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Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH. From the Lab to the Marketplace NIH SBIR/STTR Programs. National Institutes of Health. NIH Regional Seminar June 2011. SBIR & STTR Purpose. Stimulate technological innovation.

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Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH

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Michael huerta phd associate director for program development national library of medicine nih

Michael Huerta, PhD

Associate Director for Program Development

National Library of Medicine, NIH

From the Lab

to the Marketplace

NIH SBIR/STTR Programs

National Institutes of Health

NIH Regional SeminarJune 2011


Sbir sttr purpose

SBIR & STTR Purpose

  • Stimulate technological innovation

  • Commercialize innovative technologies

  • Stimulate small business & economic growth

  • Foster technology transfer between small business concerns and research institutions


Achieving the purpose

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)


Achieving the purpose1

Achieving the Purpose

  • Through SBIR & STTR awards

  • To small businesses

  • Supporting research & development of commercializable, innovative technologies

  • Serving the mission of the awarding unit

SBIR/STTR Program Overview


Sbir sttr awards

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


Michael huerta phd associate director for program development national library of medicine nih

How much is awarded through SBIR & STTR programs?


Michael huerta phd associate director for program development national library of medicine nih

How much is awarded through SBIR & STTR programs?

$2.4 Billion in FY 2010


Michael huerta phd associate director for program development national library of medicine nih

How much is awarded through SBIR & STTR programs?

$2.4 Billion in FY 2010


Michael huerta phd associate director for program development national library of medicine nih

How much is awarded through SBIR & STTR programs?

$2.4 Billion in FY 2010

NIH SBIR: $616 M

NIH STTR: $ 74 M

Total: $690M


Michael huerta phd associate director for program development national library of medicine nih

How much is awarded through SBIR & STTR programs?

$2.4 Billion in FY 2010

NIH SBIR: $616 M

NIH STTR: $ 74 M

Total: $690M

SBIR 2.5 %

STTR 0.3 %


Nih sbir sttr programs summary of key features

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

  • 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

  • Multiple Receipt Dates (Grants)

    • April 5, August 5, December 5

    • May 7, September 7, January 7 (AIDS)

    • Contracts: Early November

  • Gap Funding Programs

    • Phase IIB Competing Renewals

    • Ph I/Ph II Fast Track

    • Administrative Supplements

  • Budget and Project Period – Guidelines

    • $100-150K/6 -12months (Ph I)

    • $750K-1M/2 yrs (Ph II)

    • Deviations permitted where scientifically appropriate (eg, FOAs)

  • Technical Assistance Programs

    • Technology Niche Assessment

    • Commercialization Assistance

    • Pipeline to Partnerships (P2P)


Sbir and sttr critical differences

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

  • Research Partner

  • SBIR: Permits partnering

    33% Phase I and 50% Phase II

  • STTR: Requirespartnering with Research Institution

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

Award is always made to Small Business Concern


Michael huerta phd associate director for program development national library of medicine nih

  • PHASE I Feasibility Study

    • Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs

    • Project Period: 6 months (SBIR) or 1 year (STTR)

  • 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

NIH SBIR/STTR: 3-Phase Program

Per Congressional Guidelines – FOAs Vary


Phase iib competing renewal award

Phase IIB Competing Renewal Award

  • 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


Michael huerta phd associate director for program development national library of medicine nih

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


Michael huerta phd associate director for program development national library of medicine nih

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)!


Michael huerta phd associate director for program development national library of medicine nih

Mt. “FDA”

Mind the Gap

Phase IIB Competing Renewal Award

Phase I

Phase II

Phase III

  • No-Cost Extension

  • Phase I / Phase II Fast Track

  • Administrative / Competitive Supplements


Bridging the phase i ii funding gap

Bridging the Phase I - II Funding Gap

Phase I Final Report

7-9 months

Phase I Award

Aims/Milestones

Met

Phase II award

Phase II award

Aims/Milestones

NOT Met

NIH Phase I/Phase II Fast-Track

SBIR/STTR Phase I + Phase II

(Simultaneous Submission and Concurrent Review)

Program Staff assess completion of specific aims and milestones

Completion of Phase I

Go?

No Go?


Achieving the purpose2

Achieving the Purpose

  • Through SBIR & STTR awards

  • To small businesses

  • Supporting research & development of commercializable, innovative technologies

  • Serving the mission of the awarding unit


Achieving the purpose3

Achieving the Purpose

  • Through SBIR & STTR awards

  • To small businesses

  • Supporting research & development of commercializable, innovative technologies

  • Serving the mission of the awarding unit


Michael huerta phd associate director for program development national library of medicine nih

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 controlledby 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


Michael huerta phd associate director for program development national library of medicine nih

More SBIR/STTR Eligibility

Checkpoints

  • 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


  • Additional eligibility issues

    Additional Eligibility Issues

    • Eligibility is determined attime of award

    • Noappendices allowed in Phase I

    • The PD/PI is notrequired to have a Ph.D.

    • The PD/PI isrequired to have expertise to oversee project scientifically and technically

    • Applicationsmay besubmitted to different

      agenciesfor similar work

    • Awards may notbe accepted from different

      agencies for duplicative projects


    Achieving the purpose4

    Achieving the Purpose

    • Through SBIR & STTR awards

    • To small businesses

    • Supporting research & development of commercializable, innovative technologies

    • Serving the mission of the awarding unit


    Achieving the purpose5

    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)


    Michael huerta phd associate director for program development national library of medicine nih

    NIH Institutes and Centers (ICs)

    Office of the Director

    http://www.nih.gov/icd

    National Institute

    on Aging

    National Institute

    on Alcohol Abuse

    and Alcoholism

    National Institute

    of Allergy and

    Infectious Diseases

    National Institute

    of Arthritis and

    Musculoskeletal

    and Skin Diseases

    National Cancer

    Institute

    National Institute

    of Child Health

    and Human

    Development

    National Institute

    of Dental and

    Craniofacial

    Research

    National Institute on

    Deafness and Other

    Communication

    Disorders

    National Institute

    of Diabetes and

    Digestive and

    Kidney Diseases

    National Institute

    on Drug Abuse

    National Institute

    of Environmental

    Health Sciences

    National Eye

    Institute

    National Institute

    of General

    Medical Sciences

    National Heart,

    Lung, and Blood

    Institute

    National Human

    Genome Research

    Institute

    National Institute

    of Mental Health

    National Institute

    of Neurological

    Disorders and

    Stroke

    National Institute

    of Nursing Research

    National Institute

    On Minority Health

    and Health

    Disparities

    National Institute

    of Biomedical

    Imaging

    and

    Bioengineering

    National Center

    for Complementary

    and Alternative

    Medicine

    Fogarty

    International

    Center

    National Center

    for Research

    Resources

    National Library

    of Medicine

    No funding

    authority


    Michael huerta phd associate director for program development national library of medicine nih

    NIH Institutes & Centers

    SBIR & STTR Budget Allocations

    FY 2010 SBIR/STTR

    Budget Allocations to NIH ICs:

    SBIR: $616 M

    STTR:$ 74 M

    Total: $690 M

    NIGMS

    NIDDK


    Submitted grant applications get appropriate assignment

    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


    Submitted grant applications get appropriate assignment1

    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


    Relationship between project and study section

    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


    Relationship between project and study section1

    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


    How to determine which study section is best for your project

    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


    How to determine which study section is best for your project1

    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


    Relationship between project and ic

    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!


    Relationship between project and ic1

    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


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

    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


    How to determine which ic is the best fit for your project1

    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


    Cover letter follow up for optimal assignment

    Cover Letter - Follow up for optimal assignment

    • 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

    • Justifyall the requests you make


    Sbir sttr purpose1

    SBIR & STTR Purpose

    • Stimulate technological innovation

    • Commercialize innovative technologies

    • Stimulate small business & economic growth

    • Foster technology transfer between small business concerns and research institutions


    Achieving the purpose6

    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)


    Drilling down

    Drilling Down

    Further Information, Details, and Tips


    Michael huerta phd associate director for program development national library of medicine nih

    Small Business

    Concern

    Research idea – then contact NIH

    Scientific Review Groups

    Evaluate Scientific Merit

    IC Advisory Council or Board

    Concurs with Review

    IC Allocates

    Funds

    Application & Review Process

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

    NIH Center for Scientific Review

    Assign to IC and Study Section

    Submits

    SBIR/STTR Grant

    Application to NIH

    Electronically

    ~2-3 months

    after submission

    ~2-3 months after review

    IC Staff Prepare funding Plan

    for IC Director

    Grantee Conducts

    Research

    NIH SBIR/STTR Program Specifics


    Michael huerta phd associate director for program development national library of medicine nih

    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


    Nih sbir sttr success rates fy2010

    NIH SBIR/STTR Success Rates FY2010


    Michael huerta phd associate director for program development national library of medicine nih

    Keys to Success

    • 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


    Michael huerta phd associate director for program development national library of medicine nih

    Mt. “FDA”

    ???

    NIH Technical Assistance Program

    Helping Companies cross the “Valley of Death”

    Niche Assessment Program

    Commercialization Assistance Program

    Phase I

    Phase II

    Phase III


    Technical assistance programs understanding the b in sbir

    Technical Assistance Programs Understanding the “B” in SBIR

    Niche Assessment

    Identifies other uses of technology

    Determines competitive advantages

    Develops market entry strategy

    (Phase I awardees)

    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)


    Michael huerta phd associate director for program development national library of medicine nih

    Finding a Partner

    NIH Pipeline to Partnerships

    • 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


    Nih pipeline to partnerships p2p

    NIH Pipeline to Partnerships (P2P)

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

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


    Nih pipeline to partnerships p2p1

    NIH Pipeline to Partnerships (P2P)

    POTENTIAL PARTNERS / INVESTORS  

    Identifies technology of interest and

    contacts company


    Summary of nih sbir sttr

    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


    Eligibility criteria

    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


    Ownership and affiliations

    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.


    Ownership and affiliations1

    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


    Pd pi eligibility on sbir

    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


    Sttr eligibility criteria

    STTR Eligibility Criteria

    • Applicant Organization

    • Research Institution Partner

    • Project Director/Principal Investigator


    Sttr applicant organization

    STTR Applicant Organization

    Small Business Concern is ALWAYS

    the applicant/awardee organization


    Sttr research institution partner

    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


    Pd pi eligibility on sttr

    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


    Pd pi role on sttr

    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


    Pi role on sttr

    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


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