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Notice Number: NOT-OD-14-110
Release Date: August 4, 2014
National Institutes of Health (NIH)
The purpose of this Notice is to announce the availability of a Commercialization Assistance Program (CAP) for NIH SBIR and STTR Phase II awardees. Now in its tenth year, this program is designed to help NIH SBIR-STTR Phase II awardees transition their SBIR-STTR-developed products into the marketplace. Through a contract with Larta Inc. of Los Angeles, California, the CAP will provide early stage companies with individualized assistance toward accomplishing their commercialization goals.
The 2014 CAP will begin in September 2014 and will conclude at the end of June 2015.
The Commercialization Assistance Program is appropriate for the majority of NIH SBIR and STTR Phase II companies. Specifically, eligible companies include those with an NIH SBIR-STTR Phase II project (grant, contract, or cooperative agreement) that is or was active in the past five years, including Phase IIB competing renewal awards and those in the second phase of the Fast-Track program. SBIR Phase II awardees from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) can also apply. Participants must, however, meet the SBIR-STTR small business eligibility criteria as described in the current SBIR and STTR Parent Funding Opportunity Announcement available from the NIH Small Business Funding Opportunities website http://sbir.nih.gov. Those who may have previously participated in the program no more than two (2) times may participate again providing they have a different qualifying Phase II award. However, companies that are first time applicants to the CAP will be given priority.
The CAP is a 9-month long mentoring and training program. It is not a curriculum-based approach and should not be perceived as continuous 9 months of engagement. Instead, each participant works individually at their pace with assigned industry expert called the Principal Adviser (PA) and other current industry experts in business areas relevant to the participating company's technology space and commercialization needs to achieve program goals. The program is aimed at assisting participants with evaluating their commercialization options based on their specific technologies (including the need and prospect for investment, strategic partnerships or licensing) and to develop a solid market-entry plan covering an 18-month period. The assistance rendered under CAP is practical and actionable, oriented to addressing gaps that exist in your current commercialization status, and will allow a company to fully articulate a compelling case for market channels relevant to your business and to develop a clear understanding of potential customers, partners, investors and competitors. These goals are achieved from contact with experienced advisors and live feedback from current industry executives and others. Company CEO participation is highly encouraged and expected in this program.
The NIH CAP offers opportunities to both "emerging companies" i.e. new to, or with limited experience in the commercial marketplace and "seasoned companies" with more established commercialization experience who are facing more complex business strategic challenges. The program is customized to meet the needs of emerging and seasoned companies in three distinct tracks, each different in its objectives and outcomes: The Commercialization Training Track (CTT) for emerging companies, the Accelerated Commercialization Track (ACT), and the Regulatory Training Track (RTT). The CAP's eighty (80) available slots will be distributed between the three tracks:
Commercialization Training Track (CTT) - This track will apply to the majority of NIH SBIR/STTR Phase II companies. It is aimed at assisting participants with evaluating their commercialization options based on their specific technologies (including the need and prospect for investment, strategic partnerships or licensing) and to develop a solid market-entry plan ("Commercialization Roadmap") covering an 18-month period. It also assists participants in the development of market-appropriate tools to accomplish these objectives, and provides opportunities for direct industry feedback in live session. Participants work one-on-one with a principal advisor and industry experts as needed.
Accelerated Commercialization Track (ACT) - This track will apply to a selected group of NIH-funded companies who have successfully commercialized products and/or services, generated revenue, established partnerships and/or otherwise achieved a level of market development that is sustainable over a definitive period. However, they may need to address a specific applicable issue (such as a license-focused IP strategy or a term sheet for investors) whose resolution is key to their continued growth. This track specifically deploys domain experts to help participants achieve these outcomes.
Regulatory Training Track (RTT) - This track will apply to a selected group of NIH-funded companies whose technologies require regulation by the Food and Drug Administration (FDA). These companies are either preparing for initial engagement with and submission to the FDA or have already done so but may need to address specific applicable issues related to their application, developing a solid regulatory plan or addressing feedback from the FDA in order to move their technology development along toward achieving regulatory milestones and approval. This track specifically deploys regulatory business experts to help participants achieve these outcomes.
CAP participation is free of charge for the selected companies; however, participants are responsible for travel and lodging expenses associated with attending two mandatory workshops, one being a kick off event at the beginning of the program launch in Los Angeles, CA and another mid-way through the CAP called Feedback Sessions that are individual closed business strategy and partnering sessions with industry experts. The Feedback Sessions will be held in Washington, D.C. and Los Angeles, CA. NOTE: NIH will not provide additional funding for this purpose; however, participants with a currently active Phase II SBIR-STTR award may re-budget funds within the total costs awarded to cover allowable travel expenses for CAP events without NIH prior approval unless the re-budgeting action constitutes a change in scope or if the terms of award prohibit the use of funds for this purpose.
Detailed program information and application instructions are available at https://grants.nih.gov/grants/funding/cap/index.htm. The deadline for submitting an application is September 2, 2014. Eighty (80) companies will be selected to participate in this year's NIH CAP by the end of September 2014.
Please direct all program inquiries to:
Lenka Fedorkova, Ph.D.
National Institutes of Health
Please direct inquiries related to submission of the web application to:Judy Hsieh