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Matthew Portnoy, PhD SBIR/STTR Program Coordinator Office of Extramural Research, NIH. “Lab to Life” NIH SBIR/STTR Funding Opportu“ NIH ”tie S. National Institutes of Health. NIH Regional Seminar June 2012 Washington, DC. Topics to Discuss Today. NIH SBIR/STTR Program Specifics

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Matthew Portnoy, PhD SBIR/STTR Program Coordinator Office of Extramural Research, NIH

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Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

Matthew Portnoy, PhD

SBIR/STTR Program Coordinator

Office of Extramural Research, NIH

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

National Institutes of Health

NIH Regional SeminarJune 2012Washington, DC


Topics to discuss today

Topics to Discuss Today

  • NIH SBIR/STTR Program Specifics

  • Red Lights and Yellow Lights

  • Answer Your Questions!


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

The largest, most accessible source of SEED CAPITALfor the nation’s innovative small businesses$2.5 Billion in FY 2012

SBIR/STTR Programs

NIH SBIR: $632 M

NIH STTR: $ 85 M

Total: $717M


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

And….

  • This capital is in the form of

  • grants and contracts

    • no repayment

    • no debt service

    • no equity forfeiture

    • no IP forfeiture


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

SBIR/STTR Program Overview

SMALL BUSINESS INNOVATION

RESEARCH (SBIR) PROGRAM

Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization.

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR) PROGRAM

Set-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization.

2.6%*

0.35%*

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


Sbir purpose and goals

SBIR Purpose and Goals

  • 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

Small Business Innovation Development Act of 1982

P.L. 112-81 Re-Authorizes program through FY2017

SBIR/STTR Program Overview


Sttr purpose and goals

STTR Purpose and Goals

  • 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

Small Business Research and Development

Enhancement Act of 1992

P.L. 112-81 Re-Authorizes program through FY2017

SBIR/STTR Program Overview


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

NIH Mission

Improve human health through biomedical and behavioral research,

research training and communications.


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

Organizational Structure of NIH

Office of Research

Infrastructure Programs

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 Advancing

Translational Sciences

National Library

of Medicine

NIH Clinical Center

Center for

Information

Technology

Center for

Scientific Review

No funding

authority


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

  • PHASE I Feasibility Study

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

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

  • PHASE II Full Research/R&D

    • $1M (STTR), $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 Stage

    • NIH, generally, not the “customer”

    • Consider partnering and exit strategy early

NIH SBIR/STTR: 3-Phase Program


Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

SBIR Eligibility Criteria

Subject to change per new SBA Policy Directive pending

  • Organized as for-profit U.S. business

  • Small: 500 or fewer employees, including affiliates

  • PD/PI’s primary employment must be with small business concern at time of award and for duration of project period

  • At least 51% U.S.- owned by individuals and independently operated or

    At least 51% owned and controlledby another (one)business concern that is at least 51% owned and controlled by one or more individuals


Matthew portnoy phd sbir sttr program coordinator office of extramural research 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

  • SBIR/STTR Program Overview


    Sbir and sttr critical differences

    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

    • 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


    Important facts to remember

    Important Facts to Remember

    • Eligibility is determined attime of award

    • Noappendices allowed in Phase I

    • The PD/PI is notrequired to have a PhD/MD

    • 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


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    NIH SBIR/STTR Budget Allocations FY2012

    2.6% SBIR $632M

    0.35% STTR $85M

    Total FY2012 $717M


    Nih sbir sttr success rates

    NIH SBIR/STTR Success Rates


    Hhs nih program funding

    HHS/NIH Program Funding


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Mt. “FDA”

    Gap Funding Programs

    Phase IIB Competing Renewal Award

    Phase I

    Phase II

    Phase III

    • No-Cost Extension

    • Phase I / Phase II Fast Track

    • Administrative / Competitive Supplements

    NIH SBIR/STTR Program Specifics


    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?

    “In-NIH-vative” Approaches


    Phase iib competing renewal award

    Phase IIB Competing Renewal Award

    Purpose

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

    • OR…. NCI, NHLBI, NINDS specific announcements, ex:

    • Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (R44)

    • (seePA-11-135)

    “In-NIH-vative” Approaches


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Phase IIB Competing Renewal Award

    Eligibility

    Contact NIH Program Staff to discuss

    • SBIR/STTR 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

    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,NCI, NCATS, and ORIP)

    “In-NIH-vative” Approaches


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Solicitations and Due Dates

    http://sbir.nih.gov


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Solicitations and Due Dates

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

    • NIH, CDC, FDA & ACF Omnibus Solicitation for SBIR/STTR Grant Applications

    • Release: January Due Dates: April 5, Aug 5, Dec 5

    • (AIDS: May 7, Sept 7, Jan 7)

    • NIH & CDC SBIR Contract Solicitation

    • Release: AugustReceipt Date: November

    Parent FOAs: SBIR: (PA-12-088) STTR: (PA-12-089)

    NIH (24 ICs) – SBIR & STTR

    FDA – SBIR only

    CDC – SBIR only

    ACF– SBIR only

    NIH SBIR/STTR Program Specifics


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Investigator-initiated R&D

    • Research projects related to the NIH

      mission

    • “Other” areas of research within the

      mission of an awarding component

    SBIR/STTR Program Descriptions and Research Topics

    Suggested topic areas

    Biodefense

    Biosensors

    Nanotechnologies

    Bioinformatics

    Diagnostic and Therapeutic Devices

    Telehealth

    Biosilicon devices

    Biocompatible materials

    Acousto-optics /opto-electronics

    Imaging devices

    Genetically engineered proteins

    Proteomics / Genomics

    Keyword search the Solicitation

    Ctrl - F


    Cover letter a valuable tool

    Cover Letter: A Valuable Tool

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

    • Request SBIR/STTR study section

      • http://www.csr.nih.gov/Roster_proto/sbir_section.asp

    • Suggest key areas of expertise required

    • Indicate individual(s) or organization(s) in conflict

    • For resubmission, indicate review history

    • Justify your requests


    Targeted sbir sttr funding opportunity announcements

    Targeted SBIR/STTR Funding Opportunity Announcements

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

    • 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.


    Electronic submission

    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


    Important application changes effective january 25 2010

    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


    Updates

    Updates

    • Error correction window:

      • Eliminated effective January 25, 2011. (NIH Guide Notice NOT-OD-10-123)

      • Until January 25, 2011, two business days to correct errors and warnings.

    • Resubmissions: Must be submitted no later than 37 months after initial receipt date. (NIH Guide Notice NOT-OD-10-140)

    • New Reporting Requirement: Transparency Act requires reporting on subawards over $25K & executive compensation (NIH Guide Notice NOT-OD-11-005)

    • Annotated forms: http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Small Business

    Concern

    Applicant Initiates

    Research Idea

    Scientific Review Groups

    Evaluate Scientific Merit

    Advisory Council or Board

    Recommend approval

    IC Allocates

    Funds

    NIH Application and Review Process

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

    NIH Center for Scientific Review

    Assign to IC and IRG

    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


    Matthew portnoy phd sbir sttr program coordinator office of extramural research 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


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Competing Successfully for SBIR/STTR Funding

    • 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.


    Matthew portnoy phd sbir sttr program coordinator office of extramural research 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

    “In-NIH-vative” Approaches


    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)


    Nih sbir sttr program summary of key features

    NIH SBIR/STTR Program Summary of Key Features

    • SBIR and STTR Program

      • Single SBIR/STTR grant solicitation

      • Investigator-initiated research ideas

      • Special Funding Opportunities

        (NIH Guide for Grants and Contracts)

      • Electronic Submission (grants only)

      • Awards: Grants, Contracts,

        Cooperative Agreements

    • 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

    • Gap Funding Programs

      • Phase IIB Competing Renewals

      • Ph I/Ph II Fast Track

      • Administrative Supplements

    • Multiple Receipt Dates (Grants)

      • April 5, August 5, December 5

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

      • Contracts: Early November

    • Budget and Project Period

      • $150K/6 -12months (Ph I)

      • $1M/2 yrs (Ph II)

    • Technical Assistance Programs

      • Technology Niche Assessment

      • Commercialization Assistance

      • Pipeline to Partnerships (P2P)

    Summary


    Topics to discuss today1

    Topics to Discuss Today

    • NIH SBIR/STTR Program Specifics

    • Red Lights and Yellow Lights

    • Answer Your Questions!


    Eligibility criteria subject to change

    Eligibility CriteriaSubject to change

    • 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 subject to change

    Ownership And AffiliationsSubject to change

    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 affiliations

    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


    Pd pi role on sttr1

    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


    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


    Tips for potential applicants

    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 – they 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.


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Top 10 Reasons


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Top 10 Reasons

    10. Over $2.5 Billionavailable- annually

    9.NOT A LOAN - no repayment

    8. Provides recognition, verification

    and visibility

    7.Potentialleveraging tool to attract venture capital/other sources of $$$


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Top 10 Reasons

    6. Foster partnerships (universities, large

    corporations)that enhance

    competitivenessofsmall businesses in

    marketplace

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

    4. Provides seed money to fund high

    risk projects


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Top 10 Reasons

    3.Intellectual property rights normally retained by thesmall business

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


    Matthew portnoy phd sbir sttr program coordinator office of extramural research nih

    Intralase Corporation

    Top 10 Reasons

    Design Continuum, Inc.

    • Opportunity to improve the health ofAmerica

    Xilas Medical, Inc.

    GlycoFi, Inc.

    Altea Therapeutics Corporation

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

    Cardiac Assist, Inc.

    Cyberkinetics Neurotechnology Systems, Inc.


    For more information

    Matthew Portnoy, PhD

    NIH SBIR/STTR Program Coordinator

    Phone: 301- 435-2688

    Email: [email protected]

    For More Information

    Robert Vinson

    SBIR/STTR Program Analyst

    Phone: 301-435-2713

    Email: [email protected]

    Lenka Fedorkova, PhD

    SBIR/STTR Program Analyst

    Phone: 301-435-0921

    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


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