# Presentation: 600883

## NIH SBIR Technical Assistance Program

**8****th**** Annual NIH SBIR/STTR Conference **
**Cleveland, OH**

**Kay Etzler**
**NIH SBIR/STTR Program**
**July 13, 2006**

## Path to Innovation & Commercialization

**Competing Continuation Phase II application**

- Phase I

- Phase II

- Phase III

**Technical Assistance Program**

## Commercialization Valley 

- Phase I

- Phase II

- Phase III

- 3 months?  2 years?  10 years?

- $$$$$

## Phase II Competing Continuations

**Goal:****  **Provide _*additional research funds*_ to move already identified drugs or devices requiring regulatory approval into clinical trials
**Stipulations:**
- Phase II grantees needing regulatory approval
- Focus -- diagnostics, devices, tissue engineering, drug development
- Funding level: $750K to $1M per year for maximum of 3 years
- Response to an NIH targeted funding opportunity announcement (FOA) or NIH Omnibus SBIR/STTR Solicitation

_***Speak with Program Staff Prior to Submission***_

**TAP**

## Commercialization Assistance Program

**Commercialization Assistance Program**

**Niche Assessment Program**

- Technical Assistance Program

**(TAP)**

## What is TAP?

- Discretionary technical assistance and/or training in:
- Strategic/business planning
- FDA requirements
- Technology valuation
- Patent and licensing issues
- Manufacturing issues
- Getting closer to the customer, the market, and the competition
- Systematic approach to developing business strategies
- Individualized assistance/mentoring/consulting

## Niche Assessment Program

**   ****Identify other uses of technology**
**   ****Determine competitive advantages**
**   ****Develop market entry strategy**
**   ****Identify potential customers and/or commercialization partners**
**   *****Added benefit***** – useful info for Phase II application**

**SBIR Phase I Awardees**

_***Goals***_**:**

## Niche Assessment Nuts & Bolts

**100 SBIR Phase I projects**
**50 SBIR Phase II projects *****(pilot)***** **
**No cost to participant **
**Not labor intensive for SBIR awardee**
**Due diligence performed by contractor**
**Written report provided each participant**

## Commercialization Assistance Program (CAP)

**Provides business & strategic planning**
**Helps build strategic alliances and investor partnerships**

**SBIR Phase II awardees**

_***Goal***_**:****  Accelerate commercialization of SBIR-developed products or services**

## CAP Nuts & Bolts

**SBIR Phase II project as of January 1, 2001**
**Participation limited to those seeking to:**
**Find investors**
**Develop licensing opportunities **
**Establish strategic partnerships **
**Regulatory approvals **
**Training, mentoring, consulting**
**Approximately 120 participants**
**Labor Intensive – requires dedicated active participation by small business official**
**Culminates “opportunity event” **
**“****Free” other than travel costs**

## 2006/2007 CAP

**Sept ‘06**

**Oct ‘06**

**Oct ‘06 – May ‘07**

**April ‘07**

**June ‘07**

**July ‘07 – Dec ‘08**

**Apply, Select, Meet Advisor**

**Commercialization Workshop**

**Business & Strategic Planning**

**Outcomes Workshop**

**Showcase Event**

**Follow-up**

***10 month process***

**Status Meeting/Update**

**Feb/Mar ‘07**

## Participation by Industry Sector2005/2006 CAP

- Provided by Larta Institute

## 2004/2005 Progress* Upon Completion of CAP

***At least one event in at least one commercialization category**

- Provided by Larta Institute

## Kay Etzler

***Kay Etzler***
**SBIR/STTR CAP Program Manager**
**Phone:  301-435-2713**
**Fax: 301-480-0146         **
** ****Email:  etzlerk@od.nih.gov**

**Contact Information**