BIOMATERIALS , BIOMECHANICS AND

STEM CELLS

AT NIHRosemarie HunzikerRosemarie HunzikerTissue Engineering/Regenerative Medicine, Biomaterials/Biomechanics, and Implantable Medical Devices Program DirectorNational Institute of Biomedical Imaging

and Bioengineering (NIBIB)National Institutes of Health (NIH)

301-451-1609Rosemarie.Hunziker@nih.gov

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 materials-

based 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.

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.

Applications, Awards, Success Rates

NEDB 4

More info available at: http://report.nih.gov/success_rates/index.aspx

NIH FY12 Budget 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.

NCI

OD/CF

NCCAM

NIDA

NIEHS

NIAMS

NHGRINIDCRNIAAA

NIDCDNIMHDNLM

NIBIB

FIC

Total = $31 B

NEI

NINR

= Institutes with significant percentages of budgets in Regenerative Medicine.

NIAID

NHLBI

NIGMSNIDDK

NINDS

NIMH

NICHD

NCRR

NIA

OD/CF

There are two kinds of scientific revolutions, those driven by new

tools and those driven by new concepts… The effect of a concept-

driven 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

the NIBIB distinction…• Technology development• Enabling tools/approaches

…integrating the physical and engineering sciences w ith the life sciences to turn discovery into health.

It’s not enough to be UNIQUE… you must also be USEFUL.

Need Help with Your Proposal…

Who Ya’ Gonna’ Call?� about the scientific and

technical aspects of your

application…

� for questions during the

review…

� Find them on the solicitation

� See also the IC’s programmatic descriptions

(http://www.nih.gov/icd/index.html).

Program

Director

review…

Scientific

Review

Officer

� for help with the business

aspects of a proposal…

Grants

Specialist

� Listed on the eRA Commons link to your

submitted proposal

� See also the review group rosters at the CSR

web site

� Listed on the eRA Commons link to your

submitted proposal

� See also the IC’s programmatic descriptions

(http://www.nih.gov/icd/index.html).

NIH Institute/Center Web Sites

www.nih.gov/icd/

Institute/Center

Each NIH has a HOME PAGE

http://www.nibib.nih.gov/

Model: http://www.xxxxx.nih.gov

Does NIH Already Support My Interest Area?

http://report.nih.gov/quicklinks.aspx

NIH Searchable Databases Contain Abstracts of All Funded Projects

Search by� MESH terms� Key words� Organizations� States/Countries� Investigators� Mechanisms� Solicitations� Institutes� Investigators � …

RePORTer Delivers a Treasure Trove…

Click for

Abstract

… of Useful Information.

https://loop.nigms.nih.gov/index.php/2012/12/03/how-to-use-

reporter-when-preparing-new-grant-applications/

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• 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

Plan Ahead… Seriously!

“Family Tree” for Grants

R01(standard P01

P30, P50, P41, U54, etc.

(large collabortives)

(standard grant)

P01(collection of grants)

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– 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 (HR2)

– 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”!

Grants: A to Z

http://grants.nih.gov/grants/about_grants.htm

How Does NIH Solicit Applications?

� Parent Announcements cover basic activity codes- investigator-initiated applications

� Federal Opportunity Announcements (FOA)

published through - the NIH Guide (http://grants.nih.gov/grants/guide/)

- grants.gov

- 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

NIH Funding Opportunities (FOAs)

http://grants.nih.gov/grants/guide/

PAR 11-203: Predictive Multiscale Models for Biomedical,

Biological, Behavioral, Environmental, and Clinical Research

(Interagency U01)

MultiMulti--Agency NIH Funding Opportunities…Agency NIH Funding Opportunities…

� next generation of cutting edge multiscale modelsmultiscale models

� Participating Agencies: NIH, NSF, DOE, FDA

� Active until February, 2014

http://grants.nih.gov/grants/guide/pa-files/PAR-11-203.html

NOT-EB-11-006:

NIH Participation in the

National Robotics Initiative.

NSF-led with NIH (NIBIB, NIA,

NICHD, NINR, NINDS) and

NIH and the NIH and the

National Robotics InitiativeNational Robotics Initiative

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

http://www.nsf.gov/pubs/2011/nsf11553/nsf11553.htm# toc

NIH Bioengineering Program Announcements

� PAR-10-234: Bioengineering Research Partnerships (BRP) [R01] Supports a team approach to basic, applied, and translational multi-

disciplinary research that addresses important biological, clinical or

biomedical research problems.

� PA-12-284: Exploratory/Developmental Bioengineering Research

Grants (EBRG) [R21] Supports early and conceptual stages of new

Reissue with changes coming!

Grants (EBRG) [R21]exploratory and developmental research that may involve considerable

risk but may lead to a breakthrough.

� PA-13-137: 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.

� Small (~100 nm)

� Man-made/manipulated

� Functional properties emerge at nanoscale

NIH is a charter memberNanomaterials

� Functional properties emerge at nanoscale

Funding

� PA-11-149: 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-11-148: 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:PROMIS:Clinical Clinical

OutcomesOutcomesAssessmentAssessment

NIHNIHCenter forCenter for

RegenerativeRegenerativeMedicineMedicine

Gulf Oil Gulf Oil SpillSpill

MetabolmicsMetabolmics

Single CellSingle CellAnalysisAnalysis

Medical Medical ResearchResearchScholarsScholarsTrainingTraining

Health Health EconomicsEconomics

Library of Library of Integrated NetworkIntegrated Network--

Based Cellular Based Cellular

MolecularMolecularLibrariesLibraries

and Imagingand Imaging

Building Blocks,Building Blocks,BiologicalBiological

Pathways andPathways andNetworksNetworks

Big Data to Big Data to KnowledgeKnowledge

Human Human MicrobiomeMicrobiome

RegulatoryRegulatoryScienceScience

Bridging Bridging InterventionalInterventional

Development GapsDevelopment Gaps((BrIDGsBrIDGs))

Health CareHealth CareSystemsSystems

CollaboratoryCollaboratory

Science ofScience ofBehaviorBehaviorChangeChange

Protein Protein CaptureCapture

NanomedicineNanomedicineEarly IndependenceEarly IndependenceNew innovatorsNew innovatorsPioneersPioneersTransformative R01sTransformative R01s

GenotypeGenotype--TissueTissue

ExpressionExpression

HighHigh--riskriskResearchResearch

NIHCommon Fund

EpigenomicsEpigenomics

http://commonfund.nih.gov/

ExtracellularExtracellularRNA RNA

CommunicationCommunication

Based Cellular Based Cellular Signatures (LINCS)Signatures (LINCS)

Bioinformatics andBioinformatics andComputational BiologyComputational Biology

StructuralStructuralBiologyBiology UndiagnosedUndiagnosed

DiseasesDiseases

Knockout Knockout Mouse Mouse

PhenotypingPhenotyping

Increasing Research Increasing Research Workforce DiversityWorkforce Diversity

Strengthening BiomedicalStrengthening BiomedicalResearch WorkforceResearch Workforce

Global Global HealthHealth

May 2013

NIH Funding Initiatives: Get the scoop!

� NIH Guide to Grants and Contracts http://grants.nih.gov/grants/guide/listserv.htm

� NIH Extramural Nexus: Rock Talk! http://nexus.od.nih.gov/all/category/blog/

� NIBIB Listserve https://list.nih.gov/cgi-bin/wa.exe?SUBED1=NIBIB_LISTSERV&A=1

Sally Rockey

“Biomaterials” Projects in NIH Portfolios“Biomaterials” Projects in NIH Portfolios

NIBIB54 (6.4%)

NIDCR

OD/CF10 (5.1%)

NHLBI

NIGMS31 (0.9%)

NIDDK18 (0.7%)

NIDCD6 (0.6%)

NIA5 (0.5%)

NIH ICs with <0.5% investment

NCATS, NCCAM, NCI, NEI,

NHGRI, NIAAA, NIAID, NICHD,

NIDA, NIEHS, NINDS, NINR, NLM Source: NIH RePORTer, “Active Projects, 2012”

Total Funding: $146 M, 320 awards

NIDCR38 (5.1%)

FIC2 (1.5%)

NIAMS24 (1.4%)

NHLBI54 (0.9%)

NIMH9 (1.0%)

NIH Research Solves Health Concerns

High resolution CARS image

of live cells showing fine

structural detail.

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.

“Cellular Mechanics ” Projects in “Cellular Mechanics ” Projects in

NIH PortfoliosNIH Portfolios

NIBIB6 (0.6%) NIDCD

10 (1.9%)

NIMH3 (0.5%)

NIGMS540 (0.6%)

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

NHLBI34 (0.6%)

$35 M

in TE/RM

(Army MRMC)

Federal Investment in

Tissue Engineering and

Regenerative Medicine

$600 M

in TE/RM

$33 M

In TE/RM $1,000 M

in stem cells

US Government Support for Global Health

http://www.globalhealth.gov/index.html

NIH Common Fund and Global Health

https://commonfund.nih.gov/globalhealth/

Currently Active Funding Opportunities

http://h3africa.org/funding.cfm#al-1

NIH’s Focus on Global Health

http://www.fic.nih.gov/Global/Global-Health-NIH/Pag es/default.aspx

Foreign Applications: Special Considerations

Review procedures include�Study Section’s evaluation of the opportunity

Must offer opportunities not readily available in t he US� Unusual talent� Unique resources� Special populations� Restricted Environments

�Study Section’s evaluation of the opportunity�Individual consideration at Advisory Council

Awards (including subcontracts) require�US State Department approval�Additional processing time

Step #1: Do your homework; learn a bit about the gr ant process and the options.

Path to Success at NIH

Office of Extramural Research:

Basics - http://grants.nih.gov/grants/grant_basics.htm

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

IC priorities: http://www.nih.gov/icd/index.html

NIH Guide Provides Weekly Updates on Funding Opportunities:

http://grants.nih.gov/grants/guide/

Step #2: Contact us because… We’re from the Government, we’re here to help you!

http://grants.nih.gov/grants/guide/

NIH RePORTer – lots of statistics and abstracts of funded grants

http://report.nih.gov/

Rosemarie Hunziker, Ph.D.Program Director, Tissue

Engineering/Regenerative Medicine,

Biomaterials, and Medical Devices

National Institute of Biomedical Imaging and

Bioengineering (NIBIB)Bioengineering (NIBIB)

National Institutes of Health (NIH)

301-451-1609

Rosemarie.Hunziker@nih.gov

www.nibib.nih.gov

National Institute ofBiomedical Imaging

and Bioengineering