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National Institutes of Health Small Business Innovation Research (SBIR) ProgramSmall Business Technology Transfer (STTR) Program: 

National Institutes of Health Small Business Innovation Research (SBIR) Program Small Business Technology Transfer (STTR) Program NIH SBIR/STTR Funding Opportu”NIH”tieS Session: Federal Priorities in Bioengineering Chicago, IL October 12, 2006 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Office of Extramural Research National Institutes of Health

Topics to Discuss Today: 

Topics to Discuss Today Extramural Programs Reserved for Small Business SBIR / STTR Program Overview NIH SBIR / STTR Program Specifics Bioengineering Research Funding Opportunities

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Transforming medicine through innovation The NIH SBIR/STTR Programs Improving the Health of Americans “Lab to Life”

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SBIR: Set-aside Program for Small Business Concerns to engage in Federal R&D - with potential for commercialization. Program Descriptions 2.5% 0.3% STTR: Set-aside Program to facilitate cooperative R&D between Small Business Concerns and U.S. Research Institutions-- with potential for commercialization.

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Organized for- profit U.S. business At least 51% U.S.- owned by individuals and independently operated Small Business located in the U.S. 500 or fewer employees P.I.’s primary employment with small business during project Program Eligibility: SBIR

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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 Program Eligibility: STTR

SBIR/STTR: 3-Phase Program: 

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) PHASE III Commercialization Stage Use of non-SBIR/STTR Funds

SBIR / STTR Participating Agencies: 

DOD SBIR/STTR HHS SBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR /STTR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIR SBIR / STTR Participating Agencies

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

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Office of the Director National Center on Minority Health and Health Disparities NIH Organization 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

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SBIR /STTR Program Fully Integrated Within NIH Research Agenda 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 and STTR projects address a critical need: To bridge the “discovery to development” gap

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DHHS SBIR/STTR Budget and Awards $640M ****Propose a Realistic and Appropriate Budget for the Research**** Take Home Message #1

NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2005: 

NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2005 Success Rate (%) $640 M SBIR/STTR 776 358 42 28 147 11 34.7% 14.1% 20.8% 47.7% 25% 16.4%

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SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOA Release: January Next receipt date: Dec 1, 2006; then April 5, Aug 5, Dec 5 annually http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html SBIR Contract Solicitation (NIH, CDC) Release: August November 6, 2006 receipt date NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA http://grants.nih.gov/grants/funding/sbir.htm NIH Issues Multiple Solicitations For SBIR/STTR Applications

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NIH SBIR/STTR Research Topics Our Ideas…. examples Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto-electronics Imaging devices Genetically engineered proteins Proteomics / Genomics Bioengineering Nanotechnology Initiative …

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Take-home Message #2 Investigator-initiated R&D Research topics related to the NIH mission “Other” areas of research within the mission of an awarding component … Your ideas... NIH SBIR/STTR Research Topics http://Grants.Nih.Gov/Grants/Funding/Sbirsttr1/2006-2_sbir-sttr-topics.Doc Angioscopes to Zebrafish

Bioimaging and Bioengineering Research at the NIH: 

Bioimaging and Bioengineering Research at the NIH Multi-disciplinary – Applying principles and methods from the quantitative sciences and engineering to address problems in biology and medicine. Partnerships and collaboration – Multi-disciplinary and multi-organizational teams Design- and technology-driven research in addition to hypothesis-driven Technology transfer – Discovery-to-patient-to-commercialization (bench-to-bedside-to-practice)

All NIH ICs Fund Bioengineering-Related Research : 

All NIH ICs Fund Bioengineering-Related Research Computational cellular research Nanotechnology Tissue delivery Tissue engineering Cell-based therapies Functional Genomics Genomics Biomaterials Vaccine development Microbicide innovation Integrative physiology Cochlear implants Drug delivery Tissue Regeneration Saliva-based diagnostics Rehabilitation and Prosthesis Islet cell transplantation High-density genotyping for diabetes Biomarkers for diabetes and cancer Imaging, molecular imaging, and image-guided methods Probes for micoimaging Microtechnology Biomechanics Bioprocessing Bioelectrics, ion channels, and organ function Medical implants, biomembranes, sensors and devices Etc…….

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Transformation of Medicine and Health: The 4 Ps “Biological engineering has many roles, not just one ... Many opportunities are going to present themselves in the ongoing and future transformation from the traditional curative paradigm of medicine and health to a more pre-emptive paradigm.  And this is going to rely on very novel technologies.   For example, we know already how the technology that we’re using in genomics is enabling us to enter this era of what we call the 4 Ps of medicine: medicine is going to be more Predictive, more Personalized, more Pre-emptive, and it’s going to be more Participatory." -- Dr. Elias Zerhouni NIH Director

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DOES MY TECHNOLOGY “FIT” IN NIH? See Mission Statement! Solution to… Real Problem…. that affects Real People!

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How to Successfully Compete for NIH SBIR/STTR Funding Understand our mission. Review Topics under SBIR and STTR Parent Funding Opportunity Announcements (FOAs). Review IC- Specific FOAs. Contact NIH Staff to discuss your research idea. Give yourself ample time to prepare application. Propose innovative ideas with scientific and technical merit. http://grants.nih.gov/grants/funding/sbir.htm

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Discovery of Penicillin…. First step on the moon… Invention of the personal computer… Development of … Entrepreneurial Audacity

Implantable Replacement Heart Dr. Robert Kung Abiomed Corporation (MA): 

Implantable Replacement Heart Dr. Robert Kung Abiomed Corporation (MA) AbioCorTM

Artificial Skin Drs. Naughton, Bartel, Riley, Hollister and Ratner Advanced Tissue Sciences, Inc., U.Michigan and U. Wash. : 

Artificial Skin Drs. Naughton, Bartel, Riley, Hollister and Ratner Advanced Tissue Sciences, Inc., U.Michigan and U. Wash.

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Technology Transfer and Engineering Development Product: “Smart Variable Geometry Socket" Technology: A series of water-filled bladders, passive pumps, and valves compensate for volumetric changes of the residual limb. Importance of SBIR: The conceptualization, development, and commercialization of this device. Outcome: Consistent and precise fit, which lowers the need for, and cost of, continued rehabilitation and greatly improves the quality of life for lower-limb amputees. Synergy Innovations, Inc. (NH) (HD36154) “…. the SBIR mechanism is a unique source of support for biomedical engineers and entrepreneurs.” - Dr. Robert Dean, President , Synergy Innovations Inc.

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Intellectual Rigor + Hard Work + Passion + Mission Technology Entrepreneurship

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Real Solutions….. Real Problems…. Real People… Today’s Ideas “Lab to Life” Tomorrow’s Discoveries A Better Future for All Americans

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The Top 10

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Top 10 Reasons to Seek SBIR/STTR Funding 10. Over $2.2 Billion available 9. NOT A LOAN - no repayment 8. Provides recognition, verification and visibility 7. Potential leveraging tool to attract venture capital/other sources of $$$

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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 to Seek SBIR/STTR Funding

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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 Top 10 Reasons to Seek SBIR/STTR Funding

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1. To make economic and societal contributions to America Top 10 Reasons to Seek SBIR/STTR Funding

For More Information: 

For More Information http://grants.nih.gov/grants/funding/sbir.htm Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: jg128w@nih.gov Kay Etzler SBIR/STTR Program Analyst Phone: 301-435-2713 Fax: 301-480-0146 Email: etzlerk@od.nih.gov Kathleen Shino SBIR/STTR Program Specialist Phone: 301-435-2689 Fax: 301-480-0146 Email: shinok@mail.nih.gov