BIOMATERIALS, BIOMECHANICS AND STEM CELLS

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1 BIOMATERIALS, BIOMECHANICS AND STEM CELLS AT NIH Rosemarie Hunziker Tissue Engineering/Regenerative Medicine, Biomaterials/Biomechanics, and Implantable Medical Devices Program Director National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of Health (NIH)

FIVE TAKE AWAYS The NIH is not one organization, but 27 individual fiefdoms, each

In tight budget times, conservatism rules, but reviewers and staff are eager to be

types of grants) and many portals to access that support (e.g. FOAs).

rather in applying new materialsbased technologies and approaches to advance health.

2 FIVE TAKE AWAYS The NIH is not one organization, but 27 individual fiefdoms, each with a culture and set of practices. Find your niche. In tight budget times, conservatism rules, but reviewers and staff are eager to be wowed. Let us help you! NIH has many ways to support science (e.g. types of grants) and many portals to access that support (e.g. FOAs). There is little interest in advancing BIOMATERIALS or BIOMECHANICS per se, but rather in applying new materialsbased technologies and approaches to advance health. NIH is chiefly concerned with finding and funding the best science and engineering. Foreign applications and/or participation is part of that search.

nature and behavior of living systems and the application of that

3 NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.

4 Applications, Awards, Success Rates More info available at: NEDB 4

5 NIH FY12 Budget NIH Divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers), with <4%) allocated to trans- NIH initiatives. NHGRI NEI NIAMS NIEHS NIDA OD/CF NIA NCRR NICHD NIMH NIDCD NIAAA NINDS NLM NIDCR NIBIB NIMHD NCCAM NIDDK NINR FIC NCI NIGMS Total = $31 B NIAID NHLBI = Institutes with significant percentages of budgets in Regenerative Medicine.

6 There are two kinds of scientific revolutions, those driven by new tools and those driven by new concepts The effect of a conceptdriven revolution is to explain old things in new ways. The effect of a tool-driven revolution is to discover new things that have to be explained. -Freeman Dyson, 1997

engineering sciences with the life sciences to turn

7 the NIBIB distinction Technology development Enabling tools/approaches integrating the physical and engineering sciences with the life sciences to turn discovery into health. It s not enough to be UNIQUE you must also be USEFUL.

8 about the scientific and technical aspects of your application Find them on the solicitation See also the IC s programmatic descriptions ( for questions during the review Listed on the era Commons link to your submitted proposal See also the review group rosters at the CSR web site for help with the business aspects of a proposal Listed on the era Commons link to your submitted proposal See also the IC s programmatic descriptions ( Need Help with Your Proposal Who Ya Gonna Call? Program Director Scientific Review Officer Grants Specialist

9 NIH Institute/Center Web Sites

10 Each NIH Institute/ Center has a HOME PAGE Model:

12 Does NIH Already Support My Interest Area?

13 NIH Searchable Databases Contain Abstracts of All Funded Projects Search by MESH terms Key words Organizations States/Countries Investigators Mechanisms Solicitations Institutes Investigators

14 RePORTer Delivers a Treasure Trove Click for Abstract

15 of Useful Information.

17 Getting to the Top: Writing Great Grants Components of successful applications Strong Idea New Science/Engineering Right Team, Resources Compelling Presentation Match idea/science to the right place at NIH Every Institute or Center (IC) has specific mission Each Study Section (Review Group) is a little different Hone high-quality grant writing skills Articulate the need to capture the opportunity Communicate scientific content accurately and concisely Follow all the instructions

18 Plan Ahead Seriously!

19 Family Tree for Grants R01 (standard grant) P01 (collection of grants) P30, P50, P41, U54, etc. (large collabortives)

Different Grants Serve Different Purposes R01 Workhorse of NIH

investigation, provides new fulcrum for the field without gaps

often renewable, generally $400-$500K per year R03 A mini-r01

pilots, methods development $50K per year for two years Not used

R21 (Exploratory/Developmental) Ideal = High Risk/High Reward

per year, typically 2 years, NOT renewable Success = quantum

20 Different Grants Serve Different Purposes R01 Workhorse of NIH research, highly valued by peers An outline for rigorous investigation, provides new fulcrum for the field without gaps for others to fill Based on solid preliminary data 4-5 years, often renewable, generally $400-$500K per year R03 A mini-r01 popular with new investigators Self-contained: data analysis, pilots, methods development $50K per year for two years Not used by all institutes. R21 (Exploratory/Developmental) Ideal = High Risk/High Reward (HR 2 ) Innovation is a key, no preliminary data required $275K per year, typically 2 years, NOT renewable Success = quantum leap requiring follow up (sometimes with an R33) and/or validation (i.e. an R01 submission) NOT a new investigator starter grant!

21 Grants: A to Z

How Does NIH Solicit Applications? Federal Opportunity Announcements (FOA) published through - the NIH Guide (http://grants.nih.gov/grants/guide/) - grants.

22 How Does NIH Solicit Applications? Federal Opportunity Announcements (FOA) published through - the NIH Guide ( - grants.gov Parent Announcements cover basic activity codes - investigator-initiated applications Special Opportunities to fill gaps - Requests for Applications (RFA), a one-time call with set aside funds - Program Announcement (PA) highlights areas of focus - Program Announcement with Special Review (PAR) for special consideration and protected review - Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates

23 NIH Funding Opportunities (FOAs)

24 Multi-Agency NIH Funding Opportunities PAR : Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental, and Clinical Research (Interagency U01) next generation of cutting edge multiscale models Participating Agencies: NIH, NSF, DOE, FDA Active until February,

25 NIH and the National Robotics Initiative NOT-EB : NIH Participation in the National Robotics Initiative. NSF-led with NIH (NIBIB, NIA, NICHD, NINR, NINDS) and NASA, USDA. Next generation robotics, particularly co-robotics. NIH interests: home care, personalized care for special needs populations, rehabilitation and behavorial therapy, surgical and interventional robots, high-throughput technologies Apply through NSF

NIH Bioengineering Program Announcements PAR-10-234: Bioengineering Research Partnerships

research that addresses important biological, clinical or biomedical research problems.

PA-12-284: Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21] Supports

considerable risk but may lead to a breakthrough.

26 NIH Bioengineering Program Announcements PAR : Bioengineering Research Partnerships (BRP) [R01] Supports a team approach to basic, applied, and translational multidisciplinary research that addresses important biological, clinical or biomedical research problems. Reissue with changes coming! PA : Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21] Supports early and conceptual stages of new exploratory and developmental research that may involve considerable risk but may lead to a breakthrough. PA : Bioengineering Research Grants (BRG) [R01] Supports an integrated, systems approach to basic and applied multi-disciplinary research that addresses important biological, clinical or biomedical research problems.

developmental nanoscience and technology research that may involve considerable risk but have high potential reward.

27 NIH is a charter member Nanomaterials Small (~100 nm) Man-made/manipulated Functional properties emerge at nanoscale Funding PA : Nanoscience and Nanotechnology in Biology and Medicine (R21) Early and conceptual stages of new exploratory and developmental nanoscience and technology research that may involve considerable risk but have high potential reward. PA : Nanoscience and Nanotechnology in Biology and Medicine (R01) New and ongoing research in nanoscience and technology research focused on problems in biology.

Cross-Cutting, trans-nih Programs PROMIS: Regulatory Health Clinical Science Economics Outcomes Assessment Medical Health Care Research Systems Bridging Scholars Collaboratory Interventional Training

28 Cross-Cutting, trans-nih Programs PROMIS: Regulatory Health Clinical Science Economics Outcomes Assessment Medical Health Care Research Systems Bridging Scholars Collaboratory Interventional Training Development Gaps (BrIDGs) High-risk Research Early Independence New innovators Pioneers Transformative R01s Increasing Research Workforce Diversity Strengthening Biomedical Research Workforce NIH Center for Regenerative Medicine Gulf Oil Spill NIH Common Fund Single Cell Analysis Molecular Libraries and Imaging Global Health Protein Big Data to Capture Building Blocks, Knowledge Biological Science of Human Pathways and Behavior Microbiome Networks Change Library of Metabolmics Integrated Network- Based Cellular Signatures (LINCS) Knockout Mouse Phenotyping Nanomedicine Genotype- Tissue Epigenomics Expression Structural Biology Bioinformatics and Computational Biology Extracellular RNA Communication Undiagnosed Diseases May 2013

29 NIH Funding Initiatives: Get the scoop! NIH Guide to Grants and Contracts NIH Extramural Nexus: Rock Talk! NIBIB Listserve Sally Rockey

30 Biomaterials Projects in NIH Portfolios NIDDK 18 (0.7%) NIGMS 31 (0.9%) NIDCD 6 (0.6%) NIA 5 (0.5%) NIBIB 54 (6.4%) OD/CF 10 (5.1%) NHLBI 54 (0.9%) NIAMS 24 (1.4%) NIDCR 38 (5.1%) NIH ICs with <0.5% investment NCATS, NCCAM, NCI, NEI, NHGRI, NIAAA, NIAID, NICHD, NIMH 9 (1.0%) FIC 2 (1.5%) NIDA, NIEHS, NINDS, NINR, NLM Source: NIH RePORTer, Active Projects, 2012 Total Funding: $146 M, 320 awards

Signal results from multiple incident photons and the material response at frequencies that

31 NIH Research Solves Health Concerns Coherent anti-stokes Raman Spectroscopy (CARS) generates quantitative, microscopic images based on vibrational constrast. Signal results from multiple incident photons and the material response at frequencies that reduce background, increasing specificity and specificity. High resolution CARS image of live cells showing fine structural detail.

32 Cellular Mechanics Projects in NIBIB 6 (0.6%) NIDCD 10 (1.9%) NIGMS 540 (0.6%) NIMH 3 (0.5%) NHLBI 34 (0.6%) NIH Portfolios NIH ICs with <0.5% investment FIC, NCATS, NCCAM, NCI, NEI, NHGRI, NIA, NIAAA, NIAID, NICHD, NIAMS, NIDA, NIDCR, NIDDK, NIEHS, NIMHD, NINDS, NINR, OD/CF Source: NIH RePORTer, Active Projects, 2012 Total Funding: $45M, 125 awards

33 Federal Investment in Tissue Engineering and Regenerative Medicine $35 M in TE/RM (Army MRMC) $33 M In TE/RM $600 M in TE/RM $1,000 M in stem cells

34 US Government Support for Global Health

35 NIH Common Fund and Global Health

36 Currently Active Funding Opportunities

37 NIH s Focus on Global Health

Foreign Applications: Special Considerations

in the US Unusual talent Unique resources

Review procedures include Study Section s

consideration at Advisory Council Awards

39 Foreign Applications: Special Considerations Must offer opportunities not readily available in the US Unusual talent Unique resources Special populations Restricted Environments Review procedures include Study Section s evaluation of the opportunity Individual consideration at Advisory Council Awards (including subcontracts) require US State Department approval Additional processing time

Path to Success at NIH Step #1: Do your homework; learn a bit about the grant process and

gov/grants/grant_basics.htm Overview - http://grants.nih.gov/grants/grants_process.

html NIH Guide Provides Weekly Updates on Funding Opportunities: http://grants.nih.

40 Path to Success at NIH Step #1: Do your homework; learn a bit about the grant process and the options. Office of Extramural Research: Basics - Overview - IC priorities: NIH Guide Provides Weekly Updates on Funding Opportunities: NIH RePORTer lots of statistics and abstracts of funded grants Step #2: Contact us because We re from the Government, we re here to help you!

41 Rosemarie Hunziker, Ph.D. Program Director, Tissue Engineering/Regenerative Medicine, Biomaterials, and Medical Devices National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering

Grantsmanship at the NIH and the Device Research Landscape. Michael Wolfson, Ph.D. Program Director NIH/NIBIB 11/8/17

Grantsmanship at the NIH and the Device Research Landscape Michael Wolfson, Ph.D. Program Director NIH/NIBIB 11/8/17 The Three Gatekeepers Funder Regulator Payer Impact > Cost & Technical risk Benefit