National Institutes of Health SBIR/STTR Program: Features and Nuances

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National Institutes of Health SBIR/STTR
ProgramFeatures and Nuances
Jo Anne Goodnight SBIR/STTR Program
Coordinator National Institutes of Health
6701 Rockledge Drive Room 6186 - MSC 7910
Bethesda, MD 20892 Phone
301-435-2688 Email jg128w_at_nih.gov
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SBIR/STTR 3-Phase Program

• PHASE I
• Feasibility study
• (no preliminary data needed)
• 100K and 6 months (SBIR) or 12 months(STTR)
• PHASE II
• Full R/RD
• 2-Year Award and 750K (SBIR) or 500K (STTR)
• PHASE III
• Commercialization Stage
• Without SBIR Support

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SBIR PROGRAM ELIGIBILITY CHECKPOINTS

• Organized for- profit U.S. business
• At least 51 U.S.-owned and
• independently operated
• Small Business located in the U.S.
• P.I.s primary employment with small
• business during project
• 500 or fewer employees

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STTR PROGRAM

• FORMAL COOPERATIVE RD EFFORT
• Minimum 40 by small business
• Minimum 30 by research institution
• U.S. RESEARCH INSTITUTION (RI)
• College or University other non-profit
  research
• organization federal RD center
• PRINCIPAL INVESTIGATOR FROM SMALL
• BUSINESS and/or RESEARCH INST.
• AWARD MADE TO SMALL BUSINESS

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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Research Partner
• SBIR Allows for, but does not require,
  research institution partners
• STTR Requires partners from research
  institutions (e.g., universities)
• 40 work by small business
• and 30 work by research institution

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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

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

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Faculty Partnership Opportunities

• Own small firms (assign someone else PI)
• Principal Investigator (w/ official permission
  from University)
• Senior Personnel on SBIR
• Consultants on SBIR
• Subcontract on SBIR
• University facilities can provide analytical and
  other service support

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The NIH SBIR/STTR Application Process A closer
look ..
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NATIONAL INSTITUTES OF HEALTHSBIR/STTR
REVIEW/AWARD PROCESS
SBIR/STTR Scientific/Technical Adv
Council Awd Receipt Dates Peer
Review Board Review Date Apr 1, 2000
June/July Sept/Oct Nov Aug 1, 2000
Oct/Nov Jan/Feb Mar Dec 1, 2000
Feb/March May/June July
90-Day pre-award costs are allowable At your
own risk..
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NATIONAL INSTITUTES OF HEALTH SBIR/STTR
PROGRAM Communication

• NIH Program Director
• Advice and Guidance
• Whats Hot New initiatives
• Answer your questions
• Review Issues Dos and Donts
• Discuss funding alternatives

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NIH SBIR/STTR APPLICATION PROCEDURES

• Up to 100,000 Total Costs
• Omit Detailed Budget Form Pg. 3
• Include Narrative Justification
• Personnel
• Fixed Fee
• Consultant Costs
• Contractual Costs

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Applications Submitted to NIHCenter for
Scientific Review

• Approximately 40,000 grant applications are
  submitted to NIH each year, of which 25-30 are
  funded
• Competing grant applications are received for
  three review cycles per year

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Cover Letter A Valuable Tool

• Suggest potential awarding component(s)
• Discuss areas of expertise appropriate for the
  applications review
• Indicate individual(s) or organization(s) that
  would be in conflict

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NIH SBIR Review Criteria

• Scientific and Technical Merit based on.
• Significance
• Commercial Potential?
• Anticipated commercial and societal benefits?
• Advancement of scientific knowledge?
• Approach
• Innovation
• Investigators
• Environment

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NIH SBIR Review Criteria

• Other factors considered.
• Safeguards for animal and human subjects
• Appropriateness of the budget
• Justify costs that deviate from the guidelines!

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NIH SBIR Review Criteria (cont.)

• Phase II Standard review criteria and degree to
  which Phase I feasibility was demonstrated
• Fast Track (Phase I/Phase II)
• Specification of measurable goals to be achieved
  prior to initiating Phase II
• Concise Product Development Plan
• Extent to which applicant was able to obtain
  letters of interest, additional funding
  commitments and/or other
• non-SBIR/STTR resources

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Streamlined Procedures of NIH Grant Application
Review

• Reviewers
• Rate applications 100-500 priority score
• Discuss at review applications identified between
  100 and 300
• Triage/ UNscore applications between
• 300-500. generally
• Applicants ALL
• Automatically receive essentially verbatim
• written critiques (Summary Statements)

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NIH Allows Amended Applications

• 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

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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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What Reviewers Say About Outstanding Phase II
Applications

• principals highly experienced in their
  respective roles
• detailed Ph I Data Summary 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

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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

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What Reviewers Say About Outstanding Ph II
Applications

• strengths include satisfactory feasibility
  demonstration of prototype during Ph I,
  innovation and technical merit of the
  conceptexpertise of staff
• Ph I aims were met as was proof of feasibility
  
• Ph I data are presented to support their claims
  that a successful Ph II effort will be
  accomplished
• ..one of the best this reviewer has seen.. Data
  presented from Ph I are convincing, proposed
  research is very sound. And PI and staff are
  well-versed..

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WHERES THE MONEY?

• WHY THE AWARD MAY BE DELAYED
• OPRR Issues
• IRB (Human Subjects)
• http//ohrp.osophs.dhhs.gov/index.htm
  
• IACUC (Animal Involvement)
• http//grants.nih.gov/grants/olaw/ola
  w.htm
• EIN (Entity Identification Number)
• Third Party Involvement
• Contracts, Consortia, Consultants

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SBIR/STTR TIPS CHECKLIST

• Get to know your agency Program Manager
• Understand agencys mission needs
• Read solicitation and follow instructions
• Do not depend solely on SBIR funding
• Dont go it alone
• Have an outcome
• Be PERSISTENT

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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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