1 / 51

NIH SBIR & STTR Programs Features and Nuances

NIH SBIR & STTR Programs Features and Nuances. NIH SBIR/STTR MISSION. Though investment in scientific and technological innovation the SBIR/STTR programs develop products, processes and services that improve the health of the American people and build a strong U.S. economy

romney
Download Presentation

NIH SBIR & STTR Programs Features and Nuances

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. NIH SBIR & STTR Programs Features and Nuances

  2. NIH SBIR/STTR MISSION Though investment in scientific and technological innovation the SBIR/STTR programs develop products, processes and services that improve the health of the American people and build a strong U.S. economy One small business at a time.

  3. Organizational Structure of NIH Office of the Director 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 of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders 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 Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine No funding authority

  4. Four Major Congressional 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

  5. 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 NIH SBIR/STTR Program Specifics

  6. NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2010) Extramural R&D Set-Asides: SBIR = 2.5% STTR = 0.3% FY 2010 SBIR/STTR Budget Allocations to NIH ICs: $616 M (SBIR) $ 74 M (STTR) Total: $690 M NIGMS NIDDK

  7. Program Descriptions Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns andU.S. research institutions – with potential for commercialization. 2.5% 0.3%

  8. SBIR/STTR: 3-Phase Program PHASE I – Feasibility Study • $150K and 6 months (SBIR) • $100K and 12 months (STTR) PHASE II – Full Research/R&D • $1 million and 2-year Award – (SBIR) • $750K and 2-year Award - (STTR) • FAST TRACK – Combines Phase I and II Applications • Shortens funding cycle between Phase I and II • PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds

  9. SBIR PROGRAM ELIGIBILITY CHECKPOINTS • Organized for- profit U.S. business • 500 employees or fewer, including affiliates • PI’s primary employment must be with the small business concern at the time of award and for the duration of the project period.

  10. SBIR PROGRAM ELIGIBILITY CHECKPOINTS Small business concern must be: • At least 51% U.S.- owned by individuals and independently operated or • At least 51% owned and controlled by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

  11. STTR PROGRAM ELIGIBILITY CHECKPOINTS • 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 PropertyAgreement • Allocation of Rights in IP and Rights to Carry out • Follow-on R&D and Commercialization

  12. PERFORMANCE of RESEARCH ACTIVITIES “All research/R&D must be performed in its entirety in the U.S.” • Rare cases to conduct testing of specific • patient populations outside U.S. is • allowable • Travel to scientific meeting in foreign • country allowable • Foreign consultants/collaborators allowable, • but must perform consulting in U.S.

  13. SBIR-STTR Comparisons

  14. OUR IDEAS SBIR/STTR Omnibus Solicitation (NIH, CDC, and FDA) Release: January Topics listed reflect a range of areas of interest & are not intended to be exhaustive 2. SBIR Contract Solicitation (NIH, CDC) Release: August Early November receipt date 3. NIH Guide for Grants and Contracts Release: Weekly Various receipt dates 4. NIH Institute Websites – see their workshop and working group meeting reports

  15. SBIR/STTR Omnibus Solicitation • SBIR Parent Funding Opportunity Announcement • (PA-10-050) • http://grants.nih.gov/grants/guide/pa-files/PA-10-050.html • STTR Parent Funding Opportunity Announcement  • (PA-10-051) • http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html • SBIR/STTR Program Descriptions • and Research Topics • http://grants.nih.gov/grants/funding/sbir.htm Submission Dates: April 5, Aug 5, Dec 5 AIDS/AIDS-Related Dates: May 7, Sept.7, Jan 7

  16. NIH Guide for Grants and Contracts Targeted Funding Opportunities: http://grants.nih.gov/grants/funding/sbir_announcements.htm New Approaches to Arrhythmia Detection and Treatment • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-10-117.html • STTR: http://grants.nih.gov/grants/guide/pa-files/PA-10-118.html Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, and Blood Diseases • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-249.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-250.html Innovations in Biomedical Computational Science and Technology Initiative • SBIR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-220.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-221.html

  17. NIH Guide for Grants and Contracts Robotics Technology Development and Deployment (R43) • http://grants.nih.gov/grants/guide/pa-files/PAR-10-279.html • Receipt Date: December 20, 2010 Bioengineering Nanotechnology Initiative • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-10-150.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PA-10-149.html New Technologies for Transient Molecular Complex Characterization • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-08-110.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PA-08-111.html SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries (R43/R44) • http://grants.nih.gov/grants/guide/pa-files/PA-10-122.html

  18. NIH Guide for Grants and Contracts Manufacturing Processes of Medical, Dental, and Biological Technologies • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-113.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-114.html Energy Efficiency and Renewable Energy System Technology Research and Development • SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-100.html • STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-101.html

  19. Annual SBIRContract Solicitation Receipt Date: November 8, 2010 • SBIR Only • NIH & CDC – Various ICs • Narrowly-focused Topics • NHLBI Topics: • Development of Pathogen Inactivation Technologies for Blood Components • Point-of-Care Assay for Engraftment Potential of Umbilical Cord Stem Cells • Novel Technologies for Powering Ventricular Assist Devices • Informatics Tools and Services to Support Data Sharing and Distribution for Cardiovascular, Lung, and Blood Researchers • Interventional MRI and X-ray Invasive Hemodynamics Telemetry • Novel Concepts in Safe “Active” Transmission Lines for MRI Catheters • Strategy for Finding Cases of Moderate-to-Severe COPD • Reagents for Studying Human Lung Cell Biology and Cellular Function http://grants.nih.gov/grants/funding/sbir.htm

  20. Your Ideas … Investigator-initiated R&D • Research projects related to the NIH • mission • “Other” areas of research within the • mission of an awarding component

  21. SBIR / STTR Participating Agencies TOTAL ~ $2.3 + B • DOD SBIR/STTR • HHS SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • DHS SBIR • USDA SBIR • DOC SBIR • ED SBIR • EPA SBIR • DOT SBIR http://www.sbir.gov/

  22. NUANCES NIH SBIR & STTR Programs • Multiple Submission Dates • Revise & Resubmit • Multiple Funding Opportunities • Multiple Award Mechanisms • Investigator-initiated Research • Communication Throughout Process

  23. NUANCES NIH SBIR & STTR Programs • Budget & Project Duration Guidelines • NotPhase III Customer • Technical & Commercialization Assistance • Programs • ELECTRONIC SUBMISSION OF APPLICATIONS

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

  25. Review Criteria • 1. Significance • 2. Approach • 3. Innovation • 4. Investigators • 5. Environment • … Protection of Human Subjects • … Animal Welfare • … Budget Program staff do NOT participate in peer review process STUDY SECTIONS DO NOT FUND!

  26. 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

  27. 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

  28. NHLBI Phase II Competing Renewals • Goal: Take existing, promising compound or devices developed under a Phase II award through the next step of discovery and development. • Stipulations: • Available only to NHLBI Phase II awardees • Focus -- Diagnostics, devices, tissue engineering, drug development, related to NHLBI’s mission • Funding level: $1M per year for maximum of 3 years • Applicant must have had interaction with the FDA Contact Program Staff Prior to Submission

  29. Technical Assistance Programs Commercialization Assistance (CAP) (Announced in Aug. Apps. Due mid Sept.) Business & strategic planning Builds alliances and investor partnerships (Phase II awardees) Identify other uses of technology Determines competitive advantages Develops market entry strategy Niche Assessment (Announced in July) (Phase I awardees)

  30. NIH SBIR/STTR Home Page Links NIH SBIR/STTR Home Page: http://grants.nih.gov/grants/funding/sbir.htm 2010 SBIR FOA: http://grants.nih.gov/grants/funding/sbir.htm 2010 STTR FOA: http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html Other SBIR/STTR Funding Opportunities and Announcements: http://grants.nih.gov/grants/funding/sbir_announcements.htm Application Guide: http://grants.nih.gov/grants/funding/424/index.htm Other Important SBIR/STTR News: http://grants.nih.gov/grants/funding/sbirsttr_news.htm#20100204

  31. NIH SBIR/STTR Program Staff Ms. Kay Etzler 301-435-2713 Dr. Lenka Fedorkova 301-435-0921 Office of Extramural Research National Institutes of Health sbir@od.nih.gov

  32. Stay Informed… Listserves • NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm • NIH SBIR/STTR Notification • http://grants.nih.gov/grants/funding/listserv.htm

  33. SBIROK • SBIR National Conference • Oklahoma City, Nov. 8-10, 2010 For small, high-tech businesses, looking to innovate, research, and create products or services, there is an opportunity to receive federal funds and assistance for your research and potential commercialization.  This is the last national conference for 2010.  Technology and industry program tracks include:  aerospace, biotechnology, energy, information technology and nanotechnology.  A poster session is available to present your company's vision. http://www.sbirok.org/

  34. NHLBI Mission • To conduct and support basic research, clinical investigations and trials, observational studies, demonstration and education projects related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders; and to ensure the adequacy and safety of the Nation’s blood supply • The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on all product and service development related to the mission of the NHLBI http://www.nhlbi.nih.gov/

  35. Division of Cardiovascular Sciences Division of Lung Diseases Division of Blood Diseases and Resources Office of the Director Division of Intramural Research Division for the Application of Research Discoveries Division of Extramural Research Activities http://www.nhlbi.nih.gov/

  36. NHLBI SBIR/STTR Staff Contacts • Division of Blood Diseases and Resources: • Susan Pucie (pucies@nhlbi.nih.gov) • Phyllis Mitchell (mitchelp@nhlbi.nih.gov) • Division of Cardiovascular Sciences: • Tim Baldwin (baldwint@nhlbi.nih.gov) • Simhan Danthi (ndanthi@nhlbi.nih.gov) • Bishow Adhikari (adikarb@nhlbi.nih.gov) • Pothur Srinivas (srinivasp@nhlbi.nih.gov) • Shari Ludlam (ludlams@nhlbi.nih.gov) • Paula Einhorn (einhornp@nhlbi.nih.gov) • Division of Lung Diseases: • Ann Rothgeb (rothgeba@nhlbi.nih.gov)

  37. NHLBI Support for Small Business • STTR & SBIR Grants: • STTR Phase I (R41) • STTR Phase II (2R42) • STTR Fast Track (1R42) • SBIR Phase I (R43) • SBIR Phase II (2R44) • SBIR Fast Track (1R44) • SBIR Phase II Competing Renewal • Administrative and Competitive Supplements • SBIR Contracts • SBIR Phase I (N43) • SBIR Phase II and Fast Track (N44)

  38. NHLBI FY 2009 SBIR & STTR Grants

  39. NHLBI SBIR/STTR Award Levels • The stated Phase I and II award levels and project • periods are guidelines not ceilings. So applicants • are encouraged to propose a budget and project • duration period that is reasonable and appropriate • for completion of the research project. • Discuss deviations with NIH program staff prior • to submission of the application. • Institutes differ on how much deviation is allowed.

  40. Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation • Interventions to promote healthy lifestyles, adherence to medications, and cardiac rehabilitation, including stress and exercise • New medical imaging systems, enhancements and applications • Circulatory support systems • Point-of-care (POC) devices for monitoring, diagnostics, and personalized medicine • Novel use of information technology to enhance adherence to medical regimens or promote translational research • Technologies for gene discovery, assessment, and diagnostics • Tools to diagnose and treat respiratory abnormalities during sleep in infants, children, and adults • Virtual bronchoscopy (this is a radiologic 3D reconstruction of the lungs with imaging to approximate bronchoscopy) • Innovative smoking cessation • Personal exposure monitors for aeroallergens and other environmental pollutants • Methods to inactivate or remove microorganisms and other infectious moieties from blood, blood components, and plasma derivatives

  41. Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation MAIN MESSAGE Research topics of interest to the National Heart, Lung, and Blood Institute include, but are not limited to the topics listed in the Omnibus Solicitation • Call NHLBI contacts and send an abstract of your project. We are glad to talk to applicants about SBIR/STTR ideas and provide advice • Visit staff and present your idea

  42. NHLBI SBIR Funding Allocations Of total NHLBI SBIR funding from FY 2007-2009: grants responsive to the omnibus solicitation 84% grants responsive to an NHLBI-issued targeted FOA 11% grants responsive to other targeted FOAs (NHLBI as secondary IC) 3% 2% contracts responsive to RFPs

  43. OHIO SBIR/STTR Funding FY 2005-2009 • FYAwardsSBIRAwardsSTTR • 2005 53 14,999 6 1,330 • 2006 62 19,701 11 2,990 • 2007 54 19,132 9 2,137 • 2008 51 14,350 8 2,848 • 2009 60 21,400 11 4,091 • NIH RePORTER: http://projectreporter.nih.gov/reporter.cfm

  44. FY 2010 OHIO SBIR/STTR Companies Luccell, Inc., Cleveland - New Metallopharm, LLC, DELEWARE - R MRI Research Inc., Cleveland - R NDI Medical, Inc., Cleveland - R Nanofiber Solutions, LLC, COLUMBUS - New NANOMIMETICS, INC., Cleveland - R Neurowave Systems, Inc., Cleveland Heights - R Novelmed Therapeutics, Inc., TWINSBURG - R Orchard Kinetics, LLC, CLEVELAND HEIGHTS - new Osmic Enterprises, Inc., Cincinnati - R P2D, Inc., Cincinnati - R Peritec Biosciences, Cleveland - R Polgenix, Inc., Cleveland - R Quality Electrodynamics, LLC, MAYFIELD VILLAGE - New Vision Optimization, LLC, Columbus - R • Acme Express, Inc., CLEVELAND - R • Aeromics, LLC, Cleveland - R • Arteriocyte, Inc., Cleveland - R • Athersys, Inc., Cleveland - R • BioINvision, inc., CLEVELAND - R • Chantest, Inc., Cleveland - R • Frantz Medical Development. Ltd., MENTOR - New • GLC Biotechnology, Inc., SOLON - R • Great Lakes Pharmaceuticals, Inc., Beachwood • Guild Associates, Inc., DUBLIN - R • Cleveland Medical Devices, Inc. - R • Faraday Technology, Clayton - NEW • H-Cubed, inc., OLMSTED FALLS - R • Ideas, Inc., KIRTLAND - R • JXT Applications, Inc., Beavercreek - R • Interthyr Corporation, MARIETTA – R Note R=Repeat Company, New = New to NIH SBIR/STTR

  45. Recent OHIO SBIR/STTR Technologies • Hazmat Protection Training for Health Professionals • Obesity Therapeutic • Stent Fabrication Technology • Stem Cells for Neonatal Brain Injury • Therapeutic for Controlling Mood • Telehealth Diagnostic for Remote Parkinson’s Monitoring • Sleep Apnea Treatment Technology • Biologics for Rheumatoid Arthritis • Device for Surgical Adhesion Prevention • Life Belt CPR • Antimicrobial Nanocoating • Adaptative Wireless Computer Mouse for Movement Disorders • Telephone Speech Enhancement system • Field Deployable Automatic EEG • Immunotherapy Directly Targeting Cocaine • Tumor-Targeting Chemo-Gene Therapy

  46. New Applicant Resources • NIH eSubmission Tips for Small Business Applicants • http://grants.nih.gov/grants/ElectronicReceipt/files/NIH_eSubmission_SmBus_Tips.pdf • Annotated SBIR Application Form • http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf • Elimination of the Error Correction Window for Due Dates on or After January 25, 2011 • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-123.html Message Applicants should SUBMIT EARLY to allow time to make any necessary corrections and view the application before the submission deadline

  47. Research Portfolio Online Reporting Tool(RePORT) http://report.nih.gov

  48. NHLBI SBIR/STTR online search using RePORT NHLBI MRI SBIR & STTR 2008 & 2009 http://report.nih.gov

  49. SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years http://report.nih.gov

  50. SBIR/STTR – NHLBI Funded Imaging Grants http://report.nih.gov

More Related