# Presentation: 600878

## NIH Technical Assistance Program

**7th Annual NIH SBIR/STTR Conference**

**Kay Etzler**
**NIH SBIR/STTR Program**
**July 29, 2005**

## 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 announcement (PA, RFA, omnibus SBIR solicitation)

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

**CAP**

## Commercialization Assistance Program

**Commercialization Assistance Program**
**(CAP)**

***Pilot***** Niche Assessment Program**

- Technical Assistance Program

## What is TAP?

- Discretionary technical assistance and/or training in:
- strategic/business planning
- FDA issues
- technology valuation
- patent and licensing issues
- Getting closer to the customer, the market, and the competition
- Systematic approach focused on commercialization
- Individualized assistance

## Pilot Niche Assessment

**   ****Identify other uses of technology**
**   ****Determine competitive advantages**
**   ****Develop market entry strategy**
**   ****Added benefit – useful info for Phase II application**

**SBIR Phase I Awardees**

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

## Pilot Niche Assessment Nuts & Bolts

- 100 SBIR Phase I projects awarded Aug/Sept 2004
- Does not require active participation by company
- Research performed by contractor
- Written report provided each participant
- No cost

## 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

- Second or more year of SBIR Phase II project as of January 1
- Participation limited to those seeking to:
- Find investors
- Develop licensing opportunities
- Establish strategic partnerships
- Perform clinical trials and seek regulatory approvals
- Approximately 120 participants
- “Free” other than travel costs
- Intensive – requires dedicated active participation by small business official
- Training, mentoring, consulting
- Culminates “opportunity event”

## Workshops & Events

- Kickoff meetings (Required)
- Personal contact, CAP commitment, seminars
- Investment mentoring workshops (Optional)
- Interaction with investors
- Presentation training
- Outcomes workshop (Required)
- Work product review
- Presentation dry run
- Seminars
- Culminating Event -- NIH Life Sciences Showcase (Optional)
- The Venture Forum 2005 (Larta-sponsored annual event)
- 68 companies presented their business opportunities

## Participation by Industry Sector

- Provided by Larta Institute

## Steve Holdaway and Sandra Cummings from Zycare, Inc.

**Steve Holdaway and Sandra Cummings from Zycare, Inc.**

## Dr. Leo Liu

**Dr. Leo Liu**
**Cambria Biosciences**

**Dr. Kenneth Weil**
**Rose Biomedical Development Corp.**

**Dr. Wai Tak Law**
**Portascience, Inc.**

## 2005/2006 CAP

- Eligible participants will be notified in August/September 2005

## Kathleen Shino

**Acting NIH SBIR/STTR Program Coordinator**
**Phone: 301-435-2689**
**Fax: 301-480-0146**
**Email: shinok@mail.nih.gov**
***Kay Etzler***
**SBIR/STTR Program**
**Phone:  301-435-2713**
**Fax: 301-480-0146         **
** ****Email:  etzlerk@od.nih.gov**