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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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slide1
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
slide9

How much is awarded through SBIR & STTR programs?

$2.4 Billion in FY 2010

NIH SBIR: $616 M

NIH STTR: $ 74 M

Total: $690M

slide10

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

slide13

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
slide15

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
slide16

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)!

slide17

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
slide21

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
slide22

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)
slide26

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

slide27

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

slide42

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

slide43

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
slide45

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
slide46

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)

slide48

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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