2024-11-13T06:28:03+00:00 2023-12-31 440160260 Forvis Mazars LLP 901 East Cary Street Suite 1000 Richmond VA 23219 990 2023-01-01 521986675 Foundation for the National Institutes of Health Inc FOUN 3014025311 11400 Rockville Pike 600 North Bethesda MD 20852 Donald M Hill Chief Financial Officer 2024-11-13 true true LaKrisha Castleberry P01677333 8042827636 2024-11-13 2023 2024-10-15 13:58:12Z Donald M Hill 11400 Rockville Pike 600 North Bethesda MD 20852 302514473 false X http://www.fnih.org X 1996 MD The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visitfnih.org. 21 20 107 20 0 0 68998263 56092197 50000 50000 1459757 4762392 77179 61199 70585199 60965788 32121575 20270897 0 0 12734826 16465315 0 0 218308 32561709 32908531 77418110 69644743 -6832911 -8678955 216582542 206113368 18255107 12576790 198327435 193536578 See Schedule O, Statement of Organization's Primary Exempt Purpose Statement To create and lead alliances and public-private partnerships that advance breakthrough biomedical discoveries and improve the quality of people's lives false false 58235139 19658554 50000 SEE SCHEDULE O, PROGRAM ONE, RESEARCH PROGRAMS New Public-Private Partnership Supports Development of Pediatric Medical Devices Despite efforts to support innovation in pediatric medical devices, challenges remain in developing these technologies for children, including concerns about device longevity and long-term exposure to implanted materials. The FNIH announced the launch of a project design phase to address the gap in availability of these devices. The project is supported by a public-private partnership between the NIH, the U.S. Food and Drug Administration, the Biomedical Advanced Research and Development Authority, and partners from the private sector. A full-scale pediatric medical device public-private partnership project will follow the design phase, with the goal of developing a sustainable infrastructure for creating and commercializing these devices. STRENGTHENING THE PATIENT VOICE The FNIH puts patients first. When their perspectives are incorporated into our work, the result will be faster medical breakthroughs for some of today's most pressing health challenges. To do this, we work closely with our Patient Ambassadors, made up of people with lived experience of a disease, and our Patient Engagement Council, comprised of representatives of patient-centric organizations. The Council convened its first Patient Summit in 2023. Six Patient Ambassadors, ten members of the Council, and FNIH staff members who attended the day-long event identified and discussed strategies to better involve and engage people with health challenges in FNIH projects. RESEARCH PROGRAMS FOR ADVANCING GLOBAL HEALTH Award-Winning A-PLUS Study: Improving Outcomes for Laboring Women Worldwide Maternal sepsis affects an estimated 6 million women per year and is the third most commoncause of maternal mortality globally. The Azithromycin Prevention in Labor Use Study (A-PLUS), a groundbreaking multinational clinical trial, demonstrated that one dose of azithromycin, a low-cost, generic, oral antibiotic, given during labor to women planning to deliver vaginally could reduce the occurrence of life-threatening sepsis. Initial study results, published in the New England Journal of Medicine and presented at the Society for Maternal-Fetal Medicine's Pregnancy Meeting 2023, showed that azithromycin use cut the risk of maternal sepsis by 35% and could prevent up to 2 million such cases per year. Global Pandemic Treaty: FNIH Convenes, Informs Leaders The member countries of the World Health Organization (WHO) continued negotiation of a pandemic agreement to "address gaps in preventing, preparing for, and responding to health emergencies [through] a comprehensive and coherent approach to strengthen the global health architecture ... with a whole-of-government and whole-of-society approach, prioritizing the need for equity." The FNIH in 2023 continued its work to inform WHO and the global community as it considers the treaty. The FNIH, in partnership with WHO's collaborating center at Georgetown University's O'Neill Institute for National and Global Health Law, convened two high-level global consultations to provide technical advice and information on key topics identified by the WHO's Intergovernmental Negotiating Body (INB) as critical for the treaty's success. - In collaboration with UNAIDS, convened an expert group to consider existing models that assert equity as a priority and analyze them for possible inclusion in the treaty. Attendees included: INB Co-Chair Precious Matsoso and senior WHO observers assisting the INB. Report of the convening: Advancing a World Together Equitably - In collaboration with the University of Cape Town, organized a global meeting on the development and deployment of emergency countermeasures, including vaccines, diagnostics, and treatments. The expert group examined case studies for countermeasure development, pandemic clinical trial capabilities, and access and benefit sharing. Report of the convening: Emergency Countermeasure Development and Deployment Thought pieces providing insights into pandemic preparedness were published in Hastings Center Reports and Health Affairs Forefront. 1369576 612343 SEE SCHEDULE O, PROGRAM TWO, AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMS PROGRAM TWO - AWARDS, EVENTS, EDUCATION/TRAINING PROGRAMS - POWERING SCIENCE: 2023 FNIH AWARDS The Lurie Prize in Biomedical Sciences The 2023 Lurie Prize in Biomedical Sciences recognized the outstanding achievements of two researchers, each of whom has made important and distinct discoveries in the field of mitochondrial science. Both awardees achieved milestones in biomedical science by exploring the characteristics and functions of mitochondria in human physiology and disease. The award included a $100,000 honorarium, split between the two awardees and made possible by a donation to the FNIH by philanthropist Ann Lurie, President of the Ann and Robert H. Lurie Foundation, President of Lurie Holdings, Inc., and Honorary FNIH Board Member. A distinguished jury of biomedical researchers, chaired by FNIH board member Solomon H. Snyder, MD, selected the 2023 winners. 2023 Award Recipient: Navdeep S. Chandel, PhD, is the David W. Cugell Professor of Medicine, Biochemistry, and Molecular Genetics at Northwestern University Feinberg School of Medicine. The Chandel research team has shown that mitochondria do much more than supply energy to cells. His research team has revealed how mitochondria function as signaling organelles that control the body's normal functions and impact diseases, including cancer and inflammation. 2023 Award Recipient: Vamsi Mootha, MD, is an investigator of the Howard Hughes Medical Institute, investigator in the Department of Molecular Biology at Massachusetts General Hospital, a member of the Broad Institute of MIT and Harvard, and a professor of Systems Biology and Medicine at Harvard Medical School. Although mitochondria contain their own DNA that encodes just 13 proteins, the Mootha research team has identified the other 99% of mitochondrial proteins encoded by nuclear DNA and compiled their findings in a widely used reference tool used to discover new protein functions and disease genes. Trailblazer Prize for Clinician-Scientists The FNIH Trailblazer Prize for Clinician-Scientists recognizes the outstanding contributions of early career clinician-scientists whose work has the potential to, or has led to, innovations in patient care. In searching for potential winners, we seek to highlight true scientific innovators - and this year was no exception. The award celebrates the transformational work of individuals whose research translates basic scientific observations into new paradigm-shifting approaches for diagnosing, preventing, treating, or curing disease and disability. The Trailblazer Prize is made possible by a generous donation from John I. Gallin, MD, and Elaine Gallin, PhD, to the FNIH. 2023 Award Recipient: Vinod Balachandran, MD, is a physician-scientist in the Immuno-Oncology Service of the Human Oncology and Pathogenesis Program and a surgical oncologist at Memorial Sloan Kettering Cancer Center, where he is also immunology group leader in the David M. Rubenstein Center for Pancreatic Cancer Research. Dr. Balachandran discovered that rare long-term survivors of pancreatic cancer have unique tumors enriched in neoantigens - foreign proteins arising from cancer mutations - which may trigger immune cells to keep pancreatic cancers in check. He is now translating these laboratory discoveries into new immunotherapies for pancreatic cancer, including the first clinical trials of personalized mRNA vaccines that target neoantigens to provoke the patient's immune system to recognize their individual cancer. Charles A. Sanders, MD, Partnership Award In honor of former FNIH Chairman of the Board Charles A. Sanders, MD, we celebrate our partners and their contributions through the annual Partnership Award. In keeping with Dr. Sanders' vision, the award recognizes persons and/or organizations that have made significant contributions to our work in creating, implementing, and nurturing public-private partnerships that build bridges to breakthroughs in improved therapeutics, diagnostics, and potential cures. A committee comprised of FNIH Board members selected three partners for 2023 who have supported and accelerated the work of the FNIH for many years. 2023 Award Recipient: The National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The NICHD and the FNIH worked together to manage programs initiated by NICHD's Global Network for Women's and Children's Health Research with additional support from the Bill & Melinda Gates Foundation. These collaborations centered on two clinical trials in critical areas of maternal health: The Azithromycin Prevention in Labor Use Study (A-PLUS) and the Prevention of Iron Deficiency Anemia Post-Delivery (PRIORITY) trial. 2023 Award Recipient: GSK. GSK has been a major FNIH partner, supporting more than 35 projects. As longstanding partners of the Biomarkers Consortium, GSK has helped accelerate and advance discovery, development, and regulatory approval for biomarkers that support new drug therapeutics, preventive medicine, and diagnostics. GSK also has supported AMP Programs, tuberculosis research, and families staying at the Edmond J. Safra Family Lodge, which helps guests remain near loved ones being treated at the NIH Clinical Center. 2023 Award Recipient: The O'Neill Family. For 20 years, the O'Neill family has partnered with the FNIH to raise visibility and funds for kidney cancer research. The Dean R. O'Neill Renal Cell Cancer Research Fund supports research fellowships in the laboratory of Dr. Richard Childs at the NIH's National Heart, Lung, and Blood Institute to search for a cure for renal cell carcinoma. To date, fellowships have supported the work of ten distinguished scientists. EVENTS AND EDUCATION The Meetings and Events Department conceptualizes, plans, executes and evaluates high-quality, productive, innovative and economical convenings that advance the organization's mission. These convenings include, but are not limited to, research project team meetings and conferences, donor stewardship lectures and symposia, and special events. The department oversees the management of the FNIH's highly respected awards and prizes. In collaboration with the NIH and our generous donors and partners, we manage training initiatives that offer educational opportunities to science students, ranging from high school to post-doctoral scholars, crossing boundaries and cultures. They learn through intensive training, collaborative engagement, mentoring, and hands-on research. Legacy funds from individual benefactors and foundations help move scientific achievement farther, faster, and give hope to future patients. Individual programs provide financial support, mentoring, and recognition to promising young scientists. Here is a just a sample of how the FNIH powers science: - The Medical Research Scholars Program is a one-year intensive training program on the NIH campus offering medical, dental and veterinary students opportunities to become engaged in research early in their careers. The goal is to train the best and brightest students today to produce the leading clinicians and researchers of tomorrow. The FNIH has supported a total of 572 scholars since the program was established. - The Deeda Blair Research Initiative for Disorders of the Brain announced in 2023 its second round of awards to drive innovation in mental health research. Four awardees each received $100,000. - We support scientists and promote them through annual lectures at the National Eye Institute, the National Institute of Neurological Disorders and Stroke, the National Institute of Allergy and Infectious Diseases, the National Center for Complementary and Integrative Health, and elsewhere. - For a complete list of all the ways the FNIH is powering science, go to the FNIH website. 59604715 true true false true true false false false true true false false false true true true false false false true true false true true false false true true true false false false false false false false false true false false false false false false false false true 58 0 true 107 true false false false false false true true false false false false false false false false false X 21 20 false false true false false false false true true false false true true true true true true true true false CA FL GA AL HI IL KS KY MD MA MI MN MS NH NJ NM NY OR PA RI SC TN UT VA AR WV WI X X DONALD M HILL 3014356246 11400 ROCKVILLE PIKE 600 NORTH BETHESDA MD 20852 Dr Julie L Gerberding Chief Executive Officer 40.0 X X 613755 0 43274 Charles A Reinhart III Board Member 0.5 X 0 0 0 Dame Jillian Sackler Board Member 0.5 X 0 0 0 Dr Charles A Sanders Board Member 0.5 X 0 0 0 Dr Edison T Liu Board Member 0.5 X 0 0 0 Dr Elias Zerhouni Board Member 0.5 X 0 0 0 Dr Ellen V Sigal Board Member 0.5 X 0 0 0 Dr Freda Lewis-Hall Board Member 0.5 X 0 0 0 Dr Judy Lansing Kovler Board Member 0.5 X 0 0 0 Dr Paul Stoffels Board Member 0.5 X 0 0 0 Dr Ronald L Krall Board Member 0.5 X 0 0 0 Dr Solomon H Snyder Vice-Chairman 0.5 X 0 0 0 Dr Steven M Paul Chairman 1.5 X 0 0 0 Gilbert S Omenn Board Member 0.5 X 0 0 0 James Weiss Board Member 0.5 X 0 0 0 Jay Bradner Board Member 0.5 X 0 0 0 Mr Fred Seigel Board Member 0.5 X 0 0 0 Mr James H Donovan Board Member 0.5 X 0 0 0 Mr Russell W Steenberg Board Member 0.5 X 0 0 0 Mrs William McCormick Blair Jr Secretary 1.0 X 0 0 0 Ms Julie Bell Lindsay Treasurer 2.0 X 0 0 0 David Carmel Senior Vice President, Chief Growth and Innovation Officer 40.0 X 400911 0 40224 David Wholley Chief Strategy and Business Development (UNTIL NOV.) 40.0 X 375609 0 39802 Donald Hill Senior Vice President, Chief Financial Officer 40.0 X 289166 0 40393 Joseph Menetski Senior Vice President, Chief Translational Science Officer 40.0 X 324692 0 39943 Julie Wolf Rodda Chief Strategic Alliances and Advancement Officer (UNTIL NOV.) 40.0 X 180943 0 17503 Kevin Klock Senior Vice President, Chief Operating Officer and General Counsel 40.0 X 283492 0 37823 Michael Santos Senior Vice President, Chief Population Health Science Officer 40.0 X 368742 0 34416 Courtney Silverthorn Associate Vice President, Science Partnerships Translational Science 40.0 X 236430 0 27203 Eva Coyne Vice President -Controller 40.0 X 231174 0 32796 Robert Balthaser Vice President of Advancement (UNTIL NOV.) 40.0 X 220316 0 20295 Stacey Adam Associate Vice President, Science Partnerships Translational Science 40.0 X 258208 0 28555 Steven Hoffmann Associate Vice President, Science Partnerships Translational Science 40.0 X 240048 0 33223 4023486 0 435450 59 false true false SWOG CTI 24 FRANK LLOYD WRIGHT DRIVE PO Box 483 ANN ARBOR MI 48105 clinical trial for Lung Map Project 3519264 The Trustees of Columbia University 154 Haven Avenue 2nd Floor New York NY 10032 AMP AD 2.0 Project Research Collaboration 2050540 Emory University 1599 Clifton Road NE 4th floor Atlanta GA 30322 AMP AD 2.0 Project Research Collaboration 1923678 Dana -Farber Cancer Institute 451 Brookline Avenue Boston MA 02216 The PACT, MRD and ctDNA Research Collaboration 1808688 Deloitte Consulting LLP 4022 Sells Drive Hermitage TN 37076 covid-19 project PROFESSIONAL SERVICES 1699092 40 333929 1250000 54508268 6019419 56092197 Administrative Revenue 900099 50000 50000 0 0 0 0 50000 4421167 4421167 0 0 241379578 241038353 341225 0 341225 341225 571531 333929 510332 61199 61199 0 0 0 0 0 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69442388 202355 0 202355 69644743 Schedule D, Part V, Line 4 Intended uses of endowment funds The Foundation has one endowment that is funded by multiple donors to seed new discoveries and/or be available to respond to epidemics and Foundation's unanticipated needs. The Foundation's other endowments consist of individual donor-restricted endowment funds established for a variety of purpose. (e.g. variety of research and educational initiatives at the Foundation for the NIH, Inc). Net assets associated with endowment funds are classified and reported based on the existence or absence or donor-imposed restrictions. Schedule D, Part X, Line 2 FIN 48 (ASC 740) footnote The Foundation is exempt from federal income taxes under Section 501(c)(3) of the Internal Revenue Code; accordingly, the accompanying financial statements do not reflect a provision or liability for federal and state income taxes. The Foundation has determined that it does not have any material unrecognized tax benefits or obligations as of December 31, 2023 and 2022. Schedule D, Part XI, Line 4(b) Other revenues in form 990 not in audited financial statements Fundraising Direct Expense - -510332 Schedule D, Part XII, Line 2(d) Other expenses in audited financial statements not in form 990 Fundraising Direct Expense - 510332 true Sub-Saharan Africa 0 0 Grantmaking Grantmaking 21970 0 0 0 0 0 0 21970 0 21970 Sub-Saharan Africa Research 21970 Wire Transfer 0 1 false false false false false false Schedule F, Part I, Line 2 Procedures for monitoring use of grant funds Program and grants management staff invest considerable effort in providing scientific, administrative, and fiscal oversight for FNIH grants. Scientific and technical progress is monitored through semi-annual and annual reports from the grantees as well as through direct contact with investigators both by teleconference and site visits, and follow up to progress reports and site visits where scientific questions or administrative issues are identified. Scientific report submissions cover a wide range of items including individual objectives and overall progress review, milestone achievement, project plan update, and any other significant changes. Financial reporting is required annually for all of the grantees, and semi-annually for institutions that require additional oversight, such as some developing country institutions. Due diligence procedures, such as FNIH compliance with the USA Patriot Act and IRS requirements on expenditure responsibilities, have been incorporated into the reporting process to ensure that the grantees are complying with grant, legal, financial, and regulatory requirements. Schedule F, Part I, Line 3 Method used to account for expenditures on org's financial statements SUB-SAHARAN AFRICA-Cash Schedule F, Part II, Line 1 Method used to account for expenditures on org's financial statements SUB-SAHARAN AFRICA-Cash X X X X X true MBP Consulting LLC 20 Unity Court Boston MA 02113 Fundraising Consultancy false 0 94313 -94313 0 94313 -94313 CA CO CT DC FL GA AL HI IL KS KY ME AK MD MA MI MN MS MO NV NH NJ NM NY NC ND OH OK OR PA RI SC TN UT VA AR WA WV WI 2023 FNIH Award Ceremony 905460 333929 571531 78860 422773 2024 FNIH Award Ceremony 0 8699 0 905460 333929 571531 78860 431472 510332 61199 true NIHCC - Clinical Center 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 25500 Research NIH NIA 9001 Rockville Pike Bethesda MD 20893 520858116 170(c)(1) Govt Unit 21728 Research NIHNCI 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 1277547 Research NIHNIAID 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 2370985 Research NIHNIAMS 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 7500000 Research NIHNINDS 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 645712 Research NIH NHLBI 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 979704 Research NIHOD 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 102930 Research NIH NIMH 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 3068409 Research NIHNEI 9000 Rockville Pike Bethesda MD 20892 520858115 170(c)(1) Govt Unit 1200 Research Research Triangle Institute PO Box 900002 Raleigh NC 27675 560686338 501(c)(3) 614891 Research University of Alabama at Birmingham Dept of Pediatric Admin Lowder Bl Birmingham AL 35233 636001138 501(c)(3) 856050 Research GeorgeTown University 125 South 9th Street 2nd Floor Sher Philadelphia PA 19107 231352651 501(c)(3) 44855 Research University of North Carolina Chapel Hill 3700 O Street NW Washington DC 20057 530196603 501(c)(3) 165406 Research The Trustees of Columbia University 104 Airport Drive Suite 2200 Campus Chapel Hill NC 27599 800543561 501(c)(3) 147571 Research Trustees of Indiana University PO Box 29789 General Post Office New York NY 10087 135598093 501(c)(3) 133249 Research University of Virginia The Poplars Building400 E Seventh Bloomington IN 47405 356001673 501(c)(3) 229524 Research University of Colorado Denver PO Box 400195 Charlottesville VA 22904 546001796 501(c)(3) 35939 Research Duke UnivHuman Vaccine Institute 1100 Fairview Ave N Seattle WA 98109 237156071 501(c)(3) 55960 Research Fred Hutchinson Cancer Research Ctr 200 Lothrop St Biomedical Science Pittsburgh PA 15213 250965591 501(c)(3) 683642 Research Trustees of Boston University 85 East Newton Streetm M-921 Boston MA 02118 042103547 501(c)(3) 663875 Research Johns Hopkins University 615 N Wolfe St W1100 Baltimore MD 21205 150595110 501(c)(3) 23454 Research Friends of Cancer Research 1800 M Street NW Suite 1050 South Frederick MD 21702 521983273 501(c)(3) 138296 Research Gordon Research Conferences 5586 Post Road G02 East Greenwich RI 02818 260150662 501(c)(3) 60000 Research 24 0 Awards 5 402500 FMV Schedule I, Part I, Line 2 Procedures for monitoring use of grant funds. Program and grants management staff invest considerable effort in providing scientific, administrative, and fiscal oversight for FNIH grants. Scientific and technical progress is monitored through semi-annual and annual reports from the grantees as well as through direct contact with investigators both by teleconference and site visits, and follow up to progress reports and site visits where scientific questions or administrative issues are identified. Scientific report submissions cover a wide range of items including individual objectives and overall progress review, milestone achievement, project plan update, and any other significant changes. Financial reporting is required annually for all of the grantees, and semi-annually for institutions that require additional oversight, such as for-profit institutions. Due diligence procedures, such as FNIH compliance with the USA Patriot Act and IRS requirements on expenditure responsibilities, have been incorporated into the reporting process to ensure that the grantees are complying with grant, legal, financial, and regulatory requirements. FELLOWS SELECTED FOR FOUNDATION FELLOWSHIPS ARE SELECTED THROUGH NATIONWIDE AND INTERNATIONAL COMPETITIONS. 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Form 990, Part III, Line 4a Program Service Description PROGRAM ONE - RESEARCH PROGRAMS - ACCELERATING MEDICINES PARTNERSHIP PROGRAM (AMP) The FNIH manages the Accelerating Medicines Partnership (AMP) program with the interests of the collective scientific and medical research communities in mind. Our mission is to improve understanding of disease pathways, facilitate better selection of targets for treatment, and identify platforms and processes to accelerate new and effective therapies to patients. All AMP projects operate under the broad principle of delivering pre-competitive advancements to the research and medical fields and enabling the broadest possible access and use of AMP research discoveries. A critical component of each public-private partnership in the AMP program is an agreement among partners to make data and analyses arising from the collaboration publicly accessible to benefit the broader biomedical community. Individual AMP projects frequently establish public portals to rapidly disseminate data from their research efforts, and AMP-funded publications are required to be made available publicly within specific timeframes. At the center of the AMP program is a common goal of accelerating new and effective therapies to patients. AMP projects work towards this goal by identifying clinically relevant disease targets, improving identification of patients most likely to respond to a particular treatment, and safely reducing the development timelines for life-saving therapies and improvements in patient outcomes. Biomarkers Consortium The Biomarkers Consortium convenes government, industry, patients and patient advocacy groups, and not-for-profit organizations to address one of the most pressing needs in the diagnosis and treatment of disease: the development and the seeking of regulatory approval for disease biomarkers and surrogates. The Biomarkers Consortium creates and leads cross-sector efforts that validate and qualify biomarkers and other drug development tools to accelerate better decision making for the development of new therapeutics and health technologies. The core operations of the Biomarkers Consortium are supported through contributing membership. Organizations representing private industry (including the pharmaceutical, biotechnology, diagnostics, and information technology industries) and not-for-profit organizations (including associations, advocacy groups, trade organizations, and philanthropic organizations) that wish to support biomarkers development are eligible to become contributing members. GeneConvene The GeneConvene Global Collaborative advances best practices and informed decision making for development of genetic biocontrol technologies to improve public health. GeneConvene offers technical information, advice, training, and coordination for research on gene drive and other genetic biocontrol technologies - technologies that use genetic variants of a target species, like a disease-transmitting mosquito, to control its undesirable impacts. Efforts to control the spread of mosquito-borne diseases save hundreds of thousands of lives every year, but the tools and resources available are not sufficient to protect everyone. Gene drive is recognized as a potentially powerful tool to help control malaria. Genetic biocontrol has been used on disease-transmitting mosquitoes for over 60 years, but scientific advances in the past 20 years have dramatically improved the ability of researchers to engineer new genetic biocontrol approaches, including gene drives. GeneConvene was created to support informed decision making on the open scientific, regulatory, and policy questions raised by these new technologies. In 2023, GeneConvene members published the following: - An article in a special collection volume (organized by GeneConvene Global Collaborative) of Transgenic Research focusing on the regulatory requirements for implementing gene drive technologies in national or regional public health programs. - An article in Frontiers in Bioengineering and Biotechnology considering the approval procedures and market entry strategies for implementing gene drive-modified mosquitoes. - An assessment by a neutral third party, CSIRO, of risks associated with the release of genetically modified mosquitoes by the Target Malaria project. - A multi-country study in Malaria Journal exploring the insights and recommendations of key stakeholders across Africa on the potential of gene drive-modified mosquitoes for malaria control and elimination. Members also: - Supported training activities on operationalization of biosafety oversight and genetically modified organism decision making processes at African institutions. - Advised the United Nations Convention on Biological Diversity on developing guidance for risk assessment of engineered gene drive-modified mosquitoes. RESEARCH PROGRAMS FOR ACCELERATING NEW THERAPIES NIMBLE Results Set Stage for Improved Diagnosis, Treatment of Liver Disease To diagnose metabolic dysfunction-associated steatohepatitis (MASH), a leading cause of liver-related mortality, patients must undergo a liver biopsy, a painful and expensive procedure that carries some risk of death for patients. The Biomarkers Consortium's Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project aims to identify noninvasive blood-based and imaging biomarkers to assess their performance in diagnosing MASH, compared to liver biopsy, and to evaluate their suitability for monitoring treatment response in clinical trials. By expanding diagnostic options, more healthcare professionals and facilities would be able to diagnose MASH with greater safety, and the use of noninvasive tests may assist enrollment in future studies. - Four noninvasive blood tests for MASH and advanced liver disease were identified for assessment in NIMBLE 2. Study results published inNature Medicine. - Six imaging biomarkers shown to have the potential to measure liver fat, fibrosis, and body composition in those at risk for MASH. Study results published in Radiology. Expanding Access to Gene Therapy for Sickle Cell Disease Worldwide The FDA recently approved two treatments that use gene-editing technologies to mitigate the inherited gene mutation that causes sickle cell disease (SCD). These therapies involve procuring a patient's own bone marrow cells to repair the defective gene outside the body (ex vivo) and then transplanting the modified cells back into the patient's blood. The FNIH has supported, and continues to support, the underlying gene-editing research at NIH's National Heart, Lung, and Blood Institute (NHLBI) that helped lay the foundation for this breakthrough. Still, access to these therapies remains limited for people in low- and middle-income countries that may not have a cell-processing center and related resources necessary for ex vivo gene therapy. This is where the FNIH is seeking to broaden access to critical gene editing therapies for patients with SCD. In partnership with the NHLBI, the FNIH launched a project to explore techniques for administering gene therapy strategies entirely inside a patient's body (in vivo), which would eliminate the need for an advanced healthcare infrastructure and make SCD treatment more broadly available. BGTC Launches Clinical Trial Portfolio There are more than 10,000 known rare genetic diseases, affecting more than 30 million Americans and their families, but there is typically little to no commercial interest in developing treatments for a disorder that may impact only a dozen or so patients, leaving many such patients with little or no hope for beneficial treatments. Gene therapies hold promise for treating such patients, but progress is slowed by uncertainties about manufacturing and a clear regulatory path. Part of the AMP program, the Bespoke Gene Therapy Consortium (BGTC) partnership, now in its second year, brings experts across the biosciences ecosystem together to define the best ways to safely advance these treatments and encourage increased investments in their development. BGTC announced in 2023 the eight rare diseases that will comprise the program's initial clinical trial portfolio, which will pioneer a novel approach to the development of adeno-associated virus (AAV) gene therapy for rare diseases. The goal is to demonstrate that manufacturing and testing standards can provide a streamlined approval pathway for first-in-human clinical trials. Form 990, Part VI, Line 1a Delegate broad authority to a committee THE BOARD HAS AN EXECUTIVE COMMITTEE, WHICH CAN MAKE DECISIONS ON BEHALF OF THE BOARD (WITH SOME EXCEPTIONS) IN BETWEEN BOARD MEETINGS. Form 990, Part VI, Line 4 Significant changes to organizational documents The FNIH By-Laws were amended in October 2023 to create a category of Board membership for Founding Directors. Form 990, Part VI, Line 11b Review of form 990 by governing body Prior to the submission of the Foundation for NIH's Form 990 to the Internal Revenue Service, each voting member of the board of directors shall be provided with a copy of the draft Form 990 as approved by the Chief Financial Officer. Form 990, Part VI, Line 12c Conflict of interest policy DIRECTORS, OFFICERS AND EMPLOYEES ARE REQUIRED TO ANNUALLY SIGN A STATEMENT WHICH AFFIRMS THAT THEY HAVE: O RECEIVED A COPY OF THE CONFLICT OF INTEREST POLICY O READ, UNDERSTOOD AND AGREED TO COMPLY WITH THE POLICY O RECEIVED AND REVIEWED A LISTING OF CORPORATE AND FOUNDATION DONORS, CONTRACTORS, VENDORS, GRANTEES, PRINCIPAL INVESTIGATORS AND FINANCIAL INSTITUTIONS WITH WHOM THE FNIH HAS A CURRENT RELATIONSHIP O NO ACTUAL OR APPARENT CONFLICTS OF INTEREST OTHER THAN THOSE DISCLOSED IN THE STATEMENT. THEY MUST ALSO MAKE CERTAIN NOTIFICATIONS IN PARTICULAR CIRCUMSTANCES. THE CONFLICT OF INTEREST POLICY ALSO HAS MECHANISMS FOR HANDLING SUCH CONFLICTS. Form 990, Part VI, Line 15a Process to establish compensation of top management official The Compensation Committee of the Board reviewed and concurred with the CEO's decisions establishing and adjusting the senior executive team's annual salaries and related compensation decisions. The Compensation Committee also approved the compensation level of the CEO and related compensation decisions. Form 990, Part VI, Line 15b Process to establish compensation of other employees The Compensation Committee of the Board reviewed and concurred with the CEO's decisions establishing and adjusting the senior executive team's annual salaries and related compensation decisions. The Compensation Committee also approved the compensation level of the CEO and related compensation decisions. Form 990, Part VI, Line 19 Required documents available to the public All such documents are available upon request. In addition, the governing documents and financial statements are available on the FNIH website. Form 990, Part X, Column (B) Cash & Investments Approximately $122 Million of FNIH's Cash and Investments are invested in high quality short-term fixed income securities which are committed to FNIH's restricted assets. Form 990, Part XII, Line 2c Change of oversight process or selection process PROCESS HAS NOT CHANGED FROM THE PRIOR YEAR.