NIH SBIR Technical Assistance Programs

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NIH SBIR Technical Assistance Programs
Kay Etzler NIH SBIR/STTR Program
9th Annual NIH SBIR/STTR Conference Las Vegas,
NV November 26 27, 2007
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Path to Innovation Commercialization

• Phase II Competing Renewal Application

Phase I
Phase II
Phase III
Technical Assistance Program
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Commercialization Valley
3 months? 2 years? 10 years?
Phase II

Phase I
Phase III
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Phase II Competing Renewals
TAP

• 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

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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
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Technical Assistance Program
(TAP)
Commercialization Assistance Program
Niche Assessment Program
Pilot Manufacturing Assistance Program
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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)
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Niche Assessment Program
SBIR Phase I Awardees
Goals

• 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

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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

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Commercialization Assistance Program (CAP)
SBIR Phase II Awardees
Goals

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

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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

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2006/2007 CAP
Status Meeting/Update
Business Strategic Planning
Apply, Select, Meet Advisor
Showcase Event
Outcomes Workshop
Commercialization Workshop
Follow-up
Sept 06
Oct 06
Oct 06 May 07
April 07
May 07
June 07 Dec 08
Feb/Mar 07
10 month process
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Participation by Industry Sector
2006/2007 CAP
Provided by Larta Institute
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2004/2005 Progress Nine Months Following
Completion of CAP
At least one event in at least one
commercialization category
Provided by Larta Institute
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2004/2005 Progress Nine Months Following
Completion of CAP
18 increase
68 increase
87 increase
Provided by Larta Institute
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Pilot Manufacturing Assistance Program
SBIR Phase II Awardees
Goal
Help make better manufacturing and operational
decisions

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

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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

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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

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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

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Kay Etzler SBIR TAP Program Manager Phone
301-435-2713 Email etzlerk_at_od.nih.gov