The SBIR and STTR Programs at the National Institutes of Health General Information and Nuances.

The SBIR and STTR Programsat the

National Institutes of Health

General Information and Nuances

Agenda

Basics of the SBIR & STTR programs NIH SBIR/STTR programs

Overview What’s new Latest funding opportunities University participation/involvement

Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R&D --

with potential for commercialization.

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.

Program Descriptions

2.5%

0.3%

SBIR/STTR: 3-Phase Program

PHASE 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

SBIR AND STTR PROGRAMSCRITICAL 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

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*]

*Varies Among Agencies

SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

Organized for- profit U.S. business

At least 51% U.S.- owned and independently operated

Small Business located in the U.S.

500 or fewer employees

P.I.’s primary employment with small

business during project

SBIR 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

U.S. Research Institution College or University; other non-profit research

organization; Federal R&D center

Intellectual Property Agreement Allocation of Rights in IP and Rights to Carry out

Follow-on R&D and Commercialization

STTR PROGRAMELIGIBILITY CHECKPOINTS

DOD SBIR/STTR HHS 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

TOTAL ~ $2.0 BEst. FY 2004

New

We’re all just a little bit different ...

Agency SBIR Differences

Number and Timing of Solicitations R&D Topic Areas -- (Broad vs. Focused) Dollar Amount of Award (Phase I and II) Proposal Preparation Instructions Financial details (e.g., Indirect Cost Rates, Gap Funding)

Receipt Dates Proposal Review Process Proposal Success Rates Type of Award (Contract or Grant)

Agency SBIR Differences

Granting Agencies Investigator initiates approach Less-specified topics Assistance mechanism

More flexibility

DOD HHS/NIHNASA EDEPA DOT

DOC

Contracting Agencies Agency establishes plans, protocols, requirements Highly focused topics Procurement mechanism for DOD and NASA More fiscal requirements

HHS/NIH NSF ED USDA DOE

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

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: $ 564 M SBIR $ 67 M STTR

$631 M Total

CDC: $ 8.0 M SBIRFDA: ~ $ 0.8 M SBIRAHRQ: ~$ 2.1 M SBIR

HHS SBIR/STTR

TOTAL ~ $2.0 B FY 2004

NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003

0

5

10

15

20

25

30

35

40

45

SBIR STTR

Phase I

Phase II

Fast-Track

Su

cces

s R

ate

(%)

24%

44%

27%

43%

28%

22%

981

327 18

61

$563 M SBIR/STTR(set aside $556M)

955

NUANCESNIH SBIR & STTR Programs

SBIR and STTR Program

Multiple Award Mechanisms

Multiple Receipt Date

Budget ~$100K/ $750K

External Peer Review Critiques sent to all applicants

Phase III

Single Solicitation

~ 95% Awards are grants

April 1, Aug 1, Dec 1

Realistic & appropriate

Academia and industry

NIH: rarely your customer

Examples ofCross-Cutting Areas of Interest Nanotechnologies Bioinformatics Biodefense Proteomics / Genomics Genetically engineered proteins Biosensors Biosilicon devices Biocompatible materials Acousto-optics and opto-electronics Imaging technologies Education/communication tools Computational biology Behavioral research

Our Ideas …

SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: January Open for entire Calendar Year

SBIR Contract Solicitation (NIH, CDC) Release: August Open for ~ 3 months

NIH Guide for Grants and Contracts Release: Weekly Open as noted

Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component

Your Ideas …

SBIR/STTR Award Type

Multiple Mechanisms GRANTS, , Contracts, Cooperative Agreements

Award Amount and Project Period

Phase I ~$100,000 6 months Phase II ~$750,000 2 years

Realistic and appropriate

Application Assignments

Institutes/Centers

Scientific Review Group

Center for Scientific ReviewReceipt & Referral Office

Match between proposed research and

IC’s mission

for funding

Match between proposed research and review

groups

for scientific/technical merit

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

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 Subjects… Animal Welfare… Budget

Phase II Review Criteria

Same as Phase I Demonstrated Feasibility in Phase I Commercialization Plan High Degree of Commercial Potential based on plan

… Protection of Human Subjects… Animal Welfare… Budget

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” 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!

Speak with Program Staff Prior to Submission

Phase II Competing Continuations

What’s New?

Technical Assistance Programs

Executive Order 13329 – Encouraging Innovation in Manufacturing

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 Funding level: $750K to $1M per year for maximum

of 3 years IC must have announced the opportunity

Speak with Program Staff Prior to Submission

Phase II Competing Continuations

PAs & RFAs

• NIMH PA-01-173• NICHD PA-03-085• NCI PA-04-047• NIAAA PA-03-129• NHLBI PA-04-028• NIAID RFA-AI-04-005• NIDA PA-03-154

OmnibusSolicitation

• NIA• NIDCD• NINDS

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)

Executive Order 13329

Requires SBIR/STTR Agencies to give high priority to manufacturing-related research and development

…relating to manufacturing processes, equipment and systems; or manufacturing workforce skills and protection

Latest Funding Opportunities (Samples)http://grants.nih.gov/grants/funding/sbir_announcements.htm

RFA-CA-05-006: Innovative Technologies for Molecular Analysis of Cancer (SBIR/STTR)

PAR-03-119: Innovations in Biomedical Computational Science and Technology

PA-04-094: Novel Technologies for In Vivo Imaging

RFA-CA-05-006: Innovative Technologies for Molecular Analysis of Cancer

Unique Features: • Special receipt dates (Mar, Jun, Oct)• Initial review convened by NCI• Parallel in scope with RFA-CA-05-002• Flexible budget and project durations

Phase I: 2 yrs, $100K direct costs each yearPhase II: 3 yrs, no official budget limit

• Annual meeting of investigators

Objective: To develop highly innovative cancer-related methods and tools that enable research

PAS-02-149: Small Business Biodefense Program

Unique Features: • ~ $35M “set-aside” in FY 2003• Flexible budget and project durations Phase I: 2 yrs, $500K total costs per year Phase II: 3 yrs, $2M total costs per year• Mandatory milestone – approval of the final

clinical protocol by NIAID prior to start of clinical trial

Objective: To rapidly develop specific products for biodefense

University Partnerships(Provide analytical and other service support)

Consultants on SBIR/STTR

Subcontracts on SBIR/STTR

Senior Personnel on SBIR/STTR

Principal Investigator (with official permission from University) Own small firms (assign someone else PI)

Applicant must be the

small business!

Applicant must be the

small business!

• Alerts

• Solicitations

• Targeted Research Opportunities

• Sample Application

• Award Information

• Collaborative Opportunities

• Success Stories

http://grants.nih.gov/grants/funding/sbir.htm

I’m from the Government,

and I’m here to help you….

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

Phone: 301-435-2688Fax: 301-480-0146

Email: goodnigj@od.nih.gov

Kay EtzlerSBIR/STTR ProgramPhone: 301-435-2713

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