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September 11, 2007 Meeting Minutes

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
Sixty-seventh Meeting

 

Table of Contents

1. Call to Order and Introductory Remarks
2. Dates of Future Board Meetings
3. Review of Confidentiality and Conflict of Interest
4. Review of Applications
5. Minutes of Previous Meeting
6. Open Session: Welcome and Director's Opening Remarks
7. Future of PEPFAR and the Role of Fogarty
8. Prospects for Roadmap and Follow-up to NIH Leadership Forum
9. Update on the Fogarty Strategic Plan and Calendar
10. Office of Communications Initiatives
11. Report on Evaluation of the Fogarty International Research Collaboration Award
12. Peer Review Project
13. Concluding Remarks

The John E. Fogarty International Center for Advanced Study in the Health Sciences (Fogarty) convened the sixty-seventh meeting of its Advisory Board on Tuesday, September 11, 2007, at 8:30 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The closed session was held from 8:30 a.m. to 10:00 a.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] The meeting was open to the public from 10:30 a.m. to 3:15 p.m. Dr. Roger I. Glass, Chair, Fogarty Advisory Board and Director, Fogarty, presided. The Board roster is appended as Attachment 1.

Board Members Present:

Dr. Karen H. Antman
Dr. Robert Black
Dr. Patricia M. Danzon
Dr. Douglas C. Heimburger
Dr. Peter Hotez
Dr. Ting-Kai Li (ex officio)
Dr. Jim Yong Kim
Dr. William A. Vega
Dr. Sten Vermund

Board Members Absent:

Dr. Luz Claudio
Dr. Elizabeth Barrett-Connor
Dr. Arthur Kleinman
Dr. Arthur Reingold

Federal Employees Present:

Ms. Nalini Anand, Fogarty/NIH
Dr. Jeanne McDermott, Fogarty/NIH
Mr. Kevin Bialy, Fogarty/NIH
Dr. Ellis McKenzie, Fogarty/NIH
Ms. Daniele Bielenstein, Fogarty/NIH
Dr. Kathy Michels, Fogarty/NIH
Dr. Joel Breman, Fogarty/NIH
Mr. Tikki Pang, WHO
Dr. Kenneth Bridbord, Fogarty/NIH
Ms. Sherri Park, NICHD/OCM
Mr. Bruce Butrum, Fogarty/NIH
Dr. Aron Primack, Fogarty/NIH
Dr. Peter Billingsley, Fogarty/NIH
Ms. Eva Sereghy, NICHD
Ms. Stacy Chambers, NINDS
Ms. Katherine Serrano, NIBIB/NIH
Ms. Elizabeth Cleveland, Fogarty/NIH
Dr. Lana Shekim, NIDCD/NIH
Dr. Louis Cohen, NIDCR Consultant
Dr. Barbara Sina, Fogarty/NIH
Mr. Robert Dennis, NHGRI/NIH, Contractor
Dr. Manana Sukhareva, CSR/NIH
Dr. Sheri Dupere, CSR
Dr. Lawrence Tabak, NIH/NIDCR
Dr. Dan Gerendasy, CSR/NIH
Ms. Natalie Tomitch, OAR/OD
Dr. John Haller, NIBIB
Mr. Tim Tosten, Fogarty/NIH
Dr. Karen Hofman, Fogarty/NIH
Dr. Ed Trapido, NCI/NIH
Dr. Michael Johnson, HHS/OGHA
Dr. Richard Wyatt, OD/NIH
Mr. Andrew Jones, Fogarty/NIH
Dr. Brian Zukerman, STPI/IDA
Dr. Flora Katz, Fogarty/NIH
Dr. Brenda Korte, NIBIB/NIH
Dr. Danuta Krotosky, NICHD
Dr. Vesna Kutlesic, OD
Ms. Judy Levin, Fogarty/NIH
Dr. Xingzhu Liu, Fogarty/NIH
Ms. Sonja Madera, Fogarty/NIH
Mr. Thomas Mampilly, Fogarty/NIH

CLOSED SESSION

I. CALL TO ORDER AND INTRODUCTORY REMARKS

Dr. Glass called the meeting to order at 8:30 a.m. and welcomed the Board members.

II. DATES OF FUTURE BOARD MEETINGS

The following meeting dates are confirmed:

Tuesday, February 5, 2008
Tuesday, May 20, 2008
Tuesday, September 9, 2008

The Research Awards Subcommittee will meet on the Monday preceding each Board meeting to review of applications on behalf of the full Board.

III. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST

The rules and regulations pertaining to conflict of interest were maintained.

IV. REVIEW OF APPLICATIONS

Dr. Glass chaired the Closed Session during which the Research Awards Subcommittee reported on its activities. The Fogarty Advisory Board reviewed a total of 29 applications.^[2] The applications were in the following programs:

• 2 applications for the Ecology of Infectious Diseases (EID) out of a total of 2, for $883,488;
  
• 16 applications for the Fogarty International Research Collaboration Award (FIRCA), Basic Biomedical (BB)out of a total of 16 applications, for $408,041;
• 9 applications for the International Research Scholars Development Award (ISRDA) out of a total of 9 applications, for $952,714;
• 2 applications for the Global Research Initiative Program for New Foreign Investigators (GRIP)—SPECIAL ACTION out of a total of 2 applications, for $100,000.

The Board concurred with the initial review group recommendations for 29 of 29 applications.

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OPEN SESSION

V. MINUTES OF PREVIOUS MEETING

The minutes of the Fogarty Advisory Board meeting for September 11, 2207, were considered and approved unanimously.

VI. WELCOME AND DIRECTOR'S OPENING REMARKS

Dr. Roger I. Glass, Director, Fogarty

Dr. Glass welcomed everyone and introduced the special guests and new staff. The guests included Dr. Tikki Pang of the World Health Organization’s research cluster, Mr. Chad Gardner, The Earth Institute, New York., and Dr. Michael Johnson, Fogarty Deputy Director Designee and Liaison, the President’s Emergency Plan for AIDS Relief (PEPFAR), Department of Health and Human Services. The new staff included Mr. Robert Eiss, Senior Public Health Advisor—Mr. Eiss will be involved in supporting Roadmap activities and developing relationships with other NIH institutes and centers; Ms. Ann Puderbaugh, Director of Communications; and Mr. Tim Tosten, Executive Officer and Director, Office of Administrative Management.

Dr. Glass reported on his recent trip to Africa during which he accompanied Secretary Mike Leavitt, Department of Health and Human Services; Dr. Julie Gerberding, Director, Centers for Disease Control and Prevention; Dr. Kent Hill, Deputy Administrator, USAID; Ambassador Mark Dybul, Coordinator, PEPFAR; and Adm. R. Tim Ziemer, Coordinator, The President’s Malaria Initiative. The group visited South Africa, Mozambique, Tanzania, Rwanda and Kenya.

Although not on the official agenda, Dr. Glass had the opportunity to address the importance of integrating a research agenda and capacity building into the PEPFAR programs which are huge—research and capacity building are strongly emphasized in the Institute of Medicine (IOM) review of the PEPFAR program. The magnitude of PEPFAR programs can be illustrated by comparing the PEPFAR budget of $110 million in Rwanda to the country’s entire health budget of $30 million. In addition, the presence of Fogarty Clinical Scholars in Durban, South Africa demonstrated the importance of capacity building—a previous graduate was now running the anti-retroviral program in the field area along with conducting research to address some of the difficulties of delivering anti-retroviral drugs in the field. It was also clear from the visit that Fogarty has had a major impact in developing young staff and researchers who can now populate the PEPFAR program’s research laboratories.

While the importance of building capacity locally is critical, program sustainability is also critical to long-term outcomes. For example, although the most recent malaria intervention program in Zanzibar (Mozambique) successfully reduced the disease rate from 25% to 1% in a year, there are no programs that will sustain that level of disease reduction over time. The outcome: This was the third time malaria had effectively been eliminated in Zanzibar. Malaria was essentially eliminated in 1950 with the DBT spraying program and again in 1980 with the TDR program. Since Zanzibar is a tourist designation, hotel and/or airport related taxes were suggested as potential options for ensuring the long-term sustainability of malaria eradication programs in Mozambique.

Overall, the lessons learned included the value of sustainability and the need for implementation science. The importance of local capacity building also resonated through out the trip. Fogarty trainees and alumni, a number of which met the group at every site, are poised to play a vital role as PEPFAR and other public health related programs in the developing world mature.

On another front, NIH Director and Dr. Glass will visit India in October to sign a US-India agreement in bioengineering. India has developed at least nine collaborative programs with a number of the NIH institutes and centers in the areas of infectious diseases (including HIV/AIDS), biotechnology and bioengineering and shares in the funding of those programs. The NIH Director will meet with the Prime Minister, the Minister of Health and the Minister of Science and Technology during the trip to India. Dr. Hotez commented on the growing capacity in India and other developing countries for both research and the manufacture of biologics. About 60% of all health products moving into developing countries come from other developing countries.

Dr. Glass concluded his opening remarks by reviewing the agenda. Dr. Glass noted that the focus of the morning and afternoon sessions was building Fogarty as outlined in the new strategic plan, which is still in progress—building Fogarty in relation to other US government activities such as PEPFAR, engaging in the NIH Roadmap, building Fogarty from within, and building Fogarty messages.

VII. FUTURE OF PEPFAR AND THE ROLE OF FOGARTY

Dr. Michael F. Johnson, Deputy Director Designee, Fogarty

The focus of Dr. Johnson’s presentation was on selected PEPFAR basics and the issues raised in the Institute of Medicine (IOM) report on the review of the program. The intent was to stimulate discussion on programmatic areas within the purview of the Fogarty and NIH mission.

PEPFAR Basics

PEPFAR, in large part, is a major U.S. initiative in health diplomacy. The proposed and expected budget was projected to reach about $5.4 billion in 2008; however, the President has recently made a commitment for $30 billion over the next five years for phase 2 PEPFAR. The use of PEPFAR funds is encompassed under an authorizing law, Public Law 108-25. Approximately $10 billion is new money and approximately $5 billion comes from existing funding streams established prior to PEPFAR. NIH global AIDS research is a new area under the program.

As the HHS Liaison for PEPFAR, Dr. Johnson’s responsibilities include linking the different operational divisions of HHS into PEPFAR—linking the NIH to PEPFAR has been a challenge because of the program’s initial lack of focus on research. There are three top programmatic areas under law: (i) abstinence and be faithful, (ii) orphans and vulnerable children, and (iii) treatment. Other provisions provided for under law include limits on grants to a single partner; strategic information which incorporates monitoring and evaluation, management and staffing; and public health evaluation or operations research. Current guidance for the FY08 country operational plans includes a provision for allocating one to four percent of budgets for public health evaluation, which is quite low.

Dr. Johnson reiterated the strong legal underpinning for PEPFAR in terms of focusing on abstinence (A), being faithful (B), and condom use (C) (i.e., the ABC prevention component). The ABC prevention component also includes mother to child transmission, blood safety, injection safety and sexual transmission. And per budgetary guidance, all components must remain in balance. For example, any increase in condom promotion must be balanced by increases in the “AB” components. This type of earmarking tends to undermine parts of the prevention program.

Perhaps PEPFAR’s greatest and most publicized success is the placement of people on anti-retroviral (ARV) medications.  PEPFAR set a goal of treating two million people over a five-year period; and as of earlier this year 1.1 million had been treated—it is anticipated that the goal of treating 2 million people will be reached as early as World AIDS Day this year.  Unfortunately, in the same geographic area new infections have occurred at a rate of 4.1 million per year.

IOM Report—PEPFAR Implementation: Progress and Promise

PEPFAR has been very disciplined in terms of focusing its funds on the care, treatment and prevention of HIV with the encouragement of “wrap-arounds” to cover system strengthening for tuberculosis, sexually transmitted diseases, food and nutrition, etc. This is a source of tension; and accordingly, considerable attention has been dedicated in the IOM report to looking at how PEPFAR can do a better job linking to other programs that are not specifically focused on HIV/AIDS.

Since there is little, if any, research directed toward identifying the best prevention interventions, the IOM notes that within such a vacuum, there is an ideological debate concerning what happens with prevention and how the resources get allocated. The report also noted that while funding for HIV/AIDS has increased tremendously, the resources for basic health infrastructure training and human capacity development has remained the same. The report recommends that training be accomplished in a manner that integrates clinical care, teaching, research, public health and management. There is an expressed need for public health personnel that know how to manage programs, not just the technical aspects but how to manage a sound research program as well.

An emerging aspect of the PEPFAR program is “strategic information,” which is basically monitoring and evaluation—it currently accounts for 7 percent of the program budget. One aspect of evaluation is a focus on the overall picture of public health in the developing world. For example, although AIDS is prominent along with tuberculosis and malaria, there are other significant diseases and disorders, including diarrhea which is often fatal and acute respiratory infections. Accordingly, concern was expressed that the immense funding for AIDS might be distorting the public health systems while some countries are trying to develop balanced programs to address the full range of serious health issues that affect mortality and morbidity. The counter-argument is that the influx of AIDS funding actually strengthens the health services infrastructure and thereby enhances delivery of non-AIDS health services.

The IOM Committee for the Evaluation of PEPFAR identified the following opportunities for improvement:

• Greater emphasis on prevention of HIV infection generally and better linkage between the program planning process and improved data on prevalence and populations at risk.
• Increased attention to the factors that heighten the vulnerability of women and girls to HIV infection and its consequences, such as their legal economic, educational, and social status.
• Continued commitment to and additional emphasis on harmonization—alignment between donor and country plans, coordination with national AIDS coordinating agencies, and support for national monitoring and evaluation frameworks. Of particular importance is to transition from the current requirement to use medications approved by the US FDA to support for WHO pre-qualification as the accepted global standard.
• Enhanced ability to tailor intervention to the nature of the epidemic in each country and the countries’ national plans through removal of the limitations imposed by congressional budget allocations for particular activities.
• Expansion and better integration of services to meet the needs of all people living with HIV/AIDS, and to both improve prevention, treatment, and care interventions and capitalize on the synergy among them.
• Strengthen and expand country capacity to provide services—particularly the necessary human resources—through implementation of HIV/AIDS programs in a manner that strengthens systems overall; and
• Enhanced knowledge about what work against the pandemic, to be gained by increases the emphasis on learning from experience with the program and on conducting operations research and program evaluations.^[3]

Questions for the Future/Discussion

Dr. Johnson closed with several questions for the future:

1. Can interventions be designed to increase the prevention rate?
2. Can PEPFAR design interventions that increase human capacity development?
3. Can PEPFAR contribute to strengthening implementation science in AIDS?
4. Can the significant cohorts developed in the PEPFAR program be of benefit to other areas of research and prevention?
5. Can the PEPFAR model benefit future initiatives in, for example, malaria and tuberculosis?

Dr. Glass invited discussion. Dr. Hotez noted that Fogarty should be in a key position to lead in any implementation science initiative that would arise from PEPFAR funding. Dr. Handley (NIAID) agreed, adding that competition for such funding will be intense and that its orientation toward basic research makes NIH collaborations with the CDC, USAID and other organizations with established reputations for conducting implementation research and developing delivery systems very appropriate. Dr. Hotez added that the lack of interest among the NIH ICs in regard to PEPFAR might actually be an advantage if Fogarty decided to develop an NIH leadership position.

Dr. Black noted that new money for implementation science would likely be directed to HIV/AIDS and not to the overall public health system. Accordingly, Fogarty may want to consider a parallel initiative that would sponsor a broader approach to implementation science.

Dr. Vermund described an AITRP-funded screening program for HIV/AIDS that focused on syphilis as a marker for AIDS (a marker not included in the PEPFAR program). He noted that only when a service initiative and a research initiative were simultaneously introduced within a setting did the screening results improve over time—one or the other apparently has little effect. He added that imposing a major new program on a health system that is already stretched thin (as is the case in Zambia) seems to divert staff from existing health programs so that overall health care delivery tends to deteriorate.

Dr. Li commented that the ABC mandate encompasses a behavioral change approach that apparently has had success in the PEPFAR setting. However, behavioral science is not a strong suit at NIH.

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VIII. PROSPECTS FOR ROADMAP & FOLLOW-UP TO THE NIH LEADERSHIP FORUM

Mr. Robert Eiss, Fogarty Senior Health Advisor

The Roadmap, one of NIH’s innovative approaches to corporate planning, was developed shortly after the budget doubling. The Roadmap construct acknowledged the complexity of science and biology and focused on several themes(i) generic areas that provide enabling environments for scientists, (ii) re-evaluating the clinical research enterprise and enhancing clinical networks, (iii) provision of research tools and biological databases ranging from small molecule libraries to nanomedicine and computational biology, and (iv) finding a niche for highly exploratory, high risk research that conventionally tended to fall out of study section review.

Fogarty would like to pull together a small core of ICs to consider the Roadmap construct for global health, not necessarily adapting the same thematic areas and extrapolating to global health, but looking at how the NIH might plan, analyze and increase strategically their global health investments. The precedence for such an approach was set by former NIH Director, Dr. Harold Varmus. As a champion for malaria at a time when there was an acknowledged need for clinical trials infrastructure in developing countries and enthusiasm for sequencing the pathogen, he was able to bring together external consultants with a number of NIH institutes and centers to garner significant support—from the UK-Department for International Development (DFID), The Special Programme for Research and Training in Tropical Diseases (TDR), Novartis and others—for malaria research.

As a first step, Fogarty intends to develop a white paper or discussion piece to catalyze dialogue on the NIH campus. In order to provide a common framework for discussion, the discussion piece could be part portfolio analysis, part gap analysis, looking at NIH international commitments; and it could possibly include suggested options and opportunities in global health.

Areas that should be taken into consideration during the planning of a proposed NIH Roadmap for Global Health include the following:

1. Potential participants in the development of an NIH Global Health Roadmap. Partners would include academe, public constituencies and research partners such as the Wellcome Trust, Medical Research Councils and or the Gates Foundation.
2. Current NIH Investments in global health. The NIH aggregate funding for global health during the past fiscal year was some $526 million, including support to high income countries. The Wellcome Trust’s level of support for global health, at $90 million, ranks a distant second.
3. Demographic analysis of the international trainees (i.e., post-doctoral fellows) on campus. NIH is a prominent training locus for developing countries. Approximately one-third of the postdoctoral fellows on campus include international trainees with significant contingents from China and India.
4. International population structures and demography. Based on the aggregate DALY methodology, by 2020 the leading burden of disease, premature death, disability in low and middle income countries will be chronic diseases. Many of these risks are avertable through primary and secondary prevention programs, but there is a significant research agenda in adapting culturally relevant interventions in such settings. In addition, because we are so much better able at integrating intrinsic and extrinsic risks through gene technologies there are tremendous potentials for large cohort studies to understand genetics predispositions and environmental factors. These type studies are being pursued by a number of ICs but not systematically nor opportunistically.
5. Ascendance of “innovative developing countries.” India, for example, is shifting from the production of generic drugs through molecular copying to novel and innovative drug development. Research and development expenditures in the private sector have increased 400 fold over the last four years; and public investments in novel drug development are also escalating. India, Indonesia, Thailand and Brazil comprise the manufacturing base for childhood vaccines and meet 60 percent of the UNICEF requirements.

The presentation concluded with selected strategic questions that might be asked during the exercise of developing a NIH Roadmap for Global Health.

1. Are there limitations in the way the NIH currently supports global health research for which novel approaches might be explored as part of the Roadmap construct? Two clear examples were mentioned—developing centers of excellence and the organization of large prospective studies that could engage trans-NIH interests.
2. What interdisciplinary approaches to global health priorities might have the greatest influence and impact, given both public health needs and scientific opportunity?
3. What trans-NIH policies might be considered that might assist NIH to meet global health challenges?
4. Are there scientific and/or technical infrastructure impediments to working on multiple disorders?
5. Are there millennial challenges that fit the Roadmap profile? This could include the pursuit of translational research, risks to prospective cohorts, evaluation of priorities related to vaccines and new drugs for disease-endemic countries.

The Fogarty director noted that Fogarty would be starting a dialogue with Drs. Gray Handley and Tony Fauci of NIAID, and then the other ICs will be invited to join the discussion. Every IC has an agenda in global health so it’s a question of how best to find some general uniting principles that will carry the NIH forward. The Board members were very enthusiastic about the proposed Roadmap for Global Health concept.

Dr. Hotez asked if Fogarty would focus on two of the Roadmap themes, for example, new pathways to discovery and translational research. Noting that it was too early to answer that question, Dr. Glass added that during a recent IC directors’ meeting, the focus of most presentations was on genomics, which all agreed was an international effort. Current centers of excellence offer an opportunity for future international research collaboration through the Clinical and Science Translational Award (CTSA) Program sponsored by the National Center for Research Resources through Roadmap. The CTSA program, which originally did not have an international component, now has one.

Dr. Black commented that long-term prospective studies on emerging chronic diseases and preventive strategies are important but few currently exist because of the difficulty of establishing long-term funding. Dr. Vermund agreed, adding that investigators must seek European sponsors for long-term support. Dr. Glass added that Congressional authorization for support of the long-term Children’s Health Initiative might serve as a model. Commenting on his experiences, Dr. Pang noted that including a research component into long-term treatment and prevention programs and promoting implementation science runs into policy obstacles. Given such obstacles, the participation of policy makers in the design of long-term studies is important, especially in the developing countries. Dr. Handley added that overall budgets will affect participation. Budgets are typically flat and there is a commitment to support the expansion programs that occurred during the doubling process. Contributing to the international effort is also a policy decision. Dr. Glass agreed, noting that a number of institutes had indicated a reluctance to spend for programs outside the U.S.

Dr. Vega suggested a model of leadership in promoting international research. The World Mental Health Initiative, under WHO, developed a standard protocol for mental health studies that was adopted by a number of countries—some provided their own financing, others received outside support. He suggested that this was a model that Fogarty could consider. Dr. Li commented that 13 ICs had collaborated to develop the Neuroscience Blue Print, each contributing s small amount of funding. It was similar to the early Roadmap, when ICs contributed funding. Roadmap now has its own funding and is serving mainly as an incubator, sponsoring projects for five years to be ultimately returned to the ICs.

Highlighting an ongoing effort sponsored by NIAID, Dr. Vermund commented that the IC had six AIDS networks—two treatment, one pregnancy, one pediatric and two prevention, all of which focus on vaccines and microbicides, leaving the behavioral area relatively under-funded. There was additional money provided this year for prevention research, but it is earmarked for domestic investment, even though the walls that are built against international efforts is artificial in an era when an emerging pathogen can move from the Pacific to the U.S. with extraordinary speed.

IX. UPDATE ON THE FOGARTY STRATEGIC PLAN AND CALENDAR

Dr. Karen Hofman, Director, Division of International Science Policy, Planning & Evaluation

Dr. Glass introduced Dr. Karen Hofman, who provided an update on the draft Fogarty strategic plan and calendar. Dr. Hofman mentioned a number of events, including the Disease Control Priorities Project (DCPP) first anniversary meeting, a meeting in Hanoi on the Multinational Influenza Seasonal Mortality Study (Mark Miller will attend), a late September meeting at which Dr. Glass will discuss university global health programs, a September 19-20th meeting on polio immunization in developing countries, release of an NIH international activities report in November (including NIH international expenditures data from 2004 and 2005), the joint Fogarty-NICHD Lawton Chiles Lecture in September and the joint Fogarty-NIDCR Barmes Lecture. The Barnes Lecture will be the first event of the Fogarty 40th birthday celebration.

The revised Fogarty draft strategic plan has been distributed to staff for comment, after which it will be placed on the Fogarty web site for comment. It new strategic plan should be ready for final distribution in December. Finally, Dr. Hofman noted that the IOM is preparing a sequel to the America’s Vital Interest in Global Health Report, which should be released about February 2009.

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X. OFFICE OF COMMUNICATIONS INITIATIVES

Ms. Ann Puderbaugh, Director of Communications

Dr. Glass introduced Ann Puderbaugh, who moved from NCRR to become Fogarty’s Communications Director. He noted that she had hit the ground running, having put a new face on the web site, created a newsletter, and developed a global health report.

Ms. Puderbaugh expressed appreciation for the opportunity to contribute to Fogarty’s communication efforts. The support of ongoing communications with grantees, potential grantees, alumni, and others interested in Fogarty programs is a high priority for the office. The goals are to publicize Fogarty funding opportunities as well as maximize networking opportunities. Ms. Puderbaugh announced that the 40th birthday celebration for Fogarty would be observed throughout 2008 with a number of special events to be held in various venues, domestic as well as internationally. For example, Fogarty plans to engage congressional staff as well as staff from some of the Washington “think tanks” in a discussion of policies related to international health, to connect with the media in a specific event venue, and to contribute to the media through press releases, op-ed pieces and interviews. There will also be an effort to solicit journal articles from Fogarty supporters at NIH, its alumni cadre, and from other supporters. Finally, Fogarty will consider showcasing some of its heroes in international health who have made significant contributions in the past 40 years. Ms. Puderbaugh concluded by noting that the Fogarty image would be updated with a new logo, color theme, brochures, web site, PowerPoint presentation for staff use, etc.

In response to the announced plans for updating the Center’s image, there was a suggestion that Fogarty consider a new name. The Fogarty Director agreed that it would be helpful to include the words “global health” either in the Center’s name or tagline, particularly because a Google search on the terms “international or global health” does not include Fogarty in the search results. However, a change of name would require an Act of Congress, which can be an uncertain process. The tagline would be a simpler approach.

There was also a suggestion that the upcoming change in administration be considered in any planning process. Dr. Glass noted that the IOM’s revised America’s Vital Interest in Global Health Report should be available to the new administration; and in addition, CSIS has developed a briefing on global health for all Presidential candidates.

Finally, there was a brief discussion concerning the issue of providing a level of support for Fogarty alumni, perhaps through an association. Dr. Vermund noted that the development of a web site to enable communication among Fogarty alumni was a mandate of the Fogarty International Clinical Research Scholars Support Center.

XI. REPORT OF FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD (FIRCA) EVALUATION

Dr. Linda Kupfer, Fogarty Evaluation Officer and Dr. Brian Zukerman, STPI

Dr. Kupfer emphasized that program evaluation was a routine effort at Fogarty and that programs were usually scheduled for an evaluation about every five years. Dr. Kupfer also noted that Fogarty has a history of successfully competing for financial support for evaluating its programs through the one percent set-aside funds. This means that all Fogarty program evaluations are peer reviewed prior to their implementation. In addition, funds are available to bring in subject matter experts to assist with program evaluations and to secure the services of outside evaluators to work with the Center in regard to analyzing the data. Overall, Fogarty has conducted about eight program evaluations.

Dr. Kupfer gave a brief overview of the FIRCA program. The program began in 1992 and used the R03 grant mechanism to facilitate collaborative research between US and foreign scientists. The program focused broadly on biomedical research with a subset of grants that focused on HIV/AIDS. The AIDS component of the FIRCA program was discontinued in 2003. Dr. Krause noted that the program initially focused on supporting Latin American countries but was expanded after the fall of the Berlin Wall due to the very high interest in supporting Eastern European scientists.

Dr. Brian Zuckerman, a senior research analyst at the Scientific and Technology Policy Institute (STPI), explained the mechanics of the evaluation of the FIRCA program. Dr. Zuckerman noted that several methods were used, including a review of NIH administrative data, an email-based survey of US investigators and their collaborators, assessment of collaborative publications attributable to the FIRCA program, and site visits to countries (i.e., the former Soviet Union, Eastern Europe, selected countries in South America, etc.) that had several FIRCAs to determine if synergy existed among such programs. The evaluation process took about four years to complete.

Dr. Zuckerman noted that Fogarty had at least 10 partnering ICs; and that a requirement for the program was that the US PI must have a “parent” R01, administered by one of the NIH ICs. At least two universities—the University of Washington and the University of Pennsylvania—had more that 20 FIRCA awards. Geographically, about 30 percent of the FIRCAs are in South America and Eastern Europe respectively, 25 percent in the former Soviet Union, and the remainder in Africa and Asia.

Highlights of some of the outcomes are provided below:

1. Scientific Productivity: In terms of scientific productivity, three-quarters of the collaborating pairs produced one or more publications; however, the average number of publications per award was about four. US PIs and foreign collaborators tended to contribute to the research results equally; the cost per publication was relatively low; the quality of publications, based on the number of citations was average; and the articles were published in relatively high quality journals—the top three journals included the Journal of Biological Chemistry, Biochemistry and Proceedings of the National Academy of Sciences. Productivity in terms of the number of collaborative publications tended to be highest in the middle income countries.
2. Country Income Status and Productivity: Collaborations associated with the middle income countries and the upper middle income countries tended to be stronger in terms of scientific productivity than those in the lower income countries, in terms of the percentage of collaborations producing publications, the average publications per award, and in terms of the highly successful collaborations—those producing 10 or more publications per award.
3. Sustainability: One of the interesting statistics was that five years plus after collaborations had formally ended and the FIRCA funds had ceased, about 30 percent of the collaborations were still ongoing and the PIs were publishing together.
4. Capacity Building: About half of the responders indicated that there was a capacity building aspect to the FIRCA; and some mentioned that the funding made it possible for their labs to continue doing research. There was also a networking effect, where one FIRCA would lead to additional applications and awards in the same lab, and the multiple funding would allow more ambitious programs to be developed. Even the US PIs felt that the collaborations widened their research horizons.

Dr. Zuckerman concluded his remarks by noting that the evaluation process prompts changes in future programs. Specifically, it was clear that there should be a strategy to help the international collaborators to apply for NIH grants independently after the successful completion of a FIRCA, and there should be an opportunity to pursue projects in the behavioral and social sciences. It was also shown that collaborators who had a collaborative relationship prior to the FIRCA were more productive in terms of publications.

Dr. Michaels discussed actual changes to the program, some as a result of the evaluation process. There are now separate program announcements for biomedical, behavioral and social science proposals. A new program officer was added to develop an outreach program to increase the number of applications in the behavioral and social sciences, and the initial response has been good.

One of the challenges to converting to the electronic submission process was that applicants encountered significant obstacles due to the lack of technical support in their countries. It is anticipated, however, that the process for developing country institutions would improve over time. For example, just recently an applicant from Nigeria was successful in receiving an award with an electronic application.

Dr. Glass noted that the FIRCA program began with an emphasis on Latin America, shifted in the nineties to Eastern Europe, and now is moving into the low and middle income countries, which has broadened the portfolio of diseases that are addressed by the program. He posed the question: Should the FIRCAs be more widely distributed geographically, or have the Latin American and Eastern European countries reached a level of science at which the FIRCA program is less appropriate?

Dr. Vermund responded that Latin America and Eastern Europe have not developed such a high of science that they could not benefit from FIRCAs, but he offered a caution against swinging the geographic pendulum too far either way as the program continues. He was gratified by the Nigerian award, but noted that, partly because of experience and contacts, it may be more difficult for scientists in the low income countries to compete with scientists in Latin America, for example. Dr. Black agreed that FIRCA should not abandon the first areas of interest, but there should be an emphasis on encouraging low income countries to participate.

Dr. Hotez commented that the program is clearly a success and that should be shared with the ICs to engender support. Dr. Krause agreed, stating that the evaluation should include a reference to the fact that two major private programs (Howard Hughes Medical Institute and the Chronic Disease Research Foundation) included the FIRCA model as they developed their own international health programs.

In closing, Dr. Glass commented that it would be helpful at the next meeting to discuss the willingness of other ICs to invest in basic science versus applied science with regard to geographic areas that are of higher or lower priority.

Dr. Kupfer gave each of the Board members a copy of the FIRCA evaluation.

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XII. PEER REVIEW PROJECT UPDATE

Dr. Lawrence A. Tabak, Director, NIDCR

Dr. Tabak announced that NIH has begun an assessment of the peer review process in partnership with the scientific community. Science has become more complex and interdisciplinary research has become more important and prevalent; and accordingly, the assessment will deal with how the peer review system should respond to those changes.

Two NIH groups are supporting the study—an external working group of the Advisory Committee to the NIH Director (Dr. Tabak, Director, National Institute of Dental and Craniofacial Research (NIDCR) and Dr. Keith Yamamoto, University of California, San Francisco, co-chairs) and an internal Working Group on Peer Review (Dr. Tabak, NICDR and Dr. Jeremy Berg, NIGMS, co-chairs). Dr. Tony Scarpa, Director of the Center for Scientific Research is a member of both working groups.

Input from the community has been garnered in three ways: (i) a request for information (RFI) on a wide range of issues, from challenges to the NIH support system to specific challenges related to peer review (ii) teleconferences with about 100 deans, and (iii) two regional town meetings, one of which will be held in Chicago, IL. A common website has also been created to facilitate feedback from ADC liaisons and members. Dr. Tabak emphasized that additional comments are welcome, whether or not an individual received an inquiry, and all comments will be considered even though the official comment period has ended.

The review is on a fast track at the direction of the NIH Director, who is anticipating a report by December 2007. After examining how non-HHS agencies handle peer review, the working groups will develop a number of pilot programs for the spring of 2008. All of this data will provide the resources for the development of a revised peer review policy.

To provide a glimpse of some of the early thinking by the work groups, Dr. Tabak presented several “emerging ideas” that the Board might consider. For example:

• Should the review focus on the project or the person, should it be retrospective or prospective, and should there be different types of applications for different types of projects?
• In the area of review mechanics, should there be a two-stage review (along the lines of an editorial review), electronic review, a way for applicants and reviewers to interact, different application requirements for new concepts versus extensions of established lines of research, a method for presenting interdisciplinary research applications, a process to deal with multiple applications by the same PI, and a way to provide feedback to applicants?
• Concerning reviewers, should reviewers have access to data about similar projects, should there be incentives and/or penalties to encourage effective reviews, and should the scoring process be improved to give the applicant frank information about the quality of the application (so that a poor or inadequate applications would not receive an inflated, though unfundable, score that might encourage the applicant to spend more time on the resubmission process)?

Dr. Glass expressed appreciation for the report, adding that the review might consider a global review perspective under the rubric of electronic review, since there are highly qualified scientists serving in many foreign countries. This would be an appropriate activity for Fogarty alumni as that network is expanded. Dr. Rosenthal commented that Fogarty had had two asynchronous review experiences, neither of which was satisfactory. There tended to be a breakdown in the communication between the chair of the study section and the reviewers. Dr. Tabak agreed that reviews were mixed, although there were certain groups, like the physical sciences, that seemed to be more comfortable with the process. He added that there had been comments on the importance of face-to-face interaction in the review process, and both views were being carefully considered. Dr. Heimburger suggested considering a real-time video set-up.

XIII. CONCLUDING REMARKS

Dr. Roger I. Glass

Dr. Glass mentioned the many issues coming up in the next year or so -- a new administration, the reauthorization of PEPFAR, the NIH International Report in November that will detail investments in global health, and the year-long Fogarty birthday celebration. He closed the meeting by expressing his appreciation to all those who attended and participated.

There being no further business, the meeting was adjourned at 3:00 p.m.

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Abbreviations Used in the Minutes

Fogarty International Center Advisory Board Roster

(All terms end January 31)

September 2007

Roger I. Glass, M.D., Ph.D. (Chair) Director, Fogarty International Center and Associate Director for International Research	Elizabeth Barrett-Connor, M.D. (2008)* Professor and Division Chief Division of Epidemiology Department of Family and Preventive Medicine SCRB/Room 349 9500 Gilman University of California, San Diego La Jolla, CA 92093-0607	Arthur Kleinman, M.D., M.A. (2009) Esther and Sidney Rabb Professor and Chair Department of Anthropology Harvard University William James Hall, Room 330 33 Kirkland Street Cambridge, MA 02138
Karen H. Antman, M.D. (2010) Provost and Dean Boston University School of Medicine 715 Albany Street, A Boston, MA 02118	Douglas C. Heimburger, M.D., M.S., FACP (2008)* Professor, Division of Clinical Nutrition and Dietetics Departments of Nutrition Sciences and Medicine University of Alabama at Birmingham 1675 University Blvd., Webb 439 Birmingham, AL 35294-3360	Arthur Reingold, M.D. (2011) Professor and Chair Division of Epidemiology Center for Infectious Disease Preparedness UC Berkeley School of Public Health 1918 University Avenue, 4th Floor, MC-7350 Berkeley, CA 94720-7350 Phone: (510) 642-0327 Email: reingold@berkeley.edu
Robert A. Black, M.D., M.P.H. (2011) Department of International Health The Johns Hopkins University Bloomberg School of Public Health 615 North Wolfe Street Baltimore, MD 21205	Peter J. Hotez, M.D., Ph.D. (2011) Professor and Chair Department of Microbiology and Tropical Medicine Ross Hall 736 2300 I Street, N.W. The George Washington University & Sabine Vaccine Institute Washington, DC 20037	William A. Vega, Ph.D. (2009) Professor of Family Medicine Department of Family Medicine David Geffen School of Medicine at UCLA 10880 Wilshire Blvd., Suite 1800 Los Angeles, CA 90024-4142
Luz Claudio, Ph.D. (2010) Associate Professor Department of Community and Preventive Medicine Mount Sinai School of Medicine One Gustave L. Levy Place New York, NY 10029	Jim Yong Kim, M.D., Ph.D. (2011) Associate Clinical Professor of Social Medicine Head, Department of Social Medicine Brigham and Women's Hospital Harvard School of Public Health 651 Huntington Avenue Boston, MA 02115	Sten H. Vermund, M.D., Ph.D. (2011) Director, Institute for Global Health Professor of Pediatrics, Medicine Preventive Medicine and Obstetrics and Gynecology 319 Light Hall 0202 Vanderbilt University Medical Center 2215 Garland Avenue Nashville, TN 37232
		*Term Extended to July 2008

EX-OFFICIO Member Ting-Kai Li, M.D. (2010) Director National Institute on Alcohol Abuse and Alcoholism, NIH 5635 Fishers Lane Bethesda, MD 20892-9304

EXECUTIVE SECRETARY Robert B. Eiss Office of the Director Fogarty International Center National Institutes of Health Bethesda, MD 20892-2220

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^[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.

^[2] Applications that were noncompetitive, or unscored, or not recommended for further consideration by initial review groups were not considered by the Board.

^[3] Adapted from the Executive Summary, PEPFAR Implementation: Progress and Promise.

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