National Institutes of Health SMALL BUSINESS

FUNDINGOPPORTU“NIH”TIES

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

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

Email: jg128w@nih.gov

Research OpportunitiesResearch Opportunities ReservedReserved for Small Business for Small Business

SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAM

SMALL BUSINESS TECHNOLOGY SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAM

Updated 01/17/2006 JG)

AgendaAgenda

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

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

SBIR / STTR ProgramSBIR / STTR Program MissionMission

Supporting Supporting scientific excellencescientific excellence and and technologicaltechnological innovationinnovation

through the investment of through the investment of FederalFederal researchresearch fundsfunds

in critical in critical American prioritiesAmerican priorities to build a strong to build a strong national economynational economy……

oneone smallsmall businessbusiness atat aa timetime..

• 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 DescriptionsProgram Descriptions

2.5%

0.3%

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

SBIR AND STTR PROGRAMSSBIR 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)]

• 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*]

SBIR AND STTR PROGRAMSSBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES

Organized for- profit U.S. business 500 employees or fewer, including

affiliates PI’s primary employment must be

with the small business concern at the time of award and for the duration of the project period.

SBIR PROGRAMSBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS

Small business concern must be: At least 51% U.S.- owned by

individuals and independently operated

or At least 51% owned and controlled

by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

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

• 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 AgenciesSBIR / STTR Participating Agencies

TOTAL ~ TOTAL ~ $2.2 + B$2.2 + BFY 2006FY 2006

$640M in FY2006

2006 Budget SBIRSTTR

NIH $571M $69M

CDC

FDA

AHRQ

~8.1M

~0.8M

~2.0M

N/A

Phase I $100K*

6 months*

$100K*

1 year*

Phase II $750K*

2 years*

$750K*

2 years*

DHHS Budget and Award DHHS Budget and Award AmountAmount

$640M

****Propose a Realistic and Appropriate****Propose a Realistic and AppropriateBudget for the Research****Budget for the Research****

NIH MissionNIH Mission

IMPROVE HUMAN HEALTHthrough biomedical and behavioral

research, research trainingand communications.

Office of the Director

Largest SBIR/STTR

set-asides

National Center on Minority Health

and Health Disparities

NIH OrganizationNIH Organization

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

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

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical

Imaging and

Bioengineering

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

Small Companies Can Help Small Companies Can Help NIH Meet its MissionNIH 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

• SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOA

Release: January April 5, Aug 5, Dec 5 receipt dates(AIDS/AIDS-related: May 1, Sept 1, Jan 2 receipt dates)

SBIR: http://grants.nih.gov/grants/guide/pa-files/PA-07-180.html

STTR: http://grants.nih.gov/grants/guide/pa-files/PA-07-181.html

• SBIR Contract Solicitation (NIH, CDC) Release: August November 6, 2006 receipt date

• NIH Guide for Grants and Contracts Release: Weekly Various receipt dates

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

Our Ideas…Our Ideas…

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

Your Ideas …Your Ideas …

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

Electronically

~2-3 monthsafter submission

~2-3 months

after review

NIH SBIR/STTR PROGRAMNIH SBIR/STTR PROGRAMReview Process for Research Grant

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 CriteriaPhase 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” 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

DOES MY TECHNOLOGYDOES MY TECHNOLOGY““FIT” IN NIH?FIT” IN NIH?

See Mission Statement!See Mission Statement! Solution to…

Real Problem…. that affects Real People!

Universities / Industry Partnershipsand

Cultural Differences

Entrepreneurial Research InstitutionsEntrepreneurial Research Institutions

UNIVERSITY-BUSINESS PARTNERSHIP OPPORTUNITIES

• 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

• University facilities provide analytical and other service support

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 AND INDUSTRY:Two diverse cultures

University cultureUniversity culture

Research, discover, educate and train future

workforce Pace is slower - aligned to academic cycle Mission = basic and applied research Technology transfer activities are companion

to applied research mission Fertile ground for economic development

UNIVERSITY AND INDUSTRY:Two diverse cultures

Industry cultureIndustry culture

Mission toward research / R&D / commercialization

Quick-paced

Solve problems - develop new products profit

Maintain control of science to explore full potential of discovery (initially)

Economic impact: Jobs, societal benefit

CULTURAL DIVERSITY

University - Industry Partnerships University - Industry Partnerships 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!

Develop common goals between faculty-initiated business and mission of research institution

Create environment that enables innovation and entrepreneurship

Protect IP assets of university

Establish 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

• Purdue University: Purdue Research ParkPurdue Research Park 3 business incubators Companies benefit from shared office

concept, flexible leases, attractive rental rates, and more ...

Gateways Program Financial assistance

Examples of Successful Entrepreneurial Research Institutions (cont.)

http://www.purdueresearchpark.org

• Purdue University Environment for business to have

frequent and mutually beneficial

interactions with University

Policies / Procedures to address COI --

not to eliminate, but to minimize and

manage

Examples of Successful Entrepreneurial Research Institutions (cont.)

• Endocyte, Inc. (Purdue Research Park)

Researcher, Philip Low, discovered way to diagnose, potentially cure, ovarian cancer using vitamin folate

Sell technology or start own company to develop and market treatment????

Resisted VC offers: wanted control of science Now exploring use of folate in arthritis

ADVICE: Hire experienced CEO to handle all but science

BENEFIT: Purdue retains talent

SUCCESS STORY

STTR ELIGIBILITY CRITERIA

Applicant Organization Research Institution Partner Principal Investigator

Yellow Lights….

Red Lights

STTR APPLICANT ORGANIZATION

Small Business Concern ALWAYS the applicant/awardee organization

STTR RESEARCH STTR RESEARCH INSTITUTION PARTNERINSTITUTION PARTNER

U.S. non-profit organization owned and operated exclusively for scientific or educational purposes

Non-profit medical and surgical hospitals eligible as partner as long as these

institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques

STTR RESEARCH STTR RESEARCH INSTITUTION PARTNERINSTITUTION PARTNER

Formal collaborative relationship with SBCPerform minimum of 30% of the

research/R&D (maximum 60%)

PI Eligibility on STTRPI Eligibility on STTR

Formal collaborative relationship: PI at RI establishes contract between RI and SBC describing PI’s involvement PI is NOT required to be employed by SBC Minimum 10% effort PI and co-investigator must be paid at either SBC or RI , but NOT BOTH PI’s signature on Face Page is agreement to conforming to Solicitation requirements

PI Role on STTRPI Role on STTR

BUDGET PAGEPI must be on SBC or RI budget, but NOT BOTHPI and co-PI must be paid at either SBC or RI, but NOT BOTHPI oversees all research activities on behalf of SBC

See instructions for Multiple PI requirements

PI Role on STTRPI Role on STTR

PI also business official for SBC? Type of appointment does PI have at RI? If Owner/Business Official, s/he should also appear as employee of SBC (co-Investigator) and forego RI appointment during Phase II

PI Role on STTRPI Role on STTR

NIH Requires documentation from original employer/RI confirming change in employment status (e.g., sabbatical) for duration of SBIR/STTR project

PI cannot serve as consultant on same project

SBIR vs STTRSBIR vs STTRUNIQUE FEATURESUNIQUE FEATURES

SBIR STTR

Set-Aside of Agency Budget 2.5% 0.30%

FY06 SBIR / STTR Budget $571M $69M

Award Guidelines Phase I $100K/6mos $100K/12 mos. Phase II $750K/2 yrs $750K/ 2 yrs

Business Employment of PI >50% n/a

Subcontracts Phase I < 33.3% < 60%Phase II < 50% < 60%

Research Partner Not Required > 30%

For More Information

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

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

Phone: 301-435-2688 Fax: 301-480-0146Email: jg128w@nih.gov

Kay EtzlerSBIR/STTR Program Analyst

Phone: 301-435-2713 Fax: 301-480-0146

Email: etzlerk@od.nih.gov

Questions?Questions?