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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences
Minutes of the Advisory Board
Forty-fourth Meeting
Table of Contents
Attendance
- Call to Order
- Consideration of Minutes of Previous Meeting
- Review of Requirements for Confidentiality and Conflict
of Interest Procedures
- Future Meeting Dates
- Report of the Director
- Technology Transfer at NIH
- FIC Strategic Plan, FY 2000-03
- Multidisciplinary Centers of Research Excellence - Concept and Discussion
- Discussion
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the fiftieth meeting of its Advisory Board on Tuesday, February 5, 2002, at 8:45 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:45 a.m. to 12:10 p.m., followed by the closed session, from 1:00 p.m. to adjournment at 3:00 p.m., as provided in Sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code, and Section 10 (d) of Public Law 92-463, for the review, discussion, and evaluation of grant applications and related information.[1] Dr. Gerald T. Keusch, Director, FIC, presided as chair.
Board Members Present:
Dr. Margaret A. Chesney
Dr. Ezekiel J. Emanuel
Dr. Cutberto Garza
Dr. Mary Claire King
Dr. Cora B. Marrett
Dr. Patricia Marshall
Mr. Thomas J. McAndrew
Dr. Donald O. Nutter
Dr. Theodore Reich (ad hoc)
Dr. Catherine M. Wilfert (ad hoc)
Board Members Absent:
Dr. Francisco J. Ayala
Dr. Barry R. Bloom
Dr. Thomas W. Cole, Jr.
Dr. Steven E. Hyman
Members of the Public Present:
Ms. Georgia Persinos, Washington Insight
Mr. Haimi Shijeraw, The Blue Sheet
Federal Employees Present:
Ms. Lina Allen, FIC/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Ms. Susan Bettendorf, FIC/NIH
Dr. Karen Hofman, FIC/NIH
Mr. Amar Bhat, FIC/NIH
Dr. Allen Holt, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Josefa Ippolito-Shepherd, FIC/NIH
Dr. Virginia S. Cain, OBSSR/NIH
Dr. Gerald T. Keusch, FIC/NIH
Ms. Kathryn Chantry, FIC/NIH
Ms. Sylvia B. Kniel, FIC/NIH
Mr. David Clary, NICHD/NIH
Dr. Richard Krause, FIC/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. R. Der Simonian, OD/NIH
Ms. Silvia Mandes, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Mr. Richard Miller, FIC/NIH
Dr. Andréa Egan, FIC/NIH
Ms. Mary Plummer, NICHD/NIH
Mr. Robert Eiss, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Ms. Eileen Gardner, FIC/NIH
Dr. Luis A. Salicrup, FIC/NIH
Dr. Ron Geller, OD/NIH
Dr. Barbara Sina, FIC/NIH
Ms. Lee Ann Gschwind, FIC/NIH
Ms. Rita Singer, FIC/NIH
Dr. Sandy Warren, CSR/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Gerald T. Keusch, Director, FIC, called the open session of the Advisory Board meeting to order at 8:30 a.m. on Tuesday, February 8, 2000. He thanked Mr. Thomas J. McAndrew for accepting FIC's invitation to continue on the Board and introduced two new Board members: Dr. Catherine M. Wilfert, from Duke University and the Elizabeth Glaser Pediatric AIDS Foundation; and Dr. Theodore Reich, from Washington University School of Medicine. Dr. Steven E. Hyman, Director, National Institute of Mental Health, NIH, also is a new (ex officio) member, but was unable to attend the meeting.
II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of September 28, 1999, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
Dr. Keusch thanked the Board members for providing their updated Confidential Financial Disclosure Reports to the FIC.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, May 16, 2000
Tuesday, September 19, 2000
Tuesday, February 6, 2001
Tuesday, May 22, 2001
Tuesday, September 11, 2001
All subcommittees of the Board will meet on the Monday preceding each Board meeting.
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V. REPORT OF THE DIRECTOR
Dr. Keusch reported on personnel changes at the NIH and FIC, FIC activities since the Board's previous meeting in September 1999, and planned activities over the next few months. Mr. Richard Miller, Executive Officer, FIC, reviewed the current FIC budget and plans for Fiscal Years (FY) 2001-02 budgets. The written Report of the Director was distributed previously to Board members, was available at the meeting, and is appended to these minutes as Attachment 2.
FIC Budget
Mr. Miller reported that the President's Budget for FY 2001 was just released to Congress. This budget includes a request for $18.8 billion for the NIH, representing a 5.6 percent increase over the FY 2000 budget of $17.8 billion, which was an increase of 13.9 percent over the FY 1999 budget of $15.6 billion. For the FIC, the budget request for FY 2001 is $48.0 million, representing a 10.8 percent increase over the FY 2000 budget of $43.3 million, which was an increase of 23.2 percent over the FY 1999 budget of $35.1 million. The FY 2000 increase for the FIC exceeded the average increase across the NIH, which was 14 percent; the FIC was one of six NIH components which exceeded the average. The President's Budget for FY 2001 follows the same pattern, requesting a 10.8 percent increase for the FIC, compared to an NIH average of 5.6 percent. The 10.8 percent increase is the largest increase of all NIH components, reflecting the importance Dr. Harold Varmus, former Director, NIH, placed on international activities and the role of the FIC on behalf of the NIH. Mr. Miller noted that the FIC augments its appropriations by attracting additional resources for its programs from other NIH components and Federal agencies, which amounted to $12 million in FY 1999.
In FY 2000, the FIC is expanding support for its initiatives in AIDS, emerging infectious diseases, and maternal and child health. Four new initiatives are: the Ecology of Infectious Diseases Program, launched in collaboration with other NIH components and Federal agencies, for a total of $4.2 million; the International Research and Training in Bioethics Program; the International Malaria Research Training Program Award; and the International Health and Economics Development Program, which FIC will announce in FY 2000 with first awards to be made in FY 2001. The last three initiatives are all being implemented in conjunction with NIH institutes.
For FY 2001, the FIC has identified an additional four new initiatives, in the areas of smoking prevention and cessation, mental health disorders, molecular genetics and genomics, and clinical investigation. Mr. Miller said that the last two areas also are identified as priorities for the NIH. A chart depicting the funding of FIC's extramural programs for FY 1999-01 was provided to the Board.
The process of developing the budget for FY 2002 will begin soon. Mr. Miller noted that Dr. Ruth Kirschstein, Acting Director, NIH, anticipates convening a forum of the NIH directors in June to discuss priorities for the NIH.
In closing, Mr. Miller noted that the NIH hearings before the House Subcommittee on Appropriations will begin on February 15, and the FIC hearings are scheduled for March 1. On March 30, Dr. Kirschstein will testify for the NIH before the Senate Subcommittee on Appropriations. The FIC will continue to emphasize to the Congress and the Administration the importance and benefit of international research and cooperation for improving the health of both the people of the United States and developing nations.
In discussion, the Board asked about FIC's role in eliminating health disparities, one of four NIH initiatives highlighted in the NIH Press Release for the FY 2001 President's Budget. Dr. Keusch noted that the NIH language for this initiative includes domestic and global concerns and that the FIC hopes to lead the NIH effort to address these concerns internationally.
Dr. Sharon Hrynkow, Acting Associate Director for Program Coordination, FIC, said that eliminating health disparities is a major priority of the Administration and former Director Dr. Varmus. Dr. Kirschstein has convened a trans-NIH working group, consisting of NIH directors, to produce a plan for developing research areas that would address health disparities. This plan, which is expected to be completed within 4 months, will be tied to the FY 2002 budget process and will become part of a plan for the U.S. Department of Health and Human Services (DHHS). The working group has met once, and the FIC is contributing to the effort. Dr. Hrynkow noted that the working group is focusing initially on health disparities among racial and ethnic groups. The Board emphasized that income inequality is a major predictor of health disparity and that socioeconomic issues are an important consideration. Dr. Keusch said the working group is the beginning of an activity that will continue to be a major focus at the NIH for a long time. He also noted that, although the focus currently is on developing a domestic agenda, the FIC has initiated activities to begin to address health disparities internationally in partnership with the other NIH components. The Board noted that the challenge for the FIC and the NIH is to emphasize the linkages between the domestic and international agendas.
Personnel Changes
Dr. Keusch noted that Dr. Varmus, NIH Director from 1993-99, left the NIH in December to become President and CEO of Memorial Sloan-Kettering Cancer Center in New York City. Continuing his interest in international health, Dr. Varmus has joined the World Health Organization (WHO) Commission on Macroeconomics and Health, in which the FIC also participates, and has pledged continued support for malaria programs internationally. On Dr. Varmus' departure, Dr. Kirschstein became Acting Director, NIH, and Dr. Yvonne Maddox became Acting Deputy Director, NIH.
Other recent appointments at the NIH include the following: Dr. Allen M. Spiegel, Director, National Institute of Diabetes and Digestive and Kidney Diseases; Dr. Steven E. Straus, Director, National Center for Complementary and Alternative Medicine; and Dr. Paul Coates, Director, NIH Office of Dietary Supplements. Dr. Keusch noted that FIC staff have met with each of these individuals to discuss potential international collaborations.
Dr. Keusch also noted that Ms. Susan E. Quantius has been appointed Associate Director for Budget, NIH, and that Dr. Harold Slavkin, Director, National Institute of Dental and Craniofacial Research, will leave the NIH in July 2000 to return to the University of Southern California to serve as Dean of the School of Dentistry.
At the FIC, Dr. Richard Krause has recently joined the intramural program at the National Institute of Allergy and Infectious Diseases, but will also continue to serve as Senior Scientific Advisor, FIC. Recent appointments at the FIC include the following: Ms. Kathryn Chantry, FIC Budget Officer; Dr. Jeanne McDermott, Program Manager, Division of International Training and Research (DITR); Dr. Luis Salicrup, Program Officer for The Americas, Division of International Relations; and Dr. Mark Miller, Associate Director for Research. Dr. Keusch noted that Dr. Jack Chow, FIC's Assistant Director for External Relations, is serving as health science advisor to Under Secretary of State Frank Loy and that Ms. Cynthia Palmer, formerly a Special Expert in legislative affairs at the FIC, has joined the World Wildlife Fund.
Additional details on these and other personnel changes are provided in the written Report of the Director (see Attachment 2).
FIC Activities
Dr. Keusch reported that, since the previous Board's meeting in September 1999, the FIC's role at the NIH has continued to evolve from capacity building and support of other NIH components to leadership for international health. He noted that the FIC's interaction with other NIH components has been superb and central to increased NIH's interest in, and support of, international research. To underpin FIC's plans, the FIC has established a Division of Advanced Studies and Policy Analysis (DASPA), replacing its Office of International Science Policy and Analysis and the Division of International Advanced Studies. Mr. Robert Eiss has been named director of the new division, which will be moved to the "think-tank" setting of the Lawton Chiles International House.
One of the Center's first "think-tank" activities will be the assessment of NIH's investment internationally over the past 10 years, which will be conducted under contract with Dr. David Rothman, Professor of Social Medicine and Director, Center for the Study of Society and Medicine, Columbia University College of Physicians and Surgeons, New York, New York. The initial findings of this assessment will be presented in Bangkok, Thailand, in October 2000 at the International Conference on Health Research, sponsored by the Global Forum for Health Research.
Other activities which Dr. Keusch and staff reported on related to bioethics, health and economic development, evaluation research, minority research and training, ecology of infectious diseases, and the Multilateral Initiative on Malaria (MIM).
Global Forum for Bioethics in Research. On November 7-10, 1999, the FIC, in collaboration with eight NIH institutes and the WHO, hosted a Global Forum for Bioethics in Research, held in Bethesda, Maryland. This meeting served to launch FIC's initiative in biomedical ethics. A poster made for the meeting was given to all Board members. Dr. Keusch noted that approximately half of the participants came from developing countries and that they participated actively in the discussions, which focused on the responsibilities of research sponsors and investigators to their study populations. Planning is under way for a second forum, to be held in Bangkok, Thailand, as an adjunct to the International Conference on Health Research. The theme planned for this meeting is community benefits of research carried out internationally.
In related activities, the FIC is planning a seminar for the Bangkok meeting to discuss the harmonization of international guidelines for research and is developing a Request for Applications (RFA) for training in international bioethics. The RFA will focus on the training of individuals from developing countries and will support long-term, capacity- building efforts on bioethics internationally; short-term training in bioethics (e.g., for institutional review boards); and research on ethics in the international context. Dr. Keusch noted that, to assist FIC in its efforts on international research ethics, the FIC and the NIH Clinical Center have announced the availability of a full-time position in bioethics.
Health and Economic Development. On November 15-16, 1999, the FIC, in consultation with The World Bank, WHO, and several NIH institutes, held an International Conference on Health and Economic Development, at the NIH. As a result of the meeting, the FIC is formulating an RFA for research on the dynamics of health and productivity in low- and middle-income countries and is pursuing collaborations with The World Bank and WHO's Economic Advisory Service. Mr. Eiss noted that the relationship between education and productivity has been well documented during the past three decades, but the causal effect of the relationship between health or productivity has not developed a similar empirical foundation. With the RFA, the FIC hopes initially to support two to three research project grants in this area, possibly awarded to institutions participating in World Bank-supported regional consortia already doing economic growth analyses. FIC's support of research on the health dimension would add value to these analyses and stimulate cooperative partnerships with scientists in developing countries. The Board suggested that the FIC could contribute to the discussions of health disparities by encouraging researchers to analyze the bidirectional link between health and productivity and to develop new models and methods for studying this issue.
Evaluation Research. Dr. Catherine M. Wilfert reported on a meeting, entitled "A Link Between Research and Health Service: Paradigm Lost," which was hosted by the FIC and the Elizabeth Glaser Pediatric AIDS Foundation, at the NIH on December 14-15, 1999. The participants focused on the potential synergy among research, implementation, and evaluation. Dr. Wilfert noted that the discussions were fruitful and that various follow-up activities are being considered. A summary of the meeting will be distributed to the Board.
Minority International Research and Training (MIRT) Program. Dr. Barbara Sina, Health Scientist Administrator, FIC, reported that the FIC has received 22 applications for MIRT awards for FY 2000 and anticipates funding 9 or 10 of these, and perhaps more if additional funds are obtained from NIH's Office of Research on Minority Health. Many of the applications were revisions or renewals of the 17 awards funded in FY 1999. On January 27-28, a MIRT Network meeting was held to address issues relevant to the training program. Dr. Sina noted that the MIRT program supports the training of 200-300 U.S. undergraduate and graduate minority students each year, who participate in research projects in other countries. About one-third of the students participate in research conducted in Africa, one-third in Latin America, and one-third in Asian or European countries. Dr. Sina also noted that the FIC hopes to initiate a bioethics component in the program. The Board noted that the MIRT program has a tremendously positive effect among the students and departments at participating institutions.
Ecology of Infectious Diseases. Dr. Joshua Rosenthal, Program Manager for FIC programs in Biodiversity and Medical Informatics, DITR, reported on an RFA issued in November 1999 for a new FIC program on the Ecology of Infectious Diseases. The RFA calls for the development of interdisciplinary research programs to elucidate the underlying ecological and biological mechanisms that govern the relationships between anthropogenic environmental changes and the transmission dynamics of infectious diseases. The FIC is supporting this program in collaboration with three NIH institutes and four Federal agencies. Dr. Rosenthal noted that the FIC has received approximately 200 letters of intent in response to the RFA and anticipates funding approximately 10 awards by the end of September 2000.
MIM. Dr. Keusch reported that the FIC, as the Secretariat for the MIM, is working diligently to develop strategies for continuing MIM's capacity development and research activities and for extending the initiative's mandate to include Plasmodium vivax, as well as P. falciparum. The intent is to generate additional resources to support research on P. vivax, which is a major cause of morbidity from malaria in South Asia, the Pacific Islands, and Latin America.
Additional details on these and other activities are provided in the written Report of the Director (see Attachment 2).
Planned Activities
Dr. Keusch noted several activities and areas which are in the planning phase at FIC. These include organization of a science policy forum for India and China to address barriers to effective collaborative research; nutrition; chronic, noncommunicable diseases; mental disorders (e.g., mood disorders), in collaboration with the National Institute on Mental Health; and disease burden and demography, in collaboration with the National Institute on Aging. Dr. Keusch invited the Board to suggest additional areas for the FIC to address, noting that good programs attract the resources needed to support them.
VI. TECHNOLOGY TRANSFER AT NIH
Dr. Maria Freire, Director, Office of Technology Transfer, NIH, described the evolution of technology transfer activities in the Federal Government, the activities of NIH's Office of Technology Transfer, and specific concerns for the NIH. She also suggested several areas for the FIC and Board's consideration in the future.
U.S. Government activities in technology transfer over the past 20 years have been governed by a set of legislative authorities which include: The Bayh-Dole Act of 1980, which provided recipients of Federal funds with title to intellectual property developed with U.S. Government funds and authorizes the protection and licensing of such intellectual property; The Stevenson-Wydler Act of 1980, which provides the same authorization for Federal laboratories; and The Federal Technology Transfer Act and its amendments, which further define the authorities in the 1980 acts and requires the sharing of royalty income with Federal employee inventors.
Dr. Freire noted that, in the "first generation" of technology transfer (mid- to late 1980s), the U.S. Government and academia grappled with the interpretation and implementation of the authorities, including Federal laboratory Cooperative Research and Development Agreements (CRADAs) with industry. The "second generation" (early 1990s) was a time of growth. The NIH Office of Technology Transfer and similar offices at universities were created and assumed responsibility for identifying, protecting, and licensing their institutions' inventions.
The "third generation" (mid-1990s) can be perceived as a "coming of age." The NIH articulated its philosophy of patenting and licensing technologies, began aggressive marketing and licensing of its inventions, established a royalty administration operation, initiated reviews with NIH institutes and centers on their patent portfolios, and created a monitoring unit. Dr. Freire said that the NIH currently awards about 200 licenses a year and that, similar to academia and industry, a few licenses provide the bulk of the revenue from technology transfer (currently, about 7 of the approximately 1,500 licenses provide most of the NIH's revenue from technology transfer, which totaled about $45 million in FY 1999). Dr. Freire also noted that most research-intensive U.S. universities are at the third-generation stage.
The NIH Office of Technology Transfer evaluates, protects, markets, licenses, and monitors use of intellectual property generated by NIH intramural scientists. It is also the lead office within DHHS for policy development pertaining to both intramural and extramural technology transfer. The goals of the office are to utilize technology transfer to benefit public health, attack diseases from multiple fronts, attract new research and development resources, obtain a return on the public's investment in research, and stimulate economic development (which was the main thrust of the first two legislative authorities for Federal technology transfer). A recent key policy issue was the concern of the scientific community with the accessibility of research tools. In response to those concerns, in December 1999, the NIH issued specific guidelines for licensing of research tools by recipients of NIH funds. These guidelines specify NIH's position with regard to research uses of inventions, sharing of tools, and dissemination of research findings.
Dr. Freire noted that the office is addressing major issues in the current, "fourth generation" of technology transfer. Biomedical technologies licensed in the late 1980s are now reaching worldwide markets, raising issues of pricing and access of drugs. Intellectual property has now become integral to academia's concerns, and arrangements are becoming increasingly complex, involving international organizations and bioinformatics. In addition, serious political concerns and ramifications have to be weighed, the paradigms of industry and not-for-profits are shifting, portfolios must be closely managed for the future, and a continued pipeline of technologies must be assured. Also, the pressures of trade and intellectual property are at the forefront of international discussions (e.g., the recent meeting of the World Trade Organization in Seattle). These pressures bear on two key types of drugs: existing drugs (e.g., ddI, AZT) and null-set drugs (i.e., those that are not developed because the market is not sufficiently large to make production cost effective or because the market is so large that the return on investment is insufficient).
An example of the complexity of these issues is the case of ddI, a compound invented at the NIH which is used in a product, VIDEX, as a treatment for human immunodeficiency virus (HIV) infection. Dr. Freire noted that questions arose about the licensing of this technology to the WHO so a drug could be developed, tested, and made accessible to populations in need throughout the world. Yet, the WHO does not have sufficient resources for drug development. In 1988, the NIH awarded an exclusive license for development of ddI to Bristol-Myers-Squibb. This license only applies, however, to countries in which the NIH or the company hold a patent for ddI. In those countries where there was no patent for the compound, such as in South Africa, countries could have proceeded to develop the drug without any patent infringement. This situation raised a number of international trade concerns. Negotiations by the countries' trade representatives led to an amicable resolution of this problem. Dr. Freire noted that the broader issue of access to, and pricing of, drugs for populations in developing countries has not been resolved and will become more important.
In closing, Dr. Freire highlighted the following points, or quandaries, for the FIC and Board's consideration: (a) how to ensure both efficient development of, and widespread access to, drugs (e.g., by awarding "placeholder" licenses); (b) whether the U.S. Government's "march-in" rights to ensure that developed technologies meet public health needs, as required in the United States, could be extended to other countries; (c) how to accommodate the rights and rules of other nations in the development and distribution of pharmaceuticals and other biomedical technologies; and (d) ways of coordinating international trade and intellectual property concerns internationally. Dr. Freire noted that NIH and DHHS staff hope to address some of these issues with the U.S. Trade Representative's office and the WHO.
Discussion
Dr. Keusch noted that various ways for addressing the issues raised by Dr. Freire are being discussed. International research and development involves a multiplicity of issues and partnerships between the public and private sectors. The NIH, for example, may discover new compounds through research but relies on the private sector to develop and manufacture active drugs. The development and distribution of drugs appropriate for large populations in low- and middle-income countries has become an intense emotional issue that needs to be addressed internationally. Dr. Keusch invited the Board to comment on ways in which the FIC could enlighten this dialogue.
The Board commented that, for countries such as India, U.S. patent rights to developed drugs is a divisive issue and is perceived as imperialistic. Fostering basic research in these countries could enhance their participation in development of, and rights to, pharmaceuticals. Dr. Freire said that the NIH is considering three approaches for addressing the issues she identified: (a) potential licensing strategies that would both "protect" Western markets and give incentives for developing pharmaceuticals for developing countries; (b) possibilities for extending U.S. patent rights to developing countries; and (c) creative mechanisms for facilitating closer interactions on drug development between pharmaceutical companies and international organizations such as the WHO.
The Board suggested that some of the "lessons learned" from U.S. food-aid programs, some of which were designed to benefit both donor and recipients, and from childhood immunization programs, which used preferential pricing for developing countries, may be informative. The Board also noted the need to be cognizant of social and cultural barriers which may affect individuals' access to, and use of, drugs and which may not be adequately addressed by health officials in developing countries.
Dr. Keusch noted that much of the current debate is focused on intellectual property rights and trade-related issues. Other equally important components on which the FIC could bring perspective include effective infrastructures for drug delivery in developing countries and related public health concerns. The Board noted that the NIH policy which calls for the sharing of research tools by recipients of NIH funds has been enormously beneficial to international collaborations and should be made clear for each collaboration. It was noted that research is shifting from an individual, single-investigator model to multidisciplinary, international research teams, making issues of intellectual property even more complex. The National Institute of Dental and Craniofacial Research, for example, is initiating international collaborative research planning grants for the purpose of stimulating global research networks in dental, oral, and craniofacial research. Dr. Freire noted that intellectual property rights and issues such as preferential pricing for developing countries are increasingly being addressed in licensing situations.
Dr. Keusch thanked Dr. Freire for presenting an excellent introduction to a complex area. He said that the FIC and Board will continue the discussion in subsequent meetings and working groups of the Board.
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VII. FIC STRATEGIC PLAN, FY 2000-03
Mr. Robert Eiss, Director, DASPA, FIC, presented a brief overview of FIC's draft Strategic Plan, FY 2000-03, entitled Reducing Disparities in Global Health. The FIC provided copies of the draft plan to the Board, and Dr. Keusch invited the members' comments for revising the document. All NIH components have been preparing strategic plans, in response to a requirement in the Government Performance and Results Act, a recommendation from the Institute of Medicine, and discussions with Congress regarding the setting of priorities at the NIH.
Mr. Eiss noted that FIC's strategic plan not only is an important tool for the FIC, but also has implications for the entire NIH. The FIC budget is approaching one-half of the total NIH extramural expenditures internationally, an estimated $104 million in FY 1998. The FIC supports more than 20 broad-based research and training programs in a wide range of areas of interest to the NIH. Targeted to low- and middle-income countries, these programs enable the NIH to contribute to the building of human capital and institutional capacity in these countries and offer international research opportunities for U.S. scientists. The FIC hopes that its strategic plan also will convey to the Congress, the scientific community, and the public the importance of strengthening research capacity globally as a critical means of enhancing public health.
The draft plan presents FIC's programs and philosophy under several prominent international trends, or categorical challenges such as "the unfinished agenda" of childhood infections, malnutrition, and reproductive health disorders. The main challenges, and sections of the plan, relate to improving child and maternal health; infections, immunity, and microbial diseases; biology and the environment; chronic and degenerative diseases; global health in the information age; priority training needs for building the foundation for evidence-based medicine in low- and middle-income nations; and preparing the next generation of U.S. scientists to meet global health challenges. In addition, the plan identifies several cross-cutting priorities in international policy for the FIC to address in collaboration with others and approaches to public outreach.
New initiatives for building research capacity address the need to measure the impact of nutritional deficits on physical, emotional, and psychosocial development; to develop theoretical epidemiological models for understanding the dynamics of host-pathogen interactions; to prevent the onset of smoking and to promote the cessation of smoking, particularly among adolescents; to bridge the gap in genetics research between industrialized and developing countries (see section IX below); to provide multidisciplinary didactic training in clinical research methodologies for physician investigators from low- and middle-income nations; and to bolster FIC's outreach and dissemination of scientific information to the public. Mr. Eiss noted that these initiatives, as with other FIC programs, would add value to NIH-supported research, would be developed in consultation with the Board, and would involve the cooperation of other NIH components, Federal agencies, universities, and international organizations.
In closing, Mr. Eiss emphasized that the draft strategic plan is a "straw-man," working document intended to initiate discussions with the Board. Working groups of the Board could be organized to focus on specific topics.
Discussion
The Board indicated its willingness to participate in refining the strategic plan. Mr. Eiss noted that the FIC hopes to disseminate the completed plan on FIC's website within 2 months. The plan, which presently covers FY 2000-03, is perceived as a "living document" and would be updated frequently. Asked about the feasibility of launching and fulfilling such an ambitious agenda, Dr. Keusch noted that the FIC has made enormous progress with its initiatives during the past year. In constructing the strategic plan, the FIC aims to compile a comprehensive and cohesive philosophy for international programs and to "push" the agenda with the support and cooperation of the other NIH components.
The Board commented on the need to integrate assessment into the plan and indicated its interest in participating in efforts to assess FIC's return on investment. Mr. Eiss said that the FIC intends to measure outcomes and effects of its programs through concrete measures (e.g., publications, employment), descriptive analysis (e.g., expertise developed, institutional success in obtaining funding), and other measures (e.g., of technology transferred into public health, clinical practice). The approach currently being used to complete FIC's retrospective assessment of 10 years of NIH investment in international research may prove effective and useful.
The Board complimented staff on the organization of the plan as both a vision document and a strategic plan. For refining the plan, the Board suggested that the FIC begin with the vision statement and follow this with the strategic plan, which would set forth specific goals and objectives, a timeline, strategies for achieving the goals and objectives, and a cost estimate.
VIII. MULTIDISCIPLINARY CENTERS OF RESEARCH EXCELLENCE-- CONCEPT AND DISCUSSION
Dr. Kenneth Bridbord, Director, DITR, FIC, presented a new concept for the FIC to support development of multidisciplinary centers of research excellence. He conveyed FIC's initial thinking on this concept, which grew out of Dr. Keusch's vision for FIC's future directions and consideration of ways to achieve the aims set forth in FIC's strategic plan. Dr. Bridbord suggested that centers of excellence may provide an effective mechanism for "building the house" envisaged by Dr. Keusch and for integrating some of FIC's program activities within institutions and countries.
The centers, as presently conceived, would consist of multidisciplinary, long-term partnerships (or "twinning") between U.S. and foreign institutions that would be supported by training and research- capacity-building awards. Dr. Bridbord anticipated that first-year costs, beginning in FY 2001, could total about $10 million for support of 10-12 initial 5- to 7-year awards. Program emphasis could be given initially to research and training in infectious diseases, given the global burden of infectious diseases. Over time, centers could take on increasing activities in the noninfectious disease areas, including mental health and smoking-related illnesses. U.S. institutions would partner with two to three foreign institutions (both research- and non-research-intensive), and the role and independence of foreign investigators would increase over time. To fund the centers, the FIC could augment its support of institutions already participating in FIC programs and seek collaborations with other NIH components, U.S. agencies (e.g., the Centers for Disease Control and Prevention) and institutions, and international organizations (e.g., The Wellcome Trust).
Dr. Bridbord expected that the concept of FIC centers of excellence would be viewed as imaginative and generate enthusiasm among U.S. and foreign investigators. He noted that the centers would enhance the sustainability of international collaborative research and could have a great effect on strengthening the capacity for health research in developing countries. He noted that, although the program is conceived as a long-term (20-year) venture, a visible return on investment could be expected after 10 years, as happened with FIC's AIDS International Training and Research Program (AITRP). After its first 10 years, AITRP was stimulating or facilitating approximately $50 million in additional NIH international HIV research investments for every $10 million funded by the FIC.
Potential core programmatic elements required of the centers may include ethics, grants management, nutrition, cessation of tobacco use, clinical research, medical informatics, and outreach and continuing education to health professionals and the public. The centers also could be required to serve as regional resources, to build upon FIC's existing institutional research and training awards (D43s), and to conduct research to apply breakthroughs (e.g., in biotechnology and bioengineering) in low-resource settings. Depending on local needs and capabilities, research areas for development within the centers could include mental health, chronic diseases, biodiversity and ecology, genetics, neuroscience, health and economics, vaccinology, operational research, and traditional medicine.
In closing, Dr. Bridbord suggested that the next steps in bringing the concept to fruition are to (a) establish a working group of the Board to develop the concept further, (b) discuss the concept within the NIH community, and (c) consult with other groups that have experience in building international centers of excellence.
Discussion
The Board suggested that developing countries which participate in the centers be required to invest in them as part of their own development and that surveillance/epidemiological activities and assessment of outcomes are two essential core elements which, although implied, should be specified. The Board noted that a similar effort, which has both bilateral and multilateral support, is focused on developing nutrition centers of excellence and that the Subcommittee on Nutrition of the Administrative Coordinating Committee of the U.N. will meet in Washington, D.C., on April 10-14 to mobilize the NIH community in this effort.
The Board asked the FIC to provide background information on the distribution of FIC's programs and activities by country and by institution, to gain insight into the regional clustering of current activities. Dr. Keusch said that the FIC will address the need for this information with other NIH components as well.
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IX. FIC GENETICS INITIATIVE
Dr. Karen Hofman, Special Expert, FIC, reported on FIC plans for a program of International Training and Research in Molecular Genetics and Genomics, to be initiated in FY 2001. The goal of this program is to bridge some of the widening gaps in genetics research between the industrialized and developing world by stimulating the development of research capacity in molecular biology in developing countries. In consultation on this program, Board member Dr. Mary Claire King has advised the FIC to strive to achieve democratization of the tools of molecular biology.
Dr. Hofman noted that the Human Genome Project will complete sequencing of the human genome by FY 2002 and that scientists have already used the data emanating from this project to pinpoint many genes associated with monogenic disorders. Much of this work is being accomplished through international collaborations. The next steps will include elucidation of multigene and gene-environment interactions in the development of major diseases (e.g., cancer, cardiovascular disease) and identifying points of variations (single nucleotide polymorphisms, or SNPs) within populations and between individuals. To contribute to this research, researchers in developing countries need to be adept in the use of advanced molecular genetic tools, molecular biology techniques, population-based molecular epidemiology approaches, and surveillance methods. An understanding of ethical, legal, and social issues that may arise will be important.
To foster development of this research capacity, the FIC proposes initially to stimulate collaborations between and within countries by sponsoring regional workshops for geneticists interested in collaborating with scientists from developing countries. The workshops could be held in regions or countries that have research-intensive sites and an existing genetics infrastructure (e.g., China, India, Latin America, Mexico, South Africa). This activity and other initiatives (e.g., grants and other mechanisms of support) would be developed and supported in collaboration with other NIH components and, possibly, other Federal agencies. The overall aim is to enable researchers in the developing world to focus their own research agendas on diseases that are significant locally.
Dr. Hofman commented that genetics research and training for developing countries needs to be addressed carefully and thoughtfully because it is not "low-tech" and may not be perceived as a priority in many of these countries. Dr. Keusch welcomed the Board's comments and advice on the proposed program and specific means for developing the concept further.
X. CLOSED PORTION OF THE MEETING
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
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XI. REVIEW OF APPLICATION
A total of 58 applications requesting $2,060,245 in FY 2000 funds were reviewed by the FIC Advisory Board as follows:
13 applications for Senior International Fellowship (SIF) awards requesting $299,795;
1 application for International Research Fellowship (IRF) awards requesting $36,250;
37 applications for Fogarty International Research Collaboration Awards (FIRCAs) requesting $1,386,710;
6 applications for AIDS-FIRCA awards requesting $262,138; and
1 application for K01 awards requesting $75,352.
The Board concurred with the initial review group recommendations for 58 proposals, recommending $2,060,245.
XII. ADJOURNMENT
The meeting was adjourned at 3:00 p.m. on February 8, 2000.
[1] Members absent themselves from the meeting when the Board discusses applications from their own institutions or when a conflict of interest might occur. The procedure applies only to individual applications discussed, not to en bloc actions.
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