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: shinok@mail.nih.gov

Kay EtzlerSBIR/STTR ProgramPhone: 301-435-2713

Fax: 301-480-0146 Email: etzlerk@od.nih.gov