michael huerta, phd associate director for program development national library of medicine, nih
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Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH. From the Lab to the Marketplace NIH SBIR/STTR Programs. National Institutes of Health. NIH Regional Seminar June 2011. SBIR & STTR Purpose. Stimulate technological innovation. - PowerPoint PPT PresentationTRANSCRIPT
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Michael Huerta, PhDAssociate Director for Program Development
National Library of Medicine, NIH
From the Lab From the Lab to the Marketplaceto the Marketplace
NIH SBIR/STTR ProgramsNIH SBIR/STTR Programs
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NIH Regional SeminarJune 2011
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SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small business concerns and research institutions
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission & priority of the awarding
unit (Institute or Center)
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission of the awarding unit
SBIR/STTR Program Overview
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SBIR & STTR Awards
• Awards are funds to the small business from the federal government – control levels vary• Grants • Cooperative Agreements• Contracts
• Awards support specific R & D projects (not general business costs, infrastructure, etc.)
• Awards do not require• Repayment or debt service• Equity or intellectual property forfeiture
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How much is awarded through SBIR & STTR programs?
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How much is awarded through SBIR & STTR programs?
$2.4 Billion in FY 2010
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How much is awarded through SBIR & STTR programs?
$2.4 Billion in FY 2010
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How much is awarded through SBIR & STTR programs?
$2.4 Billion in FY 2010NIH SBIR: $616 MNIH STTR: $ 74 MTotal: $690M
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How much is awarded through SBIR & STTR programs?
$2.4 Billion in FY 2010NIH SBIR: $616 MNIH STTR: $ 74 MTotal: $690M
SBIR 2.5 %STTR 0.3 %
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NIH SBIR & STTR Programs Summary of Key Features
• SBIR & STTR Programs Single SBIR/STTR grant solicitation Investigator-initiated research ideas Special FOAs (see NIH Guide for Grants and Contracts) Electronic Submission (grants only) Awards always made to small business concern
• Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, September 7, January 7 (AIDS) Contracts: Early November
• Budget and Project Period – Guidelines $100-150K/6 -12months (Ph I) $750K-1M/2 yrs (Ph II) Deviations permitted where scientifically appropriate (eg, FOAs)
• 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 once
• 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)
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• 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
SBIR and STTR: Critical Differences
• PI 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 – for SBIR only one PI must be primarily employed by SBC
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PHASE II Full Research/R&D $750K (STTR) or $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 – not funded by gov’t NIH is generally not the “customer” Consider partnering and exit strategy early
PHASE I Feasibility Study Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs Project Period: 6 months (SBIR) or 1 year (STTR)
NIH SBIR/STTR: 3-Phase ProgramPer Congressional Guidelines – FOAs Vary
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• Purpose: Peer-reviewed continuation of Phase II R & D for complex projects
• Parameters: Up to $1M/year for up to 3 years
• Eligibility: Must have Phase II award // contact program officer for eligibility
•Participating ICs: NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR
Phase IIB Competing Renewal Award
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Beyond the Guidelines
The duration and amount of the SBIR or STTR award may exceed the congressional guidelines
• As required by the project – contact program officer before submitting the application to find out what would be allowed
• As allowed by special funding opportunity announcements (FOAs), for example PA-11-134, Lab to Marketplace:
•Phase I – up to $350,000 per year for up to two years•Phase II – up to $600,000 per year for up to three years•Phase IIB – up to $800,000 per year for up to three years
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Beyond the Guidelines
The duration and amount of the SBIR or STTR award may exceed the congressional guidelines
One project could be supported with ~ $6 million over 8 years (Ph I, II, & IIB)!
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Phase I Phase II Phase III
Mind the Gap
Mt. “FDA”
• No-Cost Extension• Phase I / Phase II Fast Track• Administrative / Competitive Supplements
Phase IIB Competing Renewal Award
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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/MilestonesAims/MilestonesNOT MetNOT Met
Go?
No Go?
NIH Phase I/Phase II Fast-Track
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission of the awarding unit
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission of the awarding unit
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SBIR/STTR Eligibility Criteria
U.S. small business organized for-profit
At least 51% U.S.- owned by individuals and independently operated or , for SBIR, at least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals
500 or fewer employees, including affiliates
SBIR: At least one PI primarily employed with the small business (STTR: not stipulated)
STTR: Formal collaboration between small business and research institution
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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
More SBIR/STTR EligibilityCheckpoints
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Additional Eligibility Issues
• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PD/PI is not required to have a Ph.D.
• 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
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission of the awarding unit
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission & priority of the awarding
unit (Institute or Center)
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Office of the Director
National Institute On Minority Health
and Health Disparities
NIH Institutes and Centers (ICs)
http://www.nih.gov/icd
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis andMusculoskeletal
and 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 ResearchResources
National Instituteof Biomedical
Imaging and
Bioengineering
No funding authority
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NIH Institutes & Centers SBIR & STTR Budget Allocations
NIDDKNIGMS
FY 2010 SBIR/STTR Budget Allocations to NIH ICs:
SBIR: $616 M STTR:$ 74 M Total: $690 M
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Submitted grant applications get appropriate assignment
• Applications received by CSR and assigned to:• A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration
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Submitted grant applications get appropriate assignment
• Applications received by CSR and assigned to:• A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration
Appropriate, however, is not necessarily optimal
You can help determine optimal assignment
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Relationship between project and study section
• Dozens of study sections with different • Areas of review responsibility• Expertise of peer reviewers
• Overlap from one study section to another
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Relationship between project and study section
• Dozens of study sections with different • Areas of review responsibility• Expertise of peer reviewers
• Overlap from one study section to another
Each study section has unique scientific focus and each reviewer has unique perspective
Determine the best match for your project
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How to determine which study section is best for your project
• Center for Scientific Review (CSR) web site:• Scientific focus of each study section• List of study sections with similar scientific foci• Roster of members of each study section
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How to determine which study section is best for your project
• Center for Scientific Review (CSR) web site:• Scientific focus of each study section• List of study sections with similar scientific foci• Roster of members of each study section
If more than one seems great,
Communicate with scientific review officers of those study sections for further guidance
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Relationship between project and IC
• Dozens of ICs with different • Missions – purviews of responsibility• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!
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Relationship between project and IC
• Dozens of ICs with different • Missions – purviews of responsibility• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!• Technologies are often cross-cutting, e.g.:
• Neuroimaging tool – cancer or stroke• Microfluidic chamber – deliver drug or growth factor
• Context of grant application or test bed for proposed feasibility test may determine IC
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How to determine which IC is the best fit for your project
• Web sites of ICs• List research priorities, strategic plans, etc.
• Annual Omnibus Solicitation for SBIR and STTR Grant Applications• ICs list specific research topics
• Special FOAs• Clear indication of participating ICs’ interests
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How to determine which IC is the best fit for your project
• Web sites of ICs• List research priorities, strategic plans, etc.
• Annual Omnibus Solicitation for SBIR and STTR Grant Applications• ICs list specific research topics
• Special FOAs• Clear indication of participating ICs’ interests
After narrowing down list of possible ICs, talk to the program officer(s) about your specific idea
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• Request potential awarding component(s): NIH Institutes/Centers – refer to program officer communication as appropriate
• Request SBIR/STTR study section• Indicate key areas of review expertise required• Indicate individual(s)/organization(s) in conflict• For resubmission, indicate review history • Justify all the requests you make
Cover Letter - Follow up for optimal assignment
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SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small business concerns and research institutions
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Achieving the Purpose
• Through SBIR & STTR awards• To small businesses• Supporting research & development of
commercializable, innovative technologies• Serving the mission & priority of the awarding
unit (Institute or Center)
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Drilling Down
Further Information, Details, and Tips
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Small Business Concern
Research idea – then contact NIH
Grantee Conducts Research
IC Staff Prepare funding Planfor IC Director
NIH Center for Scientific ReviewAssign to IC and Study Section
Scientific Review GroupsEvaluate Scientific Merit
IC Advisory Council or BoardConcurs with Review
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!
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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
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NIH SBIR/STTR Success Rates FY2010
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• Understand mission & priorities • IC Web sites, Omnibus Solicitation, FOAs
• Propose innovative ideas with significance as well as scientific and technical merit
• Give yourself ample time to prepare application
• Contact NIH Staff to discuss:• Research idea early on – program staff• Assignment issues – program and review staff• Outcome of your review – program staff
Keys to Success
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Phase I Phase II Phase III
NIH Technical Assistance Program
Mt. “FDA”???Commercialization Assistance
Program
Niche Assessment Program
Helping Companies cross the “Valley of Death”
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Technical Assistance Programs Understanding the “B” in SBIR
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)
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NIH Pipeline to Partnerships
Finding a Partner
• Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies
• Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors
• Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease
“In-NIH-vative” Approaches
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NIH Pipeline to Partnerships (P2P)
http://www.ott.nih.gov/p2p/index.aspx
SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners.
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POTENTIAL PARTNERS / INVESTORS
Identifies technology of interest and contacts company
NIH Pipeline to Partnerships (P2P)
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Summary of NIH SBIR & STTR
• Investments in innovation & economic growth• Advance the NIH mission & human health • Support and validate small business R & D• Extraordinary latitude in awards• Extraordinary assistance from idea to market
• Scientific aspects• Administrative aspects• Business aspects
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Eligibility Criteria
• Ownership: US-owned, independently operated
• Affiliations: Research Institutions,
Foundations, Foreign “Parents”
• Size: 500 employees maximum
• Business Structure: Inc, LLP, LLC, ...
• Principal Investigator: Employment
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Ownership And Affiliations
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.
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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
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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
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STTR Eligibility Criteria
• Applicant Organization
• Research Institution Partner
• Project Director/Principal Investigator
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STTR Applicant Organization
Small Business Concern is ALWAYS
the applicant/awardee organization
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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
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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
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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
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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