NIH Technical Assistance Program

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NIH Technical Assistance Program

• 7th Annual NIH SBIR/STTR Conference

Kay Etzler NIH SBIR/STTR Program July 29, 2005
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Path to Innovation Commercialization

• Competing Continuation Phase II application

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

Phase III
Phase I
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Phase II Competing Continuations
CAP

• 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
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Technical Assistance Program
Commercialization Assistance Program (CAP)
Pilot Niche Assessment Program
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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

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Pilot Niche Assessment
SBIR Phase I Awardees
Goals

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

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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

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Commercialization Assistance Program (CAP)
SBIR Phase II awardees
Goal Accelerate commercialization of
SBIR-developed products or services

• Provides business strategic planning
• Helps build strategic alliances and investor
  partnerships

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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

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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

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Participation by Industry Sector
Provided by Larta Institute
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Steve Holdaway and Sandra Cummings from Zycare,
Inc.
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Dr. Leo Liu Cambria Biosciences
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Dr. Kenneth Weil Rose Biomedical Development Corp.
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Dr. Wai Tak Law Portascience, Inc.
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2005/2006 CAP
Eligible participants will be notified in
August/September 2005
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Kathleen Shino Acting NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email shinok_at_mail.nih.gov Kay
Etzler SBIR/STTR Program Phone
301-435-2713 Fax [phone] Email
etzlerk_at_od.nih.gov