NIH Offers Assistance to Phase II HHS SBIR and STTR Awardees through the NIH Commercialization Accelerator Program (CAP)

Notice Number: NOT-OD-15-144

Key Dates
Release Date: August 14, 2015  

Related Announcements
None    

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to announce the availability of the Commercialization Accelerator Program (CAP) (previously known as the Commercialization Assistance Program) for HHS SBIR and STTR Phase II awardees. Now in its eleventh year, this program is designed to help HHS 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 2015 CAP will begin in October 2015 and will conclude at the end of June 2016.

The Commercialization Accelerator 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 assistance program. It is not a curriculum-based approach. Instead, each participant works individually at their pace with an assigned industry expert called the Principal Advisor (PA) and other current industry experts in business areas relevant to the participating company's technology space and commercialization needs to achieve his/her goals and to achieve program completion. 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 at developing 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 company’s current commercialization status, will enable your 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 which are facing more complex business strategic challenges. The program is customized to meet the needs of participating companies in three distinct tracks, each different in its objectives and outcomes: The Commercialization Transition Track (CTT) for emerging companies, the Advanced Commercialization Track (ACT), and the Regulatory Training Track (RTT) for “seasoned” companies. The CAP's eighty (80) available slots will be distributed between the three tracks:

Commercialization Transition Track (CTT) - This track will apply to the majority of HHS 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" or “Strategic Action Plan”) 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 a live session. Participants work one-on-one with a principal advisor and industry experts as needed.

Advanced Commercialization Track (ACT) - This track will apply to a selected group of HHS-funded companies which 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 HHS-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 event mid-way through the CAP called Feedback Sessions (for CTT companies only) that are individual, closed-door 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://sbir.nih.gov/cap. Also, an Information Session Webinar about the NIH CAP is scheduled for Tuesday, September 1, 2015 at 2:00pm EDT (11:00am PDT).  The session is free but pre-registration is required here.

The deadline for submitting an application is September 11, 2015. Eighty (80) companies will be selected to participate in this year's NIH CAP the week of October 5, 2015.

Inquiries

Please direct all program inquiries to:

J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.
National Institutes of Health (NIH)
Telephone: 301-435-0189
Email: sbir@od.nih.gov

Please direct inquiries related to submission of the web application to:

Judy Hsieh
Larta, Inc.
Telephone: 213-538-1444
Email: jhsieh@larta.org