May 27, 2016

Francis S. Collins, M.D., Ph.D. Director National Institutes of Health Building 1 Room 26 Bethesda, MD 20814

Dear Dr. Collins:

Per statutory requirement, enclosed you will find the 2015 FNIH Annual Report to NIH. The report is comprised of the following: • Brief FNIH overview • 2015 Allocation of NIH’s Statutory Contribution to the FNIH • 2015 Operating Revenues and Expenses • 2015 Program Revenues and Expenses • FNIH Board of Directors • 2015 NIH Proposal Review Committee Submissions to FNIH • FNIH Project Summaries through December 31, 2015 • 2015 Financial Statements and Independent Auditor Letter • 2015 FNIH Summary Annual Report

You will find the first eight items together in the spiral bound booklet. The 2015 FNIH Summary Annual Report is a separate document included in the package.

Please do not hesitate to contact me if you have any questions.

Sincerely yours,

Maria C. Freire, Ph.D. President and Executive Director

cc: Steven M. Paul, M.D., Chairman

2015 Annual Report to the National Institutes of Health

May 27, 2016 Table of Contents

Tab One ………………………………………………….….….….….….………….Brief FNIH Overview

Tab Two……………………………………..2015 Allocation of NIH’s Statutory Contribution to the FNIH

Tab Three…..………………….……………………………………2015 Operating Revenues and Expenses

Tab Four……………….……….………………………………....….2015 Program Revenues and Expenses

Tab Five…..……………….………………………………………………………FNIH Board of Directors

Tab Six……………………………………….2015 NIH Proposal Review Committee Submissions to FNIH

Tab Seven…..………………...………………………FNIH Project Summaries through December 31, 2015

Tab Eight…………….……………....….2015 Financial Statements and Report of the Independent Auditors

Enclosure…..…………………………………………………..………2015 FNIH Summary Annual Report

The Foundation for the National Institutes of Health organizes productive research collaborations, incubates new research models and channels resources for maximum impact in order to support the mission of the National Institutes of Health, the largest biomedical research agency in the world, as it works to turn discovery into health. From 1996-2015, the Foundation raised almost $850 million, consistently generating over $80 per $1 of NIH support, therefore dramatically leveraging NIH’s yearly contribution. Rated by Charity Navigator as an organization that exceeds industry standards for effective management and efficient use of resources, the FNIH has partnered with the NIH to pioneer novel, mission-critical public- private partnerships that promote human health. Notably, 2015 marked ten years since the Edmond J. Safra Family Lodge opened its doors to the families of patients receiving care at the NIH Clinical Center. With a founding gift from Ms. Lily Safra and extensive support from private sector benefactors, the Lodge has provided a home away from home for those family members who are often the most important caregivers to patients experiencing serious illness. Whether it is raising funds for novel models such as LUNG-MAP or responding to the NIH Office of the Director to design the Accelerating Medicines Partnership (AMP), the FNIH provides a place where private industry, academia, and government can come together to address critical health challenges. In this and other ways, the FNIH is a critical effector, implementer, steward and partner to the NIH.

2015 Allocation of NIH’s Statutory Contribution to the FNIH * Table 1

Activity Cost 1) Lease 12,000 sp. Feet of Office Space at FASEB$ 271,926 2) Unrecovered Program Salary & Benefits$ 294,824 3) Partial Operating Costs$ 65,966 4) Three key positions as outlined in $ 367,284 Memorandum dated October 15, 2014 Total$ 1,000,000

* 2015 Expenses Allocable to the NIH Appropriation$ 4,526,543 2015 Operating Revenues and Expenses Table 2

Program Administrative Fees 2015 Financial Support for Operating Activities

Program Administrative Fees 3,188,303 64% NIH Appropriation NIH Appropriation 1,000,000 20% Other Income 371,650 7% Unrestricted Gifts 243,921 5% Other Income In‐Kind Contributions 336,239 7% Investment Income (124,170) ‐2% Unrestricted Gifts Total Revenue 4,901,442

In‐Kind Contributions

2015 Operating Expenses S&B (not recovered as direct S&B (not recovered as direct costs) 3,617,933 75% costs) Rent (not recovered as direct cost) 271,926 5% Other Overhead Costs 972,923 20%

Rent (not recovered as direct Total Overhead Costs 4,832,734 cost)

Current Appropriation as % of Total Overhead Costs 21% Other Overhead Costs 2015 Program Revenues and Expenses Table 3

Research Partnerships 2015 Financial Support for Programs

Research Partnerships 30,604,224 96% Training Training 701,732 2% Events and Awards 660,288 2% Safra Family Lodge 39,738 0% Events and Awards Total Program Revenue 32,005,982

Safra Family Lodge

2015 Program Expenditures Research Partnerships

Research Partnerships 54,949,820 96% Training 1,257,703 2% Training Events and Awards 603,293 1% Safra Family Lodge 277,018 0% Events and Awards Total Program Expenditures 57,087,834

Safra Family Lodge

Board of Directors as of December 31, 2015

Charles A. Sanders, M.D. (Chairman) Retired Chairman and Chief Executive Officer, Glaxo Inc.

Maria C. Freire, Ph.D. President and Executive Director, Foundation for the National Institutes of Health

The Honorable John Edward Porter (Vice Chairman for Policy) Hogan Lovells US, LLP

Solomon H. Snyder, M.D. (Vice Chairman for ) Distinguished Service Professor of Neuroscience, Pharmacology & Psychiatry Solomon H. Snyder Department of Neuroscience at

Steven C. Mayer (Treasurer) Former Chief Executive Officer, CoGenesys, Inc.

Mrs. William McCormick Blair, Jr. (Secretary) Director Emeritus, Albert & Mary Lasker Foundation

Kathy Bloomgarden, Ph.D. Chief Executive Officer, Ruder Finn Inc.

Mrs. William (Buffy) N. Cafritz Honorary Trustee, The John F. Kennedy Center for the Performing Arts

James H. Donovan Managing Director, Goldman Sachs & Company; Adjunct Professor, ; Trustee, Dana-Farber Cancer Institute

Joseph M. Feczko, M.D. Retired Senior Vice President and Chief Medical Officer, Pfizer Inc

Paul L. Herrling, Ph.D. Chairman, Novartis Institute for Tropical Disease

Judy Lansing Kovler, Ph.D. Director, Kovler Foundation and Vice Chair of Sasha Bruce, Inc.

Ronald L. Krall, M.D. Former Senior Vice-President and Chief Medical Officer, GlaxoSmithKline

Freda C. Lewis-Hall, M.D., FAPA Chief Medical Officer, Senior Vice President, Pfizer Inc

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Edison T. Liu, M.D., Ph.D. President & CEO, The Jackson Laboratory

Ann Lurie President, Lurie Holdings; President and Treasurer, Ann and Robert H. Lurie Foundation

Joel S. Marcus Chairman, Chief Executive Officer and Founder, Alexandria Real Estate Equities, Inc. and Alexandria Venture Investments

Paul M. Montrone, Ph.D. Chairman, Perspecta Trust

Martin J. Murphy Jr., Ph.D. DMedSc, FASCO Founding Chairman and Chief Executive Officer, AlphaMed Consulting, Inc.

Steven M. Paul, M.D. President and Chief Executive Officer, Voyager Therapeutics, Inc. and Venture Partner at Third Rock Ventures

Jillian Sackler, D.B.E. President and Chief Executive Officer, Dame Jillian & Dr. Arthur M. Sackler Foundation for the Arts, Sciences & Humanities

Lily Safra Chairwoman, Edmond J. Safra Philanthropic Foundation

Ellen V. Sigal, Ph.D. Chairperson, Friends of Cancer Research

Nina K. Solarz Former Executive Director of Peace Links and the Fund for Peace

Russell W. Steenberg Global Head, BlackRock Private Equity Partners

Samuel O. Thier, M.D. Professor of Medicine and Health Care Policy, Emeritus, Harvard Medical School; Massachusetts General Hospital

Anne Wojcicki Chief Executive Officer and Co-founder, 23andMe

EX OFFICIO NON-VOTING DIRECTORS

Stephen Ostroff, M.D. Acting Commissioner, Food and Drug Administration

Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health

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DIRECTORS EMERITUS

Paul Berg, Ph.D. Cahill Professor in (Emeritus), Stanford University School of Medicine

Sherry Lansing Founder and Chief Executive Officer, The Sherry Lansing Foundation

HONORARY DIRECTORS

Luther W. Brady, M.D. Affiliate Faculty Member in the Department of Radiation Oncology at Drexel University; Former Chair of the Department of Radiation Oncology, MCP Hahnemann University

Patrick C. Walsh, M.D. University Distinguished Service Professor, James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions

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2015 NIH Proposal Review Committee Submissions to FNIH

2015 NIH Proposal Review Committee Submissions

UNDER CONSIDERATION Date FNIH R&D Pipeline Name of Project IC Project Description Update rec'd RFC Area NIH Archives Online: NLM 10/29/2015 The project involves digitizing completely, preserving N/A During its due diligence phase, the FNIH staff contacted 10 foundations, corporations, Legacies of Scientific for future generations, and making publicly available and individual philanthropists to gauge interest. Many of the most likely donors were Achievement via the NLM’s existing Digital Collections repository unwilling to provide definitive input absent a formal funding proposal. The FNIH the top-50 patron-requested manuscript collections submitted a $250,000 application to the Council on Library Information Resources held by the NLM’s History of Medicine Division. (CLIR), which will likely serve as a bellwether as to whether substantial funding is possible. A decision is expected by July 2016, after which the PPP Committee will determine how to proceed with the program.

ACTIVE PROJECTS Date FNIH R&D Pipeline Name of Project IC Project Description Update rec'd RFC Area Research Multi-site Randomized NIAAA 3/27/2015 Prospective epidemiological studies consistently relate Clinical As part of its due diligence before taking on this project, the FNIH worked with the Trial of Health Effects moderate alcohol consumption with lower risk of International Association for Responsible Drinking (IARD), to secure informal of Moderate Drinking cardiovascular disease, ischemic stroke, and type 2 commitments of ~$80M, the amount required of the private sector in order to fully fund diabetes. However, this association remains the study. Assured of funding, and with proper safeguards established, especially in the controversial due in part to the lack of gold-standard areas of project governance and communications, in May 2015 the FNIH Board of randomized evidence. This project is intended to meet Directors authorized the organization to formally undertake fundraising for the project. the need for a clinical trial. The primary study FNIH subsequently met on serveral occasions with NIAAA program and objectives are: 1) determine the effects of one serving communications staff and NIH OD to re-confirm that anticipated funders (alcohol of alcohol daily, compared to no alcohol intake, on companies) will have no role in the study other than to provide funds, and to develop an the time to incident cardiovascular disease among agreed upon plan for handling public communications about the program. Letters of adults at above average cardiovascular risk; and 2) to Agreement are being negotiated with the potential funders. A grant award to the determine the effects of one serving of alcohol daily Vanguard Site for year 1 of the program is expected in early 2016. on the time to incident diabetes among participants free of diabetes at baseline. The study design will be a randomized, multicenter, international, assessor- blinded, parallel group, balanced clinical trial. FNIH has been asked to secure private-sector funding and to create an arms-length relationship between funders and NIH, in order to ensure an unbiased trial.

Liberia-US Joint Clinical NIAID 5/4/2015 People stricken by epidemics in West Africa are Clinical An MOU with NIAID was fully executed on December 1, 2015 in support of this Research Partnerships among the poorest of the poor, having inadequate project. FNIH looks forward to working with NIAID to support vital communications infrastructure for responding to efforts for PREVAIL III. The FNIH has secured an in-kind gift of two shipping outbreaks or supporting survivors. Expanded containers filled with medical supplies, ranging from syringes and gloves to hospital beds, understanding of how Ebola virus causes disease and valued at nearly $1 million, from Project C.U.R.E.; Takeda Pharmaceuticals is considering how EVD affects the longer term health of survivors a $2.5 million proposal for support for the social mobilization and communication efforts and the people they live with will improve public relating to PREVAIL, and anticipates a decision on the award by July 2016. health responses to future EVD outbreaks. This can only be accomplished if the affected communities are willing to participate in Ebola research. Support of the critical social mobilization and communications component of PREVAIL III, specifically, meetings in Liberia focused on community engagement, training and strategic planning will underpin the success of the study and ensure useful results.

Events Advancing Science NINR 4/4/2015 Celebrating the 30th Anniversary of NINR, the N/A FNIH committed its best efforts to secure $50,000 by August 1, 2015 to support these Improving Lives "Advancing Science, Improving Lives" events will two activities during the NINR 30th Anniversary year. FNIH approached 20 potential bring together scientists, healthcare professionals, and funders and secured a total of $21,500 from six. The events team worked with NINR to members of the public to discuss the advancements in support aspects of an October workshop at which donors were recognized. NINR has nursing science that build the foundation for clinical set a date in September 2016 for a public lecture. The balance of funds raised will practice and enhance the health of the nation. FNIH support a small reception following the lecture. has been asked to be involved in two of these events: a scientific symposium including scientific, keynote, and poster presentations and panel discussions, and a Science and Public Lecture featuring a speaker who can bring science to a lay audience, appealing to the general public.

International Summit in NHGRI 12/14/2015 This month-long summit, to be held annually for five N/A Upon reviewing the Request for Collaboration and supplementary materials provided by Human Genetics and years, to help promote genomic research and NHGRI, the FNIH staff had some concern, also reported by the NIH review committee, Genomics medicine in under-resourced countries. The summit that without a robust capacity building component, including follow-up support for the will bring approximiately 20 researchers and trainees, the program would not achieve its optimal result. Following discussion with healthcare professionals (in early and middle career NHGRI and receipt of additional budget information, FNIH completed its due diligence stage) to the NIH campus where they will interact phase by contacting 10 corporations, fundations and nonprofit advocacy organizations to with and learn from the field’s most experienced gague interest. While those contacted felt the project to be worthwhile, it was not clear leaders. An intensive curriculum, closely tailored to that the full $200,000 requested could be secured in time to fund a September 2016 the needs and experience of the participants, will help Summit. Following PPP Committee review, the FNIH agreed on May 5 to commit its to fill the knowledge gap in genomics and best efforts to secure funding by August 1, 2016 and evaluate with NHGRI the best path communicate advances in genomic science to a larger forward. global community. COMPLETED PROJECTS

Name of Project IC Project Description R&D Pipeline Update Date FNIH Area rec'd RFC Research Public Perspectives OD 4/1/2015 President Obama recently launched the Precision Discovery Received the RFC from NIH 4/1/2015. The project was presented and approved in the About a National Medicine Initiative (PMI), an ambitious research April 8 PPP Committee teleconference. FNIH finalized the contract with GFK to Research Cohort for effort to usher in an era of tailored approaches to perform the survey on April 14 which also included the designation of an NIH technical Precision Medicine revolutionize how to improve health and treat disease. expert advisor for the project - David Kaufman. The survey was completd and results One component of PMI is the creation of a large were provided to FNIH and shared with NIH June 24, 2015. Invoices have been paid in research cohort of more than 1 million participants. full. This file is now closed. The cohort will be built through active engagement with participants, from planning through implementation. Input from cohort participants is needed to design the cohort to reflect the preferences of potential participants and address their concerns. A survey of potential participants is proposed as one way of collecting this information.

ALK-Inhibitors Master NCI 3/16/2015 Anaplastic Lymphoma Kinase (ALK) is an enzyme Clinical Received the RFC from NIH 3/16/2015. The project has been cancelled at the request Protocol coded by the ALK gene. When the ALK gene is of NCI because one of the key companies who had been interested decided not to aberrantly activated by mutation, gene amplification participate for business reasons. This file is now closed. or chromosomal rearrangement, it becomes oncogenic leading to cancers including adenocarcinoma of the lung. New therapies are needed for patients with ALK-positive NSCLC. A number of 2nd generation ALK inhibitors are in clinical development, but it is unknown what sequence is optimal when using them. This project will conduct a trial with multiple 2nd generation ALK inhibitors, tested against a common control (crizotinib), as a potential path for regulatory approval.

2016 Alzheimer's NINDS 9/23/2015 The 2016 Alzheimer's Disease-Related Dementias N/A The FNIH raised $50,000 for this event from six sponsors, and is able to cover the cost Disease-Related (ADRD) Summit will complete Action Number 1.A.8 of food and beverage for this event. The FNIH's events staff coordinated related Dementia (ADRD) of the National Plan to Address Alzheimer's Disease logistics for the March 29-30, 2016 event. Summit (2015 update). The goal of the Summit, as indicated in the action description of the National Plan, is to regularly convene an ADRD Summit to review the progress on ADRD research recommendations and refine and add new recommendations as appropriate based on recent scientific discoveries.†The NIH is the lead agency, with the National Plan naming the NINDS as the lead of this effort. The NINDS is collaborating with the NIA on the ADRD 2016 Summit, and with partnering interests named in Action Number 1.A.8 including other federal funders of dementia research, national and international experts, public and private stakeholders, and the NAPA Advisory Council on Alzheimer's Research, Care and Services. FNIH has been asked to raise funds to support this March 2016 event.

FNIH Project Summaries December 31, 2015

Project Summaries Table of Contents

1. Overview • Funds Raised for Active Projects by Activity Type: $450,214,193 • Active Project by Activity Type: 108 • Funds Raised for Each NIH IC: $351,620,842

2. Summaries • National Cancer Institute (NCI) • (NEI) • National Heart, Lung and Blood Institute (NHLBI) • National Research Institute (NHGRI) • National Institute on Aging (NIA) • National Institute on Alcohol Abuse and Alcoholism (NIAAA) • National Institute of Allergy and Infectious Diseases (NIAID) • National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) • National Institute of Mental Health (NIMH) • National Institute of Neurological Disorders and Stroke (NINDS) • National Institute of Nursing Research (NINR) • Fogarty International Center (FIC) • National Center for Complementary and Integrative Health (NCCIH) • National Institutes of Health Clinical Center (CC) • Office of the Director (OD) • Other Active Projects by Activity Type (Number, Percentage) Total = 108 Capital Projects 6 (6%)

Education & Seminars 17 (16%)

Events 7 (6%)

Research Projects 77 (71%) Other 1 (1%)

Capital Projects Education & Seminars Events Other Research Projects Total Funds Raised by Activity Type (Amount, Percentage) Total = $450,214,193

Education & Seminars, $6,322,968 (2%) Events, $1,611,195 (0%)

Capital Projects, $9,839,231 (2%) Other, $5,150 (0%)

Research Projects, $432,435,649 (96%)

Capital Projects Education & Seminars Events Other Research Projects Total Funds for Each NIH IC Total = $351,620,842 CC = $18M

FIC = $46M

NCCIH = $163K NIAMS NIDDK NCI = $61M NIMH NIAID NEI = $1M

NHGRI = $1M NIAAA NINDS NHLBI = $11M NINR OD NIA = $53M

NIA CC NIAAA = $15M

NIAID = $37M

NHLBI NIAMS = $31M FIC NHGRI NIDDK = $31M NEI NCCIH NIMH = $5M NCI NINDS = $32M

NINR = $771K

OD = $5M National Cancer Institute Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Raised Available Project (as of (as of This December 31, November Quarter? 2015) 30, 2015)

Biomarkers Consortium - Biomarkers A lack of standardized assays for quantifying the vast majority of The Biomarkers Consortium Executive Committee Fundraising Fundraising 1-Apr-15 Creating a Community Assay Consortium - CAR human proteins contributes to the irreproducibility of preclinical approved this project. FNIH Development Officers efforts are efforts are Resource for Standardizing research. The goal of the project is to create a standardized are currently fundraising. Webinars were held on July underway. underway. and Harmonizing Multiplex protein assay resource for the international biomedical 15 and 22 to provide an opportunity for the PI to Proteomic Measurements community that will serve as a resource for validated targeted present the project plan to prospective partners and Mass Spectrometry (MS)-based, Multiple Reaction Monitoring answer any questions they had. Follow-up is in (MRM) assays, reagents and SOPs for pharmaceutical target and progress. biomarker validation and to foster commercial uptake of assay kits/reagents and implementation by CROs and core facilities.

Biomarkers Consortium - Biomarkers The research assesses the use of Fluorodeoxyglucose-Positron Projects were launched in Q2 2007 and are undergoing $6,451,250 $873,068 1-Mar-06 Fluorodeoxyglucose-Positron Consortium - Emission Tomography (FDG-PET) as a companion biomarker data analysis. The project team meets on a bi-monthly Emission Tomography (FDG- FDG-PET Lung study in two separate NCI Cooperative Group clinical trials basis to monitor project progress. The two project PET) Lung and Lymphoma and Lymphoma conducted in non-Hodgkin's lymphoma (CALGB 50303) and teams joined forces with the Radiological Society of (Cancer) non-small cell (ACRIN 6678). The overall goal of the North America (RSNA)-sponsored Quantitative FDG-PET Lung and Lymphoma Projects is to determine the Imaging Biomarker Alliance (QIBA) to compile linkage of FDG-PET to the effect of conventional cytotoxic prospective clinical response data being obtained across drugs in clinical outcome and survival in these two tumor types. multiple sites and multiple scanner platforms and is The team is working with FNIH to combine the early results of engaged in the Drug Development Tool qualification these two trials with additional data from industry trials to process with the FDA Biomarker Qualification Review support biomarker qualification with the FDA in collaboration Team (BQRT). This collaborative discussion and with the Radiological Society of North America (RSNA)- information exchange with FDA will identify next steps sponsored Quantitative Imaging Biomarker Alliance (QIBA). before submission of full data packages, including the identification of what data need to be collected. The 3- year outcomes data will be ready in 2015.

Biomarkers Consortium - Biomarkers Colorectal cancer (CRC) is the second leading cause of cancer This project was approved by the FNIH Biomarkers $2,000,000 $591,464 31-Dec-14 High Definition Single Cell Consortium - HD- deaths in western countries. The five-year survival rate in early- Consortium Executive Committee on February 26, Analysis of Blood and Tissue SCA in CRC stage CRC patients falls from 90% to 60% with lymph node 2015. To date, FNIH has completed letters of Biopsies in Patients with involvement and to 10% with metastases. Early detection and agreement with four funders. To accelerate launching Colorectal Cancer undergoing treatment of mCRC would benefit from an easily obtainable the project, the PI will present a reduced scope of work Hepatic Metastasectomy (HD- biomarker signature (bio-signature) to characterize patient within a reduced budget (i.e. the amount raised to-date) SCA in CRC) subpopulations. The core hypothesis for this project is that a to the project team for consideration. In the meantime, liquid biopsy can serve as a source of rare circulating cells (CTCs) FNIH Development Officers will work with other to represent or complement the traditional solid biopsy. The prospective partners to fully fund the project plan as project is an observational clinical study in two stages, with a approved. possible third stage, to sample CTCs and solid tissue from patients with metastatic colorectal cancer (mCRC) undergoing liver resection. Cell-free DNA will also be collected as part of the liquid biopsies for later analysis if warranted.

Biomarkers Consortium - Biomarkers Leukemia is a life-threatening but treatable type of cancer of the The goal of this 3 year project is to establish minimal $2,172,500 $422,253 1-Nov-14 Minimal Residual Disease Consortium - blood or bone marrow in which numbers of immature white residual diseases (MRD) as an indicator of clinical Detection in Adult Acute MRD Project blood cells increase abnormally. In 2013 there were over 48,000 outcomes in adult acute lymphoblastic leukemia (ALL) Lymphoblastic Leukemia new cases and 23,000 deaths in the ; there are clinical trials as it is in pediatric trials. A meta-analysis multiple types of leukemia in children and adults. Minimal of study data from existing trials being conducted with residual disease (MRD) is the number of leukemic cells detected the aim of predicting event-free survival (EFS) in by molecular or cellular means in blood or bone marrow when pediatric and adult ALL, the evaluation of which could the patient is in a clinical and pathological state of remission after establish MRD as a surrogate endpoint for adult ALL. treatment. MRD has been investigated extensively in pediatric Additionally, an objective of the project is to establish a acute lymphoblastic leukemia (ALL), and its detection is standardization of laboratory MRD analyses. In associated with subsequent relapse, event-free or relapse-free addition, the standardization project team is working survival (EFS or RFS, respectively). Indeed, national pediatric collaboratively on harmonizing methods and has studies now perform risk stratification based on MRD level after completed three rounds of data analyses. induction therapy. Data concerning the association of MRD and outcome in adult ALL have not been as well investigated, and MRD does not yet have the same application in the disease.

Updated as of December 31, 2015 NCI 1 Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Raised Available Project (as of (as of This December 31, November Quarter? 2015) 30, 2015)

Biomarkers Consortium - Biomarkers The inefficiency of drug development in oncology is widely The pilot phase has launched and data from a $250,000 $167,890 1-Jul-14 Volumetric CT, Improving Consortium - Vol- acknowledged with many drugs failing late in development after completed phase III trial with >1,000 patients in Metrics for Phase II Analysis PACT Pilot Study investment of millions of dollars and thousands of patients. A colorectal cancer has been analyzed by the investigators; of Clinical Trials results review of 253 phase 3 trials of drugs for treatment of solid preliminary results are promising. FNIH is working tumors published between 2005 and 2009 showed that 158 with the project team and multiple companies to (62.5%) were negative. The large proportion of negative phase 3 facilitate additional trial data transfers and execute trials suggests failure of phase 2 trial analysis in oncology as one associated agreements. These data will be analyzed as cause, potentially stemming from inadequate endpoints for part of Phase 2 of the project. Budgets and fundraising assessing the activity of new agents and their potential for phase materials for phase 2 are being developed. Data from 3 success. There is a need to develop response metrics to better the pilot phase of the project will be used for Phase 2 predict phase 3 outcomes. Quantitative analysis of solid tumor fundraising purposes. oncology from non-small cell lung cancer, colorectal cancer, renal cell cancer, and melanoma, will be studied from phase III trials. This project aims to improve the efficiency and accuracy of phase II trial analysis through volumetric CT measurement.

Bradley Charitable Gift PG - Annuity - The Bradley family has made a $250,000 charitable gift annuity to The donors continue to be happy with the gift annuity $250,000 $51,057 1-May-12 Annuity Bradley the FNIH in support of Dr. Staudt's lab or his successors to arrangement, which will support Dr. Staudt's lab upon support lymphoma and leukemia research at the NCI. In the donors' death. The donors also receive periodic accordance with the gift annuity rates set forth by the American communications from the FNIH. The total funds Council on Gift Annuities (used by most charities in their available reflects the current remainder value of the issuance of gift annuities), the FNIH is obligated to pay the charitable gift annuity under general accounting family 4.6% annually, or $11,500, every year until the survivor of practices. them dies, at which time the remaining amount reverts to the FNIH to fund the project. The FNIH will then retain 5% of the remaining amount of the annuity and transfer 95% of the remaining amount to Dr. Staudt's lab or his successors.

Burkitt Lymphoma Genome Burkitt Lymphoma A non-Hodgkin lymphoma, Burkitt Lymphoma is a rare but FNIH transferred $200,000 to NCI in 2013, for a total $1,119,076 $80 1-Sep-10 Sequencing Project (BLGSP) aggressive cancer. The endemic form primarily affects children of $805,000 transferred since the project's inception. A (Africa), while the sporadic form affects children and adults (U.S. balance of $213,042 was transferred to NCI in Dec. and Europe). The FNIH coordinates a partnership between the 2014. Following the Dec. SAB meeting in San Foundation for Burkitt Lymphoma Research (FFBLR) and the Francisco the Foundation for Burkett Lymphoma National Cancer Institute to search for genetic clues to the Research was notified in a letter sent from Maria Freire disease that might lead to treatment and/or prevention. Key on 4/27/15 that FNIH will no longer be able to strategies are to: 1) identify and collect tissue samples and data fundraise for the program until the FFBLR established from Burkitt patients; 2) employ high throughput technology to a web presence, testimonial video, and strong business sequence patients' genes; 3) analyze and publish the data for other case to support these efforts. Importantly, it was also researchers to use. noted that scientific advances in the field would be paramount to formulating a strong case for support. While recognizing these take time to achieve, without them it is difficult to catalyze interest from potential donors. The FFBLR responded with a letter on 6/13/15 from Dr. Jean Paul Martin acknowledging receipt of the letter and looking forward to FNIH/FFBLR having the opportunity to reconsider the decision once the required elements were in place.

Cancer Research Fund Cancer Research As a part of its outreach efforts to individuals who may be As of November 30, 2015, FNIH has $109,057 available $145,211 $109,057 1-Feb-00 Fund interested in supporting NIH and, more specifically, the work of for the Fund. NCI, this fund was established to hold contributions received to support cancer research. Contributions may be designated simply for "cancer research" or, if desired by the donor, for more targeted initiatives underway at NIH. The Foundation will work with NCI to determine how this growing pool of general funds might best be applied whether through fellowships, as project seed funding, or through another mechanism.

Coding for Cancer Prize: Low Dose Coding for Cancer is an innovative public prize competition to Through its contract with Leidos, NCI has released a $2,430,000 $109,392 1-Sep-11 Helical CT develop better algorithms for detection and diagnosis of lung call for proposals from vendors to manage the logisitics cancer. The competition will use images and data drawn from the of the prize competition (Due December 18, 2015). National Lung Screening Trial (NLST), a major national study of FNIH is working with NCI staff to develop a computed tomography (CT) scanning in lung cancer patients communications strategy to announce the competitions, recently conducted in the U.S. by the NCI. It would be managed once opened; and, to announce the prize winners. In by FNIH in collaboration with NCI and the White House Office addition, FNIH continues to support NCI's effort as of Science and Technology Policy (OSTP). The initial design was the liaison with the donor. based on input gathered at a two-day workshop organized at the request of NCI and attended by invited experts and key opinion leaders in the field from government, academic institutions, and industry. The design was revised in early 2014 to include two challenges running simultaneously and planned to take 12 months from the official prize launch. The NCI lead on the project is Dr. Paula Jacobs.

Updated as of December 31, 2015 NCI 2 Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Raised Available Project (as of (as of This December 31, November Quarter? 2015) 30, 2015)

Gramlich Melanoma Research Gramlich The Gramlich Melanoma Research Fund supports melanoma Until 2012, legal constraints unrelated to FNIH $125,512 $92,855 1-Jun-08 Fund Foundation - research at NIH through an annual gift provided by the estate of prevented disbursement of these funds. FNIH's Melanoma Jack Gramlich. Advancement Officer will continue discussions with Research NCI regarding the best possible use of the funds in support of melanoma research. Under the terms set by the donor, FNIH is receiving the funds in increments over a significant period of years, with the most recent contribution in December 2014. A small amount of the total has been received thus far.

Jerry D. Jennings Memorial Jerry D. Jennings The fund honors Catherine Jennings Davis's father who passed FNIH has been in contact with the donors regarding $3,980 $3,940 1-Sep-06 Fund Memorial Fund away from renal cell cancer in July 2006. The Jennings Family uses for the fund. The donors have expressed interest funds go to support renal cell cancer research at NIH. in supporting the purchase of a device to help in renal cancer research needed by the laboratory of Richard Childs of the NHLBI. FNIH met with Dr. Childs to discuss the donors' interest and to identify additional areas of renal cell cancer research that could be supported through these funds.

Kidney Cancer Research in Kidney Cancer The FNIH received the gift in response to a proposal $213,125 $794 1-Nov-13 the Laboratory of W. Marston Research in the submitted to the Newport Foundation in October 2013 Linehan, M.D. Laboratory of W. to support kidney cancer research in Dr. Linehan's lab. Marston Linehan, The FNIH notified Dr. Linehan of the gift and an M.D. MOU between FNIH and NCI was signed. FNIH transferred the sum of $189,000 to NCI in April 2014. FNIH will be receiving updates periodically from Dr. Linehan periodically to update the donors on the lab's progress.

The Lowy Cancer Research The Lowy Cancer Funds are for the discretionary purpose of Dr. Douglas Lowy, The FNIH received a contribution in the amount of $20,000 $20,000 1-May-15 Support Fund Research Support Acting Director of NCI to provide support to cancer program $20,000 on August 10, 2015 as honorarium Dr. Lowy Fund activities. These activities could include events, meetings, etc. designated to this fund from University Hospitals which might include refreshments, travel or other support. Health System.

Lymphoma Research in the Lymphoma FNIH received contributions from Steve and Chris Wilsey to The FNIH received the first installment of $20,000 in LOA pending LOA 1-Dec-14 Laboratory of Louis M. Research in the support lymphoma research in the lab of Louis M. Staudt, M.D., October. Mr. Feinberg was sent the LOA for this pending Staudt, M.D., Ph.D. Laboratory of Ph.D. at the NCI Molecular Biology of Lymphoid Malignancies project on December 3, 2015. LOA signature is Louis M. Staudt, Section of the Center for Cancer Research. pending. Also pending is notification to Dr. Wilson M.D., Ph.D. that there are funds available for his follicular lymphoma research project.

Master Protocol for Treatment LungMAP Lung-MAP is a groundbreaking clinical trial model that uses a The Lung-MAP trial was activated on June 16, 2014. A $44,432,443 $123,139 1-Jun-14 of Advanced Squamous Cell multi-drug, targeted screening approach to match patients with major revision # 3 to the Lung-MAP protocol was Lung Cancer (Implementation sub-studies testing investigational new treatments based on their made and implemented on December 18, 2015 Phase) unique tumor profiles. Lung-MAP (SWOG S1400) is a multi- (Revision # 3 release), after the FDA approval of drug, multi-sub-study, biomarker-driven squamous cell lung Opdivo® from BMS. As of January 1, 2016 there are cancer clinical trial that uses cutting-edge genomic profiling to about 347 sites that are approved for patient accruals match patients to studies testing investigational new treatments after the release (Dec 18, 2015) of Rev # 3 and 512 that may target the genomic alterations, or mutations, found to be patients enrolled in the master protocol. FNIH is driving the growth of their cancer. Instead of having to undergo supporting and managing fortnightly meetings of the multiple diagnostic tests to determine eligibility for many trial leadership team, as well as quarterly meetings of the different studies, enrollees are tested just once according to a multi-sector Trial Oversight Committee to ensure "master protocol" and assigned to a study on the basis of this accrual and performance success. FNIH is also single screen. managing the Drug Selection Committee that keeps the pipeline of new drugs & combinations growing and provides 6-months accrual status updates to company funders of their respective sub-studies.

NCI Neuro Oncology Branch NOB Fund The Neuro-Oncology Branch (NOB) is a trans-institutional The FNIH transferred $16,810.68 to NCI on August 20, $30,055 $8,652 1-Mar-11 Fund initiative in neuro-oncology sponsored by both NCI and NINDS 2015. This is the remaining fund balance representing that launched in 2000. NOB's mission is to develop novel donations from private donors, grateful patients and diagnostic and therapeutic agents for patients with primary their families to support the work of the Neuro central nervous system tumors. They are building a biology- Oncology Branch (NOB) at NCI under the direction of driven, individualized, patient-centric, rational therapeutics the Chief, Dr. Mark Gilbert. Tribute gifts made in program. The NOB receives donations from patients, their memory of Dr. Arthur Schatzkin were not transferred families and friends, and others to support their research and as these donations were requested to be used as would like to establish a fund at FNIH to hold such donations. honoraria for speakers at an ongoing lecture at NCI in memory of Dr. Schatzkin per his wife, Dr.Tamara Harris. The FNIH transferred the $500 lecture honorarium to Dr. Anne McTiernan at Fred Hutchinson Cancer Research Center for the May 2015 lecture at NCI.

Updated as of December 31, 2015 NCI 3 Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Raised Available Project (as of (as of This December 31, November Quarter? 2015) 30, 2015)

Stephen J. Solarz Memorial Solarz Memorial The Solarz Fund supports research in the laboratory of Dr. David Mrs. Solarz also recently introduced the FNIH to Romit $614,029 $478,285 1-Nov-10 Fund Fund Schrump at the National Cancer Institute. The Solarz Fund has Bhattacharya who wrote a grateful patient/testimonial raised over $304,000 since it was established in 2010. Funds have to Dr. Freire that was used as a special year-end supported costs associated with Dr. Schrump's research using fundraising appeal to donors of the FNIH general molecular biological techniques to manipulate DNA in cells taken populous about his experience with the NIH. A follow- from a patient's tumor to produce molecules that will stimulate up email blast will complement this direct mail piece on the patient's immune system to kill cancer cells. Funds to also be 12/22/15. The Taiwanese based company: Fubon used in support of International funding opportunities of post- Financial Holding Venture Capital Corporation made a doctorate scientists/researchers in the field of cancer. wire transfer of $300,000 to the FNIH on 11/30/2015 in support of an internal fellow to join Dr. David Schrump's lab. The Taiwanese candidate is Dr. Shih- Hsin Hsiao from Taipei Medical University Hospital, Taipei City, Taiwan. He is a medical oncologist with interests in tumor heterogeneity, chemoresistance and cancer stem cells. His research project will involve characterization of the mechanisms by which cigarette smoke enhances growth and metastasis of lung cancer cells.

Education & Seminars

Project Name Display Name Description Latest News Money Total Funds Launch Date New Raised Available Project (as of (as of This December 31, November Quarter? 2015) 30, 2015)

Adam Berry Memorial Fund Adam J. Berry The Adam J. Berry Memorial Fund was established by Michael FNIH has contacted the Australian Academy of Science $17,532 $5,442 1-Jan-03 Memorial Fund and Sue Berry in memory of their beloved son, Adam. Adam to ask them to update organization information on their came from Australia to work as a research scientist at the NIH's website: https://www.science.org.au/adam-j-berry- National Cancer Institute. The fund commemorates his life and memorial-fund. his enthusiasm for work by making it possible for promising young Australian scientists to travel to the United States and work at NIH.

Anita Roberts Memorial Fund Anita Roberts Dr. Roberts was one of the first woman laboratory chiefs at NIH Bob Roberts has increased his support to $10,000 this $50,055 $28,005 1-Jun-06 Memorial Fund and ranked in the top 50 most-cited biological scientists in the year. FNIH will be contacting the AO to find out how world. She was widely recognized as an outstanding mentor, many students and conferences we will be doing. encouraging and inspiring young scientists. In recognition of her commitment to mentoring, Dr. Roberts' family and lab colleagues established scholarships to allow graduate students and post- doctoral fellows to present their work at a national meeting. Two travel scholarships are awarded to the TGF-beta Keystone Symposium held every other year. These scholarships are a fitting tribute to Dr. Roberts' passion for encouraging the career development of young scientists.

Sallie Rosen Kaplan Fund for Kaplan Fellowship The Kaplan Fund provides annual support for the Sallie Rosen Applications have been submitted for new fellows this $788,079 Project funds 1-Jan-99 Women Scientists in Cancer Kaplan Fellowships for Women Scientists in Cancer Research. past fall and the women selected will begin their are complete. Research These post-doctoral fellowship awards are given annually to one program in December/January through early fall of or more outstanding woman scientist at the National Cancer 2016. The FNIH received an update on the progress of Institute. the program from NCI in October and it was shared with Dr. Rosen who was quite pleased with the new initiatives as a result of the additional donation this year. Dr. Rosen indicated he may be visiting NIH on February 12, 2016 for a conference and would like to meet with the Fellows at that time. FNIH to work with NCI to coordinate this stewardship opportunity.

Updated as of December 31, 2015 NCI 4 National Eye Institute

Research Projects Project Name Display Name Description Latest News Money Total Funds Launch New Project Raised Available Date This (as of (as of Quarter? December 31, November 2015) 30, 2015)

Age-Related AREDS2 ancillary Age-related (AMD) and age- For the genetic study, funds raised by FNIH enabled $990,005 $381,764 1-Apr-10 Study 2 (AREDS2) related are leading causes of blindness in the NEI to collect DNA on 2,025 participants in AREDS2. Ancillary Study U.S. The Age-Related Eye Disease Study 2 These samples have been submitted for Exome Chip (AREDS2), begun in 2007, is a randomized controlled analyses with the AMD GWAS Consortium. NEI is clinical trial of 4,000 subjects who are at intermediate considering further analyses in these samples to examine risk of AMD or have advanced AMD in one eye. It the genetic association with progression to advanced will provide important information both for the AMD. FNIH transferred $69,412 to NEI in April 2014. natural history and the randomized controlled trial of An additional $381,740 is available for transfer to NEI; oral supplements with omega-3 polyunsaturated fatty in December 2015, FNIH asked for a status update on acids and / for prevention of the the genetic repository and again asked to be alerted if a development of advanced AMD. Funds raised by transfer was needed. Research is ongoing. FNIH support development of a genetic repository.

Education & Seminars Project Name Display Name Description Latest News Money Total Funds Launch New Project Raised Available Date This (as of (as of Quarter? December 31, November 2015) 30, 2015)

Dr. Jane M. Sayer Vision Sayer Vision The Sayer Vision Research Fund supports the annual The ninth Sayer Vision Research Lecture will not be $286,023 $220,140 1-Jan-01 Research Lecture & Award Research Lecture & Sayer Lecture delivered by an investigator in the area held in 2015, but rather in 2016 likely in the last two Award of vision research. The fund also supports the Sayer weeks of May. FNIH has been in contact with Dr. Vision Research Award, a grant-in-aid to support the Schneeweis regarding the potential speaker and date for research of a promising independent investigator in the event and he is very close to finalizing details. The the early stage of his or her research career in the donor will host a dinner the night of the lecture once the Division of Intramural Research at the National Eye date is determined. Institute.

Updated as of December 31, 2015 NEI 1 National Heart, Lung and Blood Institute

Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of Available This December 31, (as of Quarter? 2015) November 30, 2015)

Biomarkers Biomarkers The atherosclerosis project is a two-stage Evidera, a lead modeling company providing $1,923,000 $1,053,067 1-Jul-12 Consortium - Consortium - project. The first stage, currently in execution, services in support of this project, began Atherosclerosis Atherosclerosis will utilize published data for refining an existing working in the project in early 2015. Evidera was Computer Modeling Computer in silico model of atherosclerosis. The model selected following inability of the previous (Metabolic Disorders) Modeling platform will be provided by a leading company vendor, Entelos, to deliver on its milestones due in the field, Entelos, which was selected through to bankruptcy. With the support of David a thorough FNIH-managed review process. The Fryburg, consultant to FNIH, the model, created by the Biomarkers Consortium Atherosclerosis Core Team was formed to work project team in Stage 1, will identify the best, with Evidera through the early phases of model time-dependent group of biomarkers that development. The Core Team has completed the predict change in clinical outcomes in initial stages of biomarker selection, and is atherosclerosis due to statins and residual risk moving through the methodology and modeling after statin treatment. This model will guide the process. In parallel, the team is working on requests for subject level data in Stage 2 of the obtaining quick access to individual level data project. Successful development of a publicly- through several avenues (e.g., dbGAP, accessible atherosclerosis model may enable BioLINCC, Pfizer) to optimize the first pass similar efforts in other disease areas in the model, as adequate summary level data is not future. available publicly. The core team plans to present the progress on the first pass model to the Atherosclerosis Project Team in January 2016 to inform next steps.

Biomarkers Biomarkers The main goals of the Cardiac Troponin Fundraising for the project was completed in $962,500 $455,593 1-May-13 Consortium - Novel Consortium - Biomarker Project are: 1) to define the reference October 2015. The project kick-off was on Cardiac Biomarkers in Cardiac Troponin ranges for novel cardiac biomarkers (BM) in a December 16, 2015. the General US Biomarkers young healthy subgroup of adults and to Population describe the normal BM variation; 2) to characterize the cross-sectional associations of these novel BMs with other novel diabetes, kidney disease and cardiovascular disease risk BMs and 3) to characterize their associations with total mortality while comparing them head to head in their effectiveness for mortality risk prediction. The project will conduct a comprehensive national study, utilizing existing stored blood and urine specimens and data from NHANES, providing key reference data and informing recommendations and clinical guidelines regarding the use of these BMs.

Advancing New Biomarkers Current therapies for COPD are only The project is led by Drs. Bruce McManus and Fundraising Fundraising 1-Apr-13 COPD Therapies Consortium - moderately effective and there is a paucity of Don Sim from the PROOF Centre of efforts are efforts are Through Biomarkers: Biomarkers of biomarkers available to track progression or Excellence and the Univeristy of British underway underway Biomarkers of Lung Lung Function treatment response to therapeutics beyond Columbia. A comprehensive fundraising deck Function Decline Decline in COPD poorly correlative spirometry (forced expiratory and ask letter is has been sent to potential volume in one second; FEV1). This project is funders and fundraising is ongoing. The project designed to discover and replicate biomarkers leaders have participated in multiple calls with that predict accelerated lung function decline in funders and there are five companies who are COPD patients through a minimally invasive strongly interested. We are in final contract talks blood test (bio-signature) that utilizes the with one company, a few others will make existing ECLIPSE and CanCOLD cohorts (600 decisions in early 2016. One company has samples each) to evaluate genomic and offered in-kind additional studies to augment the proteomic biomarkers using Affymetrix project plan and this is under review by the microarrays and MRM-MS platform. The project leaders and team. We will make a final project will mine data and compare bio decision to launch this project in early Q1 2016. signatures and networks and pathways underlying lung function decline and acute exacerbation risk (AECOPD), assess recovered lung function, recovery from AECOPD, and COPD versus normal bio signatures.

Dean R O'Neill Renal O'Neill Memorial This memorial is in honor of Mr. Dean O'Neill, NHLBI informed FNIH that Susan Doh is the $468,899 $176,005 1-Dec-03 Cell Cancer Research Fellowship who, before he passed away, was treated for next Rancic-O'Neill Fellow in Dr. Childs' Fund renal cancer by Richard Childs at NHLBI. laboratory and started in August 2015. Support FNIH is working with the O'Neill family to for the fellowship was transferred by the FNIH raise additional funds to support a post doctoral to NHLBI on July 28, 2015 from the Rancic fellow to work in Dr. Childs' lab, focusing on fund. FNIH staff met with the O'Neill Family renal cell cancer research. The goal of this on June 30, 2015 to discuss the fund balance and program is to provide critical person-power to next Boo! Run for Life event, and again with accelerate the search for new breakthroughs in Brian O'Neill on July 27, 2015 for a the treatment of kidney cancer. With significant demonstration of the new fundraising platform contributions from individual donors and the for the event. The 10th Annual Boo! Run for BOO! Run For Life 10K, these funds sponsor a Life was held on October 4, 2105 at West dedicated fellowship program to support the Potomac Park in Washington, D.C. The FNIH exploration of new and existing treatments, such continues to promote the event in support of the as allogeneic transplantation, O'Neill fund to its constituents via e- chemotherapy, radiation therapy, communications and on the website. immunotherapy, vaccine therapy, and drug treatments.

Updated as of December 31, 2015 NHLBI 1 Research Projects

Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of Available This December 31, (as of Quarter? 2015) November 30, 2015)

Dr. Edward T Rancic Rancic Memorial The Dr. Edward T. Rancic Memorial Fund NHLBI informed FNIH that Susan Doh is the $124,475 $68,688 1-Jul-04 Memorial Fund for Fellowship for supports a post-doctoral fellowship in Dr. next Rancic-O'Neill Fellow in Dr. Childs' Cancer Research Cancer Research Richard Childs' lab in NHLBI that focuses on laboratory who started in August 2015. Support renal cell cancer research. The fellowship was for the fellowship was transferred by the FNIH established by the family in memory of Dr. to NHLBI on July 28, 2015 from the Rancic Edward Rancic. fund.

Heart Truth Heart Truth NHLBI launched The Heart Truth media For 2015 grants, NHLBI and FNIH agreed to a $2,188,918 $48,545 1-Jan-08 Community Action Community campaign in September 2002. The campaign is new program structure. Rather than disburse Program Grants Action Program aimed especially at women aged 40-60 with the funds directly to organizations working at the Grants goal of giving women a personal and urgent community level, FNIH awarded grants to wake-up call about their risk of heart disease. organizations with the capacity to (1) promote One of the campaign's strategies is to partner The Heart Truth message to a geographically with community-based groups committed to broad audience, (2) guide and fund multiple spreading the Heart Truth messages to women -- community partner organizations to implement especially those of color, low income, and/or in activities to motivate women, particularly rural areas -- and encouraging behavioral women at high risk, to take personal action to change leading to lower heart disease risk. lower or control their risk for heart disease and FNIH has received donations from Diet Coke, (3) provide meaningful evaluation of program Swarovski, Belk Department Stores, and a results. FNIH will announce its four grantees in number of cause-based supporters such as January 2016. NHLBI itself awarded Heart Stitch Red (which donates a percentage of yarn Truth grants to two additional organizations. sale profits) that fund the Community Action FNIH's MOU with NHLBI for management of Program grants. The grant program is this program expired on August 1, 2015. NHLBI administered by FNIH, which, since 2008, has will provide programmatic support to the 2015 awarded 33 grants with a total value of grantees and FNIH will require final financial $1,084,480. reports to ensure that all funds were expended as approved.

SubPopulations and SPIROMICS The goals of the study are 1) to divide the Phase II for SPIROMICS is set to conclude for $5,262,136 As of 1-Feb-08 InteRmediate heterogeneous population of Chronic July 31. The FNIH extension will begin August November 30, Outcomes Measures Obstructive Pulmonary Disorder (COPD) 1. As follow up to an in-person ESB meeting 2015, there are in COPD Study patients into meaningful subpopulations, and 2) held Sept. 17 and attended by 35 people, no funds (SPIROMICS) to identify intermediate outcome measures that comprised of investigators and ESB members, available. will allow increased efficiency in clinical trails of FNIH circulated a meeting summary and the COPD. NHLBI hopes to expand the study with slide presentations. The SPIROMICS private sector funding. Their needs include 1) Investigators are seeking private support of a cash; 2) industry expertise to make the study "bridge phase" of the study, that will help valuable with FDA down the line; and, 3) in- achieve scientific results needed in order to apply kind assistance (industry could perform/analyze for a second round of NIH funding. FNIH is high throughput assays). not involved in the bridge portion of the project, with the exception of convening teleconference meetings at the request of the ESB chair. Results from SPIROMICS will be published early in 2016 in a high-profile medical journal. SPIROMICS SPIROMICS The objectives of the substudy are to obtain The Exacerbation Sub-study has begun enrolling $980,250 As of 1-Feb-13 Exacerbation Sub- Exacerbation Sub- clinical data and specimens on SPIROMICS participants and distributing the PDAs for the November 30, Study Study participants before, during, and after an acute study. As of November 30, 2015, there were 2015, there are COPD exacerbation defined by health care 199 patients enrolled in the study. There are 100 no funds utilization and the Exacerbations of Chronic frequent exacerbators and 99 infrequent available. Pulmonary Disease Tool - Patient Reported exacerbators, representing 50% and 99% of Outcome (EXACT-PRO); and, to characterize enrollment goals respectively. Key areas of the non-exacerbation "stable" state in COPD focus moving forward will be systematically using EXACT. investigating exacerbation events for the entire cohort, addressing numerous issues underlying the exacerbation sub-study, and linking to other ongoing work (immunophenotyping, microbiome, etc.).

Updated as of December 31, 2015 NHLBI 2 National Human Genome Research Institute

Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Genome Research Fund Genome As a part of its outreach efforts to individuals who may be As of November 30, 2015, $2,450.85 is available for $2,735 $2,450 1-Oct-11 Research Fund interested in supporting NIH and, more specifically, the transfer to NHGRI. work of NHGRI, this Fund was established in January 2013 to hold contributions received to support genetics/genomics research. Contributions may be designated simply for "genetics or genomics research" or, if desired by the donor, for more targeted initiatives underway at NIH. The Foundation will work with NHGRI to determine how this growing pool of general funds might best be applied whether through fellowships, as project seed funding, or through another mechanism.

The NIH Undiagnosed UDP The UDP diagnoses patients who have long been unable to FNIH continues to include this fund among the $3,915 $2,405 1-Sep-11 Diseases Program find any diagnosis, to discover new disorders that will programs it discusses with potential donors who may provide insight into biochemical and cell biological find it to be of interest. pathways, and to bring genomics to modern medicine, especially in the area of rare diseases. It fosters . The FNIH would serve as a conduit for donations of funds and services; i.e., in-kind such as software packages and expertise.

Education & Seminars Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Physician Education Physician The goal of the Project is to extend the capacity of the FNIH received a commitment from Blue Cross/Blue $25,000 Project funds are 1-Sep-14 Program Education NHGRI-led Inter Society Coordinating Committee for Shield to support the ISCC, and transferred the full completed. Program Practitioner Education in Genomics (ISCC), including amount available ($23,750) to NHGRI in April 2015. strengthened administrative and project management for Expanding on this first phase of the ISCC, NHGRI ISCC resource development and maintenance, including submitted a new Request for Collaboration asking development and implementation of work plans to maintain FNIH to raise $1.2-$3M to supoprt the ISCC for three educational or resource materials' currency and quality; years and enable it to become the national leader in improvement of online resources; and outreach to keep the provider education in genomics. FNIH completed its ISCC informed about other educational resources, models feasibility scan on the project and provided its report for delivering or implementing educational opportunities to to NHGRI in August 2015. The project is now closed. practitioners.

Events Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Human Genome Human In June 2013, the National Human Genome Research FNIH and the Natural History Museum raised a total $1,155,000 $220,418 1-Oct-11 Exhibition Genome Institute (NHGRI) and the National Institutes of Health of ~$4.2M for the exhibition initiative. The four-year Exhibition (NIH), in partnership with the Smithsonian Institution, traveling exhibit is at the Oregon Museum of Science celebrated the 10th anniversary of the sequencing of the and Industry in Portland, OR from October 2, 2015- human genome and the 60th anniversary of the Watson- January 3, 2016 and will then proceed to the Discovery Crick discovery of DNA's structure with a major exhibition World in Milwaukee, WI. FNIH is supporting initiative, Genome: Unlocking Life's Code, at the National education/public programming for the traveling Museum of Natural History. Through high-tech, hands-on portion of the exhibit (FY15-18). PacBio gave $25k in interactive activities and educational programming, Genome 2015 fort The Tech exhibit in San Jose ($10k) and the celebrates the advances related to the sequencing of the genome website ($15k). Approximately 60 prospects human genome, and helps make genomics accessible, from family, corporate foundations and industry were understandable, and exciting to the general public. More identified and outreach is underway to these leads. The than just an exhibition within the walls of the Museum, the Advancement team has developed postcards for each project includes a large-scale, multi-platform educational exhibit venue so FNIH contacts are aware of the event. effort that is communicating how genomic science, and the Additionally, select attendees have been invited to era of personalized medicine is playing, and will continue to opening events - most recently in St. Louis. Plans are play, a critical role in our everyday lives and health care. underway to share additional attendance opportunities with interested FNIH supporters at upcoming exhibits.

Updated as of December 31, 2015 NHGRI 1 National Institute on Aging

Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Project Raised Available This (as of (as of Quarter? December 31, November 2015) 30, 2015)

Accelerating Medicines AMP-AD In early 2014 a final research plan for Alzheimer's disease AMP-AD investigators met at the Fall F2F meeting on November $23,180,000 $3,632,643 1-Oct-12 Partnership - Alzheimer's (AD) was completed through the AMP-AD Steering 18-19, 2015. Patient recruitment and imaging is on schedule, with Disease Committees, including representatives from AbbVie, Sanofi, 72 and 46 tau scans completed for the A4, and DIAN trials, Biogen Idec, GlaxoSmithKline, and Lilly as well as members respectively. Baseline data from Project A trials will be made from government and advocacy sectors. The AMP-AD available through the Alzheimer Association’s GAAIN effort comprises two projects: Project A will supplement platform. Start-up studies for the APOE4 trial continue, with the biomarker panels already included in three NIH-funded recruitment expected to begin in early 2016; however, tau scans Phase II/III registration trials in presymptomatic AD for this trial will not be initiated until there is clarity regarding through the addition of tau PET imaging and novel fluid funding of the scans. PaxGene tube blood collection has been biomarkers. Project B will apply integrated network placed on hold indefinitely, due to insufficient funding. Sage analysis (both RNA and proteomic studies) in human AD Bionetworks continues to coordinate data sharing, integration and brain samples to identify biologic nodes and networks linked collaborative activities within the Target Discovery and Preclinical to the development or progression of AD and create Validation project. The 4th data release to SYNAPSE, including standardized open-source data structures and formats for the first industry data contribution (RNAseq data from a easy analysis of biological data. microglial cell model), occurred on December 4th, 2015. Finally, there are a number of active and planned working groups. Alzheimer's Disease ADNI 2 ADNI 2 is the extension of the ADNI study for an Program activities continue, which include monthly ADNI Private $20,115,067 $879,567 1-Sep-08 Neuroimaging Initiative 2 additional six years (2010-2016). The ADNI project is testing Partner Scientific Board (PPSB) teleconferences, as well as whether serial MRI, PET, other biological markers (in blood, teleconferences with the Clinical Endpoints Working Group and urine, and CSF), and clinical and neuropsychological the Biofluid Biomarkers Working Group. As the ADNI 2 study assessment can be combined to measure the progression of moves closer to completion, much of the activity is focused on mild cognitive impairment (MCI) and Alzheimer's disease looking forward to the anticipated extension of ADNI 2 to a third (AD). This longitudinal study is tracking patients with early phase, known as ADNI 3. The ADNI 3 grant was submitted to MCI, late MCI, AD, and normal cognition to produce a the National Institute of Aging on October 26, 2015. Finally, public resource cataloging imaging and biochemical preparations are ongoing for the annual ADNI PPSB Spring face- biomarkers to identify and characterize MCI and AD. to-face meeting, to be held on April 17, 2016, in Vancouver, Canada.

Alzheimer's Disease ADNI 3 ADNI 3 is expected to be a 5-year extension of the ADNI ADNI 3 project goals and plans continue to be discussed on the Fundraising Fundraising 1-Aug-15 Neuroimaging Initiative 3 study. Its expected time-period is August 1, 2016 to July 31, ADNI PPSB monthly teleconferences. The ADNI 3 grant was efforts are efforts are 2021. (Funding amounts given below are estimates to be submitted to the National Institute on Aging on October 26, 2015, underway. underway. firmed up once more is known about the expected and preliminary fundraising for the project has begun. An program.) anticipated decision as to the funding status of the grant is expected in Q2 of 2016. If successfully funded, ADNI 3 is anticipated to begin on September 1, 2016.

Alzheimer's Disease ADNI 2 The Cogstate Brief Battery (CBB) is composed of four As of September 2015, the ADNI Cogstate Computerized $40,000 Project funds 31-Dec-14 Neuroimaging Initiative 2 Cogstate Pilot validated tasks measuring attention, speed of information Cognitive Battery pilot study is underway. Twenty-two ADNI sites are Computerized Cognitive Study processing, working memory, and learning. Change over an are expected to administer the study. Fifteen of these sites are completed. Battery Pilot Study 18 month period on the learning measure distinguished currently certified to administer the Cogstate Brief Battery (CBB) healthy volunteers testing positive for brain amyloid with addendum protocol, and have started the pilot study. Twenty-five PET from those testing negative for amyloid. Given the patients have been enrolled into the study, and have completed potential utility of these findings for detecting and the in-clinic portion of the CBB testing; eleven of those have quantifying the clinical effect of a potential disease modifying completed a remote session. As of October 2015, ADNI 2 PI drug, replication of these findings is an important objective. Michael Weiner indicated that funds from the ADNI Private The ADNI2 Computerized Cognitive Battery pilot study will Partner Scientific Board (PPSB) were no longer required for the examine the feasibility of adding the CBB to the ongoing project, and all supporting partner organizations were notified. ADNI 2 study, and supplementing traditional in-clinic testing Given the lack of necessity for private partner support, FNIH with a home-based computerized cognitive testing management of this project will end at the end of Q4 2015. component, and will collect preliminary data in a large, heterogeneous sample spread over a large geographical area in the United States. If the pilot study is successful, the data gathered would be used in support of the application for the ADNI3 study.

Updated as of December 31, 2015 NIA 1 Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Project Raised Available This (as of (as of Quarter? December 31, November 2015) 30, 2015)

Biomarkers Consortium - Biomarkers The main goal of the Sarcopenia Project is to validate the The project is currently in its fundraising stage and FNIH has Fundraising Fundraising 1-May-13 Outcome Measures for Consortium - predictive ability of the candidate criteria for clinically secured commitments for a third of the project budget. Several efforts are efforts are Sarcopenia Sarcopenia 2 relevant weakness and low lean mass, established by the first additional pharmaceutical companies and nonprofit organizations underway. underway. Sarcopenia project, among individuals with substantial levels are interested in contributing to the project and have already of physical impairment that are likely to qualify and benefit joined the team. Additionally, NIA has funded a grant to the from interventions to improve mobility and to perform Sarcopenia 2 investigators for some similar work, and the project additional analyses on the originally assembled data set. To team is currently working on a way to integrate and create synergy meet this goal, the following questions will be addressed: 1. among the two funding streams to create the most efficient use of What is the prevalence of clinically relevant low muscle funds for a broader, cohesive project. Once funding is secured, the strength (weakness) and low lean mass in mobility-impaired work is planned to start in early 2016. older adults? 2. Do the First Sarcopenia Project criteria need refinement among more vulnerable populations of older adults? 3. Among mobility-impaired older adults, do the FNIH Sarcopenia Project Phase I criteria validly predict clinically important outcomes (e.g., ADLs, IADLs, morbidity)? 4. What is the meaningful change in mobility impairment that correlates with intervention results? Biomarkers Consortium - Biomarkers A project to combine placebo data from large clinical trials To date 40 datasets have been acquired by the Project Team and $423,775 $221,137 1-Feb-10 Placebo Data Analysis Project Consortium - provided by multiple pharmaceutical companies with the sent to the Alzheimer's Disease Collaborative Study, for a total of in Alzheimer's Disease/Mild AD/MCI original goal of creating datasets of 3-5K subjects for over 9000 placebo subjects. Primary analyses are complete and a Cognitive Impairment Clinical Placebo Data Alzheimer's disease (AD) and mild cognitive impairment poster was presented at the 2013 AAIC meeting. Dr. Ron Trials (Neuroscience) Analysis Project (MCI) groups. The long-term goal is to develop better Peterson has prepared a final draft of a manuscript for the MCI measures of disease progression - outcome measures that portion of this project will intent to submit this to Lancet have both low variability and are sensitive to change, for use Neurology in Q1 2015. An ultimatum is being sent this month to in future clinical trials. The FNIH will manage and Dr. Paul Aisen. If he does not publish his manuscript, we will administer this project. PIs are Marilyn Albert, Ron Petersen, publish the data on our site and withhold the last payment. FNIH Paul Aisen, Ronald Thomas, Project Chair: Maria Carrillo. sent a letter to PIs and the manuscript was finally submitted to Neurology. Waiting for team to provide revised version to Lancet Neurology (Q4 2015). The UCSD-USC situation with ADCS- ATRI is having some implications on the review of the data as some of the researchers are involved in this legal battle. Biomarkers Consortium - Use Biomarkers This project is the second part of a multi-phased effort Results from the 1st specific aim (to qualify a multiplex $695,050 $75,319 1-Jul-10 of Targeted Multiplex Consortium - seeking to utilize samples collected by ADNI to qualify immunoassay panel as a tool to diagnose and monitor disease Proteomic Strategies to Identify AD Targeted multiplex panels in both plasma and cerebrospinal fluid progression in the ADNI cohort) were uploaded to the ADNI CSF-Based Biomarkers in CSF-Based (CSF) to diagnose patients with Alzheimer's Disease (AD) LONI website (adni.loni.ucla.edu) in January 2012. The Alzheimer's Disease Proteomics and monitor disease progression. An earlier phase of the manuscript is currently being resubmitted for publication with an (Neuroscience) program focused on analysis of data from ADNI plasma expected publication in Q1 2016. samples run on a multiplex panel. This project leverages CSF -Results from the 2nd specific aim (to examine Beta-site APP samples from the Alzheimer's Disease Neuroimaging Cleaving Enzyme (BACE-1) levels and enzymatic activity in CSF), Initiative (ADNI) approved for use in assessing the utility of were uploaded to the ADNI LONI website in April 2012, and existing AD biomarker panels studies. Specific Aims: 1) To was published in the Journal of Alzheimer’s Disease (Savage et al., qualify a multiplex immunoassay panel as a tool to diagnose 2015). and monitor disease progression in the ADNI cohort, 2) To -Results from the 3rd aim (to qualify a Multiple Reaction examine Beta-Site APP Cleaving Enzyme (BACE-1) levels Monitoring (MRM) Mass Spectrometry panel) were uploaded in to and enzymatic activity in CSF, 3) To qualify a Multiple the ADNI LONI website in March 2014, and the resulting Reaction Monitoring (MRM) Mass Spectrometry panel. manuscript has been published in the Proteomics Clinical Project Chair: William Potter, Ph.D. Applications (Spellman et al., 2015), In particular, completion of this aim allowed for the validation of a targeted proteomic multiplexed MS based approach. Mechanisms of Cognitive Mechanisms of The vast majority of older adults will experience some FNIH entered into a Memorandum of Understanding (MOU) $5,000,000 Project funds 1-Jan-08 Remediation in Older Adults Cognitive deterioration in cognitive function as they age. This initiative with NIA for this project in August 2013 and finalized its Letter of are Remediation in consists supports an intervention trials to remediate or Agreement with the McKnight Brain Research Foundation completed. Older Adults prevent age-related cognitive decline. A key goal is to (MBRF) in October 2013. NIA made a five-year grant award of encourage therapeutic approaches that aim to drive $15M in late 2014 to fund a multicenter clinical research trial in beneficial plasticity of the aging brain and require cognitive aging: "Remediating Age Related Cognitive Decline: investigators to monitor plastic changes through behavioral Mindfulness-Based Stress Reduction and Exercise." The Principal and biological markers. The McKnight Brain Research Investigator is Eric J. Lenze, MD, of the Washington University Foundation (MBRF) is the private funder/partner and School of Medicine. Research is underway. committed $5 million to this effort. NIA's investment brings the total project funding to $15M.

Updated as of December 31, 2015 NIA 2 Research Projects Project Name Display Name Description Latest News Money Total Funds Launch Date New Project Raised Available This (as of (as of Quarter? December 31, November 2015) 30, 2015)

The Osteoarthritis Initiative 2 OAI-2 Osteoarthritis affects over 15 million people in the United FNIH has received all final grant payments from the private-sector $3,500,050 Project funds 1-Sep-08 States. In collaboration, the National Institute of Arthritis funders, and transferred the final OAI2 funds, in the amount of are and Musculoskeletal and Skin Diseases (NIAMS), the $976,500, to NIAMS in February 2015. NIAMS staff indicated completed. National Institute on Aging (NIA), and the private sector are that a final project report would be forthcoming in late 2015; striving to improve the efficiency of drug development and FNIH will share this report with the funders when it is received. clinical trials for the treatment of osteoarthritis. In 2009, the Because of the value of this project to the scientific community, an Osteoarthritis Initiative (OAI) began extended follow-up of activity marking its end is contemplated for mid-2016, following its study cohort for an additional six years (OAI2) to gain a which the project will be completed. better understanding of the natural history and course of both early and established knee osteoarthritis and its determinants, as well as to help accrue additional endpoints for clinical investigation across the spectrum of the disease. Identifying early predictive biomarkers of osteoarthritis could lead to more efficient and faster clinical trials by identifying higher risk individuals and ultimately, to the development of drug treatments to slow progression or modify this disabling disease.

Events Project Name Display Name Description Latest News Money Total Funds Launch Date New Project Raised Available This (as of (as of Quarter? December 31, November 2015) 30, 2015)

Go4Life NIA-Go4Life The mission of Go4Life is to motivate older adults to FNIH secured funding for and oversaw production of the $250,000 $222 1-Sep-15 become more physically active, to return to exercise, or build Exercise Guide, Go4Life banner, T-shirts, and caps. Two FNIH exercise and physical activity into everyday routines. In staff attended the event and participated in the Go4Life walk, September 2015, to celebrate Go4Life month in which was held in Washington, DC on September 18, 2015. FNIH collaboration with the White House Conference on Aging, submitted its final report to Robert Wood Johnson and FNIH's the NIA along with the Surgeon General will host a Go4Life involvement with the project has now ended. walk in Washington, DC. FNIH is asking the Robert Wood Johnson Foundation to support this event by underwriting the printing and distribution of the Exercise Guide, a Go4Life banner, and t-shirts.

Updated as of December 31, 2015 NIA 3 National Institute on Alcohol Abuse and Alcoholism

Research Projects Project Name Display Description Latest News Money Total Funds Launch Date New Project Name Raised Available This (as of (as of Quarter? December 31, November 30, 2015) 2015) Multi-site Health Effects Prospective epidemiological studies consistently relate As part of its due diligence before taking on this $15,400,100 As of November 15-Apr-15 Randomized Trial of of Moderate moderate alcohol consumption with lower risk of project, the FNIH worked with the International 30, 2015, funds Health Effects of Drinking cardiovascular disease, ischemic stroke, and type 2 Association for Responsible Drinking (IARD), to are not yet Moderate Drinking diabetes. However, this association remains secure informal commitments of ~$80M, the amount available. controversial due in part to the lack of gold-standard required of the private sector in order to fully fund randomized evidence. This project is intended to meet the study. Assured of funding, and with proper the need for a clinical trial. The primary study safeguards established, especially in the areas of objectives are: 1) determine the effects of one serving project governance and communications, in May of alcohol daily, compared to no alcohol intake, on 2015 the FNIH Board of Directors authorized the the time to incident cardiovascular disease among organization to formally undertake fundraising for the adults at above average cardiovascular risk; and 2) to project. FNIH subsequently met on serveral determine the effects of one serving of alcohol daily occasions with NIAAA program and on the time to incident diabetes among participants communications staff and NIH OD to re-confirm free of diabetes at baseline. The study design will be a that anticipated funders (alcohol companies) will have randomized, multicenter, international, assessor- no role in the study other than to provide funds, and blinded, parallel group, balanced clinical trial. FNIH to develop an agreed upon plan for handling public has been asked to secure private-sector funding and communications about the program. Letters of to create an arms-length relationship between funders Agreement are being negotiated with the potential and NIH, in order to ensure an unbiased trial. funders. A grant award to the Vanguard Site for year 1 of the program is expected in early 2016.

Updated as of December 31, 2015 NIAAA 1 National Institute of Allergy and Infectious Diseases

Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch New Project (as of December Available Date This Quarter? 31, 2015) (as of November 30, 2015)

African Centers of African Centers NIAID proposes a solution to bridge the gap in Representatives from the FNIH and private partners Gifts are in-kind. Gifts are in-kind. 1-Nov-14 Excellence in of Excellence computing infrastructure and support bioinformatics supporting the ACE project participated in the last status Bioinformatics research in low- to middle-income countries, starting report teleconference on July 15. The ACE in with a network of up to five African Centers of Bioinformatics facility is fully operational and is training Excellence in Bioinformatics (ACEs). The goal of the students. project is to build a sustainable program that will: (1) provide high performance computing infrastructure and training to capable research institutes in Africa; (2) empower researchers to utilize computing resources and perform advanced biomedical data analysis; (3) create an independent community of bioinformatics specialists to encourage sharing of data, best practices, and collaborative projects; and (4) provision a sustainable model for delivering funding and in-kind donations.

Biomarkers Biomarkers There are limitations in the information to quantitatively The HABP-VABP Project Team has secured in-kind clinical $361,500 $229,245 1-May-13 Consortium - Consortium - assess the effect of antibacterial drug treatments vs. no trial data contributions from Pfizer, Theravance, Shionogi HABP/VABP HABP/VAPB treatment or placebo and in comparisons between active and a clinical study from Toni Torres at the University of Working Group agents. These undefined clinical endpoints impede the Barcelona. Data analysis of this trial data was presented at field of drug development for these indications and limit the recent F2F meeting and statistical analysis is ongoing the ability to perform clinical trials in this area. The lack according to plan. The statistical subteam was convened to of outcome measures also impedes patient care since perform and review subsequent endpoint development and clinicians and patients cannot understand similarities and aid these analyses. ICON has established 3 sites (2 more in differences between therapeutic agents that are not the works) for HABP patient recruitment for PRO content measured in a well-defined, reproducible and clinically debrief interviews. ICON has completed the literature review relevant manner. The goals of the HABP VABP project and submitted a letter of intent to FDA for the HABP PRO are to develop 1) reliable, well-defined and clinically development and the Project Team received the FDA relevant endpoints in clinical trials that measure tangible response and the team has finalized a response to these benefits for patients in terms of how they feel, function, questions. Content Validity is ongoing for the HABP PRO. and survive and/ or 2) new design components that The team recently updated the inclusion criteria to better would improve trial feasibility. These goals will be define - and pull out - patients that are HCAP from this achieved by a retrospective analyses of data from several study. existing industry-sponsored clinical trials.

Comprehensive CTVIMC 2 This is a five year continuation of the original award to The CTVIMC continues to provide the Collaboration for $16,881,922 $3,097,335 1-Nov-11 Vaccine Immune provide cellular immune monitoring services to the AIDS Vaccine Discovery with a wide range of assay services Monitoring Collaboration for AIDS Vaccine Discovery (CAVD). for measuring T and B cell responses in clinical and Consortium The project involves seven sub-awards, including the nonhuman primate trials of HIV vaccine strategies. In VRC/NIAID, Beth Israel Deaconess Medical Center, addition, the consortium continues to innovate by Duke University, Imperial College, Fred Hutchinson developing and implement advancements in flow cytometry, Cancer Research Center and Case Western Reserve single cell technologies and genomic and transcriptomic University. analyses. Efforts have begun to apply for a new grant to carry on as a provider of a cetral service facility to monitor cellular immune responses to vaccine strategy candidates within the CAVD. Development of a 2GVRC01 This is a five year project to optimize the VRC01 Dr. Mascola's team at the VRC continues to pursue the aims $1,861,176 $59,248 1-Nov-11 Second Generation antibody by increasing its potency and half-life. This of the new objective added to the project in 2014. Broadly Neutralizing optimized, second generation neutralizing antibody Antibody would be a lead candidate for advanced development, including manufacturing and use in clinical trials. Ebola-Clinical Trial Ebola-CTs The project will involve developing a review of all Ebola- The final report from this project was published on the $369,709 $4,374 1-May-15 Intervention Project focused research studies conducted in response to the WHO website. It presents current information (updated to 2014 EVD outbreak, as a reference to identify what has September 2015) on candidate vaccines, therapies and been/is being evaluated, what worked and what did not medical devices for Ebola and gives an overview of work and what were the key learnings, to be used by the completed and on-going trials. Bill & Melinda Gates Foundation, the National Institutes (http://www.who.int/medicines/ebola- of Health and other collaborators as they move forward treatment/rd_clinical_candidates_trials_report/en/). in this field of study. Epidemiology of Epi VL in Bihar, Endemic visceral leishmaniasis (VL) in Bihar, India may Development of a P. argentipes colony is underway at an $670,404 $84,135 1-Jun-13 Visceral Leishmaniasis India have an anthroponotic transmission cycle as only insectary built at KAMRC in India. The facility is fully in Bihar, India humans have been shown to harbor the etiologic agent, stocked and equipped, and staff is trained. Collection of wild Leishmania donovani. However, which infected human flies stocking the fly colony is nearly complete. Next steps populations act as functional reservoirs for transmission are to expand the colony to establish a self-sustaining colony to the sand fly vector, Phlebotomus argentipes, and are (completion target February 2016), test for pathogens and required to maintain the transmission cycle is unknown - 'certify' the colony. Once established, the sand fly colony will possibilities include: active VL and clinically-cured cases, be used to gain an understanding of the dynamics and PKDL cases, and asymptomatic individuals. epidemiology of anthroponotic transmission and identify the Understanding the dynamics and epidemiology of human reservoir(s). The problem will be addressed via anthroponotic transmission is important for developing xenodiagnostic studies of well-defined subject groups (active control strategies. The project is intended to: i) develop VL cases and those individuals progressing to disease during infrastructure; ii) evaluate technical feasibility; and, iii) the weeks to months it takes from symptom onset to write protocols for a larger follow-on study to define presentation for medical care, clinically cured cases, patients which human populations serve as L. donovani with post-kala-azar dermal leishmaniasis, and asymptomatic reservoirs. Xenodiagnostic studies using lab-reared sand individuals) using live vector sand flies. Results will inform flies, and/or via molecular genetic approaches to identify vector control strategies. specific human blood meal sources in field caught sand flies may be used.

Updated as of September 30, 2015 NIAID 1 Research Projects

Project Name Display Name Description Latest News Money Raised Total Funds Launch New Project (as of December Available Date This Quarter? 31, 2015) (as of November 30, 2015)

Identification of high- HIT-TB The program seeks to combine the power of high- Year 5 annual progress reports were submitted by sub-grant $14,825,409 $2,157,350 1-Jun-10 quality HITs for throughput screening (HTS) and target-based partners in Q4 2015. In August 2015, FNIH disbursed year 5 tuberculosis (HIT-TB) approaches to identify targets with potential for lead grant payments to the sub-grant partners to begin their final optimization for drug development for tuberculosis year of the program under the current BMGF award. On (TB). The 4 major objectives of this application are: 1) March 7-9, 2015 the HIT-TB project team held its 4th annual implementation of high-throughput screening with novel team meeting in Cape Town, South Africa. The project sources of chemical diversity; 2) generation of hit-series members reported on progress at the various partner sites with sufficient structure activity relationship to establish and identified priority action items for the coming year. In quality; 3) identification of the most vulnerable targets November, 2014 the HIT-TB program obtained for the Coenzyme A pathway; 4) enrichment in the supplemental funding from the Gates Foundation. The utility of screening libraries and analysis of data using supplement has now been activated and will build on computational predictions. previous funding by providing support for addition of two new moderate throughput assays for screening molecular libraries for hits that might provide leads for TB drug development. The supplement also supports expanded access to the NIAID marmoset colony, which provides a good predictive model for drug evaluation.

NIAID Ebola NIAID Ebola People stricken by Ebola epidemics in West Africa are An MOU with NIAID was fully executed on December 1, $115,000 $113,576 1-Oct-15 Community Community among the poorest of the poor, having inadequate public 2015 in support of this project. FNIH looks forward to Engagement Engagement health infrastructure for responding to outbreaks or working with NIAID to support vital communications supporting survivors. Expanded understanding of how efforts for PREVAIL III. The FNIH has secured an in-kind Ebola virus causes disease and how EVD affects the gift of two shipping containers filled with medical supplies, longer term health of survivors and the people they live ranging from syringes and gloves to hospital beds, valued at with will improve public health responses to future EVD nearly $1 million, from Project C.U.R.E.; TAKEDA outbreaks. This can only be accomplished if the affected Pharmaceuticals is considering a $2.5 million proposal for X communities are willing to participate in Ebola research. support for the social mobilization and communications Support of the critical social mobilization and efforts relating to PREVAIL, and anticipates a decision on communications component of PREVAIL III, the award by July 2016. specifically, meetings in Liberia focused on community engagement, training and strategic planning – will underpin the success of the study and ensure useful results.

Rapid identification of OvAF (Oncho) The goal of this project is to identify host- and parasite- The project is scheduled to end 2/28/2016 but has requested $1,539,355 $17,959 1-Dec-12 individuals with viable specific biomarker(s) present in human subjects with a nine month no cost extension to 11/30/2016 in order to adult female worms of viable adult females of Onchocerca volvulus (Ov) and to complete the work. The Ov Consortium principal Onchocerca volvulus: develop and configure rapid point of care methods to investigators attended a Biomarkers Meeting held at the a means to the end detect (or sense) these biomarkers. This would be a final Gates Foundation in November 2015. FNIH granted and necessary step in the progress towards elimination additional funds to Thomas Jefferson University to support of onchocerciasis, an important neglected tropical continuing work to assess the suitability of various mouse disease. strains, including humanized mice, as hosts for O. volvulus parasites. Year 2 annual progress reports were submitted by sub-grant partners in Q3 2015. Project team members continued to interact with the Gates Foundation Consortium of Biomarkers to Identify Female Adult Onchocerca Volvulus.

Support of Ebola Support of Ebola To support the Division of Clinical Research of the The Development and Advancement teams continue to $35,615 $1,037 1-Nov-14 Research by the Research by National Institute of Allergy and Infectious Diseases collaborate on formal proposal submissions to prospective National Institute of NIAID (NIAID) in its efforts of prevention and treatment to funders for support in continued social mobilization efforts. Allergy and Infectious carry out Ebola research response in West Africa. Several organizations are still considering their support, Diseases (Funding has been sent to NIAID in Liberia to host including areas of capacity building and clinical care. The retreat gatherings, for important meetings and for FNIH received a $7k gift from Transmar Group on independent review board fees in order to proceed with 12/18/15 designated to provide 100 care packages for Ebola the clinical trial). survivors in the Prevail studies who are pregnant or have young children. The Bill & Melinda Gates Foundation also provided a $100,000 gift on 10/13/15 specific to the logistics (meetings, travel etc) of the PREVAIL III longitudinal study of Ebola survivors.

Updated as of September 30, 2015 NIAID 2 Education & Seminars Project Name Display Name Description Latest News Money Raised Total Funds Launch New Project (as of December Available Date This Quarter? 31, 2015) (as of November 30, 2015)

The Dr. Franklin A. Neva Fund This Fund supports two ongoing programs to honor FNIH transferred funds to NIAID in September for the $51,059 $30,563 1-May-12 Neva Memorial Fund the memory and further the legacy of Dr. Franklin A. 2016 events. The donor recently approved the fund Neva, a former director of NIAID's Laboratory of project summary to be listed on the new FNIH website. Parasitic Diseases (LPD). The first is an annual lecture Planning for the fourth annual Neva Lecture has begun on a topic related to clinical tropical medicine and with outreach to Dr. Nash who has confirmed Dr. Kary associated pathophysiology as part of the LPD's Seydel will be the speaker for the lecture, which will take ongoing weekly lecture series. The second is an annual place on March 24, 2016. session devoted to parasitic and/or tropical medicine that features discussions of individual cases held by the LPD and the Greater Washington Infectious Disease Society.

Pew Latin American Pew Latin The Pew Latin American Fellows in the Biomedical FNIH has transferred a total of $37,500 to NIAID for $299,250* Project funds are 1-Aug-09 Fellows Awards American Sciences program has awarded a Pew Latin American 2014 Pew Latin American Fellow Dr. Javier David completed. Fellows Awards Fellows award to support the research of several (4) Ramirez-Gonzalez's first year of his grant award. In *This is the total post-doctoral fellows within a laboratory at an NIH addition, a first-year financial and scientific progress report amount raised and institute. The Pew Charitable Trusts asked to use the was submitted to the Pew Charitable Trust on June 15, is shared with all FNIH as a conduit to provide awards to the Fellows. 2015. FNIH continues to work with Pew Fellow Javier ICs involved in the Magadan to procure the equipment and supplies for him project. to use when he returns to the Universidad Nacional de Cuyo in Argentina. Dr. Magadan's final financial report was submitted to the Pew Charitable Trusts on September 1, 2015.

Roth Fellowship for Roth Fellowship Richard and Susan Roth are donating to fund a 2 year FNIH finalized an MOU with NIAID in July 2014. FNIH $105,000 Project funds are 1-Feb-14 CAEBV-HV for CAEBV-HV Fellowship in the lab of Dr. Jeffrey Cohen of NIAID. transferred funds for the first year of the Fellowship. Dr. completed. Research The Fellow will conduct research to accelerate efforts Chirosree Bandyopadhyay was selected as the Fellow and to find new drugs to treat Chronic Active Epstein Barr scheduled to start in October 2014, but had to withdraw. Virus (CAEBV) and Chronic Active Epstein Barr NIAID has informed FNIH that a candidate for the Virus-Hydroa Vacciniforme (HV) as well as find and Fellowship, Matthew Howe, has accepted and NIAID understand genetic causes of the diseases to lead to expects the start date to be sometime in Fall 2015. new treatments. Richard and Susan Roth's grandson, Aiden Aronoff, suffers from CAEBV-HV.

Swanson Family Swanson Family The Swanson Family Fellowship supports research in Dr. Steven Holland of NIAID provided an update of $92,500 $92,500 1-Oct-06 Fellowship in Genetic Fellowship TTF-1 Mutation Causing Benign Chorea in the needs in his lab that might be supported by the Fund. Thyroid Benign laboratory of infectious diseases under the direction of FNIH recently sent the donors a proposal for use of the Chorea & IgA Steven M. Holland, M.D., Chief of the Laboratory of funds, but has received no response from the outreach Deficiency (TTF-1) Clinical Infectious Diseases at the National Institute of efforts. Allergy and Infectious Diseases at NIH.

Events Project Name Display Name Description Latest News Money Raised Total Funds Launch New Project (as of December Available Date This Quarter? 31, 2015) (as of November 30, 2015)

Vaccine Research VRC FNIH assists the by FNIH continues to provide support for the monthly CAB $21,695 $2,155 1-Jul-03 Center's Community Community supporting the Community Advisory Board's meetings. Advisory Board Advisory Board (CAB's) scientific monthly meetings and participation (CAB) in annual conferences by CAB members.

Updated as of September 30, 2015 NIAID 3 National Institute of Arthritis and Musculoskeletal and Skin Diseases

Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015)

Accelerating Medicines AMP-RA/SLE The Accelerating Medicines Partnership (AMP), is a pre- The project has completed most aspects of Phase 0, $21,200,505 $2,447,381 1-Sep-13 Partnership: Rheumatoid competitive effort among government, academia and providing an infrastructure of approved SOPS for tissue Arthritis/Systematic Lupus industry to harness collective capabilities, scale and resources acquisition and processing for blood, urine, skin as well as Erythematosus toward improving current efforts to develop new therapies kidney and synovial biopsies. The SC has an approved for complex, heterogeneous diseases- , Charter with providing guidance and interactions with the Alzheimer's Disease, and Rheumatoid Arthritis, Lupus and NLC. Data sharing, use and publication policies are also Related Autoimmune Disorders. In Dec 2013 a final completed. In collaboration with the RhEumatoid Arthritis research plan for RA-Lupus was completed through the RA- SynOvial tissue Network (REASON), the NLC has Lupus Steering Committees, including representatives from established a Synovial Biopsy Capacity Building and AbbVie, BMS, Merck, Pfizer, Sanofi, and Takeda and Educational Program to bring expertise and harmonized government. The plan focuses on the molecular analyses of processes and SOPs for synovial tissue acquisition from the gene expression and signaling in specific subsets of UK to the US. This will allow for greater capacity for the leukocytes and resident cells in control and RA synovium necessary samples for both Phase I and II of the project. and blood and Lupus kidney biopsy, skin and blood. This The SC and NLC recently met for a F2F in early December may lead to biomarkers which predict pathological processes to review all the Phase 0 data and SOPs and to transition to that lead to end-organ damage and identify potential new Phase I. pathways or target for drug development and intervention.

Biomarkers Consortium - Biomarkers The immediate goal of the four-year Bone Quality Project is The research team at UCSF, led by Dennis Black, has $2,560,000 $1,107,766 1-Jan-13 Bone Quality Project Consortium - to advance the qualification of biomarkers for drug received data from 70,000+ individuals for the project Bone Quality development and patient management in osteoporosis. It analyses, and data are currently undergoing data cleaning aims to evaluate osteoporosis biomarkers obtained from and harmonization. UCSF has also completed the study retrospective clinical trials and qualify them for use in drug level DXA scan meta-analysis, a project milestone. Results development. The combined biochemical and imaging confirmed previous findings, that increased bone mineral measures could improve fracture efficacy prediction. The density (BMD) is associated with a decrease in spine and project team is led by Dr. Gayle Lester from NIAMS, and non-vertebral fracture risk, in a larger data set. The analysis has confirmed participation from CDER/FDA, Merck, also demonstrated that increased hip BMD is associated Lilly, Amgen, The Dairy Research Institute, Daiichi Sankyo, with a decrease in hip fracture risk, a new finding. In AgNovos and American Society for Bone and Mineral October, the Project Team met face to face in Seattle, WA Research. The Bone Quality Project launched in Q4 2013 at the annual American Society for Bone Mineral Research and is currently being executed as a four-year $2M project. (ASBMR) conference, where initial findings and publication Five pharmaceutical companies and two nonprofit planning were discussed. The first manuscripts are expected organizations have provided funds in support of this in 2016. At the conference, team members also gave two initiative, led by NIAMS/NIH. A press release announcing presentations (published in two abstracts) and spoke at two the project launch came out in early December 2013. satellite sessions on various topics related to the project.

Biomarkers Consortium - Biomarkers The goal of this project is to develop approaches that will ABBoth the CABP and ABSSSI PRO draft instruments are $820,000 $93,397 Developing Endpoints for Consortium - help the FDA develop efficacy outcome measures complete and the final reports have been received by FNIH. Clinical Trials in CABP and CABP - Skin (endpoints) for modern-day clinical trials of investigational Project Team leadership is seeking industry partners to put Skin Infections Infections agents for community-acquired bacterial pneumonia (CABP) the draft instruments in Phase II-IV trials for psychometric and acute bacterial skin and skin structure infections validation (PV) and have CDAs signed and setting meeting (ABSSSI) that can be tied to historical data in each with a couple sponsors. FDA has requested new white indication, thereby providing the basis for sound non- papers for the PV of the CABP instrument and the team is inferiority (NI) trial design and NI margin justification. working to complete and submit this as soon as possible. A Identification and qualification of effective approaches to manuscript submitted to CID focused on CABP and measuring these endpoints and any related biomarkers will ABSSSI endpoints has recently been published and is be included in the project. Collateral development of data or available online - Developing Outcomes Assessments as sample resources that could be used for ongoing biomarker Endpoints for Registrational Clinical Trials of Antibacterial research in these areas will also be considered. The project Drugs: 2015 Update from the Biomarkers Consortium of launched in January 2012. the Foundation for the National Institutes of Health.

Updated as of December 31, 2015 NIAMS 1 Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015)

Biomarkers Consortium - Biomarkers The overarching goal of this project is to establish the The main focus remains on the final statistical analysis of $3,455,085 $265,739 1-Mar-13 Osteoarthritis Project Consortium - OA predictive validity of disease progression biomarkers and imaging and biochemical biomarker data and subsequent assess the responsiveness of several imaging and manuscript submission. All project data and results have biochemical markers pertinent to knee osteoarthritis, using been uploaded and is publically available in OAI. A project the resources of the NIH Osteoarthritis Initiative. The overview manuscript has been published in Best Practice & results of the project are critical to establishing biomarkers Research Clinical Rheumatology 28 (2014). Two additional that can be effectively used to develop new disease- imaging manuscripts have been accepted for publication. 2 modifying regimens for osteoarthritis, and creating an manuscripts for the BOCL work (data and methods) are environment that encourages drug and device companies to being submitted by the end of the year as well as the invest in developing new therapies in this field. This project biochemical manuscript on serum and urine markers. The falls under the auspices of the and Immunity multivariate analysis will determine which biomarkers will Steering Committee. be taken forward for FDA and EMA qualification as a next phase project in the BC. A new concept proposal is in development for submission to the IISC in early 2016.

Biomarkers Consortium - Biomarkers Cardiovascular disease is the leading cause of excess deaths The project plan for the TARGET Biomarker Study was Fundraising efforts Fundraising efforts 1-Sep-14 TARGET Biomarker Study Consortium - in RA. Therapies that reduce joint inflammation might also developed by lead investigators Dan Solomon (BWH) and are underway. are underway. TARGET BMx reduce CV risk. This project seeks to utilize validated Joan Bathon (CU) and was approved by the BC EC on May proteomic biomarkers of RA disease activity and 22nd. The project leverages serum samples, data and inflammation to categorize baseline and disease modifying infrastructure from the TARGET Trial - a U01 funded by anti-rheumatic DMARD-associated changes in vascular NIAMS with 2016 funds. Support for the project is inflammation in RA patients. Leveraging a randomized confirmed for one industry partner and a non-profit controlled clinical trial (The TARGET Trial), this organization. Several other companies are making final companion BMx project will compare and correlate the decisions in early 2016 but have been supportive in final changes in these proteomic biomarkers with vascular FDG discussions of likely support. PET-CT between two treatment regimens in methotrexate inadequate responders that represent a critical and common decision point for rheumatologists and patients: addition of a TNF inhibitor vs. addition of sulfasalazine plus hydroxychloroquine (triple therapy) to background MTX.

The Osteoarthritis Initiative 2 OAI-2 Osteoarthritis affects over 15 million people in the United FNIH has received all final grant payments from the private- $3,500,050 Project funds are 1-Sep-08 States. In collaboration, the National Institute of Arthritis sector funders, and transferred the final OAI2 funds, in the completed. and Musculoskeletal and Skin Diseases (NIAMS), the amount of $976,500, to NIAMS in February 2015. NIAMS National Institute on Aging (NIA), and the private sector are staff indicated that a final project report would be striving to improve the efficiency of drug development and forthcoming in late 2015; FNIH will share this report with clinical trials for the treatment of osteoarthritis. In 2009, the the funders when it is received. Because of the value of this Osteoarthritis Initiative (OAI) began extended follow-up of project to the scientific community, an activity marking its its study cohort for an additional six years (OAI2) to gain a end is contemplated for mid-2016, following which the better understanding of the natural history and course of project will be completed. both early and established knee osteoarthritis and its determinants, as well as to help accrue additional endpoints for clinical investigation across the spectrum of the disease. Identifying early predictive biomarkers of osteoarthritis could lead to more efficient and faster clinical trials by identifying higher risk individuals and ultimately, to the development of drug treatments to slow progression or modify this disabling disease.

Updated as of December 31, 2015 NIAMS 2 National Institute of Diabetes and Digestive and Kidney Diseases Research Projects Project Name Display Name Description Latest News Money Raised Total Amount Launch Date New Project (as of Available This December 31, (as of Quarter? 2015) November 30, 2015)

Accelerating Medicines AMP- T2D The Accelerating Medicines Partnership (AMP) is a multiple-sector, pre- The first major deliverable of the project, the Knowledge Portal, was $21,775,000 $7,369,460 1-Sep-13 Partnership: Type 2 competitive partnership whose goal is to harness collective capabilities, publicly launched in June 2015. The AMP T2D Steering Committee Diabetes scale and resources toward improving current efforts to develop new (SC) has awarded 6 FNIH grants in support of the AMP T2D therapies for complex, heterogeneous diseases. In late 2013, the AMP Knowledge Portal, which support enhancing portal capabilities, fund Type 2 Diabetes (T2D) research plan was finalized by Steering incorporation of data sets, and fund a federated database site in the Committee members from NIDDK/NIH, Eli Lilly and Company, UK to allow incorporation of European data. The federated database Janssen Research and Development, LLC, Merck Sharp & Dohme Corp., model will allow users to query subject-level data outside the US in Pfizer Inc., Sanofi US Services, and Takeda Pharmaceuticals. AMP T2D compliance with regulatory restrictions. The awards complement aims to build a public, searchable AMP T2D Knowledge Portal for NIDDK AMP T2D funding streams. Grant agreements are currently analysis of relationships between potential therapeutic target gene under negotiation. In November 2015, results from the initial sequence variations and T2D risk or protection, quantitative traits, Steering Committee specified research queries using the portal were complications, and molecular phenotypes to inform the drug presented. These analyses provided an initial "proof of concept", development process. showing that aggregation of genetic and large scale sequencing data will be able to better identify and validate promising targets for T2D treatment. The AMP T2D Steering Committee released a fourth FNIH RFP in June to bring additional data into the portal. The AMP T2D Project Team met face to face on September 13 in Sweden at the EASD conference to continue to promote the portal launch and engage the external T2D investigator community, with a focus on responders to this RFP. The RFP deadline closed on December 7, 2015. Eight proposals were received. The Steering Committee will begin reviewing the applications mid-December, 2015.

Biomarkers Consortium - Biomarkers The Kidney Safety Project, managed by the Executive Committee of the The Kidney Safety project launched in the summer of 2011. In $3,502,000 $954,480 1-Jul-11 Clinical Evaluation and Consortium - Biomarkers Consortium, aims to qualify novel biomarkers of drug- October of 2012, the first milestone was completed: the retrospective Qualification of Kidney Kidney Safety induced acute kidney injury. The project is designed to include a learn- analyses from the mesothelioma and healthy volunteer studies were Safety Biomarkers and-confirm phase. The learn phase consists of retrospective analyses of finished, which enabled the prioritization of the novel urine mesothelioma patient and healthy volunteer data in order to establish a biomarkers for analyses in the prospective studies. The prospective prioritization for the novel biomarkers that seem most promising for the studies are currently ongoing. The 25% mark for patient recruitment prospective analyses. The prospective analyses are based on data was reached in August 2014. The first set of data analyses is expected collected from two observational clinical trials conducted at 4 different to be complete in late 2015 on 39 subjects from each arm. All sites - 2 with aminoglycosides and 2 with cisplatin - aiming to validate biomarker testing will be performed at PBI. The Project Team some important biomarkers of acute kidney injury (AKI) that perform received FDA feedback on the Limited Context of Use document and better than serum creatinine and BUN (the currently used biomarkers of provided a response in late August. The team is scheduled to present AKI). This project is funded by 6 pharma companies. their limited Context of Use of the preliminary Meso data to the EMA on January 13th.

Biomarkers Consortium - Biomarkers The Beta Cell Project, developed through a consensus process, by the The Beta Cell Project incorporates multiple clinical studies performed $6,074,500 $1,750,216 1-Jan-11 Diabetes Drug Consortium - Metabolic Disorders Steering Committee, is the first phase of a two-stage separately in healthy volunteers, pre-diabetic, and diabetic subjects in- Development: Identification Beta Cell Clinical strategy to enable the development of biomarkers that predict long term patient and out-patient assessing selected methodologies. Study 1, and Validation of Markers Trial beta cell function, particularly in response to an intervention or a new including the healthy volunteer, pre-diabetes and diabetes sub-studies, That Predict Long-Term therapy for diabetes. The project addresses key methodological issues is now complete, and the results have or are being included in multiple Beta Cell Function and Mass that are critical to the conduct of the second part of the strategy, which publications. This year, a total of three posters were presented at the will be a longitudinal study to qualify short-term markers as predictors of ADA meeting in Boston in June 2015 and the EASD Annual Meeting future beta cell function. The series of fundamental clinical studies in Stockholm, Sweden in September 2015. Additionally, one proposed in this project will provide a foundation for the effective and manuscript has been submitted to Diabetes Care, and the team is confident use of selected methodologies in long-term, multi-center working on two more manuscripts for submission in early 2016. The clinical trials. Taken together, the work from both stages should enable protocol for Study 2, evaluating the selected methodologies using multiple stakeholders to undertake consistent studies of the pharmacological interventions, has been finalized and the first subject pathophysiology and natural history of diabetes, as well as study was enrolled in October. The study should be completed in mid-2016. therapeutic effects of new interventions in a more effective manner.

Updated as of December 31, 2015 NIDDK 1 National Institute of Mental Health Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Biomarkers Consortium - Biomarkers The ultimate goal of the project to qualify a set of measures NIMH issued the grant award on 6/22/15 for a project $2,000,000 $41,575 1-Sep-15 Consortium on Biomarkers and Consortium - that can be used as stratification biomarkers and/or sensitive period of 7/1/15 through 6/30/19. The study was Outcome Measures of Social ASD and reliable objective measures of social impairment in ASD presented to the Biomarkers Consortium Executive Impairment for Use in Clinical clinical trials that could serve as indicative markers of long term Committee on 6/22/15, and approved as a Biomarkers Trials in Autism Spectrum Disorder clinical outcome. The project will support a multi-site study to Consortium Project. A joint meeting of the ABC-CT assess a well-justified set of standardized investigator- Steering Committee and the Biomarkers Consortium administered assessments of domains of social impairment as Project Team was convened on 8/6/15 to discuss details of well as neurophysiological measures (resting state and task- a feasibility study that will inform the protocol and data based EEG and eye tracking) that show promise in school age analyses for the main study, and it was subsequently individuals with ASD (ages 6-11) at baseline, 6- and 24-week finalized. The IRB approved the study on 10/20/15, and time points. In addition, at least one task-based EEG and one hosted an ABC-CT Investigators Meeting eye tracking measure from the European Autism Interventions on 10/22/15. The meeting included training on the study (EU-AIMS) study will be included among the set of proposed design and protocol, Good Clinical Practices, and study biomarker paradigms. The inclusion of these measures will measures and procedures. In addition, there have been on- foster harmonization and independent replication of a site training sessions at each of the clinical sites. All common subset of biomarker measures in the proposed Manuals of Operations and Standard Operating Procedures projects. have been finalized, and each site has begun the feasibility study protocol. Target completion of the feasibility study is 2/2016.

Baby Connectome Project Baby The Baby Connectome Project is one of several programs that Wyeth Nutrition is supporting this program with a gift of $2,903,225 $539,989 1-Dec-14 Connectome builds upon the NIH Human Connectome Project (HCP), $3M. The Letter of Agreement was finalized January 2015, Project designed to map the neural pathways that underlie human and the Memorandum of Understanding between FNIH brain function. The HCP's initial five-year version supported and NIMH, the lead Institute on the project, was finalized technology development and assessment followed by data March 2015. The project schedule is as follows: 1) Letter collection on a cohort of 1,200 healthy young adults (ages 22- of Intent Due: August 3, 2015; 2) Application Due: 34). The goal of the Baby Connectome is to obtain structural September 3, 2015; 3) Scientific Merit Review: February and functional connectivity data for the healthy human brain in 2016; 4) Advisory Council Review: May 2016; 5) Grant(s) the 0 to 4 year age range. Awarded/Earliest Grant Start Date: June 2016. FNIH communications staff is working with Wyeth Nutrition and NIH on any related communications activities. The NIH/FNIH team met with Wyeth Nutrition in October 2015 to discuss plans for the coming months, including the project launch event scheduled for June 2016. FNIH is working closely with NIH on related communications activities.

Updated as of December 31, 2015 NIMH 1 National Institute of Neurological Disorders and Stroke Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of Available This Quarter? December 31, (as of 2015) November 30, 2015) CarMollNat Muscular Dystrophy CarMollNat Muscular Carol-Ann Harris will create an Endowment to FNIH has implemented a fund sub-page on the website $26,199 Project funds are 1-Jul-13 Endowment Dystrophy fund research into one or more of the major types and has also sent fund information to solicit individuals for completed. Endowment of Muscular Dystrophy at the Neurogenetics support as provided by the donor and received Branch of the NINDS. contributions. The donor made a contribution to the Fund in 2014, and is also expecting to make a gift in 2015. She has approved the fund project summary to be posted on the new FNIH website and agreed to have it open to other donors for additional contributions.

Edna Williams Curl & Myron R. Curl Fund for MS As specified in this bequest to FNIH, interest Per the terms of the endowment agreement, once $60,302 $63,867 1-Aug-07 Curl Fund for Multiple Sclerosis Research income from the Edna Williams Curl and Myron R. sufficient interest income has accrued, the FNIH will use Research Curl Fund, established in 2007, is designated to the income to support NINDS research in the field of support multiple sclerosis research at NIH. multiple sclerosis. Once sufficient income is available, the FNIH will discuss possible uses for the fund with NIH.

Epilepsy Research in the Epilepsy Research in Dr. Zaghloul's research focuses on using direct The FNIH received the gift in response to a proposal $290,000 $148,212 1-Nov-13 Laboratory of Kareem Zaghloul, the Laboratory of human intracranial recordings in patients submitted to the Newport Foundation in October 2013 to M.D., Ph.D. Kareem Zaghloul, undergoing surgical treatment for epilepsy to support epilepsy research in Dr. Zaghloul's lab. The FNIH M.D., Ph.D. understand these mechanisms, which can provide notified Dr. Zaghloul of the gift and an MOU has been new and potent understanding of complex signed between FNIH and NINDS. FNIH has been in neurophysiologic circuitry in the human condition. contact with NINDS, most recently in June 2015 about Funds support a fellow in the lab of Dr. Zaghloul when funds might be transferred. NINDS has indicated for 2 years and a piece of equipment for the lab. that they have a fellow in place and that they will likely be requesting funds be transferred soon.

Sports and Health Research Sports & Health The Sports and Health Research Program (SHRP) Previously awarded grant and cooperative agreement $30,000,870 $16,325,242 1-Dec-11 Program Research Program is an innovative partnership among the National projects were ongoing, including: six pilot projects on (conditioned upon Institutes of Health (NIH), the National Football sports-related traumatic brain injury and spinal cord injury meeting certain League (NFL) and the FNIH. Launched in (R03, R21); and two cooperative agreements focused on milestones); 2012, the program aims to help accelerate the defining the scope of long-term changes that occur in the $1,185,868 (cash pursuit of research to enhance the health of brain years after a head injury or after multiple on-hand) athletes at all levels, past, present and future, and to concussions. NINDS Council recommended one project extend the impact of that research beyond the to be funded under the FOA for "Detect, Define and playing field to benefit others in the general Measure the Progression of Chronic Traumatic population, including members of the military. Encephalopathy (U01)," Made possible by a founding commitment of $30 (http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-14- million from the National Football League (NFL), 012.html#sthash.0iGVjssn.dpuf ). Discussions about and with an initial focus on traumatic brain injury, support for this project are ongoing. An annual report was the SHRP is designed to expand to encompass submitted by FNIH to the donor in December. other areas of research on serious medical conditions prominent in athletes and to engage additional funding partners representing a breadth of relevant interests. Research supported through the SHRP will be conducted under the direction of the NIH. The William N. Cafritz Trust - The William N. The bequest of $200,000 from the William N. According to Dr. Koroshetz, Sonya Schultz is the first $200,000 $96,977 1-May-15 Recruitment Support for Cafritz Trust - Cafritz Trust will be directed squarely at recruiting recruit (junior PD researcher) in the field of Parkinson's Parkinson's Disease Recruitment Support talented scientists and researchers to NIH studying Disease research and the FNIH is responsible for wire for Parkinson's in the field of Parkinson's Disease. transferring funds in the amount of $97,000 for the startup Disease package to Sonya. Derek Narenda is the second recruit who will come on board in the next year. The CAN 8021003 is established and the FNIH is awaiting approval for transfer from Ken Frushor.

Updated as of December 31, 2015 NINDS 1 Education & Seminars Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of Available This Quarter? December 31, (as of 2015) November 30, 2015) 2016 Alzheimer's Disease-Related 2016 ADRD Summit The 2016 Alzheimer's Disease-Related Dementias FNIH has committed its best efforts to raise $176,000 to $10,000 As of November Dementias (ADRD) Summit (ADRD) Summit will complete Action Number support the Summit. Fundraising is underway. 30, funds are not 1.A.8 of the National Plan to Address Alzheimer's yet available. Disease (2015 update). The goal of the Summit, as indicated in the action description of the National X Plan, is to regularly convene an ADRD Summit to review the progress on ADRD research recommendations and refine and add new recommendations as appropriate based on recent scientific discoveries.† The NIH is the lead agency, with the National Plan naming the NINDS as the lead of this effort. The NINDS is collaborating with the NIA on the ADRD 2016 Summit, and with partnering interests named in Action Number 1.A.8 including other federal funders of dementia research, national and international experts, public and private stakeholders, and the NAPA Advisory Council on Alzheimer's Research, Care and Services. FNIH has been asked to raise funds to support this March 2016 event. Robert Whitney Newcomb Newcomb Memorial The Robert Whitney Newcomb Memorial Fund Dr. Koroshetz's staff has confirmed that the spring lecture $1,142,612 $1,099,096 1-Jan-00 Memorial Lecture and Internship was established by the family to remember Dr. will take place on March 14, 2016 and Dr. Erik Jorgensen Newcomb, who began his scientific career at NIH has agreed to serve as the Newcomb Lecturer this year. as a high school summer intern in a laboratory at FNIH staff coordinated date and lecturer with the the National Cancer Institute. The Fund endows an Newcombs who have saved the date on their calendars. annual lecture by a recognized expert in Earlier in 2015 the donors agreed to support a 2 year post- neuroscience, selected by the National Institutes of baccalaureate fellow and Dr. Wray selected Leigh Dairaghi Neurological Disorders and Stroke (NINDS) at as the fellow who started in August 2015 and continues in NIH. Honoring Dr. Newcomb's own experience, it her fellowship position. also provides for internships for high school students at NINDS.

National Institute of Neurological NINDS/CNS Getch Beginning in 2016, an early career neurosurgeon FNIH secured support from the Congress of Neurological $200,000 $100,000 1-Aug-16 Disorders and Stroke - Congress Scholar will be competitively selected as the National Surgeons for the scholar; applications are due October 1, of Neurological Surgeons Getch Institute of Neurological Disorders and Stroke's 2015. FNIH is working with NINDS on an MOU for the Scholar Congress of Neurological Surgeons Getch Scholar project. (NINDS/CNS Getch Scholar). The Scholar, appointed as part of a larger, ongoing NINDS national career development program, will receive two years of funding to help launch a dual, clinical- research career for neurosurgeons who possesses unique clinical and research skills that identify them as the next generation of neurosurgical leaders.

The Pew Scholars Program in the Pew Scholars The Pew Scholars Program in the Biomedical FNIH has transferred $75,000 to NINDS for 2014 Pew $252,000 $29,980 1-Sep-14 Biomedical Sciences Program Sciences program provides awards to young Biomedical Scholar Dr. Kevin L. Briggman's grant. The investigators who show promise for making first year financial and scientific reports were submitted to advances in science relevant to human health. The the Pew Charitable Trusts on June 15, 2015. Pew Charitable Trusts asked to use the FNIH as a conduit to provide awards to the Scholar(s).

Updated as of December 31, 2015 NINDS 2 National Institute of Nursing Research Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Neurotropin Research Neurotropin The National Institute of Nursing Research FNIH received the final payment of $150,000 toward $750,000 $285,000 1-Mar-08 Project (NINR) is conducting two clinical trials on the the project from Nippon-Zoki in April 2013. FNIH investigational drug compound, Neurotropin, for staff contacted NINR most recently on March 30, the treatment of complex regional pain syndrome 2015 to see if a transfer of funds is needed and was (CRPS) and fibromyalgia. No effective drug told a transfer was not necessary at that time. On treatment currently exists for these chronic pain September 9, 2015, the NINR asked FNIH about disorders. Neurotropin (manufactured by the possibility of transferring the funds for a Nippon Zoki Pharmaceuticals) has been used different purpose, as the project for which the funds extensively for decades in Japan to treat a variety were originally contributed has ended. On of chronic pain conditions including CRPS and September 22, 2015, FNIH asked Nippon-Zoki for fibromyalgia. It is now being studied as an authorization to apply the funds to this new investigational new drug (IND) in the US, and initiative. The Nippon-Zoki representative will FDA approval is hoped for. The studies are consult with corporate leadership in Japan and being conducted by NINR, which is also the respond. primary funder. This grant is to assist NINR in funding the study.

Events Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December Available This Quarter? 31, 2015) (as of November 30, 2015)

Advancing Science, NINR-Improving Celebrating the 30th Anniversary of NINR, the FNIH committed its best efforts to secure $50,000 $21,500 $11,635 1-May-15 Improving Lives: NINR's Lives "Advancing Science, Improving Lives" events by August 1, 2015 to support these two activities 30th Anniversary Events will bring together scientists, healthcare during the NINR 30th Anniversary year. FNIH professionals, and members of the public to approached 20 potential funders and secured a total discuss the advancements in nursing science that of $21,500 from six. The events team worked with build the foundation for clinical practice and NINR to support aspects of an October workshop enhance the health of the nation. FNIH has been at which donors were recognized. NINR has set a asked to be involved in two of these events: a date in September 2016 for a public lecture. The scientific symposium including scientific, keynote, balance of funds raised will support a small reception and poster presentations and panel discussions, following the lecture. and a Science and Public Lecture featuring a speaker who can bring science to a lay audience, appealing to the general public.

Updated as of December 31, 2015 NINR 1 Fogarty International Center Research Projects

Project Name Display Name Description Latest News Money Raised (as Total Funds Available Launch Date New Project of December 31, (as of November 30, This Quarter? 2015) 2015)

Comprehensive Investigation MAL-ED The study is determining the impact of enteric MAL-ED Network investigators are preparing $44,948,065 $885,372 1-Nov-08 into the Risk Factors of infections/diarrhea that alter gut function and impair manuscript drafts covering MAL-ED major Malnutrition and the children's nutrition, growth and development and outcomes (cognitive development, growth [two Consequences for Child Health inform development of new intervention strategies that papers], gut function, vaccine response). It is can break the vicious enteric infection-malnutrition cycle anticipated that these manuscripts, once and reduce its global burden. Children from resource- finalized, will be submitted to together to The constrained areas will be recruited for this study at eight Lancet for consideration for contemporaneous sites in developing countries across Africa, Asia and publication. FNIH is in touch with The Lancet South America (field sites located in Bangladesh, Brazil, to assure submission requirements are India, Nepal, Pakistan, Peru, South Africa, and understood and complied with. Major messages Tanzania) to establish a birth cohort that will be from these papers will be determined and followed for at least two years. In addition, sites in disseminated to the scientific and lay public Bangladesh and Brazil will conduct case-control studies communities - a communications strategy is comparing malnourished children with those that are being developed. better nourished. Analyses will evaluate data obtained for various research areas including cognitive abilities, gut functioning, nutritional status, and socio-economic and educational status.

Education & Seminars

Project Name Display Name Description Latest News Money Raised (as Total Funds Available Launch Date New Project of December 31, (as of November 30, This Quarter? 2015) 2015)

World AIDS Foundation- Clayton- The World AIDS Foundation donated to FNIH Ten individuals from countries in Africa (Kenya $1,227,249 Project funds are 1-Dec-04 Clayton-Dedonder Scholarships Dedonder remaining funds from the existing leadership and [1], Malawi [1], Uganda [2], Zambia [1], complete. Scholarship mentorship award program for emerging leaders in Zimbabwe [1]), the Caribbean (Haiti [1]) and Awards (WAF) AIDS research in the developing world. FIC asked South America (Peru [3]) received support from FNIH to administer these funds, $50,000 for each this program beginning in January 2014. Each recipient. FIC and FNIH will work jointly, as has been of them has provided annual reports on their done in the past with the World AIDS Foundation, in activities and progress over the past year. Each reviewing and implementing these awards. fellow identified their major accomplishments as well as their plans for the current year 2015. Reports focused on their individual development as mentors as well as on their institutional activities to expand mentorship opportunities to others in the organization. Five additional individuals from Kenya (2), South Africa (1), Haiti (1) and Peru (1) were awarded in November 2014. Reports on their start p acti ities are not a ailable at this time

Updated as of December 31, 2015 FIC 1 National Center for Complementary and Integrative Health General Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of Available This December 31, (as of November Quarter? 2015) 30, 2015)

Stephen E. Straus Straus Lecture Established by Bernard and Barbro Osher in 2006, this fund honors Richie Davidson has accepted NCCIH's $163,000 $110,659 1-Jan-07 Distinguished Lecture in the late Dr. Stephen E. Straus, the founding director of NIH's invitation to be the speaker for the 2016 CAM National Center for Complementary and Integrative Health Straus lecture. It will be held on Tuesday, (NCCIH). It supports the Stephen E. Straus Distinguished Lecture in May 3, 2016 from 10-11 a.m. the Science of Complementary and Alternative Medicine, an annual lecture that brings leading figures in science and medicine to NIH to (http://www.investigatinghealthyminds.org speak about their perspective on the field of complementary and /cihmDrDavidson.html) alternative medicine. Open to the public, the lecture is videocast and archived on the NCCIH website.

Updated as of December 31, 2015 NCCIH 1 NIH Clinical Center

Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project This (as of December Available Quarter? 31, 2015) (as of November 30, 2015)

Dr. John L. Barr Barr Memorial The Dr. John L. Barr Memorial Fund helps As of November 30, 2015, $8,619 is available $24,084 $8,619 1-May-04 Memorial Fund for Fund for Cancer to support the Intramural Research Training for transfer to the Clinical Center. Cancer Research Research Award Fellowship Program at the NIH Clinical Center's Pain and Palliative Care Service. The objective of the fellowship is to conduct research on pain and palliative care, and also to encourage young investigators to become more familiar with the importance of this field of study. Clinical Center Drug Clinical Center An initiative to get medicines donated to the The FNIH has secured in-kind gifts of $6,402,195 Project funds are 1-Jun-08 Donations Drug Donations Clinical Center from pharmaceutical pharmaceutical products valued at $5,677,257 completed. companies. Having these products (or the for the NIH Clinical Center Pharmacy since funds for the products) donated will free this program began in 2009. Gifts in 2014 funds from the Clinical Center's budget to were Lovenox and Docetaxel valued at support other clinical research activities. $1,055,252, from Sanofi and Tobramycin valued at $394,426 from Novartis. Sanofi has committed a new shipment of Lovenox and Docetaxel, valued at approximately $1 million, which will arrive at the Clinical Center before 12/31/2015.

Development & Endotoxin Endotoxin is an essential tool to study the NIH has identified a vendor to produce and $1,101,800 $270,896 1-Feb-06 Production of effects of inflammation, to demonstrate vial the new strain of endotoxin. This can be Endotoxin under GMP proof of principle for the effects of accomplished with the funds that have been for Human Clinical inflammatory modulation therapies and, more raised to date. In December 2014, FNIH Research recently, as a potent stimulus to enhance transferred $501,045 to the NIH for the immune responses in trials of anti-cancer project. FNIH also received a new gift from immunotherapy. Since 1997, NIH has Pfizer in January of 2015; this is available for provided endotoxin at no cost to both additional production and/or small studies. academic and pharmaceutical industry FNIH has been asked to contract with Duke investigators. In 2008, FNIH was asked to University for a Phase I study that will raise funds to cover the cost developing and evaluate the dose response of the new producing a new strain of endotoxin under preparation of Escherichia coli (E. coli group good manufacturing practices (GMP) O 113:H10:K negative) endotoxin in healthy conditions. With funds raised through 2012, human volunteers, the final stage before the the Biological Resource Branch of the new endotoxin can be produced, vialed and National Cancer Institute (NCI) helped the distributed. FNIH is negotiating the study Clinical Center develop a Master Cell Bank contract with Duke and anticipates the study's for E. coli O113, the original bacterial strain. completion within the coming months. This qualified reagent will serve as the source material for the development of the next generation GMP endotoxin.

Updated as of December 31, 2015 CC 1 Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project This (as of December Available Quarter? 31, 2015) (as of November 30, 2015)

John and Elaine Gallin Gallin Fund The Gallin Fund provides support for the The Fund continues under the new Letter of $129,833 $117,571 1-Jan-13 Fund Edmond J. Safra Family Lodge and to Agreement that provides that the fund is a support clinical research needs of the temporarily restricted fund rather than an intramural research program at the National endowment, which could provide for more Institutes of Health. flexibility making distributions. The fund will support the Edmond J. Safra Family Lodge and clinical research needs of the intramural research program at the National Institutes of Health. FNIH's Advancement Department will schedule a time to meet with the donors to discuss possible uses of the fund.

Safe and Effective Safe and Effective Building on a successful partnership among Videotaping of course segments began in $22,711 $2,108 1-Dec-14 Prescribing Initiative Prescribing NIH, FNIH, and the PhRMA Foundation December 2014. PhRMA Foundation and that supports the NIH's Principles in Clinical ASCPT have each provided funding to Pharmacology course, this initiative is support the effort. In February 2015, FNIH designed to leverage expertise and materials transferred $18,757 to the NIH Clinical developed for that course to develop a new, Center to cover costs of videotaping interactive course modules that will be made segments for the program. A total of $1,205 available to the medical school audience remains on hand at FNIH for this project; nationwide. The course is intended to both NIH and PhRMA Foundation are aware respond to a 2008 AAMC report that cited a of the remaining balance. Program lack of sufficient training in safe and effective development and implementation continues prescribing in the medical school curriculum. at NIH. Project partners are the NIH, FNIH, the American Society for Clinical Pharmacology and Therapeutics (ASCPT), the Reagan-Udall Foundation for the FDA (RUF) and the PhRMA Foundation.

Updated as of December 31, 2015 CC 2 Capital Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project This (as of December Available Quarter? 31, 2015) (as of November 30, 2015)

Edmond J. Safra Family Safra Family The Edmond J. Safra Family Lodge offers a The Nichols family continues their pledge $3,270,553 $71,206 1-Jan-98 Lodge (Bricks and Lodge (Bricks and home-like residence for families and loved payments toward a guest room. An Mortar) Mortar) ones of adult patients who are receiving care anonymous donor gave a gift of $10,000 in at the NIH Clinical Center, a comfortable September 2015 as a matching gift challenge environment intended to alleviate the to other contributors in honor of the 10th incredible burden that accompanies serious Anniversary of the Family Lodge, which has illness. The Family Lodge features 34 guest been met and exceeded. rooms, family gathering areas including living room, dining room, kitchen, playroom, library, exercise room, and telecommuting facilities that allow families to manage their home and business lives during their time at NIH. This project was funded by the Edmond J. Safra Philanthropic Foundation and other generous individual and corporate contributors.

Safra Family Lodge - All Safra Family The Edmond J. Safra Family Lodge offers a The FNIH hosted a 10th Anniversary $3,900,527 $1,080 1-May-05 Programs Lodge - All home-like residence for families and loved Celebration at the Family Lodge on Programs ones of adult patients who are receiving care November 5, 2015 honoring Mrs. Lily Safra at the NIH Clinical Center, a comfortable with invitation to Family Lodge donors, environment intended to alleviate the guests and NIH staff. Ongoing activities incredible burden that accompanies serious include fundraising to support holiday meals, illness. The Family Lodge features 34 guest as well as "wish list" items. A donor has rooms, family gathering areas including living expressed interest in supporting holiday meals room, dining room, kitchen, playroom, again in 2015 and a potential item on the library, exercise room, and telecommuting "wish list." Donations leveraged as part of facilities that allow families to manage their the $10,000 matching gift opportunity will go home and business lives during their time at toward the Family Lodge Breakfast Program, NIH. This project was funded by the which the FNIH continues to raise funds in Edmond J. Safra Philanthropic Foundation support. and other generous individual and corporate contributors. Ongoing gifts from donors provide support of the Family Lodge's operations and comfort of its guests. Annual investment income generated by an endowment fund supports program expenses, while the principal remains intact to ensure future funding.

Edmond J. Safra Family Safra Family The GlaxoSmithKline Endowment supports In 2014, over $20,000 was expended to $1,500,000 $1,500,000 1-Jan-01 Lodge GSK Lodge GSK programs and activities for families staying at support the Edmond J. Safra Family Lodge. Endowment Endowment the Edmond J. Safra Family Lodge, including A portion of these funds were supported by services that help residents stay in touch with the interest from this endowment and employers and loved ones. contributions designated for the support of the Lodge.

Updated as of December 31, 2015 CC 3 Capital Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project This (as of December Available Quarter? 31, 2015) (as of November 30, 2015)

Edmond J. Safra Family Safra Family Mrs. Lily Safra donated funding to support a The renovations were completed and the $323,275 Project funds are 4-Feb-15 Lodge Kitchen Lodge Kitchen feasibility study to renovate the kitchen at the kitchen reopened in the spring of 2015. The completed. Renovation Renovation Edmond J. Safra Family Lodge. The kitchen final project costs were under budget at is heavily used by families staying in the $323,273.77. Lodge, with many people using the kitchen to prepare all their meals. The purpose of a renovation is to increase the number of people who can cook at the same time, and to add more storage space for refrigerated and dry foods.

Edmond J. Safra Family Safra Family The Weinberg Endowment supports In 2014, over $20,000 was expended to $830,894 $830,894 1-Dec-00 Lodge Weinberg Lodge Weinberg Edmond J. Safra Family Lodge operations support the Edmond J. Safra Family Lodge. Endowment Endowment and maintenance, ensuring that guests are A portion of these funds were supported by provided a comfortable home away from the interest from this endowment and home for years to come. contributions designated for the support of the Lodge. Tracy's Toy Box Tracy's Toy Box This fund supports the purchase of toys and Funds from Tracy's Toy Box were used $13,982 $7,940 1-Jan-04 Memorial Fund activities for children staying at the Edmond recently to create a children's area at the J. Safra Family Lodge to help make their time Edmond J. Safra Family Lodge. The area there more comfortable and pleasant. Tracy's includes two new video screens, with a Toy Box was established in memory of Tracy gaming and educational system as well as Nadel. many new games. A book purchase is also contemplated. This will provide children with outlets for activity during the difficult periods when family members are being treated at the NIH. FNIH's Advancement Officer has been in discussions with the Family Lodge about other uses for the fund and it was agreed that the funds might be used to help create a new children's area after the recently completed kitchen renovation.

Updated as of December 31, 2015 CC 4 Education & Seminars

Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project This (as of December Available Quarter? 31, 2015) (as of November 30, 2015)

John Laws Decker Decker Memorial During his lifetime, Dr. John Laws Decker The 12th John Laws Decker Lecture and $40,910 $3,135 1-Jan-03 Memorial Fund Lecture Lunch strived to connect scientific communications Luncheon was held June 10, 2015 with the around the world to exchange information lecture delivered by Ranganath Muniyappa, and accelerate important research. His MD., PhD of the Diabetes, Endocrinology dedication to education and communication and Obesity Branch of the NIDDK as about science makes this annual lecture at speaker. The topic was "Impact of Selective NIH an especially fitting tribute to a Insulin Resistance on Cardiovascular Risk recognized leader and teacher. The NIH Reduction Strategies." The Decker family is Fellows Committee identifies and awards the planning another contribution to the fund. annual Distinguished Clinical Teacher's FNIH planning will begin for the 2016 lecture Award. This recipient is also the invited in Q1 2016. lecturer of the Decker Memorial Lecture as part of the Contemporary Clinical Medicine: Great Teachers Grand Rounds Program.

NIH Medical Research MRSP 2016-2017 The National Institutes of Health (NIH) Fundraising for the MRSP 2016-2017 class is Fundraising efforts Fundraising efforts 1-Jul-11 Scholars Program 2016- Medical Research Scholars Program (MRSP) ongoing. FNIH has identified potential are underway. are underway. 2017 is a comprehensive, year-long research prospects, and continue to conduct research enrichment program designed to attract the and analysis to determine which prospects most creative, research-oriented medical, have the capacity to give, are reachable and dental, and veterinary students to the are likely to support the MRSP. FNIH has intramural campus of the NIH in Bethesda, reached out to 32 prospects and will continue MD. Student scholars engage in a mentored follow-up. Formal requests for major gifts basic, clinical, or translational research project have been submitted to eight prospects that matches their professional interests and totaling $442,500 and we have been actively career goals. The MRSP combines and following up. Seven prospects have declined replaces two successful NIH training their support. No new funders have programs, the NIH-Howard Hughes Medical committed to date. FNIH recruited 15 CRTP Institute Scholars and the Clinical Research and MRSP alumni as Team Captains to help Training Program. raise funds from individuals and other alumni. We've received 40 gifts totaling $4,147.32 as of December 9, 2015. This represents a 108% increase in funding from individual donors from last year.

Principles of Clinical Principles of The PhRMA Foundation has supported the The PhRMA Foundation committed $72,650 $516,593 $11,461 1-Mar-08 Pharmacology Course Clinical Principles of Clinical Pharmacology Course to support the Principles of Clinical Pharmacology since 2008. This program (sponsored by the Pharmacology course for the 2015-16 class Course Clinical Center) covers much of what year. In October 2015, FNIH transferred researchers need to know about the clinical $52,282 to NIH for its costs in conducting pharmacologic aspects of drug development the program. The balance of funds support and use, including pharmacokinetics, drug travel and honoraria for program speakers, metabolism and transport, assessment of drug which is handled by FNIH. The course is effects, drug therapy in special populations, underway and continues through April 2016. and drug discovery and development.

Updated as of December 31, 2015 CC 5 Office of the Director Research Projects Project Name Display Description Latest News Money Raised Total Funds Launch New Name (as of Available Date Project December 31, (as of This 2015) November 30, Quarter? 2015) Accelerating Medicines AMP- The goal of AMP is to bring together the resources FNIH continues to convene regular meetings of an $4,075,000 $2,264,582 1-Nov-13 Partnership: Membership Membership of NIH and Industry to improve our understanding Executive Committee co-chaired by Dr. of disease pathways and facilitate better selection of and Mikael Dolsten of Pfizer. FNIH also convenes targets for treatment. Collaborations with 10 monthly meetings with the three disease-area Steering companies and three NIH Institutes have been Committees in order to manage the research plans in established across three major disease areas: each of the three disease areas. FNIH completed Alzheimer's disease, Type 2 diabetes, and immune- funding agreements with all of the companies and non- mediated disorders (RA/lupus). The AMP profit organizations that have expressed interest to date, Membership supports the infrastructure required to and continues to seek additional partners for AMP. facilitate the development of the AMP projects.

NIH Director's Initiative NIH Director's This Fund was established in 2008 to honor then As of November 30, 2015, FNIH has $2,195 available to $38,350 $2,195 1-Nov-08 Fund Fund NIH Director, , MD, and his vision transfer, upon request from the NIH Director. and commitment to public-private partnerships. This Fund, established with gifts in honor of Dr. Zerhouni, allows the current NIH Director to have a pool of unrestricted funds available, managed by the FNIH, to support special initiatives not possible through other sources.

Updated as of December 31, 2015 OD 1 Education & Seminars Project Name Display Description Latest News Money Raised Total Funds Launch New Name (as of Available Date Project December 31, (as of This 2015) November 30, Quarter? 2015) Amgen Scholars Program Amgen Scholars Amgen will sponsor 20 undergraduate research The Amgen Scholars program ran from June 6 to $850,000 $184,348 1-Jun-14 Program scholars per year for four years to participate in August 14, 2015. The program began with 20 NIH's Summer Internship Program. The program undergraduate students participating in a week-long will begin in June 2015. The Program will have four orientation prior to beginning their research placements. core components: 1) independent research The training focused on developing leadership and performed under the mentorship of an NIH communication skills, successfully working in diverse intramural scientist; 2) Career guidance and communities, self-care and resiliency, and career mentorship focused on the broad array of development. The Amgen Scholars met weekly as a biomedical careers; 3) roundtable discussions cohort for activities focused on additional career exploring the intersection of research and public enrichment and leadership skills, which included journal policy; and 4) leadership training focused on the clubs, seminars, and discussions of the role of science in development of skills needed to successfully work in health disparities. Participants worked in their research the team-oriented global research environment. groups to enhance their knowledge and develop new skills, and they participated in many NIH Summer Internship Program (SIP) workshops. The program has concluded for 2015 and FNIH submitted the progress report to Amgen. Planning is underway for 2016.

JKTG Foundation - Post- JKTG The Jayne Koskinas Ted Giovanis Foundation for On 12/18/15 Ted Giovanis and Graham Atkinson of Fundraising efforts Fundraising efforts 30-Jun-15 Baccalauereate and Graduate Foundation - Health Policy (JKTG Foundation) will provide JKTG visited the NIH campus for a tour of the labs are underway are underway Intramural Research Training Post-Bacc and scholarship support of two young investigators in and meet and greet with the students they have funded Fellows Graduate the Office of Intramural Training and Education (which included Dr. Sharon Milgram as their escort). Intramural under the mentorship of Dr. Sharon Milgram. The Pictures were circulated to the JKTG Foundation and Research scholarship recipients are: Jose Delgado-Jimenez for 133 Public Affairs. They were also sent to Dr. Milgram Training Fellows the Post baccalaureate Intramural Research Training to share with the students. Award with research interest in nanotechnology and cancer therapeutics, and Ryan Phillips for the - Jose Delgado-Jimenez, Postbac Intramural Research Graduate Partnerships Program with research Training - Martin Brechbiel, Ph.D., Section Chief x interest in mathematical/molecular modeling, brain Radiation Oncology Branch at the National Cancer circuitry and pain. A total investment of $105,210 is Institute (NCI) for first year funding of both student researchers - Ryan Phillips, Awardee from the Graduate Partnership which includes: stipend, insurance, and Program - Jeffrey Smith, Ph.D., Senior Investigator, travel/education/research allowance. Cellular and Systems Nuerobiology Section, National Institute of Neurological Disorders and Stroke (NINDS)

Oxford Cambridge Oxford NIH developed a graduate training program in Program efforts continue and have expanded to include $174,569 $2,358 1-Jan-04 Scholarship Program Cambridge collaboration with Oxford University and Cambridge the provision of short-term on-campus housing for the Scholarship University in England. Trainees spend part of their students. Program time at NIH and part at Oxford or Cambridge. The latter is the degree granting institution. The program attracts very high caliber students and NIH would like to expand it. FNIH granted FAES permission to handle this program. FNIH has agreed to handle any in-kind donations to the program.

Updated as of December 31, 2015 OD 2 Other Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015)

Biomarkers Consortium - Biomarkers The Biomarkers Consortium engages a broad list As of 12/18/2015 the Biomarkers Consortium (BC) has 29 $15,042,045 $1,808,234 1-Mar-05 Contributing Membership Consortium - of stakeholders and funders (which may include contributing members (10 not-for-profit or advocacy Contributing NIH, FDA, industry, associations and organizations and 19 pharmaceutical or for-profit Membership foundations) to support the infrastructure required companies). Beginning in 2015, a new membership option to facilitate the development of a variety of was offered to qualifying for-profit companies only interested biomarkers projects. In addition to creating and in participating in select BC steering committees. Companies supporting an infrastructure for broad, cross- with a $3B+ R&D budget can join at the rate of $40K per sector communication and consensus and committee; $1-3B R&D budget can join at the rate of $28K identifying areas of promising research, the per committee; and $100M-1B R&D budget can join at the Biomarkers Consortium also facilitates joint rate of $15K per committee. A Membership on at least two financial investment in the identified research committees in Tiers 1-3 required to nominate candidates, activities each of which emerge as a distinct serve on and vote for industry EC positions. Updated BC scientific initiative under the Consortium Membership collateral materials have been developed for new administrative "umbrella". member recruitment. The Development team is actively seeking new members. Outreach for renewals is ongoing. Charles A. Sanders Legacy Charles A. The creation of the Charles A. Sanders Legacy A reception was held Thursday, November 19 in Raleigh, NC $958,561 $279,713 1-May-15 Fund - Project Legacy Sanders Legacy Fund will provide the flexibility for FNIH to at the Umstead Hotel and Spa to inaugurate The Charles A. Fund incubate new ideas and launch innovative, creative Sanders Legacy Fund campaign. Dignitaries from academia, initiatives that will continue to enhance biomedical medicine and government were represented. Follow-up research. This investment will also allow FNIH to letters and pictures were to all invited and those who maintain the operations structure to react rapidly attended. Board solicitations under the signature of Dr. and responsibly to new NIH requests under Martin Murphy were also mailed in December to evoke unique circumstances. Lastly, the fund will enable additional support. As of 12/21/15 the total amount funding FNIH to establish the Charles A. Sanders in gifts and pledges to date is $760,561.74. The Charles A. Partnership Award to recognize an outstanding, Sanders Scientific Symposium is scheduled for Thursday, top-contributing industry partner each year, March 24, 2016. Venue, speakers and guest list currently in during the annual FNIH Award Ceremony or a progress. comparable event.

Eliminate Dengue Eliminate To develop a heritable, self-sustaining biocontrol This project is an extension of an ongoing project funded $21,031,216 $5,080 31-Aug-13 Dengue (or method using Wolbachia bacteria to interrupt previously under the Grand Challenges in Global Health and ED) transmission of dengue virus in Aedes aegypti VCTR programs, and aims to develop a new self-sustaining mosquitoes. Dengue poses a serious public health vector control tool for reducing dengue transmission. risk to over 40% of the world's population. This Releases continued in Townsville, northern Australia, to test research responds to a global need for innovative the ability to deliver the technology at city-wide scale. approaches to prevent the transmission of vector- Releases were completed in Cairns, Australia. Plans are being borne diseases that are safe, easily deployed, developed for a trial to assess effects on dengue transmission effective and sustainable, and thus will improve in Vietnam. Work at other sites is proceeded according to the health and well-being of populations living in plan. under-resourced countries. FNIH Travel support for NIH Travel for This travel grant will be used to arrange for and In May 2015, the project was awarded a 3-year extension and $348,644 $271,138 1-Aug-13 NIH Scientists Gates provide support to National Institutes of Health supplemental funds from the Gates Foundation. During the (NIH) personnel to participate in technical, second quarter of 2015, FNIH began collaborations with strategic and advisory meetings as needed and NIAID to provide travel support for participants of a requested by the Gates Foundation. September workshop on Visceral Leishmaniasis Control and Elimination per a request from the Gates Foundation. The workshop titled "Visceral Leishmaniasis Control and Elimination: Is there a Clear Role for Vaccines in Achieving Regional and Global Goals" was held on September 10-11, 2015.

Support functions for Support This project will cover funding for a variety of FNIH received an award on March 13, 2015 from the Bill & $2,238,951 $848,221 1-Feb-15 development of new functions for activities in support of the Eliminate Dengue and Melinda Gates Foundation to begin this project in support of technologies for controlling VCTR Target Malaria projects. These two projects are the VCTR project. FNIH contracted with 2 consultants for transmission of mosquito- managed by FNIH under two other BMGF development of business plans for the Target Malaria and borne diseases grants, Vector-Based Control of Transmission: Eliminate Dengue programs, which have been delivered. One Discovery Research (VCTR) and Eliminate contract was extended resulting in a white paper on lessons Dengue. The activities to be supported by this learned in moving development programs from a university new grant include: consulting contracts, meeting to independent non-profit setting. In May 2015, FNIH planning and support, and a jointly funded (with ratified a contract with NAS to conduct a study on NIH) study to be conducted by the National "Reprogramming Organisms using Gene Drives: Academy of Sciences (NAS). Recommendations for Responsible Conduct of Research," and the first meeting was held on July 30. Discussions are ongoing for support of stakeholder engagement efforts in support of the Target Malaria program.

Updated as of December 31, 2015 OTHER 1 Research Projects Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015) Vector-based Control of VCTR The Vector-based Control of Transmission: discovery Funding ended under the VCTR program for the project to $58,774,067 $791,809 1-Nov-09 Transmission: Discovery Research(VCTR) program will continue investments in develop a Wolbachia-mediated biocontrol method to eliminate Research promising, ongoing projects originated under the dengue virus transmission, but remains active under the separate Grand Challenges in Global Health (GCGH) initiative Eliminate Dengue project. Funding to the Target Malaria project on chemical and genetic strategies to deplete or for development of endonucleases for control of malaria incapacitate disease-transmitting mosquitoes, and transmission is ongoing. FNIH is working with both projects in identify additional innovative approaches to prevent support of future proposals for additional funding. New grants to the transmission of vector-borne diseases. Funding be awarded in 2016 will be made directly by the Gates Foundation, for FNIH management will come from funds whereas FNIH will continue to participate in a support capacity remaining from GCGH. after current grants end. Three of the four VCTR projects on insecticide discovery are ongoing, and one ended in June 2015.

Updated as of December 31, 2015 OTHER 2 Events Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015) 2016 FNIH Award 2016 Award In 2016, FNIH will hold its forth annual award The fourth annual FNIH Award Ceremony will take place on Fundraising is Fundraising is 1-Jul-15 Ceremony Ceremony ceremony at which it will present the Lurie Prize Wednesday, May 18, 2016. Top venue selection is House of underway underway in Biomedical Sciences. Sweden, contract to be signed Q1 2016. Sponsorship materials were reviewed and approved by the Development Committee and solicitations were sent to former Award Ceremony sponsors. Thus far two returning sponsors and one new sponsor have pledged support totaling $22,000.

Lurie Prize Lurie Prize In 2013, FNIH presented the first Lurie Prize, an On May 20, 2015, FNIH presented the 2015 Lurie Prize in Fundraising is Fundraising is 1-Nov-11 annual award recognizing outstanding Biomedical Sciences to Karl Deisseroth, M.D., Ph.D., for underway underway achievement by a promising young scientist in innovative advances in brain research and technology. Dr. biomedical research. The Prize amount is Deisseroth is recognized for leading the development of $100,000, to be used as the recipient chooses. It is optogenetics, a technology for controlling cells with light to made possible by a generous gift from FNIH determine function, as well as for CLARITY, a method for Board member Ann Lurie. The winner is selected transforming intact organs into transparent polymer gels to by a jury of six distinguished biomedical allow visualization of biological structures with high researchers, chaired by Solomon H. Snyder, M.D., resolution and detail. The 2016 Lurie Prize winner has been Distinguished Service Professor of Neuroscience, chosen by the jury and will be announced by FNIH in Pharmacology & Psychiatry, The Solomon H. January. Snyder Department of Neuroscience, Johns Hopkins University School of Medicine. The 2013 and 2014 prizes were awarded to Dr. Ruslan Medzhitov and Dr. , respectively.

Education & Seminars Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015) Norman P. Salzman Salzman Dr. Norman P. Salzman's family, colleagues and The seventeenth annual Norman P. Salzman Memorial $219,537 $99,697 1-Jan-99 Memorial Award and Memorial friends remember the legacy of this noted pioneer Symposium was held Thursday, November 5, 2015 featuring Lecture in Virology Award & in molecular biology through contributions to the Keynote Speaker - Stanley Lemon, M.D., Professor of Lecture Salzman Memorial Fund, which supports the Medicine and Microbiology & Immunology, University of annual Norman P. Salzman Memorial Award and North Carolina at Chapel Hill. Other speakers included: Symposium in Virology. The half-day symposium Galit Alter, PhD, Associate Professor of Medicine, Director, addresses key topics in virology and immunology Harvard Center for Aids Research Immunology Core; Jeffrey and presents an award to a young researcher, in D. Lifson, M.D., Director, AIDS and Cancer Virus Program; recognition of Dr. Salzman's mentorship of so and Erica Ollmann Saphire, Ph.D., Professor, Dept. of many young scientists. In 2008, the Salzman Immunology & Microbial Science Co-Director, The Scripps Memorial Fund celebrated its 10th anniversary. Research Institute. FNIH promoted the Symposium on its website and assisted with various logistics for the event. The committee has approved November 17, 2016 for the 18th Annual Salzman Symposium. The first committee meeting for 2016 will take place January 20, 2016 at FNIH.

Other Project Name Display Name Description Latest News Money Raised Total Funds Launch Date New Project (as of December 31, Available This Quarter? 2015) (as of November 30, 2015) William McCormick Blair William A memorial fund established in honor of William At the request of Mrs. Blair, per Dr. Freire, the remaining $5,150 Funds are to be 1-Dec-04 III Memorial Fund McCormick McCormick Blair III. balance of this fund in the amount of $5,150 will be transferred to Blair III transferred to the Charles A. Sanders Legacy Fund. Charles A.

Updated as of December 31, 2015 OTHER 3 Foundation for the National Institutes of Health, Inc.

Financial Statements

Years Ended December 31, 2015 and 2014

Foundation for the National Institutes of Health, Inc.

Table of Contents

Independent Auditors' Report ...... 1

Financial Statements:

Statements of Financial Position ...... 3

Statements of Activities ...... 4

Statements of Cash Flows ...... 6

Notes to Financial Statements ...... 7

Supplementary Information:

Schedules of Functional Expenses ...... 25

Independent Auditors' Report

Board of Directors Foundation for the National Institutes of Health, Inc. Bethesda,

We have audited the accompanying financial statements of Foundation for the National Institutes of Health, Inc., which comprise the statements of financial position as of December 31, 2015 and 2014, and the related statements of activities and cash flows for the years then ended, and the related notes to the financial statements.

Management’s Responsibility for the Financial Statements Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

Auditors’ Responsibility Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditors’ judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Opinion In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Foundation for the National Institutes of Health, Inc. as of December 31, 2015 and 2014, and the changes in its net assets and its cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America.

1

Report on Supplementary Information Our audits were conducted for the purpose of forming an opinion on the financial statements as a whole. The schedules of functional expenses on page 25 are presented for purposes of additional analysis and are not a required part of the financial statements. Such information is the responsibility of management and was derived from and relates directly to the underlying accounting and other records used to prepare the financial statements. The information has been subjected to the auditing procedures applied in the audits of the financial statements and certain additional procedures, including comparing and reconciling such information directly to the underlying accounting and other records used to prepare the financial statements or to the financial statements themselves, and other additional procedures in accordance with auditing standards generally accepted in the United States of America. In our opinion, the information is fairly stated, in all material respects, in relation to the financial statements as a whole.

Richmond, Virginia May 6, 2016

2 Foundation for the National Institutes of Health, Inc. Statements of Financial Position December 31, 2015 and 2014

2015 2014

ASSETS Current assets: Cash and cash equivalents $ 19,229,033 $ 13,888,313 Appropriations receivable 500,000 500,000 Contributions receivable, net 9,355,038 16,050,466 Accrued interest 20,704 20,247 Prepaid expenses and other receivables 107,953 81,275

Total current assets 29,212,728 30,540,301

Contributions receivable 229,829 3,277,400

Investments 45,152,406 65,143,504

Furniture and equipment, net 50,340 54,336

Total assets $ 74,645,303 $ 99,015,541

LIABILITIES AND NET ASSETS Current liabilities: Accounts payable and accrued expenses $ 1,460,257 $ 1,338,401 Funds held for others, agency transactions 577,271 1,338,837 Charitable gift annuity 156,970 163,461 Deferred grant revenue, current portion 2,120,000 -

Total current liabilities 4,314,498 2,840,699

Deferred grant revenue 3,797,756 4,587,961

Other deferred revenue 57,501 17,500

Total liabilities 8,169,755 7,446,160

Net assets: Unrestricted: Unrestricted, general 5,165,965 5,047,787 Board designated 6,496,424 6,710,785

Total unrestricted 11,662,389 11,758,572

Temporarily restricted 51,608,294 76,594,675 Permanently restricted 3,204,865 3,216,134

Total net assets 66,475,548 91,569,381

Total liabilities and net assets $ 74,645,303 $ 99,015,541

See accompanying notes. 3 Foundation for the National Institutes of Health, Inc. Statement of Activities Year Ended December 31, 2015

U00 U01 U02 Temporarily Permanently Unrestricted Restricted Restricted Total Revenue, support and other changes: Contributions $ 243,921 $ 31,356,893 $ 8,731 $ 31,609,545 Grants 663,972 - - 663,972 In-kind contributions 874,517 - - 874,517 Government appropriations 1,000,000 - - 1,000,000 Donated services 110,811 - - 110,811 Fundraising event 257,150 - - 257,150 Investment and interest income (203,485) (1,399) - (204,884) Administrative fee, agency transactions and grants 194,500 - - 194,500 Net assets released from restrictions: Satisfaction of administrative fee requirements 2,993,803 (2,993,803) - - Satisfaction of program restrictions 53,367,972 (53,367,972) - -

Total revenue, support and other changes 59,503,161 (25,006,281) 8,731 34,505,611

Expenses: Program services: Fellowships and training programs 1,210,274 - - 1,210,274 Memorials, awards and events 734,852 - - 734,852 Capital projects 313,270 - - 313,270 Research partnerships 53,177,305 - - 53,177,305

Total program services 55,435,701 - - 55,435,701

Supporting services: Management and general 3,781,357 - - 3,781,357 Fundraising 382,386 - - 382,386

Total supporting services 4,163,743 - - 4,163,743

Total expenses 59,599,444 - - 59,599,444

Change in donor designation 100 19,900 (20,000) -

Change in net assets (96,183) (24,986,381) (11,269) (25,093,833)

Net assets, beginning of year 11,758,572 76,594,675 3,216,134 91,569,381

Net assets, end of year $ 11,662,389 $ 51,608,294 $ 3,204,865 $ 66,475,548

See accompanying notes. 4 Foundation for the National Institutes of Health, Inc. Statement of Activities Year Ended December 31, 2014 (Continued)

U00 U01 U02 Temporarily Permanently Unrestricted Restricted Restricted Total Revenue, support and other changes: Contributions $ 356,880 $ 72,405,297 $ 8,734 $ 72,770,911 Grants 634,635 - - 634,635 In-kind contributions 1,724,619 - - 1,724,619 Government appropriations 500,000 - - 500,000 Donated services 188,637 - - 188,637 Fundraising event 184,675 184,675 Investment and interest income 108,392 98,087 - 206,479 Administrative fee, agency transactions and grants 197,177 - - 197,177 Miscellaneous revenue 153,956 - - 153,956 Net assets released from restrictions: Satisfaction of administrative fee requirements 3,109,085 (3,109,085) - - Satisfaction of program restrictions 69,423,844 (69,423,844) - -

Total revenue, support and other changes 76,581,900 (29,545) 8,734 76,561,089

Expenses: Program services: Fellowships and training programs 1,605,067 - - 1,605,067 Memorials, awards and events 442,058 - - 442,058 Capital projects 103,421 - - 103,421 Research partnerships 69,780,507 - - 69,780,507

Total program services 71,931,053 - - 71,931,053

Supporting services: Management and general 3,928,920 - - 3,928,920 Fundraising 270,153 - - 270,153

Total supporting services 4,199,073 - - 4,199,073

Total expenses 76,130,126 - - 76,130,126

Change in donor restriction - 20,000 (20,000) -

Change in net assets 451,774 (9,545) (11,266) 430,963

Net assets, beginning of year 11,306,798 76,604,220 3,227,400 91,138,418

Net assets, end of year $ 11,758,572 $ 76,594,675 $ 3,216,134 $ 91,569,381

See accompanying notes. 5 Foundation for the National Institutes of Health, Inc. Statements of Cash Flows Years Ended December 31, 2015 and 2014

2015 2014

Cash flows from operating activities: Change in net assets $ (25,093,833) $ 430,963 Adjustments to reconcile change in net assets to net cash used by operating activities: Depreciation 21,850 26,542 Contributions restricted for long-term purposes (8,731) (8,734) Net realized and unrealized loss on investments 572,781 7,824 Change in assets and liabilities: Contributions receivable 9,742,999 (8,909,956) Accrued interest (457) 19,463 Prepaid expenses and other receivables (26,678) 122,950 Accounts payable and accrued expenses 121,856 (2,397,351) Funds held for others, agency transactions (761,566) 142,705 Charitable gift annuity (6,491) (6,543) Deferred grant revenue 1,329,795 (732,778) Other deferred revenue 40,001 (2,500)

Net cash used by operating activities (14,068,474) (11,307,415)

Cash flows from investing activities: Furniture and equipment acquisitions (17,854) (48,862) Sales and maturities of investments 76,492,222 71,282,940 Purchase of investments (57,073,905) (60,522,315)

Net cash provided by investing activities 19,400,463 10,711,763

Cash flows from financing activities: Contributions restricted for investment in permanent endowment 8,731 8,734

Net increase (decrease) in cash and cash equivalents 5,340,720 (586,918)

Cash and cash equivalents, beginning of year 13,888,313 14,475,231

Cash and cash equivalents, end of year $ 19,229,033 $ 13,888,313

See accompanying notes. 6 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Notes to Financial Statements

1. Organization and Nature of Activities

Foundation for the National Institutes of Health, Inc. (Foundation) is a not-for-profit organization, whose mission is to support the National Institutes of Health (NIH) in its mission, and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations.

2. Summary of Significant Accounting Policies

Basis of accounting The financial statements of the Foundation have been prepared on the accrual basis of accounting and, accordingly, reflect all significant receivables, payables, and other liabilities.

Basis of presentation The Foundation is required to report information regarding its financial position and activities according to three classes of net assets: unrestricted net assets, temporarily restricted net assets and permanently restricted net assets.

Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Accordingly, actual results could differ from those estimates.

Cash and cash equivalents For purposes of the financial statement presentation, cash and cash equivalents includes all cash on hand, demand accounts, and highly-liquid investments with original maturities of three months or less, excluding temporarily uninvested money market funds held in brokerage accounts.

Investments Investments are recorded at market value. Realized gains or losses are recognized upon sale or disposal. Interest income is recorded on the accrual basis. Unrealized gains and losses, due to market fluctuations during the year, are recognized at year-end.

Contributions and appropriations receivable Unconditional contributions receivable that are expected to be collected within one year are recorded at net realizable value. Unconditional contributions to be collected in more than one year are recorded at net present value, which approximates fair value. Conditional contributions receivable are recognized when the conditions on which they depend are substantially met. Credit risk for contributions receivable is concentrated, as a significant amount of contributions receivable are received from a few donor organizations. Appropriations receivable are stated at net realizable value and are deemed fully collectible by management.

7 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Allowance for uncollectible receivables Contributions receivable are stated at unpaid balances, less an allowance for doubtful accounts. Management has established an allowance for uncollectible contributions receivable in the amount of $15,000 as of December 31, 2015 and 2014, based on a review of historical collections. Receivables are considered delinquent if full principal payments are not received in accordance with the contractual terms. It is the Foundation’s policy to charge off uncollectible accounts receivable when management determines the receivable will not be collected. Amounts recorded as other receivables are deemed to be fully collectible by management. Accordingly, an allowance has not been recorded for those receivables.

Furniture and equipment Furniture and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which is three to five years. The Foundation’s policy is to capitalize furniture and equipment purchased with a cost of $1,000 or more. Donated equipment is recorded at fair market value at the date of contribution. As of December 31, 2015 and 2014, furniture and equipment was $680,486 and $662,632, respectively, and accumulated depreciation was $630,146 and $608,296, respectively.

Contributions Contributions received are recorded as unrestricted, temporarily restricted, or permanently restricted revenue depending on the existence and/or nature of any donor restrictions. Donor-restricted revenue is reported as an increase in temporarily or permanently restricted net assets, depending on the nature of the restriction. When a restriction expires (that is, when a stipulated time restriction ends or purpose restriction is accomplished), temporarily restricted net assets are reclassified to unrestricted net assets and reported in the statements of activities as net assets released from restrictions.

Agency transactions The Foundation recognizes a liability equal to the fair value of assets received by the Foundation for which the donor stipulates that the assets are to be used on behalf of the donor or another entity (the beneficiary) or to be transferred to another entity.

Grant revenue recognition Amounts received under grant awards are considered exchange transactions and are recognized as unrestricted revenue when the related expenses are incurred. Unexpended amounts received are recorded as deferred grant revenue. Expenditures in excess of receipts are recorded as grants receivable.

Appropriations revenue recognition Government appropriations are recognized as revenue in the year they are appropriated.

Allocation of expenses Salaries and benefits have been allocated to program and supporting services based on timekeeping by employees.

Income taxes 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, 2015 and 2014.

Subsequent events In preparing these financial statements, the Foundation has evaluated events and transactions for potential recognition or disclosure through May 6, 2016, the date the financial statements were available to be issued.

8 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

3. Concentration of Credit Risk

Financial instruments that potentially subject the Foundation to concentration of credit risk consist of cash transaction accounts. The Foundation places its cash transaction accounts with high credit quality financial institutions. On December 31, 2015 and 2014, the Foundation had deposits in excess of the amount insured by the Federal Deposit Insurance Corporation (FDIC). The Foundation has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk on cash and cash equivalents.

4. Cash and Cash Equivalents

Elements of cash and cash equivalents consisted of the following at December 31:

2015 2014

Cash in banks $ 697,708 $ 637,673 Money market funds 18,531,325 13,250,640

$ 19,229,033 $ 13,888,313

5. Investments

Investments as of December 31, 2015, are summarized as follows:

Market Cost Value

Money market funds $ 1,902,239 $ 1,902,239 Stocks 518,639 679,071 Corporate bonds 868,496 861,052 U.S. government bonds 32,488,329 32,488,437 Exchange traded funds 1,446,692 1,428,541 Bond mutual funds 2,201,608 2,099,258 Equity mutual funds 6,053,913 5,693,808

$ 45,479,916 $ 45,152,406

The following schedule summarizes the investment return and its classification for 2015.

Temporarily Unrestricted Restricted Total

Interest and dividends $ 243,527 $ 124,370 $ 367,897 Realized gains 3,062 14,492 17,554 Unrealized losses (450,074) (140,261) (590,335)

Total investment return $ (203,485) $ (1,399) $ (204,884)

9 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Investments as of December 31, 2014, are summarized as follows:

Market Cost Value

Money market funds $ 6,354,230 $ 6,354,230 Stocks 500,486 703,404 Corporate bonds 207,623 213,211 U.S. government bonds 56,901,467 56,897,792 Exchange traded funds 81,339 113,810 Bond mutual funds 614,943 591,522 Equity mutual funds 230,871 269,535

$ 64,890,959 $ 65,143,504

The following schedule summarizes the investment return and its classification for 2014.

Temporarily Unrestricted Restricted Total

Interest and dividends $ 133,514 $ 80,789 $ 214,303 Realized losses (54,907) (10,878) (65,785) Unrealized gains 29,785 28,176 57,961

Total investment return $ 108,392 $ 98,087 $ 206,479

6. Contributions Receivable

Contributions receivable at December 31, were as follows:

2015 2014

Receivable in less than one year $ 9,370,038 $ 16,065,466 Receivable in one to five years 235,000 3,355,212 Total unconditional contributions receivable 9,605,038 19,420,678 Discounts to net present value (5,171) (77,812) Allowance for uncollectible contributions receivable (15,000) (15,000)

Net unconditional contributions receivable $ 9,584,867 $ 19,327,866

The discount rate used on long-term contributions receivable was 2.25% in 2015 and 2014.

10 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

7. Conditional Contributions Receivable

As of December 31, the Foundation had the following contributions receivable subject to donor conditions:

2015 2014 Conditioned upon the funder not notifying the Foundation by a specific date that they do not wish to fund the program: Comprehensive T Cell Vaccine Immune Monitoring Consortium $ - $ 1,933,733 Comprehensive Investigation into the Risk Factors of Malnutrition and the Consequences for Child Health 1,097,544 3,767,419 Centralized Envelope Comparative Immunogenicity Study - 629,092 Vector-based Control of Transmission: Discovery Research - 1,540,004 Alzheimer’s Disease Neuroimaging Initiative-2 70,000 210,000 Lurie Prize in Biomedical Research 200,000 300,000 Identification of high-quality HITs for Tuberculosis 1,571,489 3,223,919 Support functions for Vector-based Control of Transmission Research 56,855 - Biomarkers Consortium High Definition Single Cell Analysis of Blood and Tissue Biopsies 1,200,000 - Pew Latin American Fellows Awards 15,750 39,375 Biomarkers Consortium – Bone Quality Project 100,000 810,000 Exacerbation Sub-Study of SubPopulations and Intermediate Outcomes Measure in COPD study (SIROMICS) 40,000 160,000 Lifespan Connectome Project 2,322,580 - FNIH Travel Support for NIH Scientists - 79,978 Rapid identification of individuals with viable adult female worms of Onchoerca volvulus: a means to the end - 286,932 Eliminate Dengue - 4,059,554 Accelerating Medicines Partnership, Membership - 1,900,000 Health Effects of Moderate Drinking 13,860,000 - Biomarkers Consortium Novel Cardiac Biomarkers in the General US Population 300,000 750,000 Conditioned upon meeting certain milestones and/or the funder not canceling: The Sports and Health Research Program 16,325,242 16,325,242 Biomarkers Consortium Autism Spectrum Disorder 1,000,000 - NINDS/CNS Getch Scholar 100,000 - Prize: Low Dose Helical CT (Coding for Cancer) 1,800,000 - Alzheimer’s Disease Neuroimaging Initiative-3 2,000,000 - Accelerating Medicines Partnership: Alzheimer's Disease 13,450,000 13,450,000 Accelerating Medicines Partnership: RA, SLE & Related Autoimmune Disorders 12,445,000 12,445,000 Accelerating Medicines Partnership: Type 2 Diabetes 13,000,000 13,000,000 Roth Fellowship for Chronic Active Epstein Barr Virus and Chronic Active Epstein Barr Virus-Hydroa Vacciniforme 52,500 52,500 Biomarkers Consortium Minimal Residual Disease Detection in Adult Acute Lymphoblastic Leukemia 484,000 1,384,000 Amgen NIH Scholars Program 425,000 637,500 The Pew Scholars Program in the Biomedical Sciences 126,000 204,750

$ 82,041,960 $ 77,188,998

Since these represent conditional contributions receivable, they are not recorded as contributions receivable and contribution revenue until donor conditions are met.

11 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

8. Board Designated Net Assets

The Board of Directors has established two board designated funds as follows at December 31:

2015 2014

Endowment Fund $ 6,044,650 6,259,011 Contingency Fund 451,774 451,774

$ 6,496,424 $ 6,710,785

9. Temporarily Restricted Net Assets

As of December 31, temporarily restricted net assets were available for the following purposes:

2015 2014 Fellowships and Training Programs: Amgen Scholars Program $ 184,371 $ 177,500 Clinical Research Training Program 292,561 292,561 Dean R. O'Neill Renal Cell Cancer Research Fund 184,703 167,296 Dr. Edward T. Rancic Memorial Fund 11,935 47,083 Dr. John L. Barr Memorial Fund 8,969 8,620 Neva Fund 30,567 35,033 NIH Medical Research Scholarship Program 772,377 1,256,091 NINDS/CNS Getch Scholar 95,000 - NOB Fund 8,652 25,983 Norman P. Salzman Memorial Award and Lecture in Virology 117,014 116,625 Pew Biomedical Scholars 45,020 45,000 Principles of Clinical Pharmacology Course 10,853 55,504 Robert Whitney Newcomb Memorial Lecture and Internship 1,082,254 1,124,377 Sallie Rosen Kaplan Fellowship for Women Scientists in Cancer Research - 5,227 The Penates Fellowship - 70,114 The Bernard Osher Foundation NCCAM Practitioner Research Career Development Award - 56,304 Swanson Family Fellowship in Generic Thyroid Benign Chorea and IgA Deficiency (TTF-1) 92,500 92,500 Memorials, Awards and Events: 2016 Alzheimer's Disease-Related Dementia (ADRD) Summit 6,408 - Adam J. Berry Memorial Fund 5,820 7,020 Alzheimer’s Disease Research Summit: AD Summit 31,128 73,288 Breast Cancer Summit 9,296 9,296 Breast Cancer Summit 2 65,740 65,740 Carcinoid Summit Workshop 22,129 22,129 Celebrating 50 Years of Brain Research: New Discoveries, New Hope 171,451 171,451 Clinical Research Training Program 10-Year Reunion 23,642 23,642 Dr. Anita Roberts Memorial Fund 28,005 23,805 Dr. Jane M. Sayer Vision Research Lecture and Award 220,158 219,900 Edna Williams Curl & Myron R. Curl Endowment for Multiple Sclerosis Research 63,876 63,698

12 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Human Genome Exhibition 198,010 283,832 John Laws Decker Memorial Fund 3,271 3,798 NCI National Clinical Trials Network (NCTN) Workshop - 39,007 Polio Conference 40,698 40,698 Stephen E. Straus Award 111,575 116,975 William McCormick Blair, III Memorial Fund - 5,150 Capital Projects: Edmond J. Safra Family Lodge Bricks and Mortar 80,567 70,521 Edmond J. Safra Family Lodge All Programs 9,082 - Edmond J. Safra Family Lodge GSK Endowment - 16,782 Edmond J. Safra Family Lodge Weinberg Endowment - 2,696 Edmond J. Safra Family Lodge Gallin Endowment 117,588 117,445 Edmond J. Safra Family Lodge Kitchen Renovation 676,726 929,277 Tracy's Toy Box 7,941 7,941 Research Partnerships: Accelerating Medicines Partnership Membership 2,664,882 1,933,746 Accelerating Medicines Partnership: Type 2 Diabetes 7,349,186 8,606,127 Accelerating Medicines Partnership: Alzheimer's 2,430,996 6,263,440 Accelerating Medicines Partnership: Rheumatoid Arthritis and Lupus 2,580,170 5,475,966 ADNI - Optimization of Alzheimer’s Disease Cognitive Measures Project 15,980 15,980 Alzheimer's Disease Neuroimaging Initiative – 2 937,110 7,801,102 Alzheimer's Disease Neuroimaging Initiative – 3 22,933 - AREDS2 ancillary 381,764 381,764 Biomarker Consortium 2,079,891 1,367,058 Biomarkers Consortium: Atherosclerosis Computer Modeling 1,210,714 1,440,544 Biomarkers Consortium: Autism Spectrum Disorder 541,456 - Biomarkers Consortium: Beta Cell Clinical Trial 1,662,932 2,673,165 Biomarkers Consortium: Bone Quality Project 1,287,832 684,273 Biomarkers Consortium: CABP-Skin Infection 93,137 229,302 Biomarkers Consortium: CSF-Based Biomarkers in AD 75,319 75,511 Biomarkers Consortium: HABP/VABP Working Group 235,586 331,215 Biomarkers Consortium: HD-SCA in CRC (High Definition Single Cell Analysis of Blood and Tissue Biopsies 800,000 - Biomarkers Consortium: Kidney Safety 907,393 1,388,168 Biomarkers Consortium: MRD Project 1,210,473 760,820 Biomarkers Consortium: Pet Variability 25,000 25,000 Biomarkers Consortium: Placebo Data Analysis Project in AD 221,577 222,908 Biomarkers Consortium: Target BMx 98,900 - Biomarkers Consortium: Novel Cardiac Biomarkers in the General US Population 725,000 312,500 Biomarkers Consortium: Osteoarthritis Project 244,864 373,286 Bradley Charitable Gift Annuity 45,900 52,733 Cancer Research Fund 111,622 100,137 Centralized Envelope Comparative Immunogenicity Study (CECI). 10,385 318,172 Charles A. Sanders Legacy Fund 628,514 - Coding for Cancer 195,970 - Comprehensive Investigation into the Risk Factors of Malnutrition and the Consequences for Child Health 860,881 2,560,164 Comprehensive T Cell Vaccine Immune Monitoring Consortium 299,673 327,499

13 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTVIMCS2) 3,077,211 4,661,263 Development of a Second Generation Broadly Neutralizing Antibody (2GVRC01) 58,810 229,086 Effects of Moderate Drinking 1,525,043 - Eliminate Dengue 5,081 3,818 Epidemiology of Visceral Leishmaniasis in Bihar, India 80,141 121,050 Epilepsy Research in the Laboratory of Kareem Zaghloul, M.D., Ph.D 148,212 261,000 FDG-PET Lung/Lymphoma 873,011 1,173,489 FNIH Travel support for NIH Scientists 270,852 37,839 Follicular Lymphoma Research Fund 20,700 - Gates Funding for NIAID Ebola Community Engagement project 113,308 - Gramlich Melanoma Research Trust 112,961 92,811 Grand Challenges in Global Health 119,258 119,258 Heart Truth Community Grant Award Program 47,361 773,608 HIT-TB 2,154,245 3,135,836 I-SPY TRIAL-2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) 263,268 277,965 Kids Thrive - 161,416 Lifespan Connectome Project 540,000 - Lung Cancer Master Protocol (LungMAP) 144,386 794,669 NIDDK DILIN - 185,874 Rapid identification of individuals with viable adult female worms of Onchocerca volvulus: a means to the end 14,951 27,080 Sarcopenia 2 515,653 483,453 Schizophrenia Metabolic Initiative - 108,891 Solarz Memorial Fund 478,988 186,984 Spiromic Project 329,721 1,030,424 Spiromics Exacerbation Sub-Study 71,990 420,597 Support functions for VCTR 843,121 - Support of Ebola Research by NIAID 7,845 15,943 The Hemodialysis Fistula Maturation Cohort Study 24,317 24,317 The Lowy Cancer Research Support Fund 20,000 - The Sports and Health Research Program 1,180,848 6,349,891 Sports and Health Research Program P2 CTE Research 2,629,254 - Sports and Health Research Program P3 CTE Pilot 16,797 - The William N. Cafritz Trust - Recruitment Support for Parkinson's Disease 97,000 - VCTR (Vector-based Control of Transmission) 700,067 5,795,109 Vol-PACT 107,466 243,030 Other Temporarily Restricted Programs 230,501 269,485

$ 51,608,294 $ 76,594,675

14 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

10. Permanently Restricted Net Assets

Permanently restricted net assets consist of endowment fund assets, included in investments on the statements of financial position to be held indefinitely. The earnings from these assets are to be used for the purposes established by the donors and are recorded as temporarily restricted interest revenue for those purposes.

As of December 31, permanently restricted net assets consisted of the following endowed gifts to be held in perpetuity with the income to be used for:

2015 2014

Edmond J. Safra Family Lodge: GlaxoSmithKline Endowment Fund $ 1,500,000 $ 1,500,000 Harry and Jeanette Weinberg Endowment at the Edmond J. Safra Family Lodge 830,894 830,894 Sallie Rosen Kaplan Fellowship for Women Scientists in Cancer Research 747,772 767,772 Norman P. Salzman Memorial Fund 100,000 100,000 CarMollNat Muscular Dystrophy Endowment 26,199 17,468

$ 3,204,865 $ 3,216,134

11. Endowments

The Foundation’s endowments consist of individual donor-restricted endowment funds established for a variety of purposes and board designated endowments. Net assets associated with endowment funds are classified and reported based on the existence or absence of donor-imposed restrictions.

Interpretation of relevant law The Board of Directors of the Foundation has interpreted the Maryland State Prudent Management of Institutional Funds Act (SPMIFA) as requiring the preservation of the fair value of the original gift as of the gift date of the donor- restricted endowment funds absent explicit donor stipulations to the contrary. As a result of the interpretation, the Foundation classifies as permanently restricted net assets (a) the original value of the gifts donated to the permanent endowment, (b) the original value of subsequent gifts to the permanent endowment, and (c) accumulations to the permanent endowment made in accordance with the direction of the applicable donor gift instrument at the time of the accumulation to the fund. The remaining portion of the donor-restricted endowment fund that is not classified in permanently restricted net assets is classified as temporarily restricted net assets until those amounts are appropriated for expenditures by the Foundation in a manner consistent with the standard of prudence prescribed by SPMIFA. The Foundation considers the following factors in making a determination to appropriate or accumulate donor-restricted endowment funds:

1. The duration and preservation of the fund 2. The purposes of the Foundation and the donor-restricted endowment fund 3. General economic conditions 4. The possible effect of inflation and deflation 5. The expected total return from income and the appreciation of investments 6. Other resources of the Foundation 7. The investment policies of the Foundation

15 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

The endowment net asset composition, by type of fund, was as follows as of December 31, 2015:

Temporarily Permanently Unrestricted Restricted Restricted Total

Donor-restricted endowment funds $ (79,315) $ 117,010 $ 3,204,865 $ 3,242,560 Board-designated endowment funds 6,259,011 - - 6,259,011

Total $ 6,179,696 $ 117,010 $ 3,204,865 $ 9,501,571

The changes in endowment assets were as follows for 2015:

Temporarily Permanently Unrestricted Restricted Restricted Total

Endowment net assets, beginning of year $ 6,259,011 $ 141,515 $ 3,216,134 $ 9,616,660 Investment return: Investment income - 70,821 - 70,821 Net appreciation (realized and unrealized) (79,315) (92,335) - (171,650)

Total investment return (79,315) (21,514) - (100,829)

Contributions - 1,625 8,731 10,356

Appropriation of endowment assets for expenditure - (24,616) - (24,616)

Change in donor restriction - 20,000 (20,000) -

Endowment net assets, end of year $ 6,179,696 $ 117,010 $ 3,204,865 $ 9,501,571

The endowment net asset composition, by type of fund, was as follows as of December 31, 2014:

Temporarily Permanently Unrestricted Restricted Restricted Total Donor-restricted endowment funds $ - $ 141,515 $ 3,216,134 $ 3,357,649 Board-designated endowment funds 6,259,011 - - 6,259,011

Total $ 6,259,011 $ 141,515 $ 3,216,134 $ 9,616,660

16 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

The changes in endowment assets were as follows for 2014:

Temporarily Permanently Unrestricted Restricted Restricted Total Endowment net assets, beginning of year $ - $ 153,974 $ 3,227,400 $ 3,381,374 Investment return: Investment income - 12,011 - 12,011 Net appreciation (realized and unrealized) - (370) - (370) Total investment return - 11,641 - 11,641 Contributions - 4,230 8,734 12,964 Appropriation of endowment assets for expenditure - (48,330) - (48,330) Transfers 6,259,011 - - 6,259,011 Change in donor restriction - 20,000 (20,000) -

Endowment net assets, end of year $ 6,259,011 $ 141,515 $ 3,216,134 $ 9,616,660

From time-to-time, the fair value of assets associated with individual donor-restricted endowment funds may fall below the level that the donor or state UPMIFA guidelines require the Foundation to retain as a fund of perpetual duration. In accordance with GAAP, deficiencies of this nature that are reported in unrestricted net assets as of December 31, 2015 and 2014 were $79,315 and $0, respectively. These deficiencies resulted from unfavorable market fluctuations that occurred shortly after the funds were put into a new investment fund.

Return objectives and risk parameters The Foundation has adopted investment and spending policies for endowment assets that attempt to maximize long-term results, consistent with a prudent level of risk while seeking to maintain the purchasing power of the endowment assets. Endowment assets include those assets of donor-restricted funds that the Foundation must hold in perpetuity or for a donor-specified period or purpose. Under this policy, as approved by the Board of Directors, the endowment assets are invested to maximize long-term results, consistent with a prudent level of risk. The goal is to produce a return on the assets to support the programmatic purposes, while also achieving growth of principal in order to maintain real purchasing power. This approach helps assure that gifts to endowment funds keep pace with inflation and always support the designated activity.

Strategies employed for achieving objectives To satisfy its long-term rate-of-return objectives, the Foundation relies on a total return strategy in which the investment returns are achieved through both capital appreciation (realized and unrealized) and current yield (interest and dividends). The Foundation targets a diversified asset allocation that balances fixed-income and equity-based investments to achieve its long-term return objectives within prudent risk constraints.

17 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

12. Grant Revenue

The Foundation receives a portion of its support under certain grants and contributions that may be audited by the donors and the ultimate determination of allowable costs is determined by such audits.

13. In-Kind Contributions

Telephone expense, on-line communication costs, and some office space for the Foundation are donated by NIH. The value of the telephone expense, value of the on-line communication costs, and estimated rental value, has been reflected in the accompanying financial statements as in-kind contributions with a like amount recorded as telephone expense, communications expense, or rent/housing expense. For 2015 and 2014, these in-kind contributions from NIH of $225,428 and $217,140, respectively, are reflected in the financial statements.

In 2015 and 2014, the Foundation received drugs from Sanofi-Aventis and Novartis for the Clinical Center Drug Donation project. The estimated value of the drugs is determined by the current market value that NIH pays for the drugs, and has been reflected in the accompanying financial statements as in-kind contributions with a like amount recorded as program contracts. For 2015 and 2014, in-kind contributions for these materials of $649,089 and $1,452,514, respectively, are reflected in the financial statements.

In 2014, the Foundation received other goods and services for various projects. The estimated value of the goods and services is determined by the donor, based on costs and current market value and has been reflected in the accompanying financial statements as in-kind contributions with a like amount recorded as program contracts. For 2014, in-kind contributions for these goods and services of $54,965 are reflected in the financial statements.

18 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

14. Donated Services

The Foundation receives benefit from services donated by NIH, which include various administrative and technical services performed by NIH employees. The estimated value of these services is based on the hourly rate and average benefit amount of the NIH employees. The estimated amount of these services has been reflected in the accompanying financial statements as donated services with a like amount recorded as salaries and benefits expense.

The Foundation also receives benefit from donated legal services. The value of these services has been reflected in the financial statements as donated services with a like amount recorded as professional fees expense.

For 2015 and 2014, donated services of $110,811 and $188,637, respectively, are reflected in the financial statements.

15. Retirement Plan

The Foundation has a retirement plan through TIAA-CREF. The plan calls for a mandatory contribution of at least 2% of annual salary from participating employees and an additional contribution of 10% of annual salary from the Foundation. Retirement plan expense for 2015 and 2014 was $512,501 and $458,277, respectively.

16. Concentration of Revenue

For 2015 and 2014, the Foundation received approximately 49% and 25%, respectively, of its revenue from contributions and grants from the Bill and Melinda Gates Foundation. For 2014, the Foundation received approximately 11% of its revenue from contributions from The National Football League.

17. Relationship with the Foundation for Advanced Education in the Sciences, Inc.

The Foundation was established under legislation that authorized it to be the sole entity responsible for soliciting funds on behalf of NIH and to conduct specific other activities that support NIH in its mission. Certain of the activities described in the legislation are conducted by the Foundation for Advanced Education in the Sciences, Inc. (FAES) under a Memorandum of Understanding (MOU) with the Foundation. This MOU preserves the prerogatives conferred on the Foundation by its authorizing legislation but also allows the FAES to carry on its current activities under the authority of the Foundation.

19 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

18. Fair Value of Financial Instruments

Accounting Standards Codification (ASC) Topic 820 provides a framework for measuring fair value. That framework provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). The three levels of the fair value hierarchy are described below:

Level 1 Inputs to the valuation methodology are unadjusted quoted market prices for identical assets or liabilities in active markets that the Foundation has the ability to access. Level 2 Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.

Following is a description of the valuation methodologies used for assets measured at fair value.

U.S. government and corporate bonds: Valued at quoted market price per number of units held at year-end.

Equity mutual funds: Valued at net asset value (NAV) of shares held at year-end.

Bond mutual funds: Valued at net asset value (NAV) of shares held at year-end.

Exchange traded funds: Valued at net asset value (NAV) of shares held at year-end.

Common stocks: Valued at quoted market values of shares held at year-end.

All assets have been valued using a market approach. Fair values for assets in Level 2 are calculated using quoted market prices for similar assets in markets that are not active. There were no changes in the valuation techniques during the current year.

The preceding methods described may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, although the Foundation believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

20 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

The following sets forth by level, within the fair value hierarchy, the Foundation’s assets at fair value as of December 31, 2015 and 2014:

Assets at Fair Value as of December 31, 2015 Level 1 Level 2 Level 3 Total

Corporate bonds $ 861,052 $ - $ - $ 861,052 U.S. government bonds 32,488,437 - - 32,488,437 Equity mutual funds: Large-cap growth 1,207,344 - - 1,207,344 Large-cap blend 2,181,146 - - 2,181,146 Large-cap value 673,835 - - 673,835 Mid-cap growth 442,915 - - 442,915 Mid-cap blend 285,045 - - 285,045 Small-cap blend 440,020 - - 440,020 Small-cap value 183,056 - - 183,056 Emerging market 4,841 - - 4,841 Multi-alternative 275,606 - - 275,606 Bond mutual funds: Low extensive 73,458 - - 73,458 Low limited 2,726 - - 2,726 Medium moderate 19,001 - - 19,001 Intermediate 42,597 - - 42,597 International 1,122,921 - - 1,122,921 Short term 306,930 - - 306,930 Small growth 5,454 - - 5,454 High yield bond 526,170 - - 526,170 Exchange traded funds: Large-cap growth 38,300 - - 38,300 Large-cap value 309,401 - - 309,401 Mid-cap blend 447,987 - - 447,987 Government 614,346 - - 614,346 Inflation-protected bond 10,968 - - 10,968 Intermediate-term bond 7,539 - - 7,539 Common stocks: Large-cap core 205,072 - - 205,072 Large-cap growth 135,863 - - 135,863 Large-cap value 170,144 - - 170,144 Large-cap blend 54,665 - - 54,665 Mid-cap growth 22,361 - - 22,361 Small-cap value 72,399 - - 72,399 Exchange traded fund 11,285 - - 11,285 Mid-cap value 7,283 - - 7,283

Total investments $ 43,250,167 $ - $ - $ 43,250,167

21 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

Assets at Fair Value as of December 31, 2014 Level 1 Level 2 Level 3 Total Corporate bonds $ 213,211 $ - $ - $ 213,211 U.S. government bonds 56,897,792 - - 56,897,792 Equity mutual funds: Large-cap growth 42,929 - - 42,929 Large-cap blend 73,865 - - 73,865 Large-cap value 83,017 - - 83,017 Mid-cap growth 21,841 - - 21,841 Mid-cap blend 5,290 - - 5,290 Small-cap blend 11,343 - - 11,343 Small-cap value 3,697 - - 3,697 Emerging market 5,530 - - 5,530 Multi-alternative 5,351 - - 5,351 Europe stock 8,398 - - 8,398 Pacific/Asia 8,274 - - 8,274 Bond mutual funds: Low extensive 72,240 - - 72,240 Low limited 14,563 - - 14,563 High yield 272,138 - - 272,138 Medium moderate 18,369 - - 18,369 Intermediate 66,668 - - 66,668 International 100,377 - - 100,377 Short term 27,089 - - 27,089 Small growth 6,271 - - 6,271 Emerging market 13,807 - - 13,807 Exchange traded funds: Large-cap growth 32,029 - - 32,029 Large-cap value 31,320 - - 31,320 Mid-cap value 17,263 - - 17,263 Mid-cap blend 4,725 - - 4,725 Inflation-protected bond 28,473 - - 28,473 Common stocks: Large-cap core 201,657 - - 201,657 Large-cap growth 137,981 - - 137,981 Large-cap value 189,073 - - 189,073 Large-cap blend 45,237 - - 45,237 Mid-cap core 11,382 - - 11,382 Mid-cap growth 26,568 - - 26,568 Small-cap value 83,741 - - 83,741 Mid-cap value 7,765 - - 7,765

Total investments $ 58,789,274 $ - $ - $ 58,789,274

22 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

19. Conditional Grant Awards

As of December 31, 2015 and 2014, the Foundation has authorized conditional scientific grants under the following programs:

2015 2014

Grand Challenges in Global Health and Vector-based Control of Transmission: Discovery Research $ - $ 6,295,317 Comprehensive T Cell Vaccine Immune Monitoring Consortium 1,951,416 3,490,237 HIT-TB 3,606,948 2,747,514 Accelerating Medicines Partnership: Type 2 Diabetes (AMP-Type 2 Diabetes) 2,671,484 - LungMaP (Lung Cancer Master Protocol) 400,000 - Gates GCGH/VCTR 948,002 - Biomarkers Consortium – Osteoarthritis Project - 24,500 Biomarkers Consortium – Bone Quality Project 660,115 695,115 Rapid identification of individuals with viable adult female worms of Onchocerca volvulus; a means to the end - 278,858 Eliminate Dengue - 3,866,242

$ 10,237,965 $ 17,397,783

These authorized awards would become a liability to the Foundation in the future, if the grantees meet certain conditions, including the Foundation’s satisfaction with and approval of progress reports.

20. Lease

The Foundation has an office location in Bethesda, Maryland under a lease agreement with the Federation of American Societies for Experimental Biology (FASEB). Beginning in 2007, the Foundation entered into a new lease agreement with FASEB for a ten year period which expires October 31, 2017. The Foundation also has an option to extend the lease for two additional five year terms.

The future minimum lease payments required under the operating lease for the years ending December 31, are as follows:

2016 $ 465,986 2017 401,125

$ 867,111

Rent expense under this lease was $530,842 and $431,431, respectively, for 2015 and 2014.

23 Foundation for the National Institutes of Health, Inc. Notes to Financial Statements

21. Risks and Uncertainties

The Foundation invests in various investment securities. Investment securities are exposed to various risks, such as interest rate, credit and overall market volatility risks. Due to the level of risk associated with certain securities, it is at least reasonably possible that changes in the values of investment securities will occur in the near term and such changes could materially affect the Foundation's account balances and amounts reported in the statements of financial position.

24

Foundation for the National Institutes of Health, Inc.

Supplementary Information

Foundation for the National Institutes of Health, Inc. Schedules of Functional Expenses Year Ended December 31, 2015, with Comparative Totals for 2014

X00 X01 X02 X03 X05 X06 Program Services Supporting Services Fellowships Memorials, Total Total and Training Awards and Capital Research Program Management Supporting Total Total Programs Events Projects Partnerships Services and General Fundraising Services 2015 2014

Salaries and benefits $ 67,402 $ 60,602 $ 40,226 $ 3,503,876 $ 3,672,106 $ 2,793,413 $ 254,606 $ 3,048,019 $ 6,720,125 $ 6,086,131 Stipends 3,114 164,550 - - 167,664 - 2,500 2,500 170,164 223,718 Program contracts 895,985 133,973 213,081 24,361,141 25,604,180 - - - 25,604,180 38,141,869 Grant awards - - - 21,407,698 21,407,698 - - - 21,407,698 26,712,950 Meetings and travel 168,026 113,925 19,694 1,060,087 1,361,732 71,595 70,861 142,456 1,504,188 1,447,135 Office supplies and expense 3,370 2,476 163 15,466 21,475 10,676 662 11,338 32,813 23,251 Telephone - 27 - 79,677 79,704 72,139 4,246 76,385 156,089 153,428 Books and supplies - 78 - 4,051 4,129 5,101 223 5,324 9,453 12,295 Tuition - - - 1,220 1,220 - 143 143 1,363 4,693 Insurance - - - 145,139 145,139 48,746 - 48,746 193,885 171,874 Consultants - - 17,108 2,052,587 2,069,695 157,273 - 157,273 2,226,968 1,530,830 Professional fees - - - 170,954 170,954 84,314 - 84,314 255,268 419,498 Depreciation - - - - - 21,850 - 21,850 21,850 26,542 Rent/housing 70,614 - - 177,262 247,876 282,966 - 282,966 530,842 448,755 Recruiting - - - 54,574 54,574 6,005 - 6,005 60,579 154,967 Relocation ------8,800 Temporary services ------45,014 Dues and subscriptions 110 - - 7,814 7,924 7,818 2,510 10,328 18,252 13,425 Equipment and rental and maintenance 830 - 18,628 11,920 31,378 8,640 - 8,640 40,018 54,714 Printing and photocopying - 226,069 150 12,242 238,461 2,473 24,310 26,783 265,244 101,056 Postage and delivery 132 159 1 1,183 1,475 3,543 8,075 11,618 13,093 20,993 Service charges 686 14,383 4,219 12,887 32,175 78,352 1,177 79,529 111,704 98,517 Communications 5 3,854 - 91,267 95,126 115,768 13,001 128,769 223,895 202,973 Advertising and promotion - 14,756 - - 14,756 - - - 14,756 15,000 Miscellaneous - - - 6,260 6,260 10,685 72 10,757 17,017 11,698

$ 1,210,274 $ 734,852 $ 313,270 $ 53,177,305 $ 55,435,701 $ 3,781,357 $ 382,386 $ 4,163,743 $ 59,599,444 $ 76,130,126

25 Creating a Nexus Between Discovery and Collaboration

2015 Summary Annual Report

WHO WE ARE

The Foundation for the National Institutes of Health (FNIH) is an agile team of biomedical scientists, program managers and fundraisers.

We work with a large network of forward-thinking leaders and organizations to seek new knowledge and apply it to improve health, lengthen life and reduce illness and disability. We orchestrate productive research collaborations, incubate new research models and channel resources for maximum impact. In all we do, we support the mission of the National Institutes of Health (NIH), the largest biomedical research agency in the world, as it works to turn discovery into health.

The FNIH is a not-for-profit 501(c)(3) charitable organization established by Congress in 1990. The Foundation began work in 1996 to facilitate groundbreaking research at the NIH and worldwide.

ABOUT THE COVER This colorful image was based on a 2-photon fluorescent micrograph of Purkinje cells, which are large neurons, or nerve cells, with many branching extensions. Found in the brain’s cerebellum, which is the body’s locomotion control center, these cells receive and transmit impulses that make movement possible. Purkinje cells are a fitting metaphor for the work of the FNIH, given that we function as the control center for a range of multi- partner research initiatives, facilitating the transmission of information and expertise. Letter from the Chairman and President

Since its establishment nearly two decades ago, the Foundation for the National Institutes of Health (FNIH) has become a leader in forging powerful public-private partnerships that advance biomedical science. With the careful crafting and execution of cutting-edge initiatives, such as the Grand Challenges in Global Health and the Accelerating Medicines Partnership, the FNIH helps the National Institutes of Health (NIH) turn discovery into improved health.

As with many sectors, the need for collaboration in biomedical research is a necessity and requires expertise and years of experience. Many partnerships fail due to an inability to identify the right people, meet expectations and guide the team to measurable results. This leads to missed opportunities for groundbreaking contributions to science.

The FNIH is a proven catalyst for meaningful collaboration that produces results. To begin, the FNIH convenes the right people to develop solutions to a variety of health-related problems. CHARLES A. SANDERS, M.D. The FNIH draws upon expertise from academia, industry, federal agencies and not-for-profit CHAIRMAN organizations to address problems together, rather than working individually.

Facilitating collaboration with proven, flexible management and funding models that promote innovation, the FNIH fosters consensus and leads large-scale projects that succeed with transformative results. For example, the Biomarkers Consortium’s I SPY-2 project created a new landscape for clinical trials, using precision medicine to allow multiple breast cancer treatments to be tested at the same time in a single trial. It also introduced new adaptive designs to cancer trials and helped establish an accelerated approval pathway for new breast cancer medicines. Many FNIH programs have shown that these results are greater than what could be achieved by one organization and are meaningful for the entire biomedical community. MARIA C. FREIRE, PH.D. The FNIH’s success has resulted in a robust programmatic portfolio. As evidenced in this PRESIDENT AND report, the portfolio includes work to identify predictive biomarkers that correlate with knee EXECUTIVE DIRECTOR osteoarthritis progression and better inform treatments, to support clinical research to prevent age-related cognitive decline and to build the infrastructure needed in Mali to further bioinformatics research. Additionally, the FNIH continues work to raise funds for training the next generation of young scientists and to provide free lodging for NIH Clinical Center patients and their families through the Edmond J. Safra Family Lodge.

The future of biomedical innovation relies upon a collaborative approach to tackle the world’s most pressing health challenges. Looking ahead, the FNIH is well-positioned to continue building these essential partnerships that may lead to scientific breakthroughs and improve public health for generations to come.

CHARLES A. SANDERS, M.D. MARIA C. FREIRE, PH.D. CHAIRMAN PRESIDENT AND EXECUTIVE DIRECTOR FNIH At-a-Glance Foundations & Nonprofits Corporations OUR PARTNERSHIPS Our work depends on collaboration. The partnerships U.S. we forge provide funding support as well as expertise Government and resources to help us accomplish and expand Agencies our work. What we achieve collectively is far greater than that of any single organization. FNIH

Academia

WHAT WE DO The FNIH stands at the center of a broad portfolio of initiatives focused on shared goals: Individuals supporting the mission of the NIH and advancing biomedical science to improve lives. One of the most important functions the FNIH has is fundraising—without the ongoing support of our contributors, these initiatives would not be possible.

RESEARCH PARTNERSHIPS — We develop collaborations with top experts from government, industry, academia and the not-for-profit sector and provide a neutral environment where we can work productively toward a common goal. Examples include: • Portfolio Supporting NIH Research — Supporting and raising funds for multiple projects initiated by the NIH, while also convening the right partners within and outside of the NIH. • Global Health — Coordinating and operating 17 collaborative projects in 25 countries. • Biomarkers Consortium — Initiating and managing more than 20 projects funded with more than $50 million in private dollars, designed to develop and validate biological markers to support new drug development and patient care.

SYMPOSIA, EVENTS & EXHIBITS — We organize and facilitate more than 50 events each year, creating a forum for innovative thinkers in biomedical sciences to share ideas and engage the public in disease and health awareness.

FELLOWSHIPS & AWARDS — We provide funding for training for early-career scientists, along with support and recognition for researchers whose findings have advanced biomedical science.

PATIENT SUPPORT — The FNIH helps support patient care activities and amenities that provide comfort and assistance to patients and their loved ones being treated at the NIH Clinical Center. For example, since its opening in 2005, the Edmond J. Safra Family Lodge has hosted more than 100,000 room nights for patients of the NIH Clinical Center and their families. Creating a nexus between discovery and collaboration. Making the discoveries that advance human health is not simply a matter of bringing together the best minds from government, industry, academia and not-for- profits. It is also about knowing how to help those organizations collaborate in ways that harness their full power and potential. The FNIH excels at creating and then leading the processes that drive complex research projects forward. Whether we are working on a long-time health challenge or an emerging threat, we guide collaborations to achieve groundbreaking results that spur action, ultimately improving human health.

The Power of Collaboration: Accelerating the Quest for Critical Data

Finding better markers of osteoarthritis onset and progression Osteoarthritis develops over time as a joint’s “cushion” of cartilage breaks down and bone ends rub together, causing pain and loss of function. Knee osteoarthritis (OA) is the leading cause of disability in older adults and affects about 250 million people worldwide. Right now, OA is diagnosed only after people have discomfort, and the standard tool is an X-ray showing joint space narrowing. But the disease process PARTNERS begins long before symptoms appear; identifying those at risk and intervening earlier AbbVie Amgen could help avoid costly joint replacements. Arthritis Foundation Earlier diagnosis may soon be possible thanks to the Osteoarthritis Biomarkers BIOIBERICA S.A. Project, a $3.4 million study led by the FNIH Biomarkers Consortium in partnership DePuy Synthes Mitek Sports Medicine, a division with the National Institute of Musculoskeletal and Skin Diseases, the U.S. Food and of DePuy Orthopaedics, Inc. U.S. Food and Drug Drug Administration (FDA), universities and pharmaceutical companies to identify Administration, Center for Devices biomarkers (biological markers) of knee OA onset and progression. Using data and Radiologic Health from 5,000 high-risk patients gathered through the National Institutes of Health Flexion Therapeutics, Inc. GlaxoSmithKline Osteoarthritis Initiative, another public-private partnership that created an open-access Merck Serono repository of medical images and blood and urine samples, the FNIH-led team has National Institute of Arthritis and narrowed thousands of potential biomarkers down to a subset that correlates with knee Musculoskeletal and Skin Diseases OA progression. These include bone and cartilage changes visible on MRI and proteins Rottapharm | Madaus detectable in blood and urine. The biomarkers can pave the way toward identifying Sanofi people at risk and developing treatments that target the disease process.

P. 4 2015 Summary Annual Report Identifying new targets to drive drug development Launched in 2014, the Accelerating Medicines Partnership (AMP) is a five-year, $230 million effort joining the resources of the FNIH, the National Institutes of Health (NIH) and the FDA with those of several nonprofit organizations and data repository to be launched in 2016. For the first biopharmaceutical companies to devise a more time, partner organizations will be able to precise approach to early-stage drug development. AMP PARTNERS collaborate on genome-wide analysis of these These organizations are sharing expertise and data samples to better understand the mechanisms DIABETES: to identify the biological pathways underlying four behind the destruction caused by rheumatoid American Diabetes devastating diseases—type 2 diabetes (T2D), Association arthritis and systemic lupus erythmatosus, both rheumatoid arthritis/systemic lupus erythmatosus Eli Lilly and Company diseases in which the body’s immune system (RA/SLE) and Alzheimer’s disease (AD)—and then Janssen Research & destroys healthy tissue. Development, LLC validate the best candidates for targeting new AMP-AD includes two different projects. Project JDRF International medicines. AMP’s vision is to empower researchers A seeks to validate existing biomarkers as possible Merck & Co., Inc. to pursue new treatments with better odds of indicators of response to treatment in people with Pfizer Inc moving through the clinical trials pipeline Sanofi Alzheimer’s disease. Just one example is PET successfully. Current therapies for these conditions imaging of tau proteins in the brain, which has RA/SLE: cannot reverse the disease process nor stop its been added to two major NIH-funded phase II/III AbbVie progression. Alliance for Lupus Research drug trials. Project B is working to accelerate the In 2015, the AMP-T2D Project publicly launched Arthritis Foundation discovery of new therapeutic targets, moving a knowledge portal that has amassed large Bristol-Myers Squibb beyond the traditional focus on the buildup of amounts of genetic and clinical data from an array Company proteins such as amyloid and tau in brain tissue. of studies on people with type 2 diabetes. The The Lupus Foundation Researchers build a deeper understanding of the of America portal’s data cover a wide variety of ethnicities, networks in which these novel targets operate and Merck & Co., Inc. including African-American, East Asian, South Pfizer Inc validate them in different models. The project Asian, European and Hispanic, as well as diabetes- Rheumatology Research integrates analysis of large-scale molecular data related cardiovascular and kidney complications. Foundation from more than 2,000 human brains at all stages of Researchers will be able to search and analyze the Sanofi the disease with network modeling approaches and data to identify genetic variants associated with Takeda Pharmaceuticals experimental validation. This project has created a increased risk for, or protection against, the ALZHEIMER’S DISEASE: knowledge portal that enables rapid, broad sharing development of diabetes and its complications. In AbbVie of data and analytical tools, and periodically turn, these can become potential targets for new Alzheimer’s Association® releases public waves of large-scale molecular data treatments. Alzheimer’s Drug Discovery from human brain samples. The ultimate goal is to Foundation The AMP-RA/SLE Project has developed new shorten the time between discovery of potential Biogen methods for acquiring and processing tissue from drug targets to development of new drugs for Geoffrey Beene Foundation the kidneys and synovial membranes (linings of Alzheimer’s Initiative Alzheimer’s treatment and prevention. joints) and trained researchers to use these GlaxoSmithKline methods, making multi-site clinical studies Janssen Research & Development, LLC possible. This tissue, along with blood and urine Eli Lilly and Company samples, is being utilized to generate a new public Vradenburg Foundation

Creating a Nexus Between Discovery and Collaboration P. 5 The Power of Innovative Models: Reframing Approaches to Longstanding Challenges

Identifying biomarkers in children to help advance autism research An average of one in every 68 eight-year-old children in the United States is diagnosed with Autism Spectrum Disorder (ASD), typically based on behavioral observations by parents and caregivers—but these behaviors can range widely. Developing effective interventions and treatments through clinical trials depends on developing more sensitive and objective standards for diagnosing ASD in children and evaluating change over time. In 2015, the FNIH partnered with the National Institute of Mental Health, Simons Foundation Autism Research Initiative (SFARI), FDA, Janssen Research & Development, PARTNERS Eunice Kennedy Shriver LLC and European Autism Interventions - A Multicentre Study for Developing New National Institute of Child Health and Human Medications (EU-AIMS) to support a study of preschool and school-aged children Development with ASD to validate biomarkers that could help assess social function, track changes European Autism Interventions— in behavior and neurologic function, and potentially evaluate the effectiveness A Multicentre Study for Developing New of pharmacologic treatments. The FNIH is managing a $2 million contribution from Medications (EU-AIMS) Janssen Research & SFARI to fund the Yale University study led by James McPartland, Ph.D., Principal Development, LLC Investigator, which is collecting data from children at five sites nationwide using National Institute of Mental Health assessments of social impairment, such as clinician, caregiver and lab-based tools; National Institute of Neurological Disorders neurophysiological measures, such as eye tracking and studies of brain activity (EEG, and Stroke or electroencephalogram); and blood samples from participants and their parents for Simons Foundation Autism Research Initiative genetic analysis. This $28 million large-scale U.S. partnership to identify biomarkers U.S. Food and Drug Administration associated with ASD is part of the FNIH Biomarkers Consortium.

P. 6 2015 Summary Annual Report The Power of Innovative Models: Reframing Approaches to Longstanding Challenges

ACE PARTNERS The BioTeam Inc. Continuing in the search EMC Corporation for an HIV vaccine Hewlett Packard Enterprise Since the mid-1990s, the successful development Intel Corporation Health and Life Sciences Group of medications for people with human National Institute of Allergy Building research immunodeficiency virus, or HIV, has deflected and Infectious Diseases some attention from the search for a preventive University of Sciences, infrastructure in Africa vaccine. But no medicine has cured HIV, and only Techniques, and Technology of Bamako, To develop the new vaccines and treatments that about half of the more than 33 million HIV-positive Mali, West Africa improve public health, researchers require access people worldwide can access treatment. A to high-performance computing resources for successful vaccine is still considered fundamental CTVIMC PARTNERS collecting and analyzing complex biological data. for conquering HIV/AIDS. Becton, Dickinson and Company Many low-income countries lack the infrastructure For nearly 10 years, the FNIH has served as needed for bioinformatics research, even as they Beth Israel Deaconess coordinator for the Comprehensive T Cell Vaccine Medical Center face some of the world’s most challenging and Immune Monitoring Consortium (CTVIMC), a Biomedical Primate often-neglected diseases. central service facility within the Collaboration for Research Centre Last year, the FNIH played a pivotal role in Case Western Reserve AIDS Vaccine Discovery supported by the Bill & University helping the National Institute of Allergy and Melinda Gates Foundation. With more than $50 Centre hospitalier Infectious Diseases (NIAID) launch the first African million in funding and researchers at multiple universitaire vaudois Center of Excellence in Bioinformatics (ACE) in universities, as well as the Vaccine Research Center Duke University Mali, West Africa. Building on NIAID’s ongoing at the National Institute of Allergy and Infectious Fred Hutchinson Cancer Research Center support for researchers in Mali, the FNIH invited Diseases, the CTVIMC is looking at how candidate Henry M. Jackson corporate partners such as The BioTeam Inc., Intel HIV vaccines trigger a response from the body’s Foundation Corporation Health and Life Sciences Group, the immune system “defenders,” including T cells and B Imperial College London EMC Corporation and Hewlett Packard Enterprise cells and the antibodies they activate. The FNIH’s International AIDS Vaccine Initiative to donate equipment for computing and data role is to ensure that all of the researchers have McMaster University analysis, high-speed connectivity, and research and access to a standardized set of T cell and B cell National Institute of Allergy classroom spaces. Mali ACE opened in April 2015 assays—including materials, techniques, and Infectious Diseases at the University of Sciences, Techniques and measurements and reporting—so that results can National Institute of Health Technology of Bamako (USTTB). Local researchers and Medical Research be shared meaningfully across all sites. CTVIMC (INSERM, France) are now able to conduct advanced bioinformatics represents just one slice of the work going on within SeraCare Life Sciences research while receiving long-distance training and the Collaboration for AIDS Vaccine Discovery, University of Montreal mentorship by NIAID researchers. Mali ACE will which involves more than 600 investigators across University of Oxford serve as a model for future bioinformatics research 87 institutions in 12 countries. University of Washington centers in other regions of Africa. Vaccine & Institute Florida Wits Health Consortium

Creating a Nexus Between Discovery and Collaboration P. 7 The Power of Support: Channeling Resources for Greatest Impact

Recognizing groundbreaking work by early-career scientists Due to steady declines in financial support for basic science research, today’s young scientists face a challenging environment in which tenure-track university positions are scarce and about 85 percent of research grant proposals are unfunded. It is not unusual for biomedical researchers to reach their late 30s or 40s before receiving a major research grant—and this affects their ability to make significant, career-changing discoveries. Three years ago, the FNIH established the Lurie Prize in Biomedical Sciences, named for philanthropist and Board member Ann Lurie, to help propel the work of one truly stellar, early-career researcher each year. The prestigious prize, which includes a medal and significant research honorarium, is awarded at a Washington, DC ceremony every spring. The 2015 Lurie Prize winner was Howard Hughes Medical Institute Investigator and Stanford University neuroscientist and psychiatrist Karl Deisseroth, M.D., Ph.D., who along with his team has pioneered two game-changing techniques: optogenetics, which uses light to map the neural circuits in our brains, and a technology called CLARITY that allows scientists to make organs transparent and therefore easier to study under a microscope. In his hands, both promise to revolutionize our approach to neurological diseases such as major depression, Alzheimer’s and Parkinson’s.

—(l to r) Solomon H. Snyder, M.D., Chairman, Lurie Prize Jury and FNIH Board Vice Chairman for Science; Ann Lurie, Lurie Prize Honorary Chair and FNIH Board Member; Karl Deisseroth, M.D., Ph.D., 2014 Lurie Prize Recipient; Maria C. Freire, Ph.D., FNIH President and Executive Director; Francis S. Collins, M.D., Ph.D., NIH Director and FNIH Board Ex Officio Member

P. 8 2015 Summary Annual Report Investigating the genetics of age-related eye disease In 2001, researchers with the National Eye Institute’s Age-Related Eye Disease Study (AREDS) Preventing cognitive decline reported that a nutritional supplement called the Age-related decline in cognitive function is real and “AREDS formulation”—including high doses of varies widely among individuals, influencing quality , , beta-carotene, and of life, character of personal relationships and copper—can reduce the risk of developing capacity for making informed decisions about health advanced age-related macular degeneration care, retirement and other issues faced daily by (AMD), the leading cause of vision loss and millions of older adults. blindness for Americans over 65. A follow-up study In 2007, the McKnight Brain Research called AREDS2 enrolled more than 4,200 people Foundation (MBRF) partnered with the FNIH and with AMD and found that replacing beta-carotene the National Institute on Aging (NIA) to fund the in the AREDS formulation with lutein and first Cognitive Aging Summit, where dozens of zeaxanthin provided an incremental beneficial researchers shared ideas about how best to effect and reduced the risk of lung cancer, especially understand and remediate age-related cognitive in former and current smokers. Those results were decline. The Summit led to the Research Partnership published in 2013. Preventing the progression of in Cognitive Aging in 2008, a public-private effort AMD is critical since there are no effective between the NIA and the MBRF. Beginning in 2009, treatment options for advanced AMD. the partnership funded two research initiatives, Thanks in part to support from the FNIH, the 17 grants totaling $28 million over five years. The impact of the AREDS2 study will not end there. AREDS PARTNERS partnership supported a second Summit in 2010, Alcon Research Ltd. The FNIH provided funding to create the AREDS2 with recommendations leading to a third joint Bausch & Lomb Genetic Repository, a collection of blood and saliva initiative focused on interventions. Genentech samples from AREDS2 participants. Genomic In 2014, the partnership, along with the National National Eye Institute analysis is now under way, with the goal of Center for Complementary & Integrative Health and understanding how a person’s genes play a role in the NIH Office of Behavioral and Social Sciences COGNITIVE AGING the progression of vision-threatening AMD. Several PARTNERS Research, funded the $15 million MEDEX genetic variants were already identified in a McKnight Brain (Mindfulness, Health Education, & Exercise) trial. Research Foundation December 2015 Nature Genetics article. The Now underway, the trial is comparing the National Center for repository is an important new tool for all effectiveness of mindfulness-based stress reduction, Complementary and researchers studying the genetics of AMD. Integrative Health brain health education and aerobic exercise as National Institute strategies for improving cognitive function. on Aging NIH Office of Behavioral and Social Sciences Research

Creating a Nexus Between Discovery and Collaboration P. 9 Supporting Patients and Education

A GRATEFUL PATIENT’S PRAISE FOR RESEARCH “As an engineer with a healthy dose of curiosity, the process of searching for answers has always interested me. I have been at the NIH on a daily basis for EDMOND J. SAFRA FAMILY LODGE: 10 YEARS OF CARING almost three months and have not only On November 5, 2015, the FNIH welcomed Board member and observed my caregivers taking copious guest of honor Mrs. Lily Safra to celebrate the 10th anniversary of notes based on what I’m experiencing, the Edmond J. Safra Family Lodge, which since 2005 has hosted but also overheard post-doctoral interns more than 100,000 room nights for patients of the NIH Clinical talking to their advisors in the cafeteria, Center and their families. The Family Lodge provides a home-like noticed the topics of numerous and daily setting free of charge for guests from across the nation and around seminars being displayed on the atrium the world. This service exists thanks to the generosity of the monitors and developed a clear sense for Edmond J. Safra Philanthropic Foundation and many other everyone’s focus here. They are all individual donors, corporations and foundations. Mrs. Lily Safra searching for what they don’t know, donated proceeds from her Jewels for Hope auction to support challenging the norm and looking for the preservation of the Family Lodge according to her vision. answers in areas of human suffering that until even recently seemed completely —Mrs. Lily Safra (center) with the Family Lodge staff mysterious, or at least decades away at the 10th Anniversary Open House Celebration from any reliable solutions.” “This constant drive, the never- ending curiosity to search and to search again and again—this is research! It is the bedrock of this amazing and unique institution. We need to make sure the curiosity and the drive to seek solutions never abate due to a lack of funding or worse, apathy.”

—Romit Bhattacharya of Morris Plains, New Jersey, who at the urging of family and friends, traveled 260 miles to the NIH during the summer of 2015 to receive treatment for stage III lung cancer as part of a clinical trial. The FNIH fondly remembers Mr. Bhattacharya, who passed away in March 2016.

P. 10 2015 Summary Annual Report MEDICATION DONATIONS HELP SUPPORT FOR A NEW GENERATION OF EVERY DOLLAR SPENT, REDIRECT FUNDS TO RESEARCH OF RESEARCH SCIENTISTS 93 CENTS ARE USED TO Since 2009, Sanofi Foundation for North In fall 2015, two young scholars at the NIH America and Novartis Pharmaceuticals were awarded full funding for their first SUPPORT PROGRAMS AND Corporation have donated more than $6.4 year of education and training, thanks to JUST SEVEN CENTS FOR million in medications to the NIH Clinical a generous gift to the FNIH by the Jayne ADMINISTRATION AND Center through the FNIH’s In-Kind Drug Koskinas Ted Giovanis (JKTG) Foundation FUNDRAISING. Donation Program, freeing up critical for Health and Policy. dollars for research. The center is the Jose Delgado-Jimenez received an NIH nation’s largest hospital entirely devoted to Postbaccalaureate Intramural Research clinical research, and patients receive all Training Award/Cancer Research Training care free of charge. Award (Postbac IRTA/CRTA), which offers For 11 years, Charity Navigator recent college graduates who plan to apply has rated FNIH as an organization to graduate or health professional school that exceeds industry standards the opportunity to spend one or two years and performs as well or better than performing full-time research at the NIH. most charities. Jose has a special interest in nanotechnology and cancer therapeutics. The JKTG Foundation gift also supported a scholarship to NIH’s Graduate Partnership Program (GPP), which brings Ph.D. students to the MORE FELLOWSHIPS FOR KIDNEY NIH Intramural Research Program for CANCER RESEARCH dissertation research. Awardee Ryan Phillips’ October 4, 2015, marked the 10th research interests include mathematical/ anniversary of the Boo! Run for Life event in molecular modeling and brain circuitry. Washington, DC to benefit the Dean R. Both students are working side-by-side O’Neill Renal Cell Cancer Fund. This fund, with some of the leading scientists in the together with the Dr. Edward T. Rancic world and experiencing the collaborative, Memorial Cancer Research Fund, supports interdisciplinary research environment that a rotation of full-time fellows in the NIH has to offer. laboratory of Dr. Richard Childs of the —(l to r) Ted Giovanis, FHFMA, MBA, National Heart, Lung and Blood Institute, President and Founder JKTG Foundation for where they focus on developing novel Health and Policy; Jose Delgado-Jimenez; therapies for advanced kidney cancer. J. Graham Atkinson, D.Phil., JKTG Foundation, Exec. VP for Research and —Pictured: Jennifer Melis of Washington, DC Policy; Martin Brechbiel, Ph.D., Section Chief Radiation Oncology Branch at the National Cancer Institute (Jose’s mentor)

Creating a Nexus Between Discovery and Collaboration P. 11 Supporting Patients and Education

NEW FUNDING, NEW CAREER LAUNCHING WOMEN INTO HUMAN GENOME EXHIBIT ON TOUR PATHWAYS RESEARCH CAREERS Three million Smithsonian visitors toured Two major grants through the FNIH are In 2015, the Sallie Rosen Kaplan Genome: Unlocking Life’s Code from June helping the NIH create new career-building Postdoctoral Fellowship for Women 2013 to August 2014 at the National opportunities for aspiring researchers. Scientists in Cancer Research (SRK) Museum of Natural History, an exhibition Thanks to an $850,000 grant from the Program welcomed 10 outstanding made possible through funds raised, in Amgen Foundation, the NIH is now post-doctoral National Cancer Institute part, by the FNIH. The result of a one of a select group of higher learning researchers—all female and some from collaboration between the museum and institutions taking part in the Amgen underrepresented minority groups—to the National Human Genome Research Scholars Program, which provides participate in leadership workshops and Institute, Genome showcased the hundreds of summer research seminars, receive mentoring and coaching complexity and power of the human opportunities to undergraduate students. and develop a peer network. The program genome using 3-D models, interactive A $200,000 gift from the Congress of is designed to help with their transition to displays, custom animations and real-life Neurological Surgeons (CNS) has created independent research careers. stories. The exhibit is now on a five-year the NINDS/CNS Getch Scholar Award in tour to museums and science centers collaboration with the National Institute —Pictured left to right: Elizabeth Spehalski, across North America. of Neurological Disorders and Stroke Rachel Van Duyne, Leah Randles, Mariia (NINDS). This competitive award will Novikova, Clara Bodelon, Khadijah Mitchell, —2015 HOST CITIES: provide two years of funding to help an Tiffany Lyle, Elizabeth Yanik, Pamela Portland, Saint Louis, San Diego early-career neurosurgeon launch a clinical Gallagher, Maeve Mullooly and San Jose and research career at a U.S. academic medical center. —2016 HOST CITIES: Milwaukee (Jan. 23–April 25), — 2015 NIH scholars of the Amgen Salt Lake City (May 21–Sept. 5) and Scholars Program Wichita (Sept. 30 – Jan. 1, 2017)

P. 12 2015 Summary Annual Report Financial Highlights For the years ended December 31, 2015 and 2014

REVENUE AND SUPPORT 2015 2014 2015 REVENUE BY SOURCE Contributions $31,609,545 $72,770,911 57.2% Foundations Grants 663,972 634,635

Administrative fee 194,500 197,177 34.8% Corporations Government appropriations 1,000,000 500,000 3.5% Individuals Investment earnings (204,884) 206,479

In-kind contributions 874,517 1,724,619 2.9% Government Donated services 110,811 188,637 Fundraising event 257,150 184,675 1.6% Not-for-Profit Other revenue — 153,956

TOTAL REVENUE AND SUPPORT $34,505,611 $76,561,089 2015 DONORS BY TYPE

87.6% Individuals

EXPENSES AND CHANGES IN NET ASSETS 7.3% Corporations PROGRAM SERVICES 2.6% Foundations Fellowships and training programs $1,210,274 $1,605,067 Memorials, awards and events 734,852 442,058 2.4% Not-for-Profit Capital projects 313,270 103,421 Research partnerships 53,177,305 69,780,507 0.1% Government

TOTAL PROGRAM SERVICES $55,435,701 $71,931,053

SUPPORTING SERVICES 2015 EXPENSES Management and general $3,781,357 $3,928,920 89% Research Partnerships Fundraising 382,386 270,153

TOTAL SUPPORTING SERVICES $4,163,743 $4,199,073 Management and 7% Fundraising TOTAL EXPENSES $59,599,444 $76,130,126 Education and 4% Events

CHANGE IN NET ASSETS $(25,093,833) $430,963 NET ASSETS BEGINNING OF YEAR 91,569,381 91,138,418

NET ASSETS AT END OF YEAR $66,475,548 $91,569,381

The Foundation’s audited financial statements are available on request.

P. 13 Our Donors

All FNIH donors play a critical role in providing the resources that are vital to our success. Unrestricted gifts allow us the flexibility to use them where they are most needed, from supporting core operations to developing new partnerships and emerging program ideas. Donors also can choose to restrict their gifts to an area of interest, such as a biomedical research program; a fellowship, lecture or symposium that trains scientists and helps them build their careers; or a specific laboratory or area of scientific research at the NIH.

We are grateful to the many individuals and organizations who made donations, gifts and pledges in 2015. Every attempt is made to list donors according to their wishes. For a more complete list of donors, funds and endowments, visit fnih.org/AnnualReport. Please call 301.402.4976 if you have any questions.

$5,000,000+ GlaxoSmithKline 17 $100,000–$249,999 The Pew Charitable Trusts 2 Anheuser-Busch InBev McKnight Brain Research AgNovos Healthcare Pharmaceutical Research and Foundation 10 Manufacturers of America 11 Bill & Melinda Gates Astellas Pharma Inc. 2 Foundation 14 Merck Sharp & Dohme Corp. 18 Piramal Imaging SA 5 Bioiberica S.A. 2 National Institutes of Health 20 Roche 8 Buffy Cafritz 12 ∞ $2,500,000–$4,999,999 Pfizer Inc 18 Estate of Eugene Woolf and Congress of AbbVie Inc. 2 Dismas S. Blanco Neurological Surgeons Johnson & Johnson 15 $500,000–$999,999 Doris Duke Charitable $50,000–$99,999 Eli Lilly and Company 9 Sanofi* 14 Foundation 2 Abbott 8 National Football League 2 Takeda Pharmaceuticals The Jayne Koskinas International, Inc. 7 Ted Giovanis Foundation American Association for Wyeth Nutrition for Health and Policy Dental Research 3 $250,000–$499,999 Bayer HealthCare $1,000,000–2,499,999 Healthcare Information Pharmaceuticals Inc. 3 Arthritis Foundation 6 and Management Systems Amgen, Inc. 13 4 Society Howard Hughes AstraZeneca Laura and John Arnold Medical Institute 4 Pharmaceuticals, LP 14 Institut de recherches Foundation Internationales Servier JSI Research & Training Daiichi Sankyo, Inc. 6 Biogen 5 and ADIR Institute, Inc. 2

Fubon Financial Holding 4 Bristol-Myers Squibb Ann Lurie The Medicines Company 2 Venture Capital Corporation Company 16 5 ∞ Mr. and Mrs. Joel S. Marcus Novartis Pharmaceuticals Genentech, Inc. 9 Clinical Research Associates, Martin J. Murphy, Ph.D. and Corporation 16 LLC, an affiliate of the Simons Robert Wood Johnson 10 Ann Murphy, Ph.D. PhRMA Foundation 8 Foundation Foundation In honor of Dr. and Charles A. Sanders, M.D. Regeneron Pharmaceuticals, Mrs. Charles A. Sanders 19 3 and Ann E. Sanders Inc. National Dairy Council 5 Siemens Corporation

[x] Superscript indicates number of years of consecutive giving * Indicates gifts in kind ∞ Member of the Partners for Innovation, Discovery and Health Society

P. 14 2015 Summary Annual Report Our Donors

$25,000–$49,999 Andrew and Michelle Feinberg American Heart $2,500–$4,999 Association, Inc. American Society for First Tennessee Bank Anonymous Bone and Mineral Research 3 In honor of David Goldman American Society for Ronald and Barbara Berke 6 Clinical Pharmacology The Geoffrey Beene Foundation for Advanced In memory of Jenny Berke and Therapeutics Foundation Alzheimer’s Education in the Sciences 2 Joseph M. Feczko, M.D. 3 Initiative 6 The Association for Friends of Cancer Research and Leighton K. Gleicher 8 Frontotemporal Degeneration Biotechnology Innovation 5 Estate of Jack Gramlich Fisher Foundation Organization 8 Basilea Pharmaceutica Grifols Therapeutics 4 International Ltd. 5 Paul J. Gattini 4 Boehringer Ingelheim Pharmaceuticals, Inc.* 7 Hill-Rom Booz Allen Hamilton Inc. Happy Family Brands * ∞ Colgate-Palmolive Company 3 Rose J. Lem Luther W. Brady, M.D. Chris and Laura C. Hazzard 7 In honor of Charles A. Sanders In memory of Richard Curtin Forest Laboratories, Inc. Freda C. Lewis-Hall, M.D., FAPA 3 Frank C. and Marcia M. Jed Herrmann IXICO Ltd. 4 Carlucci Douglas R. Lowy, M.D. Gary G. Kochersberger, M.D. ∞ Peter and Judy Kovler 2 The Coca-Cola Company 8 ∞ Lumos Labs, Inc. Kelly and Adam Leight 3 Meso Scale Diagnostics, LLC. 7 3 Ernesto I. Freire, Ph.D. and Steve and Sherry Mayer ∞ Mr. Mehdi Nafissi and 4 Mr. and Mrs. Paul M. Maria C. Freire, Ph.D. 8 2 Dr. Ann F. Welton ∞ 18 ∞ Melinta Therapeutics Montrone ∞ Theodore N. Giovanis, M.B.A. 6 3 Donna Nichols NeuroRx 4 Myriad RBM Carol-Ann Harris 3 In memory of Jay Nichols 2 Rheumatology Research Neurotrack Technologies Susan C. Horowitz 4 ∞ Oncology Nursing Society Foundation 2 5 Bob and Sally Newcomb In memory of Arthur G. Horowitz Matt and Robyn BioClinica, Inc. 6 Pacific Biosciences James W. Jones 2 Nichols Painter 5 George and Trish Vradenburg, Robert E. Roberts, Ph.D. 7 In memory of Brenda S. Jones In memory of Jay Nichols Co-Founders USAgainst Dame Jillian Sackler 13 Jeffrey M. Leiden, M.D., Ph.D. Margot L. Pritzker Alzheimer’s 4 and Lisa Leiden Mrs. Lily Safra 14 PTA Jankowski Charitable Fund Anne H. McMahon $10,000–$24,999 Gerald R. Sigal and Sunny Raspet 3 Ellen V. Sigal, Ph.D. 6 The Multiple Myeloma Anonymous (2) John and Katrina Rogers 2 Research Foundation Nina K. Solarz 6 In memory of Brenda S. Jones Janet B. Abrams 7 Proof Centre of Excellence 5 ∞ In memory of Bernard W. Abrams University Hospitals SunTrust Banks, Inc. Health System Radiological Society Achaogen, Inc. Christopher and of North America 7 In honor of Douglas Lowy Elizabeth Thoma 2 ∞ John and Sandra Atkins The Richard H. Yearick Matthew Scher In memory of John K. and Sarah Bartosz Foundation ∞ and Barbara Lazio 3 Oberon Christopher Thoma In memory of Barbara L. Lazio BioClinica, Inc. 6 Travelers Companies, Inc. and Carol Scher In memory of Jared Latigona CHDI Foundation $5,000–$9,999 Sigma Theta Tau International Ullmann Family Foundation 7 ∞ The Geaton & JoAnn DeCesaris Anonymous (2) Samuel O. Thier, M.D. and Family Foundation, Inc. Alzheimer’s Association® 11 Steve and Chris Wilsey 7 Paula Thier 10 James H. and Alzheimer’s Drug Transmar Commodity Christina W. Donovan 4 Discovery Foundation 3 Group LTD The Epsilon Group American Diabetes Elias A. Zerhouni, M.D. and Association 6 EUROIMMUN AG 2 Nadia Zerhouni, M.D. 3 ∞

Creating a Nexus Between Discovery and Collaboration P. 15 Our Donors

$1,000–$2,499 Mark Fernandez Lisa Paul Allen Morris and In memory of Jared Latigona In memory of Jared Latigona Barbara Bissell Anonymous (3) In memory of William and Sherry Fiorani ∞ Michael and Melissa Phillips AcademyHealth 2 Lisa Marie deCarbonel In memory of In memory of Jared Latigona Advanced Medical Oberon Christopher Thoma Tino and Dawn Calabia 2 Natalie Pyon Technology Association— Antonio T. Fojo, M.D. and Megan Camillo AdvaMed RBC Capital Markets, LLC Susan E. Bates, M.D. In memory of Jared Latigona Daniel C. and Beverly Arnold Emily Rehwinkel James and Karen Gavic 6 ∞ Dan Balliet and Jan Carlson 7 ∞ In memory of Jared Latigona Dr. Nadarajah Stanley and Eve Geller 10 Michael and Melissa Cather 2 ∞ Balasubramanian 2 ∞ Johng S. Rhim, M.D. In memory of Norman P. Salzman and Mary L. Rhim 4 ∞ Jeffrey Chow 2 Bank of America Matching Peggy J. Gerlacher 18 Gifts Program Gregory and Sherry Roper 2 Madison Cox In memory of John D. Gerlacher Julie Bell Lindsay ∞ Robert and Marjorie Laura E. Crotty Alexander, M.D. Eli Glatstein, M.D. 12 ∞ Rosenberg 5 ∞ In memory of T. Douglas Lindsay Eugene J. Dionne and Margaret Grieve 3 ∞ Ann L. Bell Stanley O. Roth 2 Mary T. Boyle In honor of Nina K. Solarz In memory of T. Douglas Lindsay The San Diego Foundation ∞ Garth M. Eddy 2 Gary and Lynn Grossman 5 3 ∞ Joe Bergera and Alice S. Cho Cyrena Simons 2 ∞ Nicholas M. and David N. E. Heath Wayne and Lea Berman 2 Jacqueline E. Ferriter 2 In memory of Jared Latigona Richard I. and Zachary T. Bloomgarden, Ph.D. Anastasia Smith 3 ∞ Richard Folkers ∞ Paul Herrling, Ph.D. 2 ∞ and Kathy F. Bloomgarden, The Drs. Tremoulet 7 Seth P. Forster 2 ∞ Ph.D. 7 Eric Hirschhorn and 8 ∞ Leah Wortham 5 Jon and Kristin Vaver Marie Francis 2 Booster In memory of Jared Latigona In honor of Nina K. Solarz Arthur L. and Lily D. Walters ∞ Christopher J. Boyd and IQ Solutions 6 Martin Friedlander, M.D. and ∞ Michael and Lisa Jamie N. Cooper Sheila F. Friedlander, M.D. 2 ∞ In memory of Jen Family Charitable Trust Nichols Whitten In memory of Jay Nichols Aaron Gibson 1 ∞ Sara Elizabeth Cooper Thomas Kenan Stewart K. Wilson 4 ∞ Guy Glazier W. J. Boyle Kevin and Teresa Klock ∞ In memory of Blaise Ribet In memory of Ewen Raballand In memory of Jared Latigona In memory of Fred E. Balding Richard G. Wyatt, M.D. and Gene and Esther Gorman Charles Cerf and Jeremy Krasner 4 ∞ Linda S. Wyatt, Ph.D. 2 Cynthia E. Dunbar, M.D. 5 ∞ Sam D. Graham, M.D. Lafayette 89 Lucas and Katrina and Jane O. Graham 5 ∞ City of Hope In memory of Ewen Raballand Yun-Nikolac 2 ∞ Mary Greer ∞ Ellen Cramer Gail Leese ∞ In memory of Thomas E. Barber Crowell & Moring LLP Howard H. and $500–$999 Ken and Yvette Guidry 9 ∞ Daniel Cunningham and Jacqueline K. Levine 5 Anonymous (3) ∞ 2 Martin Hart Mary Hennessey Jonathan D. Levine 5 Dr. and Mrs. Robert B. Allison 2 ∞ In memory of Stephen J. Solarz Eric J. and Susan Hatch Daniels Family Fund In honor of Charles A. Sanders In memory of Ida Kirstein Gruzen National League for Nursing Amy W. Hawthorne 3 James E. Balow, M.D. 4 ∞ In memory of Stephen J. Solarz Rob and Betsey Drucker Omega World Travel Inc. and Mary G. Balow 2 ∞ In honor of Kim Balow David and Carolyn Hobson Emergent BioSolutions, Inc. Matthew W. O’Neill 6 ∞ F5 Networks 2 ∞ and Erica Joyce Lam 7 Robert Barlow Eva C. Holtz In memory of Jared Latigona Rich Fachet Ankur Pandya James Howe, M.D. In memory of Jared Latigona In memory of Jared Latigona Romit Bhattacharya ∞ James M. Felser, M.D. 6

[x] Superscript indicates number of years of consecutive giving * Indicates gifts in kind ∞ Member of the Partners for Innovation, Discovery and Health Society

P. 16 2015 Summary Annual Report Harold Huston ∞ Gilbert S. Omenn, M.D., Ph.D. $250–$499 Jeffrey J. Doenges In honor of Laura Huston and Martha A. Darling 5 ∞ Anonymous (7) Taylor Draim International Society of Andrew Park Essmaeel H. Ronald Early Nurses in Genetics PDC Machines Abdel-Dayem, M.D. Empire Kosher Poultry Charles E. Kaufman In memory of Robert Medl Amazon Smile Foundation 2 In memory of Paul J. Albert Medical Fund 4 Blair Puscas Bruce J. Averbrook, M.D. 6 Shauna Ensrud 2 Kevin Kenworthy ∞ In memory of Jared Latigona In memory of Thomas E. Barber Neil Baluck Michael Erickson Research!America In memory of Michael Baluck Robert A. and Bonnie A. Kotz Jeffrey Fager Kristin Roger Paul Baluck Ronald L. Krall, M.D. and In memory of Jared Latigona Gabriel B. Fosu, Ph.D. In memory of Michael Baluck Susan J. Krall 4 ∞ Jon and Patricia Rohal Michelle Gaines Jill H. Barr 7 Colleen Kutner In memory of Jared Latigona Thomas and Susan Ross In memory of John L. Barr In memory of Jared Latigona Jason and Gloria Garver 9 Howard K. Schachman, Ph.D. 11 5 Joan Beck Arnold Lakind ∞ 2 In memory of Ethel L. Schachman Rishi Goel Patricia Bernasconi John Langford 3 ∞ Heidi M. Schambra, M.D. In memory of Jared Latigona Michael Gottlieb, Ph.D. Arlene Latigona and Joan Gottlieb 2 Linda B. Schilling ∞ Jon H. Beusen and In memory of Jared Latigona In memory of Mrunal S. Chapekar Denise D. Beusen, Ph.D. 2 Lisa Green, M.D. Michael and Maria Lewan Michael J. Shervin In memory of Robert Ness Keir Gumbs Deborrah Lindsay ∞ In memory of Michele A. Shervin Ronald Borys In memory of T. Douglas Lindsay In memory of T. Douglas Lindsay 2 Marielle Soboti In memory of Jared Latigona Parker and Kiki Gundersen Juan Liriano and In memory of Jared Latigona Anne Brockmeyer In memory of Dean R. O’Neill Genoveffa Caruso SOHO Publishing Company 4 William and Marcella Broocke Gene Gutman, D.M.D. In memory of Jared Latigona and Loren Gutman Rainer F. Storb, M.D. 2 ∞ In memory of Ewen Raballand Edison T. Liu, M.D., Ph.D. In memory of Robert Medl 3 2 ∞ Richard H. Carmona, M.D., and Margaret B. Liu Donald Thompson 3 MPH, FACS Robert Heady 7 ∞ Thomas A. and Nancy I. Lusk 2 William and Zani Tolentino Daniel Carucci, M.D., Health Advances, LLC 3 Bryan J. Traughber, M.D. John Madden, Jr. M.Sc., Ph.D. 6 James Horton, M.D. 2 3 Donald H. and Janet K. Trombley Cathleen Martin Aileen Chen Stephanie L. James, Ph.D. 5 In memory of Jared Latigona 3 ∞ In honor of Matthew W. O’Neill John and Stacy Martin Richard Jonas and Julie A. Tune 5 ∞ Kenneth V. McGinity Weiping Chen, Ph.D. Katherine Vernot-Jonas 8 In memory of Gene Lasecki Robert and Margaret Joshua G. Cohen, M.D. Samantha Kaplan 3 Beth Turetsky, Ph.D. McNamara Foundation 2 2 and Jaclyn Cohen In memory of Lizette Morazzani In honor of Nina K. Solarz Kristen Miller Rochelle Cohen Jared and Andrea Kaye Michael and Marianne In memory of Rex Sexton In memory of Michele A. Shervin 6 Walter 2 ∞ John Kennedy 3 Lloyd B. Minor, M.D. Edward G. Conture, Ph.D. Paula J. Warrick, Ph.D. 4 ∞ Jody Kris ∞ Sanford Crystal Bayard H. Morrison, III, M.D. Melissa Kuskin 6 Robert C. Watson and In memory of Jared Latigona Reverend and Debra D. Petersen 5 ∞ In memory of Bennett Camhi Louis D’Agostino Mrs. Robert H. Naylor In memory of Hayley Watson Porcia B. Love, M.D. In memory of Jared Latigona 7 4 ∞ Gerald and Elizabeth Nissen Gail G. Weinmann, M.D. Judith MacKay In honor of Matthew W. O’Neill Daughters Of Penelope Matthew Zimmerman ∞ In memory of Thomas E. Barber and Erica Lam Hermione—Chapter 11 Anne Alexander Marshall, Michael Devine Ph.D. and Davis Marshall 11 In memory of Jared Latigona

Creating a Nexus Between Discovery and Collaboration P. 17 Our Donors

Kevin Martin Brian A. and GIVING TO THE FNIH Connie S. Mattingly We are grateful to the many individuals and organizations that have established funds Larry R. and and endowments, paid tribute to loved ones or joined one of our giving societies. Donors Anne R. McDowell are recognized in a variety of ways and some societies include membership benefits. In memory of Jared Latigona Please follow the links below to learn more about these giving opportunities as published Ketan Mehta on our website. Charles Mellody ANNUAL CONTRIBUTIONS — Join the Partners for Innovation, Discovery and Health Ari and Abbey Meltzer Society at: fnih.org/PartnersSociety Roger A. and Barbara Michaels 6 PLANNED GIVING — Do you have questions regarding bequests or transferring stock? Judith Miller 2 Visit our planned giving website at: fnih.org/PlannedGiving and join other donors who have Dean J. and included the FNIH in their estate plans at: fnih.org/LegacySociety Christine Montelbano In memory of Jared Latigona TRIBUTE GIVING — Such gifts are made to honor or memorialize a loved one. Learn more: Jorge Morazzani 2 fnih.org/TributeGiving In memory of Lizette Morazzani FUNDS AND ENDOWMENTS — To establish a fund or endowment that advances research Ellen J. Nissen In honor of Matthew W. O’Neill at the NIH or the FNIH in a particular area of interest to you, search the listings of current and Erica Lam FNIH programs by visiting: fnih.org/Programs John and L. Susan Nissen For a more complete listing of donors, funds and endowments visit fnih.org/AnnualReport. OAS Lunch Group Please call 301.402.4976 or email [email protected] if you have any questions. In memory of Monique H. Granado Martin and Heather Oppenheimer Walter G. Rostykus and Russell W. Steenberg Westland Middle School In memory of Arthur G. Horowitz Catherine Elliott-Rostykus 2 and Patricia Colbert 3 In memory of Ewen Raballand Kermit J. and Dr. Michael Ryan and Bonnie S. Stein Sara Lou Whildin 3 Dorothy W. Osborne Dr. Linda Ryan 3 In memory of Jared Latigona In memory of Janice Weymouth Ingrid Wiley 7 Lawrence E. Samelson, M.D. Matt Stillinger Julie and Howard Wolf-Rodda 9 Sigmona Park In memory of T. Douglas Lindsay Barbara Santos 2 In memory of Thomas E. Barber Steven Wong 3 Suresh and Feroza Subramani 2 Mansi Sarihan, M.D. Robert Petterson Robert Q. Wyckoff Anthony Tassone 3 Martha Price 3 Nicole Schoeni-Toye and Alicia A. Longobardo 3 In memory of Jennifer R. Price In honor of Matthew W. O’Neill Ryan Temming In memory of Shelby B. Reinish and Erica Lam William J. Price 6 Hughes Turner Joyce A. Yarington 12 Michelle Schumaker 5 In memory of Martha Maddox Sharon Raksnis Arlene Urquhart John G. Setter 8 In memory of Jared Latigona Richard and Joel Yesley Carole Rawson Jill Small Tracy Nichols Waggoner In memory of Jared Latigona In memory of Jay Nichols The Relias Family Alan D. Sofranko, M.D. Dr. and Mrs. Roy Weiner 2 Yasmin A. Rheubottom Morch and Caitlin M. Sofranko Kenneth W. and 6 In memory of Albert D. Sofranko James and Lora Rodenberg Susan J. Weinstein In honor of Dr. Lonser

[x] Superscript indicates number of years of consecutive giving * Indicates gifts in kind ∞ Member of the Partners for Innovation, Discovery and Health Society

P. 18 2015 Summary Annual Report Board of Directors As members between January and December 2015

Charles A. Sanders, M.D. (Chairman) Retired Chairman and Chief Executive INTRODUCING NEW BOARD MEMBERS Officer, Glaxo, Inc. In May 2015, the FNIH unanimously elected two new directors of the Foundation. Mrs. William McCormick Blair, Jr. (Secretary) Russell W. Steenberg, is the founder and global head of BlackRock Private Equity Director Emeritus, Albert and Mary Lasker Partners, with more than 32 years of experience in private equity investment. Judy Foundation Lansing Kovler, Ph.D., is a psychotherapist in private practice with more than 30 Kathy Bloomgarden, Ph.D. years of experience working as a consultant to government agencies, including the Chief Executive Officer, Ruder Finn, Inc. White House, State Department and Secret Service.

Mrs. William (Buffy) N. Cafritz Honorary Trustee, The John F. Kennedy Center for the Performing Arts Steven C. Mayer (Treasurer) Samuel O. Thier, M.D. Former Chief Executive Officer, Professor of Medicine and Health Care James H. Donovan CoGenesys, Inc. Policy, Emeritus, Harvard Medical School; Managing Director, Massachusetts General Hospital Goldman Sachs & Company; Paul M. Montrone, Ph.D. Adjunct Professor, University of Virginia; Chairman, Perspecta Trust Anne Wojcicki Trustee, Dana-Farber Cancer Institute Chief Executive Officer and Co-Founder, Martin J. Murphy, Jr., Ph.D. 23andMe Joseph Feczko, M.D. DMedSc, FAFSCO Founding Chairman and Chief Executive Retired Senior Vice President and Chief HONORARY DIRECTORS Medical Officer, Pfizer Inc Officer, AlphaMed Consulting, Inc. Luther W. Brady, M.D. Maria C. Freire, Ph.D. Steven M. Paul, M.D. Affiliate Faculty Member in the President and Executive Director, President and Chief Executive Officer Department of Radiation Oncology Foundation for the National Institutes at Voyager Therapeutics, Inc. and at Drexel University; Former Chair of of Health Venture Partner at Third Rock Ventures the Department of Radiation Oncology, MCP Hahnemann University Paul L. Herrling, Ph.D. The Honorable John Edward Porter Chairman, Novartis Institute (Vice Chairman for Policy) Patrick C. Walsh, M.D. for Tropical Disease Hogan Lovells US, LLP University Distinguished Service Professor, James Buchanan Brady Urological Institute, Ronald L. Krall, M.D. Jillian Sackler, D.B.E. Johns Hopkins Medical Institutions Former Senior Vice-President and President and Chief Executive Officer, Chief Medical Officer, GlaxoSmithKline Dame Jillian & Dr. Arthur M. Sackler Foundation for the Arts, Sciences DIRECTOR EMERITUS Judy Lansing Kovler, Ph.D. & Humanities Director, Kovler Foundation and , Ph.D. Vice Chair of Sasha Bruce, Inc. Lily Safra Cahill Professor in Biochemistry Chairwoman, The Edmond J. Safra (Emeritus), Stanford University Freda C. Lewis-Hall, M.D., FAPA Philanthropic Foundation School of Medicine Chief Medical Officer, Senior Vice President, Pfizer Inc Ellen V. Sigal, Ph.D. Sherry Lansing Chairperson, Friends of Cancer Research Founder and Chief Executive Officer, Edison T. Liu, M.D., Ph.D. The Sherry Lansing Foundation President and CEO, Solomon H. Snyder, M.D. The Jackson Laboratory (Vice Chairman for Science) Distinguished Service Professor of EX-OFFICIO Ann Lurie Neuroscience, Pharmacology & Psychiatry, Francis S. Collins, M.D., Ph.D. President, Lurie Holdings; Solomon H. Snyder Department of Director, National Institutes of Health President and Treasurer, Neuroscience at Johns Hopkins University Ann and Robert H. Lurie Foundation Stephen Ostroff, M.D. Nina K. Solarz Acting Commissioner, Joel S. Marcus Former Executive Director of Food and Drug Administration Chairman, Chief Executive Officer Peace Links and the Fund for Peace and Founder, Alexandria Real Estate Equities, Inc. and Russell W. Steenberg Alexandria Venture Investments Global Head, BlackRock Private Equity Partners Creating a Nexus Between Discovery and Collaboration P. 19 Our Staff As employed between January and December 2015

PRESIDENT AND EXECUTIVE MEETINGS & EVENTS Dennis Lang, Ph.D. Senior Program Coordinator (Contractor) DIRECTOR’S OFFICE Jolie Mak, C.M.P. Karen H. Tountas, Ph.D. Maria C. Freire, Ph.D. Meetings and Events Manager Scientific Program Manager President and Executive Director Jasmin Miles, C.M.P. Senior Events Coordinator Susan Wiener, M.A. Ann Ashby, M.B.A. Senior Project Manager, Deputy Executive Director Janelle Lewis Grand Challenges in Global Health Meetings and Events Planner Andrea Baruchin, Ph.D. David Brown, Ph.D. Senior Advisor to the President Sarah Kay Scientific Program Manager, CTC-VIMC Events Assistant Erika Tarver Gail Levine, M.A., C.R.C.C. Senior Project Manager Dalia Travis Scientific Program Manager, CTC-VIMC Felicia Gray Events Assistant Tiffany Francis Executive Assistant Executive Assistant ADVANCEMENT Contract Specialist OPERATIONS Melissa Cather Kevin A. Klock, J.D. Director of Advancement RESEARCH PARTNERSHIPS Director of Operations Jamie Cooper, M.A. David Wholley, M.Phil. Advisor to the President Advancement Officer Director of Research Partnerships Susan Powell, M.T.S. Rob Drucker, J.D. Maria Vassileva, Ph.D. Senior Grants Manager Advancement Officer Senior Scientific Program Manager, Metabolic Disorders Kathy Peterson Laren Friedman, M.F.A. Paula Eason, Ph.D. Operations Officer Writer/Researcher Scientific Program Manager, Cancer Liz Johns Cassandra Hoye Steven C. Hoffmann, M.S. Executive Assistant Advancement Assistant Scientific Program Manager, Inflammation and Immunity FINANCE DEVELOPMENT Rosa Canet-Aviles, Ph.D. Julie Tune, C.P.A., C.F.E. Julie Wolf-Rodda, M.A. Scientific Program Manager, Neuroscience Chief Financial Officer Director of Development Sanya Whitaker, Ph.D., P.M.P. Eva Coyne, C.P.A. Renee Bullion, M.P.A. Scientific Program Manager, Controller Development Officer Metabolic Disorders Cathy Martin, C.P.A. Meredith Donnelly Ron Benjamin, Pharm B, M.B.A. Senior Accountant Development Officer Clinical Operations Manager Noemi Rodriguez Dinetta Parrott Jessica Ratay, M.S. Staff Accountant Development Officer Clinical Project Manager Peggy J. Gerlacher Will Tolentino Dorothy Jones-Davis, Ph.D. Operations Associate Development and Scientific Project Manager, Neuroscience Communications Systems Officer Nicole Spear, M.A. COMMUNICATIONS Anisa Sanghrajka Scientific Project Manager Abbey Meltzer, M.P.S. Development Assistant Cheryl Melencio Director of Communications Executive Assistant Jillian Bante Richard Folkers Development Assistant Jessica Jones Director of Communications Administrative Assistant Kai Yee SCIENCE INTERNS Digital Administrator Stephanie James, Ph.D. Director of Science and Director, Samantha Gonzales Grand Challenges in Global Health Amber Langway Michael Gottlieb, Ph.D. Celia Rumbin Deputy Director of Science

P. 20 2015 Summary Annual Report

ART & PHOTO CREDITS Cover: Digitally altered 2-photon fluorescent micrograph of Purkinje cells. Original image: Science Source Page 1: Image of Maria C. Freire, Ph.D, by Robert Burke Photography Page 4: iStockphoto.com Page 5: iStockphoto.com Page 6: GettyImages.com Page 7, left: iStockphoto.com Page 7, right: GettyImages.com Page 8: Richard Folkers Page 9, left: iStockphoto.com Page 9, right: GettyImages.com Page 10: Richard Folkers Page 10: Romit Bhattacharya Page 11, top left: National Institutes of Health Page 11, bottom left: Tara L. O’Neill Page 11, top right: Foundation for the National Institutes of Health Page 12, left: Office of Intramural Training & Education at the National Institutes of Health Page 12, center: Sallie Rosen Kaplan fellowship: Erika Ginsburg, Center for Cancer Training, National Cancer Institute at the National Institutes of Health Page 12, right: Don Hurlbert, Smithsonian Institution

DESIGN Rector Communications, Inc. Philadelphia, PA www.rector.com Foundation for the National Institutes of Health 9650 Rockville Pike Bethesda, MD 20814-3999 fnih.org