Commercialization Assistance Program (CAP) - More on Cap
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National Institutes of Health

Commercialization Assistance Program (CAP)
For Phase II SBIR & STTR Awardees


Personalized AssistanceKnowledge TransferBusiness OutcomesStay on Track with CAP

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Program Description

What is CAP?

The NIH Commercialization Assistance Program (CAP), offered annually since 2004, is designed to help some of the agency's most promising small life science and healthcare Phase II grantees develop their commercial businesses and transition their SBIR/STTR-funded technologies into the marketplace. Applicants are selected via a competitive process for a limited number of slots in the program.

Funded by NIH and managed through a contract with Humanitas, Inc. (www.humanitas.com) of Silver Spring, MD which is teaming up with Larta, Inc. (www.lartainc.com) of Los Angeles, CA, the CAP provides selected participants with individualized assistance toward accomplishing their commercialization goals. This is achieved through individual mentoring and consulting sessions, training workshops, access to domain experts and focus on outcomes that will enhance the commercialization profile and readiness of participating grantees.

Applications are now open and the deadline is EXTENDED to November 14, 2012. All applications will be competitively reviewed, and participants will be notified on or about November 21, 2012. This year we expect to accept 75 companies into the program. The assistance through CAP begins in December 2012 and spans nine (9) months, ending in August 2013.

Who is Eligible to Participate?

  • Companies whose NIH SBIR and STTR Phase II award is or was active in the past 5 years, including Phase IIB competing renewals (grant, contract, or cooperative agreement) and those in the Fast-Track program. Projects that ended before August 2007 are not eligible.
  • Companies that meet the current SBIR/STTR small business eligibility criteria as described in the NIH SBIR/STTR Omnibus solicitation. (The solicitation and its parent funding opportunity announcements are available from the NIH Small Business Funding Opportunities website)
  • Previous NIH CAP participants with a different Phase II award. Please note that first time applicants to the CAP will be given priority due to the limited number of slots.

Is CAP Right for You?

The NIH CAP offers opportunities to both “emerging companies” new to the commercial marketplace and “seasoned companies” with more established commercialization experience and are facing more complex business strategic challenges. The program is customized to meet the needs of emerging and seasoned companies in two distinct tracks, each different in its objectives and outcomes: The Commercialization Training Track (CTT) for emerging companies, and the Accelerated Commercialization Track (ACT). The CAP's seventy five (75) available slots will be distributed between the two tracks as follows:

  • Commercialization Training Track (CTT) - With sixty (60) slots available, 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. Participants work one-on-one with a principal advisor and industry experts as needed.
  • Accelerated Commercialization Track (ACT) - With fifteen (15) slots, this track will apply to a select 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 solid regulatory plan, a license-focused IP strategy or a term sheet for investors) whose resolution is key to their continued growth. This track specifically deploys industry experts to help participants achieve these outcomes.

The commitment of time and resources with management support is vital. Company CEO participation is highly encouraged and expected in this program. Past experience indicates that the best results are achieved when the CEO serves as the company's CAP Leader and is actively involved. Hence, successful applicants will be those where top management - founder, CEO, or other key team member leading the commercialization efforts - are directly involved in the Program.

CAP participation is free of charge for selected participating companies; however, participants in both, the ACT and CTT tracks, are responsible for travel and lodging expenses associated with attending the mandatory Commercialization Training Workshop (CTW) and, in the case of CTT track participants, for one Industry Feedback Session.

NOTE: NIH will not provide additional funding covering your participation in CAP; however, participants with a current active Phase II SBIR or STTR award may rebudget funds within the total costs awarded, to cover allowable travel expenses for CAP events without NIH prior approval unless the rebudgeting action constitutes a change in scope or if the terms of award prohibit the use of funds for this purpose. Selected companies are encouraged to contact their funding NIH institute program officer for inquires in this regard.

The CAP in Detail

As already mentioned, the CAP is a two-track program customized to serve the needs of companies at different levels of commercialization experience and expertise.

1. Commercialization Training Track (CTT)

 

The Commercialization Training Track (CTT) applies to the majority of NIH SBIR Phase II companies. Sixty (60) slots are available. CTT 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 Commercialization Roadmap (a strategic action plan) covering an 18-month period. It also assists participants in the development of market-appropriate tools to accomplish these objectives.

Over a 9-month period, each CTT participant will:

CAP Timeline CTT Companies

CAP Timeline CTT Companies

By the completion of the program, each participant should have a solid understanding of the commercial value of their technology, and also how it is positioned in the current market landscape, what the true competitive posture of the company is, and what gaps remain to be addressed. Each participant will have developed their own Management Toolkit which includes an 18-month Commercialization Roadmap (strategic action plan) that addresses their next steps.

CTT Orientation Webinar - December 4, 2012

All participants are expected to participate in the Orientation Webinar, which will cover the following topics:

  • An introduction to the program and to some of the key people associated with the program.
  • Guide to the program timelines, specific guidelines on your Road Show Presentation and 18-Month Commercialization Roadmap (strategic action plan)
  • Sample documents and resources available via the program
  • Introduction and Orientation to the NIH CAP portal, maintained by Larta, Inc. (a member of Team Humanitas)
  • Discussion concerning program expectations

Principal Advisor Assigments and Work Plan Development - December 2012 to January 2013

Upon selection as a CTT participant, a Principal Advisor (PA) is assigned to work closely with each participant and is matched with the company based on the advisor's experience and expertise and the company's needs. Your PA operates as a facilitator and counselor, helping you to prepare materials as needed, and serving as a sounding board throughout the program as you develop an 18-month Commercialization Roadmap (your Strategic Action Plan). Participants work one-on-one with their PA on a regular monthly basis, and other investment and/or industry advisors/experts will be consulted when warranted. The PAs are experienced consultants and business executives with recorded success in guiding innovative enterprises. Advisors will not do the work for you, but will mentor, guide, and assist. All participants will be coached and mentored via face-to-face meetings and/or via remote communication tools, e.g., phone, email, Internet.

Your first communications with your PA will focus on your commercialization needs and developing a program work plan that identifies obstacles and hurdles you face (or are likely to face) and broad outlines of solutions available to you. This plan is referred to as the CAP Planning/Assessment Template (“Template”) and will be completed at the onset of the program to guide your work through the program. The Template will help identify gaps in operations, systems, technology product development, etc. and will be useful in defining the optimal path to market and commercialization. It is also used to align with the steps participants need to take to resolve the gaps, and thus to develop an 18-month Commercialization Roadmap (strategic action plan).

During this phase of the CAP, you and your PA will also prepare for your face-to-face meeting at the program's Commercialization Training Workshop, to take place in January, 2012.

Commercialization Training Workshop - January 15-16, 2013, Los Angeles, CA

(The CEO or other top management team member(s) with oversight and authority over commercialization issues is strongly encouraged to attend.)

All participants (ACT & CCT) are required to attend the Commercialization Training Workshop (CTW). All participants are responsible for travel and lodging expenses associated with attending this mandatory event. This workshop offers in-depth interactive seminars led by advisors and experts from the legal, investment, and industry communities. A key feature is a face-to-face meeting with your Principal Advisor (PA). The CTW also provides excellent opportunities to network with fellow CAP participants, other key people associated with the program, industry experts in attendance and NIH staff.

January 15, 2013- Interactive seminars

Agenda topics may include but are not restricted to:

  • Financing and Funding Issues for Life Science Companies
  • Partnering/investment Planning
  • Intellectual Property Management
  • Early Stage Branding and Marketing issues and concerns (including social media)
  • Healthcare IT Commercialization Issues (for those companies in the Healthcare/IT field)
  • Regulatory and Reimbursement Issues

January 16, 2013- Face-to-Face Meeting with your Principal Advisor

A 1-hour face-to-face meeting with your PA will be scheduled the day after the workshop. It will be a continuation of your November/December discussions with your PA and will include an in-depth discussion of the company's status, commercialization needs, and the work plan (Planning/Assessment Template). Participants will also discuss various elements of the program including program timeline and the program's management toolkit. At the end of this meeting, there should be a clear understanding of all program details, a customized commercialization approach, and a firm commitment from the participant to invest the required time and effort to the CAP.

Business and Strategic Planning and Development of Management Toolkit -

January 2013 through August 2013

After the CTW, companies and PAs start working on the work plan agreed upon and the development of the Management Toolkit, which will include materials useful for implementing their commercialization plan both during and after the program ends. While the Toolkit will be customized for each participant's needs, it will include information relevant to the following components:

18-Month Commercialization Roadmap (also referred to as the Roadmap or strategic action plan): At the end of the program, each company will have a list of strategies, tasks and milestones with a timeline looking forward over the next 18 months. Ideally, this would include budgets necessary to accomplish the necessary tasks, and may be broken down by specific periods over the course of the 18 months covered by the Roadmap. This tool will be useful in managing and tracking your commercialization progress and outcomes after the CAP.

Road Show Presentation: This is a short PowerPoint presentation to “pitch” the company to potential investors, strategic partners, licensees or customers. It will provide a brief, informative and compelling glimpse of the company, to attract the interest of a targeted audience at private meetings or at pitch events such as investment forums, conferences, or trade shows. (Note: This is not intended to serve as preparation for a specific event nominated by CTT participants, nor is there a commitment to performing this task for that purpose).

Quad Chart/Virtual Showcase and Keywords - February 2013

Each company will develop a quad chart that can be used for showcasing and promoting the company's technology assets, including on NIH's Web site and portal. Each chart will include:  (1) specific company information, (2) your management team, (3) an overview of your technology and its competitive advantage(s), and (4) your company's pipeline of products under development or a detailed description of the technology.

Feedback Sessions - April-May 2013

Feedback Sessions are face-to-face working meetings for the participant to present its Commercialization Roadmap (18-month Strategic Action Plan) to a group of mentors and life science industry experts for critique and constructive feedback. Only CTT participants are expected to attend. (See previous note regarding travel costs.) These outside experts will provide objective and frank feedback on the company's commercialization opportunity and strategy (as presented) with fresh perspectives and, perhaps, suggestions and options other than those presented. You will have the opportunity to adjust and amend materials in your Management Toolkit based on the advice and recommendations provided. In addition, you will have the unparalleled opportunity to meet and network with industry experts, thus providing you contacts for future reference. Feedback Sessions are widely considered to be a major highlight and distinguishing feature of NIH's CAP.

Feedback Sessions are designed to be as convenient as possible for participating companies, and also to cultivate networking. Participants need attend only one day at any one location of the following three Feedback Sessions:

Los Angeles, CA - April 17-18, 2013
Washington, DC - April 29-30, 2013

Dates are tentative and may change due to unforeseen circumstances. Participants will be informed in a timely fashion should any changes occur.

Following the Feedback Sessions, participants will continue to work with their PAs on refining their strategies, action plans, presentations, and other Management Toolkit documents. If there is a need for other advisors from a particular specialty area, e.g. legal, regulatory, etc., such expertise may be brought in during this period as well.

Close-out Web Meetings - July 2013

A Close-out Web Meeting is the final CAP event. This is an opportunity for the participant to provide NIH program managers, your Principal Advisor and key program staff a "live" look at the company's progress at the end of the program.  The primary focus of this event is for you to present to NIH SBIR/STTR program managers the feedback received from the Feedback Sessions, what you and your company has accomplished since the Feedback Sessions, your 18-month Action Plan (next steps/goals), and your plan to achieve the milestones set out in the Plan. The meeting is informal, similar to the monthly teleconferences with the Principal Advisor, and will last approximately 30 minutes. A Web tool will be used to facilitate the sharing of the documents being discussed.

Program Feedback and Tracking - At completion of the program

All participants will be expected to provide feedback to NIH concerning their experiences with the program as well as commercialization tracking information for 18 months in three intervals: (1) Baseline: immediately upon completion of the program, (2) First Interval Tracking: nine months following completion, and (3) Second Interval Tracking: eighteen months following the program's completion.

The feedback will allow NIH to assess the program and its implementation, and the tracking will keep NIH informed of the progress your company has made with commercializing the NIH SBIR-developed product.

 

2. ACCELERATED COMMERCIALIZATION TRACK (ACT)

The Accelerated Commercialization Track (ACT) of the NIH-CAP applies to a select 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, in this particular technology under which they have enrolled in CAP, they may be lacking with respect to (may need to address) a specific applicable issue (such as a solid regulatory plan, a license-focused IP strategy or a term sheet for investors), whose resolution is key to their continued growth. This track uses industry experts (called “expert resources”) to help participants achieve these outcomes. 15 slots are available for the Accelerated Commercialization Track.

During the program, each ACT participant will:

CAP Timeline ACT Companies

CAP Timeline ACT Companies

The following are the key identifiable phases of the ACT track, in sequence.

ACT Orientation Webinar - December 4, 2012

All ACT participants are expected to participate in the ACT Orientation Webinar, which will feature the following topics:

  • Introduction to the program and to some of the key people associated with the program (including “expert resources” who may assist with the resolution of your outcome).
  • Orientation with program timeline, specific guidelines on your Outcome Proposal and Final Outcome Report
  • Sample documents and resources available via the program
  • Introduction and Orientation to the NIH-CAP Portal, maintained by Larta Inc. (a member of Team Humanitas)
  • Discussion concerning program expectations

Principal Advisor Assignments and Outcome Proposal Development -

November 2012- mid-January , 2012

Upon selection as an ACT participant, a Principal Advisor (PA) is assigned to work closely with each participant and is matched with the company based on the advisor's experience and expertise and the company's needs. Your PA operates as a facilitator and counselor, helping you to prepare materials as needed, and serving as a sounding board throughout the program as you develop, and work towards the achievement of, a Targeted Outcome for the CAP. Participants work one-on-one with their PA on a regular monthly basis. The PAs are experienced consultants and business executives with recorded success in guiding innovative enterprises. Advisors will not do the work for you, but will mentor, guide, assist and generate strategic connections for you. All participants will be coached and mentored via face-to-face meetings and/or via remote communication tools, e.g., phone, email, Internet.

Your first communications with your PA will focus on the development of an “Outcome Proposal.” The parties will discuss the companies' most critical commercialization issues in order to focus on developing a “Targeted Outcome” to be accomplished during the program. Targeted outcomes may include, but are not limited to, addressing regulatory issues, legal and/or financial structuring/restructuring, management recruitment, term-sheet development, product or prototype design or other issues. Whether a specific outcome is appropriate for the company is determined in discussions between the PA and the Company. A single targeted outcome will become a part of an Outcome Proposal which will discuss the participant's proposed approach to achieve the targeted outcome. The Proposal will spell out clearly the most critical issues pertinent to creating a desired solid commercialization outcome, what the targeted outcome will be (e.g. a “regulatory guidance” document, a design, a recruit), the best path of resolution within a timeline consistent with the duration of the program, and any “expert resources” who may be needed to achieve the targeted outcome. NIH must approve this Outcome Proposal before moving forward in the program.

During this phase of the CAP, you and your PA will also prepare for your face-to-face meeting at the program's Commercialization Training Workshop, to take place in January, 2012.

Commercialization Training Workshop - January 15-16, 2013, Los Angeles, CA

(The CEO or other top management team member(s) with oversight and authority over commercialization issues is strongly encouraged to attend.)

All participants (ACT & CCT) are expected to attend the Commercialization Training Workshop (CTW). ). All participants are responsible for travel and lodging expenses associated with attending this mandatory event. This workshop offers in-depth interactive seminars led by advisors and experts from the legal, investment, and industry communities. A key feature is a face-to-face meeting with your Principal Advisor (PA). The CTW also provides excellent opportunities to network with fellow CAP participants, other key people associated with the program, industry experts in attendance and NIH staff.

January 15, 2013- Interactive seminars and networking workshops

Agenda topics may include but are not restricted to:

  • Financing and Funding Issues for Life Science Companies
  • Partnering/investment Planning
  • Intellectual Property Management
  • Early Stage Branding and Marketing issues and concerns (including social media)
  • Healthcare IT Commercialization Issues (for those companies in the Healthcare/IT field)
  • Regulatory and Reimbursement Issues

January 16, 2013- Face-to-Face Meeting with your Principal Advisor

A 1-hour face-to-face meeting with your PA will be scheduled the day after the workshop. It will be a continuation of your December discussions with your PA and will include an in-depth discussion of the company's status, commercialization needs, and your targeted Outcome, the Outcome Proposal. One of the items for discussion between the PA and the ACT company is the type of “expert resource” necessary to help accomplish the nominated Outcome. Participants will also discuss the program timeline and other program deliverables. At the end of this meeting, there should be a clear understanding of all program details and a firm commitment from the participant to invest the required time and effort to the CAP.

Transaction-Oriented Work Plan - December 2012 through Completion

Upon NIH approval of the Outcome Proposal, the participant will work with his/her PA to complete the transaction-oriented work plan. The work plan should clearly indicate a specific need and a clear path to accomplish a tangible outcome and will include a timeline with specific milestones, and an estimated date for completion. The plan should be capable of being accomplished within the duration of the program.

ACT companies are also provided with the assistance of Expert Resources (ER), who are professionals identified jointly by each ACT company and its PA as critical to the achievement of the targeted outcome. ERs are experts in critical aspects of commercialization, such as intellectual property, regulatory clearance, accounting, management recruiting, government procurement, etc. The assistance provided by the PAs and ERs during the course of the CAP is fully covered by the NIH; participants should use these resources only for the length and scope directed by the program. However, participants are free to negotiate contingency arrangements with a provider of services of their choice for work that may endure beyond the CAP, covered by their own financial resources.

* Disclaimer: NIH does not endorse the expert resources/advisors for the purpose of retaining them for any purpose following the conclusion of the Program. Any arrangement with such resources/advisors beyond the service rendered under the program is the responsibility of the CAP participating Company ONLY.

Quad Chart/Virtual Showcase and Keywords - February 2013

Each company will develop a quad chart that can be used for showcasing and promoting the company's technology assets, including on NIH's Web site and portal. Each chart will include:  (1) specific company information, (2) your management team, (3) an overview of your technology and its competitive advantage(s), and (4) your company's pipeline of products under development or a detailed description of the technology.

Final Outcome Report - Near completion of the program

Working with the company, the PA will prepare a Final Outcome Report that documents the participant's progress and end-results with meeting the company's desired outcome. It will address whether the timeline and work plan were adhered to throughout the program and if the desired outcome was accomplished. In cases where the desired outcome is not reached, the Final Outcome Report will specify the key issues that prevented the outcome from occurring and the company's next steps towards achieving the targeted outcome.

Close-out Web Meetings - May through July 2013

A Close-out Web Meeting is the final CAP event. This is an opportunity for the participant to provide NIH program managers, your Principal Advisor and key program staff a "live" look at the company's progress at the end of the program. The primary focus of this event is for you to present to NIH SBIR/STTR program managers what your company has accomplished on the targeted outcome, your Transaction-Oriented Work Plan, and your strategy to achieve the milestones set out in the Work Plan. The meeting is informal, similar to the monthly teleconferences with the Principal Advisor, and will last approximately 30 minutes. A Web tool will be used to facilitate the sharing of the documents being discussed.

Program Feedback and Tracking - At completion of program

All participants will be expected to provide feedback concerning their experiences with the program as well as commercialization tracking information for 18 months in three intervals: (1) Baseline: immediately upon completion of the program, (2) 1st Interval Tracking: nine months following completion, and (3) 2nd Interval Tracking: eighteen months following the program's completion. The feedback will allow NIH to assess the program and its implementation, and the tracking will keep NIH informed of the progress your company has made with commercializing the NIH SBIR-developed product.

Contacts

NIH
Lenka Fedorkova, Ph.D.
Assistant Program Manager
SBIR/STTR Program Office
Office of Extramural Programs
National Institutes of Health
Ph: (301) 435-0921
http://sbir.nih.gov

 

This page last updated on February 22, 2013
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