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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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slide1
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!
slide3
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

slide4
And….
  • This capital is in the form of
  • grants and contracts
          • no repayment
          • no debt service
          • no equity forfeiture
          • no IP forfeiture
slide5

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

slide8

NIH Mission

Improve human health through biomedical and behavioral research,

research training and communications.

slide9

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

slide10

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

slide11

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

slide12

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

slide15

NIH SBIR/STTR Budget Allocations FY2012

2.6% SBIR $632M

0.35% STTR $85M

Total FY2012 $717M

slide18

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

slide21

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

slide22

Solicitations and Due Dates

http://sbir.nih.gov

slide23

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: August Receipt 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

slide24

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
slide30

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

slide31

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
slide32

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.
slide33

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.
slide50

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 $$$

slide51

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

slide52

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

slide53

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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