Takin ’ Care of Business: SBIR/STTRs
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Transcript of Takin ’ Care of Business: SBIR/STTRs
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: [email protected]
Lenka Fedorkova, PhDAssistant Program Manager
Phone: 301-435-0921Email: [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
Robert Vinson, Jr.Assistant Program Manager
Phone: 301-435-2713Email: [email protected]