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Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH. “Lab to Life” NIH SBIR/STTR Funding Opportu“ NIH ”tie S. National Institutes of Health. NIH Regional Seminar June 2010 Portland, OR. Topics to Discuss Today. SBIR/STTR Program Overview - PowerPoint PPT Presentation
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Jo Anne GoodnightSBIR/STTR Program Coordinator
Office of Extramural Research, NIH
““Lab to Life”Lab to Life”NIH SBIR/STTR Funding NIH SBIR/STTR Funding
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NIH Regional SeminarJune 2010
Portland, OR
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Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
•Partnering Incentives for Research Institutions and Industry through SBIR/STTR
• Red Lights and Yellow LightsRed Lights and Yellow Lights
• Answer Your Questions!Answer Your Questions!
33
The largest, most accessible source of
SEED CAPITAL for the nation’s innovative small businesses
$2.4 Billion in FY 2010
SBIR/STTR Programs
NIH SBIR: $616 MNIH STTR: $ 74 M Total: $690M
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And….
This capital is in the form ofgrants and contracts
• no repayment• no debt service• no equity forfeiture • no IP forfeiture
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SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization.
SMALL BUSINESS TECHNOLOGY SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization.
2.5%
0.3%
The best way to predict the future… is to create it.
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SBIR Purpose and Goals
Small Business Innovation Development Act of 1982P.L. 106-554 (Signed 12/21/2000 extended program through 09/30/2008)
• 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
“We in government must work in partnership with small businesses to ensure that technologies and processes are readily transferred to commercial applications.” – Ronald Reagan, July 22, 1982.
SBIR/STTR Program Overview
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STTR Purpose and Goals
Small Business Research and Development Enhancement Act of 1992
P.L. 107-50 (Program reauthorized through 09/30/2009)
• 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
SBIR/STTR Program Overview
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SBIR and STTR Program Extended Temporarily Through April 30, 2010
P.L. 111-136 temporarily extends all programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR)
SBIR/STTR Program Overview
SBIR/STTR Extension
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•PHASE II Full Research/R&D $750K and 2-year Award (SBIR & STTR) Pre-requisite: Phase I award
•PHASE III Commercialization Stage Must use non-SBIR/STTR Funds
• PHASE I Feasibility Study $100K and 6- month (SBIR) or 12- month (STTR) Award
SBIR/STTR: 3-Phase Program
SBIR/STTR Program Overview
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SBIR/STTR Eligibility Criteria
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: PI primarily employed with the small business (STTR: primary employment not stipulated)
STTR: Formal collaboration between small business and research institution
SBIR/STTR Program Overview
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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 (unless a waiver is issued)
More SBIR/STTR EligibilityCheckpoints
SBIR/STTR Program Overview
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University-Industry Partnership Opportunities
• Own small firm (assign someone else PD/PI)
• Principal Investigator– with official permission from university– NIH allows multiple PD/PIs
• Senior Personnel on SBIR/STTR
• Consultant on SBIR/STTR
• Subcontract work on SBIR/STTR
• Use university facilities for analytical and
other service support
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• 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 ConcernAward is always made to Small Business Concern
SBIR and STTR: Critical Differences
• Principal Investigator Employment
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
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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 Ph.D.
• The P/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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Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
•Partnering Incentives for Research Institutions and Industry through SBIR/STTR
• Red Lights and Yellow LightsRed Lights and Yellow Lights
• Answer Your Questions!Answer Your Questions!
1717
NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
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Office of the Director
National Center on Minority Health
and Health Disparities
Organizational Structure of NIH
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
No funding authority
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NIH Institute/Center SBIR/STTR Budget Allocations
NIDDKNIGMS
FY 2010 SBIR/STTR Budget Allocations to NIH ICs:
SBIR: $616 M STTR:$ 74 M Total: $690 M
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PHASE II (Full Research/R&D) Average $850K and 2-years; can be longer
PHASE II+ (Competing Renewal/R&D) Clinical R&D; Complex Instrumentation/Tools Many, but not all, ICs participate $1M/year; 3 years
PHASE III (Commercialization Stage) NIH, generally, not the “customer” Consider exit strategy early
PHASE I (Feasibility Study) Average award: $170K Project Period: Varies. Most awards on a 1-yr NCE
NIH SBIR/STTR: 3-Phase Program
NIH SBIR/STTR Program Specifics
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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 Competing Renewal Award
NIH SBIR/STTR Program Specifics
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Bridging the Phase I - II Funding Gap
(Simultaneous Submission and Concurrent Review)
SBIR/STTR Phase I + Phase II
Phase I Award
7-9 months
Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones
Phase II award
Aims/Milestones Met
Phase II award
Aims/MilestonesAims/MilestonesNOT MetNOT Met
Go?
No Go?
NIH Phase I/Phase II Fast-Track
“In-NIH-vative” Approaches
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• 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)
Purpose
OR….
• To support complex instrumentation, clinical research tools, behavior interventions/treatments(see PA-08-056)
Phase II Competing Renewal Award
“In-NIH-vative” Approaches
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• SBIR 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
Contact NIH Program Staff to discussContact NIH Program Staff to discussEligibility
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, and NCRR)
Phase II Competing Renewal Award
“In-NIH-vative” Approaches
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http://grants.nih.gov/grants/funding/sbir.htm
Solicitations and Due Dates
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Biodefense
Biosensors
Nanotechnologies
Bioinformatics
Diagnostic and Therapeutic Devices
Telehealth
Biosilicon devices
Biocompatible materials
Acousto-optics / opto-electronics
Imaging devices
Genetically engineered proteins
Proteomics / Genomics
……
Suggested topic areas
SBIR/STTR Program Descriptions and Research Topics
Investigator-initiated R&D
Research projects related to the NIH mission
“Other” areas of research within the
mission of an awarding component Keyword search the Solicitation
Ctrl - F
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Suggest potential awarding component(s): NIH Institutes/Centers
Request study section Suggest key areas of expertise required Indicate individual(s) or organization(s) in
conflict For resubmission, indicate review history Justify your requests
Cover Letter: A Valuable Tool
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Targeted SBIR/STTR Funding Opportunity Announcements
• 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.
http://grants.nih.gov/grants/funding/sbir_announcements.htm
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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
• 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
Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods
Research Strategy Significance Innovation Approach
Guide Notice: NOT-OD-09-149
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Small Business Concern
Applicant Initiates
Research 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 Application and Review Process
NIH SBIR/STTR Program Specifics
Remember: First get registered in Grants.gov AND eRA Commons!
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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
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0
5
10
15
20
25
30
35
40
45
SBIR STTR
Phase I
Phase II
Fast-Track
NIH SBIR/STTR Success RatesS
ucc
ess
Rat
e (%
)
$672 M SBIR/STTR
654
262
33
54
105
40.6%
23.1%
19.6%
31.1%
14.9%
22%
PRELIMINARY -- Fiscal Year 2009
7
# Awards
% funded
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• 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.
Competing Successfully for SBIR/STTR Funding
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Phase I Phase II Phase III
NIH Technical Assistance Program
Mt. “FDA”???Commercialization Assistance
Program
Niche Assessment Program
Helping Companies cross the “Valley of Death”
“In-NIH-vative” Approaches
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Technical Assistance Programs Understanding the “B” in SBIR
Commercialization Assistance
“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
(Phase II awardees)
Niche Assessment Identifies other uses of technology
Determines competitive advantages
Develops market entry strategy
(Phase I awardees)
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NIH Pipeline to Partnerships
Finding a Partner
• 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
“In-NIH-vative” Approaches
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NIH Pipeline to Partnerships (P2P)
http://www.ott.nih.gov/p2p/index.aspx
SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners.
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POTENTIAL PARTNERS / INVESTORS
Identifies technology of interest and contacts company
NIH Pipeline to Partnerships (P2P)
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Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
•Partnering Incentives for Research Institutions and Industry through SBIR/STTR
• Red Lights and Yellow LightsRed Lights and Yellow Lights
• Answer Your Questions!Answer Your Questions!
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SBIR/STTR Historical Relationships
20081982
SmallBusinesses Academia
University Research Parks Faculty & Graduate
Students Technology Incubators Research Foundations
Quasi-Government Corporations
Economic Development Entities
Technology Centers
FederalGovernment
State Government
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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 forchanneling scientific discovery to thebenefit 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 Industry Researchers
are from MARSare from MARS
University Researchers University Researchers
are from Venusare from Venus
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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
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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
UNIVERSITY AND INDUSTRY:Two diverse cultures
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CULTURAL DIVERSITY
University - Industry PartnershipsUniversity - Industry Partnerships Critical dimension of the new “Innovation-based Economy”
Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property
Universities and Industry learning to work together
is KEY!
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• 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)
Entrepreneurial Research Institution
Key Ingredients
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• The Ohio State University
• Purdue University
• University of Wisconsin
• N.C. State University
• Georgia Tech
• Virginia Tech
Examples of Successful Entrepreneurial Research 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
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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
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
•Partnering Incentives for Research Institutions and Industry through SBIR/STTR
• Red Lights and Yellow LightsRed Lights and Yellow Lights
• Answer Your Questions!Answer Your Questions!
5656
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
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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.
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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 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
6666
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 – s/he 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
10.10. Over $2.3 Billion available- annually
9.9. NOT A LOANNOT A LOAN - no repayment
8.8. Provides recognition, verificationand visibility
7.7. Potential leveraging tool to attract venture capital/other sources of $$$
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5.5. Creates jobs / stimulates local and state economies – stronger National Economy
4.4. Provides seed money to fund high risk projects
6.6. Foster partnerships (universities, large niversities, large corporations)corporations) that that enhance competitiveness ofof small businesses in small businesses in marketplacemarketplace
Top 10 Reasons
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3.3. Intellectual property rights normally retained by the small business
2.2. Small business concerns recognized as a unique national resource of technological innovation
Top 10 Reasons
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Top 10 Reasons
Cardiac Assist, Inc.
Intralase Corporation
Xilas Medical, Inc.
Cyberkinetics Neurotechnology Systems, Inc.
Merck pays $400 million in cash for small New Hampshire company … largest sum ever reported for a privately held biotech.
GlycoFi, Inc.
Altea Therapeutics Corporation
Design Continuum, Inc.
1. Opportunity to improve the health of AmAmerericaica
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR
For More InformationFor More Information
Jo Anne GoodnightNIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688 Fax: 301- 480-0146
Email: goodnight@nih.gov
Kay EtzlerSBIR/STTR Program Analyst Email: kay.etzler@nih.gov
Lenka FedorkovaSBIR/STTR Program Analyst
Email: lenka@nih.gov
Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name
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12th Annual NIH SBIR/STTR Conference
June 2-3, 2010Raleigh, NC
Save the Date!
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Thank You!
Questions?
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