1. Special NIH Funding Opportunities Elizabeth Wilder, Ph.D. Director Office of Strategic Coordination Division of Program Coordination, Planning, and Strategic Initiatives Office of the NIH Director March 15, 2013 http://www.commonfund.nih.gov

2. 27 NIH Institutes and Centers Clinical Center International Center National Institute of Biomedical Imaging and Bioengineering National Institute of Deafness and Communications Disorders National Institute of Diabetes and Digestive and Kidney Diseases NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases

3. The Office of the Director (OD)

4. International Center 27 NIH Institutes and Centers Most focus on a specific disease or targeted area of health research Common Fund programs develop the tools, technologies, datasets, and models that enable research broadly across IC missions These programs are usually too BROAD IN SCOPE, COMPLEX, or EXPENSIVE for a single Institute to take on

5. SingleCellAnalysis Current Common Fund Programs Increasing the Diversity of the NIH-Funded Workforce PROMIS:ClinicalOutcomesAssessment NIH Center for RegenerativeMedicineRegulatoryScience Molecular Libraries Libraries and Imaging and Imaging HumanMicrobiome ProteinCapture Pioneer Awards New Innovator Awards Transformative Research Awards Early Independence Awards StructuralBiology Bioinformatics and Computational Biology Computational Biology Building Blocks, Biological Pathways And Networks Genotype-TissueExpression Library of Integrated Network- Based Cellular Signatures(LINCS) Nanomedicine Science of BehaviorChange Gulf Oil Spill Long Term Follow Up GlobalHealth KnockoutMousePhenotyping NIH Medical ResearchScholars BridgingInterventionalDevelopment Gaps (BrIDGs) Big Data to Knowledge(BD2K) HCS Research Collaboratory High-RiskResearch NIH Common Fund HealthEconomics Epigenomics http://commonfund.nih.gov/ Metabolomics UndiagnosedDiseasesProgram Extracellular RNA Communication Strengtheningthe Biomedical Research Workforce

6. Transformative: Must have potential for exceptionally high impact — to dramatically affect biomedical and/or behavioral research over the next decade Synergistic: Outcomes must synergize with research supported by the NIH Institues and Centers (ICs) to promote and advance individual missions of ICs and to benefit health Cross-Cutting: Program areas must cut across missions of multiple NIH ICs. Similarly, programs must be relevant to multiple diseases or conditions Unique: Must be something no other entity is likely or able to do, or, if similar efforts exist, the Common Fund programs must be coordinated with others. The CF supports projects that would be unlikely to be supported through traditional, investigator-initiated mechanisms. Catalytic: Must achieve a defined set of goals within 5-10 years which will then catalyze further work supported by the ICs FY11 Budget: $543M Criteria for Common Fund Programs Common Fund program areas are selected through a strategic planning process that identifies trans-NIH challenges or areas of exceptional opportunity that meet the following criteria:

7. CF Programs Build “Foundations” to Catalyze Research ■ New Tools, Infrastructure, and Data to Support or Establish New Fields of Study ■ Extracellular RNA Communication ■ Epigenomics ■ Knock-Out Mouse Phenotyping Project (KOMP2) ■ New Technologies and Approaches to Overcome Barriers to Progress in a Field ■ Structural Biology ■ PROMIS: Patient Report Outcomes Management System ■ Microphysiological Systems for Drug Screening ■ New Approaches to Foster Innovation and Invigorate the Research Workforce ■ High-Risk High-Reward (Pioneer, New Innovator, Transformative Research, Early Independence Awards) ■ Broadening Experiences in Scientific Training (BEST) Awards (New in FY13) ■ Increasing Diversity in the NIH-funded Workforce (New in FY13)

8. High-Risk High-Reward (HRHR) Research New approaches to support exceptionally creative scientists who propose highly innovative approaches to major contemporary challenges in biomedical research Novel approaches to peer review and funding mechanisms TRA Preliminary data not required Shortened application Transformative Research Awards allow multi-disciplinary teams of investigators

9. High-Risk High-Reward (HRHR) Research Awards TRANSFORMATIVE RESEARCH PIONEER NEW INNOVATOR EARLY INDEPENDENCE What? Transformative ideas that may involve large budgets Creative scientists proposing paradigm shifting research Early stage investigators proposing high potential impact research Junior scientists ready for research independence All areas of basic, clinical and translational science within the NIH mission Budget? Up to $25 million per year for 5 years Up to $500,000 per year for 5 years Up to $300,000 per year for 5 years Up to $250,000 per year for 5 years Prelim data? Preliminary data not required Preliminary data requirements less stringent than R01 award Preliminary data not required For more information: http://commonfund.nih.gov/highrisk Who? All career stages, applications from teams of investigators welcome All career stagesEarly stage Investigators Junior investigators (within 1 year of Ph.D. or medical residency)

10. Personalized therapeutics for inhibiting breast cancer metastasis New Innovator Awardee: Debra Auguste …will develop personalized therapeutics that target metastatic breast cancer cells and mechanisms that govern metastasis.

11. New Innovator Awardee: Trever Bivona Discovery of Rational Companion Therapeutic Targets to Optimize Cancer Treatment …efficiently design effective cocktails of targeted cancer therapies that synergistically destroy human lung (and other) cancers

12. High-Risk High-Reward (HRHR) Research Awards TRANSFORMATIVE RESEARCH PIONEER NEW INNOVATOR EARLY INDEPENDENCE What? Transformative ideas that may involve large budgets Creative scientists proposing paradigm shifting research Early stage investigators proposing high potential impact research Junior scientists ready for research independence All areas of basic, clinical and translational science within the NIH mission Budget? Up to $25 million per year for 5 years Up to $500,000 per year for 5 years Up to $300,000 per year for 5 years Up to $250,000 per year for 5 years Prelim data? Preliminary data not required Preliminary data requirements less stringent than R01 award Preliminary data not required For more information: http://commonfund.nih.gov/highrisk Who? All career stages, applications from teams of investigators welcome All career stagesEarly stage Investigators Junior investigators (within 1 year of Ph.D. or medical residency) We WILL have all 3 competitions again next year! Look for announcements next spring. http://nihroadmap.nih.gov/ We WILL have all 4 competitions again next year! Look for announcements next spring. http://COMMONFUND.nih.gov/

13. CF Programs Build “Foundations” to Catalyze Research ■ New Tools, Infrastructure, and Data to Support or Establish New Fields of Study ■ Extracellular RNA Communication ■ Epigenomics ■ Knock-Out Mouse Phenotyping Project (KOMP2) ■ New Technologies and Approaches to Overcome Barriers to Progress in a Field ■ Structural Biology ■ PROMIS: Patient Report Outcomes Management System ■ Microphysiological Systems for Drug Screening ■ New Approaches to Foster Innovation and Invigorate the Research Workforce ■ High-Risk High-Reward (Pioneer, New Innovator, Transformative Research, Early Independence Awards) ■ Broadening Experiences in Scientific Training (BEST) Awards (New in FY13) ■ Increasing Diversity in the NIH-funded Workforce (New in FY13)

14. Extracellular RNA Communication Trans-NIH Involvement: -- Led by NCI and NCATS -- Working Group Members from 18 Institutes/Centers

15. Epigenomics: Data and Resources for the Biomedical Research Community Reference epigenome maps Technology development Discovery of novel marks Epigenomic basis of disease International coordination Data sharing Standards http://www.roadmapepigenomics.org/ For more information: http://commonfund.nih.gov/epigenomics/

16. Knockout Mouse Phenotyping Program (KOMP 2 ) Cohort breeding Phenotyping Data Upload Cohort breeding Phenotyping Data Upload KOMP Repository Mouse Production ES cells Mice/Embryos Database Web server Data Mouse Phenotyping Center(s) Mice/Embryos KOMP ES cells EuCOMM ES cells Mice/Embryos Microinjection Germline Transmission LacZ staining Lethality/Fertility Cryopreservation Tracking Analysis Display Cohort breeding Phenotyping Data Upload ■ Partnership with International Mouse Phenotyping Consortium (IMPC) ■ Standardized, broad phenotyping of 5,000 KO mice derived from IKMC ES cells ■ Definition of in vivo function of mammalian genes and identification of new models of disease ■ Data stored in a centralized database (European Molecular Biology Lab) KOMP 2 Phenotyping Process For more information: http://commonfund.nih.gov/KOMP2/ Nominate a gene for phenotyping at http://www.kompphenotype.org/ Learn about the international effort at http://www.mousephenotype.org/

17. CF Programs Build “Foundations” to Catalyze Research ■ New Tools, Infrastructure, and Data to Support or Establish New Fields of Study ■ Extracellular RNA Communication ■ Epigenomics ■ Knock-Out Mouse Phenotyping Project (KOMP2) ■ New Technologies and Approaches to Overcome Barriers to Progress in a Field ■ Structural Biology ■ PROMIS: Patient Report Outcomes Management System ■ Microphysiological Systems for Drug Screening ■ New Approaches to Foster Innovation and Invigorate the Research Workforce ■ High-Risk High-Reward (Pioneer, New Innovator, Transformative Research, Early Independence Awards) ■ Broadening Experiences in Scientific Training (BEST) Awards (New in FY13) ■ Increasing Diversity in the NIH-funded Workforce (New in FY13)

18. Regulatory Science: Improving the process for developing new therapies Human-on-a-Chip – a collaborative initiative between NIH, DARPA, and FDA for improved toxicity and efficacy testing Ten microphysiological systems to be represented on an integrated platform Must replicate known responses to drugs and toxins Must allow sustained analysis – up to 4 weeks – with multiple read-outs Should be extendable to include mimics of pathology NIH to encourage development of more accurate representations of physiology and pathology NIH will also encourage development of microsystems from iPS cells

20. 20 For more information: Contact information: Today’s talk – Betsy Wilder betsywilder@nih.govbetsywilder@nih.gov Pioneer, TR01, New Innovators, Early Independence Award – Ravi Basavappa basavapr@od.nih.gov basavapr@od.nih.gov Other Questions: Ellie Murcia murciae@od.nih.govmurciae@od.nih.gov http://commonfund.nih.gov/

21. Thank you! Any Questions?