The NIH / NHLBI Pipeline of Opportunities

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1 1 Building and Sustaining a Research Career in Hemostasis &Thrombosis The NIH / NHLBI Pipeline of Opportunities Donna DiMichele MD, Deputy Director, DBDR 2018 HTRS/NASTH Research Colloquium March 6-7, 2018

2 Disclosures No Affiliations or Conflicts of Interest to Disclose

3 Presentation Outline NIH/ NHLBI/ DBDR ongoing and new mechanisms and initiatives to support: Pre- and post- doctoral training Career development PhD scientists Physician scientists Clinician scientists Early Stage (ESI) and Early Emerging (EEI) Investigators

4 4 The Blood Science Training Pipeline

5 Stepping Stones to Success: Mechanisms to Support the Development of a Diverse Biomedical Workforce Post-doctoral fellowship Early Career Established Investigator High School and College Medical and Graduate School Fellowship and Training Grants (T32/35, F30) Fellowship and Training Grants (F32, T32) Career Development Awards ESI Grants (Ks, R25, R35, R56, K-R03) Summer Research Education (R25) Diversity Supplement Program

6 6 NSRA F & T Awards

7 NHLBI F30 & F31 Fellowship Awards Eligibility: Baccalaureate degree, dissertation phase of training & US Citizenship or Permanent Residency F30: Enrolled in dual degree program (e.g., MD/PhD) F31: Enrolled in PhD program Up to 6 yrs. pre-doctoral support F30: Minimum 50% effort devoted to graduate training Award budget: Stipend, tuition & fees (No F&A) Standard F Receipt Dates: April 8, August 8, December 8 Project cannot propose independent clinical trial

8 NHLBI F32 Fellowship Award Eligibility: Clinical or research doctorate & US Citizenship or Permanent Residency Up to 3 yrs. post-doctoral support, full time research training Cannot be used to support residency training Can be used to support research fellowship years Award budget: stipend, tuition & fees (No F&A) Standard F receipt dates: April 8, August 8, December 8 Project cannot propose independent clinical trial

9 NHLBI T32 Training Award Institutional award for recruitment of pre- or post-doctoral trainees Appointee Eligibility: Clinical or research doctorate & US Citizenship or Permanent Residency Project period up to 5 years, renewable Award budget: Reflect needs of project Standard T receipt dates: January 25, May 25, September 25 Application cannot propose clinical trial

10 Career Development K Awards

11 Stepping Stones to Success: Mechanisms to Support the Development of a Diverse Biomedical Workforce Post-doctoral fellowship Early Career Established Investigator High School and College Medical and Graduate School Fellowship and Training Grants (T32/35, F30) Fellowship and Training Grants (F32, T32) Career Development Awards ESI Grants (Ks, R25, R35, R56, K-R03) Summer Research Education (R25) Diversity Supplement Program

12 NHLBI K08 and K23 Career Awards Eligibility: Clinical* doctorate with US licensure & US citizenship or permanent residency K08: must have a clinical doctoral degree K23: must have a health professional doctoral degree Minimum 75% effort during 3-5 yr. award (Total K award yrs.-6) Salary: $100K + 8 % F&A; Research Support: $25K (K08); $50 K (K23) Standard K receipt dates: February 12, June 12, and October 12 Resubmission dates: March 12, July 12, November 12 All NIH K awards include two FOAs clinical trials required and clinical trials not required : K08: NIH PA (CT req) K08: NIH PA (CT n/a) K23: NIH PA (CT req) K23: NIH PA (CT n/a)

13 NHLBI K01 Career Award for Diversity Eligibility: Clinical/ research doctorate & US citizenship or permanent residency; full-time non-tenured faculty Underrepresented backgrounds, including racial/ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds Minimum 75% effort during 3-5 yr. award (Total K award yrs.= 6) Salary: $100K + 8 % F&A; Research Support: $30K K01 for Diversity receipt dates: February 12 and October 12 All NIH K awards include two FOAs clinical trials required and clinical trials not required : RFA HL : K01 to Promote Faculty Diversity (CT req) RFA HL : K01 to Promote Faculty Diversity (CT n/a)

14 NHLBI K01 Career Awards Eligibility: Clinical or research doctorate & US citizenship/ permanent residency; full-time non-tenured faculty Epidemiology, Biostatistics, Outcomes, EMR, and Implementation research only Minimum 75% effort during 3-5 yr. award (Total K award yrs.= 6) Salary: $100K + 8 % F&A; Research Support: $30K Standard K receipt dates: February 12, June 12, and October 12 Resubmission dates: March 12, July 12, November 12 All NIH K awards include two FOAs clinical trials required and clinical trials not required : NIH PA (CT req) NIH PA (CT n/a)

15 NHLBI K99/R00 Pathway to Independence Award Eligibility: Clinical or research doctorate; < 48 mos. postdoc research US Citizenship NOT required Minimum 75% effort during 1 2 yr. mentored + < 3 yrs. tenuretrack independent faculty position Salary:$100K + F&A = 8%; Research Support: $25K; R00 TC up to $249K/yr. Standard K receipt dates: February 12, June 12, and October 12 Resubmission dates: March 12, July 12, November 12 All NIH K awards include two FOAs clinical trials required and clinical trials not required : NIH PA (CT req) NIH PA (CT n/a) (CT n/a)

16 1 6 Blood Science K applicants represented only 11% of all NHLBI K applications in FY 2016 How can we increase the # of K applicants in hematology and blood science especially since the K Award is the gateway to becoming an independent investigator?

17 Partnering with Foundations and Professional Societies to ensure that starter grants prepare applicants for K (Career) Awards

18 Stepping Stones to Success: Mechanisms to Support the Development of a Diverse Biomedical Workforce Post-doctoral fellowship Early Career Established Investigator High School and College Medical and Graduate School Fellowship and Training Grants (T32/35, F30) Fellowship and Training Grants (F32, T32) Summer Research Education (R25) Diversity Supplement Program Foundation & Society Support Career Development Awards ESI Grants (Ks, R25, R35, R56, K-R03) DBDR Mentoring Partnership

19 1 9 How do we most effectively increase recruitment and retention of physician scientists into the blood science research enterprise? Start in Residency!

20 GAPS IN THE PIPELINE

21 Stepping Stones to Success: Mechanisms to Support the Development of a Diverse Biomedical Workforce Medical and Graduate School Post-doctoral fellowship Early Career Established Investigator High School and College Fellowship and Training Grants (T32/35, F30) Fellowship and Training Grants (F32, T32) Career Development Awards ESI Grants (Ks, R25, R35, R56, K-R03) Research in Residency Summer Research Education (R25) Diversity Supplement Program

22 R38 Stimulating Access To Research In Residency (Starr) Institutional award to support mentored research activities for Resident- Investigators (RIs) expected to pursue subspecialty training and a PS career RI training = that which would occur directly after completion of medical (or eq.) school and prior to subspecialty training (fellowship) A fellowship or subspecialty residency training with a prerequisite residency is not eligible (e.g. critical care or pediatric surgery) Research within NHLBI-mission (HLBS diseases) with expectation that RIs matriculate to subspecialty research training in NHLBI-relevant disease areas RIs do 12 months of research at 80% effort ( 3 mos. contiguous) during residency training Application Receipt Dates: January 24, 2018, 2019, and 2020

23 K38 Stimulating Access To Research In Residency Transition Scholar (Starrts) Provide a continuum of NIH-funded research support for residents who participated in the R38 Research in Residency (RnR) program (transition scholars) This individual research award can occur at the transition scholar s RnR institution or another institution offering subspecialty training Up to 2 years of support during subspecialty training and in addition to the project mentor, an additional career sponsor will be required Career development plan and additional research funds to help foster the transition scholar s subsequent career development (e.g. K08, K23) or independent research awards (e.g. R21, R01, R34) Anticipated first receipt date: October 2020

24 Stepping Stones to Success: Mechanisms to Support the Development of a Diverse Biomedical Workforce Post-doctoral fellowship Early Career Established Investigator High School and College Medical and Graduate School Fellowship and Training Grants (T32/35, F30) Fellowship and Training Grants (F32, T32) Research in Residency Career Development Awards ESI Grants (Ks, R25, R35, R56, K-R03) Summer Research Education (R25) Diversity Supplement Program Stay tuned for other new initiatives soon to be released!

25 NHLBI : Helping you become an independent investigator Your 1 st R01 should be an Early Stage investigator Award

26 Early Stage Investigators (ESIs) Fostering success of ESIs is high priority, and NHLBI continues its commitment in accordance with NIH guidelines Includes special consideration in both funding priority and period of support FY18 pay line for ESIs is 10 %ile above R01 pay line (25%ile) All awards to ESI applications are funded for all years recommended by NHBLAC ( usually 5yrs. ) Time given for A1 resubmission of an unsuccessful appl. ~ 3 yrs. Type 2 application handicap is 5%ile Funding advantage given to ESI apps from PIs who maintain New Investigator status when funding decisions are made

27 NHLBI : Helping you get to your second R01 and beyond Programs for Early Emerging Investigators

28 2 8 NIH Next Generation Researchers Initiative and Policy Early Established Investigator (EEI): An EEI is a PD/PI who is within 10 years of receiving their first substantial, independent competing NIH R01-equivalent research award as an ESI. A meritorious application with a designated PD/PI EEI may be prioritized for funding if: The EEI lost or is at risk for losing all NIH research support if not funded by competing awards this year, OR The EEI is supported by only one active award. NIH will identify EEIs in their era Commons profile by January An NIH grant application with more than one PD/PI (MPI) will be prioritized for funding only if all MPIs have EEI status $ meet criteria.

29 NHLBI Support of ESI s and EEI s: Select Pay FY 2018 Payline with Selective Pay Depending on availability of funds, NHLBI will make funding decisions on competing applications above the payline through selective pay actions. Criteria for Selective Pay Criteria relevant to scientific merit, program balance, and NHLBI strategic priorities including: Scientific and technical merit determined by peer review and NHLBAC Relevance to NHLBI s strategic research priorities Overall programmatic portfolio balance and need (e.g., scientific gaps, NHLBI areas of interest, poorly represented areas in NHLBI portfolio, etc.,) Development and diversity of the biomedical workforce (e.g., career stage, etc.) Potential for high scientific or public health impact (e.g., highly innovative research, research relevant to special populations that are disproportionately affected or understudied [women, minorities, pediatric populations, patients with rare diseases], etc.)

30 Emerging Investigator Award ( R35) NHLBI Emerging Investigator Award (EIA) - RFA-HL Eligibility Requirements Currently have two NHLBI R01 awards, of which one must be an NHLBIfunded NIH Early Stage Investigator (ESI) R01; and Can commit a minimum of 50% research effort (i.e., min.6 mos.) / EIA yr. EIA R35 Award Specifics Up to $600,000 DC/yr. x up to 7 yrs.; commensurate with PI's recent NHLBI support; Support for currently-funded NHLBI grants folded into the EIA and thereby renewed; Increased flexibility to pursue new ideas and opportunities as they arise during the course of research, since the EIA is not tied to SAs; A reduction in administrative burden associated with writing multiple grant applications and managing multiple grant awards.

31 NIH Tools and Staff to help you to write your grant

Find Similar Projects with Matchmaker function on NIH RePORTER In Progress: Matchmaker for PO Choose Similar Projects or Program Officials The research group

The work is focused on the systematic study of the human brain of drug abusers and subjects with psychiatric disorders in relation to opioid neuropeptide,

mesocorticolimbic system, which regulate emotional function.

32 Find Similar Projects with Matchmaker function on NIH RePORTER In Progress: Matchmaker for PO Choose Similar Projects or Program Officials The research group investigates the neurobiology underlying drug abuse and related psychiatric disorders. The work is focused on the systematic study of the human brain of drug abusers and subjects with psychiatric disorders in relation to opioid neuropeptide, cannabinoid and dopamine neuronal systems. Drug abuse and, e.g., major depression are associated with alterations of mood, cognition, and motivation, thus, an important goal is to identify and map specific genes in the mesocorticolimbic system, which regulate emotional function. Techniques such as in situ hybridization, RT-PCR, DNA microarray, in vitro autoradiography, and general biochemical assays are used for the detailed analyses of genes, and respective protein products, in discrete mesocorticolimbic brain areas. Molecular, biochemical, and in vivo studies of the human brain are assessed in relation to individual genotype in order to identify neurobiological correlates of functional genetic polymorphisms linked to addiction and affective disorders. Epigenetic mechanisms, e.g., DNA methylation, are also evaluated in relation to the regulation of gene expression. View similar projects or View program officials

33 In Progress: A PO Finder through NIH RePORTER Connect PIs with Program Officers before they apply NIH Research Portfolio Online Reporting Tools (RePORT) NIH Office of Extramural Research March 27, 2018

34 3 4 Find your Funding Opportunity Contact your DBDR Program Officer On Line Phone and Telephone: donna.dimichele@nih.gov Social

35 Clinical Research Training at the NIH The Lasker Award

Lasker Clinical Research Scholars An Intramural Program The program supports a small number of exceptional clinical researchers in the early stages of their careers to promote their development to

36 Lasker Clinical Research Scholars An Intramural Program The program supports a small number of exceptional clinical researchers in the early stages of their careers to promote their development to fully independent positions. Lasker Scholars receive a unique combination of NIH funding for clinical research for up to 10 years. Phase 1: Scholars will receive appointments for 5-7 yrs. as tenure-track investigators within the NIH Intramural Research Program with independent budgets. Phase 2: Successful Scholars will receive up to 3 yrs. of NIH support for their research at an extramural research facility; or the Scholar can be considered to remain a DIR investigator. Additional information can be obtained at Contact: Charles Dearolf, Asst. Director for Intramural Research, at LaskerScholar@nih.gov.

37 NIH Loan Repayment Programs (LRPs) Good Success Rates at NHLBI- Apply! (Following slides courtesy of Dr. Ericka Boone, Director of the NIH LRP)

NIH Loan Repayment Programs (LRPs) NIH LRPs will repay: Up to $70K over 2 yrs in educational loan repayment Depending on debt level Coverage of most Federal taxes resulting from the NIH LRP 2 year

38 NIH Loan Repayment Programs (LRPs) NIH LRPs will repay: Up to $70K over 2 yrs in educational loan repayment Depending on debt level Coverage of most Federal taxes resulting from the NIH LRP 2 year initial contracts You may apply for 1 or 2 year competitive renewals Approximately 1,600 researchers funded yearly 50% application success rate overall *Visit the LRP website to find out more:

39 5 Extramural NIH LRPs: For individuals conducting research at non-profit institutions Clinical Research Patient-oriented research conducted with human subjects or materials of human origin (including cognitive phenomenon) on the causes and consequences of disease in humans Pediatric Research Research related to diseases or disorders in children Basic research allowed Health Disparities Research Research focusing on minority and other health disparity populations Basic, clinical, social and behavioral research allowed Applications reviewed by NIMHD Contraception & Infertility Research Research focusing on conditions impacting ability to conceive or bear children and provide new or improved methods of preventing pregnancy Applications reviewed by Eunice Kennedy Shriver NICHD Clinical DB Same as Clinical Research LRP Available to clinical researchers from verifiable disadvantaged backgrounds Reviewed by NIMHD

Basic LRP Eligibility Criteria Extramural Doctoral Degree M.D., Ph.

LRP Research Funding Domestic nonprofit, university, or

40 Basic LRP Eligibility Criteria Extramural Doctoral Degree M.D., Ph.D., or equivalent Exception: Contraception & Infertility Research LRP Research Funding Domestic nonprofit, university, or government organization; NIH grant support NOT required Citizenship U.S. Citizen or permanent resident Educational Loan Debt At least 20% of applicant s annual income Research Time At least 20 hours/week

41 Application Cycle Timeline September 1 November 15: Application Cycle Open November 15: Application, IBO and Colleague Deadline February May: Application Peer Review May: IC Initial Selections May July: Financial Vetting and Verifications August: Final Funding Decisions/Recipient Notifications November: First Lender Payments 41

42 What Are Reviewers Looking For? Reviewers evaluate an applicant s potential to succeed in a research career by rating: Applicant s previous training and research experience Applicant s commitment to a research career Strength and quality of letters of recommendation Quality and appropriateness of the research environment Research progress (for Renewal applications only)

43 Before you Start Your Application Things to do to be ahead of the curve: 1. Read LRP website and published notices to determine which NIH LRP is the right one for you 2. Talk to an NIH LRP Program Officer/Liaison at the NIH Institute and Center that you would like to review your application 3. Talk to your mentor, potential recommenders and your institutional business official about your interest in applying for an LRP award 4. Contact your lender to get specific loan information (including account numbers and amounts owed) 5. Make sure you have an era Commons ID

44 Tips for Writing a Competitive LRP Application These tips will help you strengthen your application Know the funding priorities of the NIH Institute or Center that will review your application Effectively demonstrate your qualifications and commitment to research Describe resources and support thoroughly Write a strong research plan (and if mentored, a strong mentoring plan) Use tables/chart to outline timelines/activities Provide strong letters of recommendation from individuals familiar with you and your research

45 Contact LRP Website: Phone: (9am to 5pm, EST) Inquiries: Facebook:

Early Stage Investigators and the Program Perspective

Early Stage Investigators and the Program Perspective Michael Sesma, Ph.D. National Institute of Mental Health Following up on Dr. Rockey s talk Get to know the Program Director for your scientific area