National Institutes of Health Small Business Innovation Research (SBIR) Program Small Business Technology Transfer (STT

Presentation Transcript

National Institutes of Health Small Business Innovation Research (SBIR) ProgramSmall Business Technology Transfer (STTR) Program

8th Annual NIH SBIR/STTR Conference

Renaissance Cleveland HotelCleveland, OhioJuly 13, 2006

Jo Anne Goodnight

NIH SBIR/STTR Program Coordinator

Office of Extramural Research

National Institutes of Health

Extramural Programs Reserved for Small Business

SMALL BUSINESS INNOVATION

RESEARCH (SBIR) PROGRAM

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR) PROGRAM

“The best way to predict the future…

is to create it.”

SBIR/STTR PROGRAM

GENERAL FEATURES

SBIR / STTR Program

Mission

Supporting scientific excellence and technological innovation

through the investment of

federal research funds

in critical American priorities

to build a strong national economy…

onesmallbusinessatatime.

Program Descriptions

Small Business Innovation Research (SBIR)

Set-aside program for small business

concerns 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.

2.5%

0.3%

WHY SBIR????

Small Business Innovation Development Act of 1982

Congress designated 4 major 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

2000 REAUTHORIZATION

MAJOR PROVISIONS OF P.L. 106-554; Signed 12/21/00

Program Extension until 9/30/2008
Output and Outcome Data

- Public Database: basic award information

(Tech-Net-- http://technet.sba.gov)

- Government Database: program evaluation

(Phase II awardees -- e.g., new product sale revenues;

other investment funding sources)

WHY STTR????

Small Business Research and Development

Enhancement Act of 1992

Stimulate and foster scientific and technological innovation through cooperative research and development carried out betweensmall business concerns andresearch institutions

Foster technology transfer between small business concerns and research institutions

2001 STTR REAUTHORIZATION

Reauthorized through FY2009
Set-aside increased from 0.15% to 0.30% in FY 2004
Phase II award levels increased from $500,000 to $750,000 in FY 2004
Participating agencies to implement similar outreach efforts as SBIR

“Never, ever, think outside the box.”

SBIR/STTR: 3-Phase Program

PHASE I

Feasibility Study
$100K and 6-month (SBIR)

or 12-month (STTR) Award

PHASE II

Full Research/R&D
$750K and 2-year Award

(SBIR/STTR)

PHASE III

Commercialization Stage
Use of non-SBIR/STTR Funds

SBIR PROGRAM

ELIGIBILITY CHECKPOINTS

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

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

STTR PROGRAM

Applicantis Small Business ConcernSubsidiaries are NOT eligible for STTR program
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

SBIR / STTR ELIGIBILITY

OWNERSHIP AND CONTROL

got questions?

Contact the SBA Size Specialists
Request an eligibility determination
http://www.sba.gov/size/indexcontacts.html

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.

FEE/PROFIT

Up to 7% of total direct and F&A costs may

be requested for fee

Must be REQUESTED/JUSTIFIED in application/proposal
Only SBC eligible; no contracts, consortium or other third party are eligible for fee
Not direct or indirect cost

*DISCUSS WITH AGENCIES

TOTAL $2.0 + B

FY 2006

SBIR / STTR Participating Agencies

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

We’re all just a little bit different ...

About 6-9 months

Standard Phase I Process

Solicitation

Topics

Agencies describe R&D topics

in solicitations.

Small Business Concerns prepare
short (usually 25-page)proposals.
Unsolicited proposals not accepted.

Proposal

Submission

Evaluation

Agencies evaluate based on technical
merit, firm’s qualifications, and
commercial potential / societal benefit.

Ph I award

Agenciesmake Phase I awards.

Agency SBIR Differences

Number and Timing of Solicitations
R&D Topic Areas -- (Broad vs. Focused)
Dollar Amount of Award (Phase I and II)
Proposal Preparation Instructions
Financial details (e.g., Indirect Cost Rates, Gap Funding)
Receipt Dates
Proposal Review Process
Proposal Success Rates
Type of Award (Contract or Grant)

SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

Research Partner

SBIR:Permits research institution partners

[Outsource ~ 33% Phase I and 50% Phase II R&D]

STTR:Requiresresearch institution partners (e.g., universities)

[40% small business concerns (for-profit) and

30% U.S. research institution (non-profit)]

AWARD ALWAYS MADE TO SMALL BUSINESS

SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

Principal Investigator

SBIR: Primary (>50%) employment must be with small business concern

STTR: Primary employment not stipulated

[PI can be from research institution and/or

from small business concern*]

*DISCUSS WITH AGENCIES

Important Facts to Remember

Eligibility is determined at time of award
Noappendices allowed in Phase I
The PI is not required to have a Ph.D. or M.D.
The 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

Advice from Awardees

Don’t judge an agency’s interests by

its “name ”

Understand agency’s mission & needs
Get to know your agency Program

Manager

Read solicitation and follow

instructions

Advice from Awardees

Don’t depend solely on SBIR funding
Don’t go it alone - use support systems
Have an outcome
Win or lose - get and review evaluations
Be PERSISTENT

NIH SBIR/STTR PROGRAM

FEATURES and NUANCES

The

Secretary

Deputy Secretary

Administration for

Children and Families

(ACF)

Administration on

Aging

(AoA)

Food and Drug

Administration

(FDA)

Health Resources

and Services

Administration

(HRSA)

Centers for Medicare

And Medicaid Services

(CMS)

Agency for Healthcare

Research and Quality

(AHRQ)

Indian Health

Services

(IHS)

National Institutes

of Health

(NIH)

Centers for

Disease Control

and Prevention

(CDC)

Agency for Toxic

Substances and

Disease Registry

(ATSDR)

Substance Abuse and

Mental Health Services

Administration

(SAMHSA)

Program Support

Center

(PSC)

U. S. Department of Health and Human Services

Improve human health through biomedical and behavioral research,

research training and communications.

NIH Mission

SBIR Program:Importance to NIHTransforming medicine through innovation

The SBIR program is integrated within the NIH research agenda.

Improve human health of the Nation (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.

SBCs can use SBIR/STTR

help NIH meet its mission

Conduct innovative R/R&D that results in product, process, or service that will...

Improve patient health
(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
Help in training of research investigators
Increase health knowledge base

DHHS Budget and Award Amount

$640M

****Propose a Realistic and Appropriate

Budget for the Research****

Take Home Message #1

Types of SBIR / STTR Awards

~95%

GRANTS: you decide the research and product to be designed or developed (SBIR / STTR)
CONTRACTS: The government decides the research and general product to fill their perceived need (SBIR only)
COOPERATIVE AGREEMENTS: Similar to grants, but awarding IC has substantial involvement in carrying out the project's activities.

~4-5%

<1%

NIH ISSUES MULTIPLE SOLICITATIONS

SBIR/STTR Omnibus Grant Solicitation

(NIH, CDC, and FDA) = Parent FOARelease: January April 1, Aug 1, Dec 1 receipt dates

SBIR Contract Solicitation (NIH, CDC)

Release: August Early November receipt date

NIH Guide for Grants and Contracts

Release: Weekly Various receipt dates

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

SBIR/STTR Omnibus Solicitation

SBIR Parent Funding Opportunity Announcement
(PA-06-120)
STTR Parent Funding Opportunity Announcement
(PA-06-121)
SBIR/STTR Program Descriptions and Research Topics (PDF or MS Word)

http://grants1.nih.gov/grants/funding/sbir.htm

NIH Guide for Grants & ContractsSpecial SBIR/STTR Opportunities

http://grants.nih.gov/grants/guide/index.html

Go Beyond the SBIR/STTR Omnibus Solicitation….

NIH GUIDE: FOAs

SBIR/STTR Opportunities (cont.)

Parent SBIR FOA

SBIR/STTR RESEARCH GRANT TOPICS

Our Ideas…. examples

Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Behavioral research

Computational Biology

Cell and Gene Therapy

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Imaging technologies

Genetically engineered proteins

Proteomics / Genomics

Complementary & Alt. Med (CAM)

…

SBIR/STTR RESEARCH GRANT TOPICS

Your ideas...

Investigator-initiated R&D
Research topics related to the NIH mission
“Other” areas of research within the
mission of an awarding component
…

Take-home Message #2

NIH SBIR/STTR

RESEARCH AREAS

Angioscopes

to Zebrafish

NIH Center for Scientific Review

Assign to IC and IRG

Small Business

Concern

Applicant Initiates

Research Idea

Scientific Review Groups

Evaluate Scientific Merit

Advisory Council or Board

Recommend approval

IC Allocates

Funds

NIH SBIR/STTR PROGRAM

Review Process for Research Grant

Submits

SBIR/STTR Grant

Application to NIH

~2-3 months

after submission

~2-3 months after review

IC Staff Prepare funding Plan

for IC Director

Grantee Conducts

Research

Grant Application Process

E

Are you R ady?

Submitting an Application Electronically

Find out at http://era.nih.gov/ElectronicReceipt/.
New electronic Grants.gov application SF424 (R&R)

Check the Timeline
Register EARLY…http://grants.gov/

Electronic Submission Information:

http://era.nih.gov/ElectronicReceipt/

Grants.gov: How It Works

Before an applicant can Apply

1) Complete these registration steps:

a) Go to http://grants.gov/GetStarted

Obtain a DUNS number

(DUNS=Data Universal Numbering System).

Register in Central Contractor Registry (CCR).
Register with Grants.gov.

b) Go to https://commons.era.nih.gov/commons/

Set up institution and PI profiles in eRA Commons.

Grants.gov: How It Works

Before an applicant can Apply

2) Establish capacity to fill out applications:

Download PureEdge Viewer (from Grants.gov site) OR
Establish an electronic system that allows the applicant to submit to Grants.gov using system-to-system (XML) datastream

Can be created by institution OR
Institution can establish an agreement with a commercial Service Provider to develop the system

APPLICATION TO AWARD TIMELINE

2-tiered review process

SBIR/STTR Scientific/Technical Adv Council Est.Award Receipt Dates Peer Review Board Review Date

Apr 1 June/July Sept/Oct Nov

Aug 1 Oct/Nov Jan/Feb Mar

Dec 1 Feb/March May/June July

90-Day pre-award costs are allowable:

At applicant’s own risk…..

Common Problems with Applications

Inadequately defined test of feasibility
Diffuse, superficial, or unfocused research plan

Lack of sufficient experimental detail

Questionable reasoning in experimental approach

Uncritical 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

Gap Funding Options

Phase I

Phase II

NIH SBIR/STTR ProgramGap Funding Options

Phase I / Phase II Fast Track
Simultaneous submission / concurrent review
No-Cost Extension (Ph I or Ph II)
Extension in time with no additional funds
Administrative / Competitive Supplements
Discuss with Program Director
Phase II Competing Renewal
Maximum of $1M/yr for 3 years

Response to IC-specific PA

nih sbir sttr fast track bridging the phase i ii funding gap

Phase I Final Report

7-9 months

Phase I Award

Aims/ Milestones

Met

Phase II award

Aims/ Milestones

NOT Met

NIH SBIR/STTR FAST-TRACKBridging the Phase I - II Funding Gap

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?

NIH SBIR “FAST-TRACK”Best Option For Everyone?

No!!

Convincing preliminary data?
Clear, measurable, achievable milestones?
Well-conceived Commercialization Plan?
Letters of Phase III support/interest?
Track record for commercializing?

Example of an NIH SBIRFast Track GranteeSyntrix BiosystemsAuburn, WA

Product:Instrumentation for High-Resolution Analysis of Cancer

Technology:Develop a method for tissue microdissection called "biolithography." This method relies on a projected light pattern and suitable reagents to extract regions of interest from a tissue sample for further analysis.

Fast-Track award = $2.2 Million (Phase I and Phase II, multi-year)

Funded under a special SBIR announcement: PAR-01-105, "Innovative Technologies for the Molecular Analysis of Cancer“

SBIR funding was critical in establishing the feasibilityof developinga prototype automated biolithography system provide an easy and cost-effective method to address whole organism analysis for a wide audience of researchers and clinicians engaged in cancer analysis.

REVIEW CRITERIA

(Phase I)

Significance (Real Problem/Real People)
Approach (Research Design, Feasible)
Innovation (New or Improved?)
Investigators (PI and team)
Environment (Facilities/Resources)

… Protection of Human Subjects

… Animal Welfare

… Budget

NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2005

42

$640 M

SBIR/STTR

44%

47.7%

358

34.7%

147

11

Success Rate (%)

776

28

25%

20.8%

16.4%

14.1%

AWARD PROCESS

Congratulations!The check is “in the mail…”

(almost)

WHY THE AWARD MAY BE DELAYED

Human Subject Issues (OHRP)

IRB and Assurances

http://ohrp.osophs.dhhs.gov/index.htm

Animal Welfare Issues (OLAW)

IACUC (Animal Involvement)

http://grants.nih.gov/grants/olaw/olaw.htm

EIN (Entity Identification Number)

http://www.irs.gov

Third Party Involvement

Contracts, Consortia, Consultants

NIH SBIR/STTR ProgramGap Funding Options

Phase I / Phase II Fast Track
Simultaneous submission / concurrent review
No-Cost Extension (Ph I or Ph II)
Extension in time with no additional funds
Administrative / Competitive Supplements
Discuss with Program Director
Phase II Competing Renewal
Maximum of $1M/yr for 3 years
Response to IC-specific PA

Mt. “FDA”

???????

Transitioning SBIR / STTR Projects to the Marketplace

Phase I

Phase II

Phase III

Competing Renewal Phase II Award

Purpose

To take existing, promising compounds or devices developed under a Phase II through the next step of drug discovery and development.

Provide additional Phase II research support to continue assessing and improving devices or conducting preclinical studies of drugs or devices that ultimately require:
clinical evaluation
approval of a Federal regulatory agency
refinements to durable medical equipment (DME) designs

“From the Test Tube to the Medicine Cabinet”

Competing Renewal Phase II Award

Eligibility and Criteria

SBIR Phase II awardee
Promising pharmacologic agents or devices have already been identified(or developed) and some preclinical pharmacology has been conducted.
Response to an NIH Program Announcement
Generally, $750k-$1M/year for up to 3 years

Contact your Program Director to discuss!

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

Alerts/News Flashes
Solicitations
Targeted Research Opportunities
Award Information
Collaborative Opportunities
Success Stories
Resources

www.nih.gov

For More Information

Subscribe to SBIR/STTR ListServ:

LISTSERV@LIST.NIH.GOV

subscribe SBIR-STTR Jane Doe

Final Exam

The Top 10 List

Top 10 Reasons

to Seek SBIR/STTR Funding

10. Over $2.0 Billion available

9.NOT A LOAN - no repayment

8. Provides recognition, verification

and visibility

7.Potentialleveraging tool to attract

venture capital/other sources of $$$

Top 10 Reasons

6.Industry-University research partnerships

enhance competitiveness of

small businesses in marketplace

5. Creates jobs / stimulates local and state

economies – stronger National Economy

4. Provides seed money to fund high

risk projects

Top 10 Reasons

3.Intellectual property rights are

normally retained by the small

business

2. Small business concerns are

recognized as a unique national

resource of technological

innovation

Top 10 Reasons

1. To make economic and societal

contributions toAmerica

Technological Innovation OccursThroughout the U.S.

TissueTech (FL)

Product: AmnioGraft™

Technology: Use of amniotic membrane for ocular surface reconstruction to treat ocular surface diseases. AmnioGraft is used to replace

the damaged or lost basement membrane of the

host tissue on the ocular surface.

Phase I award: $103,123 (EY14768)

SBIR funding was critical: in establishing the feasibility to develop and evaluate a "sutureless" AmnioLens to be used as a corneal graft.

CardiacAssist, Inc. (PA)

Product: TandemHeart PTVA ®

TandemHeart System helps restore blood circulation and increase blood flow through a cardiac catheterization procedure, in as little as 30 minutes.

Helps to save vital organs and gives damaged hearts a chance to heal when patients experience acute, life-threatening heart conditions.

More than 525 procedures have been done in 28 countries at 70 facilities by 170 physicians.

Feb 2006- FDA 510(k) approval for new, high-flow cannula.

TandemHeart® PTVA® (Percutaneous Transseptal Ventricular Assist) System

http://www.cardiacassist.com/Video/

technological innovation occurs throughout the u s

Intralase Corporation (CA)

Corneal Surgery with Femtosecond Lasers

Product: Bladeless laser technology

Technology uses proprietary, computer-guided femtosecond laser technology for greater precision, improved safety and better results as compared to the use of traditional microkeratomes to create a corneal flap in the first step of LASIK eye surgery.

http://www.intralase.com/corporate/aboutus/index.html

Femtosecond laser technology provided the basis of femtochemistry research that won the 1999 Nobel Prize in Chemistry.

technological innovation occurs throughout the u s73

Novera Pharmaceuticals (KY)

Product: VitaSol

Topically applied wound healing product

Allows for the rapid delivery of energy to cells in the form of adenosine triphosphate, or ATP, and dramatically improves and promotes cell preservation, growth and healing.

Ph III Trials in chronic wound healing of diabetic ulcers.

Direct Cellular Energy (ATP) Delivery System: Cell preservation, growth and wound healing

technological innovation occurs throughout the u s74

NovaRx (CA)

Product: Vaccine for Glioma (Brain Cancer)
NovaRx uses two technologies:
1) TGF-ß antisense gene-modification. TGF-ß is one of the most potent immunosuppressive molecules produced by tumor cells.
Patented TGF-ß antisense technology blocks the production of TGF-Beta by the cancer cells.
2) Replaces autologous tumor cells with allogeneic tumor cells (other peoples tumor cells) that may be used "off the shelf" to treat a large number of patients
SBIR award (4 years) will help fund pivotal Phase II/III clinical trial.
SBIR funding was critical in establishing the feasibility of developing a whole-cell vaccine for the treatment of gliomas.

Allogeneic glioma vaccine using TGF-beta knockouts