NIH SBIR/STTR Programs Summary...7 National Institutes of Health Office of Extramural Research...

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National Institutes of Health Office of Extramural Research

Lenka Fedorkova, Ph.D. Assistant Manager

SBIR/STTR Programs

Office of Extramural Research, NIH

NIH SBIR/STTR Programs

Summary

National SBIR Spring Conference

Washington, D.C.

May 15, 2013

Nati

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NIH Mission

Improve human health

through biomedical and

behavioral research,

research training and

communications.

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SBIR/STTR in Your Portfolio

Capital is in the form of grants and contracts

Strategic Investment in Innovation

Non-diluted funding:

• no repayment

• no debt service

• no equity forfeiture

• no IP forfeiture

National Institutes of Health Office of Extramural Research Agency Differences

Granting Agencies

Investigator initiates approach

Less-specified topics

Assistance mechanism

More flexibility

DOD HHS/NIH

NASA ED

EPA DOT

DOC DHS

Contracting Agencies Agency establishes plans,

protocols, requirements

Highly focused topics

Procurement mechanism for DOD and NASA

More fiscal requirements

HHS/NIH NSF ED USDA DOE

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Office of the Director

National Institute

on Minority Health

and Health

Disparities

National Institutes of Health

http://www.nih.gov/icd

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Arthritis and

Musculoskeletal

and Skin Diseases

National Cancer

Institute

National Institute

on Aging

National Institute

of Child Health

and Human

Development

National Institute

of Allergy and

Infectious Diseases

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National Institute

of Dental and

Craniofacial

Research

National Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National Institute on

Deafness and Other

Communication

Disorders

National Eye

Institute

National Human

Genome Research

Institute

National Heart,

Lung, and Blood

Institute

National Institute

of Mental Health

National Institute

of Neurological

Disorders and

Stroke

National Institute

of General

Medical Sciences

National Institute

of Nursing Research

National Library

of Medicine

National Center

for Complementary

and Alternative

Medicine

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National Institute

of Biomedical

Imaging

and

Bioengineering

No funding

authority

Center for

Information

Technology

Center for

Scientific Review NIH Clinical Center

Office of Research

Infrastructure Programs

NCI

NIAID

NHLBI

NIGMS NIDDK

NINDS

NIMH

NICHD

NIA

NIDA

NEI

NCATS

NIEHS NIAMS

NHGRI NIAAA

NIDCD

NIDCR

NIBIB NIMHD

ORIP NINR

NCCAM

NLM

NIH SBIR/STTR Budget Allocations FY2012

2.6% SBIR $632M

0.35% STTR $85M

Total FY2012 $717M

FY13 budgets

pending NIH

Appropriation

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Success Rates

0

5

10

15

20

25

30

35

40

45

SBIR 2011 STTR 2011 SBIR 2012 STTR 2012

Phase I

Phase II

Fast Track

2011 Total: 14.1% 2012 Total: 18.7%

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Program Status

P.L. 112-81 Re-Authorized

SBIR and STTR Programs through FY2017

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Key Re-Authorization Provision

FY Set-aside SBIR Set-aside STTR

2011 2.5% 0.30%

2012 2.6% 0.35%

2013 (current) 2.7% 0.35%

2014 2.8% 0.40%

2015 2.9% 0.40%

2016 3.0% 0.45%

2017 3.2% 0.45%

Set aside requirements for Agencies will increase


PHASE II Full Research/R&D

$1M SBIR & STTR; 2 years ($1.5M Max)

PHASE IIB Competing Renewal/R&D

Varies ~$1M/year; 3 years

Clinical R&D; Complex Instrumentation, Pre-IND

Seek 3rd party partnerships and investors early!

PHASE III Commercialization Stage

NIH, generally, not the “customer”

Plan exit strategy early!

PHASE I Feasibility Study $150K SBIR & STTR Total Costs ($225 Max)

6 months SBIR; 1 year STTR

3-Phased Program:

50% Hard Cap

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Important changes in 2013

Omnibus Grant Solicitations

• See http://grants.nih.gov/grants/guide/notice-files/NOT-

OD-13-027.html for details.

• New SBIR/STTR award budget HARD caps in place

• Applicants are strongly encouraged to contact NIH

program officials prior to submitting any application in

excess of the hard cap – limited award waiver from SBA

ABOUT TO REISSUE!!!


• Research Partner

SBIR: Permits partnering

33% Phase I and 50% Phase

II

STTR: Requires partnering

with Research Institution

Small business (40%) and U.S. research institution (30%)

Award is always made

to Small Business Concern

SBIR and STTR

Critical Differences

• Principal Investigator SBIR: Primary (>50%)

employment must be with

small business concern

STTR: PI may be employed

by either research institution

or small business concern

and must commit min 10%

effort

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-027.html










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SBIR/STTR:

Important Facts to Remember

• Eligibility is determined at time of award

• PD/PI is not required to have a Ph.D./M.D.

• PD/PI is required to have expertise to oversee

project scientifically and technically

• Applications may be submitted to different

agencies for similar work

• Awards may not be accepted from different

agencies for duplicative projects


• Annual SBIR/STTR Omnibus Grant Solicitation

“Parent FOAs” SBIR: PA-13-088 STTR: PA-13-089

Release: January

Standard Due Dates: April 5, Aug 5, Dec 5

(AIDS/AIDS-related: May 7, Sept 7, Jan 7)

• SBIR Contract Solicitation (NIH,CD

Release: August Due Date: November 2013

• Targeted FOA – various due dates, other review criteria,

different project duration, limited funds!

• NIH Guide for Grants and Contracts

Release: Weekly Receipt dates specified in each

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

Solicitations

ABOUT TO REISSUE!!!

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Important changes in this year’s

Omnibus Grant Solicitations

• Technical Assistance option

• NIH offers distinct technical assistance programs to

SBIR Phase I and Phase II awardees (Niche & CAP)

• Applicants wishing to utilize their own technical

assistance vendor are required to include this in your

budget and provide a detailed budget justification.

• Please note, if funds are requested to utilize your own

technical assistance vendor and an award is made,

the awardee is not eligible to apply for the NIH-

provided technical assistance program for the phase

of their award.


NOT implemented in this year’s

Omnibus Grant Solicitations at this time

1. No Switching mechanisms at Phase II • Applicants cannot apply for Phase II SBIR funding based on a

Phase I STTR award or conversely a Phase II STTR based on

a Phase I SBIR award. Similarly, applicants cannot apply for a

Phase IIB SBIR or STTR based on a Phase II STTR or SBIR

award, respectively.

2. No Direct Phase II applications (pilot FOAs

when implemented)

Why not? NIH is currently updating its electronic

systems and forms for these provisions.

http://grants.nih.gov/grants/funding/tap.htm

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NOT implemented in this year’s

Omnibus Grant Solicitations at this time

3. VC-backed companies (VCOC, Hedge fund, or

private equity firm) CANNOT apply at this time.

4. SBA Company registry at SBIR.gov.

Why not? SBA’s new eligibility rules went into

effect after NIH issued the Omnibus solicitations.

NIH is currently updating its electronic systems

and forms for these provisions.

ABOUT TO REISSUE!!!


If not now, when?

• NIH intends to revise, amend or re-issue

the Omnibus solicitations in the middle of

2013 to implement additional

reauthorization provisions as guidance

from the SBA is received and electronic

system and form updates at NIH and SBA

are implemented.

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NIH Website

Reauthorization pages

http://sbir.nih.gov

Standard Due Dates:

Apr 5; Aug 5; Dec 5


• http://grants.nih.gov/grants/funding/sbir/reauthorization.h

tm

NIH Website

Reauthorization pages

http://sbir.nih.gov/

http://grants.nih.gov/grants/funding/sbir/reauthorization.htm



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Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and

Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics

Behavior modification

Health IT

Imaging devices

Engineered proteins

Mobile applications…

Your Ideas: Suggested topic areas

SBIR/STTR Program Descriptions

and Research Topics


Electronic Submission

• SBIR/STTR grant applications must be

submitted electronically. SBIR contract

proposals still in paper form.

• Registrations are required!!!

– System for Award Management (SAM)

– Grants.gov (company)

– eRA Commons (company and all PD/PIs)

– NEW SBA company registry at SBIR.gov

http://era.nih.gov/ElectronicReceipt/index.htm

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Review Criteria

Overall Impact Score

Scored Review Criteria (score 1-9)

Significance (Real Problem/Commercial Potential)

Investigators (PI and team) Innovation (New or Improved?) Approach (Research Design, Feasible) Environment (Facilities/Resources)

Additional Review Criteria (not scored individually) Protection of Human Subjects

Inclusion of Women, Minorities & Children

Vertebrate Animals

Biohazards

National Institutes of Health Office of Extramural Research Timeline: New Applications

Due Date

April 5

August 5

December 5

Scientific Review

July

November

March

Council Review

October

January

May

Award Date (earliest)

December

April

July

2 4 5

<……………….……6-9 months…………………….>

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Common Application Problems

• No Significance

Unimportant problem, unconvincing case for

commercial potential or societal impact

• Inadequately defined test of feasibility

• Lack of innovation

• Diffuse, superficial, or unfocused research plan

• Questionable reasoning in experimental approach

Failure to consider potential pitfalls and alternatives

• Lack of experience with essential methodologies

• Unfamiliar with relevant published work

• Unrealistically large amount of work proposed


• Understand our mission.

• Review Funding Opportunity Announcements (FOAs).

• Propose innovative ideas with significance as well as

scientific and technical merit.

• Give yourself ample time to prepare application.

• Communicate. Communicate. Communicate.

• Contact NIH Staff to discuss

• your research idea.

• outcome of your review.

• challenges and opportunities.

Competing Successfully for

SBIR/STTR Funding

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Phase I Phase II Phase III

Gap Funding Programs

Mt. “FDA”

• No-Cost Extension

• Phase I / Phase II Fast Track

• Administrative / Competitive

Supplements

Phase II B Competing

Renewal Award

“Valley of Death”


Gap Funding Programs

Phase I & II Fast Track

SBIR/STTR Phase I + II one-time

simultaneous submission!

Concurrent review (7-9 months)

Phase I Final Report

Milestones met = Phase II Award

Save 6-9 months

Phase IIB Competing

Renewal

Takes Phase II - developed

promising compounds & devices

to next stage of medical

device/ drug refinement &

development

$$$ support clinical research

tools, complex

instrumentation, prototype

development

Maximum $1 M/ year x 3 years

13 Institutes & Centers accept

No Matching Funds Required!

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Phase I Phase II Phase III

Innovative Approaches to Commercialization Challenges

Mt. “FDA”

???

Commercialization Assistance Program

Technology Niche Assessment

NIH Technical Assistance Programs

“Valley of Death”


Niche Assessment Program

Technology Niche Analysis ™

Report helps Phase II submissions:

Identify other uses of technology

Determines competitive advantages

Market size and potential

Barriers to entry & strategy

Feedback from potential end-users

Eligibility:

Phase I SBIR/STTR

awardees

Active or soon to be

awarded Phase I (Notice

of Award)

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Commercialization Assistance

Program (CAP)

Personalized Business

Mentoring; Knowledge Transfer;

Business Outcomes!

•Business & strategic planning

•Investor & partnership pitch

•Technology Value Proposition

•FDA regulatory requirements

•IP & Licensing Issues

•Go-to-market strategy…

Phase II SBIR/STTR

awardees

Active or 5 years since

completion of project


Stay Informed…

NIH Guide for Grants and Contracts (weekly

notification)

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

NIH SBIR/STTR Notification

Send email to [email protected] with the

following text in the message body:

subscribe SBIR-STTR your name.

http://images.google.com/imgres?imgurl=http://www.dtsupport.eu/Portals/3/hand 400 296.jpg&imgrefurl=http://www.dtsupport.nl/AboutUs/Companyprofile/tabid/203/Default.aspx&usg=__GzHfbMlK4xWT6l3CBEFux1-oIgk=&h=296&w=400&sz=45&hl=en&start=17&tbnid=1Ul-cpSdPOwCSM:&tbnh=92&tbnw=124&prev=/images?q=business+support&gbv=2&ndsp=20&hl=en&sa=G

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Save the Date!

15th Annual NIH SBIR/STTR Conference

• October 28-30, 2013

• Sioux Falls, South Dakota

• Hosted by University of South Dakota Research Park, Inc.

• Stay tuned to NIH SBIR website and listserv for details!


Thank You

Lenka Fedorkova, PhD

Assistant Manager

Phone: 301-435-0921

Email: [email protected]

Subscribe to the SBIR/STTR List Serv:

Email [email protected] with the following text

in the message body: subscribe SBIR-STTR your name

[email protected]

Twitter: @NIHsbir

http://grants.nih.gov/grants/funding/sbir.htm

http://grants.nih.gov/grants/funding/listserv.htm

mailto:[email protected]

http://twitter.com/NIHsbir

http://twitter.com/NIHsbir

NIH SBIR/STTR Programs Summary...7 National Institutes of Health Office of Extramural Research...

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