories but other supporting laboratories on each side as well, thereby building expanded networks of collabo- rators that would strengthen the future international framework for collaboration. As previously noted, these networks might also include clusters of small groups of researchers from different institutions. An early concern of the committee was the capabilities of a sufficient number of Russian laboratories to operate at the international level for such a program. However, the Russian Academy of Sciences has several hundred biological research laboratories that have capabilities of worldwide interest. Expanding this estimate to include laboratories of all three Russian academies, Russian universities, and branch institutes in Russia, there are a sufficient num- ber of well-rated Russian laboratories to warrant establishment of the program— with 5 to 20 experienced investigators and highly talented young investigators in each laboratory.

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120 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY As to the size of the grants, the megagrant program of the Russian govern- ment provides 3-year grants of $5 million to individual universities that are expected to create new research laboratories with outreach internally and inter- nationally. At the other extreme, the Russian Foundation for Basic Research provides small grants, usually less than $25,000 to support individual investiga- tors within Russia. As yet another relevant example, a World Bank program in Kazakhstan provides 3-year grants of $1.5 million to laboratories that intend to pursue research that leads to commercialization of research results. In the United States, the size of grants varies greatly depending on the purpose of the grant and policy of the funder. Grants to establish centers of excellence sometimes provide several million dollars per year, with the grants renewable after an initial 5-year award period. Thus, the proposed size of the new grants seems to be reasonable. In building networks of universities, larger projects (including subprojects) are most likely to have lasting impacts. Once the topics of mutual interest are determined, a scenario such as the fol- lowing could be followed, although the governments might well decide to modify the approach as they work out the details. • The board of directors would issue unified calls for research proposals to be prepared jointly by teams of scientists from the two countries. These calls would reflect agreement within the board on research priorities, anticipated out- comes, and range of funding levels. Lessons learned set forth in this report might also be important in shaping the approach. • The board would refer proposals that are received to appropriate peer reviewers in the two countries. The board members would then meet to consider jointly the results of the peer review and to select the winners of each competi- tion. Competitions might be held on an annual basis. • The Russian financial contributions to the program would be used to cover the costs incurred by Russian participants in projects, and the U.S. contribu- tions would cover the costs incurred by the American participants. Usually, there would be no need for cross-border transfers of funds. The division of funding need not be equal for each project, but in the aggregate there should be an equal sharing of the costs. • The board’s staff would arrange for periodic reviews and evaluations of the funded projects, and it would assist award recipients in making arrangements for carrying out projects. MOVING FORWARD In summary, an overall bioengagement effort that adequately reflects the importance of bilateral collaboration can be achieved by a combination of (a) increased support for carefully selected ongoing cooperative programs, and for currently dormant collaborations that have proven their value in the past, (b) a

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RECOMMENDATIONS FOR FUTURE BIOENGAGEMENT 121 new bilateral research fund that supports joint research projects selected on a competitive basis, and (c) an increased emphasis on reducing impediments to carrying out approved projects. Both governments should take the initiative for and share the costs of these recommendations. Clearly, with additional financial support on both sides there could be new productive joint efforts to (a) capitalize on the capabilities of revitalized world- class scientific institutions of Russia that are ready to deepen cooperation with American colleagues, (b) lead global efforts in addressing selected global and regional issues requiring new and improved scientific insights, and (c) stimulate a global culture of “responsible biological science” that draws on U.S.-Russian experience in dealing with pathogens of concern and related technologies. In looking to the future, of particular importance are the involvement of young researchers in bioengagement, a commitment of program managers to responsible science, incentives to offset the brain drain, and reporting of research results to the broader international scientific community in a timely and easily accessible way. These are keystones for long-term continuation of joint efforts. Finally, the Russian government is in the process of terminating its involve- ment in the U.S.-sponsored Cooperative Threat Reduction Program administered by the Department of Defense (the Nunn-Lugar Program), foreign assistance efforts of the U.S. Agency for International Development, and activities of the International Science and Technology Center. These three programs have been important pillars of U.S.-Russian bioengagement efforts for many years. Also, as we have seen, during the past several years, the U.S. government has significantly reduced financial support for bioengagement through these and other channels in favor of other budgetary imperatives. 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 are clear. The broad-ranging assessment in this report of lessons learned and of future collaborative opportunities should help ensure that the governments and the scientific leaders in both countries now give adequate attention to the many dimensions and rewards from bioengagement. Rewards are often measured in terms of research discoveries, development of new products, improved health and agriculture services, and protection from misuse of biotechnologies. While these indicators of success are important, the major payoff from new-found friendships across the ocean, an outcome that can last for decades, is the network of scientists who are interested in working together—through visits, conference attendance, e-mails or other means—during many years of their professional careers. There is no better assurance than the respect and camaraderie surrounding such friendships that the life sciences will indeed be used for the betterment of the global population.

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