Notice Number: NOT-OD-18-213
Release Date: July 26, 2018
National Institutes of Health (NIH)
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. Offered by the National Institutes of Health (NIH) for more than 14 years now, this annual 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 2018 CAP will begin in September 2018 and will conclude at the end of June 2019.
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 current or was active in the past five fiscal 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 small businesses that 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. Companies may be accepted in the program no more than three (3) times. However, companies that are first time applicants to the CAP will be given priority. Projects under Phase II awards that ended BEFORE August 2013 are NOT eligible.
The NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1,000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and up to 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.
The NIH CAP is a 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; and will enable a small business/company to fully articulate a compelling case for market channels relevant to its 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. We recommend and strongly encourage the participation of the CEO and/or other top management team member(s) with oversight and decision-making authority over commercialization strategy and issues for the company.
The NIH CAP is set up as a three-track customized program, conducted for the most part virtually, and designed to serve the needs of up to 80 HHS/NIH SBIR/STTR Phase II awardees at different levels of commercialization experience and expertise, such as for "emerging companies" (i.e. new to, or with limited experience in the commercial marketplace) and for "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/Reimbursement Training Track (RTT) for “seasoned” companies. The available slots will be distributed among the three tracks, and it should be noted that a participant company may only be accepted into one of the three tracks. Based on your background and experience, your company will be assigned into one of these three tracks:
Commercialization Transition Track (CTT) - Relevant for the majority of HHS SBIR/STTR Phase II companies, this track offers tools and customized approaches to commercialization for "emerging" companies. It will help your company develop and execute on plans and activities critical to commercialization of your technology. The degree of customization enables the Program to work with you to address issues specific to your company’s stage, level, and background. You also have an opportunity to receive, in an in-person live session, direct feedback from executives and experts drawn from the life sciences industry, investment community, regulatory affairs, and research. For example, the track 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. Participants work one-on-one with a Principal Advisor and industry experts as needed.
Advanced Commercialization Track (ACT) - For "seasoned" companies that have more experience in commercialization, and have a history of running a company, developing products, generating sales and revenues, and have customers, the ACT may be suitable. This track will focus (with the help of an “Expert Resource” (ER)) on a specific “high value” gap or issue, which resolution is crucial or critical to the company's continued success. For example, the company may need to address a specific applicable issue (such as a license-focused IP strategy or a term sheet for investors) which resolution is key to their continued growth. This track specifically deploys domain experts to help participants achieve these outcomes.
Regulatory/Reimbursement Training Track (RTT) - Similar to the ACT, this track is applicable to those "seasoned" companies with previous commercialization experience. This track will apply to a selected group of HHS-funded companies seeking regulatory approval by the Food and Drug Administration (FDA) or seeking reimbursement from CMS (Centers for Medicare & Medicaid Services) and private insurance to achieve payment for products/services provided. As in the Advanced Commercialization Track (ACT), this track will focus (with the help of an “Expert Resource” (ER)) on developing a regulatory or reimbursement outcome (a framework and/or approach).
As noted above, NIH CAP is, for the most part, a virtual program, i.e. most assistance and interactions are conducted remotely. There are, however, two (2 ) notable exceptions, both of which require mandatory in-person attendance of the applicant enrolled in the Program: (1) the CAP launch event, called the Commercialization Training Workshop, or CTW, to be held in the Los Angeles, CA area on October 24-25, 2018; and (2) one of the FeedForward™ Sessions or “FFS” to be held in one of 2 locations, Los Angeles, CA (on March 13-14, 2019), and Washington, DC (on March 20-21, 2019). FFS attendance only applies to participants accepted into the Commercialization Transition Track (CTT).
For this 2018-2019 cohort year, NIH CAP is also working on piloting a new feature, namely “FDA Day.” The NIH has long worked collaboratively with its sibling HHS Agency, the U.S. Food and Drug Administration (FDA), on many programs and projects. Recognizing that certain small businesses will need to work with the FDA for federal approval(s) prior to their product being commercialized on the market, “FDA Day” is planned to be held on March 19, 2018 and intended to be an opportunity for selected CAP participant companies of the 2018-2019 cohort to have meetings with FDA officials to learn more about FDA approval processes, reviews, and requirements as these relate to the small business’ technology/product.
CAP participation is free of charge for the selected companies; however, participants are responsible for travel and lodging expenses associated with attending the mandatory workshop(s). 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. For an active SBIR contract, you will need to confer with your contracting officer.
NOTE: Please remember that participation in the NIH CAP is a business commitment like any other commitment that your small business makes. NIH expects that each applicant company that is accepted into the program will honor these commitments through completion of the program. Accordingly, please be certain your small business can and will commit to the CAP if accepted, e.g., attending required meetings, and complying with program deliverables and deadlines (e.g., as described at http://sbir.nih.gov/cap) through completion of the program.
Detailed program information and application instructions are available at http://sbir.nih.gov/cap. Also, an Information Session Webinar about the NIH CAP is scheduled for Thursday, August 9, 2018 at 1:00 pm-2:30 pm EDT (10:00 am-11:30 am PDT). The session is free but pre-registration is required here.
The deadline for submitting an application for NIH CAP is August 16, 2018 by 11:59 pm PDT. Up to eighty (80) companies will be selected to participate in this year's NIH CAP in early September 2018.
Please direct all inquiries to:
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.
National Institutes of Health (NIH)
Please direct inquiries related to submission of the web application to: