Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH

11

Jo Anne GoodnightSBIR/STTR Program Coordinator

Office of Extramural Research, NIH

““Lab to Life”Lab to Life”NIH SBIR/STTR Funding NIH SBIR/STTR Funding

Opportu“Opportu“NIHNIH”tie”tieSS

Nat

ion

al In

stit

ute

s o

f H

ealt

h

NIH Regional SeminarJune 2010

Portland, OR

22

Topics to Discuss Today

• SBIR/STTR Program OverviewSBIR/STTR Program Overview

• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics

•Partnering Incentives for Research Institutions and Industry through SBIR/STTR

• Red Lights and Yellow LightsRed Lights and Yellow Lights

• Answer Your Questions!Answer Your Questions!

33

The largest, most accessible source of

SEED CAPITAL for the nation’s innovative small businesses

$2.4 Billion in FY 2010

SBIR/STTR Programs

NIH SBIR: $616 MNIH STTR: $ 74 M Total: $690M

44

And….

This capital is in the form ofgrants and contracts

• no repayment• no debt service• no equity forfeiture • no IP forfeiture

55

SBIR/STTR Program Overview

SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization.

SMALL BUSINESS TECHNOLOGY SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization.

2.5%

0.3%

The best way to predict the future… is to create it.

66

SBIR Purpose and Goals

Small Business Innovation Development Act of 1982P.L. 106-554 (Signed 12/21/2000 extended program through 09/30/2008)

• Stimulate technological innovation

• Use small business to meet Federal R&D needs

• Foster and encourage participation by minorities and disadvantaged persons in technological innovation

• Increase private-sector commercialization innovations derived from Federal R&D

“We in government must work in partnership with small businesses to ensure that technologies and processes are readily transferred to commercial applications.” – Ronald Reagan, July 22, 1982.


77

STTR Purpose and Goals

Small Business Research and Development Enhancement Act of 1992

P.L. 107-50 (Program reauthorized through 09/30/2009)

• Stimulate and foster scientific and technological innovation through cooperative research and development between small business concerns and research institutions

• Foster technology transfer between small business concerns and research institutions


88

SBIR and STTR Program Extended Temporarily Through April 30, 2010

P.L. 111-136 temporarily extends all programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR)


SBIR/STTR Extension

99

•PHASE II Full Research/R&D $750K and 2-year Award (SBIR & STTR) Pre-requisite: Phase I award

•PHASE III Commercialization Stage Must use non-SBIR/STTR Funds

• PHASE I Feasibility Study $100K and 6- month (SBIR) or 12- month (STTR) Award

SBIR/STTR: 3-Phase Program


1010

SBIR/STTR Eligibility Criteria

U.S. small business organized for-profit

At least 51% U.S.- owned by individuals and independently operated or , for SBIR, at least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals

500 or fewer employees, including affiliates

SBIR: PI primarily employed with the small business (STTR: primary employment not stipulated)

STTR: Formal collaboration between small business and research institution


1111

STTR: Formal collaborative effort means:

• Minimum 40% by small business• Minimum 30% by U.S. research institution

STTR: Intellectual Property Agreement Needed

Allocation of Rights in IP and Rights to Carry out

Follow-on R&D and Commercialization

SBIR/STTR: Applicant is Small Business Concern

SBIR/STTR: All of the work must be done in the US (unless a waiver is issued)

More SBIR/STTR EligibilityCheckpoints


1212

University-Industry Partnership Opportunities

• Own small firm (assign someone else PD/PI)

• Principal Investigator– with official permission from university– NIH allows multiple PD/PIs

• Senior Personnel on SBIR/STTR

• Consultant on SBIR/STTR

• Subcontract work on SBIR/STTR

• Use university facilities for analytical and

other service support

1313

• Research Partner

SBIR: Permits partnering

33% Phase I and 50% Phase II

STTR: Requires partnering with Research Institution

Small business (40%) and U.S. research institution (30%)

Award is always made to Small Business ConcernAward is always made to Small Business Concern

SBIR and STTR: Critical Differences

• Principal Investigator Employment

SBIR: Primary employment (>50%) must be with small business concern

STTR: PI may be employed by either research institution or small business concern

Multiple PD/PI allowable

1414

Important Facts to Remember

• Eligibility is determined at time of award

• No appendices allowed in Phase I

• The PD/PI is not required to have a Ph.D.

• The P/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

1515







1717

NIH Mission

Improve human health through biomedical and

behavioral research, research training and

communications.

1818

Office of the Director

National Center on Minority Health

and Health Disparities

Organizational Structure of NIH

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

No funding authority

1919

NIH Institute/Center SBIR/STTR Budget Allocations

NIDDKNIGMS

FY 2010 SBIR/STTR Budget Allocations to NIH ICs:

SBIR: $616 M STTR:$ 74 M Total: $690 M

2121

PHASE II (Full Research/R&D) Average $850K and 2-years; can be longer

PHASE II+ (Competing Renewal/R&D) Clinical R&D; Complex Instrumentation/Tools Many, but not all, ICs participate $1M/year; 3 years

PHASE III (Commercialization Stage) NIH, generally, not the “customer” Consider exit strategy early

PHASE I (Feasibility Study) Average award: $170K Project Period: Varies. Most awards on a 1-yr NCE

NIH SBIR/STTR: 3-Phase Program

NIH SBIR/STTR Program Specifics

2222

Phase I Phase II Phase III

Gap Funding Programs

Mt. “FDA”

• No-Cost Extension• Phase I / Phase II Fast Track• Administrative / Competitive Supplements

Phase II Competing Renewal Award


2323

Bridging the Phase I - II Funding Gap

(Simultaneous Submission and Concurrent Review)

SBIR/STTR Phase I + Phase II

Phase I Award

7-9 months

Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones

Phase II award

Aims/Milestones Met

Phase II award

Aims/MilestonesAims/MilestonesNOT MetNOT Met

Go?

No Go?

NIH Phase I/Phase II Fast-Track

“In-NIH-vative” Approaches

2424

• To take existing, promising compounds or devices developed under a Phase II through the next step of drug discovery / medical device refinement and development (see SBIR/STTR Solicitation)

Purpose

OR….

• To support complex instrumentation, clinical research tools, behavior interventions/treatments(see PA-08-056)



2525

• SBIR Phase II awardee• Promising pharmacologic compound identified in original Phase II• Device prototype developed in original Phase II• Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop

Contact NIH Program Staff to discussContact NIH Program Staff to discussEligibility

Parameters

• Maximum of $1M/year for up to 3 years • IC must accept Competing Renewal applications(NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR)



2626

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

Solicitations and Due Dates

2828

Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Imaging devices

Genetically engineered proteins

Proteomics / Genomics

……

Suggested topic areas

SBIR/STTR Program Descriptions and Research Topics

Investigator-initiated R&D

Research projects related to the NIH mission

“Other” areas of research within the

mission of an awarding component Keyword search the Solicitation

Ctrl - F

2929

Suggest potential awarding component(s): NIH Institutes/Centers

Request study section Suggest key areas of expertise required Indicate individual(s) or organization(s) in

conflict For resubmission, indicate review history Justify your requests

Cover Letter: A Valuable Tool

3030

Targeted SBIR/STTR Funding Opportunity Announcements

• NIH Guide for Grants and Contracts– High priority areas for ICs– Various IC participation– Nuances:

• Various due dates• Additional review criteria• Limited funds and project duration periods• Etc.

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

3131

Electronic Submission

• SBIR/STTR grant applications must be submitted electronically.

(SBIR contract proposals still in paper form)

• Registrations are required!!!– Grants.gov (company)– eRA Commons (company and all PD/PIs)

http://era.nih.gov/ElectronicReceipt/index.htm

3232

Important Application Changes (Effective January 25, 2010)

• Research Plan Restructure

• Page Limits– Introduction (resubmission or revision) – 1page– Specific Aims – 1page– Research Strategy

• Phase I – 6 pages• Phase II – 12 pages• Phase II Commercialization Plan – 12 pages

Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods

Research Strategy Significance Innovation Approach

Guide Notice: NOT-OD-09-149

3333

Small Business Concern

Applicant Initiates

Research 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 Application and Review Process


Remember: First get registered in Grants.gov AND eRA Commons!

3434

Review Criteria

• Overall Impact Score

• Scored Review Criteria (score 1-9) Significance (Real Problem/Commercial Potential) Investigators (PI and team) Innovation (New or Improved?) Approach (Research Design, Feasible) Environment (Facilities/Resources)

• Additional Review Criteria (not scored individually) Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards

3636

0

5

10

15

20

25

30

35

40

45

SBIR STTR

Phase I

Phase II

Fast-Track

NIH SBIR/STTR Success RatesS

ucc

ess

Rat

e (%

)

$672 M SBIR/STTR

654

262

33

54

105

40.6%

23.1%

19.6%

31.1%

14.9%

22%

PRELIMINARY -- Fiscal Year 2009

7

# Awards

% funded

3737

• Understand our mission. • Review Funding Opportunity Announcements (FOAs).• Propose innovative ideas with significance as well as

scientific and technical merit. • Give yourself ample time to prepare application.• Communication. Communication. Communication.• Contact NIH Staff to discuss

• your research idea.• outcome of your review.• challenges and opportunities.

Competing Successfully for SBIR/STTR Funding

3838

Phase I Phase II Phase III

NIH Technical Assistance Program

Mt. “FDA”???Commercialization Assistance

Program

Niche Assessment Program

Helping Companies cross the “Valley of Death”


3939

Technical Assistance Programs Understanding the “B” in SBIR

Commercialization Assistance

“Menu” of technical assistance/training programs in:

•Strategic/business planning•FDA requirements•Technology valuation•Manufacturing issues•Patent and licensing issues

Helps build strategic alliances

Facilitates investor partnerships

Individualized mentoring/consulting

(Phase II awardees)

Niche Assessment Identifies other uses of technology

Determines competitive advantages

Develops market entry strategy

(Phase I awardees)

4040

NIH Pipeline to Partnerships

Finding a Partner

• Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies

• Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors

• Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease


4141

NIH Pipeline to Partnerships (P2P)

http://www.ott.nih.gov/p2p/index.aspx

SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners.

4242

POTENTIAL PARTNERS / INVESTORS

Identifies technology of interest and contacts company

NIH Pipeline to Partnerships (P2P)

4343







4444

SBIR/STTR Historical Relationships

20081982

SmallBusinesses Academia

University Research Parks Faculty & Graduate

Students Technology Incubators Research Foundations

Quasi-Government Corporations

Economic Development Entities

Technology Centers

FederalGovernment

State Government

4545

University Roles in SBIR/STTR Programs

• Universities are the intellectual capital of scientific and engineering knowledge.

• Small Businesses are a vehicle forchanneling scientific discovery to thebenefit of society.

• Partnerships between the University and the Small Business benefits BOTH.

4646

Research Institution 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

4747

UNIVERSITY AND INDUSTRY:Two diverse cultures

Industry Researchers Industry Researchers

are from MARSare from MARS

University Researchers University Researchers

are from Venusare from Venus

4848

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


4949

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


5050

CULTURAL DIVERSITY

University - Industry PartnershipsUniversity - Industry Partnerships Critical dimension of the new “Innovation-based Economy”

Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property

Universities and Industry learning to work together

is KEY!

5151

• 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 Institution

Key Ingredients

5252

• The Ohio State University

• Purdue University

• University of Wisconsin

• N.C. State University

• Georgia Tech

• Virginia Tech

Examples of Successful Entrepreneurial Research 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

5353

“Land” of Opportunities

• Providing incubator facilities on university property

• Taking equity position (e.g., 5%) in commercial ventures

• Investing funds in new companies• Providing technical and business services

to new firms (e.g., alumni, business school)• Entering into joint ventures with private

entities• Modernizing the tenure process

5454

Case Study: Texas A&M

5555







5656

Eligibility Criteria

• Ownership: US-owned, independently operated

• Affiliations: Research Institutions,

Foundations, Foreign “Parents”

• Size: 500 employees maximum

• Business Structure: Inc, LLP, LLC, ...

• Principal Investigator: Employment

5757

Ownership And Affiliations

Eligibility of wholly-owned subsidiary

• Owners of the SBIR organization must be "individuals" who are "citizens of, or permanent resident aliens in, the United States." • The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.

5858

Ownership And Affiliations

• Parent of wholly-owned subsidiary is FOREIGN• Sum TOTAL of ALL employees more than 500 (parent + subsidiary) • Sharing of officers on Board of Directors

5959

PD/PI Eligibility on SBIR

• PI must have primary employment with SBC (unless waiver is granted)• More than 50% of PI’s time spent in employ of SBC• Primary employment with SBC precludes full-time employment at another organization

Eligibility is determined at the time of award

6060

STTR Eligibility Criteria

• Applicant Organization

• Research Institution Partner

• Project Director/Principal Investigator

6161

STTR Applicant Organization

Small Business Concern is ALWAYS

the applicant/awardee organization

6262

STTR Research Institution Partner

• Must establish formal collaborative relationship with SBC

• Must perform minimum of 30% of the research/R&D (maximum 60%)

• 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

6363

PD/PI Eligibility on STTR

• PD/PI: Not required to be employed by SBC

• PD/PI: Must commit 10% effort (minimum)

• PD/PI at RI: Must establish contract between RI and SBC describing PD/PI’s involvement

PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements

6464

PD/PI Role on STTR

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

6565

PD/PI Role on STTR

• Is PD/PI also business official for SBC?

• Type of appointment does PD/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

6666

PI 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

6767

Tips for Potential Applicants

• Explore the OER website – a wealth of information there! http://grants.nih.gov/grants/oer.htm

• Explore Institute/Center (IC) websites - to find the most likely home for your project

• Explore the CSR website - identify potential study sections http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/

• Contact appropriate program staff – s/he can help you!

• Include a cover letter with your application - to request IC and study section assignments

• Be persistent and don’t get discouraged: NIH extramural staff are your links with the ICs and are there to help you.

6868

Top 10 Reasons

6969

Top 10 Reasons

10.10. Over $2.3 Billion available- annually

9.9. NOT A LOANNOT A LOAN - no repayment

8.8. Provides recognition, verificationand visibility

7.7. Potential leveraging tool to attract venture capital/other sources of $$$

7070

5.5. Creates jobs / stimulates local and state economies – stronger National Economy

4.4. Provides seed money to fund high risk projects

6.6. Foster partnerships (universities, large niversities, large corporations)corporations) that that enhance competitiveness ofof small businesses in small businesses in marketplacemarketplace

Top 10 Reasons

7171

3.3. Intellectual property rights normally retained by the small business

2.2. Small business concerns recognized as a unique national resource of technological innovation

Top 10 Reasons

7272

Top 10 Reasons

Cardiac Assist, Inc.

Intralase Corporation

Xilas Medical, Inc.

Cyberkinetics Neurotechnology Systems, Inc.

Merck pays $400 million in cash for small New Hampshire company … largest sum ever reported for a privately held biotech.

GlycoFi, Inc.

Altea Therapeutics Corporation

Design Continuum, Inc.

1. Opportunity to improve the health of AmAmerericaica

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

For More InformationFor More Information

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

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

Email: [email protected]

Kay EtzlerSBIR/STTR Program Analyst Email: [email protected]

Lenka FedorkovaSBIR/STTR Program Analyst

Email: [email protected]

Subscribe to the SBIR/STTR List Serv: Email [email protected] with the following text in the message body: subscribe SBIR-STTR your name

7474

12th Annual NIH SBIR/STTR Conference

June 2-3, 2010Raleigh, NC

Save the Date!

7575

Thank You!

Questions?

Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH

Documents

Transcript of Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH