Jo Anne Goodnight

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Lab to LifeNIH SBIR/STTR Funding
OpportuNIHtieS
National Institutes of Health

• Jo Anne Goodnight
• SBIR/STTR Program Coordinator
• Office of Extramural Research, NIH

NIH Regional SeminarJune 2010Portland, OR
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Topics to Discuss Today

• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Partnering Incentives for Research Institutions
  and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!

3
The largest, most accessible source of SEED
CAPITAL for the nations innovative small
businesses2.4 Billion in FY 2010
SBIR/STTR Programs
4
And.

• This capital is in the form of
• grants and contracts
• no repayment
• no debt service
• no equity forfeiture
• no IP forfeiture

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SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION RESEARCH (SBIR)
PROGRAM Set-aside program for small business
concerns to engage in Federal RD -- with
potential for commercialization. SMALL
BUSINESS TECHNOLOGY TRANSFER (STTR)
PROGRAM Set-aside program to facilitate
cooperative RD 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.
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SBIR Purpose and Goals
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.

• Stimulate technological innovation

• Use small business to meet Federal RD needs

• Foster and encourage participation by minorities
  and disadvantaged persons in technological
  innovation

• Increase private-sector commercialization
  innovations derived from Federal RD

Small Business Innovation Development Act of
1982 P.L. 106-554 (Signed 12/21/2000 extended
program through 09/30/2008)
SBIR/STTR Program Overview
7
STTR Purpose and Goals

• 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

Small Business Research and Development
Enhancement Act of 1992 P.L. 107-50 (Program
reauthorized through 09/30/2009)
SBIR/STTR Program Overview
8
SBIR/STTR Extension
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)
Apr 30
SBIR/STTR Program Overview
9
SBIR/STTR 3-Phase Program
SBIR/STTR Program Overview
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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
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More SBIR/STTR Eligibility Checkpoints

• 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 RD 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)

SBIR/STTR Program Overview
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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

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SBIR and STTR Critical Differences

• 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)

• Principal Investigator Employment
• SBIR Primary employment (gt50) must be with
  small business concern
• STTR PI may be employed by either research
  institution or small business concern
• Multiple PD/PI allowable

Award is always made to Small Business Concern
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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

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Topics to Discuss Today

• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Partnering Incentives for Research Institutions
  and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!

16
NIH SBIR/STTR Program Summary of Key Features

• SBIR and STTR Program
• Single SBIR/STTR grant solicitation
• Investigator-initiated research ideas
• Special Funding Opportunities
• (NIH Guide for Grants and Contracts)
• Electronic Submission (grants only)
• Awards Grants, Contracts,
• Cooperative Agreements

• External Peer Review
• Option to request review group
• Experts from Academia/Industry
• 5 Criteria Significance, Approach, PI(s),
  Innovation, Environment
• Summary Statement for all applicants
• Revise resubmit

• Gap Funding Programs
• Phase II Competing Renewals
• Ph I/Ph II Fast Track
• Administrative Supplements

• Multiple Receipt Dates (Grants)
• April 5, August 5, December 5
• May 7, September 7, January 7 (AIDS)
• Contracts Early November

• Budget and Project Period
• 100K/6 months (Ph I)
• 750K/2 yrs (Ph II)
• Deviations permitted.

• Technical Assistance Programs
• Technology Niche Assessment
• Commercialization Assistance
• Pipeline to Partnerships (P2P)

Summary
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NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
18
Organizational Structure of NIH
Office of the Director
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 Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
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 Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources

No funding authority
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NIH Institute/Center SBIR/STTR Budget Allocations
FY 2010 SBIR/STTR Budget Allocations to NIH
ICs SBIR 616 M STTR 74 M Total 690 M
NIDDK
NIGMS
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HHS/NIH Program Funding
2010 Budget SBIR STTR
NIH 616M 74M
CDC FDA AHRQ 8.1M 0.8M 2.0M N/A
Phase I 100K 6 months 100K 1 year
Phase II 750K 2 years 750K 2 years
Propose a Realistic and Appropriate Budget for
the Research Key Take Home Message
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NIH SBIR/STTR 3-Phase Program
NIH SBIR/STTR Program Specifics
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Gap Funding Programs
Phase II Competing Renewal Award
Phase I
Phase II
Phase III

• No-Cost Extension
• Phase I / Phase II Fast Track
• Administrative / Competitive Supplements

NIH SBIR/STTR Program Specifics
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Bridging the Phase I - II Funding Gap
NIH Phase I/Phase II Fast-Track
SBIR/STTR Phase I Phase II
(Simultaneous Submission and Concurrent Review)
Program Staff assess completion of specific aims
and milestones
Completion of Phase I
Go? No Go?
In-NIH-vative Approaches
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Phase II Competing Renewal Award
Purpose

• 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)

• OR.
• To support complex instrumentation, clinical
  research tools, behavior interventions/treatments
• (see PA-08-056)

In-NIH-vative Approaches
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Phase II Competing Renewal Award
Eligibility
Contact NIH Program Staff to discuss

• 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

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)

In-NIH-vative Approaches
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Solicitations and Due Dates
http//grants.nih.gov/grants/funding/sbir.htm
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Solicitations and Due Dates
http//grants.nih.gov/grants/funding/sbir.htm

• NIH, CDC, FDA ACF Omnibus Solicitation for
  SBIR/STTR Grant Applications
• Release January Due Dates April 5,
  Aug 5, Dec 5
• 
  (AIDS May 7, Sept 7, Jan 7)
• NIH CDC SBIR Contract Solicitation
• Release August Receipt Date November

Parent FOAs SBIR (PA-10-050) STTR
(PA-10-051)
NIH (23 ICs) SBIR STTR
FDA SBIR only
CDC SBIR only
ACF SBIR only
NIH SBIR/STTR Program Specifics
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SBIR/STTR Program Descriptions and Research Topics
Suggested topic areas
Biodefense Biosensors Nanotechnologies Bioinforma
tics Diagnostic and Therapeutic Devices Telehealth
Biosilicon devices Biocompatible
materials Acousto-optics / opto-electronics Imagin
g devices Genetically engineered
proteins Proteomics / Genomics
Keyword search the Solicitation Ctrl - F
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Cover Letter A Valuable Tool

• 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

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Targeted SBIR/STTR Funding Opportunity
Announcements
http//grants.nih.gov/grants/funding/sbir_announce
ments.htm

• 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.

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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
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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
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NIH Application and Review Process
Remember First get registered in Grants.gov AND
eRA Commons!
Submits SBIR/STTR Grant Application to
NIH Electronically
2-3 months after submission
2-3 months after review
IC Staff Prepare funding Plan for IC Director
Grantee Conducts Research
NIH SBIR/STTR Program Specifics
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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

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Timeline New and Resubmission Applications
lt.6-9 months.gt
4
2
5
Council Review October January May
Award Date (earliest) December April July

• Due
• Date
• April 5
• August 5
• December 5

Scientific Review July October March
Solicitations and Funding Opportunities
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NIH SBIR/STTR Success Rates
PRELIMINARY -- Fiscal Year 2009
672 M SBIR/STTR
262
40.6
33
54
31.1
Success Rate ()
654
105
7
23.1
22
19.6
Awards
14.9
funded
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Competing Successfully for SBIR/STTR Funding

• 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.

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NIH Technical Assistance Program
Helping Companies cross the Valley of Death
Niche Assessment Program
Commercialization Assistance Program
Phase I
Phase II
Phase III
In-NIH-vative Approaches
39
Technical Assistance Programs Understanding the
B in SBIR

• 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

• Commercialization
• Assistance

(Phase II awardees)
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Finding a Partner
NIH Pipeline to Partnerships

• 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
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NIH Pipeline to Partnerships (P2P)
SBIR/STTR awardees and NIH licensees can showcase
technologies in a virtual space for potential
partners.
http//www.ott.nih.gov/p2p/index.aspx
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NIH Pipeline to Partnerships (P2P)
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Topics to Discuss Today

• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Partnering Incentives for Research Institutions
  and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!

44
SBIR/STTR Historical Relationships
2008
1982
State Government
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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.

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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

47
UNIVERSITY AND INDUSTRYTwo diverse cultures
Industry Researchers are from MARS
University Researchers are from Venus
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UNIVERSITY AND INDUSTRYTwo 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

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UNIVERSITY AND INDUSTRYTwo diverse cultures

• Industry culture
• Mission toward research / RD /
  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

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CULTURAL DIVERSITY

• University - 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

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Entrepreneurial Research Institution
Key Ingredients

• 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)

52
Examples of Successful Entrepreneurial Research
Institutions

• The Ohio State University
• Purdue University
• University of Wisconsin
• N.C. State University
• Georgia Tech
• Virginia Tech

• Texas AM 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
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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

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Case Study Texas AM
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Topics to Discuss Today

• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• Partnering Incentives for Research Institutions
  and Industry through SBIR/STTR
• Red Lights and Yellow Lights
• Answer Your Questions!

56
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

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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.

58
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

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PD/PI Eligibility on SBIR

• PI must have primary employment
• with SBC (unless waiver is granted)
• More than 50 of PIs 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
60
STTR Eligibility Criteria

• Applicant Organization
• Research Institution Partner
• Project Director/Principal Investigator

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STTR Applicant Organization

• Small Business Concern is ALWAYS
• the applicant/awardee organization

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STTR Research Institution Partner

• Must establish formal collaborative relationship
  with SBC
• Must perform minimum of 30 of the research/RD
  (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

63
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/PIs involvement
• PD/PIs signature on Face Page represents
  agreement to conforming to Solicitation
  requirements

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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

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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

66
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

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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/CSRIRGD
  escription/
• 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 dont get discouraged NIH
  extramural staff are your links with the ICs and
  are there to help you.

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Top 10 Reasons
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Top 10 Reasons
10. Over 2.3 Billion available- annually
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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Top 10 Reasons
6. Foster partnerships (universities, large
corporations) that enhance
competitiveness of small businesses in
marketplace
5. Creates jobs / stimulates local and state
economies stronger National Economy
4. Provides seed money to fund high risk
projects
71
Top 10 Reasons
3. Intellectual property rights normally
retained by the small business
2. Small business concerns recognized as a
unique national resource of technological
innovation
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Top 10 Reasons

1. Opportunity to improve the health of America

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For More Information
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax 301-
480-0146 Email goodnight_at_nih.gov
Kay Etzler SBIR/STTR Program Analyst Email
kay.etzler_at_nih.gov
Lenka Fedorkova SBIR/STTR Program Analyst Email
lenka_at_nih.gov
Subscribe to the SBIR/STTR List Serv Email
LISTSERV_at_LIST.NIH.GOV with the following text in
the message body subscribe SBIR-STTR your name
74
Save the Date!
12th Annual NIH SBIR/STTR Conference
June 2-3, 2010Raleigh, NC
75
Thank You! Questions?
76
NIH ICs and General Areas of Research
NCI -- cancer cause, prevention, detection,
diagnosis, treatment and control
NHLBI -- diseases of heart, blood vessels, lungs,
blood, and transfusion medicine
NIDCR -- understand, treat and prevent infectious
and inherited craniofacial-oral-dental diseases
and disorders
NINDS -- diagnosis, treatment, and prevention of
disorders of the nervous system, neuromuscular
apparatus, and special senses of touch/pain
NIDDK -- diabetes, endocrinology, and metabolic
diseases digestive diseases and nutrition
kidney, urologic and hematologic diseases
NIAID -- understand, treat and prevent
infectious, immunologic, and allergic diseases
77
NIH ICs and General Areas of Research
NIGMS -- basic biomedical research not targeted
to diseases or disorders recombinant DNA
technology
NICHD -- fertility, pregnancy, growth,
development, and medical rehabilitation
NEI -- blinding eye diseases, visual disorders,
mechanisms of visual function, preservation of
sight, requirements of the blind
NIEHS -- identification, assessment, and
mechanism of action of environmental agents that
are potentially harmful to human health
NIA -- biomedical, social, and behavioral aspects
of aging process prevention of age-related
diseases and disabilities promotion of better
QOL for older Americans
78
NIH ICs and General Areas of Research
NIAMS -- arthritis/rheumatic diseases, connective
tissue diseases, musculoskeletal and skin
disorders
NIDCD -- normal mechanisms diseases, and
disorders of hearing, balance, smell, taste,
voice, speech and language
NIMH -- understanding, treating, preventing
behavioral and mental disorders (including HIV
prevention, neuro-AIDS research)
NIDA -- treatment of drug addiction behavioral
strategies for treatment medication training in
drug abuse treatment techniques drug abuse
treatment
NIAAA -- treatment and prevention of alcoholism
and alcohol-related problems
NINR-- understand effects of acute and chronic
illness, improving QOL, approaches to promote
health and prevent disease, improving clinical
environments
79
NIH ICs and General Areas of Research
NHGRI -- efforts toward achieving the goals of
the Human Genome Project (Science vol. 262,
pp.43-46 Oct. 1, 1993)
NCRR -- RD in instrumentation and specialized
technologies for biomedical research RD in
comparative medicine discovery-oriented software
for science education
NCCAM -- complementary and alternative treatment,
diagnostic, and prevention modalities,
disciplines and systems education and public
information patient management botanical
products research-related issues (e.g., models,
methods)
NLM -- innovative methods, systems, and services
for managing health knowledge and information