NIH Update James M. Anderson, M.D., Ph.D. NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives National Institutes of

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2 NIH Update James M. Anderson, M.D., Ph.D. NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives National Institutes of Health AIRI Meeting October 2, 2017

3 Topics Budget Update NIH Strategic Plan 21 st Century Cure Act Next Generation Researchers Initiative New Common Fund programs 3

4 Billions of Dollars (constant 2016 Dollars) National Institutes of Health Funding $60 $50 $40 $30 $20 $10 $0

5 Success Rate Grant Success Rates FY 1978 to % 35% 30% 25% 20% 15%? 10% 5% 0% Fiscal Year

6 Impact of NIH-Supported Research on U.S. Economy In 2011, NIH research supported 432,000 jobs at more than 2,500 institutions and small businesses nationwide In 2011, NIH funding generated $62 billion in new economic activity double taxpayers investment NIH serves as foundation for entire U.S. medical innovation sector that: Employs 1 million U.S. citizens Generates $84 billion in wages, salaries Exports $90 billion in goods, services Source: An Economic Engine: NIH Research, Employment and the Future of the Medical Innovation Sector, United Medical Research, May

7 NIH Funds Scientists Across U.S. Alaska Hawaii 7

8 Topics Budget Update NIH Strategic Plan 21 st Century Cure Act Next Generation Researchers Initiative New Common Fund programs 8

9 Development Process Extensive consultation with NIH Leadership NIH Director and his Deputies Institute, Center, and Office (ICO) Directors Formation of NIH working group with ICO representatives Public presentations to and feedback from the Advisory Council to the NIH Director (ACD) 9

10 Goals of the NIH-Wide Strategic Plan The strategic plan clearly articulates the highest trans- NIH priorities and how to achieve them The strategic plan is a living document that will require refinement throughout its lifecycle The strategic plan does not describe all the many important things that NIH does and will do in the future The strategic plan does not address priorities of the individual ICOs, since each has its own strategic plan 10

11 NIH-Wide Strategic Plan Framework 11

12 A Unique Moment of Opportunity in Biomedical Research: Fueled by Advances in Technology, Increased Molecular Knowledge, and Interdisciplinary Approaches to Problem Solving 12

13 Advance Opportunities in Biomedical Research: Select Examples People 7,067 Institutions 5,666 People 2,857 Institutions 2,516 13

14 Set Priorities and Enhance Stewardship: Select Examples 14

15 Manage for Results: Select Examples 15

16 Topics Budget Update NIH Strategic Plan 21 st Century Cure Act Next Generation Researchers Initiative New Common Fund programs 16

17 Dollars (in millions) NIH in the 21st Century Cures Act 500 Establishes the NIH Innovation Account Funding: $4.8B for 10 years that must be appropriated each year Does not count against the budget caps Reauthorizes NIH: FY18: $34,851,000,000 FY19: $35,585,871,000 FY20: $36,472,442, Fiscal Year PMI = $1.45 B BRAIN = $1.5 B Moonshot = $1.8 B Regenerative Med = $30 M 17

18 Precision Medicine Initiative (PMI)/ All of Us SM Research Program Goal Deliver a national resource of clinical, environmental, lifestyle, and genetic data from one million or more participants who are consented and engaged to provide data on an ongoing, longitudinal basis that will accelerate scientific discovery and breakthroughs in precision medicine 16

19 Current Status of All of Us Robust network of partners Recruit 1M participants from underrepresented groups Pilot tests completed on language, concepts, interfaces Biobank capacity ready for alpha/beta launch Enrollment website, 1-800#, smartphone apps, and data center developed Security testing, user testing, workflow testing, & training started ~3k beta test participants Aiming for national launch in October

20 Cancer Moonshot Themes National network of patient biological and clinical data Prevention Health disparities research Development of biomarkers, technology and preclinical models Data sharing, analytics and predictive computational modeling Collaborations, public-private partnerships FY17: funding through existing well aligned FOAs FY18-23: new FOAs 20

21 BRAIN* Initiative *Brain Research through Advancing Innovative Neurotechnologies Goal: Elucidate circuit structure and function to understand: How the brain moves, plans, executes How to monitor/manipulate circuits for improved function That disordered brain circuits cause neuro/mental/substance abuse disorders Long-term goal: Make circuit abnormalities the basis of diagnostics, and normalization of circuit function the target of intervention Molecular/Structural Pathology Circuit Dysfunction Neuro/Mental/Substance Abuse Functional Disability 17

22 Regenerative Medicine Goal: in coordination with FDA, support clinical research using adult stem cells (including autologous stem cells), to further the field of regenerative medicine; applicants required to provide matching funds Opportunity: Catalyze a focused and systematic trans-nih approach to advancing the field Work with the FDA to address patient safety, public trust, and the integrity of clinical research in RM FY2017 FY2020 funds will be informed by workshops and expert consultation 22

23 NIH Funding Trends: Basic and Applied Research 60% 50% 40% 30% Basic Applied 20% 10% 0% FY 2009 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 Est FY 2017 Est 23

24 Topics Budget Update NIH Strategic Plan 21 st Century Cure Act Next Generation Researchers Initiative New Common Fund programs 24

25 Signs of Stress Nature 2016;538:446-9

26 What They re Saying Desperate pursuit of grants No time for science Extreme competition to cut corners Dependence on senior scientists Administrative overload... No help Long hours Nature 2016;538:446-9

27 Is This True? What caused the drop in number of young scientists? Older grantees are getting money at the expense of younger grantees Study sections are biased... OER SARB PNAS 2017;114:

28 Congressional Input

29 What the Law (21 st Century Cures) Calls For The Director of the National Institutes of Health shall develop, modify, or prioritize policies, as needed to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity.

30 Next-Gen Researchers Initiative Increase EEI Awardees by ~200 Increase ESI Awardees by ~200

31 Next-Gen Researcher Considerations Where will the money ($210M in 2017) come from? Adjustment of other IC Priorities Include existing mechanisms: R56, R35, NIAMS STAR Monitoring will be essential Workforce size and diversity Scientific excellence and outcome Opportunity for further development of metrics Working Group for the Advisory Committee to the Director

32 NIH Guide Notice

33 Topics Budget Update NIH Strategic Plan 21 st Century Cure Act Next Generation Researchers Initiative New Common Fund programs 33

34 Current Common Fund Programs (FY17) New Types of Clinical Partnerships Illuminating the Druggable Genome Strengthening the Biomedical Research Workforce HCS Research Collaboratory Pioneer Awards New Innovator Awards Transformative Research Awards Early Independence Awards Molecular Transducers of Physical Activity Gabriella Miller Kids First Health Economics Undiagnosed Diseases Network High-Risk Research Glycoscience Metabolomics Genotype- Tissue Expression Extracellular RNA Communication Transformative Workforce Support Regenerative Medicine Program Common Fund $565,456,000 Epigenomics Protein Capture Big Data to Knowledge (BD2K) Single Cell Analysis Knockout Mouse Phenotyping Science of Behavior Change 4D Nucleome Library of Integrated Network-Based Cellular Signatures (LINCS) New Paradigms Data/Tools/Methods Stimulating Peripheral Activity to Relieve Conditions (SPARC) Enhancing the Diversity of the NIH-Funded Workforce Global Health Human Microbiome Long Term Trans- NIH Program

35 New Common Fund programs starting in FY2018: HubMAP Transformative High Resolution Cryo-Electron Microscopy In planning stage for potential FY2019 funding: Somatic Cell Genome Editing Pain: Acute-to-Chronic Transition Signatures 35

36 The Human Biomolecular Atlas Program (HuBMAP) Overall Goal: Catalyze the development of a comprehensive atlas of cellular organization in human tissues that will elucidate the principles of organization-function Challenges: There are ~40 trillion cells in the human body Integrating imaging and omics for comprehensive mapping Maintaining the spatial context of tissue architecture at the same time as sequencing Opportunities: Accelerate recent technological advances in in situ sequencing, modeling and predicting, and lineage tracing Develop a common coordinate framework for organizing spatial data about the human body, akin to Google Maps Collaborate with other programs, funding organizations, and businesses as part of international consortium

37 NIH Turning Discovery Into Health

38 Programs and Priorities at NIGMS Jon Lorsch

39 2017 NIGMS budget is $2.65 Billion

40 Some Governing Principles at NIGMS NIGMS supports fundamental research on living systems that lays the foundation for advances in disease diagnosis, treatment and prevention. NIGMS focuses on supporting investigator-initiated research. o The best ideas come from the investigators themselves. NIGMS prioritizes supporting a broad and diverse portfolio of research, researchers and research institutions. o Maximizes the scientific return on investment for taxpayers and the chances for breakthroughs.

41 Maximizing Investigators Research Award (MIRA) One NIGMS research grant per PI R35 Bigger and longer (5 years) than current R01 averages Direct cost range up to $750K Not tied to specific aims Review based on track record and overall research ideas Includes consideration of service & contributions to workforce development At renewal, budgets can be modulated based on review rather than using all-or-none funding decisions Separate panels and modified review considerations for early-stage investigators

42 Expansion of the MIRA Pilot Early Stage Investigators (PAR ) ~29% success rate in FY16 and FY17 (estimated) Median awarded yearly direct costs of $250K Compared to $198K for ESI R01 awards in FY 2015 Established Investigators (PAR ) Must have at least one active NIGMS R01-equivalent up for renewal Well-funded investigators (>$400K NIGMS direct costs) will generally receive somewhat (~12% on average) less than their recent average NIGMS funding level Investigators currently supported by a single, modular NIGMS R01 can request an increase, if well justified Hope to be able to make median award $250K

43 Help Us Bust Myths about MIRA

44 Some Ongoing Priorities for NIGMS New Technology Development Pipeline o Exploratory/proof of concept grants (R21): PAR No preliminary data allowed! o Focused technology R&D grants (R01): PAR o Revised Biomedical Technology Research Resource (P41) FOA: PAR New Team Science FOA (PAR ) o Designed to support investigator-initiated research that must be done in organized teams and which needs a dedicated funding stream for the whole team. o Team must be working on a common goal. o Replaces NIGMS P01s and most centers grants (except IDeA, AIDS, P41s and P30s).

45 Some Ongoing Priorities for NIGMS Catalyze the modernization of graduate biomedical education o Completely Revised T32 Funding Opportunity Announcement coming soon! Focus on skills development: technical, operational, professional. Use evidence-based approaches to teaching, learning and mentoring. Encourage innovation, experimentation, evaluation, dissemination. Question: If a PI is expected to get 100% of his/her salary from research grants, should he/she be involved in training graduate students?

46 Questions, Comments?