11
Jo Anne Goodnight
SBIR/STTR Program Coordinator
Office of Extramural Research, NIH
““Lab to Life”Lab to Life”
NIH SBIR/...
22
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBI...
33
The largest, most accessible source of
SEED CAPITAL
for the nation’s innovative small businesses
$2.4 Billion in FY 201...
44
And….
This capital is in the form of
grants and contracts
• no repayment
• no debt service
• no equity forfeiture
• no ...
55
SBIR/STTR Program Overview
SMALL BUSINESS INNOVATIONSMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PR...
66
SBIR Purpose and Goals
Small Business Innovation Development Act of 1982
P.L. 106-554 (Signed 12/21/2000 extended progr...
77
STTR Purpose and Goals
Small Business Research and Development
Enhancement Act of 1992
P.L. 107-50 (Program reauthorize...
88
SBIR and STTR Program Extended
Temporarily Through April 30, 2010
P.L. 111-136 temporarily extends all programs
authori...
99
•PHASE II
 Full Research/R&D
 $750K and 2-year Award (SBIR & STTR)
 Pre-requisite: Phase I award
•PHASE III
 Commer...
1010
SBIR/STTR Eligibility Criteria
 U.S. small business organized for-profit
 At least 51% U.S.- owned by individuals a...
1111
 STTR: Formal collaborative effort means:
• Minimum 40% by small business
• Minimum 30% by U.S. research institution...
1212
University-Industry Partnership
Opportunities
• Own small firm (assign someone else PD/PI)
• Principal Investigator
–...
1313
• Research Partner
 SBIR: Permits partnering
33% Phase I and 50% Phase II
 STTR: Requires partnering with
Research ...
1414
Important Facts to Remember
• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PD/...
1515
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH S...
1717
NIH Mission
Improve human
health through
biomedical and
behavioral research,
research training and
communications.
1818
Office of the Director
National Center on
Minority Health
and Health
Disparities
Organizational Structure of NIH
http...
1919
NIH Institute/Center
SBIR/STTR Budget Allocations
NIDDKNIGMS
FY 2010 SBIR/STTR
Budget Allocations to NIH ICs:
SBIR: $...
2121
PHASE II (Full Research/R&D)
 Average $850K and 2-years; can be longer
PHASE II+
(Competing Renewal/R&D)
 Clinical ...
2222
Phase I Phase II Phase III
Gap Funding Programs
Mt. “FDA”
• No-Cost Extension
• Phase I / Phase II Fast Track
• Admin...
2323
Bridging the Phase I - II Funding Gap
(Simultaneous Submission
and Concurrent Review)
SBIR/STTR Phase I + Phase II
Ph...
2424
• To take existing, promising compounds or devices
developed under a Phase II through the next step of
drug discovery...
2525
• SBIR Phase II awardee
• Promising pharmacologic compound identified in original Phase II
• Device prototype develop...
2626
http://grants.nih.gov/grants/funding/sbir.htm
Solicitations and Due Dates
2828
Biodefense
Biosensors
Nanotechnologies
Bioinformatics
Diagnostic and
Therapeutic Devices
Telehealth
Biosilicon device...
2929
Suggest potential awarding
component(s): NIH Institutes/Centers
Request study section
Suggest key areas of expertise ...
3030
Targeted SBIR/STTR Funding
Opportunity Announcements
• NIH Guide for Grants and Contracts
– High priority areas for I...
3131
Electronic Submission
• SBIR/STTR grant applications must be
submitted electronically.
(SBIR contract proposals still...
3232
Important Application Changes
(Effective January 25, 2010)
• Research Plan Restructure
• Page Limits
– Introduction (...
3333
Small Business
Concern
Applicant
Initiates
Research Idea
Grantee Conducts
Research
IC Staff Prepare funding Plan
for ...
3434
Review Criteria
• Overall Impact Score
• Scored Review Criteria (score 1-9)
 Significance (Real Problem/Commercial P...
3636
0
5
10
15
20
25
30
35
40
45
SBIR STTR
Phase I
Phase II
Fast-Track
NIH SBIR/STTR Success RatesSuccessRate(%)
$672 M
SB...
3737
• Understand our mission.
• Review Funding Opportunity Announcements (FOAs).
• Propose innovative ideas with signific...
3838
Phase I Phase II Phase III
NIH Technical Assistance Program
Mt. “FDA”
???Commercialization Assistance
Program
Niche A...
3939
Technical Assistance Programs
Understanding the “B” in SBIR
Commercialization
Assistance
“Menu” of technical assistan...
4040
NIH Pipeline to Partnerships
Finding a Partner
• Showcases SBIR/STTR (Phase I and Phase II)
technologies and NIH-lice...
4141
NIH Pipeline to Partnerships (P2P)
http://www.ott.nih.gov/p2p/index.aspx
SBIR/STTR
awardees and
NIH licensees
can sho...
4242
POTENTIAL PARTNERS / INVESTORS
Identifies technology of interest and
contacts company
NIH Pipeline to Partnerships (P...
4343
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH S...
4444
SBIR/STTR
Historical Relationships
20081982
Small
Businesses Academia
⇒ University Research Parks
⇒ Faculty & Graduat...
4545
University Roles
in SBIR/STTR Programs
• Universities are the intellectual capital of
scientific and engineering know...
4646
Research Institution
Partnership Opportunities
• Own small firms (assign someone else PI)
• Principal Investigator
(w...
4747
UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry ResearchersIndustry Researchers
are from MARSare from MARS
Uni...
4848
University cultureUniversity culture
• Research, discover, educate and train future
workforce
• Pace is slower - alig...
4949
Industry cultureIndustry culture
• Mission toward research / R&D /
commercialization
• Quick-paced
• Solve problems -...
5050
CULTURAL DIVERSITY
University - Industry PartnershipsUniversity - Industry Partnerships
Critical dimension of the new...
5151
• Synergistic goals between faculty-
initiated business and mission of
research institution
• Environment that enable...
5252
• The Ohio State University
• Purdue University
• University of Wisconsin
• N.C. State University
• Georgia Tech
• Vi...
5353
“Land” of Opportunities
• Providing incubator facilities on university
property
• Taking equity position (e.g., 5%) i...
5454
Case Study: Texas A&M
5555
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH S...
5656
Eligibility Criteria
• Ownership: US-owned, independently operated
• Affiliations: Research Institutions,
Foundations...
5757
Ownership And Affiliations
Eligibility of wholly-owned subsidiary
• Owners of the SBIR organization must be
"individu...
5858
Ownership And Affiliations
• Parent of wholly-owned subsidiary is
FOREIGN
• Sum TOTAL of ALL employees
more than 500 ...
5959
PD/PI Eligibility on SBIR
• PI must have primary employment
with SBC (unless waiver is granted)
• More than 50% of PI...
6060
STTR Eligibility Criteria
• Applicant Organization
• Research Institution Partner
• Project Director/Principal Invest...
6161
STTR Applicant Organization
Small Business Concern is
ALWAYS
the applicant/awardee organization
6262
STTR Research Institution
Partner
• Must establish formal collaborative relationship
with SBC
• Must perform minimum ...
6363
PD/PI Eligibility on STTR
• PD/PI: Not required to be employed by SBC
• PD/PI: Must commit 10% effort (minimum)
• PD/...
6464
PD/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 S...
6565
PD/PI Role on STTR
• Is PD/PI also business official for SBC?
• Type of appointment does PD/PI have at RI?
• If Owner...
6666
PI Role on STTR
• NIH requires documentation from original
employer/RI confirming change in employment
status (e.g., ...
6767
Tips for Potential Applicants
• Explore the OER website – a wealth of information there!
http://grants.nih.gov/grants...
6868
Top 10 Reasons
6969
Top 10 Reasons
10.10. Over $2.3 Billion available- annually
9.9. NOT A LOANNOT A LOAN - no repayment
8.8. Provides re...
7070
5.5. Creates jobs / stimulates local and state
economies – stronger National Economy
4.4. Provides seed money to fund...
7171
3.3. Intellectual property rights normally
retained by the small business
2.2. Small business concerns recognized
as ...
7272
Top 10 Reasons
Cardiac Assist, Inc.
Intralase Corporation
Xilas Medical, Inc.
Cyberkinetics Neurotechnology
Systems, ...
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR
For More InformationFor More Information
Jo Anne Goodnight
NIH SBIR/STTR Program ...
7474
12th
Annual NIH SBIR/STTR Conference
June 2-3, 2010
Raleigh, NC
Save the Date!
7575
Thank You!
Questions?
Upcoming SlideShare
Loading in …5
×

Takin' Care of Business: SBIR/STTRs

707 views

Published on

Published in: Business, Technology
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
707
On SlideShare
0
From Embeds
0
Number of Embeds
6
Actions
Shares
0
Downloads
14
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Takin' Care of Business: SBIR/STTRs

  1. 1. 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH ““Lab to Life”Lab to Life” NIH SBIR/STTR FundingNIH SBIR/STTR Funding Opportu“Opportu“NIHNIH”tie”tieSS NationalInstitutesofHealth NIH Regional Seminar June 2010 Portland, OR
  2. 2. 22 Topics to Discuss Today • SBIR/STTR Program OverviewSBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow LightsRed Lights and Yellow Lights • Answer Your Questions!Answer Your Questions!
  3. 3. 33 The largest, most accessible source of SEED CAPITAL for the nation’s innovative small businesses $2.4 Billion in FY 2010 SBIR/STTR Programs NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M
  4. 4. 44 And…. This capital is in the form of grants and contracts • no repayment • no debt service • no equity forfeiture • no IP forfeiture
  5. 5. 55 SBIR/STTR Program Overview SMALL BUSINESS INNOVATIONSMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGYSMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization. 2.5% 0.3% The best way to predict the future… is to create it.
  6. 6. 66 SBIR Purpose and Goals Small Business Innovation Development Act of 1982 P.L. 106-554 (Signed 12/21/2000 extended program through 09/30/2008) • 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 “We in government must work in partnership with small businesses to ensure that technologies and processes are readily transferred to commercial applications.” – Ronald Reagan, July 22, 1982. SBIR/STTR Program Overview
  7. 7. 77 STTR Purpose and Goals Small Business Research and Development Enhancement Act of 1992 P.L. 107-50 (Program reauthorized through 09/30/2009) • Stimulate and foster scientific and technological innovation through cooperative research and development between small business concerns and research institutions • Foster technology transfer between small business concerns and research institutions SBIR/STTR Program Overview
  8. 8. 88 SBIR and STTR Program Extended Temporarily Through April 30, 2010 P.L. 111-136 temporarily extends all programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR) SBIR/STTR Program Overview SBIR/STTR Extension
  9. 9. 99 •PHASE II  Full Research/R&D  $750K and 2-year Award (SBIR & STTR)  Pre-requisite: Phase I award •PHASE III  Commercialization Stage  Must use non-SBIR/STTR Funds • PHASE I  Feasibility Study  $100K and 6- month (SBIR) or 12- month (STTR) Award SBIR/STTR: 3-Phase Program SBIR/STTR Program Overview
  10. 10. 1010 SBIR/STTR Eligibility Criteria  U.S. small business organized for-profit  At least 51% U.S.- owned by individuals and independently operated or , for SBIR, at least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals  500 or fewer employees, including affiliates  SBIR: PI primarily employed with the small business (STTR: primary employment not stipulated)  STTR: Formal collaboration between small business and research institution SBIR/STTR Program Overview
  11. 11. 1111  STTR: Formal collaborative effort means: • Minimum 40% by small business • Minimum 30% by U.S. research institution  STTR: Intellectual Property Agreement Needed Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization  SBIR/STTR: Applicant is Small Business Concern  SBIR/STTR: All of the work must be done in the US (unless a waiver is issued) More SBIR/STTR Eligibility Checkpoints SBIR/STTR Program Overview
  12. 12. 1212 University-Industry Partnership Opportunities • Own small firm (assign someone else PD/PI) • Principal Investigator – with official permission from university – NIH allows multiple PD/PIs • Senior Personnel on SBIR/STTR • Consultant on SBIR/STTR • Subcontract work on SBIR/STTR • Use university facilities for analytical and other service support
  13. 13. 1313 • 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%) Award is always made to Small Business ConcernAward is always made to Small Business Concern SBIR and STTR: Critical Differences • Principal Investigator Employment  SBIR: Primary employment (>50%) must be with small business concern  STTR: PI may be employed by either research institution or small business concern  Multiple PD/PI allowable
  14. 14. 1414 Important Facts to Remember • Eligibility is determined at time of award • No appendices allowed in Phase I • The PD/PI is not required to have a Ph.D. • The P/PI is required to have expertise to oversee project scientifically and technically • Applications may be submitted to different agencies for similar work • Awards may not be accepted from different agencies for duplicative projects
  15. 15. 1515 Topics to Discuss Today • SBIR/STTR Program OverviewSBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow LightsRed Lights and Yellow Lights • Answer Your Questions!Answer Your Questions!
  16. 16. 1717 NIH Mission Improve human health through biomedical and behavioral research, research training and communications.
  17. 17. 1818 Office of the Director National Center on Minority Health and Health Disparities Organizational Structure of NIH http://www.nih.gov/ic d 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 No funding authority
  18. 18. 1919 NIH Institute/Center SBIR/STTR Budget Allocations NIDDKNIGMS FY 2010 SBIR/STTR Budget Allocations to NIH ICs: SBIR: $616 M STTR:$ 74 M Total: $690 M
  19. 19. 2121 PHASE II (Full Research/R&D)  Average $850K and 2-years; can be longer PHASE II+ (Competing Renewal/R&D)  Clinical R&D; Complex Instrumentation/Tools  Many, but not all, ICs participate  $1M/year; 3 years PHASE III (Commercialization Stage)  NIH, generally, not the “customer”  Consider exit strategy early PHASE I (Feasibility Study)  Average award: $170K  Project Period: Varies. Most awards on a 1-yr NCE NIH SBIR/STTR: 3-Phase Program NIH SBIR/STTR Program Specifics
  20. 20. 2222 Phase I Phase II Phase III Gap Funding Programs Mt. “FDA” • No-Cost Extension • Phase I / Phase II Fast Track • Administrative / Competitive Supplements Phase II Competing Renewal Award NIH SBIR/STTR Program Specifics
  21. 21. 2323 Bridging the Phase I - II Funding Gap (Simultaneous Submission and Concurrent Review) SBIR/STTR Phase I + Phase II Phase I Award 7-9 months Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones Phase II award Aims/Milestones Met Phase II award Aims/MilestonesAims/Milestones NOT MetNOT Met Go? No Go? NIH Phase I/Phase II Fast-Track “In-NIH-vative” Approaches
  22. 22. 2424 • To take existing, promising compounds or devices developed under a Phase II through the next step of drug discovery / medical device refinement and development (see SBIR/STTR Solicitation) Purpose OR…. • To support complex instrumentation, clinical research tools, behavior interventions/treatments (see PA-08-056) Phase II Competing Renewal Award “In-NIH-vative” Approaches
  23. 23. 2525 • SBIR Phase II awardee • Promising pharmacologic compound identified in original Phase II • Device prototype developed in original Phase II • Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop Contact NIH Program Staff to discussContact NIH Program Staff to discussEligibility Parameters • Maximum of $1M/year for up to 3 years • IC must accept Competing Renewal applications (NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR) Phase II Competing Renewal Award “In-NIH-vative” Approaches
  24. 24. 2626 http://grants.nih.gov/grants/funding/sbir.htm Solicitations and Due Dates
  25. 25. 2828 Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto- electronics Imaging devices Genetically engineered proteins Proteomics / Genomics …… Suggested topic areas SBIR/STTR Program Descriptions and Research Topics Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component Keyword search the Solicitation Ctrl - F
  26. 26. 2929 Suggest potential awarding component(s): NIH Institutes/Centers Request study section Suggest key areas of expertise required Indicate individual(s) or organization(s) in conflict For resubmission, indicate review history Justify your requests Cover Letter: A Valuable Tool
  27. 27. 3030 Targeted SBIR/STTR Funding Opportunity Announcements • NIH Guide for Grants and Contracts – High priority areas for ICs – Various IC participation – Nuances: • Various due dates • Additional review criteria • Limited funds and project duration periods • Etc. http://grants.nih.gov/grants/funding/sbir_announcements.htm
  28. 28. 3131 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
  29. 29. 3232 Important Application Changes (Effective January 25, 2010) • Research Plan Restructure • Page Limits – Introduction (resubmission or revision) – 1page – Specific Aims – 1page – Research Strategy • Phase I – 6 pages • Phase II – 12 pages • Phase II Commercialization Plan – 12 pages Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods Research Strategy Significance Innovation Approach Guide Notice: NOT-OD-09-149
  30. 30. 3333 Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific Review Assign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review NIH Application and Review Process NIH SBIR/STTR Program Specifics Remember: First get registered in Grants.gov AND eRA Commons!
  31. 31. 3434 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
  32. 32. 3636 0 5 10 15 20 25 30 35 40 45 SBIR STTR Phase I Phase II Fast-Track NIH SBIR/STTR Success RatesSuccessRate(%) $672 M SBIR/STTR 654 262 33 54 105 40.6% 23.1% 19.6% 31.1% 14.9% 22% PRELIMINARY -- Fiscal Year 2009 7 # Awards % funded
  33. 33. 3737 • Understand our mission. • Review Funding Opportunity Announcements (FOAs). • Propose innovative ideas with significance as well as scientific and technical merit. • Give yourself ample time to prepare application. • Communication. Communication. Communication. • Contact NIH Staff to discuss • your research idea. • outcome of your review. • challenges and opportunities. Competing Successfully for SBIR/STTR Funding
  34. 34. 3838 Phase I Phase II Phase III NIH Technical Assistance Program Mt. “FDA” ???Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death” “In-NIH-vative” Approaches
  35. 35. 3939 Technical Assistance Programs Understanding the “B” in SBIR Commercialization Assistance “Menu” of technical assistance/training programs in: •Strategic/business planning •FDA requirements •Technology valuation •Manufacturing issues •Patent and licensing issues Helps build strategic alliances Facilitates investor partnerships Individualized mentoring/consulting (Phase II awardees) Niche Assessment Identifies other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees)
  36. 36. 4040 NIH Pipeline to Partnerships Finding a Partner • Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies • Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors • Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease “In-NIH-vative” Approaches
  37. 37. 4141 NIH Pipeline to Partnerships (P2P) http://www.ott.nih.gov/p2p/index.aspx SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners.
  38. 38. 4242 POTENTIAL PARTNERS / INVESTORS Identifies technology of interest and contacts company NIH Pipeline to Partnerships (P2P)
  39. 39. 4343 Topics to Discuss Today • SBIR/STTR Program OverviewSBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow LightsRed Lights and Yellow Lights • Answer Your Questions!Answer Your Questions!
  40. 40. 4444 SBIR/STTR Historical Relationships 20081982 Small Businesses Academia ⇒ University Research Parks ⇒ Faculty & Graduate Students ⇒ Technology Incubators ⇒ Research Foundations ⇒ Quasi-Government Corporations ⇒ Economic Development Entities ⇒ Technology Centers Federal Government State Government
  41. 41. 4545 University Roles in SBIR/STTR Programs • Universities are the intellectual capital of scientific and engineering knowledge. • Small Businesses are a vehicle for channeling scientific discovery to the benefit of society. • Partnerships between the University and the Small Business benefits BOTH.
  42. 42. 4646 Research Institution 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
  43. 43. 4747 UNIVERSITY AND INDUSTRY: Two diverse cultures Industry ResearchersIndustry Researchers are from MARSare from MARS University ResearchersUniversity Researchers are from Venusare from Venus
  44. 44. 4848 University cultureUniversity 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
  45. 45. 4949 Industry cultureIndustry 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 UNIVERSITY AND INDUSTRY: Two diverse cultures
  46. 46. 5050 CULTURAL DIVERSITY University - Industry PartnershipsUniversity - Industry Partnerships Critical dimension of the new “Innovation-based Economy” Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property Universities and Industry learning to work together is KEY!
  47. 47. 5151 • Synergistic goals between faculty- initiated business and mission of research institution • Environment that enables innovation and entrepreneurship • Agreement on IP issues • Policies to manage, reduce or eliminate conflict of interest (COI) Entrepreneurial Research Institution Key Ingredients
  48. 48. 5252 • The Ohio State University • Purdue University • University of Wisconsin • N.C. State University • Georgia Tech • Virginia Tech Examples of Successful Entrepreneurial Research Institutions • Texas A&M University • Penn. State University • UC San Diego • University of Utah • Carnegie Mellon University • Stanford University Source: Innovation U. “New University Roles in A Knowledge Economy” Southern Technology Council and Southern Growth Policies Board
  49. 49. 5353 “Land” of Opportunities • Providing incubator facilities on university property • Taking equity position (e.g., 5%) in commercial ventures • Investing funds in new companies • Providing technical and business services to new firms (e.g., alumni, business school) • Entering into joint ventures with private entities • Modernizing the tenure process
  50. 50. 5454 Case Study: Texas A&M
  51. 51. 5555 Topics to Discuss Today • SBIR/STTR Program OverviewSBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics •Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow LightsRed Lights and Yellow Lights • Answer Your Questions!Answer Your Questions!
  52. 52. 5656 Eligibility Criteria • Ownership: US-owned, independently operated • Affiliations: Research Institutions, Foundations, Foreign “Parents” • Size: 500 employees maximum • Business Structure: Inc, LLP, LLC, ... • Principal Investigator: Employment
  53. 53. 5757 Ownership And Affiliations Eligibility of wholly-owned subsidiary • Owners of the SBIR organization must be "individuals" who are "citizens of, or permanent resident aliens in, the United States." • The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.
  54. 54. 5858 Ownership And Affiliations • Parent of wholly-owned subsidiary is FOREIGN • Sum TOTAL of ALL employees more than 500 (parent + subsidiary) • Sharing of officers on Board of Directors
  55. 55. 5959 PD/PI Eligibility on SBIR • PI must have primary employment with SBC (unless waiver is granted) • More than 50% of PI’s time spent in employ of SBC • Primary employment with SBC precludes full-time employment at another organization Eligibility is determined at the time of award
  56. 56. 6060 STTR Eligibility Criteria • Applicant Organization • Research Institution Partner • Project Director/Principal Investigator
  57. 57. 6161 STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization
  58. 58. 6262 STTR Research Institution Partner • Must establish formal collaborative relationship with SBC • Must perform minimum of 30% of the research/R&D (maximum 60%) • 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
  59. 59. 6363 PD/PI Eligibility on STTR • PD/PI: Not required to be employed by SBC • PD/PI: Must commit 10% effort (minimum) • PD/PI at RI: Must establish contract between RI and SBC describing PD/PI’s involvement PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements
  60. 60. 6464 PD/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
  61. 61. 6565 PD/PI Role on STTR • Is PD/PI also business official for SBC? • Type of appointment does PD/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
  62. 62. 6666 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
  63. 63. 6767 Tips for Potential Applicants • Explore the OER website – a wealth of information there! http://grants.nih.gov/grants/oer.htm • Explore Institute/Center (IC) websites - to find the most likely home for your project • Explore the CSR website - identify potential study sections http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/ • Contact appropriate program staff – s/he can help you! • Include a cover letter with your application - to request IC and study section assignments • Be persistent and don’t get discouraged: NIH extramural staff are your links with the ICs and are there to help you.
  64. 64. 6868 Top 10 Reasons
  65. 65. 6969 Top 10 Reasons 10.10. Over $2.3 Billion available- annually 9.9. NOT A LOANNOT A LOAN - no repayment 8.8. Provides recognition, verification and visibility 7.7. Potential leveraging tool to attract venture capital/other sources of $$$
  66. 66. 7070 5.5. Creates jobs / stimulates local and state economies – stronger National Economy 4.4. Provides seed money to fund high risk projects 6.6. Foster partnerships (universities, largeniversities, large corporations)corporations) thatthat enhance competitiveness ofof small businesses insmall businesses in marketplacemarketplace Top 10 Reasons
  67. 67. 7171 3.3. Intellectual property rights normally retained by the small business 2.2. Small business concerns recognized as a unique national resource of technological innovation Top 10 Reasons
  68. 68. 7272 Top 10 Reasons Cardiac Assist, Inc. Intralase Corporation Xilas Medical, Inc. Cyberkinetics Neurotechnology Systems, Inc. Merck pays $400 million in cash for small New Hampshire company … largest sum ever reported for a privately held biotech. GlycoFi, Inc. Altea Therapeutics Corporation Design Continuum, Inc. 1. Opportunity to improve the health of AmAmerericaica
  69. 69. OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR For More InformationFor More Information Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Fax: 301- 480-0146 Email: goodnight@nih.gov Kay Etzler SBIR/STTR Program Analyst Email: kay.etzler@nih.gov Lenka Fedorkova SBIR/STTR Program Analyst Email: lenka@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
  70. 70. 7474 12th Annual NIH SBIR/STTR Conference June 2-3, 2010 Raleigh, NC Save the Date!
  71. 71. 7575 Thank You! Questions?

×