Takin` Care of Business: SBIR/STTRs

Report
National Institutes of Health
1
“Lab to Life”
NIH SBIR/STTR Funding
Opportu“NIH”tieS
Matthew Portnoy, PhD
SBIR/STTR Program Coordinator
Office of Extramural Research, NIH
NIH Regional Seminar
April 2012
Indianapolis, IN
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Topics to Discuss Today
• NIH SBIR/STTR Program Specifics
• Partnering Incentives for Research
Institutions and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!
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Registration Open!
14th Annual NIH SBIR/STTR Conference
•
•
•
•
May 30 to June 1, 2012
Louisville, Kentucky
Hosted by Kentucky Science and Technology Corporation
2 day conference with optional workshops on June 1.
http://nih.kysbir.com/
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SBIR/STTR Programs
The largest, most accessible source of
SEED CAPITAL
for the nation’s innovative small businesses
$2.5 Billion in FY 2012
SBIR/STTR Set-Aside
NIH SBIR: $632 M
NIH STTR: $ 85 M
Total:
$717M
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NIH
$717M
$2.5B
4
And….
This capital is in the form of
grants and contracts
•
•
•
•
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no repayment
no debt service
no equity forfeiture
no IP forfeiture
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SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
2.6%*
Set-aside program for small business
concerns to engage in Federal R&D -- with
potential for commercialization.
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM
0.35%* Set-aside program to facilitate cooperative
R&D between small businesses and research
institutions -- with potential for
commercialization.
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The best way to predict the future… is to create it. 6
SBIR Purpose and Goals
• Stimulate technological innovation
• Use small business to meet Federal R&D needs
• Foster and encourage participation by
minorities and disadvantaged persons in
technological innovation
• Increase private-sector commercialization
innovations derived from Federal R&D
Small Business Innovation Development Act of 1982
P.L. 112-81 Re-Authorizes program through FY2017
7
SBIR/STTR Program Overview
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STTR Purpose and Goals
• Stimulate and foster scientific and technological
innovation through cooperative research and
development between small business concerns
and research institutions
• Foster technology transfer between small
business concerns and research institutions
Small Business Research and Development
Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
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SBIR/STTR Program Overview
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NIH Mission
Improve human
health through
biomedical and
behavioral research,
research training and
communications.
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Organizational Structure of NIH
Office of Research
Infrastructure Programs
Office of the Director
http://www.nih.gov/icd
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute
on Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
NIH Clinical Center
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Center for
Information
Technology
National Library
of Medicine
Center for
Scientific Review
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
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NIH SBIR/STTR: 3-Phase Program
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
 Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
 $1M (STTR), $1M (SBIR) over two years
PHASE IIB Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
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 NIH, generally, not the “customer”
 Consider partnering and exit strategy early
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SBIR Eligibility Criteria
Subject to change per new SBA Policy Directive pending
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
Organized as for-profit U.S. business

Small: 500 or fewer employees, including affiliates

PD/PI’s primary employment must be with small
business concern at time of award and for duration of
project period

At least 51% U.S.- owned by individuals and
independently operated or
At least 51% owned and controlled by another (one)
business concern that is at least 51% owned and
controlled by one or more individuals
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More SBIR/STTR Eligibility
Checkpoints
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
STTR: Formal collaborative effort means:
• Minimum 40% by small business
• Minimum 30% by U.S. research institution

STTR: Intellectual Property Agreement Needed
Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization

SBIR/STTR: Applicant is Small Business Concern

SBIR/STTR: All of the work must be done in the US
SBIR/STTR Program Overview
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SBIR and STTR:
Critical Differences
• Research Partner
• Principal Investigator
Employment
 SBIR: Permits partnering
 SBIR: Primary employment
(>50%) must be with small
business concern
 STTR: PI may be employed by
either research institution or
small business concern
 Multiple PD/PI allowable
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
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Important Facts to Remember
• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PD/PI is not required to have a PhD/MD
• The 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
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NIH SBIR/STTR Budget Allocations FY2012
NIAAA
NCATS
NHGRI
NIEHS NIAMS
NIBIB NIMHD
NIDCR
ORIP
NIDCD
NCCAM
NINR
NLM
NCI
NEI
NIDA
NIAID
NIA
NICHD
NIMH
NHLBI
NINDS
NIDDK
2.6% SBIR $632M
0.35% STTR $85M
Total FY2012 $717M
NIGMS
NIH SBIR/STTR Success Rates
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Fiscal Year
SBIR/STTR
Phase
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
SBIR
SBIR
SBIR
STTR
STTR
STTR
FY TOTAL
SBIR
SBIR
SBIR
STTR
STTR
STTR
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
2011
FY TOTAL
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total Funding
430
4,496
734
47
539
92
6,338
409
4,672
681
42
508
103
67
614
246
11
109
32
1,079
42
536
203
4
80
37
15.6%
13.7%
33.5%
23.4%
20.2%
34.8%
17.0%
10.3%
11.5%
29.8%
9.5%
15.7%
35.9%
$16,795,150
$129,218,371
$146,228,959
$2,300,971
$21,620,399
$18,207,113
$334,370,963
$10,059,904
$123,802,074
$137,152,687
$813,900
$18,321,516
$20,977,584
6,415
902
14.1%
$311,127,665
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HHS/NIH Program Funding
2012 Budget
SBIR
STTR
NIH
$632M
$85M
CDC
FDA
ACF
Phase I
$8.3M
$1 M
~350K
$150K*
6 months*
$1M*
2 years*
Phase II
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N/A
$150K*
1 year*
$1M*
2 years*
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Gap Funding Programs
Phase IIB Competing
Renewal Award
Mt. “FDA”
Phase I
Phase II
Phase III
• No-Cost Extension
• Phase I / Phase II Fast Track
• Administrative / Competitive
Supplements
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NIH SBIR/STTR Program Specifics
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NIH Phase I/Phase II Fast-Track
Bridging the Phase I - II Funding Gap
SBIR/STTR Phase I + Phase II
7-9 months
(Simultaneous Submission
and Concurrent Review)
Completion of Phase I
Go?
Phase I Award
Phase I Final Report
Program Staff assess
completion of specific
aims and milestones
Aims/Milestones
Met
Phase II award
No Go?
Aims/Milestones
NOT Met
Phase II award
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“In-NIH-vative” Approaches20
Phase IIB Competing Renewal Award
Purpose
• To take existing, promising compounds or devices
developed under a Phase II through the next step of
drug discovery / medical device refinement and
development (see SBIR/STTR Solicitation)
OR…. NCI, NHLBI, NINDS specific announcements, ex:
• Competing Renewal Awards of SBIR Phase IIB
Grants for Brain and Behavior Tools (R44)
(see PA-11-135)
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“In-NIH-vative” Approaches21
Phase IIB Competing Renewal Award
Eligibility
Contact NIH Program Staff to discuss
• SBIR/STTR Phase II awardee
• Promising pharmacologic compound identified in original Phase II
• Device prototype developed in original Phase II
• Instrumentation/Interventional technologies not subject to FDA
regulatory approval but require extraordinary time/effort to develop
Parameters
• Maximum of $1M/year for up to 3 years
• IC must accept Competing Renewal applications
(NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI,
NHLBI, NIMH, NINDS, NCI, NCATS, and ORIP)
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“In-NIH-vative” Approaches22
Solicitations and Due Dates
http://grants.nih.gov/grants/funding/sbir.htm
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SBIR/STTR Program Descriptions
and Research Topics
Suggested topic areas
Biodefense
Biosilicon devices
Investigator-initiated
R&D
Biosensors
Biocompatible materials
Nanotechnologies
/ opto Research projectsAcousto-optics
related to the NIH
electronics
mission
Bioinformatics
Imaging devices
Diagnostic
and
 “Other” areas of research within the
Therapeutic Devices
Genetically engineered
mission of an awarding component
proteins
Telehealth
Keyword search the Solicitation
Proteomics / Genomics
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… - F
Ctrl
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Cover Letter: A Valuable Tool


Suggest potential awarding
component(s): NIH Institutes/Centers
Request SBIR/STTR study section





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http://www.csr.nih.gov/Roster_proto/sbir_section.asp
Suggest key areas of expertise required
Indicate individual(s) or organization(s) in
conflict
For resubmission, indicate review history
Justify your requests
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Targeted SBIR/STTR Funding
Opportunity Announcements
http://grants.nih.gov/grants/funding/sbir_announcements.htm
• NIH Guide for Grants and Contracts
– High priority areas for ICs
– Various IC participation
– Nuances:
• Various due dates
• Additional review criteria
• Limited funds and project duration periods
• Etc.
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Electronic Submission
• SBIR/STTR grant applications must be
submitted electronically.
(SBIR contract proposals still in paper form)
• Registrations are required!!!
– Grants.gov (company)
– eRA Commons (company and all PD/PIs)
http://era.nih.gov/ElectronicReceipt/index.htm
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Important Application Changes
(Effective January 25, 2010)
• Research Plan Restructure
Research Plan
Research Strategy
Background & Significance
Preliminary Studies/Progress Report
Research Design and Methods
Significance
Innovation
Approach
• Page Limits
– Introduction (resubmission or revision) – 1page
– Specific Aims – 1page
– Research Strategy
• Phase I – 6 pages
• Phase II – 12 pages
• Phase II Commercialization Plan – 12 pages
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Guide Notice: NOT-OD-09-149
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Updates
1. Error correction window:
•
Eliminated effective January 25, 2011. (NIH Guide Notice NOTOD-10-123)
•
Until January 25, 2011, two business days to correct errors and
warnings.
2. Resubmissions: Must be submitted no later than 37 months after
initial receipt date. (NIH Guide Notice NOT-OD-10-140)
3. New Reporting Requirement: Transparency Act requires reporting
on subawards over $25K & executive compensation (NIH Guide
Notice NOT-OD-11-005)
4. Annotated forms:
http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf
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NIH Application and Review Process
Remember: First get registered in Grants.gov AND eRA Commons!
Small Business
Concern
Applicant
Initiates
Research Idea
Submits
SBIR/STTR Grant
Application to NIH
Electronically
NIH Center for Scientific Review
Assign to IC and IRG
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months
after submission
~2-3
months
after review
Grantee Conducts
Research
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IC
Allocates
Funds
Advisory Council or Board
Recommend approval
IC Staff Prepare funding Plan
for IC Director
NIH SBIR/STTR Program Specifics
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Review Criteria
•
Overall Impact Score
•
Scored Review Criteria (score 1-9)
•
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




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
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Competing Successfully for
SBIR/STTR Funding
• 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.
• Communication. Communication. Communication.
• Contact NIH Staff to discuss:
• your research idea.
• outcome of your review.
• challenges and opportunities.
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NIH Technical Assistance Program
Helping Companies cross the “Valley of Death”
Niche Assessment Program
Mt. “FDA”
???
Commercialization
Assistance
Program
Phase I
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Phase II
Phase III
“In-NIH-vative” Approaches35
Technical Assistance Programs
Understanding the “B” in SBIR
Niche Assessment
Identifies other uses of technology
(Phase I awardees)
Determines competitive advantages
Develops market entry strategy
Commercialization
Assistance
(Phase II awardees)
“Menu” of technical assistance/training
programs in:
•Strategic/business planning
•FDA requirements
•Technology valuation
•Manufacturing issues
•Patent and licensing issues
Helps build strategic alliances
Facilitates investor partnerships
Individualized mentoring/consulting
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NIH SBIR/STTR Program
Summary of Key Features
• SBIR and STTR Program
 Single SBIR/STTR grant solicitation
 Investigator-initiated research ideas
 Special Funding Opportunities
(NIH Guide for Grants and Contracts)
 Electronic Submission (grants only)
 Awards: Grants, Contracts,
Cooperative Agreements
• External Peer Review
 Option to request review group
 Experts from Academia/Industry
 5 Criteria: Significance, Approach,
PI(s), Innovation, Environment
 Summary Statement for all
applicants
 Revise & resubmit
• Gap Funding Programs
• Multiple Receipt Dates (Grants)
 Phase IIB Competing Renewals
 April 5, August 5, December 5
 Ph I/Ph II Fast Track
 May 7, September 7, January 7 (AIDS)
 Administrative Supplements
 Contracts: Early November
• Budget and Project Period
 $150K/6 -12months (Ph I)
 $1M/2 yrs (Ph II)
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• Technical Assistance Programs
 Technology Niche Assessment
 Commercialization Assistance
 Pipeline to Partnerships (P2P)
Summary
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Topics to Discuss Today
• NIH SBIR/STTR Program Specifics
•Partnering Incentives for Research
Institutions and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!
38
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University Roles
in SBIR/STTR Programs
• Universities are the intellectual capital of
scientific and engineering knowledge.
• Small Businesses are a vehicle for
channeling scientific discovery to the
benefit of society.
• Partnerships between the University
and the Small Business benefits BOTH.
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Research Institution
Partnership Opportunities
• Own small firms (assign someone else PI)
• Principal Investigator
(with official permission from university)
• Senior Personnel on SBIR/STTR
• Consultants on SBIR/STTR
• Subcontracts on SBIR/STTR
• University facilities provide analytical
and other service support
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UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry Researchers
are from MARS
University Researchers
are from Venus
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UNIVERSITY AND INDUSTRY:
Two diverse cultures
University culture
• Research, discover, educate and train future
workforce
• Pace is aligned to academic cycle
• Mission = basic and applied research
• Technology transfer activities are companion
to applied research mission
• Fertile ground for economic development
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UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry culture
• Mission toward research / R&D /
commercialization
• Quick-paced
• Solve problems - develop new products  profit
• Maintain control of science to explore full
potential of discovery (initially)
• Economic impact: Jobs, societal benefit
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CULTURAL DIVERSITY
University - Industry Partnerships
Critical dimension of the new
“Innovation-based Economy”


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Universities are establishing creative and
entrepreneurial environments for the
commercialization of university
intellectual property
Universities and Industry learning to
work together
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Entrepreneurial
Research Institution
Key Ingredients
• Synergistic goals between faculty-
initiated business and mission of
research institution
• Environment that enables innovation
and entrepreneurship
• Agreement on IP issues
• Policies to manage, reduce or
eliminate conflict of interest (COI)
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Examples of Successful
Entrepreneurial Research Institutions
• The Ohio State University
• Texas A&M University
• Purdue University
• Penn. State University
• University of Wisconsin
• UC San Diego
• N.C. State University
• University of Utah
• Georgia Tech
• Carnegie Mellon University
• Virginia Tech
• Stanford University
Source: Innovation U. “New University Roles in A Knowledge Economy”
Southern Technology Council and Southern Growth Policies Board
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“Land” of Opportunities
• Providing incubator facilities on university
property
• Taking equity position (e.g., 5%) in
commercial ventures
• Investing funds in new companies
• Providing technical and business services
to new firms (e.g., alumni, business school)
• Entering into joint ventures with private
entities
• Modernizing the tenure process
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Case Study: Texas A&M
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Topics to Discuss Today
• NIH SBIR/STTR Program Specifics
•Partnering Incentives for Research
Institutions and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!
49
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Eligibility Criteria
Subject to change
• Ownership: US-owned, independently operated
• Affiliations: Research Institutions,
Foundations, Foreign “Parents”
• Size: 500 employees maximum
• Business Structure: Inc, LLP, LLC, ...
• Principal Investigator: Employment
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Ownership And Affiliations
Subject to change
Eligibility of wholly-owned subsidiary
• Owners of the SBIR organization must be
"individuals" who are "citizens of, or
permanent resident aliens in, the United
States."
• The regulations nowhere provide that
corporations or artificial entities may qualify
as "individuals" who are U.S. citizens.
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Ownership And Affiliations
• Parent of wholly-owned subsidiary is
FOREIGN
• Sum TOTAL of ALL employees
more than 500 (parent + subsidiary)
• Sharing of officers on Board of Directors
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PD/PI Eligibility on SBIR
• PI must have primary employment
with SBC (unless waiver is granted)
• More than 50% of PI’s time spent in
employ of SBC
• Primary employment with SBC
precludes full-time employment at another
organization
Eligibility is determined at the time of award
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STTR Eligibility Criteria
• Applicant Organization
• Research Institution Partner
• Project Director/Principal Investigator
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STTR Applicant Organization
Small Business Concern is
ALWAYS
the applicant/awardee organization
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STTR Research Institution
Partner
• Must establish formal collaborative relationship
with SBC
• Must perform minimum of 30% of the
research/R&D (maximum 60%)
• Non-profit organization owned and operated
exclusively for scientific or educational purposes
• Non-profit medical and surgical hospitals

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eligible as partner as long as these institutions are
exclusively engaged in scientific research and/or
application of scientific principles and techniques
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PD/PI Eligibility on STTR
• PD/PI: Not required to be employed by SBC
• PD/PI: Must commit 10% effort (minimum)
• PD/PI at RI: Must establish contract between
RI and SBC describing PD/PI’s involvement
PD/PI’s “signature” on Face Page represents
agreement to conforming to Solicitation
requirements
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PD/PI Role on STTR
BUDGET PAGE
• PI must be on SBC or RI budget,
but NOT BOTH
• PI and co-PI must be paid at either SBC or RI,
but NOT BOTH
• PI oversees all research activities on behalf of
SBC
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PD/PI Role on STTR
• Is PD/PI also business official for SBC?
• Type of appointment does PD/PI have at RI?
• If Owner/Business Official, s/he should also
appear as employee of SBC (co-Investigator)
and forego RI appointment during Phase II
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PI Role on STTR
• NIH requires documentation from original
employer/RI confirming change in employment
status (e.g., sabbatical) for duration of
SBIR/STTR project
• PI cannot serve as consultant on same project
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Tips for Potential Applicants
• Explore the OER website – a wealth of information there!
http://grants.nih.gov/grants/oer.htm
• Explore Institute/Center (IC) websites - to find the most
likely home for your project
• Explore the CSR website - identify potential study sections
http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/
• Contact appropriate program staff – they can help you!
• Include a cover letter with your application - to request IC
and study section assignments
• Be persistent and don’t get discouraged: NIH extramural
staff are your links with the ICs and are there to help you.
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Top 10 Reasons
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Top 10 Reasons
10. Over $2.5 Billion available- annually
9. NOT A LOAN - no repayment
8. Provides recognition, verification
and visibility
7. Potential leveraging tool to
attract venture capital/other sources
of $$$
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Top 10 Reasons
6. Foster partnerships (universities, large
corporations) that enhance
competitiveness of small businesses in
marketplace
5. Creates jobs / stimulates local and state
economies – stronger National Economy
4. Provides seed money to fund high
risk projects
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Top 10 Reasons
3. Intellectual property rights normally
retained by the small business
2. Small business concerns recognized
as a unique national resource of
technological innovation
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Top 10 Reasons
Intralase Corporation
Cardiac Assist, Inc.
Design Continuum, Inc.
GlycoFi, Inc.
1. Opportunity to improve
the health of America
Xilas Medical, Inc.
Altea Therapeutics Corporation
Merck pays $400 million in cash for small New Hampshire
company … largest sum ever reported for a privately held
biotech.
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Cyberkinetics Neurotechnology
Systems, Inc.
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Save the Date!
14th Annual NIH SBIR/STTR Conference
•
•
•
•
May 30 to June 1, 2012
Louisville, Kentucky
Hosted by Kentucky Science and Technology Corporation
2 day conference with optional workshops on June 1.
http://nih.kysbir.com/
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For More Information
Matthew Portnoy, PhD
NIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688
Email: [email protected]
Lenka Fedorkova, PhD
SBIR/STTR Program Analyst
Phone: 301-435-0921
Email: [email protected]
Robert Vinson
SBIR/STTR Program Analyst
Phone: 301-435-2713
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
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

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