Overview of the NIH SBIR/STTR Program “Lab to Life” National Institutes of Health Susan Pucie National Heart, Lung, and Blood Institute, NIH pucies@nhlbi.nih.gov

NIH SBIR/STTR Program Coordinator For More Information http://grants.nih.gov/grants/funding/sbir.htm Dr. Matthew Portnoy NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Dr. Lenka Fedorkova NIH SBIR/STTR Program Phone: 301-435-0921

Infrastructure Programs Translational Sciences Organizational Structure of NIH Office of Research Infrastructure Programs Office of the Director http://www.nih.gov/icd 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 Institute on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority

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

SBIR/STTR Mission through the investment of federal research funds Supporting scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy… one small business at a time. So on to the basics of the NIH SBIR/STTR programs. The SBIR/STTR program mission is to support scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy …one small business at a time.

Bridging the Discovery to Development Gap SBIR/STTR Programs Are Fully Integrated With the NIH Research Mission 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 The SBIR and STTR programs are fully integrated with the NIH research agenda. That is they are meant to:   Improve human health through prevention, detection, diagnosis and treatment of disease or disability Speed the process of discovery Reduce the cost of medical care Improve research tools and reduce the cost of research And increase the health knowledge base. So, the SBIR and STTR programs are not only integral to NIH’s mission, but unlike NIH’s traditional research programs, for instance those that fund regular investigator-initiated research project (R01 type) grants, the SBIR and STTR programs exist to move a great idea, perhaps your great idea, to a commercially viable product, process, or service that meets a recognized need. NIH SBIR/STTR Program Specifics

SBIR Purpose and Goals 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. 112-81 Re-Authorizes program through FY2017

STTR Purpose and Goals 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 Small Business Research and Development Enhancement Act of 1992 P.L. 112-81 Re-Authorizes program through FY2017

SBIR Eligibility Criteria Subject to change per new SBA Policy Directive pending 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 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

STTR Eligibility Criteria Applicant is Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business Minimum 30% by U.S. research institution U.S. Research Institution College or University; other non-profit research organization; Federal R&D center Intellectual Property Agreement Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization

SBIR and STTR: Critical Differences 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%) Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: PI may be employed by either research institution or small business concern Award is always made to Small Business Concern

NIH SBIR/STTR: 3-Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR) PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years PHASE II Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, ICs participate Varies ~$1M/year; 3 years PHASE III Commercialization Stage NIH, generally, not the “customer” Consider partnering and exit strategy early

NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2011) NIMHD Extramural R&D Set-Asides: SBIR = 2.5% STTR = 0.3% FY 2011 SBIR/STTR Budget Allocations to NIH ICs: $609 M (SBIR) $ 73 M (STTR) Total: $682 M FY2012-pending Go to Rob at end NIGMS NIDDK

NIH SBIR/STTR Success Rates Fiscal Year SBIR/STTR Phase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 2010 SBIR Fast Track 430 67 15.6% $16,795,150 Phase 1 4,496 614 13.7% $129,218,371 Phase 2 734 246 33.5% $146,228,959 STTR 47 11 23.4% $2,300,971 539 109 20.2% $21,620,399 92 32 34.8% $18,207,113 FY TOTAL   6,338 1,079 17.0% $334,370,963 2011 409 42 10.3% $10,059,904 4,672 536 11.5% $123,802,074 681 203 29.8% $137,152,687 4 9.5% $813,900 508 80 15.7% $18,321,516 103 37 35.9% $20,977,584 6,415 902 14.1% $311,127,665

Multiple Funding Opportunities Annual SBIR/STTR Omnibus Grant Solicitation Release: January Receipt Dates: April 5, Aug 5, Dec 5 (non-AIDS) May 7, Sept 7, Jan 7 (AIDS) To be released soon for 2012 Targeted SBIR/STTR Grant Funding Opportunity Announcements (NIH Guide for Grants & Contracts) Release: Weekly Various receipt dates Annual SBIR Contract Solicitation (NIH, CDC) Release: August Receipt Date: Early November

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

Gap Funding Phase I Phase II Phase III Phase I / Phase II Fast Track Phase IIB Competing Renewals Pipeline to Partnerships http://www.ott.nih.gov/p2p/ Phase I Phase II Phase III Technical Assistance Programs http://grants.nih.gov/grants/funding/nap.htm http://grants.nih.gov/grants/funding/cap/index.htm

Technical Assistance Programs Niche Assessment Identify other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees) Business & strategic planning Help help build strategic alliances and investor partnerships Commercialization Assistance (Phase II awardees)

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

Advice from Awardees Don’t judge an Institute’s interests by its “name ” Understand an Institute’s mission & needs Get to know your Institute Program Manager Read solicitation and other funding opportunities and follow instructions When trying to determine which agency to apply to, many awardees advise that you don’t judge an agency’s interests by its name. It’s important to understand an agency’s mission and needs, to get to know your agency program manager, and of course to read the published solicitations and follow the instructions.

Cover Letter: A Valuable Tool Suggest potential awarding component(s) Request same or different study section Suggest key areas of expertise required Indicate individual(s) or organization(s) in conflict A valuable tool to submit with your application is a cover letter. This cover letter will allow the NIH Center for Scientific Review to see the applicant’s suggestion for potential awarding components, study sections, and areas of expertise. Also the letter allows the applicant to indicate individuals and organizations that are in conflict.

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

Common Pitfalls with Applications What Reviewers Say… Common Pitfalls with Applications Inadequately defined test of feasibility Lack of sufficient experimental detail Questionable reasoning in experimental approach Failure to consider potential pitfalls and alternatives Lack of innovation Unconvincing case for commercial potential or societal impact Lack of experience with essential methodologies Unfamiliar with relevant published work Unrealistically large amount of work proposed There are a number of common pitfalls with applications that the reviewers regularly come across (see list on slide 34).

TEXAS SBIR/STTR 55 Companies – Active Awardees RESONANT SENSORS INC. ARLINGTON ATACTIC TECHNOLOGIES, INC. HOUSTON AMBION DIAGNOSTICS, INC. AUSTIN BIOTEX, INC. ASURAGEN, INC. COVALENT BIOSCIENCE, INC. BIOO SCIENTIFIC CORPORATION HOUSTON PHARMACEUTICALS, INC. CAISSON BIOTECH, LLC IONWERKS, INC. MICROSURFACES, INC. Austin LC SCIENCES, LLC MIRNA THERAPEUTICS, INC. NANOSPECTRA BIOSCIENCES, INC. PLASTIPURE, INC. PHARMAREVIEW CORPORATION RULES-BASED MEDICINE, INC. PULMOTECT, INC Houston SAVARA, INC. RADIANT CREATIVE GROUP, LLC SELENIUM, LTD SYNTHECON, INC. SERALOGIX TOMOWAVE LABORATORIES, INC. SILICON AUDIO, LLC VIVID TECHNOLOGIES XERIS PHARMACEUTICALS, INC. LASER TISSUE WELDING, INC. HUMBLE KJ BIOSCIENCES, LLC COLLEGE STATION BIO-SYNTHESIS, INC. LEWISVILLE LYNNTECH, INC. NOVOMEDICS, LLC Missouri City POSITIVEMOTION, LLC REBELLION PHOTONICS, INC. PEARLAND STATACORP, LP MARTINGALE RESEARCH CORPORATION Plano CRO LABORATORIES, INC. DALLAS MICROFAB TECHNOLOGIES, INC. PLANO DENTAL DESIGNS OF DALLAS VITAL ART AND SCIENCE, INC. Richardson IMAGINATION STATION, INC. Dallas ACCESSIBLE DESIGNS, INC. SAN ANTONIO MICROTRANSPONDER, INC. APPLIED HUMAN FACTORS, INC. RADIX THERAPEUTICS, LLC DICKINSON BIOMEDICAL DEVELOPMENT CORPORATION EP PHARMA, INC. EL PASO CARE TEAM SOLUTIONS, LLC ORGANIZATIONAL WELLNESS & LEARNING SYS FORT WORTH PROBETEX, INC. MAJESTECK BIOSCIENCE GALVESTON TELEHEALTH HOLDINGS, LLC AGENNIX, INC. NIMBIC SYSTEMS, INC. STAFFORD AM BIOTECHNOLOGIES, LLC

NHLBI SBIR/STTR online search using RePORT MRI SBIR & STTR Here is the URL for the REPORT. REPORT is a powerful tool for searching NIH grants. For example – One can search for a keyword. Here I am using “MRI” as the key word. You can restrict the search to “SBIR/STTR” grants. Here you can select one or more or all of the NIH institutes – I am restricting this search to grants funded by “NHLBI”. You can choose one or more FY – here I am restricting grants to the past three FY. You can choose one or more states or entire United States like I have done. Thus I am searching for SBIR/STTR grants with MRI focus funded by NHLBI in the past three FY. 2008 & 2009 http://report.nih.gov

SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years Here is the URL for the REPORT. REPORT is a powerful tool for searching NIH grants. For example – One can search for a keyword. Here I am using “MRI” as the key word. You can restrict the search to “SBIR/STTR” grants. Here you can select one or more or all of the NIH institutes – I am restricting this search to grants funded by “NHLBI”. You can choose one or more FY – here I am restricting grants to the past three FY. You can choose one or more states or entire United States like I have done. Thus I am searching for SBIR/STTR grants with MRI focus funded by NHLBI in the past three FY. http://report.nih.gov

SBIR/STTR – NHLBI Funded Imaging Grants Now I can see the grant#, Project title, the PI’s name, an abstract and the duration of the project. This is a powerful tool to search for the funded grants. Note this is a search mechanism for any type of NIH grant and not just for SBIR/STTRs. Also I would like to emphasize that the small businesses are not restricted to apply only to SBIR/STTR grants. http://report.nih.gov

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 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 Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, September 7, January 7 (AIDS) Contracts: Early November Budget and Project Period $150K/6 -12months (Ph I) $1M/2 yrs (Ph II) Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P) Summary

Save the Date! 14th Annual NIH SBIR/STTR Conference May 30 to June 1, 2012 Louisville, Kentucky Hosted by Kentucky Science and Technology Corporation 2 day conference with optional workshop on June 1. Stay tuned to NIH SBIR website and listserv for details!

Stay Informed… Listserves NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm NIH SBIR/STTR Notification Send email to LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name.

For More Information Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov Lenka Fedorkova, PhD SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@nih.gov Robert Vinson SBIR/STTR Program Analyst 301-435-2713 Email: vinsonr@mail.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