11 nih sbir & sttr programs features and nuances

11

NIH SBIR & STTR Programs

Features and Nuances

22

NIH SBIR/STTR MISSION

Though investment in scientific and technological innovation the

SBIR/STTR programs develop products, processes and services

that improve the health of the American people and build a

strong U.S. economyOne small business at a time.

33

Office of the Director

National Center on Minority Health

and Health Disparities

Organizational Structure of NIH

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

44

1. Stimulate technological innovation

2. Use small business to meet federal R&D needs

3. Foster and encourage participation by minorities and disadvantaged persons in technological innovation

4. Increase private-sector commercialization innovations derived from federal R&D

Four Major Congressional Goals

55

• Improve human health through prevention, detection, diagnosis and treatment of disease or disability• Speed process of discovery• Reduce cost of medical care• Improve research tools/ reduce cost of research• Increase health knowledge base

SBIR/STTR Programs Are Fully Integrated With the NIH Research Mission

Bridging the Discovery to Development Gap

NIH SBIR/STTR Program Specifics

66

NIH INSTITUTE/CENTER SBIR/STTR NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2010)BUDGET ALLOCATIONS (FY2010)

Extramural R&D Set-Asides:SBIR = 2.5%STTR = 0.3%

NIDDKNIGMS

FY 2010 SBIR/STTR Budget Allocations to NIH ICs:

$616 M (SBIR) $ 74 M (STTR)

Total: $690 M

77

Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R&D --

with potential for commercialization.

Small Business Technology Transfer (STTR) Set-aside program to facilitate

cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization.

Program Descriptions

2.5%

0.3%

88

SBIR/STTR: 3-Phase Program

PHASE I – Feasibility Study• $150K and 6 months (SBIR) • $100K and 12 months (STTR)

PHASE II – Full Research/R&D• $1 million and 2-year Award – (SBIR)• $750K and 2-year Award - (STTR)

PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds

FAST TRACK – Combines Phase I and II Applications• Shortens funding cycle between Phase I and II

99

Organized for- profit U.S. business 500 employees or fewer, including

affiliates PI’s primary employment must be with

the small business concern at the time of award and for the duration of the project period.

SBIR PROGRAM ELIGIBILITY CHECKPOINTS

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Small business concern must be: At least 51% U.S.- owned by

individuals and independently operated or At least 51% owned and controlled by

another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

SBIR PROGRAM ELIGIBILITY CHECKPOINTS

1111

Formal Cooperative R&D Effort • Minimum 40% by small business• Minimum 30% by U.S. research institution

U.S. Research Institution• College or University; other non-profit research

organization; Federal R&D center

Intellectual Property Agreement•Allocation of Rights in IP and Rights to Carry out

Follow-on R&D and Commercialization

STTR PROGRAMELIGIBILITY CHECKPOINTS

1212

PERFORMANCE of RESEARCH ACTIVITIES

“All research/R&D must be performed in its entirety in the U.S.”

• Rare cases to conduct testing of specific patient populations outside U.S. is allowable• Travel to scientific meeting in foreign country allowable• Foreign consultants/collaborators allowable, but must perform consulting in U.S.

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SBIR-STTR Comparisons

RequirementsRequirements SBIR (Grants & Contracts)SBIR (Grants & Contracts) STTR (Grants only)STTR (Grants only)

PurposePurpose To support high-risk feasibility projectsTo support high-risk feasibility projects To support high-risk feasibility projects with To support high-risk feasibility projects with research institution partnershipresearch institution partnership

ApplicantApplicant Small Business (SB)Small Business (SB) Small Business (SB)Small Business (SB)

Award PeriodAward Period Phase I – 6 months, normallyPhase I – 6 months, normally

Phase II – 2 years, normallyPhase II – 2 years, normally

Phase I – year, normallyPhase I – year, normally

Phase II – 2 years, normallyPhase II – 2 years, normally

Total CostsTotal Costs Phase I - $150K, normallyPhase I - $150K, normally

Phase II - $1,000 mil.Phase II - $1,000 mil.

Phase I $100K, normallyPhase I $100K, normally

Phase II $750K, normallyPhase II $750K, normally

PIPI Employed by company more than 50% of time Employed by company more than 50% of time during award.during award.* * Minimum level of effort on the Minimum level of effort on the project not stipulated.project not stipulated.

Employment not stipulated.Employment not stipulated.

PI must spend a minimum of 10% effort on PI must spend a minimum of 10% effort on the project the project

Subcontracts/Subcontracts/

ConsultantsConsultants

Phase I – Total amount normally may not Phase I – Total amount normally may not exceed 33% of total costexceed 33% of total cost**

Phase II – Total amount normally may not Phase II – Total amount normally may not exceed 50% of total costexceed 50% of total cost**

Phase I and II SB must perform minimum Phase I and II SB must perform minimum 40% of work and the single, partnering U.S. 40% of work and the single, partnering U.S. non-profit research institution must perform non-profit research institution must perform at least 30% of the work. at least 30% of the work. No deviations No deviations allowedallowed.. There must be an IP agreement There must be an IP agreement established at time of award.established at time of award.

Performance SitePerformance Site Must be entirely in U.SMust be entirely in U.S..**

Part of research must take place in company-Part of research must take place in company-controlled space.controlled space.

Must be entirely in U.S.Must be entirely in U.S.** Part of research Part of research must take place in company-controlled must take place in company-controlled space and part in the partnering U.S. space and part in the partnering U.S. research institution.research institution.

** = Deviations permitted = Deviations permitted with written justification with written justification and approvaland approval from from programprogram

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OUR IDEAS

1. SBIR/STTR Omnibus Solicitation (NIH, CDC, and FDA) Release: January

Topics listed reflect a range of areas of interest & are not intended to be exhaustive

2. SBIR Contract Solicitation (NIH, CDC) Release: August Early November receipt date

3. NIH Guide for Grants and Contracts Release: Weekly Various receipt dates

4. NIH Institute Websites – see their workshop and working group meeting reports

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SBIR/STTR Omnibus Solicitation

• SBIR Parent Funding Opportunity Announcement(PA-10-050) http://grants.nih.gov/grants/guide/pa-files/PA-10-050.html

• STTR Parent Funding Opportunity Announcement (PA-10-051) http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html

• SBIR/STTR Program Descriptions and Research Topicshttp://grants.nih.gov/grants/funding/sbir.htm

Submission Dates:

April 5, Aug 5, Dec 5

AIDS/AIDS-Related Dates:May 7, Sept.7,Jan 7

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NIH Guide for Grants and Contracts

Targeted Funding Opportunities:http://grants.nih.gov/grants/funding/sbir_announcements.htm

New Approaches to Arrhythmia Detection and Treatment

• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-10-117.html

• STTR: http://grants.nih.gov/grants/guide/pa-files/PA-10-118.html

Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, and Blood Diseases


• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-250.html

Innovations in Biomedical Computational Science and Technology Initiative

• SBIR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-220.html

• STTR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-221.html

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Robotics Technology Development and Deployment (R43)

• http://grants.nih.gov/grants/guide/pa-files/PAR-10-279.html

• Receipt Date: December 20, 2010

Bioengineering Nanotechnology Initiative



New Technologies for Transient Molecular Complex Characterization



SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries (R43/R44)

• http://grants.nih.gov/grants/guide/pa-files/PA-10-122.html

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Manufacturing Processes of Medical, Dental, and Biological Technologies



Energy Efficiency and Renewable Energy System Technology Research and Development



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Annual SBIR Contract Solicitation

Receipt Date: November 8, 2010

•SBIR Only

•NIH & CDC – Various ICs

•Narrowly-focused Topics

NHLBI Topics:•Development of Pathogen Inactivation Technologies for Blood Components

•Point-of-Care Assay for Engraftment Potential of Umbilical Cord Stem Cells

•Novel Technologies for Powering Ventricular Assist Devices

•Informatics Tools and Services to Support Data Sharing and Distribution for Cardiovascular, Lung, and Blood Researchers

•Interventional MRI and X-ray Invasive Hemodynamics Telemetry

•Novel Concepts in Safe “Active” Transmission Lines for MRI Catheters

•Strategy for Finding Cases of Moderate-to-Severe COPD

•Reagents for Studying Human Lung Cell Biology and Cellular Function

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

2020

• Research projects related to the NIH mission

• “Other” areas of research within the mission of an awarding component

Your Ideas …

Investigator-initiated R&D

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• DOD SBIR/STTR• HHS SBIR/STTR• NASA SBIR/STTR• DOE SBIR/STTR• NSF SBIR/STTR• DHS SBIR • USDA SBIR• DOC SBIR• ED SBIR• EPA SBIR• DOT SBIR

http://www.sbir.gov/

SBIR / STTR Participating Agencies

TOTAL ~ TOTAL ~ $2.3 + B$2.3 + B

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NUANCESNIH SBIR & STTR Programs

• Multiple Submission Dates

• Revise & Resubmit

• Multiple Funding Opportunities

• Multiple Award Mechanisms

• Investigator-initiated Research

• Communication Throughout Process

2323

NUANCESNIH SBIR & STTR Programs

• Budget & Project Duration Guidelines • Not Phase III Customer

• Technical & Commercialization Assistance Programs

• ELECTRONIC SUBMISSION OF APPLICATIONS

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0

5

10

15

20

25

30

35

40

45

SBIR STTR

Phase I

Phase II

Fast-Track

NIH SBIR/STTR Success RatesS

ucc

ess

Rat

e (%

)

$672 M SBIR/STTR

654

262

33

54

105

40.6%

23.1%

19.6%

31.1%

14.9%

22%

PRELIMINARY -- Fiscal Year 2009

7

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Review Criteria

1. Significance2. Approach3. Innovation4. Investigators 5. Environment

… Protection of Human Subjects… Animal Welfare… Budget

Program staff do NOT participate in peer review process

STUDY SECTIONS DO NOT FUND!

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• Suggest potential awarding component(s)

• Request same or different Request same or different study sectionstudy section

• Suggest key areas of expertise Suggest key areas of expertise requiredrequired

• Indicate individual(s) or organization(s) in conflict

Cover Letter: A Valuable Tool

2727

What Reviewers Say…Common Pitfalls with Applications

• Inadequately defined test of feasibility• Lack of sufficient experimental detail• Questionable reasoning in experimental approach• Failure to consider potential pitfalls and alternatives• Lack of innovation• Unconvincing case for commercial potential or societal

impact• Lack of experience with essential methodologies• Unfamiliar with relevant published work• Unrealistically large amount of work proposed

2828

NHLBI Phase II Competing Renewals

• Goal: Take existing, promising compound or devices developed under a Phase II award through the next step of discovery and development.

• Stipulations:– Available only to NHLBI Phase II awardees– Focus -- Diagnostics, devices, tissue engineering, drug

development, related to NHLBI’s mission– Funding level: $1M per year for maximum of 3 years– Applicant must have had interaction with the FDA

Contact Program Staff Prior to Submission

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Technical Assistance Programs

Commercialization Assistance (CAP)(Announced in Aug. Apps. Due mid Sept.)

Business & strategic planning

Builds alliances and investor partnerships

NicheAssessment(Announced in July)

Identify other uses of technology

Determines competitive advantages

Develops market entry strategy

(Phase II awardees)

(Phase I awardees)

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NIH SBIR/STTR Home Page Links

NIH SBIR/STTR Home Page: http://grants.nih.gov/grants/funding/sbir.htm

2010 SBIR FOA: http://grants.nih.gov/grants/funding/sbir.htm

2010 STTR FOA: http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html

Other SBIR/STTR Funding Opportunities and Announcements:

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

Application Guide: http://grants.nih.gov/grants/funding/424/index.htm

Other Important SBIR/STTR News:

http://grants.nih.gov/grants/funding/sbirsttr_news.htm#20100204

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NIH SBIR/STTR Program Staff

Ms. Kay Etzler 301-435-2713Dr. Lenka Fedorkova 301-435-0921

Office of Extramural ResearchNational Institutes of Health

[email protected]

3232

Stay Informed…

Listserves

NIH Guide for Grants and Contracts (weekly notification)

http://grants.nih.gov/grants/guide/listserv.htm

NIH SBIR/STTR Notification

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

3333

SBIROK

• SBIR National Conference

• Oklahoma City, Nov. 8-10, 2010 For small, high-tech businesses, looking to innovate, research, and

create products or services, there is an opportunity to receive federal funds and assistance for your research and potential commercialization. This is the last national conference for 2010. Technology and industry program tracks include: aerospace, biotechnology, energy, information technology and nanotechnology. A poster session is available to present your company's vision.

http://www.sbirok.org/

343434

NHLBI Mission

To conduct and support basic research, clinical investigations and trials, observational studies, demonstration and education projects related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders; and to ensure the adequacy and safety of the Nation’s blood supply

The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on all product and service development related to the mission of the NHLBI

http://www.nhlbi.nih.gov/

353535

Office of the Director

Division of Extramural Research Activities

Division for the Application of

Research Discoveries

Division of Cardiovascular Sciences

http://www.nhlbi.nih.gov/

Division of Intramural Research

Division of Lung

Diseases

Division of Blood

Diseases and Resources

3636

NHLBI SBIR/STTR Staff Contacts

36

•Division of Blood Diseases and Resources:•Susan Pucie ([email protected])

•Phyllis Mitchell ([email protected])

•Division of Cardiovascular Sciences:•Tim Baldwin ([email protected])

•Simhan Danthi ([email protected])

•Bishow Adhikari ([email protected])

•Pothur Srinivas ([email protected])

•Shari Ludlam ([email protected])

•Paula Einhorn ([email protected])

•Division of Lung Diseases:•Ann Rothgeb ([email protected])

373737

NHLBI Support for Small Business

– STTR & SBIR Grants:

• STTR Phase I (R41)

• STTR Phase II (2R42)

• STTR Fast Track (1R42)

• SBIR Phase I (R43)

• SBIR Phase II (2R44)

• SBIR Fast Track (1R44)

• SBIR Phase II Competing Renewal

• Administrative and Competitive Supplements

– SBIR Contracts

• SBIR Phase I (N43)

• SBIR Phase II and Fast Track (N44)

383838

NHLBI FY 2009 SBIR & STTR Grants

Grant TypeGrant

Mechanism# of

Awards Award

$Millions

STTR Phase I R41 8 $1.753

STTR Phase II R42 12 $7.072

SBIR Phase I R43 60 $11.182

SBIR Phase II R44 92 $56.334

Total 172 $76.341

3939

NHLBI SBIR/STTR Award Levels

39

• The stated Phase I and II award levels and project periods are guidelines not ceilings. So applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project.

• Discuss deviations with NIH program staff prior to submission of the application.

• Institutes differ on how much deviation is allowed.

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Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation

– Interventions to promote healthy lifestyles, adherence to medications, and cardiac rehabilitation, including stress and exercise

New medical imaging systems, enhancements and applications

Circulatory support systems

– Point-of-care (POC) devices for monitoring, diagnostics, and personalized medicine

Novel use of information technology to enhance adherence to medical regimens or promote translational research

Technologies for gene discovery, assessment, and diagnostics

Tools to diagnose and treat respiratory abnormalities during sleep in infants, children, and adults

Virtual bronchoscopy (this is a radiologic 3D reconstruction of the lungs with imaging to approximate bronchoscopy)

Innovative smoking cessation

Personal exposure monitors for aeroallergens and other environmental pollutants

Methods to inactivate or remove microorganisms and other infectious moieties from blood, blood components, and plasma derivatives

40

4141

Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation

MAIN MESSAGE

Research topics of interest to the National Heart,

Lung, and Blood Institute include, but are not

limited to the topics listed in the Omnibus

Solicitation– Call NHLBI contacts and send an abstract of your

project. We are glad to talk to applicants about SBIR/STTR ideas and provide advice

– Visit staff and present your idea

41

4242

NHLBI SBIR Funding Allocations

Of total NHLBI SBIR funding from FY 2007-2009:

42

84% grants responsive to the omnibus solicitation

11%grants responsive to an NHLBI-issued targeted FOA

3%grants responsive to other targeted FOAs (NHLBI as secondary IC)

2% contracts responsive to RFPs

4343

OHIO SBIR/STTR Funding FY 2005-2009

FY Awards SBIR Awards STTR

2005 53 14,999 6 1,3302006 62 19,701 11 2,9902007 54 19,132 9 2,1372008 51 14,350 8 2,8482009 60 21,400 11 4,091

NIH RePORTER: http://projectreporter.nih.gov/reporter.cfm

4444

FY 2010 OHIO SBIR/STTR Companies

• ACME EXPRESS, INC., CLEVELAND - R• AEROMICS, LLC, CLEVELAND - R• ARTERIOCYTE, INC., CLEVELAND - R• ATHERSYS, INC., CLEVELAND - R• BIOINVISION, INC., CLEVELAND - R• CHANTEST, INC., CLEVELAND - R• FRANTZ MEDICAL DEVELOPMENT. LTD.,

MENTOR - NEW• GLC BIOTECHNOLOGY, INC., SOLON - R• GREAT LAKES PHARMACEUTICALS, INC.,

BEACHWOOD• GUILD ASSOCIATES, INC., DUBLIN - R• CLEVELAND MEDICAL DEVICES, INC. - R• FARADAY TECHNOLOGY, CLAYTON - NEW• H-CUBED, INC., OLMSTED FALLS - R• IDEAS, INC., KIRTLAND - R• JXT APPLICATIONS, INC., BEAVERCREEK - R• INTERTHYR CORPORATION, MARIETTA – R

Note R=Repeat Company, New = New to NIH SBIR/STTR

• LUCCELL, INC., CLEVELAND - NEW• METALLOPHARM, LLC, DELEWARE - R• MRI RESEARCH INC., CLEVELAND - R• NDI MEDICAL, INC., CLEVELAND - R• NANOFIBER SOLUTIONS, LLC, COLUMBUS -

NEW• NANOMIMETICS, INC., CLEVELAND - R• NEUROWAVE SYSTEMS, INC., CLEVELAND

HEIGHTS - R• NOVELMED THERAPEUTICS, INC., TWINSBURG

- R• ORCHARD KINETICS, LLC, CLEVELAND

HEIGHTS - NEW• OSMIC ENTERPRISES, INC., CINCINNATI - R• P2D, INC., CINCINNATI - R• PERITEC BIOSCIENCES, CLEVELAND - R• POLGENIX, INC., CLEVELAND - R• QUALITY ELECTRODYNAMICS, LLC, MAYFIELD

VILLAGE - NEW• VISION OPTIMIZATION, LLC, COLUMBUS - R

4545

Recent OHIO SBIR/STTR Technologies

Hazmat Protection Training for Health ProfessionalsObesity TherapeuticStent Fabrication TechnologyStem Cells for Neonatal Brain InjuryTherapeutic for Controlling MoodTelehealth Diagnostic for Remote Parkinson’s MonitoringSleep Apnea Treatment TechnologyBiologics for Rheumatoid ArthritisDevice for Surgical Adhesion PreventionLife Belt CPRAntimicrobial NanocoatingAdaptative Wireless Computer Mouse for Movement DisordersTelephone Speech Enhancement systemField Deployable Automatic EEGImmunotherapy Directly Targeting CocaineTumor-Targeting Chemo-Gene Therapy

4646

New Applicant Resources

• NIH eSubmission Tips for Small Business Applicants

– http://grants.nih.gov/grants/ElectronicReceipt/files/NIH_eSubmission_SmBus_Tips.pdf

• Annotated SBIR Application Form– http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf

• Elimination of the Error Correction Window for Due Dates on or After January 25, 2011

– http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-123.html

Message Applicants should SUBMIT EARLY to allow time to make any necessary corrections and view the application before the submission deadline

4747

Research Portfolio Online Reporting Tool(RePORT)

47http://report.nih.gov

4848

NHLBI SBIR/STTR online search using RePORT


MRI

2008 & 2009

NHLBI

SBIR & STTR

4949

SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years


5050

SBIR/STTR – NHLBI Funded Imaging Grants


5151

Overview of the NIH SBIR/STTR Programs

Susan PucieSBIR/STTR Program Coordinator

National Heart, Lung, and Blood InstituteNational Institutes of Health

[email protected]

11 nih sbir & sttr programs features and nuances

Documents