National Institutes of Health SMALL BUSINESS FUNDING OPPORTU“NIH”TIES Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: email@example.com Research Opportunities Reserved for Small Business SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Updated 01/17/2006 JG) Agenda • Basics of the SBIR & STTR programs • NIH SBIR/STTR programs Overview What’s new Latest funding opportunities University participation/involvement SBIR / STTR Program Mission 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. Program Descriptions • Small Business Innovation Research (SBIR) 2.5% Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. • Small Business Technology Transfer (STTR) 0.3% Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 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 AND STTR PROGRAMS CRITICAL DIFFERENCES • Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES • Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] 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. 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 STTR PROGRAM ELIGIBILITY CHECKPOINTS 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 / STTR Participating Agencies • DOD SBIR/STTR • HHS SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • DHS SBIR • USDA SBIR • DOC SBIR • ED SBIR TOTAL ~ $2.2 + B • EPA SBIR FY 2006 • DOT SBIR DHHS Budget and Award Amount STTR 2006 Budget SBIR NIH $571M $69M $640M CDC ~8.1M ****Propose a Realistic and Appropriate the Research**** Budget for ~0.8M FDA N/A AHRQ ~2.0M Phase I $100K* $100K* 6 months* 1 year* Phase II $750K* $750K* 2 years* 2 years* NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications. NIH Organization Office of the Director http://www.nih.gov/icd National Institute National Institute National Institute National Institute National Institute of Arthritis and National Cancer of Child Health on Alcohol Abuse of Allergy and on Aging Musculoskeletal Institute and Human and Alcoholism Infectious Diseases and Skin Diseases Development National Institute on National Institute National Institute National Institute Deafness and Other of Dental and of Diabetes and National Institute National Eye of Environmental Communication Craniofacial Digestive and on Drug Abuse Institute Health Sciences Disorders Research Kidney Diseases National Institute National Institute National Heart, National Human National Institute National Institute of Neurological of General Lung, and Blood Genome Research of Nursing Research of Mental Health Disorders and Medical Sciences Institute Institute Stroke National Center on National Center National Institute Fogarty National Center Minority Health for Complementary National Library of Biomedical International for Research and Health and Alternative of Medicine Imaging Center Resources Disparities Medicine and Bioengineering Largest SBIR/STTR set-asides Examples of Cross-Cutting Areas of Interest Nanotechnologies Bioinformatics Biodefense Proteomics / Genomics Genetically engineered proteins Biosensors Biosilicon devices Biocompatible materials Acousto-optics and opto-electronics Imaging technologies Education/communication tools Computational biology Behavioral research Small Companies Can Help NIH Meet its Mission Conduct innovative R/R&D that results in product, process, or service that will... Improve patient health Speed process of discovery Reduce cost of medical care/cost of research Improve research & communication tools Our Ideas… • SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOA Release: January April 5, Aug 5, Dec 5 receipt dates (AIDS/AIDS-related: May 1, Sept 1, Jan 2 receipt dates) SBIR: http://grants.nih.gov/grants/guide/pa-files/PA-07-180.html STTR: http://grants.nih.gov/grants/guide/pa-files/PA-07-181.html • SBIR Contract Solicitation (NIH, CDC) Release: August November 6, 2006 receipt date • NIH Guide for Grants and Contracts Release: Weekly Various receipt dates http://grants.nih.gov/grants/funding/sbir.htm Your Ideas … Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component NIH SBIR/STTR PROGRAM Review Process for Research Grant Submits NIH Center for Scientific Review SBIR/STTR Grant Assign to IC and IRG Small Business Application to NIH Concern Electronically Applicant Initiates Scientific Review Groups Research Idea Evaluate Scientific Merit ~2-3 months after submission Advisory Council or Board ~2-3 Recommend approval months after review IC IC Staff Prepare funding Plan Grantee Conducts Allocates for IC Director Research Funds REVIEW CRITERIA (Phase I) Significance (Real Problem/Real People) Approach (Research Design, Feasible) Innovation (New or Improved?) Investigators (PI and team) Environment (Facilities/Resources) … Protection of Human Subjects … Animal Welfare … Budget Phase II Review Criteria Same as Phase I Demonstrated Feasibility in Phase I Commercialization Plan High Degree of Commercial Potential based on plan … Protection of Human Subjects … Animal Welfare … Budget SBIR “FAST-TRACK” Standard application, review, award process 7-9 months Phase I 7-9 months Phase II 6 months 24 months Fast-Track review option Phase I + Phase II 7-9 months Satisfactory Phase I Final Report Simultaneous 6 months submission/review Phase II DOES MY TECHNOLOGY “FIT” IN NIH? See Mission Statement! Solution to… Real Problem…. that affects Real People! Entrepreneurial Research Institutions Universities / Industry Partnerships and Cultural Differences 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 UNIVERSITY AND INDUSTRY: Two diverse cultures Industry Researchers are from MARS University Researchers are from Venus UNIVERSITY AND INDUSTRY: Two diverse cultures 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 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 CULTURAL DIVERSITY That was then… This is now… University - Industry Partnerships Critical dimension of the new “Knowledge-based Economy” Universities are establishing creative and is KEY! entrepreneurial environments for the commercialization of university intellectual property Universities and Industry learning to work together Entrepreneurial Research Institution Key Ingredients 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) Examples of Successful Entrepreneurial Research Institutions • The Ohio State University • Texas A&M University • Purdue University • Penn. State University • University of Wisconsin • UC San Diego • N.C. State University • University of Utah • Georgia Tech • Carnegie Mellon University • Virginia Tech • Stanford University Source: Innovation U. “New University Roles in A Knowledge Economy” Southern Technology Council and Southern Growth Policies Board Examples of Successful Entrepreneurial Research Institutions (cont.) • Purdue University: Purdue Research Park 3 business incubators Companies benefit from shared office concept, flexible leases, attractive rental rates, and more ... Gateways Program Financial assistance http://www.purdueresearchpark.org Examples of Successful Entrepreneurial Research Institutions (cont.) • Purdue University Environment for business to have frequent and mutually beneficial interactions with University Policies / Procedures to address COI -- not to eliminate, but to minimize and manage SUCCESS STORY • Endocyte, Inc. (Purdue Research Park) Researcher, Philip Low, discovered way to diagnose, potentially cure, ovarian cancer using vitamin folate Sell technology or start own company to develop and market treatment???? Resisted VC offers: wanted control of science Now exploring use of folate in arthritis ADVICE: Hire experienced CEO to handle all but science BENEFIT: Purdue retains talent STTR ELIGIBILITY CRITERIA Applicant Organization Research Institution Partner Principal Investigator Yellow Lights…. Red Lights STTR APPLICANT ORGANIZATION Small Business Concern ALWAYS the applicant/awardee organization STTR RESEARCH INSTITUTION PARTNER U.S. 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 STTR RESEARCH INSTITUTION PARTNER Formal collaborative relationship with SBC Perform minimum of 30% of the research/R&D (maximum 60%) PI Eligibility on STTR Formal collaborative relationship: PI at RI establishes contract between RI and SBC describing PI’s involvement PI is NOT required to be employed by SBC Minimum 10% effort PI and co-investigator must be paid at either SBC or RI , but NOT BOTH PI’s signature on Face Page is agreement to conforming to Solicitation requirements 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 See instructions for Multiple PI requirements PI Role on STTR PI also business official for SBC? Type of appointment does 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 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 SBIR vs STTR UNIQUE FEATURES SBIR STTR Set-Aside of Agency Budget 2.5% 0.30% FY06 SBIR / STTR Budget $571M $69M Award Guidelines Phase I $100K/6mos $100K/12 mos. Phase II $750K/2 yrs $750K/ 2 yrs Subcontracts Phase I < 33.3% < 60% Phase II < 50% < 60% Research Partner Not Required > 30% Business Employment of PI >50% n/a 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: firstname.lastname@example.org Kay Etzler SBIR/STTR Program Analyst Phone: 301-435-2713 Fax: 301-480-0146 Email: email@example.com Questions?
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