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February 11, 2020 Advisory Board Meeting Summary Minutes

The FIC Advisory Board met in the Stone House Conference Room, Building 16, National
Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland, at 9:00 a.m., Roger Glass, Chair, presiding.

BOARD MEMBERS PRESENT

ROGER GLASS, M.D., Ph.D., Director, Fogarty International Center; Chair
ROBERT BOLLINGER, M.D., Johns Hopkins University School of Medicine
JANINE CLAYTON, M.D., Director, Office of Research on Women’s Health
JAMES CURRAN, M.D., Emory University
ROBERT EINTERZ, M.D., Indiana University School of Medicine
JACOB GAYLE, Jr., Ph.D., Vice President, Philanthropy/President, Medtronic Foundation
GREGORY GERMINO, M.D., National Institutes of Diabetes and Digestive and Kidney Diseases; ex officio
VIKAS KAPIL, D.O., M.P.H., Centers for Disease Control and Prevention; ex officio
GBENGA OGEDEGBE, M.D., M.P.H., F.A.C.P., Dr. Adolph and Margaret Berger Professor of Population Health and Medicine, Chief, Division of Health and Behavior, Director, Center for Healthful Behavior Change, New York University
JOHN MONAHAN, J.D., Georgetown University
MICHELLE WILLIAMS, S.M., Sc.D., Harvard University
MARY WILSON, M.D., University of California, San Francisco School of Medicine

ALSO PRESENT

PETER KILMARX, M.D., Deputy Director, FIC
KRISTEN WEYMOUTH, Executive Secretary
BLYTHE BEECROFT, M.S., FIC
JOEL BREMAN, M.D., DTPH, FASTM, American Society of Tropical Medicine & Hygiene
KEN BRIDBORD, M.D., M.P.H., FIC
DEXTER COLLINS, M.P.A., FIC
CAROL DAHL, Ph.D., The Lemelson Foundation
KAREN GORALESKI, MSW, CEO, American Society of Tropical Medicine & Hygiene
DAUDI JJINGO, Ph.D., Programme Director/PI for the Ugandan NIH H3Africa Bioinformatic Training Programme (BrecA), and a Co-PI of the Ugandan node of H3BioNet
FLORA KATZ, Ph.D., FIC
JOSEPH KOLARS, M.D., University of Michigan Medical School
AMIT MISTRY, Ph.D., FIC
KEITH MARTIN, M.D., PC, Executive Director, Consortium of Universities for Global Health
NICOLA MULDER, Ph.D., Professor and Head of the Computational Biology (CBIO) Division, University of Cape Town, Principal Investigator of H3ABioNet (remote)
VIVIAN PINN, M.D., Former Director, NIH Office of Research on Women’s Health
LAURA POVLICH, Ph.D., FIC
ANN PUDERBAUGH, FIC
CHARLES ROTIMI, Ph.D., Director, Center for Research on Genomics and Global Health, National Human Genome Research Institute
BARBARA SINA, Ph.D., FIC
DAVID SPIRO, Ph.D., FIC
RACHEL STURKE, Ph.D., FIC
DEBARA TUCCI, M.D., M.S., Director, National Institute on Deafness and Other
Communication Disorders
JENNEL WALKER, NICHD
STEN VERMUND, M.D., Ph.D., Dean, Yale School of Public Health
CECILE VIBOUD, Ph.D., FIC
SUSAN VORKOPER, M.P.H., FIC

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

Dr. Glass opened the meeting at 9:03 a.m. He welcomed Jenelle Walker from the National Institute of Child Health and Human Development (NICHD), Karen Goraleski from the American Society of Tropical Medicine & Hygiene, Carol Dahl from the Lemelson Foundation, Keith Martin from the Consortium of Universities for Global Health (CUGH), Debara Tucci from National Institute on Deafness and Other Communication Disorders (NIDCD), among others. A key topic of this meeting is “Women in Global Health” and the Advisory Board will hear from Dr. Janine Clayton, Director of the Office of Research on Women’s Health (ORWH), later in the day.

Dr. Glass mentioned that Dr. Linda Birnbaum from the National Institute of Environmental Health Sciences (NIEHS) just retired. She has been a terrific partner on the GEOhealth, the Household Air Pollution Intervention Network (HAPIN) Trial, the Medical Education Partnership Initiative (MEPI), the Health Education Partnership Initiative (HEPI), and the Data Science and Innovation Program (DS-I). He also gave a shout-out to Drs. Satish Gopal and Vivian Pinn. Dr. Pinn was the former Director of ORWH. Dr. Gopal was a Fogarty Fellow who established a Center for Cancer and Infectious Disease in Malawi and will be speaking at the June meeting.

Dr. Peter Kilmarx talked about the African Postdoctoral Training Initiative. There are ten fellows from six countries here on the NIH campus for two years. There have been hundreds of applicants for the next generation of fellows. The Bill & Melinda Gates Foundation (BMGF) supports the fellows for two years after they return home to settle back into their home laboratories in Africa.

The Fogarty International Center has struggled with how to continue its robust programs in China. The programs started in 1979 when the first National Cancer Institute (NCI) grant began. NIH would send fellows to China where they would receive excellent mentorship while learning how to work in the Chinese society. One of those mentors is You-Lin Qiao, the head of the Cancer Institute in the Chinese Academy of Medicine. Dr. Glass highlighted the work of former fellow Dr. Evelyn Hsieh who furthered research on osteoporosis and women with breast cancer who had early ovariectomies.

Dr. Glass and Dr. Francis Collins, the NIH Director, visited the UN General Assembly in September 2019. They were able to meet with former President of Tanzania Jakaya Kikwete who visited the NIH Campus along with several other African leaders back in 2014. In October of 2019 they went to Addis Ababa, Ethiopia for the Grand Challenges meeting. Dr. Collins was the only man to speak on a panel about the importance of getting women globally into the workforce.

Dr. Glass then went to the National Academy of Science meeting where he met with the Qatar Minister of Public Health Hasan Al-Kuwari and Dr. Michelle Kvalsund who was an ophthalmologist and neurologist fellow at Fogarty. The NIH Council of Council’s approved the Data Science and Innovation for Health in Africa Initiative and NIH made a presentation to the joint membership of the National Academy to raise interest and find partners.

NIH has signed an agreement with Argentina for joint funding of research. Agreements have additionally been signed with Peru and Uganda with one being finalized with Tanzania. Dr. Glass was invited to Harvard University for the 15th year of the President’s Emergency Plan for AIDS Relief (PEPFAR).

Dr. Glass was invited to give a video presentation to the Rakai Health Science Program in Uganda. Rakai is a small village which has accomplished a great deal to advance the HIV/AIDS research agenda. One hundred and forty-one individuals have been trained by Fogarty programs in Rakai over a 30-year period. The Rakai Health Science Program has had 573 publications and has become a center of excellence for research and for clinical trials.

Dr. Gretchen Birbeck will be talking to the Board at a future Board meeting about the Institute of Neurology in Zambia, which she helped establish over the last 12 years with fellows who were trained through Fogarty programs.

Michael Strong, President of the Canadian Institutes of Health Research, is working with Fogarty to schedule a meet-and-greet, a sort of scientific speed dating session by topic. Dr. Glass went to the AFREhealth Symposium meeting in Lagos to speak about HIV/AIDS and bioengineering. Bill Gates came to NIH to give the Barmes Global Health lecture seven years ago and since then the NIH and BMGF has an annual meeting with several working groups who work collaboratively throughout the year. BMGF and NIH both contributed $100 million to a major African sickle cell program with a ten-year agenda.

Dr. Kilmarx mentored a medical student who worked on a paper on global research publication data. The question was how much of NIH-funded research is global research. They found that there were about 80,000 publications with NIH funding in 2017. Thirty-five percent of all published researched had at least one foreign co-author. China was the country where the largest number of foreign co-authors came from with 4,000-plus publications.

The next FIC Advisory Board meeting will be June 9, 2020, and prior to that is the annual Consortium of Universities for Global Health (CUGH) conference in April and many FIC program network meetings including the first Data Science and Innovation Symposium (DS-I) in Kampala, Uganda.

Ms. Ann Puderbaugh updated the Board on the FIC communications program. She welcomed January Payne, from the National Institute of Diabetes and Digestive and Kidney (NIDDK), and Susan Scutti from CNN who are two new writer/editors. The Fogarty website is now a mobile-friendly website with increasing traffic. There is now a total subscriber base of 73,000 for the electronic newsletters.

Dr. Cecile Viboud talked about how the coronavirus epidemic is being monitored from abroad. Data is taken from social media, specifically from the social media site DXY, with information coming in from local, provincial, and national disease control centers. The information trickles in about every half hour or so.

Ms. Susan Vorkoper talked about a study started in 2014 on Child Obesity in Latin America. There is research focused on Latino populations within the United States to find opportunities for synergy. In November 2019 a workshop was held which brought together a diverse group of researchers across a wide range of disciplines. The workshop helped foster a number of cross-cutting research endeavors which will result in peer reviewed articles to be published in Obesity Reviews in February 2021.

Dr. Amit Mistry and Ms. Blythe Beecroft updated the Board on FIC’s Advancing Health Research in Humanitarian Crises. The project was established to engage researchers, humanitarian organizations and policymakers to share strategies on conducting health research in the context of humanitarian crises in low- and middle-income countries (LMICs). The ultimate goal is to facilitate actionable research and encourage the use of evidence-based data in the policy arena. Dr. John Monahan is the mentor for this project. The program was able to help facilitate a panel at CUGH looking at health research and humanitarian crises and to start a pilot global forum on humanitarian health research with meetings to begin in September.

Dr. Rachel Sturke gave updates on the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) program. Dr. Sturke recently returned from the 4th annual meeting in Cape Town, South Africa. The meeting brought together 26 teams of NIH-funded researchers. NICHD and the National Institute of Mental Health (NIMH) are two NIH Institutes that are partners with FIC on this program. NIH funded seven local AHISA branches in Kenya, Uganda, Zambia, and South Africa. The most advanced network is CAPRISA based in Central and West Africa. The 5th annual meeting will be held in Kenya in February 2021.

Global Health at the National Institute on Deafness and Other Communication Disorders

Dr. Glass introduced Dr. Debara Tucci, Director of the National Institute on Deafness and Other Communication Disorders (NIDCD), to discuss NIDCD’s global health initiatives.

NIDCD was founded in 1988 with a mission to conduct and support research and research training in areas of hearing, balance, taste, smell, voice, speech, and language. Most of the funding supports R01s and R21s with 5% of the portfolio going to training. NIDCD has frequently collaborated with Fogarty. The intramural program has the strongest partnerships in Africa, Pakistan, and Japan which trains investigators in genetic science and in-country collaborations.

NIDCD has developed a program in Pakistan with 2,000 consanguineous families enrolled to study genetic disorders. 22,000 subjects from these families are enrolled in these intramural studies. Recessive genes responsible for non-syndromic hearing loss have been identified through collaboration with Dr. Thomas Friedman at NIH. However, NIDCD does not currently have principal investigators (PIs) in low income countries and is working on changing that.

Dr. Tucci talked about the work of the Lancet Commission on Global Hearing Loss. It is a two-year project to look at recommendations to address the global burden of hearing loss using sophisticated economic analyses. The next meeting will be in May of 2021.

Dr. Tucci briefly noted collaborations with Dr. Blake Wilson from Duke University, who helped develop the cochlear implant. In 2006 she was invited to go to India to consult with scientists attempting to develop a low-cost cochlear implant. She also went to Nairobi, Kenya and partnered with the Duke Global Health Institute to create a newborn screening program at a local hospital. Studies have found that there are 1.34 billion people worldwide who have mild to profound hearing loss, or about 18% of the world’s population.

Hearing loss has been the fourth leading cause of disability worldwide since 2013 based on global burden of disease data. The disability weight is greater when accompanied with tinnitus. People with hearing loss have an increased cost of healthcare, approximately 10 to 20 percent over adults without hearing impairment. Global annual costs attributed to unaddressed hearing loss in data tabulated by the WHO amounts to almost $800 billion per year. Data also shows that children are more affected in low income countries while adults are more likely to be affected in high income countries. Among the 130 million children born annually, almost 3 million children are born with some form of hearing impairment. Six per 1,000 children born in low income countries have significant hearing loss compared with 2-3 per 1,000 born in high income countries.

There is currently a lack of training programs in many LMIC and many of these nations are also dealing with a brain drain problem.

Here in the U.S., legislation was passed in 2017 mandating that hearing aids be over the counter which gave the FDA three years to create conforming regulations. 2020 is the year those regulations are due. NIDCD will also be looking into making hearing aids more accessible and effective. NIDCD is collaborating with the Lawrence Livermore Lab at Berkeley, California to develop machine made thin-film electrode artificial ear technology.

NIDCD has set up a working group on Hepatitis B and hearing loss in partnership with NIAID. Genetic causes may have a big impact on hearing loss. One of the cross-cutting issues NIDCD is focusing on is vaccination. Some countries have excellent immunization programs while others have very little. Being able to identify main causes for hearing loss in each country and region can help with making decisions on the best and most effective ways to help prevent hearing loss.

The World Health Organization (WHO) is working on a world report on hearing loss and NIDCD looks forward to reviewing the report and its data. NIDCD is also drawing data from WHO’s Global Burden of Disease project. Data suggests an association between dementia and hearing loss but there is no definitive studies on why.

Global Health at the Office of Research on Women’s Health

Dr. Glass introduced Dr. Janine Clayton, Director of the NIH Office of Research on Women’s Health (ORWH) and ex officio member of the FIC Advisory Board. Dr. Clayton gave a presentation on the state of global women’s health research. The latest data on life expectancies from our peer countries has us falling off the bell curve. Many diseases like Alzheimer’s, musculoskeletal disorders, multiple sclerosis, autoimmune diseases, among others are much more likely to affect women over men. Women are 7 to 10 years older than they were in the 1970’s when they had their first pregnancy. Maternal mortality rates globally have been on a downward trend while they are going up in the United States.

ORWH was founded through the advocacy of women in Congress, the Women’s Caucus, and women in the scientific community, among others. Today over half the participants of NIH-supported studies are women. ORWH helped fund basic research being done in the NCI’s intramural program which developed the human papillomavirus (HPV) vaccine. The top three mission areas of the office are expanding women’s health research broadly, making sure women in underrepresented groups are included in research, and promoting career advancement for women in biomedical careers.

Through programs like Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) and other career development efforts, ORWH has supported over 700 scholars, 90 of whom have gone on to become principal investigators on studies. The office expanded the NIH’s only Disease Agnostic Sex Differences Research Centers of Excellence and added a training component called the SCORE program that encourages investigators to think about male and female differences. ORWH has also supplemented existing investments for investigators across every Institute and Center, with over 340 grants funded in the last 6 years for a total of almost $40 million.

The office has brought attention to populations of women that are understudied, underreported, or underrepresented. ORWH is looking into how to develop research strategies that address their particular needs and contexts. In partnership with 11 ICs, ORWH has created the first R01 focused on both sex and gender and health and disease. NIH has a policy on Sex as a Biological Variable (SABV). ORWH recently published a piece in the Journal of Women’s Health on a five-year update about SABV within NIH. Dr. Francis Collins has announced that he will vet invitations to speak based on the diversity of the conference or event and its panels. He has declined invitations due to lack of gender diversity.

ORWH has partnered with the Office of Women’s Health at the Food and Drug Administration and released an update on online courses. As mandated in the 21st Century Cures Act, NIH reports the proportion of women and men by disease category in NIH RePORTER. If you look at any Research, Condition, and Disease Categorization (RCDC) category you can look at the proportion. NIH is also now required that all Phase III clinical trials starting December 2017 have to report the primary outcome analysis by sex, gender, race, and ethnicity. Dr. Clayton noted that elderly women represent a significant portion of people who are excluded from clinical trials often due to comorbidities. The 21st Century Cures Act also established a taskforce specific to pregnant and lactating women that has come out with 15 recommendations.

Dr. Jim Curran talked about how Georgia has one of the highest maternal mortality rates in the United States. He mentioned that there are not very many obstetricians in the state. The United States has the least equity of healthcare financing with the highest amount of uninsured people in the world. Dr. Gbenga Ogedegbe mentioned his experience with his wife at a leading medical institution on treatment they received while she was pregnant. He talked about how the doctors were not friendly to black women and that the treatment was highly shocking to him.

Dr. Clayton mentioned that the state level differences across the country are frustrating. Access to care is granted on very different levels across various states. There is a maternal health atlas where you can look at local circumstances and environment. ORWH in coordination with NICHD has created a maternal mortality taskforce. Dr. Clayton co-chairs this taskforce with Dr. Diana Bianchi, the Director of NICHD, along with Dr. Tara Schwetz, the NIH Associate Deputy Director. The taskforce is working on a two-pronged approach based on social behavioral factors and local tailored customizable interventions.

Dr. Vivian Pinn thanked Dr. Clayton for leading the ORWH in the work she and many others started in the first 20 years of the office. She brought up slides she made in the early 90’s and noted that many factors, like biological and genetic factors, among others, that are at the forefront of science today were mentioned in those slides. She pointed out that National Academy’s convened a committee to review the state of women’s health and what was important for women’s health. The Affordable Care Act (ACA) incorporated the National Academy’s recommendations.

Human Heredity and Health in Africa (H3Africa): What’s Next

Dr. Glass turned the floor over to Drs. Barbara Sina and Laura Povlich to discuss Human Heredity and Health in Africa through the H3Africa Program.

Dr. Sina gave an overview on the H3Africa Program. She said it has been going on for 7 years and is funded by the Common Fund. The group meets twice a year and covers 34 countries across the African continent. Activities include 14 collaborative research centers, 13 research projects, ethics research grants, biorepositories, and training programs in bioinformatics with a bioinformatics network. There are over 500 consortium members with about 250 meetings biannually. Six bioinformatics degree programs have been established, and some of the postdoc students from the first five years of the program have now become PIs in the second stage of the program. These efforts have built an enormous amount of infrastructure to conduct genomics research like sequencing equipment, state-of-the art laboratory equipment, biorepositories in each region of the continent, and finally creating a cloud computing bioinformatics system to support the data. Data from over 100,000 participants with linked bio-specimens has been formed into a centralized catalogue, including phenotypic data taken from the samples.

Output from the program includes the African SNP Chip that looks at African genomic variation, and a low-cost genomics test to identify several types of infections where fever is the major symptom. A total of 330 publications to date have flowed out of the program, and these publications have on average three times more citations than an average NIH publication. The program has also advanced identification of novel genes that contribute to non-communicable diseases in African populations. Program investigators have discovered risk alleles for chronic kidney disease and various geographic-related risk factors for cardiovascular diseases such as obesity and hypertension.

Dr. Laura Povlich gave a presentation on bioinformatics training in the H3Africa program. Fogarty has traditionally overseen management of the training grants. The bioinformatics network is led by Professor Nicola Mulder from the University of Cape Town. Most work has been around capacity-building for bioinformatics, accomplished through in-person workshops, training the trainer, internships at the University of Cape Town, live online training and development of bioinformatics curriculum for master’s programs. An introduction to bioinformatics hybrid online course held in 2017 had 27 sites across 12 African countries with 600 participants and 150 volunteers involved. There are about 15 to 25 fellows annually that are sponsored to work on grants in the consortium, receive travel fellowships to come to meetings and receive training in scientific skills and professional development.

A few years of activities in the H3Africa program revealed a need to develop Masters, Ph.D., and postdoc long term research training programs. In 2017, the Fogarty Center awarded four- and five-year cooperative agreements for the research training programs. The four institutions that signed agreements are Covenant University in Nigeria, USTTB in Mali, ICIPE in Kenya, and Makerere University in Uganda. These agreements feature unique training approaches, including development and implementation of a new bioinformatics curriculum, strengthening local leadership, and thinking about sustainability. An increasing number of students coming into the programs are not sponsored by Fogarty programs, with some students receiving funding from the World Bank. Students at ICIPE in Kenya are looking to develop a countrywide peer training and mentorship network on bioinformatics and computational skills.

Dr. Nicola Mulder, Professor and Head of Computation Biology at the University of Cape Town and Principal Investigator of the H3ABioNet, presented her insights on the program. The consortium has reached critical mass and “pockets of excellence” have developed around the continent particularly around bioinformatics. New research projects can start with a solid base unlike some of the original H3Africa projects. She hopes that after the last round of funding is over, they can continue building on the foundation by funding the core resources like the biorepositories, components of the bioinformatics network, working groups, and individual research projects. More data is needed on underrepresented populations. H3Africa has phenotype data for up to 100,000 participants, representing enormous potential to benefit African and global health overall. The program’s goal is to leverage resources to further the fields of human genomics research and the genetic basis for diseases.

Dr. Charles Rotimi, Director for the Center for Research on Genomics and Global Health at the National Human Genome Research Institute (NHGRI), gave a presentation on how the NHGRI is working on H3Africa. He said H3Africa was meant to create a cultural change that uses grant funding to create infrastructure and develop skills among African investigators. Prior to H3Africa, there were very few opportunities for postdoctoral training on the African continent. The African Academy of Sciences has been a major player, working with NIH to push H3Africa to a more successful level. H3Africa is providing opportunities to naturally blend public health and genomics research together. The program may develop tools to make public health decisions easier.

Dr. Povlich introduced Dr. Daudi Jjingo who is the Programme Director and PI for the Ugandan NIH H3Africa Bioinformatics Training Programme (BrecA). This program has students from Kenya, Uganda, and Swaziland, and is recruiting good candidates for the established Ph.D. program. Building a strong program requires the ability to work with many working pieces, and he noted the strong need for sustainability within programs.

Dr. Glass asked Dr. Mulder for comment on her vision of how H3Africa will have changed knowledge on diseases in 5 and 10 years and what might be the first diseases that are most impacted by genomic evidence and revolution. Dr. Mulder replied that the large amount of data H3Africa has compiled can be used to accomplish further research in programs like pharmacogenetics, and new Chips, among others. Dr. Mary Wilson asked who will have access to the unique database that H3Africa has built up. The consortium has the ability to make the data available to the research community. Consortium data is submitted to the European Genome-Phenome Archive (EGA). Steps are being taken to make the data as accessible as possible. Dr. Mulder noted initiatives for teaching genomic medicine for individuals in response to a question by Dr. Gbenga Ogedegbe about the level of training needed. Dr. Mulder invited the group to identify what would be of value to them from African genomics research. Dr. Curran asked whether the phenotypes and demographic variables of the H3Africa data have been published. Dr. Mulder replied that about 30,000 people have been phenotyped on a Chip. Though EGA has no requirements for the number of variables collected, H3Africa has created a catalogue to facilitate information submitted to the database. The catalogue will be available, and all the data will eventually be put into one phenotype database.

Dr. Sten Vermund asked Dr. Rotimi to estimate how many people have been trained in integrated data management and bioinformatics for H3Africa. Dr. Rotimi replied that the last data showed over 350 individuals trained from Cape Town to Cairo. Every country that has a bioinformatics node has been training individuals. Dr. Povlich said it is hard to track all the training going on, especially of the students getting master’s and PhD’s receiving separate research grants with efforts to collect that information which is ongoing. H3Africa is fairly successful in retaining staff yet, due to need for well-trained bioinformaticians, has caused a slow brain drain in the public sector. The private sector is not as well developed in Africa which means the public sector is not being challenged as severely as it is in North America and Europe.

Dr. Glass brought up the Data Science and Innovation Initiative which has developed different ways to use genomics as a hub. There are currently hubs for malaria, innovation in diagnostics, and spatial mapping, among others. Data may be used to address problems in infectious disease surveillance by monitoring and identifying strains in an outbreak with handheld sequencing. He suggested putting teams together in the data science and innovation space as well as genomicists who understand the H3Africa database to determine which genomic profiles can be linked or determined.

Dr. Glass asked Dr. Carol Dahl for comment on the metrics being used by the genomics community to advance research and make simpler, cost-effective devices. Dr. Dahl replied that much is being done at the local level to grow businesses and find solutions that will improve lives with new discoveries through innovation. She identified an issue in that students do not receive interdisciplinary training. There needs to be better education and preparation for the innovators. Less than half of intellectual property from Kenya is coming from the universities and research institutions. People find it hard to turn ideas into businesses due to a lack of infrastructure in networks, coaching, mentoring, and especially funding. Dr. Glass ended the day with a recap of the meeting.

There being no further business, Dr. Glass adjourned the meeting at 2:57 p.m.