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Takin ’ Care of Business: SBIR/STTRs . NIH Regional Seminar on Program Funding & Grants Administration June 27-28, 2013 Baltimore, MD. Robert Vinson, Jr. Assistant Program Manager NIH SBIR/STTR Program Office. Topics to Discuss Today. * NIH SBIR/STTR Program Specifics

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Takin care of business sbir sttrs

Takin’ Care of Business:SBIR/STTRs

NIH Regional Seminar on Program Funding & Grants Administration June 27-28, 2013 Baltimore, MD

Robert Vinson, Jr.

Assistant Program Manager

NIH SBIR/STTR Program Office


Topics to discuss today

Topics to Discuss Today

  • * NIH SBIR/STTR Program Specifics

  • * Red Lights and Yellow Lights

  • * Answer Your Questions!


Takin care of business sbir sttrs

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

SBIR/STTR Programs

NIH SBIR: $632 M

NIH STTR: $ 85 M

Total: $717M


Takin care of business sbir sttrs

and….

  • This capital is in the form of

  • grants and contracts

    • no repayment

    • no debt service

    • no equity forfeiture

    • no IP forfeiture


Takin care of business sbir sttrs

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.

2.7%*

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


Takin care of business sbir sttrs

NIH Mission

Improve human health through biomedical and behavioral research,

research training and communications.


Takin care of business sbir sttrs

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


Takin care of business sbir sttrs

  • 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


Takin care of business sbir sttrs

SBIR/STTR 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 controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals


Takin care of business sbir sttrs

more EligibilityCheckpoints

  • 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

    Award is always made to Small Business Concern

    * Research Partner

    • SBIR:Permitspartnering

      33% Phase I and 50% Phase II

    • STTR: Requirespartnering with Research Institution

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


    Important facts to remember

    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 PhD/MD

    * 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


    Takin care of business sbir sttrs

    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


    Takin care of business sbir sttrs

    Mt. “FDA”

    Gap Funding Programs

    PhaseIIBCompetingRenewalAward

    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

    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

    Bridging the Phase I - II Funding Gap

    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 renewals

    Phase IIB Competing Renewals

    Purpose

    * 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)

    or…NCI, NHLBI, NINDS specific announcements, ex:

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

    (see PA-11-135)

    “In-NIH-vative” Approaches


    Takin care of business sbir sttrs

    Phase IIB Competing Renewals

    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


    Takin care of business sbir sttrs

    Solicitations & Due Dates

    http://sbir.nih.gov


    Takin care of business sbir sttrs

    Solicitations & 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-13-088) STTR: (PA-13-089)

    NIH (24 ICs) – SBIR & STTR

    FDA – SBIR only

    CDC – SBIR only

    ACF– SBIR only

    NIH SBIR/STTR Program Specifics


    Takin care of business sbir sttrs

    Investigator-initiated R&D

    • * Research projects related to the NIH

      mission

    • *“Other” areas of research within the

      mission of an awarding component

    Descriptions & 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 foa

    Targeted SBIR/STTR FOA

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

    * NIH Guide for Grants and Contracts

    - High priority areas for ICs

    - Various IC participation

    - Nuances:

    a) Various due dates

    b) Additional review criteria

    c) Limited funds and project duration periods

    d) Etc.


    Electronic submission

    Electronic Submission

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

    • 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)


    Important application changes effective january 25 2010

    Important Application Changes (Effective January 25, 2010)

    Research Plan

    Background & Significance

    Preliminary Studies/Progress Report

    Research Design and Methods

    Research Strategy

    Significance

    Innovation

    Approach

    Guide Notice: NOT-OD-09-149

    • 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


    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


    Takin care of business sbir sttrs

    Small Business

    Concern

    Applicant Initiates

    Research Idea

    Scientific Review Groups

    Evaluate Scientific Merit

    Advisory Council or Board

    Recommend approval

    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 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


    Takin care of business sbir sttrs

    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


    Takin care of business sbir sttrs

    Competing Successfully

    • ∙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:

      • a) your research idea.

      • b) outcome of your review.

      • c) challenges and opportunities.


    Takin care of business sbir sttrs

    Mt. “FDA”

    ???

    Technical Assistance Programs

    Helping Companies cross the “Valley of Death”

    Niche Assessment Program

    Commercialization Assistance Program

    Phase II

    Phase I

    Phase III

    “In-NIH-vative” Approaches


    Technical assistance programs

    Niche Assessment

    Identifies other uses of technology

    Determines competitive advantages

    Develops market entry strategy

    (Phase I awardees)

    Technical Assistance Programs

    • “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)

    Commercialization

    Assistance


    Summary of key features

    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 w/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.


    Takin care of business sbir sttrs

    Top 10 Reasons


    Takin care of business sbir sttrs

    Top 10 Reasons

    10. Over $2.5 Billion available annually

    9.NOT A LOAN - no repayment

    8. Provides recognition, verification

    and visibility

    7.Potentialleveraging tool to attract

    venture capital/other sources of

    $$$$$


    Takin care of business sbir sttrs

    Top 10 Reasons

    6. Foster partnerships (universities, large

    corporations) that enhance

    competitiveness of small businesses in

    marketplace

    5. Creates jobs / stimulates local and state

    economies –stronger National Economy

    4. Provides seed money to fund high

    risk projects


    Takin care of business sbir sttrs

    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


    Takin care of business sbir sttrs

    Intralase Corporation

    Top 10 Reasons

    Design Continuum, Inc.

    • Opportunity to improve the health of America

    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, Jr.

    Assistant Program Manager

    Phone: 301-435-2713

    Email: [email protected]

    Lenka Fedorkova, PhD

    Assistant Program Manager

    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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