Transcript SBIR NIH programs

An In-Depth Look at the
NIH SBIR and STTR Programs
Connecticut SBIR/STTR Conference
April 2005
Kathleen Shino, MBA
NIH SBIR/STTR Program
Issues Discussed
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Review of NIH SBIR/STTR Nuances
NIH Evaluation/Review/Selection Process
Updates & Reminders
Identifying Funding Opportunities
Communication & Other Tips
Technical Assistance Program
NIH Resources
Q&A
NIH Mission
IMPROVE HUMAN HEALTH
through biomedical and behavioral
research, research training
and communications.
Small Companies Can Help
NIH meet its mission
Conduct innovative R/R&D that results in
product, process, or service that will...
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Improve patient health
Speed process of discovery
Reduce cost of medical care/cost of
research
Improve research & communication tools
Program Descriptions and Goals
Small Business Innovation Research (SBIR)
Set-aside program for small business concerns to engage
in federal R&D -- with potential for commercialization.
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2.5%
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Stimulate technological innovation
Meet Federal R&D needs
Foster and encourage participation by
minorities and disadvantaged persons in
technological innovation
Increase private-sector commercialization
of innovations derived from Federal R&D
Small Business Innovation Development Act of 1982
Program Descriptions and Goals
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.
0.30%
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Stimulate and foster scientific and
technological innovation through
cooperative research
Foster technology transfer between small
business concerns and research
institutions
Small Business Research and Development
Enhancement Act of 1992
SBIR PROGRAM
ELIGIBILITY CHECKPOINTS
 Organized for- profit U.S. business in U.S.
 At least 51% U.S.- owned by individuals and
independently operated or (2) SBIR it must be a
for-profit business concern that is at least
51% owned and controlled by another SBC that
is 51% U.S.- owned by individuals and
independently operated & < 500 Employees
 P.I.’s primary employment with SBC
STTR PROGRAM
ELIGIBILITY CHECKPOINTS
 Applicant is Small Business Concern
 Formal Cooperative R&D Effort
 Minimum 40% by small business
 Minimum 30% by U.S. research institution
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U.S. Research Institution
 College or University; other non-profit research
organization; Federal R&D center
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Intellectual Property Agreement
Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES

Research Partner
SBIR: Permits research institution partners
[Outsource ~ 33% Phase I and 50% Phase II R&D]
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
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES

Principal Investigator
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
SBIR / STTR ELIGIBILITY
OWNERSHIP AND CONTROL
got questions?
• Contact the SBA Size Specialists
• Request an eligibility determination
http://www.sba.gov/size/indexcontacts.html
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.

The PI is required to have expertise to oversee
project scientifically and technically
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Applications may be submitted to different
agencies for similar work
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Awards may not be accepted from different
agencies for duplicative projects
SBIR/STTR Participating Agencies
TOTAL ~ $2.0 B FY 2005
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DOD
HHS
NASA
DOE
NSF
DHS
USDA
DOC
ED
EPA
DOT
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR/STTR
SBIR
SBIR
SBIR
SBIR
SBIR
SBIR
NIH: $ 571 M SBIR
$ 69 M STTR
$640 M Total
CDC:
$ 8.0 M SBIR
FDA: ~ $ 0.8 M SBIR
AHRQ: ~$ 2.1 M SBIR
NIH SBIR/STTR FUNDING RATES
FISCAL YEAR 2004 (Preliminary)
50
45
40
35
30
25
20
15
10
5
0
$631 M
SBIR/STTR
32
44%
49.2%
302
215
37%
49%
15
39%
37%
973
20%
59
18%
SBIR
STTR
Phase I
Phase II
Fast-Track
National Institutes of Health
http://www.nih.gov/icd/
Office of the Director
National Center on
Minority Health
and Health
Disparities
SBIR/STTR: 3-Phase Program
PHASE I
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Feasibility Study
$100K and 6-month (SBIR)
or 12-month (STTR) Award
PHASE II
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Full Research/R&D
$750K and 2-year Award
(SBIR/STTR)
PHASE III
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Commercialization Stage
Use of non-SBIR/STTR Funds
NUANCES
NIH SBIR & STTR Programs
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SBIR and STTR Program
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Single Solicitation
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Multiple Award Mechanisms
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~ 95% Awards are grants
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Multiple Receipt Dates
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April 1, Aug 1, Dec 1
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Budget Guidelines
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Realistic & appropriate
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Academia and industry
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Original + 2 amendments
~$100K/ $750K
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External Peer Review
Critiques sent to all applicants
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Revise & Resubmit
Our Ideas …
1. SBIR/STTR Omnibus Grant Solicitation
(NIH, CDC, and FDA)
Release: January
April 1, Aug 1, Dec 1 receipt dates
2. SBIR Contract Solicitation (NIH, CDC)
Release: August
Early November receipt date
3. NIH Guide for Grants and Contracts
Release: Weekly
Various receipt dates
http://grants.nih.gov/grants/funding/sbir.htm
Your Ideas …
Investigator-initiated R&D
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Research projects related to the NIH
mission
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“Other” areas of research within the
mission of an awarding component
SBIR “FAST-TRACK”
Standard application, review, award process
7-9 months
Phase I 7-9 months
Phase II
6 months
24 months
Fast-Track review option
Phase I + Phase II 7-9 months
Simultaneous
submission/review
6 months
Phase II
Satisfactory Phase I
Final Report
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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NIH SBIR/STTR Program
Gap 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 Continuation
Maximum of $1M/yr for 3 years
Response to IC-specific PA
Phase II Competing
Continuations
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Goal: Provide additional research funds to move
already identified drugs or devices requiring
regulatory approval into clinical trials
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Stipulations:
 Available only to Phase II grantees preparing for
clinical trials
 Focus -- Diagnostics, devices, tissue engineering,
drug development, biologics
 Funding level: Maximum $1M per year for
maximum of 3 years
 IC must have announced the opportunity
Speak with Program Staff Prior to Submission
Peer Review of SBIR/STTR
Grant Applications
NIH SBIR/STTR PROGRAM
Review Process for Research Grant
Small Business
Concern
Submits
SBIR/STTR Grant
Application to NIH
Applicant Initiates
Research Idea
NIH Center for Scientific Review
Assign to IC and IRG
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months
after submission
~2-3
months
after review
Grantee Conducts
Research
IC
Allocates
Funds
Advisory Council or Board
Recommend approval
IC Staff Prepare funding Plan
for IC Director
APPLICATION, REVIEW, and
AWARD TIMELINE
SBIR/STTR
Receipt Dates
Apr 1
Aug 1
Dec 1
Scientific/Technical
Peer Review
June/July
Oct/Nov
Feb/March
Adv Council
Board Review
Sept/Oct
Jan/Feb
May/June
7 to 9 months
90-Day pre-award costs are allowable:
At your own risk…..
Awd
Date
Nov
Mar
July
Center for Scientific Review
Receipt & Referral Office
Application Assignments
Scientific Review
Group
Match between proposed
research and review
groups
for scientific/technical
merit
Institutes/Centers
Match between
proposed research and
IC’s mission
for funding
REVIEW CRITERIA
(Phase I)
 Significance (Real Problem/Real People)
Approach (Research Design, Feasible)
 Innovation (New or Improved?)
 Investigators (PI and team)
 Environment (Facilities/Resources)
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… Protection of Human Subjects
… Animal Welfare
… Budget
Phase II Review Criteria
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Same as Phase I
Demonstrated Feasibility in Phase I
High Degree of Commercial Potential
based on Commercialization Plan
… Protection of Human Subjects
… Animal Welfare
… Budget
Phase II Commercialization
Plan
Included in ALL Phase II applications.
Detailed instructions provided.
1.
2.
3.
4.
5.
6.
Value of the SBIR/STTR Project, Expected Outcomes,
and Impact
Company Description
Market, Customer, and Competition
Intellectual Property (IP) Protection
Finance Plan
Production and Marketing Plan
7.
Revenue Stream
WHAT HAPPENS IN A
STUDY SECTION MEETING?
• Closed
• Orientation
• Streamlining
• Application by application discussion
• Every member scores every application
Assignment of gender, minority, and
children codes, human subjects codes;
• Recommended changes to budget
•
SCIENTIFIC REVIEW GROUP
Scientific Review Administrator
• Recruits and selects reviewers
• Insures review that is competent, thorough and fair (unbiased)
• Proper review criteria used to evaluate application
Reviewers
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All ad hoc reviewers
Scientists with appropriate expertise
High professional profiles
Dependable, reasonable, open minded
Grants Technical Assistant
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Mails material to reviewers
Handles paperwork
Organizes meeting room
Enters scores and codes
Assists with summary statements
Criteria for Selection of Peer Reviewers
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Demonstrated Scientific Expertise
Doctoral Degree or Equivalent
Mature Judgment
Work Effectively in a Group Context
Breadth of Perspective
Impartiality
Interest in Serving
Diversity (Women and Minority Scientists)
Business skills/experience
You can be a reviewer too!!!
Scientific Review Group or
Study Section Actions
 Scored,
Scientific Merit Rating (priority
scores 100 to 300, typically)
 Unscored
(lower half; priority scores 301-
500)
 Deferral
STUDY SECTIONS DO NOT
FUND!
INSTITUTES FUND!
NIH Allows Amended
Applications
An opportunity to revise and
improve your application
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Two amended applications allowed
Generally half of the reviewers are new
Request for change of reviewers must
be supported
What Reviewers Say…
Common Pitfalls with Applications
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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
What Reviewers Say About
Outstanding Phase II Applications
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“principals … highly experienced in their
respective roles”
“ detailed Ph I Final Report was included”
Ph I effort was substantial and addressed
reservations of the Ph I review solidly”
“…product promises to fill a long-felt need in
neuroscience and in the larger community”
“… resources are outstanding”
“limitations of the project have been
realistically addressed”
What Reviewers Say About
Outstanding Phase II Applications
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“A prototype has been developed… pre-tested in
Phase I… good feasibility results
“…well-defined goals presented in the work plan…
to address required improvements that arose during
testing in Phase I”
“clearly stated rationale for developing such a
program is a major strength”
“commercial applications for the … are significant”
“innovative with high promise of producing a major
advance in…”
Update: 2005 SBIR/STTR NIH
Omnibus Solicitation Changes
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Modular budget no longer applicable to
SBIR/STTR
Fonts – Must use Helvetica or Arial, 11 points or
larger
Review criteria updated (interdisciplinary,
translational, clinical projects)
Final reports format changed
PHS 398 Forms Required after May 9, 2005
Reminders
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Similar, Essentially Identical or Identical
Applications to NIH awarding components
(ICs) NOT allowed
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Submission Dates: Postmark Date
acceptable for applications submitted in
response to PHS 2005-2
Funding Opportunities
1. SBIR/STTR Omnibus Grant Solicitation
(NIH, CDC, and FDA)
Release: January
April 1, Aug 1, Dec 1 receipt dates
2. SBIR Contract Solicitation (NIH, CDC)
Release: August
Early November receipt date
3. NIH Guide for Grants and Contracts
Release: Weekly
Various receipt dates
http://grants.nih.gov/grants/funding/sbir.htm
Latest Funding Opportunities
(Samples)
http://grants.nih.gov/grants/funding/sbir_announcements.htm
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RFA-06-005: Innovative Technologies for
Molecular Analysis of Cancer
PA-04-156: Bioengineering Approaches to
Energy Balance and Obesity
PAR-03-119: Innovations in Biomedical
Computational Science and Technology
PA-04-161: Manufacturing Processes of
Medical, Dental, & Biological Technologies
PA--05-014: Molecular Libraries Screening
Instrumentation
PAR-03-119: Innovations in Biomedical
Computational Science and Technology
Objective: To support research and development of
tools and approaches for computing on data
Unique Features:
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Special receipt dates (Oct ’04, Feb ’05, Oct ’05, Feb ’06)
Trans-NIH opportunity
Flexible budget and project durations
Phase I: 2 yrs, $100K direct costs each year
Phase II: 3 yrs, no official budget limit
Parallel Announcement (PAR-03-106)
RFA-AT-05-005: Improving Measurement
Tools for Sternal Skin Conductance & Hot
Flashes
Objective: To improve measurement tools or
devices for sternal skin conductance.
Unique Features:
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Special receipt date (Jan 25, 2005)
Letter of Intent Receipt Date: (Dec 20, 2004)
Only SBIR Phase I apps. accepted
Flexible budget and project durations
1 yr, $200K total costs
Multiple IC participation (NCCAM, NIA, NIBIB)
Tips/Suggestions
Key to the
NIH Application, Review,
and Award Process
Communication
Contact NIH Staff
Program Staff : Pre- Application
Assess the “fit”
What’s New: PAs/RFAs
Assist in finding collaborators
Review Issues: Dos and Don’ts
Define product and focus application
Application
Review
Award
Identification Tools: Solicitation Part II & CRISP Database
Contact NIH Staff
Program Staff : Post Review
Discuss outcome of peer review
 Review Summary Statement
 What the rating means (numeric vs. **)
 Strengths and weaknesses
 Likelihood of funding
 Next steps
If at first you don’t succeed….
Revise and resubmit
Application
Review
Identification Tool: Summary Statement
Award
Contact NIH Staff
Review Staff
Scientific Review Administrator….
 Point of contact during review process
 Recruitment/Assignment of Reviewers
 Concerns about I/C Assignment or Review
Review
Identification Tool: Grant Receipt Notice
Contact NIH Staff
Grants Management Staff

Pre-Award Steps
Budget, Eligibility, Submission
 Post-Award Advice Guidance
Prior approval requirements
Changes in PI, organization,
Final reporting requirements
scope
Award
Identification Tools: Solicitation Part I & Notice of Grant Award
Tips/Suggestions
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READ Solicitation INSTRUCTIONS--MOST important
Submit to multiple agencies to increase chances of
winning
Submit multiple INDEPENDENT grants to support
one product
Be cautious of 25-page limitation
Include well-designed graphics, tables, figures
Be persistent – revise and resubmit
Get help
Don’t miss the deadline
Don’t leave $$$$ on the table
Tips/Suggestions
When You Get Your Summary Statement…
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Read it and then put it down for 24 hours
Don’t take it personally
Contact Program Director for advice
(upper left corner of Summary Statement)
Consider revising and resubmitting
Entrepreneurial Research
Institutions
Universities / Industry Partnerships
and
Cultural Differences
UNIVERSITY AND INDUSTRY:
Two diverse cultures
Industry Researchers
are from MARS
University Researchers
are from VENUS
University Partnerships
University facilities provide analytical and other
service support
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Own small firms (assign someone else PI)
Principal Investigator
(with official permission from University)
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Senior Personnel on SBIR/STTR
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Consultants on SBIR/STTR
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Subcontracts on SBIR/STTR
Applicant is always the small business
CULTURAL DIVERSITY
That was then…
This is now…
Critical dimension of the new
“Knowledge-based Economy”
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Universities are establishing creative and
entrepreneurial environments for the
commercialization of university
intellectual property
is KEY!
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Universities and Industry learning to
work together
Entrepreneurial Research Institution
Key Ingredients

Synergistic goals between
faculty-initiated business and
mission of research institution
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Environment that enables
innovation and entrepreneurship

Agreement on IP issues

Policies to manage, reduce
or eliminate conflict of interest (COI)
Examples of
Successful Entrepreneurial
Research Institutions
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The Ohio State University
• Texas A&M University
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Purdue University
• Penn. State University
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University of Wisconsin
• UC San Diego
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N.C. State University
• University of Utah
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Georgia Tech
• Carnegie Mellon University
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Virginia Tech
• Stanford University
Source: Innovation U. “New University Roles in A Knowledge Economy”
Southern Technology Council and Southern Growth Policies Board
FINDING A PARTNER

CRISP Award Database
http://crisp.oit.nih.gov

NIH Collaboration Opportunities and Research
Partnerships
http://grants.nih.gov/grants/funding/corp.htm

NIH Office of Technology Transfer
http://ott.od.nih.gov/
Commercialization Valley
Phase II
3 months? 2 years? 10 years?
$$$$$
Phase I
Phase III
Technical Assistance Programs
Commercialization
Assistance
(Phase II awardees)
Business & strategic
planning
Builds alliances and
investor partnerships
Identify other uses of
technology
Pilot Niche
Assessment
(Phase I awardees)
Determines competitive
advantages
Develops market entry
strategy
http://grants.nih.gov/grants/funding/sbir.htm
Alerts/News Flashes
Solicitations
Targeted Research Opportunities
Award Information
Collaborative Opportunities
Success Stories
Resources
Stay Informed…
Listserves
 NIH Guide for Grants and Contracts (weekly
notification)
http://grants.nih.gov/grants/guide/listserv.htm
 NIH SBIR/STTR Notification
http://grants.nih.gov/grants/funding/listserv.htm
7th Annual NIH SBIR/STTR
Conference
July 28-29, 2005
Natcher Conference Center
NIH Campus
Bethesda, Maryland
http://grants.nih.gov/grants/funding/SBIRConf2005/index.htm
RESOURCES
A GOOD STARTING POINT
 NIH Small Business Funding Site
http://grants.nih.gov/grants/funding/sbir.htm
 Computer Retrieval of Information on Scientific
Projects (CRISP)
http://crisp.cit.nih.gov
 Contacts at NIH
http://grants.nih.gov/grants/contacts.htm
 National SBIR/STTR Resource Center
http://www.sbirworld.com
RESOURCES
HOW TO WRITE A GRANT APPLICATION
Grant Application Preparation
http://grants1.nih.gov/grants/grant_tips.htm
http://grants1.nih.gov/grants/funding/sbir_policy.htm
http://www.niaid.nih.gov/ncn/grants/
http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm
http://www.nlm.nih.gov/ep/Tutorial.html
National Institute
on Aging
National Institute
of Environmental
Health Sciences
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
of Child Health
and Human
Development
National Cancer
Institute
National Eye
Institute
National Institute
of Dental and
Craniofacial
Research
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Institute
of General
Medical Sciences
Fogarty
International
Center
National Institute
on Drug Abuse
National Institute
of Biomedical
Imaging
and
Bioengineering
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Nursing Research
National Institute on
Deafness and Other
Communication
Disorders
National Center on
Minority Health
and Health
Disparities
Largest SBIR/STTR
set-asides
National Heart,
Lung, and Blood
Institute
National Center
for Research
Resources
National Institute
of Allergy and
Infectious Diseases
National Institute
of Neurological
Disorders and
Stroke
National Library
of Medicine
National Institute
on Alcohol Abuse
and Alcoholism
National Center
for Complementary
and Alternative
Medicine
New!
National Institutes of Health
http://www.nih.gov/icd/
Office of the Director
National Center on
Minority Health
and Health
Disparities
Kathleen Shino
Acting NIH SBIR/STTR Program Coordinator
Phone: 301-435-2689
Fax: 301-480-0146
Email: [email protected]
Kay Etzler
SBIR/STTR Program
Phone: 301-435-2713
Fax: 301-480-0146
Email: [email protected]