National Institutes of Health Small Business Innovation Research SBIR Program Small Business Technol

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National Institutes of Health Small Business
Innovation Research (SBIR) ProgramSmall Business
Technology Transfer (STTR) Program
8th Annual NIH SBIR/STTR Conference Renaissance
Cleveland HotelCleveland, Ohio July 13,
2006 Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Office of Extramural
Research National Institutes of Health
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Extramural Programs Reserved for Small Business
SMALL BUSINESS INNOVATION RESEARCH (SBIR)
PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER
(STTR) PROGRAM The best way to predict the
future is to create it.
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SBIR/STTR PROGRAM
GENERAL FEATURES
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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.
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Program Descriptions

• Small Business Innovation Research (SBIR)
• Set-aside program for small business
• concerns to engage in federal RD --
• with potential for commercialization.
• Small Business Technology Transfer (STTR)
• Set-aside program to facilitate cooperative
• RD between small business concerns and U.S.
  research institutions -- with
• potential for commercialization.

2.5
0.3
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WHY SBIR????
Small Business Innovation Development Act of 1982

• Congress designated 4 major goals

• 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

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2000 REAUTHORIZATION
MAJOR PROVISIONS OF P.L. 106-554 Signed 12/21/00

• Program Extension until 9/30/2008
• Output and Outcome Data
• - Public Database basic award information
  
• (Tech-Net-- http//technet.sba.gov)
• - Government Database program evaluation
• (Phase II awardees -- e.g., new
  product sale revenues
• other investment funding sources)

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WHY STTR????
Small Business Research and Development
Enhancement Act of 1992

• Stimulate and foster scientific and technological
  innovation through cooperative research and
  development carried out between small business
  concerns and research institutions

• Foster technology transfer between small business
  concerns and research institutions

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2001 STTR REAUTHORIZATION

• Reauthorized through FY2009
• Set-aside increased from 0.15 to 0.30 in FY
  2004
• Phase II award levels increased from 500,000 to
  750,000 in FY 2004
• Participating agencies to implement similar
  outreach efforts as SBIR

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Never, ever, think outside the box.

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SBIR/STTR 3-Phase Program

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

• PHASE II
• Full Research/RD
• 750K and 2-year Award
• (SBIR/STTR)

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

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SBIR PROGRAM ELIGIBILITY CHECKPOINTS

• Organized for- profit U.S. business
• 500 employees or fewer, including affiliates
• PIs primary employment must be with the small
  business concern at the time of award and for the
  duration of the project period.

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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

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STTR PROGRAM ELIGIBILITY CHECKPOINTS

• Applicant is Small Business Concern
  Subsidiaries are NOT eligible for STTR program
• Formal Cooperative RD 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 RD center
• Intellectual Property Agreement
• Allocation of Rights in IP and Rights to Carry
  out
• Follow-on RD and Commercialization

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SBIR / STTR ELIGIBILITY OWNERSHIP AND CONTROL
got questions?

• Contact the SBA Size Specialists
• Request an eligibility determination
• http//www.sba.gov/size/indexcontac
  ts.html

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PERFORMANCE of RESEARCH ACTIVITIES

• All research/RD must be performed in its
  entirety in the U.S.
• Rare cases to conduct testing of specific
• patient populations outside U.S. is allowable
• Travel to scientific meeting in foreign
• country allowable
• Foreign consultants/collaborators allowable,
• but must perform consulting in U.S.

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FEE/PROFIT

• Up to 7 of total direct and FA costs may
• be requested for fee
• Must be REQUESTED/JUSTIFIED in application/proposa
  l
• Only SBC eligible no contracts, consortium or
  other third party are eligible for fee
• Not direct or indirect cost

DISCUSS WITH AGENCIES
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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

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Were all just a little bit different ...
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Standard Phase I Process
Solicitation Topics

• Agencies describe RD topics
• in solicitations.

• Small Business Concerns prepare
• short (usually 25-page)proposals.
• Unsolicited proposals not accepted.

Proposal Submission
Evaluation

• Agencies evaluate based on technical
• merit, firms qualifications, and
• commercial potential / societal benefit.

Ph I award

• Agencies make Phase I awards.

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Agency SBIR Differences

• Number and Timing of Solicitations
• RD Topic Areas -- (Broad vs. Focused)
• Dollar Amount of Award (Phase I and II)
• Proposal Preparation Instructions
• Financial details (e.g., Indirect Cost Rates, Gap
  Funding)
• Receipt Dates
• Proposal Review Process
• Proposal Success Rates
• Type of Award (Contract or Grant)

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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Research Partner
• SBIR Permits research institution partners
• Outsource 33 Phase I and 50
  Phase II RD
• STTR Requires research institution partners
  (e.g., universities)
• 40 small business concerns
  (for-profit) and
• 30 U.S. research institution
  (non-profit)

AWARD ALWAYS MADE TO SMALL BUSINESS
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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Principal Investigator
• SBIR Primary (gt50) employment must be with
  small business concern
• STTR Primary employment not stipulated
• PI can be from research institution
  and/or
• from small business concern

DISCUSS WITH AGENCIES
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Important Facts to Remember

• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PI is not required to have a Ph.D. or M.D.
• The 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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Advice from Awardees

• Dont judge an agencys interests by
• its name
• Understand agencys mission needs
• Get to know your agency Program
• Manager
• Read solicitation and follow
• instructions

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Advice from Awardees

• Dont depend solely on SBIR funding
• Dont go it alone - use support systems
• Have an outcome
• Win or lose - get and review evaluations
• Be PERSISTENT

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NIH SBIR/STTR PROGRAM
FEATURES and NUANCES
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U. S. Department of Health and Human Services
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NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
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SBIR Program Importance to NIHTransforming
medicine through innovation
The SBIR program is integrated within the NIH
research agenda.

• Improve human health of the Nation (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.

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• SBCs can use SBIR/STTR
• help NIH meet its mission
• Conduct innovative R/RD that results in product,
  process, or service that will...
• Improve patient health
• (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
• Help in training of research investigators
• Increase health knowledge base

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DHHS Budget and Award Amount
640M
Propose a Realistic and Appropriate Budget
for the Research Take Home Message 1
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Types of SBIR / STTR Awards

• GRANTS you decide the research and product to be
  designed or developed (SBIR / STTR)
• CONTRACTS The government decides the research
  and general product to fill their perceived need
  (SBIR only)
• COOPERATIVE AGREEMENTS Similar to grants, but
  awarding IC has substantial involvement in
  carrying out the project's activities.

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4-5
lt1
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NIH ISSUES MULTIPLE SOLICITATIONS

• SBIR/STTR Omnibus Grant Solicitation
• (NIH, CDC, and FDA) Parent FOA Release
  January April 1, Aug 1, Dec 1 receipt dates
• SBIR Contract Solicitation (NIH, CDC)
• Release August Early November receipt date
• NIH Guide for Grants and Contracts
• Release Weekly Various receipt dates

http//grants.nih.gov/grants/funding/sbir.htm
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SBIR/STTR Omnibus Solicitation

• SBIR Parent Funding Opportunity Announcement
• (PA-06-120)
• STTR Parent Funding Opportunity Announcement 
• (PA-06-121)
• SBIR/STTR Program Descriptions and Research
  Topics (PDF or MS Word)

http//grants1.nih.gov/grants/funding/sbir.htm
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NIH Guide for Grants ContractsSpecial
SBIR/STTR Opportunities
http//grants.nih.gov/grants/guide/index.html
Go Beyond the SBIR/STTR Omnibus Solicitation.
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NIH GUIDE FOAs SBIR/STTR Opportunities (cont.)
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Parent SBIR FOA
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SBIR/STTR RESEARCH GRANT TOPICS
Our Ideas. examples Biodefense Biosensors
Nanotechnologies Bioinformatics Behavioral
research Computational Biology Cell and Gene
Therapy
Biosilicon devices Biocompatible
materials Acousto-optics / opto-electronics Imagin
g technologies Genetically engineered
proteins Proteomics / Genomics Complementary
Alt. Med (CAM)
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SBIR/STTR RESEARCH GRANT TOPICS
Your ideas...

• Investigator-initiated RD
• Research topics related to the NIH mission
• Other areas of research within the
• mission of an awarding component

Take-home Message 2
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NIH SBIR/STTR RESEARCH AREAS
Angioscopes to Zebrafish
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NIH SBIR/STTR PROGRAM Review Process for
Research Grant
Submits SBIR/STTR Grant Application to NIH
2-3 months after submission
2-3 months after review
IC Staff Prepare funding Plan for IC Director
Grantee Conducts Research
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Grant Application Process
E
Are you R ady?
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Submitting an Application Electronically

• Find out at http//era.nih.gov/ElectronicReceipt/.
  
•  New electronic Grants.gov application SF424
  (RR)
• Check the Timeline
• Register EARLY http//grants.gov/

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Electronic Submission Information http//era.nih.
gov/ElectronicReceipt/
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Grants.gov How It Works

• Before an applicant can Apply
• 1) Complete these registration steps
• a) Go to http//grants.gov/GetStarted
• Obtain a DUNS number
• (DUNSData Universal Numbering System).
• Register in Central Contractor Registry (CCR).
• Register with Grants.gov.
• b) Go to https//commons.era.nih.gov/commons/
• Set up institution and PI profiles in eRA Commons.

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Grants.gov How It Works

• Before an applicant can Apply
• 2) Establish capacity to fill out applications
• Download PureEdge Viewer (from Grants.gov site)
  OR
• Establish an electronic system that allows the
  applicant to submit to Grants.gov using
  system-to-system (XML) datastream
• Can be created by institution OR
• Institution can establish an agreement with a
  commercial Service Provider to develop the system

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APPLICATION TO AWARD TIMELINE
2-tiered review process
SBIR/STTR Scientific/Technical Adv
Council Est.Award Receipt
Dates Peer Review Board Review
Date Apr 1 June/July Sept/Oct
Nov Aug 1 Oct/Nov Jan/Feb
Mar Dec 1 Feb/March May/June
July
90-Day pre-award costs are allowable At
applicants own risk..
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Common Problems with Applications

• Inadequately defined test of feasibility
• Diffuse, superficial, or unfocused research plan
• Lack of sufficient experimental detail
• Questionable reasoning in experimental approach
• Uncritical approach
• Failure to consider potential pitfalls and
  alternatives
• Lack of innovation
• Unconvincing case for commercial potential or
  societal impact
• Lack of experience with essential methodologies
• Unfamiliar with relevant published work
• Unrealistically large amount of work proposed

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Gap Funding Options
Phase I
Phase II
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NIH SBIR/STTR ProgramGap Funding Options

• Phase I / Phase II Fast Track
• Simultaneous submission / concurrent review
• No-Cost Extension (Ph I or Ph II)
• Extension in time with no additional funds
• Administrative / Competitive Supplements
• Discuss with Program Director
• Phase II Competing Renewal
• Maximum of 1M/yr for 3 years
• Response to IC-specific PA

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NIH SBIR/STTR FAST-TRACK Bridging the Phase I -
II Funding Gap
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?
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NIH SBIR FAST-TRACK Best Option For Everyone?
No!!

• Convincing preliminary data?
• Clear, measurable, achievable milestones?
• Well-conceived Commercialization Plan?
• Letters of Phase III support/interest?
• Track record for commercializing?

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Example of an NIH SBIRFast Track Grantee
Syntrix BiosystemsAuburn, WA
Product Instrumentation for High-Resolution
Analysis of Cancer Technology Develop a
method for tissue microdissection called
"biolithography." This method relies on a
projected light pattern and suitable reagents to
extract regions of interest from a tissue sample
for further analysis. Fast-Track award 2.2
Million (Phase I and Phase II, multi-year) Funded
under a special SBIR announcement PAR-01-105,
"Innovative Technologies for the Molecular
Analysis of Cancer SBIR funding was critical in
establishing the feasibility of developing a
prototype automated biolithography system provide
an easy and cost-effective method to address
whole organism analysis for a wide audience of
researchers and clinicians engaged in cancer
analysis.
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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

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NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2005
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640 M SBIR/STTR
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47.7
358
34.7
147
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Success Rate ()
776
28
25
20.8
16.4
14.1
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AWARD PROCESS
Congratulations!The check is in the mail
(almost)
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WHY THE AWARD MAY BE DELAYED

• Human Subject Issues (OHRP)
• IRB and Assurances
• http//ohrp.osophs.dhhs.gov/index.htm
• Animal Welfare Issues (OLAW)
• IACUC (Animal Involvement)
• http//grants.nih.gov/grants/olaw/olaw.htm
• EIN (Entity Identification Number)
• http//www.irs.gov
• Third Party Involvement
• Contracts, Consortia, Consultants

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NIH SBIR/STTR ProgramGap Funding Options

• Phase I / Phase II Fast Track
• Simultaneous submission / concurrent review
• No-Cost Extension (Ph I or Ph II)
• Extension in time with no additional funds
• Administrative / Competitive Supplements
• Discuss with Program Director
• Phase II Competing Renewal
• Maximum of 1M/yr for 3 years
• Response to IC-specific PA

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Transitioning SBIR / STTR Projects to the
Marketplace
Phase I
Phase II
Phase III
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Competing Renewal Phase II Award Purpose

• To take existing, promising compounds or devices
  developed under a Phase II through the next step
  of drug discovery and development.

• Provide additional Phase II research support to
  continue assessing and improving devices or
  conducting preclinical studies of drugs or
  devices that ultimately require
• clinical evaluation
• approval of a Federal regulatory agency
• refinements to durable medical equipment (DME)
  designs

From the Test Tube to the Medicine Cabinet
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Competing Renewal Phase II Award Eligibility and
Criteria

• SBIR Phase II awardee
• Promising pharmacologic agents or devices have
  already been identified (or developed) and some
  preclinical pharmacology has been conducted.
• Response to an NIH Program Announcement
• Generally, 750k-1M/year for up to 3 years

Contact your Program Director to discuss!
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http//grants.nih.gov/grants/funding/sbir.htm

• Alerts/News Flashes
• Solicitations
• Targeted Research Opportunities
• Award Information
• Collaborative Opportunities
• Success Stories
• Resources

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For More Information
www.nih.gov
Subscribe to SBIR/STTR ListServ LISTSERV_at_LIST.NIH
.GOV subscribe SBIR-STTR Jane Doe
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Final Exam The Top 10 List
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Top 10 Reasons to Seek SBIR/STTR Funding
10. Over 2.0 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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Top 10 Reasons to Seek SBIR/STTR Funding
6. Industry-University research partnerships
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
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Top 10 Reasons to Seek SBIR/STTR Funding
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

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Top 10 Reasons to Seek SBIR/STTR Funding
1. To make economic and societal
contributions to America
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TissueTech (FL)
Technological Innovation OccursThroughout the
U.S.
Product AmnioGraft Technology Use of amniotic
membrane for ocular surface reconstruction to
treat ocular surface diseases. AmnioGraft is used
to replace the damaged or lost basement membrane
of the host tissue on the ocular surface. Phase
I award 103,123 (EY14768) SBIR funding was
critical in establishing the feasibility to
develop and evaluate a "sutureless" AmnioLens to
be used as a corneal graft.
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Technological Innovation OccursThroughout the
U.S.
CardiacAssist, Inc. (PA)
Product TandemHeart PTVA TandemHeart System
helps restore blood circulation and increase
blood flow through a cardiac catheterization
procedure, in as little as 30 minutes. Helps to
save vital organs and gives damaged hearts a
chance to heal when patients experience acute,
life-threatening heart conditions. More than 525
procedures have been done in 28 countries at 70
facilities by 170 physicians. Feb 2006- FDA
510(k) approval for new, high-flow cannula.
TandemHeart PTVA (Percutaneous Transseptal
Ventricular Assist) System
http//www.cardiacassist.com/Video/
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Technological Innovation OccursThroughout the
U.S.
Intralase Corporation (CA)
Corneal Surgery with Femtosecond Lasers
Product Bladeless laser technology Technology
uses proprietary, computer-guided femtosecond
laser technology for greater precision, improved
safety and better results as compared to the use
of traditional microkeratomes to create a corneal
flap in the first step of LASIK eye surgery.
http//www.intralase.com/corporate/aboutus/index.h
tml
Femtosecond laser technology provided the basis
of femtochemistry research that won the 1999
Nobel Prize in Chemistry.
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Technological Innovation OccursThroughout the
U.S.
Novera Pharmaceuticals (KY)
Product VitaSol Topically applied wound healing
product Allows for the rapid delivery of energy
to cells in the form of adenosine triphosphate,
or ATP, and dramatically improves and promotes
cell preservation, growth and healing. Ph III
Trials in chronic wound healing of diabetic
ulcers.
Direct Cellular Energy (ATP) Delivery System
Cell preservation, growth and wound healing
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Technological Innovation OccursThroughout the
U.S.
NovaRx (CA)

• Product Vaccine for Glioma (Brain Cancer)
• NovaRx uses two technologies
• 1) TGF-ß antisense gene-modification. TGF-ß is
  one of the most potent immunosuppressive
  molecules produced by tumor cells.
• Patented TGF-ß antisense technology blocks the
  production of TGF-Beta by the cancer cells.
• 2) Replaces autologous tumor cells with
  allogeneic tumor cells (other peoples tumor
  cells) that may be used "off the shelf" to treat
  a large number of patients
• SBIR award (4 years) will help fund pivotal Phase
  II/III clinical trial.
• SBIR funding was critical in establishing the
  feasibility of developing a whole-cell vaccine
  for the treatment of gliomas.

Allogeneic glioma vaccine using TGF-beta knockouts
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Im from the Government, and Im here to help
you.
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National Institute of Environmental Health
Sciences
Fogarty International Center
National Institute on Aging
National Institute of Diabetes and Digestive
and Kidney Diseases
National Cancer Institute
National Institute of Child Health and
Human Development
National Eye Institute
National Institute of Biomedical Imaging and
Bioengineering
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Rese
arch
National Human Genome Research Institute
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Nursing Research
National Center for Research Resources
National Heart, Lung, and Blood Institute
National Institute on Deafness and
Other Communication Disorders
National Institute of Allergy and Infectious
Diseases
National Institute of Neurological Disorders
and Stroke
National Library of Medicine
National Center on Minority Health and Health
Disparities
National Institute on Alcohol Abuse and Alcoholism
National Center for Complementary and
Alternative Medicine
Largest SBIR/STTR set-asides
New!
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National Institutes of Health
http//www.nih.gov/icd/
Office of the Director
National Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
Largest SBIR/STTR set-asides

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NIH Program Activities and 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
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NIH Program Activities and Areas of
Research (cont.)
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
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NIH Program Activities and Areas of Research
(cont.)
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
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NIH Program Activities and Areas of Research
(cont.)
NIHGRI-- 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
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Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email jg128w_at_nih.gov
Kathleen Shino SBIR/STTR Program
Specialist Phone [phone] Fax
301-480-0146 Email shinok_at_mail.nih.gov Kay
Etzler SBIR/STTR Program Analyst Phone
301-435-2713 Fax [phone] Email
etzlerk_at_od.nih.gov
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Thank You