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September 13, 2011 Advisory Board Meeting Summary Minutes


Meeting Information

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
Seventy-fourth Meeting of the Advisory Board
Minutes of Meeting
September 13, 2011

The John E. Fogarty International center for Advanced Study in the Health Sciences (FIC) convened the seventy-eighth meeting of its Advisory Board on Tuesday, September 13, 2011 at 9:00 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The closed session was held on September 13 from 8:30 to 9:00, as provided in Sections 552(b)(4) and 552(b)(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. The meeting was open to the public on September 13, 2011 at 9:00 a.m., until adjournment at 3:00 p.m. Dr. Roger I. Glass, Director, FIC, presided. The Board roster is appended as Attachment 1.

Attendee Information

  • Board Members Present:
    • Dr. Roger Glass, Chair
    • Dr. Robert A. Black
    • Dr. Gail H. Cassell
    • Dr. Maria Friere (via telephone)
    • Dr. Peter Hotez (via telephone)
    • Dr. Ariel Pablos-Mendez
    • Dr. Bonita Stanton
    • Dr. Sten Vermund
    • Dr. Alan Guttmacher, NICHD/NIH (ex officio)
    • Dr. Susan Shurin (ex officio)
  • Board Members Absent:
    • Dr. Roscoe Moore
  • Members of the Public Present:
    • Ms. Ashley Bennett, Global Health Technologies Coalition
    • Dr. Robert Black, Johns Hopkins University
    • Dr. Katherine Bliss, Global Health Policy Center
    • Dr. Scott Campbell, Executive Director and CEO, Foundation for the National Institutes of Health, Bethesda, MD
    • Kaitlin Christiansen, Global Health Technologies Coalition
    • Molly Maguire, AIRI
    • Dr. Steve Morrison, Global Health Policy Center
    • Dr. Patrick Kelley, Institute of Medicine, Washington, DC
    • Ms. Pattie Simone
  • Federal Employees Present:
    • Nalini Anand, FIC
    • Amie Batson, USAID
    • Danielle Bielenstein, FIC/NIH
    • Dr. Barry Bloom, FIC
    • Stephanie Borkhome, OD NIH
    • Norica Ruiz Bravo, USAID
    • Dr. Joel Bremen, FIC/NIH
    • Dr. Kenneth Bridbord, FIC
    • Stacey Chambers, NINDS
    • Dr. Arun Chockalingham, NHLBI
    • Dr. Lois Cohen, NIDCR
    • Dr. Dexter Collins, FIC
    • Jill Conley, FIC
    • E. Ann Davis, FIC
    • Dr. Alex Dehgan, USAID
    • Robert Eiss, FIC/NIH
    • Dr. Steve Goldstein, FIC
    • Gray Handley, NIAID
    • Jessica Hancock, HHS/OGA
    • George Herrfurth, FIC
    • Dr. James Herrington, FIC
    • Dr. Christine Jessup, FIC
    • Dr. Flora Katz, FIC
    • Linda Kupfer, FIC
    • Lora Kutkat, OD NIH
    • Yuan Liu, NINDS
    • Dr. Enid Light, NIMH/FIC
    • Dr. Jeanne McDermot, FIC
    • Dr. Kathleen Michaels, FIC
    • Joseph Millum, FIC
    • Dr. Roscoe Moore FIC
    • Elise Morocco, FIC
    • Dr. Yvonne Njage, FIC
    • Dr. Funmi Olopade
    • Sybil Philip, NICHD
    • Mark Peterson, USAID
    • Jane Peterson, NHGRI
    • Ann Puderbaugh, FIC
    • Dr. Myat Htoo Razak, FIC
    • Louise Rosenbaum, NIAMS
    • Dr. Joshua Rosenthal, FIC
    • Dr. Hillary Sigmon, CSR/FIC
    • Dr. Lou Valdez, FDA
    • Stacy Wallick, FIC
    • Annica Wayman, NIAID
    • Kristen Weymouth, FIC
  • Contractor Present:
    • Mr. Sean Jeffrey, FIC/NIH

Closed Session

  • Fogarty International Research Collaboration Award – Basic Biomedical (FIRCA-BB) ­­16 of 33 applications, for a total of $826,466.
  • Fogarty International Research Collaboration Award - Behavioral and Social Sciences ( FIRCA-BSS) 5 of 6 applications, for a total of $266,700.
  • Global Research Initiative Program – Behavioral/Social Sciences (GRIP-BSS) (RO1) 11 of 12 applications, for a total of $747,711.
  • Global Research Initiative Program – Basic Biomedical (GRIP-BB) (RO1) 14 of 28 applications, for a total of $641,302.
  • Independent Scientist in Global Health Award (ISGHA) (KO2) 2 of 3 applications, for a total of $184,567.
  • International Research Scientist Development Award (IRSDA) (KO1) 14 of 18 applications, for a total of $1,675,412.
  • Brain Disorders in the Developing World - Research Across the Lifespan (R01) 9 of 10 applications, for a total of $3,468,331.
  • Brain Disorders in the Developing World: Research Across the Lifespan (R21) 22 of 49 applications, for a total of $2,311,110.

Open Session

Director’s Update and Discussion of Current and Planned FIC Activities

Welcoming Remarks

Dr. Glass called the meeting to order and welcomed those present. He announced the retirement of several Board members and expressed appreciation for their dedicated service. Drs. Sten Vermund and Arthur Reingold would be leaving the Board at the end of their terms, and Dr. Ariel Pablos-Mendez had left the Board to accept the responsibility of Assistant Administrator of USAID. Finally, Dr. Glass announced that former FIC Director Phil Schambra had passed on, leaving important contributions from his tenure from 1988 to 1998, including developing the AITRP, which was one of the early model programs at FIC.

Concerning transitions at FIC, Dr. Glass announced that Dr. John Rosenthal had been appointed Acting Deputy Director of FIC, and that Linda Kupfer would be leaving FIC for a detail at OGAC. He welcomed Mike Martin; Elise Morocco, who would be supporting the MEPI program; Lydia Kline, joining DISSPE as a project officer; and Katie Handley, who will be liaison between FIC, NIH and USAID.

Dr. Glass announced that the 2011 Scholars and Fellows Program, under the direction of Myat Htoo Razak, has 33 current Fellows from a number of ICs, including Fellows in the current cohort from NHLBI, representing noninfectious diseases. A new program has also been established in cooperation with the Department of State’s Fulbright Program, the Fogarty Fulbright Scholarship Program. Four Fellows have been awarded scholarships, and it is anticipated that over a hundred applications will be received for up to 50 positions.

Dr. Glass recalled the presentation at the last Board meeting about the Center for Global Health Studies, noting that several Board members and staff participated in a review of the Center after that meeting. He invited Dr. Robert Black, the rapporteur at the meeting, and Ms. Nalini Anand, Acting Director of the Center, to comment. Dr. Black noted that the Board members toured the facility and discussed potential activities, adding that there was agreement that the Center would be appropriate for establishing short-term coordination of focused scientific projects. He reported that the Center could provide training in some specific areas that would not compete with training offered by academic institutions.

Ms. Anand commented that the strategic planning for the Center began two years ago, including consideration of projects that would be trans-NIH in mission and content. One such project has been finalized, a collaboration with NICHD and the Office of the Global AIDS Coordinator, that will bring researchers and implementers (USAID, CDC and NGOs) together to facilitate an exchange of information about the state and direction of research and the real world challenges of AIDS program in developing countries. Dr. Glass noted that the Center’s scientific board of advisors would include Drs. Susan Shurin (NHLBI), Alan Guttmacher (NICHD) and Thomas Insel (NIMH).

Dr. Glass stated that a second presentation and review at the last meeting was about the FIC communications program. He added that Board member Mary Freire would report by telephone since she was involved in the announcement of the Lasker Awards in New York City. Dr. Frieire announced that the Basic Medical Research Award went to Franz Ulrich Hartl and Arthur Horwich for discoveries about the cell’s protein-folding machinery; and the Clinical Medical Research Award went to Tu Youyou for her discovery of artemisinin, a malaria therapy that has saved millions of lives. Dr. Freire stated that the third award, the Public Service Award, went to the NIH Clinical Center, for the high quality care provided and for supporting the development of many outstanding physician-scientists who have served at the Clinical Center during the past nearly 60 years.

Concerning the FIC communications program, Dr. Freire said that a post-meeting review after Anne Puderbaugh’s presentation included John Burklow, head of NIH Communications, Jenna Mills from the Foundation for the NIH, Aaron Sherinian from the UN Foundation, and Mary Wooley from Research America. The group agreed that the FIC communications organization was robust and capable of developing high quality communications. The challenge will be to define the target audience, and it was clear to the group that there are diverse needs – some messages are for the general public, some for congressional decision makers, and some for the scientific and academic community.

The committee recognized that Dr. Glass holds two positions at NIH, as Director of FIC and as Associate Director for Global Health, which may result in two messages – one representing the Fogarty International programs and interests, and the other the broader area of NIH global health. For the latter the committee agreed that there should be liaison with the Trans-NIH Working Group for Global Health. When the Director, or any representative of Fogarty, comments in public, the message must be considered in light of the two roles and the specific venue. Every public comment should be considered an opportunity for outreach to defend the global health agenda. Dr. Glass agreed that such outreach is particularly important now when there are certain interests that are questioning U.S. involvement in international health collaborations.

Dr. Glass moved to recent activities, including the Indoor Air Pollution meeting in May, with participation by a number of ICs and by CDC, EPA and NSF. FIC has supported the NIMH Grand Challenge in global mental health, and the NIH campus presentation by Fiona Godlee (British Medical Journal) on “Lessons from the MMR Scare.”

Dr. Glass mentioned the activities of the Presidential Commission on Ethics, FIC being represented by Joe Millum, and the Commission’s focus on the over-regulation of human subjects protection review, especially for minimal risk studies. The Commission developed a number of recommendations to simplify and streamline the approval process, including increased use of expedited review, limiting review to a single IRB for domestic research (even though several different research sites may be involved), simplifying the consent process to include oral consent for research involving surveys and interviews, strict adherence to data security and HIPAA requirements, and a requirement that any study receiving Common Rule funding be subject to federal regulations.

Upcoming events include a high level meeting at the UN to discuss non-communicable diseases. Dr. Glass added that he and Dr. Collins would participate in that meeting. The last such meeting was about HIV/AIDS, held about ten years ago and resulting in the Global Fund program. Dr. Glass noted that the FIC strategic plan, developed five years ago, specifically included non-communicable disease as a future priority.

In October, in Nairobi, the six-month meeting of the MEPI PI Council will take place to review progress and identify areas that require attention. The program has begun with a number of primary and secondary sites in place. In addition to FIC there are a number of important partners supporting the program – the NIH Office of the Director, HRSA and the U.S. Global AIDS Coordinator. Dr. Cassell suggested that the Association of Academic Health Centers might be an appropriate partner for the MEPI program.

Dr. Glass discussed the Consortium of Universities for Global Health, which held its first meeting at Fogarty three years earlier. This was the first group to advocate for global health training. This year it will meet in Montreal in November and over 1,200 participants are expected to attend. Partners include 61 universities, a number of medical schools not associated with universities, and foreign partners.

Dr. Glass commented that Dr. Cassell had been an important part of efforts by FIC and the Office of Global Health to establish the U.S.-Russia Scientific Forum in Biomedical and Behavioral Research. This was an unfunded mandate by the Obama administration, and through Dr. Cassell’s efforts and support from the Foundation for the NIH, the Forum has become a reality. After a planning meeting in April, the first meeting of the Forum will occur in November. Agenda topics will include maternal and child health, and rare diseases.

Dr. Glass commented that Fogarty has developed good partnerships in India over the past 40 years resulting in a number of MOUs between Indian organizations and a number of NIH ICs. Although there have been some issues with clearance, the goal is to continue to develop such partnerships. Dr. Collins will visit India in December.

Finally, also on December 5-7, the 2011 mHealth Summit will take place in Washington, DC. It is a good follow-on to the recent NIH Leadership Forum in September, at which the president of Qualcom demonstrated a number of fascinating and innovative technologies that will support mHealth innovation in the future.

In closing, Dr. Glass noted that January would see six new Board members who would fill the vacancies of departing members. He expressed appreciation for the service and contributions of the Board members who will be leaving. Finally, he announced the 2012 Board meeting dates – February 7, May 15 and September 11. He invited comments or questions.

Dr. Lou Valdez, FDA, announced release of the FDA Commissioner’s Report on the Pathway to Global Products and Equality, which is available on the FDA web site. She added that there have been some organizational changes at FDA to position the agency as a global health entity.

Dr. Kelley, Institute of Medicine, announced that the IOM, in conjunction with the Robert Wood Johnson Foundation, had released a study on the future of nursing. At the same time the Lancet Commission published a report on health education and education of health professional in the future, written at a strategic level, recommending the formation of national forums on the subject. Taking the cue, IOM is in the process of establishing a global forum on innovations in health professions education that will be launched in February. Workshops sponsored by the forum will be webcast broadly in an effort to develop a global virtual community focused on interdisciplinary health professional education for the century.

Dr. Campbell, Foundation for the NIH, announced that as a result of an organizational meeting in April attended by about 25 companies, an agenda has been developed for the November meetings in Russia and at NIH. The mHealth Summit in December at the Gaylord National Resort and Convention Center will draw about 5,000 participants. There will be over a thousand abstracts submitted, and there will be participation by most major corporate players in the mHealth arena.

Strategies for Innovation: The Role of Prize Competitions and Challenges
Dr. James Anderson

Dr. Anderson explained that NIH has almost 200 mechanisms to enable the creation of knowledge, including various grants and awards, fellowships and so on. On December 21, 2010, Congress passed the America COMPETES Reauthorization Act, which stands for Creating Opportunities to Meaningfully Promote Excellence in Technology Education and Science. It authorized a new mechanism to encourage contribution to science through contests and awards programs. There was already in place an NIH mechanism to conduct contests, a statute called Necessary Expense that allowed the NIH Director to authorize such competitions. Each competition was uniquely designed and there was little standardization in design.

The America COMPETES Act provides standard procedures for conducting competitions, which involves publishing a challenge, allowing independent development of responses to the challenge, and rewarding only those responses that are acceptable to NIH. The program, which is a high administration priority, is meant to stimulate private sector investment, attract nontraditional participants and spur innovation.

Dr. Anderson commented that there are prior examples of this type of approach, one that produces a result in anticipation of a reward. NASA invited high school students to design and submit experiments to be done in space. The reward was that those selected would be included in an orbital mission. The Air Force invited submission of a business plan for a collaborative nano-bio manufacturing institute – one $10,000 prize for the best. And NCI published a challenge for anyone interested to develop a program to glean data from any public source on cancer (epidemiology, incidence, risk factors, prevalence, etc.) such that researchers, clinicians, consumers or anyone interested could use the program’s web-based application to locate and interpret the agglomerated data. The total prize money of $80,000 is comparatively nominal, and the individuals who participate do not risk much since there is little infrastructure required.

The America COMPETES Act does have statutory requirements for agencies adopting the program. There must be extensive consultation within and outside the federal government when designing the challenge. The challenge must be published in the Federal Register, and there must be clear detail about the rules of the challenge, the rewards, the procedures and the judging criteria. The latter must ensure fairness and transparency. The prize money must be appropriated in advance and the agency may not require intellectual property rights without the consent of the awardee. Finally, participants must be covered by insurance or other guarantee for liability during the challenge period.

Dr. Anderson added that NIH is working on the policies that will apply to the process, including delegation of authority to authorize a challenge and its concomitant award. These policies will be developed by a working group made up of IC deputy directors.

Dr. Bloom expressed reservations about the challenge program concept, noting that he felt it was an inappropriate approach to encouraging young people to choose science as a career. He noted his opinion that innovation should be financed up front, and not as a final reward for a product. He recommended a modification, to provide a small percentage of funding up front with a promise of the full reward when the product is delivered. Dr. Shurin agreed in part that the process is not conducive to developing science, but a way to obtain a product that is specified. Dr. Glass closed the discussion by describing NAE member Dean Kamen’s national robotics prize for high school students who develop innovative robots, a competition that was enthusiastically received by many students. He added that the NIH Challenge Program should stimulate positive ideas for global health.

Program Update: Human Health and Heredity in Africa – H3Africa
Dr. Jane L. Peterson, NHGRI

Dr. Peterson stated that NIH has recognized the need for a genomics research initiative in Africa based on the emergence of non-communicable disease as a major health issue, and the disproportionate amount of research focused on HIV/AID, malaria and tuberculosis. It is time to introduce more genetic and genomic research, particularly involving African researchers, to bolster the effort to reduce African “brain drain.” Dr. Peterson noted that Africa has an exceptional genetic diversity, especially when combined with environmental differences. It is timely to mount a program to expand knowledge of the genetic variations among the African populations.

The origins of Human Health and Heredity in Africa, H3Africa, began with a meeting of the African Society of Human Genetics in Cairo, at which Dr. Collins and Dr. Charles Rotimi proposed an African owned and directed health initiative in genomics, which was made a reality through a partnership between the Wellcome Trust and the African Society. The NIH Common Fund promised $5 million a year, later increased to almost $7 million a year. In early 2010 a press released announced the H3Africa project. A working group met later in the year and a report of that group was released in January 2011 detailing recommendations for H3Africa. The mission is to encourage African scientists to study genetic and environmental determinants of diseases common to Africa to improve the health of African populations. The goals include increasing the number of African scientists who are competitive in genomics and population-based research, to establish collaborative networks of African investigators and to create an infrastructure for genomic research, particularly facilities for bioinformatics and a biorepository.

The first meeting of H3Africa was held in Cape Town in March, 2011. It provided the basis for developing projects, getting approval and writing RFAs. There will be five initiatives. First, collaborative centers will be established in various locations in Africa to host research groups. Second, these centers will be the loci of research projects whose dominant theme will be genetic/environmental factors in both communicable and non-communicable diseases. Third, a bioinformatics network will be built based on sites around Africa that will link African researchers. Fourth, biorepositories in Africa will give African researchers more control over the samples they collect; and fifth, later projects related to societal implications research will be developed to more broadly look at genomics and genetics on the whole African continent.

To participate in the H3Africa collaborative centers, all researchers must take advantage of the biorepositories and the bioinformatics network. With regard to the biorepositories, a feasibility study will be completed to determine the best way to approach the final design and structure. The budget is about $10 million annually through FY 2016, and then about $6 million through 2019, mainly for support of the biorepositories. The FOAs will be released shortly, responses due in December, to be approved at the May Council meeting, and awarded in July 2012. The FOA for the societal implications research will be released in 2013.

Concerning the bioinformatics area, Dr. Cassell noted that a survey of Ph.D. awards in Africa in 2007 revealed only ten in the computer sciences. Dr. Peterson commented that there is a computer science school in Cape Town, and that, regardless, individuals with bachelor’s and master’s degrees do well in informatics in the U.S., and that should be the case in Africa as well.

Discussion of Current and Emerging Global Health Priorities
Dr. Francis Collins, Director, NIH

Dr. Collins commented that he had been NIH Director for two years. At the outset he published his five priorities for his tenure, one of which was global health. Since then he said he had traveled on several occasions, beginning in January 2010 with the World Economic Forum in Davos, Switzerland, a meeting that has increasingly included global health in its agenda. In June of the same year he attended the Heads of International Research Organization (HIRO) meeting in London. HIRO’s membership includes the NIH Director, the Director of the Wellcome Trust, Gates Foundation leadership, and similar leaders from Asia and Canada. In June 2011 another HIRO meeting was held in Seattle, followed by the Pacific Health Summit. In October 2010, the World Health Summit focused on non-communicable diseases, which fit well with the next trip to Beijing, China in October, where discussions about hypertension and stroke emphasized the importance of those diseases among the Chinese people.

In January 2011, Dr. Collins said that he repeated his attendance at the Davos meeting, followed in March by a week in Africa, where he attended the H3Africa meeting discussed earlier. While there Dr. Collins visited the African Leadership Academy Executive Seminar, a program for high school juniors and seniors who receive two years of intense liberal education that typically qualifies them for admission to many of the world’s leading universities. They all commit to return to Africa upon completion of their degree programs.

Dr. Collins attended the kickoff meeting for MEPI in March. Looking ahead, Dr. Collins commented that he and Dr. Glass would participate in the UN conference on non-communicable diseases, and in November he would attend the HIRO meeting in Australia, followed by a trip to India to talk to potential collaborators in Bangalore and New Delhi.

Turning to the NIH appropriations, Dr. Collins observed that the FY 2011 budget was the second in forty years that was less than the previous year, a decrement of $321 million. He expressed some confidence that the 2012 budget, which would probably not be approved before the end of the year, would not be as negative in terms of any reductions. He added that it is a challenge to manage science budgets when the appropriations cycle is yearly and most scientific projects are on at least a five-year cycle. There is also the political issue of NIH investing in projects abroad, particularly in China, which currently has stronger GDP growth than the U.S. Those reservations have not been raised with regard to investments in Africa.

Dr. Collins closed by expressing his confidence in the programs that are part of Fogarty International, particularly the MEPI program and H3Africa. NIH is looking at other potential synergies and collaborations that make the use of limited funds more effective and efficient. He proffered his appreciation to the members of the Board for serving on an important advisory body.

During discussion, Dr. Bloom commented that, although the traditional approach to international collaboration has been an enlightened self-interest in promoting science around the world, he felt that under the present circumstances Fogarty International could leverage that collaboration into the area of diplomacy. Dr. Collins agreed that the administration might resonate with that comment, but there is a significant diversity in Congress about the role of science in the international arena. He did feel that investments in science aboard serve to nurture more friendly relationships.

Dr. Cassell commented that the U.S. has few programs to support U.S. scientists going abroad to work in countries that may be ahead of the U.S. in some areas of science. She felt that the BRIC countries would be an appropriate beginning for such a policy change. Asked about the influence of the HIRO group, Dr. Collins explained that the group is very informal, with almost no staff, and the agenda at meetings is very fluid. Concerning partnerships and collaborations that may arise in HIRO group discussions; he felt that developing a fair cost-sharing plan for each project was very important.

Dr. Collins commented that, among other accomplishments during the trip to China, he had worked out an agreement with the Chinese NSF such that NIAID, OCR and NCI have contributed funding to support American investigators who collaborate with Chinese investigators, who in turn are supported by similar levels of funding provided by the Chinese NSF. Dr. Collins added that MEPI and H3Africa have both been discussed in HIRO meetings. However, HIRO is not yet the place to seek funding; the mechanisms available have not yet evolved to that point.

Dr. Glass expressed appreciation to Dr. Collins for his participation in the Board meeting.

Strategies for Partnerships with BRIC countries

Dr. Glass observed that one of the five major priorities is the FIC strategic plan was to build strategic alliances and partnerships in global health research and training. FIC has been successful in that effort, with partnerships and collaborations with other ICs at NIH, with foundations, like the Gates Foundation and the Laerdal Foundation, with outside agencies like PEPFAR and HRSA, and with a number of international organizations. There have been many investments in global health projects in the BRIC countries – Brazil, Russia, India and China, as well as Russia and countries in Africa.

There are new models for developing collaborations, one of which is the partnership between NIH and Brazil on Scientific and Technological Development. Mr. Bialy, of the NIH Division of International Relations, commented that the program there is in response to a goal set by Brazil’s Council for Technological Development (CNPq) to train 75,000 Brazilians in science and technology over the next four years. The agreement is for CNPQ to fund half of the stipends for all intramural postdocs, which reduces the stipend costs for NIH in this joint venture. There are other institutions in Brazil involved in this program, including the graduate education component of the Ministry of Education. The next step will be to develop joint research RFAs that should result in mutually beneficial research priorities and programs. Fogarty’s role is to harmonize the interests of the ICs in this project.

Mr. Mampilly discussed a neuroscience agreement between NIH and India, stating that there has been a 40-year history of collaboration between NIH and various institutions and agencies in India, particularly the Indian Council of Medical Research, within the Ministry of Health and Family Welfare. One recent partnership involves a joint effort to develop low cost medical technologies. There are currently nine such partnerships with various ICs.

Concerning the Neuroscience Agreement, FIC worked with NINDS, NIMH and NIDA to structure a collaboration based on past models in which the Indian government provided partial funding for the project. An FOA was released early this year and there were 50 applications. The first India-U.S. Neuroscience Joint Working Group met in August to work out the agreement. Out of that NINDS and NIDA agreed to support funding for eight R21 awards.

Mr. Mampilly mentioned other irons in the fire including NIDDK’s interested in developing a partnership with India focused on a diabetes research collaboration, NIBIB’s Low-Cost Summit, and the OAR Joint Working Group.

Ms. Tina Chung described the first co-managed and co-funded initiative between China and NIH, the result of an MOU negotiated by Dr. Collins and Dr. Chen, president of the Chinese NSF. The pilot year of the program has just ended. OAR, NIAID and NCI each contributed about a million dollars, matched by the Chinese NSF, with the funds dedicated to supporting U.S. and Chinese scientists respectively. Investigators from both countries submitted identical applications, which were reviewed by NIH and the Chinese NSF. Out of 200 applications the joint working group agreed to fund 34 projects. Although the pilot year was considered successful, the joint working group recently met to discuss improvements in the process. Now FIC will make other ICs aware of the agreement and perhaps the trans-NIH Global Health Research Working Group will convene a special session to provide information about the program to interested ICs.

Dr. Glass commented that the BRICs were selected for this initiative because they are the largest countries that benefit from NIH investment, but there are a number of other countries that would be good candidates for participation in the initiative – Mexico, Argentina, Chile, Venezuela, Turkey and Indonesia. Dr. Glass asked the Board to consider mechanisms, such as whether funding should be tiered based on the ability of each country to contribute. NIH might fully fund programs in the low income countries, and negotiate more balanced collaborative agreements with middle income countries. Similarly, he asked if NIH should continue to support only the highest quality peer-reviewed science, or accept other standards to accommodate those lower income countries. He invited Dr. Morrison to comment as a discussant from CSIS.

Dr. Steve Morrison, Senior Vice President and Director, Global Health Policy Center, CSIS

Dr. Morrison stated that he would address the larger political issues with regard to the BRIC countries, including the current period of austerity and political polarization that is accompanied by an increased vulnerability to risk in developing international collaborations. He noted cross-cutting factors among the BRIC countries – all are emerging powers, but they vary in size and strength. The U.S. has developed different mechanisms to manage bilateral relationships that can be complicated and unique to each country. An important consideration is that the U.S. and other countries in the world are very dependent on these countries for healthy economic growth at home. Therefore there is a constraint across the U.S. political spectrum, including Congress, to attack these countries economically or otherwise.

Dr. Morrison mentioned a third consideration, the Congressional Super Committee. In this era of economic stress in the U.S., operating under a mandate to reduce the national deficit by $1.2 trillion and generally negotiating behind closed doors, The Super Committee has heightened concern about the budgetary process in Congress. Another factor is that the change in the balance of power in Congress, and the increased influence to the Tea Party, has not resulted in an isolationist sentiment in Congress, and has put a damper on confrontation with economic powers, such as China. The debate about whether China’s goal is to overtake U.S. hegemony, which is a strategic threat, or whether China and the United States can coexist in the world economy, will continue and may be at times disruptive

With regard to Russia, Dr. Morrison felt that the relationship is basically positive, despite the historical issues of corruption, lack of transparency and the potential for violent autocracy. Russia’s position on Iran and Libya has softened, but trade relations with the U.S. continue to be weak.

India and the U.S. are experiencing a period of bipartisan ascending relations with exceptional potential for economic expansion. Although the bilateral relationship with Brazil can be challenging at times, that relationship and cooperation seem to be improving. Finally, Africa is the new BRIC kid on the block as a result of a strong collaborative history that includes very large investments ($3.1 billion in South Africa through PEPFAR since 2004) and many research collaborations.

During discussion, asked about how to approach Congress in the new economic environment, and how to manage the more diverse interest groups, Dr. Morrison suggested that being aware that the playing field is changing, perhaps deteriorating, demands a sober reassessment of the desired outcomes. The basics have not changed – we pursue goals because of human values, our self-interest in global security, stability and economic growth – and those goals must be pursued with support from diverse constituencies, not just the research community, but faith-based groups, the business sector, and academia.

Dr. Glass asked about the Global Health Initiative, which has been somewhat sidelined in the recent past. Dr. Morrison responded that the Global Health Initiative has suffered from lack of identity and clear branding, whether it represents new programs and new money, whether a change in the way the research business is done, and whether current platforms in HIV/AIDS, TB and malaria can be integrated into a new approach that results in benefits. Dr. Morrison expressed the view that although it has taken time to get off the ground, there is still potential. Programs take time to start up – the Millennium Challenge Corporation was announced in 2002 but didn’t get out of the gate for five years; PEPFAR was announced in January 2003 but took two years to become operational.

Dr. Vermund observed that trying to negotiate agreements with the relatively large number of upper middle income countries could be burdensome administratively. Dr. Morrison noted that there were some opportunities to ease that burden, such as the UNASUR in the Southern Cone. That group facilitates cooperation among the southern hemisphere countries.

Dr. Katherine Bliss, Deputy Director and Senior Fellow at the Global Health Policy Center, CSIS

Dr. Bliss described an ongoing study at the Global Health Policy Center that centers around two questions: First, as the BRIC countries experience improved economies, how will they fit in the multilateral interactions that occur among the richer countries, and particularly what role will they play in the World Trade Organization, the G20 countries and as G8 outreach countries? Second, if the BRIC countries are becoming more engaged in global health, what does that mean to the United States and other traditional donor countries?

Dr. Bliss explained that, in terms of the study, “BRIC countries” included Russia and South Africa. In the study, the Center sent researchers to each BRIC country to interview government officials, representatives from NGOs and other private entities, staff of multilateral groups and the U.S. missions abroad and embassies in the U.S. The researchers looked at government web sites and other secondary resources. The interviews focused on five questions.

First, what was the rationale for the country’s decisions regarding when to engage in global health issues beyond its borders? Second, how are domestic factors and foreign policy considerations integrated into the decision making process? What bilateral/multilateral partnerships in existence are most significant and what drives the country to engage in those kinds of partnerships? Fourth, what is the legal, financial, bureaucratic and institutional framework within the country that supports engagement in global health? Fifth, the researchers were asked to consider how circumstances might develop in the next 5-15 years.

The first phase of the study was completed at the end of 2010, and the answers to those five questions became the basis for a report that was subsequently published. The second phase of the study is more proactive. CSIS researchers would explore the same questions in greater depth, encourage contacts/partners in each country to undertake research and analysis of the country’s role in global health, and identify opportunities for strengthening U.S. partnerships.

Dr. Bliss commented that, during 2011, a number of meetings were held on the topic of global health in Russia, China, and South Africa, and additional meetings will be held before the end of the year in Brazil and India. In a third concurrent phase there will be meetings of the researchers and partners in the countries to develop an agenda for future research in the BRICs’ role in global health issues.

In terms of study outcomes, Dr. Bliss stated that it was clear that the BRICs are not new to the global health arena. Most have been involved for decades. During the Soviet era, Russia cultivated extensive international relationships in the health care field, although its 2007 declaration to become a donor nation is new. China began sending medical teams abroad in 1963. Brazil will rely on its longstanding internal recipient organizations to transform into a donor capability. And since 1964, India has maintained training programs in 154 countries.

Secondly, the study showed that, although each country’s motivation for moving into donor status in global health was similar, there was some consensus that South-South cooperation was an important issue. That consensus may be based on common ties as developing countries, or there may be an interest in leveling the playing field vis-à-vis the Northern Hemisphere countries.

With regard to the individual countries, Brazil’s 1988 constitution guaranteed health care, which resulted in the Brazil Universal Health System, which has been reasonably successful. Brazil has shared the road to that success with other Latin American countries, and its main outreach is now in that area. In 2007 Russia made a move to begin the process of becoming a donor nation, developing a supportive legal and regulatory framework, establishing priorities, creating channels of multilateral and bilateral communication, and setting up pilot programs. Unlike the Southern countries’ commonality, Russia’s self-image may be a more important motivation for this process. In India, researchers found that there was a sentiment that domestic health care was the most important priority, but in 2003 India announced it would begin a transition. For a time it would be a recipient/donor nation, continuing to receiving financial assistance from a few countries, but it would begin to provide assistance to Afghanistan, Bangladesh, Nepal, Sri Lanka, and Sub-Saharan Africa. China’s goal is to strengthen ties with other countries on the development path, and China seems to prefer health partnerships with countries that have resources that it needs.

Discussion

Dr. Vermund observed that the Wellcome Trust’s early interest in multilateral or triangular collaborations, which was relatively successful, might have stimulated longer-term arrangements among partners such as the U.S.-Eastern and Western Europe or India-Southeast Asia-U.S. But that did not happen. He also mentioned the lack of interest on the part of the wealthy Middle East-North Africa (MENA) countries to support their poorer MENA neighbors. He felt that was an area that should be explored.

Dr. Michael Merson, Director, Duke Global Health Institute

Dr. Merson mentioned the dramatic change in the way universities are looking at education related to global issues. The concept of a global university is on the agenda of most universities in the U.S. In many universities incoming freshmen who have been abroad, many to Africa, comprise as much as two-thirds of the student body. And the students are driving the issue of global studies, particularly global health studies.

Secondly, as faculty contemplate future curricula in global studies, the BRIC countries are going to play a dominate role. For students who want to study abroad, the BRICs are going to be important. And as universities increasingly recruit international faculty, the BRICs will be a resource.

Dr. Merson offered some statistics about the BRIC countries. From 2002 to 2007, China, India and Brazil nearly doubled their investment in science research. Thirty-five percent of papers published in international journals include authors from two or more countries, a doubling since 1990. China may overtake the U.S. as the dominant world publisher of scientific research by 2013. BRICs comprise 12% of leadership at journals. And China and Brazil have indicated a desire to spend 2.5% of GDP on research by 2020.

With regard to the individual countries, China is very aggressive in trying to attract U.S. universities to collaborate. The country wants its students to begin to think in different ways that would be facilitated by exposure to western education. In India, there is little research in universities. Most is conducted by institutes, which U.S. universities find challenging in terms of developing partnerships. There are few U.S. universities collaborating with sister universities in Brazil, partly because of the language gap and partly because Brazil imposes very stringent selection criteria when it comes to international partnerships. Similarly, there are few U.S. universities involved with Russian universities, again because of difficulties in negotiating agreements.

Dr. Merson commented that it is important to understand that the donor-recipient mentality is gone when dealing with BRIC countries. It is a non-starter when present in negotiations between universities. The BRICs see themselves as partners, not recipients. The objective should be to develop programs that will support that partnership. There are common issues among the BRIC countries that should serve that objective. First, non-communicable diseases are an issue in all BRICs – hypertension, stroke, heart disease, diabetes, obesity. Second, there are similar environmental issues, such as high rates of smoking. Third, most BRIC countries are involved in health system reform.

Finally, Dr. Merson observed that many of the health issues facing the BRIC countries are similar to those in the U.S., so collaborative research should produce results of benefit to both countries.

Discussion

Dr. Glass posed the first question about research related to smoking in China. Although it is a significant health issue, smoking research is not going to produce science useful to the U.S. As well, the U.S. has proven effective smoke deterrence through taxes and other programs. Finally, the tobacco industry is controlled by the Chinese government. However, he added that NIDA has an interest in research related to a tobacco vaccine so it is not an issue totally outside the area of NIH research.

Dr. Merson responded that there is no assurance that what works in the U.S. would work in China and research might reveal new possibilities, as well as characterize the effect of smoking on the Chinese populations. He conceded that it might not be an NIH issue. Dr. Vermund added that NIH had conducted research on tobacco use reduction in New York City, where the mayor banned smoking in public indoor spaces (which researchers agreed would help those actively trying to quit smoking), and doubled cigarette taxes (which did not affect adults, but put a significant crimp in teenage smoking). He suggested that public policy and structural reform could be part of the NIH health research agenda.

Dr. Merson mentioned the hypertension issue and an NHLBI study reducing sodium chloride in table salt with a 40% mixture of potassium chloride and magnesium chloride. He suggested that could be useful research in the BRIC countries as well as the U.S. Dr. Glass added, with regard to hypertension, that stroke in the U.S. is typically embolic and stroke in China is hemorrhagic. Since there is a large Chinese-American population in the U.S., it might be appropriate research to determine which type of stroke affects the U.S. population. It would be research appropriate to collaboration with Chinese scientists.

Dr. Vermund mentioned parallel studies in cardiovascular disease in the U.S. and Shanghai looking at commonalities in the two populations. They are able to compare two very different diets, one soy dominant with high consumption of green tea, the other the typical American diet. It is a study that could not be done except in such a collaboration. Dr. Merson added another study of readmissions for cardiac failure related to environmental parameters, comparing China and the U.S.

Dr. Glass commented tat the stroke study and the heart failure study provide models for a partnership between NSF China and NIH, although the institutes involved in those studies are not part of the agreement. The model would be different from the traditional NIH-funded grant to study an issue. He invited comment from Gray Handley and Julie Schneider, who have been working with the NSF China agreement.

Dr. Handley agreed that other institutes are welcome to join the agreement as long they understand the importance of contributing financially. NSF China is open to the idea and there are discussions underway with NICHD and NINDS. He commented that the next project under consideration is to transition one of the bilateral programs into a multilateral program, but not in the context of multilateral organizations. There must be care to keep the focus on advances in sciences, and avoid being seen as a development organization or an instrument of foreign policy. The program being considered is a longstanding U.S.-Japan program that could be expanded into a regional program that includes countries like Indonesia, Thailand, and Vietnam. That program could be synergistic, tapping the strengths of the various countries, as long as each partner was willing to come into the program with shared resources.

Dr. Handley also described a program begun five years ago with NIAID that identified five countries that would become involved in bilaterally-funded initiatives. About half of the five countries have established such a bilateral agreement. Dr. Handley felt that it was important that the bilateral agreements begin with an initiative from the other side, coming to the table with both interest and resources. When that happens, NIH is willing to add funding to the project.

Dr. Handley stated that it is important to maintain credibility with the intramural and extramural community by assuring the integrity of the NIH process in soliciting and making awards, including peer review. That was an element that made the NSF China agreement work, a strong commitment to peer review. Dr. Schneider mentioned that when the joint working group was considering the funding of projects, NSF China requested a workshop on how NIH handles peer review. So there is interest there in doing it well.

Asked about Fogarty’s role in the process, Dr. Handley commented that the Trans-NIH Global Health Working Group was established to provide a forum for ICs to discuss global health issues, including these new initiatives. He felt Fogarty was important in bringing people together in support of that process. He added that many of the problems and projects require substantial effort, which has to come from the larger institutes that have the resources to help.

Dr. Bloom suggested that it might be helpful for ICs involved in these agreements to solicit feedback from the recipients, which might still view the program as the traditional grant funding process rather than a shared financial responsibility. He added that consideration should also be given to the issue of lack of funding for indirect costs, which can be a sticking point for some scientists.

Dr. Glass closed the discussion with two points. First, FIC is vulnerable in participating in these associations because the issues are big, like resistant tuberculosis, because the funding is substantial, and FIC is not able to fund such projects. Fogarty has a number of smaller programs, and it is a challenge to manage that kind of portfolio.

Second, Fogarty is very involved in training and capacity building for research, and the primary outcome is not scientific discovery itself. That is a factor that makes the partnership agreements a challenge for Fogarty.

Development Policy and Health Implications
Dr. Alex Dehgan, Science and Technology Advisor, USAID
Ms. Amie Batson, Deputy Assistant Administrator, Global Health, USAID

Dr. Glass introduced the discussion of Fogarty’s relationship with USAID, noting that the focus of interest is Sub-Saharan Africa, where Fogarty’s assets are mainly the scientists who have been trained under Fogarty programs. He suggested that the discussion might reveal how best to take advantage of those assets to answer the research questions on USAID’s agenda. Some of those answers could be provided by local investigators who would support local ownership of the research; that in turn would build a local capacity for leadership in the future. He invited Dr. Dehgan to comment.

Dr. Dehgan stated that the Administrator supports the enhancement of science and technology that now exists within USAID. He noted that a goal is to restore science and technology to the level it occupied in the nineties, when it was an important part of the culture of the agency. There is a reform agenda that includes five areas, the first of which is to rebuild capacity for science and technology. An Office of Science and Technology has been established, and the Policy Bureau, removed from the organization for about five years, has been restored.

An early step was to recruit AAAS Fellows, and USAID now has the highest number of any federal agency. There will be engagement with the Embassy Science Fellows Program, which facilitates placing scientists from federal agencies in overseas embassies and missions. NIH could participate in that program.

As a place-based agency, USAID is involved in geospatial technology, which is appropriate to managing programs, such as a tuberculosis project – tracking where people live, population densities, road networks, where clinics are located, security threats and so on. It allows a systems approach to project management. USAID has significant geospatial resources, including a GIS center within AID and an agreement with the National Geospatial Intelligence Agency for access to huge imagery resources. USAID has large data resources and there is an initiative to disaggregate and geocode the data to make it more accessible and publicly available.

Dr. Dehgan described the first USAID grand challenge for development, ensuring that all women, from onset of labor until 48 hours after delivery, have access to medical care whether they are in a hospital, clinic on a hut. In doing that USAID learned to avoid dictating solutions and to allow ideas to emerge from the process. Secondly, it was clear that the agency should develop partnerships, not only because of the stressed economic environment, but because there are threats that have a trans-boundary component – infectious disease, food security, clean water. All of these require cooperative solutions.

Dr. Dehgan commented that one approach being considered is the awarding of prizes, payment for specific success. He suggested that drawing people from fields other than traditional development might result in innovative solutions to specific challenges.

Another area of interest is in leveraging federal science agencies and universities. An example is working with the National Science Foundation, that has funding that can only be directed to U.S. researchers. USAID can fund developing country counterparts, and has partnered with NSF through a program called Partnerships for Enhanced Engagement in Research (PEER). With regard to universities, there is an interest in changing the image of USAID from a revenue source to a potential partner.

Finally, Dr. Deghan said that there will be capacity building in the developing countries -- for example, helping a country establish a “national science foundation” or a grand challenges program.

Ms. Batson described USAID’s global health work, the largest part of the USAID budget, which includes implementation of the PEPFAR initiatives related to HIV/AIDS, malaria, TB, neglected tropical diseases, pandemics, maternal and child health, food and water issues, sanitation, family planning, and strengthening health systems. Two big successes emerged – the significant inroads PEPFAR made in the AIDS epidemic and the dramatic decrease in mortality related to malaria. They enhanced confidence that other serious issues could be addressed, such as the widely dispersed health care clinics, many of which deal with only a single disease. The Global Health Initiative has stressed the importance of country ownership of health systems, and of recognizing that women and girls have special health needs.

Ms. Batson suggested that one of the most challenging problems in resolving the issue of coordination and collaboration across federal health agencies. There are unique competencies in these agencies that should be shared, and there is duplicative effort that should be consolidated; for example, in one area USAID, the Peace Corps and the Department of Defense are doing essentially the same thing. There must also be a way to assess whether programs work or not, and address those that are not working well.

Ms. Batson suggested several areas conducive to cooperative effort between USAID and NIH. One was geospatial mapping, which can be a good resource for the research community. A second very important common area is improved linkage between the research community and the U.S. missions. Most researchers have never visited a mission, and setting up communication could enhance research outcomes. There should be a common goal to improve access to scientific literature. Capacity building with regard to the research base -- USAID is considering direct contact with researchers to interest them in GHI issues, and then making USAID funding available. Finally, USAID and NIH should work to overcome the bureaucratic obstacles that exist in both agencies.

During discussion Ms. Batson explained that the President’s health initiatives are in every country that receives funding in global health programs. It started in the GHI plus, involving eight countries that endorsed GHI objectives. It has expanded now to 20 additional countries that submitted GHI strategies. The last 40 countries should be on board by the end of the year.

Asked about USAID funding for universities, Ms. Batson stated that there is none thus far, that currently researchers are being introduced to in-country program people, but that an RFA was published inviting proposals for use of end-of-year NIH funds to pursue GHI-related projects. About 30 proposals are being reviewed. Dr. Dehgan added that for the RFPs related to Saving Lives at Birth, half of the proposals came from abroad, one quarter from developing countries. That is very different from the typical USAID RFP process. He noted that USAID is in the process of rethinking the higher education investments to see if there is a better way to distribute the funding. He added that the higher education is relatively small, about $75 million, compared to the PEER program where the leveraged NFS involvement of $100 million exists. The PEER program began in August and has the potential for future growth.

Dr. Black asked if Saving Lives at Birth might be a candidate program for co-funding by a country like India and whether the State Department might serve as a broker to effect an agreement. Ms. Batson commented that Saving Lives at Birth is a cooperative program with Norway and Grand Challenges Canada, and there have been discussions about the programs global reach. It could be focused on a country like India, or it could a regional program, such as eastern Africa. Dr. Glass added that, although NICHD did not have funding available at the time, the institute has significant resources that would fit into the mission of the program. Ms. Batson agreed, noting that the some of the ICs were very helpful in reviewing the proposals and selecting the best ideas.

Ms. Batson mentioned that one of the President’s major development initiatives is related to food security in the context of global health. It raises the issue of getting those in agriculture interested in nutrition, in addition to the focus on markets and pricing. Dr. Shurin commented that the Trans-NIH Obesity Task Force has a subgroup, the National Coordinating Committee for Obesity Research, which might be able to broaden its focus to include nutrition.

Dr. Glass noted that USAID has a substantial interest in Nigeria, but it is not clear how researchers in Nigeria learn about the USAID opportunities. Ms. Batson stated that there were several mechanisms, including making sure that the research networks are aware so that their researchers have access to appropriate information. She suggested that it would be helpful to have a discussion about the issue and see whether there are points of contact between USAID and NIH that could facilitate getting the information out to the proper recipients. Ms. Batson added that in some countries researchers don’t even know how to get to the U.S. mission, they know nothing about the development programs that are up and running, and the development programs don’t know about the researchers. She suggested that a step should be made to begin to establish linkages with the researchers.

Dr. Handley mentioned that in Zambia the NIH, working with the CDC, has planned a scientific symposium to which all scientists in the country, both American and Zambian, will be invited. There is also interest in getting representatives of the government to attend. He added that it would be helpful if USAID would inform the U.S. missions and invite them to participate.

Dr. Glass commented that USAID and NIH evaluate program impact, which might be another area for cooperation between the two agencies. Ms. Kupfer noted that that evaluation of international programs requires qualified evaluators in country, and that Fogarty has developed a database of most trainees that is available on the web, that embassies and mission may freely access.

Dr. Olopade announced that NCI has just established a new Center for Global Health and that she had recently participated in a discussion of how to coordinate the work on cancer control in different countries. Considering the fact that NCI, USAID, NIH and Fogarty all have funds committed to programs in those countries, that the time is right to consider how to coordinate those program efforts and share resources.

Dr. Herrington responded that there was greater communication between researchers and agencies partly because of the need to implement the science that has been developed. Working with the geospatial experts to map NIH investments around the world is developing information that is going to be an important first step in facilitating cooperation.

Asked about moving science and technology to the policy level in developing countries, Ms. Batson conceded that it was not a top priority. Country ownership is the priority, helping countries develop the capacity to pose their own research questions, accumulate the data and make evidence-based decision that might then result in policy. It is a change for federal agencies that have, in the past, been more likely to provide the evidence and suggest the policy. Engaging the successful researchers that Fogarty and NIH have trained is a positive step.

Dr. Dehgan added that one process is to allow the country to self-select, make an investment and then be open for specific assistance from USAID. That focuses the issue and more clearly defines the effort required on both sides. Second, there should be an effort to replicate the USAID-NSF PEER program, perhaps with USDA. That facilitates direct support for both researchers, rather than having to create a pass-through mechanism.

Closing Remarks and Adjournment

Dr. Roger Glass

Dr. Glass expressed appreciation to Dr. Dehgan and Ms. Batson for leading the discussion on USAID-NIH opportunities for cooperation and collaboration. He noted that after the last meeting two review groups met to discuss two agenda presentations on the Center for Global Health Studies and Fogarty Communications. That precedent worked well and two review groups would meet after the meeting to discuss the BRIC country presentation and the USAID discussion.

Dr. Glass expressed appreciation to the Board members and to other who attended and participated in the meeting.

The meeting was adjourned at 3:00 p.m.

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