Transcript National Institutes of Health Overview of the NIH SBIR/STTR Program “Lab to Life” Susan Pucie National Heart, Lung, and Blood Institute, NIH [email protected].

National Institutes of Health
1
Overview of the NIH
SBIR/STTR Program
“Lab to Life”
Susan Pucie
National Heart, Lung, and
Blood Institute, NIH
[email protected]
1
For More Information
http://grants.nih.gov/grants/funding/sbir.htm
Dr. Matthew Portnoy
NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688
Dr. Lenka Fedorkova
NIH SBIR/STTR Program
Phone: 301-435-0921
2
2
Organizational Structure of NIH
Office of Research
Infrastructure Programs
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute
on Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
NIH Clinical Center
3
http://www.nih.gov/icd
Center for
Information
Technology
National Library
of Medicine
Center for
Scientific Review
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
3
NIH Mission
Improve human
health through
biomedical and
behavioral research,
research training and
communications.
4
4
SBIR/STTR 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.
5
5
Bridging the Discovery to
Development Gap
SBIR/STTR Programs Are Fully Integrated With
the NIH Research Mission
• Improve human health through
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
6
NIH SBIR/STTR Program Specifics6
SBIR Purpose and Goals
• 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
Small Business Innovation Development Act of 1982
P.L. 112-81 Re-Authorizes program through FY2017
7
7
STTR Purpose and Goals
• 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
Small Business Research and Development
Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
8
8
SBIR Eligibility Criteria
Subject to change per new SBA Policy Directive pending
9

Organized as for-profit U.S. business

Small: 500 or fewer employees, including affiliates

PD/PI’s primary employment must be with small
business concern at time of award and for duration of
project period

At least 51% U.S.- owned by individuals and
independently operated or
At least 51% owned and controlled by another (one)
business concern that is at least 51% owned and
controlled by one or more individuals
9
STTR Eligibility Criteria
 Applicant is Small Business Concern
 Formal Cooperative R&D Effort
• Minimum 40% by small business
• Minimum 30% by U.S. research institution
10

U.S. Research Institution
• College or University; other non-profit research
organization; Federal R&D center

Intellectual Property Agreement
• Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
10
SBIR and STTR: Critical Differences
• Research Partner
• Principal Investigator
 SBIR: Permits partnering
 SBIR: Primary (>50%)
employment must be with
small business concern
33% Phase I and 50%
Phase II
 STTR: PI may be employed
 STTR: Requires partnering
by either research institution
or small business concern
with Research Institution
Small business (40%) and
U.S. research institution
(30%)
Award is always made
to Small Business Concern
11
11
NIH SBIR/STTR: 3-Phase Program
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
 Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
 $1M (STTR), $1M (SBIR) over two years
PHASE II Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
12
 NIH, generally, not the “customer”
 Consider partnering and exit strategy early
12
NIH INSTITUTE/CENTER SBIR/STTR
BUDGET ALLOCATIONS (FY2011)
NIMHD
Extramural R&D Set-Asides:
SBIR = 2.5%
STTR = 0.3%
FY 2011 SBIR/STTR
Budget Allocations to NIH ICs:
$609 M (SBIR)
$ 73 M (STTR)
Total: $682 M
FY2012-pending
NIGMS
13
NIDDK
13
NIH SBIR/STTR Success Rates
14
Fiscal Year
SBIR/STTR
Phase
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
SBIR
SBIR
SBIR
STTR
STTR
STTR
FY TOTAL
SBIR
SBIR
SBIR
STTR
STTR
STTR
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
2011
FY TOTAL
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total Funding
430
4,496
734
47
539
92
6,338
409
4,672
681
42
508
103
67
614
246
11
109
32
1,079
42
536
203
4
80
37
15.6%
13.7%
33.5%
23.4%
20.2%
34.8%
17.0%
10.3%
11.5%
29.8%
9.5%
15.7%
35.9%
$16,795,150
$129,218,371
$146,228,959
$2,300,971
$21,620,399
$18,207,113
$334,370,963
$10,059,904
$123,802,074
$137,152,687
$813,900
$18,321,516
$20,977,584
6,415
902
14.1%
$311,127,665
14
Multiple Funding Opportunities
 Annual SBIR/STTR Omnibus Grant Solicitation
Release: January Receipt Dates: April 5, Aug 5, Dec 5 (non-AIDS)
May 7, Sept 7, Jan 7 (AIDS)
To be released soon for 2012
 Targeted SBIR/STTR Grant Funding Opportunity
Announcements (NIH Guide for Grants &
Contracts)
Release: Weekly
Various receipt dates
 Annual SBIR Contract Solicitation (NIH, CDC)
Release: August
15
Receipt Date: Early November
15
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
16
16
Gap Funding
Phase I / Phase II
Fast Track
Phase I
Phase IIB Competing
Renewals
Pipeline to Partnerships
http://www.ott.nih.gov/p2p/
Phase II
Phase III
Technical Assistance Programs
http://grants.nih.gov/grants/funding/nap.htm
http://grants.nih.gov/grants/funding/cap/index.htm
17
17
Technical Assistance Programs
Niche Assessment
Identify other uses of technology
(Phase I awardees)
Determines competitive advantages
Develops market entry strategy
Commercialization
Assistance
(Phase II awardees)
18
Business & strategic planning
Help help build strategic
alliances and investor
partnerships
18
Solicitations and Due Dates
http://grants.nih.gov/grants/funding/sbir.htm
19
19
Advice from Awardees

Don’t judge an Institute’s interests by
its “name ”

Understand an Institute’s mission & needs

Get to know your Institute Program
Manager
 Read solicitation and other funding
opportunities and follow instructions
20
20
Cover Letter: A
Valuable Tool
• Suggest potential awarding
component(s)
• Request same or different
study section
• Suggest key areas of expertise
required
• Indicate individual(s) or
organization(s) in conflict
21
21
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)
22



Protection of Human Subjects
Inclusion of Women, Minorities & Children
Vertebrate Animals

Biohazards
22
What Reviewers Say…
Common Pitfalls with Applications
•
•
•
•
•
•
Inadequately defined test of feasibility
Lack of sufficient experimental detail
Questionable reasoning in experimental 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
23
23
TEXAS SBIR/STTR
55 Companies – Active Awardees
RESONANT SENSORS INC.
ARLINGTON
ATACTIC TECHNOLOGIES, INC.
HOUSTON
AMBION DIAGNOSTICS, INC.
AUSTIN
BIOTEX, INC.
HOUSTON
ASURAGEN, INC.
AUSTIN
COVALENT BIOSCIENCE, INC.
HOUSTON
BIOO SCIENTIFIC CORPORATION
AUSTIN
HOUSTON PHARMACEUTICALS, INC.
HOUSTON
CAISSON BIOTECH, LLC
AUSTIN
IONWERKS, INC.
HOUSTON
MICROSURFACES, INC.
Austin
LC SCIENCES, LLC
HOUSTON
MIRNA THERAPEUTICS, INC.
AUSTIN
NANOSPECTRA BIOSCIENCES, INC.
HOUSTON
PLASTIPURE, INC.
AUSTIN
PHARMAREVIEW CORPORATION
HOUSTON
RULES-BASED MEDICINE, INC.
AUSTIN
PULMOTECT, INC
Houston
SAVARA, INC.
Austin
RADIANT CREATIVE GROUP, LLC
HOUSTON
SELENIUM, LTD
AUSTIN
SYNTHECON, INC.
HOUSTON
SERALOGIX
AUSTIN
TOMOWAVE LABORATORIES, INC.
HOUSTON
SILICON AUDIO, LLC
AUSTIN
VIVID TECHNOLOGIES
HOUSTON
XERIS PHARMACEUTICALS, INC.
Austin
LASER TISSUE WELDING, INC.
HUMBLE
KJ BIOSCIENCES, LLC
COLLEGE STATION
BIO-SYNTHESIS, INC.
LEWISVILLE
LYNNTECH, INC.
COLLEGE STATION
NOVOMEDICS, LLC
Missouri City
POSITIVEMOTION, LLC
COLLEGE STATION
REBELLION PHOTONICS, INC.
PEARLAND
STATACORP, LP
COLLEGE STATION
MARTINGALE RESEARCH CORPORATION
Plano
CRO LABORATORIES, INC.
DALLAS
MICROFAB TECHNOLOGIES, INC.
PLANO
DENTAL DESIGNS OF DALLAS
DALLAS
VITAL ART AND SCIENCE, INC.
Richardson
IMAGINATION STATION, INC.
Dallas
ACCESSIBLE DESIGNS, INC.
SAN ANTONIO
MICROTRANSPONDER, INC.
DALLAS
APPLIED HUMAN FACTORS, INC.
SAN ANTONIO
RADIX THERAPEUTICS, LLC
DICKINSON
BIOMEDICAL DEVELOPMENT CORPORATION
SAN ANTONIO
EP PHARMA, INC.
EL PASO
CARE TEAM SOLUTIONS, LLC
SAN ANTONIO
ORGANIZATIONAL WELLNESS & LEARNING SYS
FORT WORTH
PROBETEX, INC.
SAN ANTONIO
MAJESTECK BIOSCIENCE
GALVESTON
TELEHEALTH HOLDINGS, LLC
SAN ANTONIO
AGENNIX, INC.
HOUSTON
NIMBIC SYSTEMS, INC.
STAFFORD
AM BIOTECHNOLOGIES, LLC
HOUSTON
24
24
NHLBI SBIR/STTR online search using RePORT
NHLBI
MRI
SBIR & STTR
2008 & 2009
25
25
http://report.nih.gov
25
SBIR/STTR Grants With MRI Focus Funded by NHLBI in
the Past Two Years
26
26
http://report.nih.gov
26
SBIR/STTR – NHLBI Funded
Imaging Grants
27
27
http://report.nih.gov
27
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
• Multiple Receipt Dates (Grants)
 Phase II Competing Renewals
 April 5, August 5, December 5
 Ph I/Ph II Fast Track
 May 7, September 7, January 7 (AIDS)
 Administrative Supplements
 Contracts: Early November
• Budget and Project Period
 $150K/6 -12months (Ph I)
 $1M/2 yrs (Ph II)
28
• Technical Assistance Programs
 Technology Niche Assessment
 Commercialization Assistance
 Pipeline to Partnerships (P2P)
Summary
28
Save the Date!
14th Annual NIH SBIR/STTR Conference
•
•
•
•
May 30 to June 1, 2012
Louisville, Kentucky
Hosted by Kentucky Science and Technology Corporation
2 day conference with optional workshop on June 1.
• Stay tuned to NIH SBIR website and listserv for details!
29
29
Stay Informed…
Listserves
 NIH Guide for Grants and Contracts (weekly
notification)
http://grants.nih.gov/grants/guide/listserv.htm
 NIH SBIR/STTR Notification
Send email to [email protected] with the
following text in the message body:
subscribe SBIR-STTR your name.
30
30
For More Information
Matthew Portnoy, PhD
NIH SBIR/STTR Program Coordinator
Phone: 301- 435-2688
Email: [email protected]
Lenka Fedorkova, PhD
SBIR/STTR Program Analyst
Phone: 301-435-0921
Email: [email protected]
Robert Vinson
SBIR/STTR Program Analyst
301-435-2713
Email: [email protected]
Subscribe to the SBIR/STTR List Serv:
Email [email protected] with the following text
in the message body: subscribe SBIR-STTR your name
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR