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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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National Institutes of Health Office of Extramural Research
NIH Mission
Improve human health
through biomedical and
behavioral research,
research training and
communications.
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National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
Program Status
P.L. 112-81 Re-Authorized
SBIR and STTR Programs through FY2017
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National Institutes of Health Office of Extramural Research
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
National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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!!!
National Institutes of Health Office of Extramural Research
• 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
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National Institutes of Health Office of Extramural Research
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
National Institutes of Health Office of Extramural Research
• 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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National Institutes of Health Office of Extramural Research
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.
National Institutes of Health Office of Extramural Research
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.
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National Institutes of Health Office of Extramural Research
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!!!
National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
NIH Website
Reauthorization pages
http://sbir.nih.gov
Standard Due Dates:
Apr 5; Aug 5; Dec 5
National Institutes of Health Office of Extramural Research
• http://grants.nih.gov/grants/funding/sbir/reauthorization.h
tm
NIH Website
Reauthorization pages
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National Institutes of Health Office of Extramural Research
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
National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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
National Institutes of Health Office of Extramural Research
• 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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National Institutes of Health Office of Extramural Research
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”
National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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”
National Institutes of Health Office of Extramural Research
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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National Institutes of Health Office of Extramural Research
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
National Institutes of Health Office of Extramural Research
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.
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National Institutes of Health Office of Extramural Research
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!
National Institutes of Health Office of Extramural Research
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
Twitter: @NIHsbir