National Institutes of National Institutes of HealthHealth

SBIR/STTR Program:SBIR/STTR Program:Features and NuancesFeatures and Nuances

Jo Anne GoodnightSBIR/STTR Program Coordinator

National Institutes of Health

6701 Rockledge Drive Room 6186 - MSC 7910 Bethesda, MD 20892 Phone: 301-435-2688

Email: jg128w@nih.gov

SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase ProgramPHASE I

Feasibility study

(no preliminary data needed)

$100K and 6 months (SBIR) or 12 months(STTR)

PHASE II

Full R/R&D

2-Year Award and $750K (SBIR) or $500K (STTR)

PHASE III

Commercialization Stage

Without SBIR Support

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

SBIR PROGRAM SBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS

FORMAL COOPERATIVE R&D 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 R&D center

PRINCIPAL INVESTIGATOR FROM SMALL

BUSINESS and/or RESEARCH INST.

AWARD MADE TO SMALL BUSINESS

STTR PROGRAMSTTR PROGRAM

SBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL 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

SBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES

Principal InvestigatorSBIR: PI’s primary (>50%) employment must be with small business concern

STTR: Primary employment not stipulated

= PI can be from research institution or

from small business concern

Faculty Partnership OpportunitiesFaculty 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

The NIH SBIR/STTR Application The NIH SBIR/STTR Application

Process: A closer look …..Process: A closer look …..

NATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH

SBIR/STTR REVIEW/AWARD PROCESSSBIR/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…..

NATIONAL INSTITUTES OF HEALTHSBIR/STTR PROGRAMSBIR/STTR PROGRAM

Communication

NIH Program Director

AAdvice and GGuidanceWWhat’s Hot: New initiativesAAnswer your questions RReview Issues: Dos and Don’tsDDiscussiscuss funding alternatives

NIH SBIR/STTR APPLICATION PROCEDURESAPPLICATION PROCEDURES

Up to $100,000 Total Costs

– Omit Detailed Budget Form Pg. 3

– Include Narrative Justification: Personnel Fixed Fee Consultant Costs Contractual Costs

Budget JustificationNarrative ONLY

Form Page 4

Applications Submitted to NIHApplications Submitted to NIHCenter for Scientific ReviewCenter 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

Cover Letter: A Valuable Tool

Suggest potential awarding component(s)

Discuss areas of expertise appropriate for the application’s review

Indicate individual(s) or organization(s) that would be in conflict

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

NIH SBIR Review Criteria

Other factors considered…. Safeguards for animal and human subjects

Appropriateness of the budgetJustify costs that deviate from the

guidelines!

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

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)

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

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

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”

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…”

What Reviewers Say About What Reviewers Say About Outstanding Ph II ApplicationsOutstanding Ph II Applications

“strengths include satisfactory feasibility demonstration of prototype during Ph I, innovation and technical merit of the concept…expertise 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..”

WHERE’S THE MONEYWHERE’S 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/olaw.htm

EIN (Entity Identification Number)

Third Party Involvement Contracts, Consortia, Consultants

SBIR/STTR TIPS CHECKLISTSBIR/STTR TIPS CHECKLIST

Get to know your agency Program Manageragency Program Manager

Understand agency’s mission & needsagency’s mission & needs

Read solicitation and follow instructionsfollow instructions

Do not depend solelysolely on SBIR funding

Don’t go it alonealone

Have an outcomeoutcome

Be PERSISTENTPERSISTENT

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

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

NIDCR-- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders

NIH Program Activities and Areas of Research

(cont.)

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

NIGMS-- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology

NIH Program Activities and Areas of Research (cont.)

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

NIAMS-- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders

NINR-- understand effects of acute and chronic illness, improving QOL, approaches to promote health and prevent disease, improving clinical environments

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-- R&D in instrumentation and specialized technologies for biomedical research; R&D 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

Innovative ideas that

change the way we

work, think and live.