National Institutes of Health
1
From the Lab
to the Marketplace
NIH SBIR/STTR Programs
Michael Huerta, PhD
Associate Director for Program Development
National Library of Medicine, NIH
NIH Regional Seminar
June 2011
1
SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small
business concerns and research institutions
2
2
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission & priority of the awarding
unit (Institute or Center)
3
3
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission of the awarding unit
4
SBIR/STTR Program Overview
4
SBIR & STTR Awards
• Awards are funds to the small business from
the federal government – control levels vary
• Grants
• Cooperative Agreements
• Contracts
• Awards support specific R & D projects (not
general business costs, infrastructure, etc.)
• Awards do not require
• Repayment or debt service
• Equity or intellectual property forfeiture
5
5
How much is awarded through
SBIR & STTR programs?
6
6
How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
7
7
How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
8
8
How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
NIH SBIR: $616 M
NIH STTR: $ 74 M
Total:
$690M
9
9
How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
NIH SBIR: $616 M
NIH STTR: $ 74 M
Total:
$690M
SBIR 2.5 %
STTR 0.3 %
10
10
NIH SBIR & STTR Programs
Summary of Key Features
• SBIR & STTR Programs
 Single SBIR/STTR grant solicitation
 Investigator-initiated research ideas
 Special FOAs (see NIH Guide for
Grants and Contracts)
 Electronic Submission (grants only)
 Awards always made to small
business concern
• 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 once
• Multiple Receipt Dates (Grants)
• Gap Funding Programs
 April 5, August 5, December 5
 Phase IIB Competing Renewals
 May 7, September 7, January 7 (AIDS)
 Ph I/Ph II Fast Track
 Contracts: Early November
 Administrative Supplements
• Budget and Project Period – Guidelines
 $100-150K/6 -12months (Ph I)
 $750K-1M/2 yrs (Ph II)
 Deviations permitted where
scientifically appropriate (eg, FOAs)
11
• Technical Assistance Programs
 Technology Niche Assessment
 Commercialization Assistance
 Pipeline to Partnerships (P2P)
11
SBIR and STTR:
Critical Differences
• Research Partner
• PI Employment
 SBIR: Permits partnering
 SBIR: Primary employment
(>50%) must be with small
business concern
33% Phase I and 50% Phase II
 STTR: Requires partnering with
Research Institution
Small business (40%) and U.S.
research institution (30%)
 STTR: PI may be employed by
either research institution or
small business concern
 Multiple PD/PI allowable – for
SBIR only one PI must be
primarily employed by SBC
Award is always made to Small Business Concern
12
12
NIH SBIR/STTR: 3-Phase Program
Per Congressional Guidelines – FOAs Vary
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs
 Project Period: 6 months (SBIR) or 1 year (STTR)
PHASE II Full Research/R&D
 $750K (STTR) or $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 – not funded by gov’t
 NIH is generally not the “customer”
 Consider partnering and exit strategy early
13
13
Phase IIB Competing Renewal Award
• Purpose: Peer-reviewed continuation of Phase II R & D
for complex projects
• Parameters: Up to $1M/year for up to 3 years
• Eligibility: Must have Phase II award // contact program
officer for eligibility
•Participating ICs: NIA, NIAAA, NIAID, NICHD, NIDA,
NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and
NCRR
14
14
Beyond the Guidelines
The duration and amount of the SBIR or STTR
award may exceed the congressional guidelines
• As required by the project – contact program officer before
submitting the application to find out what would be allowed
• As allowed by special funding opportunity announcements
(FOAs), for example PA-11-134, Lab to Marketplace:
•Phase I – up to $350,000 per year for up to two years
•Phase II – up to $600,000 per year for up to three years
•Phase IIB – up to $800,000 per year for up to three years
15
15
Beyond the Guidelines
The duration and amount of the SBIR or STTR
award may exceed the congressional guidelines
One project could be supported with
~ $6 million over 8 years (Ph I, II, & IIB)!
16
16
Mind the Gap
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
17
17
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
18
18
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission of the awarding unit
19
19
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission of the awarding unit
20
20
SBIR/STTR Eligibility Criteria
21

U.S. small business organized for-profit

At least 51% U.S.- owned by individuals and
independently operated or , for SBIR, at least 51%
owned and controlled by another (one) business
concern that is at least 51% owned and controlled by
one or more individuals

500 or fewer employees, including affiliates

SBIR: At least one PI primarily employed with the
small business (STTR: not stipulated)

STTR: Formal collaboration between small
business and research institution
21
More SBIR/STTR Eligibility
Checkpoints
22

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
22
Additional Eligibility Issues
• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PD/PI is not required to have a Ph.D.
• 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
23
23
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission of the awarding unit
24
24
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission & priority of the awarding
unit (Institute or Center)
25
25
NIH Institutes and Centers (ICs)
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 Research
Resources
National Library
of Medicine
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
26
26
NIH Institutes & Centers
SBIR & STTR Budget Allocations
FY 2010 SBIR/STTR
Budget Allocations to NIH ICs:
SBIR: $616 M
STTR:$ 74 M
Total: $690 M
NIGMS
27
NIDDK
27
Submitted grant applications
get appropriate assignment
• Applications received by CSR and assigned to:
• A CSR (usually) study section for peer review
• An IC for programmatic (funding) consideration
28
28
Submitted grant applications
get appropriate assignment
• Applications received by CSR and assigned to:
• A CSR (usually) study section for peer review
• An IC for programmatic (funding) consideration
Appropriate, however, is not necessarily optimal
You can help determine optimal assignment
29
29
Relationship between
project and study section
• Dozens of study sections with different
• Areas of review responsibility
• Expertise of peer reviewers
• Overlap from one study section to another
30
30
Relationship between
project and study section
• Dozens of study sections with different
• Areas of review responsibility
• Expertise of peer reviewers
• Overlap from one study section to another
Each study section has unique scientific focus
and each reviewer has unique perspective
Determine the best match for your project
31
31
How to determine which study
section is best for your project
•
Center for Scientific Review (CSR) web site:
• Scientific focus of each study section
• List of study sections with similar scientific foci
• Roster of members of each study section
32
32
How to determine which study
section is best for your project
•
Center for Scientific Review (CSR) web site:
• Scientific focus of each study section
• List of study sections with similar scientific foci
• Roster of members of each study section
If more than one seems great,
Communicate with scientific review officers of
those study sections for further guidance
33
33
Relationship between
project and IC
• Dozens of ICs with different
• Missions – purviews of responsibility
• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!
34
34
Relationship between
project and IC
• Dozens of ICs with different
• Missions – purviews of responsibility
• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!
• Technologies are often cross-cutting, e.g.:
• Neuroimaging tool – cancer or stroke
• Microfluidic chamber – deliver drug or growth factor
• Context of grant application or test bed for
proposed feasibility test may determine IC
35
35
How to determine which IC is
the best fit for your project
•
Web sites of ICs
• List research priorities, strategic plans, etc.
•
Annual Omnibus Solicitation for SBIR and
STTR Grant Applications
• ICs list specific research topics
•
Special FOAs
• Clear indication of participating ICs’ interests
36
36
How to determine which IC is
the best fit for your project
•
Web sites of ICs
• List research priorities, strategic plans, etc.
•
Annual Omnibus Solicitation for SBIR and
STTR Grant Applications
• ICs list specific research topics
•
Special FOAs
• Clear indication of participating ICs’ interests
After narrowing down list of possible ICs, talk to
the program officer(s) about your specific idea
37
37
Cover Letter - Follow up for
optimal assignment
•
•
•
•
•
•
38
Request potential awarding component(s): NIH
Institutes/Centers – refer to program officer
communication as appropriate
Request SBIR/STTR study section
Indicate key areas of review expertise required
Indicate individual(s)/organization(s) in
conflict
For resubmission, indicate review history
Justify all the requests you make
38
SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small
business concerns and research institutions
39
39
Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of
commercializable, innovative technologies
• Serving the mission & priority of the awarding
unit (Institute or Center)
40
40
Drilling Down
Further Information,
Details, and Tips
41
41
Application & Review Process
Remember: First get registered in Grants.gov AND eRA Commons!
Small Business
Concern
Research idea –
then contact NIH
Submits
SBIR/STTR Grant
Application to NIH
Electronically
NIH Center for Scientific Review
Assign to IC and Study Section
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months
after submission
~2-3
months
after review
Grantee Conducts
Research
43
IC
Allocates
Funds
IC Advisory Council or Board
Concurs with Review
IC Staff Prepare funding Plan
for IC Director
NIH SBIR/STTR Program Specifics
43
Review Criteria
•
Overall Impact Score
•
Scored Review Criteria (score 1-9)
•
44





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
44
NIH SBIR/STTR Success Rates FY2010
35
Success Rate (%)
30
34.8
33.5
FY2010 $690 M
SBIR/STTR
25
Phase I
20
20.2
15
10
23.4
Phase II
Fast-Track
15.6
13.7
5
0
SBIR
45
STTR
45
Keys to Success
• Understand mission & priorities
• IC Web sites, Omnibus Solicitation, FOAs
• Propose innovative ideas with significance as
well as scientific and technical merit
• Give yourself ample time to prepare application
• Contact NIH Staff to discuss:
• Research idea early on – program staff
• Assignment issues – program and review staff
• Outcome of your review – program staff
46
46
NIH Technical Assistance Program
Helping Companies cross the “Valley of Death”
Niche Assessment Program
Mt. “FDA”
???
Commercialization
Assistance
Program
Phase I
47
Phase II
Phase III
47
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
48
48
Finding a Partner
NIH Pipeline to Partnerships
• Showcases SBIR/STTR (Phase I and Phase II)
technologies and NIH-licensed technologies
• Facilitates matchmaking between NIH
SBIR/STTR awardees and potential strategic
partners and investors
• Searches by application category (diagnostics,
therapeutic, tool, etc.) and/or disease
49
“In-NIH-vative” Approaches49
NIH Pipeline to Partnerships (P2P)
SBIR/STTR
awardees and
NIH licensees
can showcase
technologies in
a virtual space
for potential
partners.
http://www.ott.nih.gov/p2p/index.aspx
50
50
NIH Pipeline to Partnerships (P2P)
POTENTIAL PARTNERS / INVESTORS
Identifies technology of interest and
contacts company
51
51
Summary of NIH SBIR & STTR
•
•
•
•
•
52
Investments in innovation & economic growth
Advance the NIH mission & human health
Support and validate small business R & D
Extraordinary latitude in awards
Extraordinary assistance from idea to market
• Scientific aspects
• Administrative aspects
• Business aspects
52
53
53
Eligibility Criteria
• Ownership: US-owned, independently operated
• Affiliations: Research Institutions,
Foundations, Foreign “Parents”
• Size: 500 employees maximum
• Business Structure: Inc, LLP, LLC, ...
• Principal Investigator: Employment
58
58
Ownership And Affiliations
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.
59
59
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
60
60
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
61
61
STTR Eligibility Criteria
• Applicant Organization
• Research Institution Partner
• Project Director/Principal Investigator
62
62
STTR Applicant Organization
Small Business Concern is
ALWAYS
the applicant/awardee organization
63
63
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

64
eligible as partner as long as these institutions are
exclusively engaged in scientific research and/or
application of scientific principles and techniques
64
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
65
65
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
66
66
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
67
67