Transcript SBIR/STTR Overview

National Institutes of Health
SMALL BUSINESS
FUNDING
OPPORTU“NIH”TIES
Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688
Fax: 301-480-0146
Email: [email protected]
Research Opportunities
Reserved for Small Business
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM
Updated 01/17/2006 JG)
Agenda
• Basics of the SBIR & STTR programs
• NIH SBIR/STTR programs
 Overview
 What’s new
 Latest funding opportunities
 University participation/involvement
SBIR / STTR Program
Mission
Supporting scientific excellence and
technological innovation
through the investment of
Federal research funds
in critical American priorities
to build a strong national economy…
one small business at a time.
Program Descriptions
• Small Business Innovation Research (SBIR)
2.5%
Set-aside program for small business
concerns to engage in federal R&D -with potential for commercialization.
• Small Business Technology Transfer (STTR)
0.3% Set-aside program to facilitate cooperative
R&D between small business concerns
and U.S. research institutions -- with
potential for commercialization.
SBIR/STTR: 3-Phase Program
PHASE I
 Feasibility Study
 $100K and 6-month (SBIR)
or 12-month (STTR) Award
PHASE II
 Full Research/R&D
 $750K and 2-year Award
(SBIR/STTR)
PHASE III
 Commercialization Stage
 Use of non-SBIR/STTR Funds
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
• Research Partner
SBIR: Permits research institution partners
[Outsource ~ 33% Phase I and 50% Phase II R&D]
STTR: Requires research institution partners
(e.g., universities)
[40% small business concerns (for-profit) and
30% U.S. research institution (non-profit)]
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
• Principal Investigator
SBIR: Primary (>50%) employment must
be with small business concern
STTR: Primary employment not stipulated
[PI can be from research institution and/or
from small business concern*]
SBIR PROGRAM
ELIGIBILITY CHECKPOINTS
 Organized for- profit U.S. business
 500 employees or fewer, including
affiliates
 PI’s primary employment must be
with the small business concern at
the time of award and for the
duration of the project period.
SBIR PROGRAM
ELIGIBILITY CHECKPOINTS
Small business concern must be:
 At least 51% U.S.- owned by
individuals and independently
operated
or
 At least 51% owned and controlled
by another (one) for-profit business
concern that is at least 51% owned
and controlled by one or more
individuals
STTR PROGRAM
ELIGIBILITY CHECKPOINTS
 Applicant is Small Business Concern
 Formal Cooperative R&D Effort
 Minimum 40% by small business
 Minimum 30% by U.S. research institution

U.S. Research Institution
 College or University; other non-profit research
organization; Federal R&D center

Intellectual Property Agreement
Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
SBIR / STTR Participating Agencies
TOTAL ~ $2.2 + B
FY 2006
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DOD
HHS
NASA
DOE
NSF
DHS
USDA
DOC
ED
EPA
DOT
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR
SBIR
SBIR
SBIR
SBIR
SBIR
DHHS Budget and Award Amount
2006 Budget
SBIR
NIH
$571M
STTR
$69M
$640M
CDC
~8.1M and Appropriate
****Propose
a Realistic
Budget for~0.8M
the Research****
FDA
N/A
AHRQ
~2.0M
Phase I
$100K*
$100K*
6 months*
1 year*
Phase II
$750K*
$750K*
2 years*
2 years*
NIH Mission
IMPROVE HUMAN HEALTH
through biomedical and behavioral
research, research training
and communications.
NIH Organization
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 Center on
Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Research
Resources
Largest SBIR/STTR
set-asides
National Library
of Medicine
National Institute
of Biomedical
Imaging
and
Bioengineering
Examples of
Cross-Cutting Areas of Interest
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Nanotechnologies
Bioinformatics
Biodefense
Proteomics / Genomics
Genetically engineered proteins
Biosensors
Biosilicon devices
Biocompatible materials
Acousto-optics and opto-electronics
Imaging technologies
Education/communication tools
Computational biology
Behavioral research
Small Companies Can Help
NIH Meet its Mission
Conduct innovative R/R&D that results in
product, process, or service that will...
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Improve patient health
Speed process of discovery
Reduce cost of medical care/cost of
research
Improve research & communication tools
Our Ideas…
• SBIR/STTR Omnibus Grant Solicitation
(NIH, CDC, and FDA) = Parent FOA
Release: January
April 5, Aug 5, Dec 5 receipt dates
(AIDS/AIDS-related: May 1, Sept 1, Jan 2 receipt dates)
SBIR: http://grants.nih.gov/grants/guide/pa-files/PA-07-180.html
STTR: http://grants.nih.gov/grants/guide/pa-files/PA-07-181.html
• SBIR Contract Solicitation (NIH, CDC)
Release: August
November 6, 2006 receipt date
• NIH Guide for Grants and Contracts
Release: Weekly
Various receipt dates
http://grants.nih.gov/grants/funding/sbir.htm
Your Ideas …
Investigator-initiated R&D
 Research projects related to the NIH
mission
 “Other” areas of research within the
mission of an awarding component
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NIH SBIR/STTR PROGRAM
Review Process for Research Grant
Small Business
Concern
Submits
SBIR/STTR Grant
Application to NIH
Electronically
Applicant Initiates
Research Idea
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
IC
Allocates
Funds
Advisory Council or Board
Recommend approval
IC Staff Prepare funding Plan
for IC Director
REVIEW CRITERIA
(Phase I)
Significance (Real Problem/Real People)
 Approach (Research Design, Feasible)
 Innovation (New or Improved?)
 Investigators (PI and team)
 Environment (Facilities/Resources)
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… Protection of Human Subjects
… Animal Welfare
… Budget
Phase II Review Criteria
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Same as Phase I
Demonstrated Feasibility in Phase I
Commercialization Plan
High Degree of Commercial Potential
based on plan
… Protection of Human Subjects
… Animal Welfare
… Budget
SBIR “FAST-TRACK”
Standard application, review, award process
7-9 months
Phase I 7-9 months
Phase II
6 months
24 months
Fast-Track review option
Phase I + Phase II 7-9 months
Simultaneous
submission/review
6 months
Phase II
Satisfactory Phase I
Final Report
DOES MY TECHNOLOGY
“FIT” IN NIH?
See Mission Statement!
Solution to…
Real Problem….
that affects Real People!
Entrepreneurial Research Institutions
Universities / Industry Partnerships
and
Cultural Differences
UNIVERSITY-BUSINESS
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
UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry Researchers
are from MARS
University Researchers
are from Venus
UNIVERSITY AND INDUSTRY:
Two diverse cultures
University culture
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Research, discover, educate and train future
workforce
Pace is slower - aligned to academic cycle
Mission = basic and applied research
Technology transfer activities are companion
to applied research mission
Fertile ground for economic development
UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry culture

Mission toward research / R&D /
commercialization

Quick-paced
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Solve problems - develop new products  profit
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Maintain control of science to explore full
potential of discovery (initially)
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Economic impact: Jobs, societal benefit
CULTURAL DIVERSITY
That was then…
This is now…
University - Industry Partnerships
Critical dimension of the new
“Knowledge-based Economy”
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Universities are establishing creative and
entrepreneurial environments for the
commercialization of university
intellectual property
is KEY!
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Universities and Industry learning to
work together
Entrepreneurial Research Institution
Key Ingredients
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Develop common goals between
faculty-initiated business and
mission of research institution
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Create environment that enables
innovation and entrepreneurship
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Protect IP assets of university
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Establish policies to manage, reduce
or eliminate conflict of interest (COI)
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
Examples of Successful Entrepreneurial
Research Institutions (cont.)
• Purdue University: Purdue Research Park
 3 business incubators
 Companies benefit from shared office
concept, flexible leases, attractive rental rates,
and more ...
 Gateways Program
 Financial assistance
http://www.purdueresearchpark.org
Examples of Successful Entrepreneurial
Research Institutions (cont.)
• Purdue University
 Environment for business to have
frequent and mutually beneficial
interactions with University
 Policies / Procedures to address COI -not to eliminate, but to minimize and
manage
SUCCESS STORY
• Endocyte, Inc. (Purdue Research Park)
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Researcher, Philip Low, discovered way to diagnose,
potentially cure, ovarian cancer using vitamin folate
Sell technology or start own company to develop and
market treatment????
Resisted VC offers: wanted control of science
Now exploring use of folate in arthritis
 ADVICE: Hire experienced CEO to handle all but science
 BENEFIT: Purdue retains talent
STTR ELIGIBILITY CRITERIA
 Applicant Organization
 Research Institution Partner
 Principal Investigator
Yellow Lights….
Red Lights
STTR
APPLICANT ORGANIZATION
Small Business Concern ALWAYS
the applicant/awardee organization
STTR RESEARCH
INSTITUTION PARTNER
U.S. non-profit organization owned and
operated exclusively for scientific or
educational purposes
Non-profit medical and surgical hospitals
 eligible as partner as long as these
institutions are exclusively engaged in
scientific research and/or application of
scientific principles and techniques
STTR RESEARCH
INSTITUTION PARTNER
Formal collaborative relationship with SBC
Perform minimum of 30% of the
research/R&D (maximum 60%)
PI Eligibility on STTR
 Formal collaborative relationship: PI at RI
establishes contract between RI and SBC
describing PI’s involvement
 PI is NOT required to be employed by SBC
 Minimum 10% effort
 PI and co-investigator must be paid at either
SBC or RI , but NOT BOTH
 PI’s signature on Face Page is agreement to
conforming to Solicitation requirements
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
See instructions for Multiple PI requirements
PI Role on STTR
PI also business official for SBC?
 Type of appointment does 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

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
SBIR vs STTR
UNIQUE FEATURES
Set-Aside of Agency Budget
SBIR
2.5%
STTR
0.30%
FY06 SBIR / STTR Budget
$571M
Award Guidelines Phase I
Phase II
$100K/6mos $100K/12 mos.
$750K/2 yrs $750K/ 2 yrs
Subcontracts
Phase I
Phase II
Research Partner
Business Employment of PI
$69M
< 33.3%
< 50%
< 60%
< 60%
Not Required
>50%
> 30%
n/a
For More Information
http://grants.nih.gov/grants/funding/sbir.htm
Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688 Fax: 301-480-0146
Email: [email protected]
Kay Etzler
SBIR/STTR Program Analyst
Phone: 301-435-2713
Fax: 301-480-0146
Email: [email protected]
Questions?