Slide #1.

National Institutes of Health 1 “Lab to Life” NIH SBIR/STTR Funding Opportu“NIH”tieS Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH Regional Seminar June 2010 Portland, OR 1
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Slide #2.

Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions! 2 2
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Slide #3.

SBIR/STTR Programs The largest, most accessible source of SEED CAPITAL for the nation’s innovative small businesses $2.4 Billion in FY 2010 NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M 3 3
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And…. This capital is in the form of grants and contracts • • • • 4 no repayment no debt service no equity forfeiture no IP forfeiture 4
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Slide #5.

SBIR/STTR Program Overview 2.5% SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM 0.3% 5 Set-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization. The best way to predict the future… is to create it. 5
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Slide #6.

SBIR Purpose and Goals “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. • 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. 106-554 (Signed 12/21/2000 extended program through 09/30/2008) 6 SBIR/STTR Program Overview 6
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Slide #7.

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. 107-50 (Program reauthorized through 09/30/2009) 7 SBIR/STTR Program Overview 7
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Slide #8.

SBIR/STTR Extension 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) 8 SBIR/STTR Program Overview 8
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Slide #9.

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)  Pre-requisite: Phase I award •PHASE III  Commercialization Stage  Must use non-SBIR/STTR Funds 9 SBIR/STTR Program Overview 9
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Slide #10.

SBIR/STTR Eligibility Criteria 10  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 10
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Slide #11.

More SBIR/STTR Eligibility Checkpoints 11  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) SBIR/STTR Program Overview 11
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Slide #12.

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 12 12
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Slide #13.

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 13 13
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Slide #14.

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 14 14
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Slide #15.

Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions! 15 15
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Slide #16.

NIH Mission Improve human health through biomedical and behavioral research, research training and communications. 17 17
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Slide #17.

Organizational Structure of NIH Office of the Director http://www.nih.gov/ic d 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 National Library of Medicine National Institute of Biomedical Imaging and Bioengineering No funding authority 18 18
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Slide #18.

NIH Institute/Center SBIR/STTR Budget Allocations FY 2010 SBIR/STTR Budget Allocations to NIH ICs: SBIR: $616 M STTR:$ 74 M Total: $690 M NIGMS 19 NIDDK 19
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Slide #19.

NIH SBIR/STTR: 3-Phase Program PHASE I (Feasibility Study)  Average award: $170K  Project Period: Varies. Most awards on a 1-yr NCE 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 21 NIH SBIR/STTR Program Specifics 21
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Slide #20.

Gap Funding Programs Phase II Competing Renewal Award Mt. “FDA” Phase I Phase II Phase III • No-Cost Extension • Phase I / Phase II Fast Track • Administrative / Competitive Supplements 22 NIH SBIR/STTR Program Specifics 22
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Slide #21.

NIH Phase I/Phase II Fast-Track Bridging the Phase I - II Funding Gap SBIR/STTR Phase I + Phase II (Simultaneous Submission and Concurrent Review) Completion of Phase I Go? 7-9 months 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 23 “In-NIH-vative” Approaches23
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Slide #22.

Phase II 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…. • To support complex instrumentation, clinical research tools, behavior interventions/treatments (see PA-08-056) 24 “In-NIH-vative” Approaches24
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Slide #23.

Phase II Competing Renewal Award Eligibility Contact NIH Program Staff to discuss • 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 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) 25 “In-NIH-vative” Approaches25
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Slide #24.

Solicitations and Due Dates http://grants.nih.gov/grants/funding/sbir.htm 26 26
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Slide #25.

SBIR/STTR Program Descriptions and Research Topics Suggested topic areas Biosilicon devices Biodefense Investigator-initiated R&D Biocompatible materials Biosensors  Research projectsAcousto-optics / optorelated to the NIH Nanotechnologies electronics mission Bioinformatics Imaging devices  “Other” Diagnostic and areas of research within the Genetically engineered Therapeutic Devices mission of an awarding component proteins Telehealth Keyword search the Solicitation Proteomics / Genomics 28 … - F Ctrl 28
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Slide #26.

Cover Letter: A Valuable Tool       29 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 29
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Slide #27.

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. 30 30
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Slide #28.

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 31 31
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Slide #29.

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 32 Guide Notice: NOT-OD-09-149 32
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Slide #30.

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 ~2-3 months after submission Advisory Council or Board Recommend approval ~2-3 months after review Grantee Conducts Research 33 Scientific Review Groups Evaluate Scientific Merit IC Allocates Funds IC Staff Prepare funding Plan for IC Director NIH SBIR/STTR Program Specifics 33
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Slide #31.

Review Criteria • Overall Impact Score • Scored Review Criteria (score 1-9)      • Additional Review Criteria (not scored individually)     34 Significance (Real Problem/Commercial Potential) Investigators (PI and team) Innovation (New or Improved?) Approach (Research Design, Feasible) Environment (Facilities/Resources) Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards 34
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Slide #32.

NIH SBIR/STTR Success Rates PRELIMINARY -- Fiscal Year 2009 $672 M SBIR/STTR Success Rate (%) 262 40.6% 654 33 54 31.1% 105 7 23.1% 22% 19.6% 14.9% # Awards % funded 36 36
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Slide #33.

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. 37 37
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Slide #34.

NIH Technical Assistance Program Helping Companies cross the “Valley of Death” Niche Assessment Program Mt. “FDA” ??? Commercialization Assistance Program Phase I 38 Phase II Phase III “In-NIH-vative” Approaches38
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Slide #35.

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 39 39
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Slide #36.

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 40 “In-NIH-vative” Approaches40
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Slide #37.

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 41 41
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Slide #38.

NIH Pipeline to Partnerships (P2P) POTENTIAL PARTNERS / INVESTORS Identifies technology of interest and contacts company 42 42
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Slide #39.

Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions! 43 43
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Slide #40.

SBIR/STTR Historical Relationships 1982 2008 Federal Government Small Businesses 44 State Government  Quasi-Government Corporations  Economic Development Entities  Technology Centers Academia  University Research Parks  Faculty & Graduate Students  Technology Incubators  Research Foundations 44
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Slide #41.

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. 45 45
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Slide #42.

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 46 46
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Slide #43.

UNIVERSITY AND INDUSTRY: Two diverse cultures Industry Researchers are from MARS University Researchers are from Venus 47 47
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UNIVERSITY AND INDUSTRY: Two diverse cultures University 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 48 48
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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 49 49
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Slide #46.

CULTURAL DIVERSITY University - Industry Partnerships Critical dimension of the new “Innovation-based Economy”   50 Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property is KEY! Universities and Industry learning to work together 50
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Slide #47.

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) 51 51
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Slide #48.

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 52 52
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Slide #49.

“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 53 53
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Slide #50.

Case Study: Texas A&M 54 54
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Slide #51.

Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions! 55 55
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Slide #52.

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 56 56
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Slide #53.

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. 57 57
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Slide #54.

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 58 58
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Slide #55.

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 59 59
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Slide #56.

STTR Eligibility Criteria • Applicant Organization • Research Institution Partner • Project Director/Principal Investigator 60 60
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Slide #57.

STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization 61 61
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Slide #58.

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  62 eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques 62
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Slide #59.

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 63 63
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Slide #60.

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 64 64
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Slide #61.

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 65 65
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Slide #62.

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 66 66
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Slide #63.

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. 67 67
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Slide #64.

Top 10 Reasons 68 68
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Slide #65.

Top 10 Reasons 10. Over $2.3 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 $$$ 69 69
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Slide #66.

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 70 70
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Slide #67.

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 71 71
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Slide #68.

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. 72 Cyberkinetics Neurotechnology Systems, Inc. 72
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Slide #69.

For More Information 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 Email: [email protected] Lenka Fedorkova SBIR/STTR Program Analyst 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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Slide #70.

Save the Date! 12th Annual NIH SBIR/STTR Conference June 2-3, 2010 Raleigh, NC 74 74
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Slide #71.

Thank You! Questions? 75 75
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