# Presentation: 600861

## NIH SBIR Technical Assistance Programs

**NIH **_***SBIR***_** Technical Assistance Programs**

**Kay Etzler**
**NIH SBIR/STTR Program**

**9****th**** Annual NIH SBIR/STTR Conference**
**Las Vegas, NV**
**November 26 & 27, 2007**

## Path to Innovation & Commercialization

**Phase II Competing Renewal 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 Renewals

**Purpose: ****Provide **_***additional research funds***_** to:**
**Take existing, promising compounds or devices through the next step of drug discovery and/or development**
**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**

**TAP**

## Phase II Competing Renewals

**Stipulations:**
**SBIR Phase II projects needing regulatory approval**
**Focus – pharmacologic agents or devices that have already been identified (or developed) and some preclinical pharmacology has been conducted**
**Response to an NIH targeted funding opportunity announcement (FOA) or NIH Omnibus SBIR/STTR Solicitation**
**Funding level: $750K to $1M per year for maximum of 3 years**

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

## Commercialization Assistance Program

**Commercialization Assistance Program**

**Niche Assessment Program**

- Technical Assistance Program

**(TAP)**

***Pilot***** Manufacturing Assistance Program**

## 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

***SBIR Only (STTR not included)***

## 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

**125 SBIR Phase I projects**
**25 SBIR Phase II projects *****(pilot)***** **
**No cost to participant **
**Not labor intensive for SBIR awardee**
**Due diligence performed by contractor**
**Detailed written report provided each participant**
_***Free***_

## Commercialization Assistance Program (CAP)

**   ****Accelerate commercialization of SBIR-         developed products or services**
**   ****Provide business & strategic planning**
**   ****Help build strategic alliances and investor partnerships**

**SBIR Phase II Awardees**

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

## CAP Nuts & Bolts

**SBIR Phase II project in previous 5 years**
**Participation limited to those seeking to:**
**Find investors**
**Develop licensing opportunities **
**Establish strategic partnerships **
**Obtain regulatory approvals **
**Training, mentoring, consulting**
**Approximately 120 participants**
**Labor Intensive – requires dedicated participation by small business decision-making official**
**Culminates “opportunity event” **
_***Free***_** other than travel costs**

## 2006/2007 CAP

**Sept ‘06**

**Oct ‘06**

**Oct ‘06 – May ‘07**

**April ‘07**

**May ‘07**

**June ‘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

- Provided by Larta Institute

**2006/2007 CAP**

## 2004/2005 Progress Nine Months Following Completion of CAP

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

- Provided by Larta Institute

## 2004/2005 Progress Nine Months Following Completion of CAP

- 18% increase

- 68% increase

- 87% increase

## Pilot Manufacturing Assistance Program

_***Goal***_**:**

-   Decreasing development costs
-   Decreasing cycle time to market
-   Minimize operational expenses
-   Increasing product quality

- Help make better manufacturing and operational decisions

**SBIR Phase II Awardees**

## Pilot Manufacturing Assistance Program

**   ****Manufacturing transition strategies**
** ****Method of scale up**
** ****Cost estimation**
** ****Quality control**
** ****Prototyping**
** ****Design for manufacturability**
** ****Facility design**
** ****Process development/improvement**
** ****Vendor identification and section**
** ****Plant layout**
**...**

## Pilot MAP Nuts & Bolts

** ****Collaboration with NIST Manufacturing Extension Partnership**
** ****25 companies (diverse technologies and geographical locations)**
** ****Phase II awardees (last 3 years)**
** ****one-on-one assistance**
** ****50 – 100 hours over 2-month period**
** **_***Free ***_

## 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**

## Kay Etzler

***Kay Etzler***
**SBIR TAP Program Manager**
**Phone:  301-435-2713**
** ****Email:  etzlerk@od.nih.gov**