National Institutes of Health SMALL BUSINESS
FUNDINGOPPORTU“NIH”TIES
Jo Anne GoodnightNIH SBIR/STTR Program Coordinator
Phone: 301-435-2688Fax: 301-480-0146
Email: [email protected]
Research OpportunitiesResearch Opportunities ReservedReserved for Small Business for Small Business
SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAM
SMALL BUSINESS TECHNOLOGY SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAM
Updated 01/17/2006 JG)
AgendaAgenda
• Basics of the SBIR & STTR programs• NIH SBIR/STTR programs
Overview What’s new Latest funding opportunities University participation/involvement
SBIR / STTR ProgramSBIR / STTR Program MissionMission
Supporting Supporting scientific excellencescientific excellence and and technologicaltechnological innovationinnovation
through the investment of through the investment of FederalFederal researchresearch fundsfunds
in critical in critical American prioritiesAmerican priorities to build a strong to build a strong national economynational economy……
oneone smallsmall businessbusiness atat aa timetime..
• Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R&D --
with potential for commercialization.
• Small Business Technology Transfer (STTR) Set-aside program to facilitate
cooperative R&D between small business concerns and U.S. research institutions -- with
potential for commercialization.
Program DescriptionsProgram Descriptions
2.5%
0.3%
SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase ProgramPHASE 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 PROGRAMSSBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES
• Research PartnerResearch 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)]
• Principal InvestigatorPrincipal 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 AND STTR PROGRAMSSBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES
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 PROGRAMSBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY 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
SBIR PROGRAMSBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY 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 AgreementAllocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
STTR PROGRAMSTTR PROGRAMELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS
• DOD SBIR/STTR
• HHS SBIR/STTR
• NASA SBIR/STTR
• DOE SBIR/STTR
• NSF SBIR/STTR
• DHS SBIR
• USDA SBIR
• DOC SBIR
• ED SBIR
• EPA SBIR
• DOT SBIR
SBIR / STTR Participating AgenciesSBIR / STTR Participating Agencies
TOTAL ~ TOTAL ~ $2.2 + B$2.2 + BFY 2006FY 2006
$640M in FY2006
2006 Budget SBIRSTTR
NIH $571M $69M
CDC
FDA
AHRQ
~8.1M
~0.8M
~2.0M
N/A
Phase I $100K*
6 months*
$100K*
1 year*
Phase II $750K*
2 years*
$750K*
2 years*
DHHS Budget and Award DHHS Budget and Award AmountAmount
$640M
****Propose a Realistic and Appropriate****Propose a Realistic and AppropriateBudget for the Research****Budget for the Research****
NIH MissionNIH Mission
IMPROVE HUMAN HEALTHthrough biomedical and behavioral
research, research trainingand communications.
Office of the Director
Largest SBIR/STTR
set-asides
National Center on Minority Health
and Health Disparities
NIH OrganizationNIH Organization
http://www.nih.gov/icd
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National CancerInstitute
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Allergy and
Infectious Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Libraryof Medicine
National Centerfor Complementary
and AlternativeMedicine
FogartyInternational
Center
National Centerfor ResearchResources
National Instituteof Biomedical
Imaging and
Bioengineering
Examples ofCross-Cutting Areas of Interest
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 Small Companies Can Help NIH Meet its MissionNIH Meet its Mission
Conduct innovative R/R&D that results in product, process, or service that will...
Improve patient health Speed process of discovery Reduce cost of medical care/cost of research Improve research & communication tools
• 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
Our Ideas…Our Ideas…
Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component
Your Ideas …Your Ideas …
Small Business Concern
Applicant InitiatesResearch Idea
Grantee Conducts Research
IC Staff Prepare funding Planfor IC Director
NIH Center for Scientific ReviewAssign to IC and IRG
Scientific Review GroupsEvaluate Scientific Merit
Advisory Council or BoardRecommend approval
IC Allocates
Funds
SubmitsSBIR/STTR Grant Application to NIH
Electronically
~2-3 monthsafter submission
~2-3 months
after review
NIH SBIR/STTR PROGRAMNIH SBIR/STTR PROGRAMReview Process for Research Grant
REVIEW CRITERIA (Phase I)
Significance (Real Problem/Real People) Approach (Research Design, Feasible) Innovation (New or Improved?) Investigators (PI and team) Environment (Facilities/Resources)
… Protection of Human Subjects… Animal Welfare… Budget
Phase II Review CriteriaPhase II Review Criteria
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” SBIR “FAST-TRACK”
Standard application, review, award process
Fast-Track review option
Satisfactory Phase I Final Report
Phase I 7-9 months
Simultaneous submission/review
Phase I + Phase II
7-9 months
Phase II6 months
24 months
6 months
Phase II
7-9 months
DOES MY TECHNOLOGYDOES MY TECHNOLOGY““FIT” IN NIH?FIT” IN NIH?
See Mission Statement!See Mission Statement! Solution to…
Real Problem…. that affects Real People!
Universities / Industry Partnershipsand
Cultural Differences
Entrepreneurial Research InstitutionsEntrepreneurial Research Institutions
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 Industry Researchers
are from MARSare from MARS
University Researchers University Researchers
are from Venusare from Venus
UNIVERSITY AND INDUSTRY:Two diverse cultures
University cultureUniversity culture
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 cultureIndustry 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
CULTURAL DIVERSITY
University - Industry Partnerships University - Industry Partnerships Critical dimension of the new “Knowledge-based Economy”
Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property
Universities and Industry learning to work together
This is now…That was then…
is KEY!is KEY!
Develop common goals between faculty-initiated business and mission of research institution
Create environment that enables innovation and entrepreneurship
Protect IP assets of university
Establish policies to manage, reduce or eliminate conflict of interest (COI)
Entrepreneurial Research InstitutionKey Ingredients
• The Ohio State University
• Purdue University
• University of Wisconsin
• N.C. State University
• Georgia Tech
• Virginia Tech
Examples of Successful EntrepreneurialResearch Institutions
• Texas A&M University
• Penn. State University
• UC San Diego
• University of Utah
• Carnegie Mellon University
• Stanford University
Source: Innovation U. “New University Roles in A Knowledge Economy”Southern Technology Council and Southern Growth Policies Board
• Purdue University: Purdue Research ParkPurdue Research Park 3 business incubators Companies benefit from shared office
concept, flexible leases, attractive rental rates, and more ...
Gateways Program Financial assistance
Examples of Successful Entrepreneurial Research Institutions (cont.)
http://www.purdueresearchpark.org
• 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
Examples of Successful Entrepreneurial Research Institutions (cont.)
• Endocyte, Inc. (Purdue Research Park)
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
SUCCESS STORY
STTR ELIGIBILITY CRITERIA
Applicant Organization Research Institution Partner Principal Investigator
Yellow Lights….
Red Lights
STTR RESEARCH STTR RESEARCH INSTITUTION PARTNERINSTITUTION 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 STTR RESEARCH INSTITUTION PARTNERINSTITUTION PARTNER
Formal collaborative relationship with SBCPerform minimum of 30% of the
research/R&D (maximum 60%)
PI Eligibility on STTRPI 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 STTRPI Role on STTR
BUDGET PAGEPI must be on SBC or RI budget, but NOT BOTHPI and co-PI must be paid at either SBC or RI, but NOT BOTHPI oversees all research activities on behalf of SBC
See instructions for Multiple PI requirements
PI Role on STTRPI 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 STTRPI 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 STTRSBIR vs STTRUNIQUE FEATURESUNIQUE FEATURES
SBIR STTR
Set-Aside of Agency Budget 2.5% 0.30%
FY06 SBIR / STTR Budget $571M $69M
Award Guidelines Phase I $100K/6mos $100K/12 mos. Phase II $750K/2 yrs $750K/ 2 yrs
Business Employment of PI >50% n/a
Subcontracts Phase I < 33.3% < 60%Phase II < 50% < 60%
Research Partner Not Required > 30%
For More Information
http://grants.nih.gov/grants/funding/sbir.htm
Jo Anne GoodnightNIH SBIR/STTR Program Coordinator
Phone: 301-435-2688 Fax: 301-480-0146Email: [email protected]
Kay EtzlerSBIR/STTR Program Analyst
Phone: 301-435-2713 Fax: 301-480-0146
Email: [email protected]
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