11 Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH From the Lab to the Marketplace NIH SBIR/STTR Programs.

11

Michael Huerta, PhDAssociate Director for Program Development

National Library of Medicine, NIH

From the Lab to the Marketplace

NIH SBIR/STTR Programs

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NIH Regional SeminarJune 2011

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SBIR & STTR Purpose

• Stimulate technological innovation

• Commercialize innovative technologies

• Stimulate small business & economic growth

• Foster technology transfer between small business concerns and research institutions

33

Achieving the Purpose

• Through SBIR & STTR awards• To small businesses• Supporting research & development of

commercializable, innovative technologies• Serving the mission & priority of the awarding

unit (Institute or Center)

44



commercializable, innovative technologies• Serving the mission of the awarding unit

SBIR/STTR Program Overview

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SBIR & STTR Awards

• Awards are funds to the small business from the federal government – control levels vary• Grants • Cooperative Agreements• Contracts

• Awards support specific R & D projects (not general business costs, infrastructure, etc.)

• Awards do not require• Repayment or debt service• Equity or intellectual property forfeiture

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How much is awarded through SBIR & STTR programs?

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$2.4 Billion in FY 2010

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$2.4 Billion in FY 2010

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$2.4 Billion in FY 2010NIH SBIR: $616 MNIH STTR: $ 74 MTotal: $690M

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$2.4 Billion in FY 2010NIH SBIR: $616 MNIH STTR: $ 74 MTotal: $690M

SBIR 2.5 %STTR 0.3 %

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NIH SBIR & STTR Programs Summary of Key Features

• SBIR & STTR Programs Single SBIR/STTR grant solicitation Investigator-initiated research ideas Special FOAs (see NIH Guide for

Grants and Contracts) Electronic Submission (grants only) Awards always made to small business

concern

• Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, September 7, January 7 (AIDS) Contracts: Early November

• Budget and Project Period – Guidelines $100-150K/6 -12months (Ph I) $750K-1M/2 yrs (Ph II) Deviations permitted where scientifically

appropriate (eg, FOAs)

• External Peer Review Option to request review group Experts from Academia/Industry 5 Criteria: Significance, Approach,

PI(s), Innovation, Environment

Summary Statement for all applicants

Revise & resubmit once• Gap Funding Programs

Phase IIB Competing Renewals Ph I/Ph II Fast Track Administrative Supplements

• Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P)

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• 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 Concern

SBIR and STTR: Critical Differences

• PI 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 – for SBIR only one PI must be primarily employed by SBC

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PHASE II Full Research/R&D $750K (STTR) or $1M (SBIR) over two years

PHASE IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, ICs participate Varies ~$1M/year; 3 years

PHASE III Commercialization – not funded by gov’t NIH is generally not the “customer” Consider partnering and exit strategy early

PHASE I Feasibility Study Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs Project Period: 6 months (SBIR) or 1 year (STTR)

NIH SBIR/STTR: 3-Phase ProgramPer Congressional Guidelines – FOAs Vary

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• Purpose: Peer-reviewed continuation of Phase II R & D for complex projects

• Parameters: Up to $1M/year for up to 3 years

• Eligibility: Must have Phase II award // contact program officer for eligibility

• Participating ICs: NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR

Phase IIB Competing Renewal Award

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Beyond the Guidelines

The duration and amount of the SBIR or STTR award may exceed the congressional guidelines

• As required by the project – contact program officer before submitting the application to find out what would be allowed

• As allowed by special funding opportunity announcements (FOAs), for example PA-11-134, Lab to Marketplace:• Phase I – up to $350,000 per year for up to two years• Phase II – up to $600,000 per year for up to three years• Phase IIB – up to $800,000 per year for up to three years

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Beyond the Guidelines

The duration and amount of the SBIR or STTR award may exceed the congressional guidelines

One project could be supported with ~ $6 million over 8 years (Ph I, II, & IIB)!

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Phase I Phase II Phase III

Mind the Gap

Mt. “FDA”

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

Supplements

Phase IIB Competing Renewal Award

http://www.dnr.state.wi.us/org/water/fhp/papers/p2/img008.jpg

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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/MilestonesNOT Met

Go?

No Go?

NIH Phase I/Phase II Fast-Track

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2020




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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: At least one PI primarily employed with the small business (STTR: not stipulated)

STTR: Formal collaboration between small business and research institution

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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

More SBIR/STTR EligibilityCheckpoints

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Additional Eligibility Issues

• 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 PD/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

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Office of the Director

National Institute On Minority Health

and Health Disparities

NIH Institutes and Centers (ICs)

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland 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

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NIH Institutes & Centers SBIR & STTR Budget Allocations

NIDDKNIGMS

FY 2010 SBIR/STTR Budget Allocations to NIH ICs:

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

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Submitted grant applications get appropriate assignment

• Applications received by CSR and assigned to:• A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration

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Submitted grant applications get appropriate assignment

• Applications received by CSR and assigned to:• A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration

Appropriate, however, is not necessarily optimal

You can help determine optimal assignment

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Relationship between project and study section

• Dozens of study sections with different • Areas of review responsibility• Expertise of peer reviewers

• Overlap from one study section to another

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Relationship between project and study section

• Dozens of study sections with different • Areas of review responsibility• Expertise of peer reviewers

• Overlap from one study section to another

Each study section has unique scientific focus and each reviewer has unique perspective

Determine the best match for your project

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How to determine which study section is best for your project

• Center for Scientific Review (CSR) web site:• Scientific focus of each study section• List of study sections with similar scientific foci• Roster of members of each study section

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How to determine which study section is best for your project

• Center for Scientific Review (CSR) web site:• Scientific focus of each study section• List of study sections with similar scientific foci• Roster of members of each study section

If more than one seems great,

Communicate with scientific review officers of those study sections for further guidance

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Relationship between project and IC

• Dozens of ICs with different • Missions – purviews of responsibility• Priorities – areas of special interest or emphasis

• A project could match mission, but not priority!

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Relationship between project and IC

• Dozens of ICs with different • Missions – purviews of responsibility• Priorities – areas of special interest or emphasis

• A project could match mission, but not priority!• Technologies are often cross-cutting, e.g.:

• Neuroimaging tool – cancer or stroke• Microfluidic chamber – deliver drug or growth factor

• Context of grant application or test bed for proposed feasibility test may determine IC

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How to determine which IC is the best fit for your project

• Web sites of ICs• List research priorities, strategic plans, etc.

• Annual Omnibus Solicitation for SBIR and STTR Grant Applications• ICs list specific research topics

• Special FOAs• Clear indication of participating ICs’ interests

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How to determine which IC is the best fit for your project

• Web sites of ICs• List research priorities, strategic plans, etc.

• Annual Omnibus Solicitation for SBIR and STTR Grant Applications• ICs list specific research topics

• Special FOAs• Clear indication of participating ICs’ interests

After narrowing down list of possible ICs, talk to the program officer(s) about your specific idea

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• Request potential awarding component(s): NIH Institutes/Centers – refer to program officer communication as appropriate

• Request SBIR/STTR study section• Indicate key areas of review expertise required• Indicate individual(s)/organization(s) in

conflict• For resubmission, indicate review history • Justify all the requests you make

Cover Letter - Follow up for optimal assignment

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SBIR & STTR Purpose

• Stimulate technological innovation

• Commercialize innovative technologies

• Stimulate small business & economic growth

• Foster technology transfer between small business concerns and research institutions

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Drilling Down

Further Information, Details, and Tips

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Small Business Concern

Research idea – then contact NIH

Grantee Conducts Research

IC Staff Prepare funding Planfor IC Director

NIH Center for Scientific ReviewAssign to IC and Study Section

Scientific Review GroupsEvaluate Scientific Merit

IC Advisory Council or BoardConcurs with Review

IC Allocates

Funds

SubmitsSBIR/STTR Grant Application to NIH

Electronically

~2-3 monthsafter submission

~2-3 months

after review

Application & Review Process

NIH SBIR/STTR Program Specifics

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

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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

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NIH SBIR/STTR Success Rates FY2010

SBIR STTR0

5

10

15

20

25

30

35

13.7

20.2

33.5 34.8

15.6

23.4Phase IPhase IIFast-Track

Su

cc

es

s R

ate

(%

)

FY2010 $690 M SBIR/STTR

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• Understand mission & priorities • IC Web sites, Omnibus Solicitation, FOAs

• Propose innovative ideas with significance as well as scientific and technical merit

• Give yourself ample time to prepare application

• Contact NIH Staff to discuss:• Research idea early on – program staff• Assignment issues – program and review staff• Outcome of your review – program staff

Keys to Success

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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”

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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)

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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

“In-NIH-vative” Approaches

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

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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.

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POTENTIAL PARTNERS / INVESTORS

Identifies technology of interest and contacts company

NIH Pipeline to Partnerships (P2P)

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Summary of NIH SBIR & STTR

• Investments in innovation & economic growth• Advance the NIH mission & human health • Support and validate small business R & D• Extraordinary latitude in awards• Extraordinary assistance from idea to market

• Scientific aspects• Administrative aspects• Business aspects

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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

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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.

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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

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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

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STTR Eligibility Criteria

• Applicant Organization• Research Institution Partner • Project Director/Principal Investigator

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STTR Applicant Organization

Small Business Concern is ALWAYS

the applicant/awardee organization

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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

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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

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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

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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

11 Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH From the Lab to the Marketplace NIH SBIR/STTR Programs.

Documents

nih sttr

sbir sttr purpose

sbir sttr awards awards

small business concern

small business concern

research partner sbir

center slide

sbc slide