Takin’ Care of Business:SBIR/STTRs

Robert Vinson, Jr.Assistant Program ManagerNIH SBIR/STTR Program Office

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

Topics to Discuss Today

* NIH SBIR/STTR Program Specifics

* Red Lights and Yellow Lights

* Answer Your Questions!

The largest, most accessible source of

SEED CAPITAL for the nation’s innovative small

businesses$2.5 Billion in FY 2012

SBIR/STTR Programs

SBIR/STTR Set-Aside

$2.5B

NI H$717M

NIH SBIR: $632 MNIH STTR: $ 85 M Total: $717M

and….

This capital is in the form ofgrants and contracts

• no repayment• no debt service• no equity forfeiture • no IP forfeiture

SBIR/STTR Program Overview

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization.

SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMSet-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

Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017

* 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

SBIR/STTR Program Overview

STTR Purpose and Goals

Small Business Research and Development Enhancement Act of 1992

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

* 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

SBIR/STTR Program Overview

NIH Mission

Improve human health through biomedical and

behavioral research, research training and

communications.

Office of the Director

National Institute on Minority Health

and Health Disparities

Organizational Structure of NIHhttp://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor Advancing

Translational Sciences

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

Center for Information Technology

Center for Scientific Review

NIH Clinical Center

Office of Research Infrastructure Programs

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

PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR)

NIH SBIR/STTR: 3-Phase Program

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

STTR: Formal collaborative effort means:* Minimum 40% by small business* Minimum 30% by U.S. research institution

STTR: Intellectual Property Agreement NeededAllocation 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

more Eligibility Checkpoints

SBIR/STTR Program Overview

SBIR and STTR: Critical Differences

* Research Partner

SBIR: Permits partnering 33% Phase I and 50% Phase II

STTR: Requires partnering with Research Institution

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

Award is always made to Small Business Concern

* 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

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

NCI

NIAID

NHLBINIGMSNIDDKNINDS

NIMH

NICHD

NIA

NIDA

NEINCATS

NIEHS

NI-AMS

NHGRI

NI-AAA

NIDCD

NIDCRNIBIB NIMHD ORIP NINR NCCAMNLM

NIH SBIR/STTR Budget Allocations FY2012

2.6% SBIR $632M0.35% STTR $85MTotal FY2012 $717M

NIH SBIR/STTR Success Rates

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

AwardedSuccess

Rate Total Funding

2010 SBIR Fast Track 430 67 15.6% $16,795,1502010 SBIR Phase 1 4,496 614 13.7% $129,218,3712010 SBIR Phase 2 734 246 33.5% $146,228,9592010 STTR Fast Track 47 11 23.4% $2,300,9712010 STTR Phase 1 539 109 20.2% $21,620,3992010 STTR Phase 2 92 32 34.8% $18,207,1132010 FY TOTAL 6,338 1,079 17.0% $334,370,9632011 SBIR Fast Track 409 42 10.3% $10,059,9042011 SBIR Phase 1 4,672 536 11.5% $123,802,0742011 SBIR Phase 2 681 203 29.8% $137,152,6872011 STTR Fast Track 42 4 9.5% $813,9002011 STTR Phase 1 508 80 15.7% $18,321,5162011 STTR Phase 2 103 37 35.9% $20,977,5842011 FY TOTAL 6,415 902 14.1% $311,127,665

HHS/NIH Program Funding

2012 Budget SBIR STTR

NIH $632M $85M

CDC FDAACF

$8.3M$1M

~350KN/A

Phase I $150K*6 months*

$150K*1 year*

Phase II $1M* 2 years*

$1M* 2 years*

Phase I Phase II Phase III

Gap Funding Programs

Mt. “FDA”

• No-Cost Extension• Phase I / Phase II Fast Track• Administrative / Competitive Supplements

Phase IIB Competing Renewal Award

NIH SBIR/STTR Program Specifics

Bridging the Phase I - II Funding Gap

(Simultaneous Submission and Concurrent Review)

SBIR/STTR Phase I + Phase II

Phase I Award

7-9 months

Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones

Phase II award

Aims/Milestones Met

Phase II award

Aims/MilestonesNOT Met

Go?

No Go?

NIH Phase I/Phase II Fast-Track

“In-NIH-vative” Approaches

* 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)

Purpose

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)

Phase IIB Competing Renewals

“In-NIH-vative” Approaches

* 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

Contact NIH Program Staff to discussEligibility

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)

Phase IIB Competing Renewals

“In-NIH-vative” Approaches

http://sbir.nih.govSolicitations & Due Dates

* 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 SolicitationRelease: August Receipt Date: November

Solicitations & Due Dates

Parent FOAs: SBIR: (PA-13-088) STTR: (PA-13-089)

NIH SBIR/STTR Program Specifics

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

NIH (24 ICs) – SBIR & STTR FDA – SBIR only CDC – SBIR only ACF– SBIR only

BiodefenseBiosensorsNanotechnologiesBioinformaticsDiagnostic and Therapeutic DevicesTelehealth

Biosilicon devicesBiocompatible materialsAcousto-optics / opto-electronicsImaging devicesGenetically engineered proteinsProteomics / Genomics…

Suggested topic areas

Descriptions & Research Topics

Investigator-initiated R&D

* Research projects related to the NIH mission

* “Other” areas of research within the mission of an awarding component Keyword search the Solicitation

Ctrl - F

*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

Cover Letter: A Valuable Tool

Targeted SBIR/STTR FOA

* NIH Guide for Grants and Contracts- High priority areas for ICs- Various IC participation- Nuances:

a) Various due datesb) Additional review criteriac) Limited funds and project duration periodsd) Etc.

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

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)

• 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

1. 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.

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

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

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

Small Business Concern

Applicant Initiates

Research Idea

Grantee Conducts Research

IC Staff Prepare funding Planfor IC Director

NIH Center for Scientific ReviewAssign to IC and IRG

Scientific Review GroupsEvaluate Scientific Merit

Advisory Council or BoardRecommend approval

IC Allocates

Funds

SubmitsSBIR/STTR Grant Application to NIH

Electronically

~2-3 monthsafter submission

~2-3 months

after review

Application & Review Process

NIH SBIR/STTR Program Specifics

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

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

∙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.

Competing Successfully

Phase I Phase II Phase III

Technical Assistance Programs

Mt. “FDA”???Commercialization Assistance

Program

Niche Assessment Program

Helping Companies cross the “Valley of Death”

“In-NIH-vative” Approaches

Technical Assistance Programs

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)

Niche Assessment Identifies other uses of technology Determines competitive advantages Develops market entry strategy

(Phase I awardees)

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

* 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)

* 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

* Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P)

Summary

Topics to Discuss Today

* NIH SBIR/STTR Program Specifics

* Red Lights and Yellow Lights

* Answer Your Questions!

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 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

* 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

* 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

* Applicant Organization

* Research Institution Partner

* Project Director/Principal Investigator

STTR Applicant Organization

Small Business Concern is ALWAYS

the applicant/awardee organization

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: 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

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 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

* 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

* 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.

Top 10 Reasons

Top 10 Reasons

10. Over $2.5 Billion available annually

9. NOT A LOAN - no repayment

8. Provides recognition, verificationand visibility

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

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

4. Provides seed money to fund high risk projects

6. Foster partnerships (universities, large corporations) that enhance competitiveness of small businesses in marketplace

Top 10 Reasons

3. Intellectual property rights normally retained by the small business 2. Small business concerns recognized as a unique national resource of technological innovation

Top 10 Reasons

Top 10 Reasons

Cardiac Assist, Inc.

Intralase Corporation

Xilas Medical, Inc.

Cyberkinetics Neurotechnology Systems, Inc.

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

GlycoFi, Inc.

Altea Therapeutics Corporation

Design Continuum, Inc.

1. Opportunity to improve the health of America

For More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301-435-2688Email: mportnoy@mail.nih.gov

Lenka Fedorkova, PhDAssistant Program Manager

Phone: 301-435-0921Email: fedorkoval@mail.nih.gov

Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text

in the message body: subscribe SBIR-STTR your name

Robert Vinson, Jr.Assistant Program Manager

Phone: 301-435-2713Email: vinsonr@mail.nih.gov