kathleen shino, mba nih sbir/sttr program
DESCRIPTION
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. Review of NIH SBIR/STTR Nuances NIH Evaluation/Review/Selection Process Updates & Reminders - PowerPoint PPT PresentationTRANSCRIPT
Kathleen Shino, MBANIH SBIR/STTR Program
An In-Depth Look at theNIH SBIR and STTR Programs
Connecticut SBIR/STTR Conference
April 2005
Issues Discussed
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 HEALTHthrough biomedical and behavioral
research, research trainingand communications.
Small Companies Can Help NIH meet its mission
Conduct innovative R/R&D that results in product, process, or service that will...
Improve patient health Speed process of discovery Reduce cost of medical care/cost of research Improve research & communication tools
Small Business Innovation Research (SBIR)
Program Descriptions and GoalsProgram Descriptions and Goals
2.5%
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
Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization.
Small Business Technology Transfer (STTR)
Program Descriptions and GoalsProgram Descriptions and Goals
0.30%
Small Business Research and DevelopmentEnhancement Act of 1992
Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization.
Stimulate and foster scientific and technological innovation through cooperative research
Foster technology transfer between small business concerns and research institutions
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
SBIR PROGRAMSBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS
Applicant is Small Business Concern
Formal Cooperative R&D 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 R&D center
Intellectual Property AgreementAllocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
STTR PROGRAMSTTR PROGRAMELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS
SBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES
Research PartnerResearch 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
Principal InvestigatorPrincipal 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 AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES
SBIR / STTR ELIGIBILITYSBIR / STTR ELIGIBILITYOWNERSHIP AND CONTROLOWNERSHIP AND CONTROL
• Contact the SBA Size Specialists• Request an eligibility determination http://www.sba.gov/size/indexcontacts.html
got questions?
Important Facts to RememberImportant 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
Applications may be submitted to different agencies for similar work
Awards may not be accepted from different agencies for duplicative projects
DOD SBIR/STTR
NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIR
SBIR/STTR Participating Agencies
NIH: $ 571 M SBIR $ 69 M STTR
$640 M Total
CDC: $ 8.0 M SBIRFDA: ~ $ 0.8 M SBIRAHRQ: ~$ 2.1 M SBIR
HHS SBIR/STTR
TOTAL ~ $2.0 B FY 2005
NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2004 (Preliminary)S
ucc
ess
Rat
e (%
) 44% 49.2%$631 M SBIR/STTR
05
101520253035404550
SBIR STTR
Phase I
Phase II
Fast-Track20%
973
302
32
59
215 15
37%
18%
37%
49%
39%
National Institutes of HealthNational Institutes of Health
Office of the Director
National Center on Minority Health
and Health Disparities
http://www.nih.gov/icd/
SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase ProgramPHASE I
Feasibility Study $100K and 6-month (SBIR)
or 12-month (STTR) Award
PHASE II Full Research/R&D $750K and 2-year Award
(SBIR/STTR)
PHASE III Commercialization Stage Use of non-SBIR/STTR Funds
NUANCESNIH SBIR & STTR Programs
SBIR and STTR Program
Multiple Award Mechanisms
Multiple Receipt Dates
Budget Guidelines ~$100K/ $750K
External Peer Review Critiques sent to all applicants
Revise & Resubmit
Single Solicitation
~ 95% Awards are grants
April 1, Aug 1, Dec 1
Realistic & appropriate
Academia and industry
Original + 2 amendments
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
Research projects related to the NIH mission
“Other” areas of research within the mission of an awarding component
Your Ideas …
Investigator-initiated R&D
SBIR “FAST-TRACK”
Standard application, review, award process
Fast-Track review option
Satisfactory Phase I Final Report
Phase I 7-9 months
Simultaneous submission/review
Phase I + Phase II
7-9 months
Phase II6 months
24 months
6 months
Phase II
7-9 months
NIH SBIR “FAST-TRACK”NIH SBIR “FAST-TRACK” Best Option For Everyone?Best Option For Everyone?
Convincing preliminary data? Clear, measurable, achievable milestones? Well-conceived Commercialization Plan? Letters of Phase III support/interest? Track record for commercializing?
No!!
NIH SBIR/STTR ProgramNIH SBIR/STTR Program
Gap Funding OptionsGap Funding OptionsPhase 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
Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials
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 Peer Review of SBIR/STTR Grant ApplicationsGrant Applications
Small Business Concern
Applicant InitiatesResearch Idea
Grantee Conducts Research
IC Staff Prepare funding Planfor IC Director
NIH Center for Scientific ReviewAssign to IC and IRG
Scientific Review GroupsEvaluate Scientific Merit
Advisory Council or BoardRecommend approval
IC Allocates
Funds
SubmitsSBIR/STTR Grant Application to NIH
~2-3 monthsafter submission
~2-3 months
after review
NIH SBIR/STTR PROGRAMNIH SBIR/STTR PROGRAMReview Process for Research Grant
APPLICATION, REVIEW, and
AWARD TIMELINE
SBIR/STTR Scientific/Technical Adv Council Awd
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 your own risk…..
7 to 9 months
Application Assignments
Institutes/Centers
Center for Scientific ReviewReceipt & Referral Office
Match between proposed research and
IC’s mission
Scientific Review Group
Match between proposed research and review
groups
for scientific/technical merit
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)
… Protection of Human SubjectsProtection of Human Subjects… … Animal WelfareAnimal Welfare… … BudgetBudget
Phase II Review Criteria
Same as Phase I Demonstrated Feasibility in Phase I High Degree of Commercial Potential based on Commercialization Plan
… Protection of Human SubjectsProtection of Human Subjects… … Animal WelfareAnimal Welfare… … BudgetBudget
Phase II Commercialization Phase II Commercialization PlanPlan
1. Value of the SBIR/STTR Project, Expected Outcomes, and Impact
2. Company Description
3. Market, Customer, and Competition
4. Intellectual Property (IP) Protection
5. Finance Plan
6. Production and Marketing Plan
7. Revenue Stream
Included in ALL Phase II applications.Detailed instructions provided.
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 GROUPScientific Review Administrator • Recruits and selects reviewers • Insures review that is competent, thorough and fair (unbiased)• Proper review criteria used to evaluate application
Reviewers• All ad hoc reviewers• Scientists with appropriate expertise• High professional profiles• Dependable, reasonable, open minded
Grants Technical Assistant• Mails material to reviewers• Handles paperwork• Organizes meeting room• Enters scores and codes• Assists with summary statements
Criteria for Selection of Peer Reviewers
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!!!You can be a reviewer too!!!
Scientific Review Group or Scientific Review Group or Study Section ActionsStudy Section Actions
Scored, Scientific Merit Rating (priority scores 100 to 300, typically)
Unscored (lower half; priority scores 301-500)
DeferralSTUDY SECTIONS DO NOT
FUND!INSTITUTES FUND!
NIH Allows Amended NIH Allows Amended ApplicationsApplications
Two amended applications allowed Generally half of the reviewers are new Request for change of reviewers must
be supported
An opportunity to revise and improve your application
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
What Reviewers Say About Outstanding Phase II Applications
“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
“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
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
Similar, Essentially Identical or Identical Applications to NIH awarding components (ICs) NOT allowed
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
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
Unique Features: • 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 yearPhase II: 3 yrs, no official budget limit
• Parallel Announcement (PAR-03-106)
Objective: To support research and development of tools and approaches for computing on data
RFA-AT-05-005: Improving Measurement Tools for Sternal Skin Conductance & Hot Flashes
Unique Features: • 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)
Objective: To improve measurement tools or devices for sternal skin conductance.
Key to the NIH Application, Review,
and Award Process
Communication
Tips/Suggestions
Contact NIH Staff Program Staff : Pre- Application
Assess the “fit”What’s New: PAs/RFAsAssist in finding collaborators Review Issues: Dos and Don’tsDefine product and focus application
Application Review Award
Identification Tools: Solicitation Part II & CRISP Database
Contact NIH StaffProgram 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
Application Review Award
If at first you don’t succeed…. Revise and resubmit
Identification Tool: Summary Statement
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 StepsBudget, Eligibility, Submission
Post-Award Advice GuidancePrior approval requirementsChanges in PI, organization, scopeFinal reporting requirements
Award
Identification Tools: Solicitation Part I & Notice of Grant Award
Tips/Suggestions
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
When You Get Your Summary Statement…
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
Tips/Suggestions
Entrepreneurial Research Entrepreneurial Research InstitutionsInstitutions
Universities / Industry Partnershipsand
Cultural Differences
UNIVERSITY AND INDUSTRY:Two diverse cultures
Industry Researchers Industry Researchers
are from MARSare from MARS
University Researchers University Researchers
are from VENUSare from VENUS
University Partnerships
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
Applicant is always the small business
University facilities provide analytical and other service support
CULTURAL DIVERSITY
Critical dimension of the new “Knowledge-based Economy”
Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property
Universities and Industry learning to work together
This is now…That was then…
is KEY!is KEY!
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)
Entrepreneurial Research InstitutionKey Ingredients
The Ohio State University
Purdue University
University of Wisconsin
N.C. State University
Georgia Tech
Virginia Tech
Examples of Successful EntrepreneurialResearch Institutions
• Texas A&M 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
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 I
Phase II
Phase III
3 months? 2 years? 10 years?
$$$$$
Technical Assistance Programs
Commercialization Assistance
Business & strategic planning
Builds alliances and investor partnerships
Pilot NicheAssessment
Identify other uses of technology
Determines competitive advantages
Develops market entry strategy
(Phase II awardees)
(Phase I awardees)
Alerts/News Flashes Solicitations Targeted Research Opportunities Award Information Collaborative Opportunities Success Stories Resources
http://grants.nih.gov/grants/funding/sbir.htm
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, Marylandhttp://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
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
Grant Application Preparation
RESOURCES
HOW TO WRITE A GRANT APPLICATION
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National CancerInstitute
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Libraryof Medicine
National Centerfor Complementary
and AlternativeMedicine
National Instituteof Allergy and
Infectious Diseases
FogartyInternational
Center
National Centerfor ResearchResources
Largest SBIR/STTRset-asides
National Instituteof Biomedical
Imaging and
Bioengineering
National Center on Minority Health
and Health Disparities
New!
National Institutes of HealthNational Institutes of Health
Office of the Director
National Center on Minority Health
and Health Disparities
http://www.nih.gov/icd/
Kathleen ShinoActing NIH SBIR/STTR Program Coordinator
Phone: 301-435-2689Fax: 301-480-0146
Email: [email protected]
Kay EtzlerSBIR/STTR ProgramPhone: 301-435-2713
Fax: 301-480-0146 Email: [email protected]