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NIH… From 10,000 Feet

NIH… From 10,000 Feet. NIH Regional Seminar Washington, DC June 21, 2012. Sally J. Rockey, PhD Deputy Director for Extramural Research National Institutes of Health.

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NIH… From 10,000 Feet

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  1. NIH… From 10,000 Feet NIH Regional Seminar Washington, DC June 21, 2012 Sally J. Rockey, PhD Deputy Director for Extramural Research National Institutes of Health

  2. “To help this country compete for new jobs and businesses, we also need to invest in basic research and technology, so the great ideas of the future will be born in our labs and in classrooms like these.” President Obama Signing of America Invents ActThomas Jefferson High SchoolSeptember 16, 2011

  3. NIH: Steward of Biomedical & Behavioral Research for the Nation “Science in pursuit offundamentalknowledgeabout the nature and behavior of living systems . . . and theapplication of that knowledge to extend healthy life and reduce the burdens of illness and disability

  4. Birthplace of the NIH: 1887 Marine Hospital -- Staten Island, NY

  5. NIH Campus 1948 NIH Campus -- 1947

  6. U.S. Dept. of Health & Human Services Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Center for Medicare & Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA)

  7. National Institutes of Health Office of the Director Office of Extramural Research National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of NursingResearch National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review

  8. Understanding the Dual Nature of NIH NIH is an institution (Intramural Research) ~Approx. 6,000 scientists ~Approx. 10% of NIH budget NIH supports institutions & people (Extramural Research) >4,000 institutions >300,000 scientists & research personnel ~Approx. 80% of the NIH budget

  9. NIH SupportsBiomedical and Behavioral Research Around the GlobeIncluding Scientists at Institutions in over 90 Countries! KENYA LEBANON MALAWI MEXICO NETHERLANDS NEW ZEALAND NIGERIA PAKISTAN PERU POLAND RUSSIA SENEGAL SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM URUGUAY ZIMBABWE AND MORE… ARGENTINA AUSTRALIA BELGIUM BOTSWANA BRAZIL CAMBODIA CANADA CHILE CHINA COLUMBIA CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT ESTONIA FINLAND FRANCE GERMANY HAITI HONG KONG HUNGARY ICELAND IRELAND ISRAEL ITALY JAPAN

  10. OER: The Authority on NIH Extramural Research OER, the Office of Extramural Research, supports the NIH mission by providing the extramural research community and the NIH extramural program (internal and external) with leadership, coordination, and guidance on NIH extramural research, policies, and procedures. We Talk to Everyone! Office of the Director Institutions & Investigators Institutes and Centers Federal Agencies The Public • Grants Management • Program Offices • Communication Offices • Office of Sponsored Programs & Dep’t Staff • Mentors & Advisors • Trainees, Fellows • Investigators • Congress • Other Federal Agencies • Freedom of Information Act • Public

  11. Grants Management Administrator The Extramural Research Partnership Applicant Institution NIH Program Administrator Principal Investigator Authorized Institutional Official Review Administrator Sponsored Research Administrator

  12. NIH Leadership • NIH Leadership • The B Word: NIH Budget • Translational Research/NCATS • NIH Funding Trends & the Future • of the Biomedical Research • Workforce • Diversity in Research • Other Issues of Interest • Get (and Stay) Connected NIH Initiatives and Hot Topics

  13. NIH Leadership To better understand the direction of NIH, here’s some known (and little known) facts about the leader of NIH: NIH Director as of August 17, 2009 Former Director of the National Human Genome Research Institute, NIH Leader of the Human Genome Project Dr. Collins’ own lab discovered a number of important genes, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, a familial endocrine cancer syndrome, and most recently, genes for type 2 diabetes and the gene that causes Hutchinson-Gilford progeria syndrome. New York Times best selling book author Interest in the interfacing of science and faith. Believes the value of the NIH community is one where hard work, laughter, and compassion allow the imagination to soar. But that’s not all… Francis S. Collins, Ph.D., MD No one can whistle a symphony; you need a team to make that kind of music!

  14. The B Word: The NIH Budget Where does the money go and what can we expect in the future?

  15. NIH Extramural & Intramural FundingFY 2011 Enacted: $30.9 Billion • $3.3 B Intramural Research • $1.5 B Research Management & Support • $0.2 B Buildings and Facilities, Other Spending at NIH $5.0 B 16% • Supports over 325,000 Scientists & Research Personnel • Supports over 3,000 Institutions Spending Outside NIH$25.9 B 84%

  16. FY 2011 Percent Distribution of Basic and Clinical Research

  17. FY 2013 President’s Budget RequestNIH Total Program Level - $30,860 Million

  18. FY 2013: Budget Highlights • Funding at same total program level as FY 2012 • Makes tough choices within constraints • Maintains number of new and competing Research Project Grants • Ramps up Cures Acceleration Network by $40 million • Provides additional support for Alzheimer’s Disease research from the Public Health and Prevention Fund – $80 million as part of HHS-wide initiative

  19. Grants Management in FY 2013 President’s Budget • Reduce non-competing RPGs by 1% from FY 2012 level. • Negotiate budgets of competing RPGs to avoid growth in average award size. • Eliminate inflationary increases in out year budgets of both competing and non-competing RPGs. • Applications from PIs who already receive in excess of $1.5 million per year in total costs would be given additional scrutiny and review by the IC Advisory Council. • Continue policy of funding applications from early stage investigators at the same success rate as established investigators for new R01 equivalent applications.

  20. Research Project Grants Applications, Awards, and Success Rates

  21. Potential Levers for Dealing with Budget Challenges October 2011 presentation http://report.nih.gov/UploadDocs/Ways%20to%20Manage%20Final.pdf 23

  22. Options for Managing NIH Resources • Current Way of Managing • Bottom out success rates (doing nothing but letting the system correct itself) • Other Options • Reducing or limiting size of awards • Limiting number of awards held by an PI • Limiting the amount of funds an PI can hold • Limiting salaries of Pis • Find savings through indirects

  23. Current Way of Managing • Generally project based • Competitive peer review • Average of $414K per year for 4.3 years • Approximately 50 institutions get 70% of the funds • Approximately 20% of the investigators get 50% of the funds

  24. Translational Research/ NCATS What’s New on Campus?

  25. Development of New Therapeutics

  26. The Therapeutics Development Pipeline Disease Target ID Assay Dev. HTS Probe to Lead Pre-Clinical FDA IND Ph. 0 Ph. I Ph. II Ph. III FDA Re-view NIH Molecular Libraries Initiative NIH TRND Pharma, Biotech, NIH Clinical Center, CTSAs NIH RAID NIH Supported Basic Research New NIH FDA Partnerships

  27. Creation of theNational Center for Advancing Translational Sciences (NCATS) To catalyze the development of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Updated 5.18.11

  28. NCATS: Challenges & Opportunities • Deluge of new discoveries of potential targets • Unmet therapeutic needs for many conditions, especially rare and neglected diseases • Need to view drug development pipeline as a scientific problem – ripe for experimentation and process engineering

  29. NCATS: Functions Improve the processes of diagnostics and therapeutics development, testing, and implementation by: • Experimenting with innovative approaches in an open-access model • Choosing therapeutic projects to evaluate these innovative approaches • Promoting interactions to advance the field of regulatory science Catalyze the development and implementation of new diagnostics and therapeutics by: • Encouraging collaborations across all sectors • Providing resources to enable diagnostics and therapeutic development and implementation • Enhancing training in relevant disciplines

  30. NCATS will: • Facilitate – not duplicate – other translational research activities supported by NIH • Complement – not compete with – the private sector • Reinforce – not reduce – NIH’s commitment to basic research

  31. Current NCATS Programs • NCATS unifies three existing programs under one focused mission, creating new synergies in translational research: • Clinical and Translational Science Activities • Clinical and Translational Science Awards, a national consortium of institutions working to improve the way clinical and translational research is conducted • Rare Diseases Research and Therapeutics • Office of Rare Diseases Research • Therapeutics for Rare and Neglected Diseases, a program to encourage and speed the development of new drugs for rare and neglected diseases • Re-engineering Translational Sciences • NIH Chemical Genomics Center • Bridging Interventional Development Gaps, which makes available critical preclinical resources needed for the development of new therapeutic agents • Toxicology in the 21st Century, - screening 10,000 compounds to identify potentially toxic disruptions in biological pathways and develop ways to better predict toxicity • NCATS also will develop the Cures Acceleration Network, which was created in FY 2012 to advance the development of “high need cures” by funding research projects

  32. NIH OD, DPCPSI, Office of Research Infrastructure Programs (ORIP) • All Division of Comparative Medicine Programs • Nonhuman Primate Resources • Vertebrate and Invertebrate Animal Resources • Genetic, Biological and Other Resources • Human Tissue and Organ Resource for Research Program • Career Development • Extramural Construction • Research and Animal Facilities Improvement • Shared and High-End Instrumentation Grants • Science Education Partnership Awards • Small Business (SBIR/STTR) Grants for Comparative Medicine and for K-12 Educational Resources

  33. NIH Funding Trends & The Future of the Biomedical Research Workforce What the Numbers Tell Us!

  34. NIH Establishes Working Group to Examine the Future Biomedical Workforce Using appropriate expertise from NIH and external sources, the group will develop a model for a sustainable and diverse U.S. biomedical research workforce that can inform decisions about training of the optimal number of people for the appropriate types of positions that will advance science and promote health. Based on this analysis and the input gathered from the extramural community, the committee will make recommendations for actions that NIH should take to support a future sustainable biomedical infrastructure.

  35. Career Stages of Funding Programs

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  48. 1992

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