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11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health.

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Presentation on theme: "11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health."— Presentation transcript:

1 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health 11 th Annual NIH SBIR/STTR Conference June 30 – July 1, 2009 Omaha, Nebraska

2 22 CONFERENCE GOALS l We really ARE here to help you l Understand NIH SBIR/STTR Program and Funding Opportunities l Understand NIH application, review and award process better l More confident about submitting a competitive application l Take advantage of the one-on-one and networking opportunities l Enjoy yourself!

3 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR Topics to Discuss SBIR/STTR Program Overview SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Solicitations and Funding Opportunities Solicitations and Funding Opportunities The NIH Peer-Review Process The NIH Peer-Review Process Industry- University Partnership Opportunities Industry- University Partnership Opportunities Gap-Funding Programs Gap-Funding Programs Transitioning to the Marketplace Transitioning to the Marketplace

4 44 SBIR/STTR Program Overview SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program for small businessconcerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 2.5% 0.3% SBIR/STTR Program Overview

5 55 SBIR Purpose and Goals Small Business Innovation Development Act of 1982 P.L (Signed 12/21/2000 extends 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, SBIR/STTR Program Overview

6 66 SBIR Program Extended Temporarily Until July 31, 2009 P.L temporarily extends programs authorized under the Small Business Act and the Small Business Investment Act of (Extension includes SBIR) -- signed into law on March 19, 2009 SBIR/STTR Program Overview SBIR Program Update

7 77 S.1233: A bill to reauthorize and improve the SBIR and STTR programs and for other purposes. Introduced Jun 10, 2009 H.R. 2747: To amend the Small Business Act to improve outreach and support activities and to increase award recipients from rural areas with respect to the Small Business Innovation Research Program and the Small Business Technology Transfer Program, and for other purposes. Introduced Jun 8, 2009 H.R. 2769: Commercializing Small Business Research and Development Act Introduced Jun 9, 2009 H.R. 2767: Investing in Tomorrow's Technology Act Introduced Jun 9, 2009 H.R. 2772: SBIR and STTR Enhancement Act Introduced Jun 9, 2009 SBIR Legislative Update SBIR/STTR Program Overview

8 88 STTR Purpose and Goals Small Business Research and Development Enhancement Act of 1992 P.L (Program reauthorized through 09/30/2009) Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions Foster technology transfer between small business concerns and research institutions SBIR/STTR Program Overview

9 99 The largest, most accessible source of SEED CAPITAL for the nation’s innovative small businesses ~$2.3 Billion in 2009 SBIR/STTR Programs 25 years later… DODSBIR/STTR HHSSBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHSSBIR USDASBIR DOCSBIR EDSBIR EPASBIR DOTSBIR $670M

10 10 …and This capital is in the form of grants and contracts no repayment no debt service no equity forfeiture no IP forfeiture SBIR/STTR Program Overview

11 11 PHASE II  Full Research/R&D  $750K and 2-year Award (SBIR & STTR)  Pre-requisite: Phase I award PHASE III  Commercialization Stage  Use of 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

12 12 SBIR/STTR Program Overview

13 13 SBIR Eligibility Criteria Applicant must be a Small Business Concern Organized as for-profit U.S. business Small: 500 or fewer employees, including affiliates PD/PI’s primary employment must be with small business concern at time of award and for duration of project period (unless a waiver is granted) At least 51% U.S.- owned by individuals and independently operated or At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals SBIR/STTR Program Overview

14 14 Applicant must be a 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 STTR Eligibility Criteria SBIR/STTR Program Overview

15 15 STTR Research Institution Partner U.S. non-profit organization owned and operated exclusively for scientific or educational purposes U.S. 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 SBIR/STTR Program Overview

16 16 PI Eligibility on STTR PD/PI is not required to be employed by SBC PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement PD/PI must commit a minimum of 10% effort PD/PI’s “signature” on application is agreement to conforming to Solicitation requirements SBIR/STTR Program Overview

17 17 PI Eligibility on STTR PD/PI is not required to be employed by SBC PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement PD/PI must commit a minimum of 10% effort PD/PI’s “signature” on Face Page is agreement to conforming to Solicitation requirements SBIR/STTR Program Overview

18 18 Research Partner  SBIR: Permits partnering  STTR: Requires partnering with Research Institution Small Business Concern is ALWAYS Applicant/Awardee Organization SBIR vs STTR: Which Program is Best for You? Consider major differences Principal Investigator  SBIR: Primary employment must be with small business concern  STTR: PI may be employed by research institution or small business concern SBIR/STTR Program Overview

19 19 Important Facts to Remember Eligibility is determined at time of award PD/PI is not required to have a Ph.D./M.D. 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 SBIR/STTR Program Overview

20 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR Topics to Discuss Today SBIR/STTR Program Overview SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Solicitations and Funding Opportunities Solicitations and Funding Opportunities The NIH Peer-Review Process The NIH Peer-Review Process Industry- University Partnership Opportunities Industry- University Partnership Opportunities Gap-Funding Programs Gap-Funding Programs Transitioning to the Marketplace Transitioning to the Marketplace

21 21 NIH Mission: Improve Human Health Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability—from the rarest genetic disorder to the common cold. NIH SBIR/STTR Program Specifics

22 22 Improve human health through prevention, detection, diagnosis and treatment of disease or disability Speed process of discovery Reduce cost of medical care Improve research tools/ reduce cost of research Increase health knowledge base SBIR/STTR Programs Are Fully Integrated Within NIH Research Agenda Bridging the Discovery to Development Gap NIH SBIR/STTR Program Specifics

23 23 Office of the Director National Center on Minority Health and Health Disparities Organizational Structure of NIH National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering No funding authority

24 24 NIH Institute/Center SBIR/STTR Budget Allocations (FY2009) $600 M (SBIR) $ 72 M (STTR) Total: $672 M NIDDK NIGMS NIH SBIR/STTR Program Specifics Extramural R&D Set-Asides: SBIR = 2.5% STTR = 0.3%

25 25 PHASE II Full Research/R&D  Average $850K and 2-years PHASE II Competing Renewal/R&D  Clinical R&D; Complex Instrumentation/Tools  Some, 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: Most awards on a 1-yr NCE NIH SBIR/STTR: 3-Phase Program NIH SBIR/STTR Program Specifics

26 26 Phase IPhase IIPhase 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

27 27 (Simultaneous Submission and Concurrent Review) SBIR/STTR Phase I + Phase II Phase I Award 7-9 months Completion of Phase I Phase I Final ReportProgram Staff assess completion of specific aims and milestones Phase II award Aims/Milestones Met Phase II award Aims/Milestones NOT Met Go? No Go? NIH Phase I/Phase II Fast-Track NIH SBIR/STTR Program Specifics

28 28 Important Considerations Convincing preliminary data Clear, measurable, achievable milestones Well-conceived Commercialization Plan Letters of Phase III support/interest? Track record for commercializing? Discussed with NIH Program Staff? NIH Phase I/Phase II Fast-Track NIH SBIR/STTR Program Specifics

29 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR Topics to Discuss Today SBIR/STTR Program Overview SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Solicitations and Funding Opportunities Solicitations and Funding Opportunities The NIH Peer-Review Process The NIH Peer-Review Process Industry- University Partnership Opportunities Industry- University Partnership Opportunities Gap-Funding Programs Gap-Funding Programs Transitioning to the Marketplace Transitioning to the Marketplace

30 30 NIH, CDC & FDA SBIR/STTR Grant Solicitation Release: January Standard Due Dates: April 5, Aug 5, Dec 5 (AIDS/AIDS-related: May 7, Sept 7, Jan 7) SBIR Contract Solicitation (NIH, CDC) Release: AugustNovember receipt date NIH Guide for Grants and Contracts Release: WeeklyReceipt dates specified in each FOA (http://grants.nih.gov/grants/guide/index.html) Solicitations and Due Dates “Parent” FOAs: SBIR: PA STTR: PA PA PA Solicitations and Funding Opportunities

31 31 Small Businesses can apply for NIH Recovery Act funding opportunities: Challenge Grants (RC1) Grand Opportunities [“GO” Grants] (RC2) Administrative Supplements Competing Supplements (“Revisions”)  Biomedical Research, Development and Growth [BRDG-SPAN] (RC3)  Catalyst Awards (R43) SBIR/STTR and ARRA NIH Recovery Act Funding Opportunities: Solicitations and Funding Opportunities

32 32 NIH SBIR/STTR Web Site Solicitation and Funding Opportunities

33 33 NIH SBIR/STTR Solicitation Research Topics Our Ideas* Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto- electronics Imaging devices Genetically engineered proteins Proteomics / Genomics *Examples from 200+ pages of topics! Parent Solicitations SBIR: PA and STTR: PA PA PA

34 34 Investigator-initiated Ideas Investigator-initiated Ideas (a.k.a. “I can’t find a topic match”) Research projects related to NIH mission “Other” areas of research within mission of an awarding component NIH SBIR/STTR Research Topics Keyword search the Solicitation Ctrl - F Solicitations and Funding Opportunities

35 35 Common Application Problems No Significance  Unimportant problem, unconvincing case for commercial potential or societal impact Inadequately defined test of feasibility Lack of innovation Diffuse, superficial, or unfocused research plan  Lack of sufficient experimental detail Questionable reasoning in experimental approach  Failure to consider potential pitfalls and alternatives Lack of experience with essential methodologies Unfamiliar with relevant published work Unrealistically large amount of work proposed Solicitations and Funding Opportunities

36 36 Identifying Funding Opportunities Electronic Submission Using Grants.gov and the NIH eRA Commons Solicitations and Funding Opportunity Announcements Solicitations and Funding Opportunities

37 37 Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific Review Assign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review NIH Application and Review Process Solicitations and Funding Opportunities

38 38 Timeline: New ApplicationsDueDate April 5 August 5 December 5 Scientific Review July October March Council Review October January May Award Date (earliest) December April July Solicitations and Funding Opportunities

39 39 An In-Depth Look at the NIH SBIR/STTR Receipt, Referral, and Review Process All You Ever Wanted to Know About the Electronic Submission Process NIH Application Submission and Review Process Solicitations and Funding Opportunities

40 40 NIH SBIR/STTR Success Rates: FY 2008 Success Rate (%) $650 M SBIR/STTR % 32% 16% 39% 9.5% 27.2% 4 Solicitations and Funding Opportunities

41 41 Preparing a Successful Application Pre-Award and Post Award Issues Indirect Cost Rates and Accounting Systems: Workshop Solicitations and Funding Opportunities

42 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR Topics to Discuss Today SBIR/STTR Program Overview SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Solicitations and Funding Opportunities Solicitations and Funding Opportunities The NIH Peer-Review Process The NIH Peer-Review Process Industry- University Partnership Opportunities Industry- University Partnership Opportunities Gap-Funding Programs Gap-Funding Programs Transitioning to the Marketplace Transitioning to the Marketplace

43 43 SBIR/STTR Historical Relationships 1997 Federal Government Small Businesses 1982 Industry-University Partnerships

44 44  Quasi-Government Corporations  Economic Development Entities  Technology Centers  State Venture Funds State Government Small Businesses Federal Government SBIR/STTR Historical Relationships Industry-University Partnerships

45 45 SBIR/STTR Historical Relationships Small Businesses Academia  University Research Parks  Faculty & Graduate Students  Technology Incubators  Research Foundations  University Start-Ups  Quasi-Government Corporations  Economic Development Entities  Technology Centers State Government Federal Government Industry-University Partnerships

46 46 University Start-Ups: Roles in the SBIR/STTR Programs University is the intellectual capital of scientific and engineering knowledge Small Business is a vehicle for channeling scientific discovery to the benefit of society Partnership between the University and the Small Business benefits BOTH Industry-University Partnerships

47 47 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 Industry-University Partnerships

48 48 University and Industry: Two diverse cultures Industry Researchers are from MARS! are from MARS! University Researchers University Researchers are from Venus! are from Venus! Industry-University Partnerships

49 49 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 University and Industry: Two diverse cultures Industry-University Partnerships

50 50 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 University and Industry: Two diverse cultures Industry-University Partnerships

51 51 Cultural Diversity University - Industry Partnerships University - Industry Partnerships Critical dimension of the new “Innovation-based Economy” u Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property u Universities and Industry learning to work together is KEY! Industry-University Partnerships

52 52 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 Institution Key Ingredients Industry-University Partnerships

53 53 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 Industry-University Partnerships

54 54 Texas A&M Allows commercialization of faculty research to be considered in the granting of tenure to faculty at A&M System universities. Examples of Successful Entrepreneurial Research Institutions (cont.) Industry-University Partnerships

55 55 Endocyte, Inc. (Purdue Research Park) l Researcher, Dr. Philip Low, discovered way to diagnose, potentially cure, ovarian cancer using vitamin folate l Sell technology or start own company to develop and market treatment???? l Resisted VC offers initially…. wanted control of science l Also exploring use of folate in arthritis University Start-Up Success Story Industry-University Partnerships

56 56 Faculty entrepreneur Dr. Phil Low, along with CEO, Ron Ellis, and angel investor Jack Clawson found Endocyte NIH SBIR Funding $1.63 M from NCI M from Indiana 21 st Century Res & Technology Fund Multiple rounds of financing received Collaborations with Bristol-Myers Squibb Endocyte has a strong pipeline with a number of products in various stages of clinical and preclinical development. BENEFIT: Purdue retained his talent. ADVICE: Hire experienced CEO to handle all but science. Unversity Start-Up Success Story (cont)

57 57 Ivory Tower Innovation & University Start-Ups Tools for Building and Facilitating Partnerships

58 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR Topics to Discuss Today SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics Solicitations and Funding Opportunities The NIH Peer-Review Process Industry- University Partnership Opportunities Gap-Funding Programs Gap-Funding Programs Transitioning to the Marketplace Transitioning to the Marketplace

59 59 Phase IPhase IIPhase III Challenges for Biotech Firms: Navigating the Peaks and Valleys Unusually long development times (5-12 yrs) High & intense capital needs (>$1B) Exceptionally high burn rate for investment funds Multiple rounds of financing required Transitioning to the Marketplace

60 60 In-NIH-vative Approaches to Overcoming Commercialization Challenges Phase II Competing Renewal Awards BRDG-SPAN Awards Technical Assistance Program Finding a Partner

61 61 Phase IPhase IIPhase III Mt. “FDA” ???? Phase II Competing Renewal Awards Gap Funding and Transitioning to the Market

62 62 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 Solicitation) Purpose OR…. To support complex instrumentation, clinical research tools, behavior interventions/treatments (http://grants.nih.gov/grants/guide/pa-files/PA html)http://grants.nih.gov/grants/guide/pa-files/PA html Phase II Competing Renewal Award Gap Funding and Transitioning to the Market

63 63 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 discuss Eligibility Parameters Maximum of $1M/year for up to 3 years IC must accept Competing Renewal applications (NIA, NIAAA, NIAID, NIDA, NIDCD, NIDDK, NEI, NHLBI, NIMH, NICHD, NINDS, NIGMS and NCRR) Phase II Competing Renewal Award Gap Funding and Transitioning to the Market

64 64 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program Application Due Date: September 1, 2009 Activity Code: RC3 (Not SBIR/STTR) Purpose: To address the funding gap between promising research and development (R&D) and transitioning to the market -- often called the “Valley of Death -- by contributing to the critical funding needed to pursue the next appropriate milestone(s) toward ultimate commercialization; i.e., to carry out later stage research activities necessary to that end. Budget/Project Period: $1 million total costs per year for a maximum of three years. Eligible Institutions/Organizations. A U.S.-owned, for-profit enterprise/commercial organization doing a majority of its business in the United States.

65 65 Technical Assistance Programs Commercialization Assistance Business & strategic planning Builds alliances and investor partnerships (Phase II awardees) Niche Assessment Identify other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees) Manufacturing Assistance (Phase II awardees) Partnership with NIST MEP Centers Help make better manufacturing and operational decisions Transitioning to the Marketplace

66 66 NIH Pipeline to Partnerships (Ph I and Ph II awardees) Finding a Partner Showcase of SBIR/STTR 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 Gap Funding and Transitioning to the Market

67 67 Pipeline to Partnerships (P2P) asp

68 68 Pipeline to Partnerships (P2P) p2p/index.asp Potential partner identifies technology of interest and contacts company's Web site. Transitioning to the Marketplace

69 69 Pipeline to Partnerships (P2P) Gap Funding and Transitioning to the Market

70 70 Pipeline to Partnerships (P2P) Potential partner identifies technology of interest and contacts company's Web site. Gap Funding and Transitioning to the Market

71 71 Pipeline to Partnerships (P2P) p2p/index.asp Gap Funding and Transitioning to the Market

72 72 Pipeline to Partnerships (P2P) Gap Funding and Transitioning to the Market

73 73 Phase IPhase IIPhase III NIH Technical Assistance Program Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death” “In-NIH-vative” Approaches

74 74 Business Planning Basics Strategies for Commercialization Life Science Venture Funds and Angels Building Corporate Alliances & Partnerships Commercialization of Behavioral Services Interventions and Products Moving from R&D to Manufacturing Commercializing Your Healthcare/IT/Media Product To Market We Go

75 75 Top 10 Reasons

76 76 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 $$$

77 77 5. Creates jobs / stimulates local and state economies – stronger National Economy 4. Provides seed money to fund high risk projects 6. Foster partnerships (universities, large corporations) that enhance competitiveness of small businesses in marketplace Top 10 Reasons

78 78 3. Intellectual property rights are normally retained by the small business 2. Small business concerns are recognized as a unique national resource of technological innovation – creating AND sustaining Top 10 Reasons

79 79 BrainGate TM System Cyberkinetics Neurotechnology Systems, Inc. Percutaneous Ventricular Assist Device TM Cardiac Assist, Inc. Next Generation Therapeutics TM GlycoFi, Inc. Intralase Corporation Femtosecond Laser Intralase Corporation PediSedate TM Design Continuum, Inc. 1. Opportunity to make important contributions to America the health of America Top 10 Reasons

80 80 Stay Informed…  NIH Guide for Grants and Contracts (weekly notification)  NIH SBIR/STTR Notification Send to with the following text in the message body: subscribe listname your name. ListServes

81 OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR For More Information Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: Fax: Kay Etzler SBIR/STTR Program Analyst Lenka Fedorkova SBIR/STTR Program Analyst

82 82 Web-based Resources

83 83 Resources/Links (1) Office of Extramural Research Grants Home Page: of Extramural Research Grants Home Page: NIH Grants Policy Statement (12/03): Grants Policy Statement (12/03): NIH Guide: Guide: SF 424 (R&R): 424 (R&R): PHS 398 Application (form pgs are PDF-fillable): 398 Application (form pgs are PDF-fillable):

84 84 Resources/Links (2) PHS 2590 Progress Report (Form pgs are PDF-fillable): Progress Report (Form pgs are PDF-fillable): Grants Administration Information Sources (Contact information for Grants Administration staff at all NIH ICs): Administration Information Sources (Contact information for Grants Administration staff at all NIH ICs): eRA Website: Website: Contact list for NIH Chief Grants Management Officers: list for NIH Chief Grants Management Officers:

85 85 Resources/Links (3) OER Help and Other Resources (Includes Organizational Charts) Help and Other Resources (Includes Organizational Charts) Handy Reference: Activity Code, Organization Codes and Definitions Used In Extramural ProgramsHandy Reference: Activity Code, Organization Codes and Definitions Used In Extramural Programs Grants Administration Manual B Peer Review ProcessGrants Administration Manual B Peer Review Process Center for Scientific Review (CSR)Center for Scientific Review (CSR)http://cms.csr.nih.gov/

86 86 Thank You! Questions?


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