Dental Implants Grant or Financial Assistance

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					National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basi c discovery to impro ved patIent care




            The Small Business Grant program
                  www.ncrr.nih.gov/sbo
Today’s Presentation

   SBIR/STTR Program Overview
   Eligibility Requirements
   Funding Opportunities
   Follow-on Assistance Programs




                                    NCRR
 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.

                                                 NCRR
SBIR/STTR Helps NIH Meet Its Mission

Conduct innovative R&D that results in
 product, process, or service that will...
      Improve human health

      Speed process of discovery
      Reduce cost of medical care/cost of
      research
      Improve research tools




                                             NCRR
   Why are SBIR and STTR programs important
                  to NCRR Researchers?

 NCRR provides clinical and translational researchers
 with the training and tools they need to understand,
 detect, treat, and prevent a wide range of diseases
 SBIR and STTR
   • an excellent resource for enabling commercialization of innovative
     high impact technologies essential for clinical and translational
     research, such as:
       research tools, medical devices, therapeutics

   • provide incentive to academic investigators to translate
     technology (form new company or collaborate with existing)
   • a large source of early-stage life sciences R&D financing

                                                                          NCRR
                                                                            5
Program Descriptions

Small Business Innovation Research (SBIR)
       Set-aside program for small business
2.5%
       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.              NCRR
SBIR/STTR: 3-Phase Program

      PHASE  I (R43 or R41)
      • Feasibility Study
      • $100K and 6-month (SBIR)
      • or 12-month (STTR) Award

     PHASE II (R44 or R42)
      • Full Research/R&D
      • $750K and 2-year Award (SBIR & STTR)
      • Commercialization plan required



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


                                               NCRR
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basi c discovery to impro ved patIent care




                 Eligibility Requirements
SBIR/STTR Eligibility Requirements

 Applicant is Small Business Concern
 Organized for-profit U.S. business
 500 or fewer employees, including affiliates
 Must be:
   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


                                                      NCRR
SBIR Eligibility Requirements


 Principal Investigator’s primary
  employment must be with the Small
  Business Concern at the time of award
  and for the duration of the project period
 Subawards are permitted
  • May outsource 33% activities in Phase I
  • May outsource 50% activities in Phase II



                                               NCRR
STTR Eligibility Requirements

 Principal Investigator’s primary employment may be with either
  the Small Business Concern or the research institution
 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
   • Defines allocation of IP rights and rights to carry out follow-
     on R&D and commercialization
                                                                   NCRR
A New Opportunity:
Multiple Principal Investigators on SBIR Grants

 More than one Principal Investigator is allowed
  on SBIR research projects

 This policy offers new approaches to maximize
  the potential of “team science” efforts

 Only the contact PI need be employed primarily
  by the small business concern




                                                    NCRR
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basi c discovery to impro ved patIent care




SBIR/STTR Funding Opportunities
NIH SBIR/STTR Budget

 SBIR – 2.5% NIH budget ($580 M. FY08)
 STTR– 0.3% NIH budget ($70 M, FY08)

 NCRR FY2008
 SBIR - $27 M
 STTR - $3.2 M

 Award level range 2000-2007:
  • R43: $77 K - $1.9 M
  • R44: $162 K - $1.8 M

                                          NCRR
NIH Issues Multiple SBIR & STTR
Solicitations
  SBIR/STTR Omnibus Grant Solicitation
    Release: January
    Receipt Dates: April 5, August 5, and December 5
    (2008 Release: PA-08-050 & PA-08-051)

  SBIR Contract Solicitation (NIH, CDC)
    Release: August
    Receipt Date: Early November

  NIH Guide for Grants and Contracts
    Release: Weekly
    Receipt Dates: Various
                    For more information visit:
          http://grants.nih.gov/grants/funding/sbir.htm

                                                          NCRR
Current NCRR-sponsored SBIR/STTR
Funding Opportunity Announcements

 New Technologies for Proteomics and
  Glycomics:
  SBIR PA-07-451, STTR PA-07-452

 Technologies for Transient Molecular Complex
  Characterization:
  SBIR PA-08-110, STTR PA-08-111

 Visualizing Biomedical Research Characteristics
  Contract Topic 012

                                                    NCRR
Current SBIR/STTR Initiatives in which
NCRR Participates
 Lab to Marketplace: Tools for Biomedical and Behavioral
  Research: SBIR only PA-08-114

 Technological Innovations for Interdisciplinary Research
  Incorporating the Behavioral and Social Sciences: SBIR
  PA-08-202, STTR PA-08-201

 Bioengineering Nanotechnology Initiative: SBIR PA-08-
  009, STTR PA-08-008

 Manufacturing Processes of Medical, Dental, and
  Biological Technologies: SBIR PA-06-013, STTR PA-06-
  012

 Innovations in Biomedical Computational Science and
  Technology Initiative: SBIR PA-07-160, STTR PA-07-161

                                                             NCRR
Keys to a Strong Application

 Significant, innovative, and focused science
 Significant product and/or commercial potential
   • A product-focused application is more likely to have
     support of business reviewers
   • A project with sound financial projections is more likely
     to attract a partner
 Translational research/clinical applications projects should
  involve the appropriate collaborators
   • Clinical investigator in appropriate specialty
   • Statisticians
   • …

                                                                 NCRR
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basi c discovery to impro ved patIent care




     SBIR Follow-on Opportunities
Competing Continuation Phase II Award


 available to SBIR Phase II awardees

require extraordinary time and effort in the R&D phase
or may require FDA approval for the development of
such projects, including drugs, devices, vaccines,
therapeutics, and medical implants Response to an NIH
Announcement

Generally, $750k-$1M/year for up to 3 years



                                                      NCRR
Transitioning to Phase III

 Pipeline to Partnerships
 http://ott.od.nih.gov/p2p/index.asp


 SBIR Technical Assistance Programs
  • Commercialization Assistance Program (CAP)
  • Niche Assessment Program (NAP)
  • Manufacturing Assistance Program (MAP)


                                                 NCRR
 Technical Assistance Programs
 http://grants.nih.gov/grants/funding/tap.htm


Commercialization Assistance Program
…for phase II awardees
 Business & strategic planning
 Builds alliances and investor partnerships
Niche Assessment Program
…for phase I awardees
 Identify other uses of the technology
 Determine competitive advantages
 Develop market entry strategy



                                                NCRR
Technical Assistance Programs, cont’d.

Manufacturing Assistance Program

 Help developing operational manufacturing
  transition strategies




                                              NCRR
Useful Web Links

 NCRR SBIR Web Site
www.ncrr.nih.gov/sbo
NIH SBIR Web Site
http://grants.nih.gov/grants/Funding/sbirsttr_programs.htm




                                                             NCRR

				
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