11 jo anne goodnight sbir/sttr program coordinator office of extramural research, nih “lab to...

11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH Lab to Life NIH SBIR/STTR Funding OpportuNIHtieS National Institutes of Health NIH Regional Seminar June 2010 Portland, OR

22 Topics to Discuss Today SBIR/STTR Program Overview SBIR/STTR Program Overview NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Partnering Incentives for Research Institutions and Industry through SBIR/STTR Red Lights and Yellow Lights Red Lights and Yellow Lights Answer Your Questions! Answer Your Questions!

33 The largest, most accessible source of SEED CAPITAL for the nations innovative small businesses $2.4 Billion in FY 2010 SBIR/STTR Programs NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M

44 And. This capital is in the form of grants and contracts no repayment no debt service no equity forfeiture no IP forfeiture

55 SBIR/STTR Program Overview 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 Set-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.

66 SBIR Purpose and Goals Small Business Innovation Development Act of 1982 P.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

77 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

88 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

99 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

10 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

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) More SBIR/STTR Eligibility Checkpoints SBIR/STTR Program Overview

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

13 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 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

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

16 NIH SBIR/STTR Program Summary of Key Features SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator-initiated research ideas Special Funding Opportunities (NIH Guide for Grants and Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, September 7, January 7 (AIDS) Contracts: Early November Budget and Project Period $100K/6 months (Ph I) $750K/2 yrs (Ph II) Deviations permitted. External Peer Review Option to request review group Experts from Academia/Industry 5 Criteria: Significance, Approach, PI(s), Innovation, Environment Summary Statement for all applicants Revise & resubmit Gap Funding Programs Phase II Competing Renewals Ph I/Ph II Fast Track Administrative Supplements Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P) Summary

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

18 Office of the Director National Center on Minority Health and Health Disparities Organizational Structure of NIH http://www.nih.gov/icd 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

19 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

20 HHS/NIH Program Funding 2010 BudgetSBIR STTR NIH$616M$74M 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* *Propose a Realistic and Appropriate Budget for the Research* Key Take Home Message

21 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

22 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

23 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 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 In-NIH-vative Approaches

24 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)PA-08-056 Phase II Competing Renewal Award In-NIH-vative Approaches

25 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, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR) Phase II Competing Renewal Award In-NIH-vative Approaches

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

27 NIH, CDC, FDA & ACF Omnibus Solicitation for SBIR/STTR Grant Applications Release: January Due Dates: April 5, Aug 5, Dec 5 (AIDS: May 7, Sept 7, Jan 7) NIH & CDC SBIR Contract Solicitation Release: AugustReceipt Date: November Solicitations and Due Dates Parent FOAs: SBIR: (PA-10-050) STTR: (PA-10-051) NIH SBIR/STTR Program Specifics http://grants.nih.gov/grants/funding/sbir.htm NIH (23 ICs) SBIR & STTRFDA SBIR onlyCDC SBIR onlyACF SBIR only

28 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 l Research projects related to the NIH mission l Other areas of research within the mission of an awarding component Keyword search the Solicitation Ctrl - F

29 l Suggest potential awarding component(s): NIH Institutes/Centers l Request study section l Suggest key areas of expertise required l Indicate individual(s) or organization(s) in conflict l For resubmission, indicate review history l Justify your requests Cover Letter: A Valuable Tool

30 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

31 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

32 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

33 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 NIH SBIR/STTR Program Specifics Remember: First get registered in Grants.gov AND eRA Commons!

34 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

35 Timeline: New and Resubmission Applications Due Date April 5 August 5 December 5 Scientific Review July October March Council Review October January May Award Date (earliest) December April July 2 2 4 4 5 5 Solicitations and Funding Opportunities

36 NIH SBIR/STTR Success Rates Success Rate (%) $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

37 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

38 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

39 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)

40 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

41 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.

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

44 SBIR/STTR Historical Relationships 20081982 Small Businesses Academia University Research Parks Faculty & Graduate Students Technology Incubators Research Foundations Quasi-Government Corporations Economic Development Entities Technology Centers Federal Government State Government

45 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.

46 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

47 UNIVERSITY AND INDUSTRY: Two diverse cultures Industry Researchers are from MARS are from MARS University Researchers University Researchers are from Venus

48 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

49 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

50 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!

51 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

52 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

53 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

54 Case Study: Texas A&M

56 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

57 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.

58 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

59 PD/PI Eligibility on SBIR PI must have primary employment with SBC (unless waiver is granted) More than 50% of PIs 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

60 STTR Eligibility Criteria Applicant Organization Research Institution Partner Project Director/Principal Investigator

61 STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization

62 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

63 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/PIs involvement PD/PIs signature on Face Page represents agreement to conforming to Solicitation requirements

64 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

65 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

66 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

67 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 dont get discouraged: NIH extramural staff are your links with the ICs and are there to help you.

68 Top 10 Reasons

69 Top 10 Reasons 10. 10. Over $2.3 Billion available- annually 9.NOT A LOAN 9. NOT A LOAN - no repayment 8. 8. Provides recognition, verification and visibility 7. 7. Potential leveraging tool to attract venture capital/other sources of $$$

70 5. 5. Creates jobs / stimulates local and state economies stronger National Economy 4. 4. Provides seed money to fund high risk projects 6.niversities, large 6. Foster partnerships (universities, large corporations) that corporations) that enhance of small businesses in competitiveness of small businesses in marketplace marketplace Top 10 Reasons

71 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

72 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. America 1. Opportunity to improve the health of America

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR 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

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

75 Thank You! Questions?

76 NIH ICs and General Areas of Research NCI -- cancer cause, prevention, detection, diagnosis, treatment and control NHLBI -- diseases of heart, blood vessels, lungs, blood, and transfusion medicine NINDS -- diagnosis, treatment, and prevention of disorders of the nervous system, neuromuscular apparatus, and special senses of touch/pain NIDDK -- diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; kidney, urologic and hematologic diseases NIAID -- understand, treat and prevent infectious, immunologic, and allergic diseases NIDCR -- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders

77 NICHD -- fertility, pregnancy, growth, development, and medical rehabilitation NEI -- blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, requirements of the blind NIEHS -- identification, assessment, and mechanism of action of environmental agents that are potentially harmful to human health NIA -- biomedical, social, and behavioral aspects of aging process; prevention of age-related diseases and disabilities; promotion of better QOL for older Americans NIGMS -- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology NIH ICs and General Areas of Research

78 NIDCD -- normal mechanisms diseases, and disorders of hearing, balance, smell, taste, voice, speech and language NIMH -- understanding, treating, preventing behavioral and mental disorders (including HIV prevention, neuro-AIDS research) NIDA -- treatment of drug addiction; behavioral strategies for treatment medication; training in drug abuse treatment techniques; drug abuse treatment NIAAA -- treatment and prevention of alcoholism and alcohol-related problems NIAMS -- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders NINR-- understand effects of acute and chronic illness, improving QOL, approaches to promote health and prevent disease, improving clinical environments NIH ICs and General Areas of Research

79 NHGRI -- efforts toward achieving the goals of the Human Genome Project (Science vol. 262, pp.43-46; Oct. 1, 1993) NCRR -- R&D in instrumentation and specialized technologies for biomedical research; R&D in comparative medicine; discovery- oriented software for science education NCCAM -- complementary and alternative treatment, diagnostic, and prevention modalities, disciplines and systems: education and public information; patient management; botanical products; research- related issues (e.g., models, methods) NLM -- innovative methods, systems, and services for managing health knowledge and information NIH ICs and General Areas of Research

11 jo anne goodnight sbir/sttr program coordinator office of extramural research, nih “lab to...

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