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Lenka Fedorkova, Ph.D. Assistant Manager NIH SBIR/STTR Programs. CEO Roundtable : Technical Assistance Programs. National Institutes of Health. Mt. “FDA” ???. NIH Technical Assistance Programs. Niche Assessment Program. Commercialization Assistance Program. Phase I. Phase II.

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Lenka Fedorkova, Ph.D.

Assistant Manager


CEO Roundtable:

Technical Assistance Programs

National Institutes of Health

Mt. “FDA”


NIH Technical Assistance Programs

Niche Assessment Program

Commercialization Assistance Program

Phase I

Phase II

Phase III

“Valley of Death”

Nih awardee needs
NIH Awardee Needs

  • Investment = Cash Flow “Valley of Death”

  • Market Validation = who will buy your product or pay for your service?

  • Defining Your Customer – Is your technology a “needed” solution to a defined problem?

  • Penetrating well-established/ crowded markets = Who is your competition versus strategic partner?

  • Protecting Intellectual Property = your “worth”

Niche assessment program

Technology Niche Analysis

Report helps Phase II submissions:

Identify other uses of technology

Determines competitive advantages

Market size and potential

Barriers to entry & strategy

Feedback from potential end-users

Phase I SBIR/STTR awardees

With current or soon to be awarded Phase I (Notice of Award)

Niche Assessment Program

Commercialization assistance program cap
Commercialization Assistance Program (CAP)

  • Personalized Business Mentoring; Knowledge Transfer; Business Outcomes!

  • Business & strategic planning

  • Investor & partnership pitch

  • Technology Value Proposition

  • FDA regulatory requirements

  • IP & Licensing Issues

  • Market Readiness

Phase II SBIR/STTR awardees

Active or 5 years since completion of project

Nih cap participants 2004 2013


116 Companies


142 Companies


97 Companies


89 Companies

Healthcare IT

99 Companies

Medical Devices

215 Companies

*Includes Clinical Research, Instrumentation, Research Tools

How cap works
How CAP Works

  • Customized Approach

    • Commercialization Training Track

    • Accelerated Commercialization Track

    • Regulatory Training Track

  • High-level industry and commercial expertise

    • Live feedback from active industry contacts

    • Mediated connections to industry partners and investors

  • High-quality workshops and events

  • Nationwide network of resources, referrals

The impact
The Impact

  • How do we measure SUCCESS?

    • Met with or closed deals with investors

    • Met with the FDA or obtained approval

    • Launched a product

    • Achieved revenue

    • Signed licensing agreements

    • Hired new employees

    • Established partnerships

    • Signed CDA

Nih cap results 2004 2012
NIH-CAP RESULTS: 2004-2012

  • Deals: Signed legal documents committing partners to a process, timeframe and outcome, including.:

  • Acquisitions

  • Distribution Agreements

  • Investment

  • - Licensing Agreements

  • - Technical Collaborations

Why nih cap matters

Strategic Introductions


New Jobs Created

Millions Raised




Results directly attributed by the companies to their participation in CAP



Get Connected

  • NIH Guide for Grants and Contracts (weekly notification)


  • NIH SBIR/STTR Notification

  • Email [email protected] with ‘subscribe SBIR-STTR your name’

    in the message body:

  • Follow us on Twitter: @NIHsbir

  • Submit your SBIR/STTR Success Story at our Website: http://nih.sbir.gov

InvivoSciences, Inc.

  • Provides phenotypic compound screening services for first-in-class drug discovery and drug repositioning

  • Madison, WI

Ayla Annac, MBACo-Founder& CEO

  • http://www.invivosciences.com/

SenesTech, Inc.

  • Revolutionary technology for animal pest control that targets the heart of the problem: Reproduction

  • Flagstaff, AZ

  • http://senestech.com/

Loretta Mayer, Ph.D.

Founder & CEO

Actuated Medical, Inc.

  • Designs and develops next-generation, FDA-compliant medical devices

  • Bellefonte, PA

Maureen Mulvihill, Ph.D.

Co-Founder & CEO

  • http://www.actuatedmedical.com/

Biopsy Sciences, LLC.

  • A medical device company best known for their lead products, the BioSEAL and the HydroMARK

  • Clearwater, FL

  • http://www.hydromark.com/

John Fisher, M.D.

Founder & CEO

Learn More at