National Institutes of Health
Commercialization Assistance Program (NIH-CAP)
For NIH SBIR Phase II Awardees
(Managed by Larta Institute)

Program Description

Objective

The NIH SBIR Commercialization Assistance Program (CAP), now in its fifth year, is designed to help some of the nation's most promising small life science and healthcare companies develop their commercial businesses and transition their SBIR-funded technologies into the marketplace. Through a contract with Larta Institute (www.larta.org) of Los Angeles, CA, the CAP will provide participants with individualized assistance toward accomplishing their commercialization goals.

Program Eligibility

Who is eligible to participate?

  • Companies whose NIH SBIR (not STTR) Phase II award (grant, contract, or cooperative agreement) was active in the past 5 years.
  • Companies that meet the current SBIR 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 http://grants.nih.gov/grants/funding/sbir.htm.)
  • Previous NIH SBIR CAP participants. However, the same SBIR Phase II award may not be used

Eligible SBIR Phase II awardees who are seeking to advance their commercialization progress through investments or strategic alliances AND who are willing to invest the time and effort needed to do so are encouraged to apply. The company's "decision maker" will be expected to have a key role in the CAP as past experience indicates that the best results are achieved when the CEO serves as the company's CAP Leader and is actively involved.

Selected participants will be notified by October 6, 2008.

About the CAP

The 2008-2009 CAP will officially be launched in October 2008 and will span ten months ending in July 2009. The NIH CAP offers opportunities to both "emerging companies" who are making their first foray into the commercial marketplace and "seasoned companies" who have considerable business and/or commercialization experience. The program is customized to meet the needs of early stage and seasoned companies in two distinct tracks, Commercialization Training Track (CTT), and Accelerator Commercialization Track (ACT), respectively. Each is different in their objectives and outcomes.

CTT focuses on training and mentoring by key industry and investment professionals and the development of a clear and focused strategy toward commercialization. ACT is geared toward the participant achieving clearly identified, very specific objectives, using domain experts with current market experience, provided by the program (referred to hereafter as "expert resources").

CAP participation is free of charge for selected participating companies; however, participants are responsible for travel and lodging expenses associated with attending workshops and partnering investment events.


1. Commercialization Training Track (CTT)

The Commercialization Training Track (CTT) is customized for early stage companies in need of establishing a strong basic understanding of the industry/marketplace dynamics before presenting themselves to potential partners. Participants in CTT will acquire or enhance their skills and tools and create the infrastructure, documentation, and business models needed to become viable commercial partners.

Over a 10-month period, each CTT participant will:

60 slots are available for the Commercialization Training Track. Participation in the program is free; however, those participating in the CTT are responsible for the travel and lodging expenses associated with attending two mandatory workshops: (1) the Commercialization Training Workshop and (2) the Feedback Session. If a company applies to Larta's 2009 Partnering/Investment Forum and is chosen to present, presenting fees and travel and lodging costs are also the responsibilities of the participants.

Commercialization Training Workshop -- October 27 & 28, 2008, Los Angeles, CA
(The CEO is encouraged to attend.)

The Commercialization Training Workshop (CTW) is the first event of the CAP and participation is mandatory. As the first step in determining your commercialization pathway, this workshop will offer in-depth interactive seminars led by Larta advisors and experts from the legal, investment, and industry communities. The CTW also features a face-to-face meeting with your Principal Advisor, networking with fellow CAP participants, and introductions to other key people associated with the program.

October 27, 2008- Face-to-Face Meeting with your Principal Advisor

A get-to-know, two-hour face-to-face meeting with your Principal Advisor will be scheduled the day before the workshop itself. It will include an in-depth discussion of the company's status, suitability of the CAP, commercialization needs, and a work plan. Participants and their Principal Advisors will focus on completing the Assessment Template and set the stage for the Analysis Document. The participant will also discuss various elements of the program including program timeline, an action plan, presentation documents, etc. 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.

October 28, 2008- Seminars and interactive workshops

Agenda topics may include:

  • Introduction and Orientation to NIH-CAP
  • Business Planning
  • Financing and Funding Issues for Life Science Companies
  • Intellectual Property Management and Negotiation
  • Early Stage Branding and Marketing Your Company
  • Healthcare IT
  • Reimbursement and Regulatory Issues
  • Lessons Learned: Success Stories from Previous CAP Companies

Business and Strategic Planning - October 2008 through June 2009

Participants will work one-on-one with their Principal Advisors on a regular basis, and with other investment and/or industry advisors, as needed, to develop a Management Toolkit. (Other advisors are available through the Program, and while every effort will be made to ensure that these resources are employed in a timely fashion on your behalf, you are encouraged to assess and communicate your need for such expertise early in the Program).


By the completion of the program, each participant should have not only a solid understanding of the commercial value of their technology, but also how it positions with 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 Action Plan that addresses their next steps.

Larta's Principal Advisors 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.

Management Toolkit - October 2008 through June 2009

Each participant will develop a Management Toolkit that will include materials useful for implementing the 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:

Assessment Template: This template is used to help identify gaps in operations, systems, technology and/or product development, including those that may require additional research resources. Working with your PA, this will be customized to your company's specific situation. The PA will use the Assessment Template either during an introductory call i.e. phone "entry interview", prior to the first face-to-face meeting, or in his/her communications with you via email. In all cases, this is a valuable guide to the issues you face in your commercialization efforts.

Analysis Document: This document will be used to define the optimal path to market and commercialization. It is also used to aligned with the steps participants need to take to resolve the gaps, and thus to develop the 18-month Action Plan.

18-Month 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. This tool is also 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 or licensees. It will provide a brief, but 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.

Business Case Presentation: The Business Case Presentation is a comprehensive, in-depth PowerPoint presentation of the company's intellectual property, technology, product/service, value proposition, customer base, financials, management team, and other important features of the company. The goal of the Business Case Presentation is to provide an audience with a detailed overview of the company and may also be used for one-on-one meetings with prospective partners and/or investors.

Upon the completion of the CAP, all toolkit materials must be submitted to NIH via an online Project Management System specially created for the program and its participants.

Feedback Session - February 2009

The Feedback Session is the second face-to-face event of the CAP. It is a one-day working meeting for the participant to present its Management Toolkit to a group of mentors and life science industry experts. Each company will work over a period of two hours in private with a dedicated group of mentors and industry experts. The mentors and industry experts will provide objective and frank feedback on the company's commercialization opportunity and strategy. If the company has prepared a road-show presentation, these industry experts and mentors will also offer comments on the presentation for both content and presentation style. By this point in the program, you will have worked closely and diligently with your Principal Advisor. Receiving feedback from outside experts will provide new perspectives and valuable feedback and direction. You will have the opportunity to adjust and amend materials in the Management Toolkit (your strategy, action plan, and presentations) based on the advice and recommendations provided by the mentors and industry experts. 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 designed to be as convenient as possible to participating companies, and also to cultivate local networking. Participants need attend only one day at one location of the following three Feedback Sessions, and are responsible for their own travel and lodging costs:

Washington, DC February 2-3, 2009
Boston, MA February 5-6, 2009
Los Angeles, CA February 18-19, 2009

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

On-going Mentoring - February through May 2009

Following the Feedback Sessions, participants will continue to work with their Principal Advisors (PA)s 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.

Moving Forward/Next Steps Web Meeting - May & June 2009

The "Moving Forward" Web meeting is the final CAP event. This is an opportunity for the participant to provide its Principal Advisor, NIH program officers, and other Larta staff a "live" look at the company's progress at the end of the program. Larta will recruit experts drawn from professional providers, other Larta advisors, industry representatives, and others to provide participants with a final feedback opportunity

At the conclusion of this meeting, participants should have completed the Assessment Template, the Analysis Document, developed any necessary PowerPoint presentations, and have in place an 18-Month Action Plan. The meeting is informal and similar to the monthly teleconferences with the Principal Advisor, but a Web tool will be provided to facilitate the sharing of the documents being discussed.

Program Feedback- At completion of program

Following completion of the program, 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) immediately upon completion of the program, (2) nine months following completion, and (3) eighteen months following the program's completion. The feedback will allow NIH to assess the program and its implementation. The tracking will keep NIH informed of the progress your company has made with commercializing the NIH SBIR-developed product.

Partnering/Investment Event - June 2009
(Provided for informational purposes only)

This event is OPTIONAL for CTT companies, and while it is not part of the CAP, companies may apply to present at Larta's 2009 Venture Forum. Larta's selection criteria include having an attractive business case, and an effective presentation. Application and registration fees are the CAP participant's responsibility.

The Venture Forum is Larta's annual investment and partnering event and will be held in June 2009*, in San Jose, CA (www.theventureforum.com). Larta has organized this event for 15 years with the goal of showcasing some of the most innovative technologies in the nation to potential investors and industry professionals. The Forum will include concurrent business presentation sessions by select companies, keynote speeches, and panel discussions on the latest technology issues.

The audience at the Venture Forum comprises of investors and industry players as well as professional service providers that may be of potential interest to CAP participants, especially those representing the life science sector. Efforts will be made to attract investors and industry representatives that are specifically targeted by Venture Forum CAP participants. The Forum will also feature an online 'Strategic Partnering' tool allowing attendees to pre-schedule meetings with potential investors and industry.

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


2. ACCELERATOR COMMERCIALIZATION TRACK (ACT)

The Accelerator Commercialization Track (ACT) of the NIH-CAP, as the name implies, is an accelerated customized program designed for the high-performer grantee. Unlike the CTT, this is not a training program. The goal is to target the most critical issues pertinent to the participant and to create a desired commercialization outcome (referred to as the "negotiated outcome"). Achieving a specific commercialization outcome is the principal objective. Participants in this track may very well complete the program in as short as three months.

The Accelerator Commercialization Track is appropriate for companies who may have commercialized other products, have clearly-defined markets and partners, and have raised financing through institutional channels. The ACT is also for companies who are undertaking or have completed clinical studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application; or medical devices approvals.

15 slots are available for the Accelerator Track. Participation is free; however, those participating in the ACT are responsible for their travel and lodging expenses associated with attending an optional public partnering/investment event. (NIH will pay up to $1200 in event presentation fees.)

During the program, each ACT participant will:

One-on-One with Principal Advisor - October 2008 through Completion

Upon the selection as an ACT participant, Larta will assign a designated Principal Advisor (PA) to each participating company. Your PA operates as a facilitator and aide, helping to prepare material as needed, and serving as a sounding board for the participant throughout the program and until the negotiated outcome is achieved.

The Principal Advisor (PA) will discuss with the participant his/her most critical commercialization issue(s). Each participating company will determine the outcomes/results it would like to achieve during the program, the "negotiated outcomes." In addition, the PA will assist in discussions with the expert resource(s) identified as the key enabler of the outcome; discuss the elements involved in the negotiated outcome, which will constitute the Outcomes Document, a critical program deliverable. These negotiated outcomes may include, but are not limited to, addressing regulatory, legal, financial structuring/restructuring, or management recruitment issues.

The following are the key identifiable phases of the Program, in sequence:

Virtual Webinars - November 2008

The Accelerator Commercialization Track will be launched via Webinars, Web-based sessions organized by Larta Institute in conjunction with each participant's assigned Principal Advisor (PA). Each webinar features specific expert resources in Larta's network, and other experts from the industry. In advance of the Virtual Webinar, participants will have discussed and identified the key outcomes they desire from the program ("negotiated outcomes"). The purpose of the Webinars is to provide participants with the opportunity to interact with the key expert resources who have the expertise in the areas identified as critical to them, and to help participants assess the path to resolution of their outcomes. These expert resources (all of them contracted to the Program) will interact with participants during the Webinars (which will be repeated depending on the number of participants in any specific Webinar). After the Webinar, participants will work with their PA on the "Outcomes Document", which is a critical deliverable for the Program.

Participants who may be competitors will not participate in the same Webinar(s).

Transaction-Oriented Work Plan - November 2008 through Completion

After the Virtual Webinar, the participant will work with his/her Principal Advisor (PA) and the key expert resource/s to finalize the negotiated outcome, to develop a timeline, and work plan moving toward accomplishing the commercialization outcome desired by the participant.

NIH will approve the agreed-upon work plan and timeline as represented in an Outcomes Document. Once approved, the Outcomes Document will provide the framework for the transaction-oriented work plan phase of the Program.

A note on working with expert resources:

The PA will have access to the expert resource(s) identified as key to the work plan in the Outcomes Document (e.g. an intellectual property lawyer, accountant, management recruiter, etc.)

Larta and the PAs will introduce prospective resources either directly from, or through referrals from Larta's network: regulatory, management, investment or other experts, depending on the desired "outcome". A designated threshold of free service will be available, (3 hours per expert resource, for a maximum of 3 expert resources per CAP participant). Beyond the threshold, payment of applicable fees to expert resource(s) for consummating a specific transaction will be your responsibility outside of the CAP offering. Companies are free to negotiate contingency arrangements with a provider of services of their choice that may endure beyond the CAP, covered by their own financial resources.

The "Negotiated Outcomes" - September 2008 through Program Completion

To facilitate progress, each AT participant will have an account on the online project management system. Each AT participant will develop the following documents to ensure progress and completion of the critical milestones of the program.

Outcomes Document: This document will spell out clearly, identified the most critical issues pertinent to create a desired solid commercialization outcome, and the best path of resolution within a timeline 'negotiated" with the company. Expert resources and targets will be identified as targets to be employed in the achievement of the "outcomes" in the Outcomes Document.

Final Report: Working with the company, the PA will prepare a final report near the completion of the program, that documents the participant's progress and end results with meeting the company's desired outcome. In cases where the desired outcome is not reached, the final report will specify the key issues that prevented the outcome from occurring. The final report will be signed off by the participant and uploaded into the project management system.

Partnering/Investment Event - Anytime during program as appropriate

As an Accelerator Commercialization Track participant, you will be given the opportunity to present at Larta's 2009 Venture Forum or at an investment or partnering event of your choice. If you choose Larta's event, your presenter fee will be paid. If you choose another event, NIH will pay up to $1200 in presentation fees. In both cases, you will be responsible for your travel and lodging costs.

The 2009 Venture Forum is Larta's annual investment and partnering event and will be held in June 2009*, in San Jose, CA (www.theventureforum.com). Larta has organized this event for 15 years with the goal of showcasing some of the most innovative technologies in the nation to potential investors and industry professionals. The Forum will include concurrent business presentation sessions by select companies, and keynote speeches and panel discussions on the latest technology issues.

The audience at the Venture Forum comprises of investors and industry players as well as professional service providers that may be of potential interest to CAP participants, especially those representing the life science sector. Efforts will be made to attract investors and industry representatives that are specifically targeted by Venture Forum CAP participants. The Forum will also feature an online 'Strategic Partnering' tool allowing attendees to pre-schedule meetings with potential investors and industry. Larta will actively assist with facilitating meetings for the AT participants.

*Venture Forum location and date are tentative and may change due to unforeseen circumstances. Participants will be informed in a timely fashion should any changes occur.

Program Feedback- At completion of program

Following completion of the program, 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) immediately upon completion of the program, (2) nine months following completion, and (3) eighteen months following the program's completion. The feedback will allow NIH to assess the program and its implementation. The tracking will keep NIH informed of the progress your company has made with commercializing the NIH SBIR-developed product.

Application closed.