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National Institutes of Health Small Business Innovation Research (SBIR) Program Small Business Technology Transfer (STTR) Program 8 th Annual NIH SBIR/STTR Conference Renaissance Cleveland Hotel Cleveland, Ohio July 13, 2006 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator
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8th Annual NIH SBIR/STTR Conference
Renaissance Cleveland HotelCleveland, OhioJuly 13, 2006
Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
Office of Extramural Research
National Institutes of Health
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.”
GENERAL FEATURES
Mission
Supporting scientific excellence and technological innovation
through the investment of
federal research funds
in critical American priorities
to build a strong national economy…
onesmallbusinessatatime.
Small Business Innovation Research (SBIR)
Set-aside program for small business
concerns to engage in federal R&D --
with potential for commercialization.
Small Business Technology Transfer (STTR)
Set-aside program to facilitate cooperative
R&D between small business concerns and U.S. research institutions -- with
potential for commercialization.
2.5%
0.3%
Small Business Innovation Development Act of 1982
Congress designated 4 major goals
MAJOR PROVISIONS OF P.L. 106-554; Signed 12/21/00
- 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)
Small Business Research and Development
Enhancement Act of 1992
PHASE I
or 12-month (STTR) Award
PHASE II
(SBIR/STTR)
PHASE III
ELIGIBILITY CHECKPOINTS
ELIGIBILITY CHECKPOINTS
Small business concern must be:
or
ELIGIBILITY CHECKPOINTS
organization; Federal R&D center
Follow-on R&D and Commercialization
OWNERSHIP AND CONTROL
got questions?
Up to 7% of total direct and F&A costs may
be requested for fee
*DISCUSS WITH AGENCIES
FY 2006
SBIR / STTR Participating AgenciesSolicitation
Topics
in solicitations.
Proposal
Submission
Evaluation
Ph I award
SBIR:Permits research institution partners
[Outsource ~ 33% Phase I and 50% Phase II R&D]
STTR:Requiresresearch 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
SBIR: Primary (>50%) employment must be with small business concern
STTR: Primary employment not stipulated
[PI can be from research institution and/or
from small business concern*]
*DISCUSS WITH AGENCIES
project scientifically and technically
agencies for similar work
agencies for duplicative projects
its “name ”
Manager
instructions
FEATURES and NUANCES
Secretary
Deputy Secretary
Administration for
Children and Families
(ACF)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Health Resources
and Services
Administration
(HRSA)
Centers for Medicare
And Medicaid Services
(CMS)
Agency for Healthcare
Research and Quality
(AHRQ)
Indian Health
Services
(IHS)
National Institutes
of Health
(NIH)
Centers for
Disease Control
and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA)
Program Support
Center
(PSC)
U. S. Department of Health and Human Services
Improve human health through biomedical and behavioral research,
research training and communications.
The SBIR program is integrated within the NIH research agenda.
Conduct innovative R/R&D that results in product, process, or service that will...
$640M
****Propose a Realistic and Appropriate
Budget for the Research****
Take Home Message #1
~95%
~4-5%
<1%
NIH ISSUES MULTIPLE SOLICITATIONS
SBIR/STTR Omnibus Grant Solicitation
(NIH, CDC, and FDA) = Parent FOARelease: 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
http://grants1.nih.gov/grants/funding/sbir.htm
http://grants.nih.gov/grants/guide/index.html
Go Beyond the SBIR/STTR Omnibus Solicitation….
SBIR/STTR Opportunities (cont.)
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
Imaging technologies
Genetically engineered proteins
Proteomics / Genomics
Complementary & Alt. Med (CAM)
…
SBIR/STTR RESEARCH GRANT TOPICS
Your ideas...
Take-home Message #2
NIH Center for Scientific Review
Assign to IC and IRG
Small Business
Concern
Applicant Initiates
Research Idea
Scientific Review Groups
Evaluate Scientific Merit
Advisory Council or Board
Recommend approval
IC Allocates
Funds
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
Electronic Submission Information:
http://era.nih.gov/ElectronicReceipt/
Before an applicant can Apply
1) Complete these registration steps:
a) Go to http://grants.gov/GetStarted
(DUNS=Data Universal Numbering System).
b) Go to https://commons.era.nih.gov/commons/
Before an applicant can Apply
2) Establish capacity to fill out applications:
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 applicant’s own risk…..
Common Problems with Applications
Response to IC-specific PA
7-9 months
Phase I Award
Aims/ Milestones
Met
Phase II award
Phase II award
Aims/ Milestones
NOT Met
NIH SBIR/STTR FAST-TRACKBridging the Phase I - II Funding GapPhase I + Phase II
(Simultaneous Submission and Concurrent Review)
Program Staff assess completion of specific aims and milestones
Completion of Phase I
Go / No Go?
No!!
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 feasibilityof developinga 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.
(Phase I)
… Protection of Human Subjects
… Animal Welfare
… Budget
42
$640 M
SBIR/STTR
44%
47.7%
358
34.7%
147
11
Success Rate (%)
776
28
25%
20.8%
16.4%
14.1%
http://ohrp.osophs.dhhs.gov/index.htm
http://grants.nih.gov/grants/olaw/olaw.htm
http://www.irs.gov
Competing Renewal Phase II Award
Purpose
“From the Test Tube to the Medicine Cabinet”
Competing Renewal Phase II Award
Eligibility and Criteria
Contact your Program Director to discuss!
http://grants.nih.gov/grants/funding/sbir.htm
Subscribe to SBIR/STTR ListServ:
LISTSERV@LIST.NIH.GOV
subscribe SBIR-STTR Jane Doe
The Top 10 List
to Seek SBIR/STTR Funding
10. Over $2.0 Billion available
9.NOT A LOAN - no repayment
8. Provides recognition, verification
and visibility
7.Potentialleveraging tool to attract
venture capital/other sources of $$$
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
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
Technological Innovation OccursThroughout the U.S.
TissueTech (FL)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.
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/
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.html
Femtosecond laser technology provided the basis of femtochemistry research that won the 1999 Nobel Prize in Chemistry.
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
NovaRx (CA)
Allogeneic glioma vaccine using TGF-beta knockouts
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
Research
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!
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
NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688
Fax: 301-480-0146
Email: jg128w@nih.gov
Kathleen Shino
SBIR/STTR Program Specialist
Phone: 301-435-2689
Fax: 301-480-0146
Email: shinok@mail.nih.gov
Kay Etzler
SBIR/STTR Program Analyst
Phone: 301-435-2713
Fax: 301-480-0146
Email: etzlerk@od.nih.gov