# Presentation: 544312

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

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

**8****th**** Annual NIH SBIR/STTR Conference**
**Renaissance Cleveland Hotel****Cleveland, Ohio** **July 13, 2006**
***Jo Anne Goodnight***
***NIH SBIR/STTR Program Coordinator***
**Office of Extramural Research**
**National Institutes of Health**

## SMALL  BUSINESS  INNOVATION 

**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****...**

_***one***_*** ***_***small***_*** ***_***business***_*** ***_***at***_*** ***_***a***_*** ***_***time***_**.**

## 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.

**	****	****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.**

**Program Descriptions**

**2.5%**

**0.3%**

## WHY SBIR????

**Congress designated 4 major goals**

- Small Business Innovation Development Act of 1982

**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

**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)****        **

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

## 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 ****between**** ****small business**** concerns ****and**** ****research 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.”

**“****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

**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**

## SBIR PROGRAM

**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**

## 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**** **

**STTR PROGRAM**
**ELIGIBILITY CHECKPOINTS**

## SBIR / STTR ELIGIBILITY

**OWNERSHIP AND CONTROL**

** ****Contact the ****SBA**** Size Specialists**
** ****Request an eligibility determination**
-                _[http://](http://www.sba.gov/size/indexcontacts.html)__[www.sba.gov/size/indexcontacts.html](http://www.sba.gov/size/indexcontacts.html)_

- got questions?

## 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**_

## 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

**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**

**SBIR / STTR Participating Agencies**

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

## Standard Phase I Process

**Agencies ****describe R&D topics**
**    ****in solicitations.**

**Evaluation**

**Ph I award**

**Solicitation**
**Topics**

**Proposal**
**Submission**

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

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

**  ****Agencies**** ****make ****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 PROGRAMSCRITICAL DIFFERENCES

**  ****Research Partner**** **
**	****  ****SBIR:****  ****Permits ****research institution partners**
**        ****         ****[Outsource ~ 33% Phase I and 50% Phase II R&D]**** **
**	****  ****STTR:****  ****Requires**** ****research 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**

## 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*]

**	****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**_

**SBIR AND STTR PROGRAMS*****CRITICAL DIFFERENCES***

## Important Facts to Remember 

** ****Eligibility is determined at **_**time of award**_
** **_**No**_** ****appendices 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***

## U. S. Department of Health and Human Services

## NIH Mission

**NIH Mission**

***Improve human health through biomedical and behavioral research, ***
***research training and communications. ***

## SBIR Program: Importance to NIHTransforming medicine through innovation

**SBIR Program:**** ****Importance to NIH*****Transforming medicine through innovation***

** *****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.***

**The SBIR program is integrated within the NIH research agenda.**

**Notes:**
The Department of Health and Human Services (HHS), is the 
United States government's principal agency for protecting the health 
of all Americans and providing essential human services. 

The National Institutes of Health (NIH), is part of the Department   of Health and Human Services, and is the primary Federal organization charged with conducting and supporting biomedical, behavioral and clinical research.  Helping to lead the way toward important biomedical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease and identify causes, treatments,   and cures for common and rare diseases.

NIH is made up of 27 different components called Institutes and Centers, each having its own specific research mission and agenda. 

The Office of the Director is the central office responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities implemented by the NIH Institutes and Centers.

## 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

|  | SBIR | STTR |
| --- | --- | --- |
| 2006 Budget
NIH | $571M | $69M |
| CDC 
FDA
AHRQ | ~8.1M
~0.8M
~2.0M | 
N/A |
| Phase I
 | $100K*
6 months* | $100K*
1 year* |
| Phase II | $750K* 
2 years* | $750K* 
2 years* |

******Propose a Realistic and Appropriate**
**Budget for the Research******
**Take Home Message #1**

**DHHS Budget and Award Amount**

**$640M**

## Types of SBIR / STTR Awards

- 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.

- ~95%

- ~4-5%

- <1%

##  NIH ISSUES MULTIPLE SOLICITATIONS

**    ****(NIH, CDC, and FDA) = Parent FOA**** *****Release: 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 r******eceipt dates***

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

** ****NIH ISSUES MULTIPLE SOLICITATIONS**

## SBIR/STTR Omnibus Solicitation

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

-  SBIR Parent Funding Opportunity Announcement
- (_[PA-06-120](http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html)__) _
-  STTR Parent Funding Opportunity Announcement
- (_[PA-06-121](http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html)__) _
-  SBIR/STTR Program Descriptions and Research Topics (_[PDF](http://grants.nih.gov/grants/funding/sbirsttr1/2006-2_SBIR-STTR-topics.pdf)__ or __[MS Word](http://grants.nih.gov/grants/funding/sbirsttr1/2006-2_SBIR-STTR-topics.doc)__)_

## NIH Guide for Grants & ContractsSpecial SBIR/STTR Opportunities

**NIH Guide for Grants & Contracts****Special SBIR/STTR Opportunities**

- _[http://](http://grants.nih.gov/grants/guide/index.html)__[grants.nih.gov/grants/guide/index.html](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

**Biodefense**
** ****Bio****sensors**
** ****Nanotechnologies**
** ****Bio****informatics**
** ****Behavioral research**
** ****Computational Biology**
** ****Cell and Gene Therapy**

**Bio****silicon**** 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***
***  ...***

_**Your**_ ideas...

**SBIR/STTR RESEARCH GRANT TOPICS**

## Angioscopes 

**to ****Zebrafish**** **

**NIH SBIR/STTR **
**RESEARCH AREAS**

##  NIH SBIR/STTR PROGRAM

**Grantee Conducts **
**Research**

**IC Staff Prepare funding Plan**
**for IC Director**

**Submits**
**SBIR/STTR Grant **
**Application to NIH**

**~2-3 months**
**after submission**

**~2-3 months after review**

** ****NIH SBIR/STTR PROGRAM**
***Review Process for Research Grant***

## Grant Application Process

**Are you R   ady?**

- E

## Submitting an Application Electronically 

- Find out at _[http://era.nih.gov/ElectronicReceipt/](blocked::http://era.nih.gov/ElectronicReceipt/)__._
-  New electronic Grants.gov application SF424 (R&R)
-  Check the Timeline
-  Register EARLY... _http://grants.gov/_

## Electronic Submission Information:

**Electronic Submission Information:**
- _[http://era.nih.gov/ElectronicReceipt/](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](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/](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

**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.....***

- 2-tiered review process

## Common Problems with Applications

**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 II

_**Gap Funding Options**_

## NIH SBIR/STTR ProgramGap 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

**(Simultaneous Submission and Concurrent Review)**

**Phase I + Phase II**

**Completion of Phase I**

**Program Staff assess completion of specific aims and milestones**

**Go / No Go?**

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

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

**No!!**

## Example of an NIH SBIRFast Track Grantee Syntrix BiosystemsAuburn, 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 feasibility**** ****of developing**** ****a ****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.**

**Example of an NIH SBIR****Fast Track Grantee**** *****Syntrix Biosystems******Auburn, WA***

## 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 RATESFISCAL YEAR 2005

**NIH SBIR/STTR FUNDING RATES****FISCAL YEAR 2005**

**Success Rate (%)**

**44%**

**$640 M **
**SBIR/STTR**

**776**

**358**

**42**

**28**

**147**

**11**

**34.7%**

**14.1%**

**20.8%**

**47.7%**

**25%**

**16.4%**

## (almost)

***(almost)***

**AWARD PROCESS**

## WHY THE AWARD MAY BE DELAYED

**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 ProgramGap 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**

## Transitioning SBIR / STTR Projects to the Marketplace

- Phase II

- Phase III

**Transitioning SBIR / STTR Projects to the Marketplace**

## Purpose

**Competing Renewal Phase II Award**
**Purpose**

-  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”** *

## Eligibility and Criteria

-  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!

**Competing Renewal Phase II Award**
**Eligibility and Criteria**

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

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

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

## For More Information

- www.nih.gov

**Subscribe to SBIR/STTR ListServ:**
**LISTSERV@LIST.NIH.GOV**
_***subscribe SBIR-STTR Jane Doe***_

## The Top 10 List

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

## Top 10 Reasons 

**     ****economies**** – ****stronger National Economy**

** ****4.****  Provides ****seed money**** to fund ****high**
**      ****risk**** projects**

** ****6.**** ****Industry-University research partnerships **
**     ****enhance competitiveness**** of **
**     ****small businesses in marketplace**

**Top 10 Reasons **
**to Seek SBIR/STTR Funding**

## Top 10 Reasons 

**	****normally ****retained ****by the**** small**
**	****business**

**  ****2.****  ****	****Small business concerns are**
**        ****recognized as a ****unique national**
**        ****resource**** of  technological**
**        ****innovation**

**Top 10 Reasons **
**to Seek SBIR/STTR Funding**

## Top 10 Reasons 

**      ****contributions to**** ****Am****er****ica**

**Top 10 Reasons **
**to Seek SBIR/STTR Funding**

## TissueTech (FL)

***TissueTech (FL)***

**Product**: **AmnioGraftTM**
**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.

**Technological Innovation Occurs****Throughout the U.S.**

## Technological Innovation OccursThroughout the U.S. 

***CardiacAssist, Inc. (PA)***

**TandemHeart® PTVA® (Percutaneous Transseptal Ventricular Assist) System**

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

**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.

**Technological Innovation Occurs****Throughout the U.S.**

## Technological Innovation OccursThroughout the U.S. 

**Technological Innovation Occurs****Throughout the U.S.**

***Intralase Corporation (CA)***

**Corneal Surgery with Femtosecond Lasers**

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

- 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

## Technological Innovation OccursThroughout the U.S. 

***Novera Pharmaceuticals (KY)***

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

**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.

**Technological Innovation Occurs****Throughout the U.S.**

## Technological Innovation OccursThroughout the U.S. 

**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

***NovaRx (CA)***

**Technological Innovation Occurs****Throughout the U.S.**

## I’m from the Government, and I’m here to help  you....

**I’m from the Government, and I’m here to help  you....**

## New!

**National Institute**
**on Alcohol Abuse**
**and Alcoholism**

**National Institute**
**of Arthritis and**
**Musculoskeletal**
**and Skin Diseases**

**National Cancer**
**Institute**

**National Institute**
**of Diabetes and**
**Digestive and**
**Kidney Diseases**

**National Institute**
**of Dental and**
**Craniofacial**
**Research**

**National Institute**
**on Drug Abuse**

**National Institute**
**of Environmental**
** ****Health Sciences**

**National Institute**
**on Aging**

**National Institute**
**of Child Health**
**and Human**
**Development**

**National Institute on**
**Deafness and Other**
**Communication**
**Disorders**

**National Eye**
**Institute**

**National Human**
**Genome Research**
**Institute**

**National Heart,**
**Lung, and Blood**
**Institute**

**National Institute**
**of Mental Health**

**National Institute**
**of Neurological**
**Disorders and**
**Stroke**

**National Institute**
**of General**
**Medical Sciences**

**National Institute**
**of Nursing Research**

**National Library**
**of Medicine**

**National Center**
**for Complementary**
**and Alternative**
**Medicine**

**National Institute**
**of Allergy and**
**Infectious Diseases**

**Fogarty**
**International**
**Center**

**National Center**
**for Research**
**Resources**

**Largest SBIR/STTR**
**set-asides**

**National Institute**
**of Biomedical **
**Imaging **
**and **
**Bioengineering**

**National Center on **
**Minority Health **
**and Health **
**Disparities**

## National Institutes of Health

**National Institutes of Health**

**Office of the Director**

** **

**Largest SBIR/STTR**
**set-asides**

**National Center on **
**Minority Health **
**and Health **
**Disparities**

- _[http://www.nih.gov/icd](http://www.nih.gov/icd/)__[/](http://www.nih.gov/icd/)_

**National Institute of **
**Biomedical Imaging **
**and Bioengineering**

## NIH Program Activities and Areas of Research

**NCI****-- cancer cause, prevention, detection, diagnosis, treatment and control**

**NHLBI****-- diseases of heart, blood vessels, lungs, blood, and transfusion medicine**

**NINDS****-- diagnosis, treatment, and prevention of disorders of the nervous system, neuromuscular apparatus, and special senses of touch/pain**

**NIDDK****-- diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; kidney, urologic and hematologic diseases**

**NIAID****-- understand, treat and prevent infectious, immunologic,**
**and allergic diseases**

**NIDCR****-- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders**

## NIH Program Activities and Areas of Research

**(cont.)**

**NICHD****-- fertility, pregnancy, growth, development, and medical rehabilitation **

**NEI****-- blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, requirements of the blind**

**NIEHS****-- identification, assessment, and mechanism of action of environmental agents that are potentially harmful to human health**

**NIA****-- biomedical, social, and behavioral aspects of aging process; prevention of age-related diseases and disabilities; promotion **
**of better QOL for older Americans**

**NIGMS****-- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology**

## NIH Program Activities and Areas of Research  (cont.)

**NIDCD****-- normal mechanisms diseases, and disorders of hearing, balance, smell, taste, voice, speech and language **

**NIMH****-- understanding, treating, preventing behavioral and mental disorders (including HIV prevention, neuro-AIDS research)**

**NIDA****-- treatment of drug addiction; behavioral strategies for treatment medication; training in drug abuse treatment techniques; drug abuse treatment **

**NIAAA****-- treatment and prevention of alcoholism and alcohol-related problems**

**NIAMS****-- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders**

**NINR****-- understand effects of acute and chronic illness, **
**improving QOL, approaches to promote health and prevent **
**disease, improving clinical environments**

## NIH Program Activities and Areas of Research   (cont.)

**NIHGRI****-- efforts toward achieving the goals of the Human Genome Project  **
***(Science vol. 262, pp.43-46; Oct. 1, 1993)***

**NCRR****-- R&D in instrumentation and specialized technologies for biomedical research; R&D in comparative medicine; discovery-oriented software for science education**

**NCCAM****-- complementary and alternative treatment, diagnostic, and prevention modalities, disciplines and systems: education and public information; patient management; botanical products; research-related issues (e.g., models, methods)  **

**NLM****-- innovative methods, systems, and services for managing health knowledge and information **

## Jo Anne Goodnight

**NIH SBIR/STTR Program Coordinator**
**Phone: 301-435-2688**
**Fax: 301-480-0146**
**Email: jg128w@nih.gov**

***Kathleen Shino***
**SBIR/STTR Program Specialist**
**Phone: 301-435-2689**
**Fax: 301-480-0146**
**Email: shinok@mail.nih.gov**
***Kay Etzler***
**SBIR/STTR Program Analyst**
**Phone:  301-435-2713**
**Fax: 301-480-0146         **
** ****Email:  etzlerk@od.nih.gov**

## Thank You