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Welcome to the
National Institutes of Health
Commercialization Assistance Program (CAP)
For Phase II SBIR Awardees
(Managed by Larta Institute)
Personalized Assistance • Knowledge Transfer • Business Outcomes • Stay on Track with CAP
Applications Deadline Closed! | Program Selection: September 30, 2009
Program Description
The NIH SBIR Commercialization Assistance Program (CAP), now in its sixth 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.
Funded by NIH and managed through a contract with Larta Institute (www.larta.org) of Los Angeles, CA, the CAP provides selected participants with individualized assistance toward accomplishing their commercialization goals. This is achieved through training workshops, individual mentoring and consulting sessions, as well as public events in which companies present their technologies to the investment community, potential strategic partners and licensees.
The 2009-2010 CAP application deadline is September 14, 2009. All applications will go through a review process and selected participants will be notified no later than September 30, 2009. The program begins in October 2009 and spans 10 months, ending in July 2010.
- Companies whose NIH SBIR (not STTR) Phase II award (grant, contract, or cooperative agreement) was active in the past 6 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.
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, different in their objectives and outcomes.
- Commercialization Training Track (CTT) - focuses on training and mentoring by key industry and investment professionals and the development of a clear and focused strategy toward commercialization.
- Accelerated Commercialization Track (ACT) - geared toward the participant achieving clearly identified, very specific objectives, and uses domain experts with current market experience (referred to hereafter as “expert resources”.)
The commitment of time and resources with management support is vital. Past experience indicates that the best results are achieved when the CEO serves as the company’s CAP Leader and is actively involved.
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. NOTE: NIH will not provide additional funding for this purpose; however, participants with a currently active Phase II SBIR 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.
1. Commercialization Training Track (CTT)
The Commercialization Training Track (CTT) for which 60 slots are available, 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:
By the completion of the program,each participant should have a solid understanding of the commercial value oftheir technology, and 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.
BUSINESS & STRATEGIC PLANNING: Development of Management Toolkit –
October 2009 through July 2010
Upon selection as a CTT participant, your business and strategic planning begins immediately. A principal advisor (PA) is assigned to work closely with each participant and is matched based on the advisor’s experience and expertise and the companies’ needs. Your PA operates as a facilitator and aide, helping to prepare materials as needed, and serving as a sounding board throughout the program as you develop your strategic plan for commercialization. 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. 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.
Your first communication with your PA will focus on your commercialization needs and developing a CAP plan that targets solutions to obstacles/hurdles you may face when going to market. This plan is referred to as the CAP Planning/Assessment Template and will guide your work through the program.
The Template will help identify gaps in operations, systems, technology and/or product development 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 action plan. Working with your PA, the Template will be completed at the onset of the program and will be used to guide your work through the program.
Management Toolkit: In addition to the Template, each participant will develop a Management Toolkit that 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.
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.
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 will be useful in managing and tracking your commercialization progress and outcomes after the CAP.
Quad Chart/Virtual Showcase and Keywords: Quad Charts will be posted on an NIH website to showcase and add visibility to your company and SBIR-supported technology. Each company’s 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.
Commercialization Training Workshop -- November 17 & 18, 2009, Los Angeles, CA
(The CEO is encouraged to attend.)
All CTT participants are expected to attend the Commercialization Training Workshop (CTW). (See previous note regarding travel costs.) This workshop offers in-depth interactive seminars led by Larta advisors and experts from the legal, investment, and industry communities. It 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.
November 17, 2009- Face-to-Face Meeting with your Principal Advisor
A one and one-half hour face-to-face meeting with your Principal Advisor will be scheduled the day before the workshop itself. It will be a continuation of your October discussions with your PA and will include an in-depth discussion of the company’s status, commercialization needs, and its 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.
November 18, 2009- 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
- Partnering/investment Planning
- Early Stage Branding and Marketing Your Company
- Healthcare IT Commercialization Issues and Barriers to Market Entry
- Reimbursement and Regulatory Issues
- Lessons Learned: Success Stories from Previous CAP Companies
Feedback Sessions – February 2009
Feedback Sessions are face-to-face working meetings for the participant to present its Management Toolkit to a group of mentors and life science industry experts and all 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 that will include fresh perspectives and perhaps suggestions for new directions to consider. 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 designed to be as convenient as possible for participating companies, and also to cultivate local networking. Participants need attend only one day at one location of the following three Feedback Sessions:
| Washington, DC |
February 1-2, 2010 |
| Cambridge, MA |
February 4-5, 2010 |
| Los Angeles, CA |
February 17-18, 2010 |
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 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.
Close-out Web Meetings – June 2010
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 Larta 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 what you and your company has accomplished since the Feedback Sessions, your next steps/goals, and your plan to get there. 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.
2. ACCELERATED COMMERCIALIZATION TRACK (ACT)
The Accelerated Commercialization Track (ACT) of the NIH-CAP, as the name implies, is an accelerated customized program designed for the high-performing SBIR awardees. Unlike the CTT, this is not a training program. The goal is to target the most critical issues pertinent to the participant and to achieve a desired commercialization outcome Participants in this track may very well complete the program in as short as three months.
The Accelerated Commercialization Track is appropriate for companies that may have commercialized other products, have clearly-defined markets and partners, or have raised financing through institutional channels. Participants could include but are not limited to those that are undertaking or have completed clinical studies as required by the Food and Drug Administration for an Investigational New Drug or Radioactive Drug Research Committee application; those seeking medical device approvals; or those who have developed a focused multimedia/IT product or service and are seeking to enhance their offering to specific channel partners.
20 slots are available for the Accelerated Track. Participation is free and unlike the CTT, there are no events requiring participants to convene at a specific location.
During the program, each ACT participant will:
The following are the key identifiable phases of the ACT track, in sequence.
Outcomes Proposal – October 2009
Upon selection for the Accelerated Commercialization Track, participants will begin work immediately with their assigned Principal Advisors (PAs). 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, legal, financial structuring/restructuring, or management recruitment issues. A single targeted outcome will become a part of an Outcomes Proposal which will discuss the participant’s proposed approach to the achievement of 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 document, a design, a recruit), the best path of resolution within a timeline consistent with the duration of the program, and any expert resources that may be needed to achieve the targeted outcome. NIH must approve this Outcomes Proposal before moving forward in the program.
Virtual Webinars – November 2009
Upon NIH approval of the Outcomes Proposal, a web-based planning meeting (Virtual Webinar) will be organized for each participant that includes principal advisors, NIH, and Larta staff. The purpose is to begin to develop a timeline and a transaction-oriented work plan to achieve the targeted outcome.
Timeline and Transaction-Oriented Work Plan – November 2009 through Completion
After the webinar, the participant will work with his/her Principal Advisor (PA) and any needed expert resources to complete a transaction-oriented work plan. The work plan should clearly indicate a specific need and clear path to accomplish a tangible outcome and will include a timeline with specific milestones. Action items for the participant, the PA, and any expert resources will be included along with estimated completion dates for each action item. The plan should be capable of being accomplished within the duration of program.
A note on working with expert resources*: A designated threshold of 9 hours total of free service from a maximum of 2 expert resources (e.g. an intellectual property lawyer, accountant, management recruiter, etc.) will be available to each participant. If participants desire to exceed the threshold, payment of applicable fees made directly to the expert resources will be the participant’s responsibility. Participants 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.
* Disclaimer: NIH does not endorse the expert resources/advisors for businesses following their appointed services. Any arrangement with such resources/advisors beyond the service rendered under the program is the responsibility of the Company ONLY.
Quad Chart/Virtual Showcase and Keywords – November/December 2009
Quad Charts will be posted on an NIH website to showcase and add visibility to your company and SBIR-supported technology. Each company’s 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.
Partnering/Investment Event – Anytime during program as appropriate
As an Accelerated Commercialization Track participant, you will be given the opportunity to present your business opportunity at an investment or partnering event of your choice. NIH will pay a presentation fee up to $1250 and unless your travel costs are covered by your Phase II award (see previous note regarding travel costs), you will be responsible for any travel expenses incurred.
Final Outcomes Report – Near completion of the program
Working with the company, the PA will prepare a final outcomes report near the completion of the program, which 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 throughout the program and if the desired outcome was accomplished. In cases where the desired outcome is not reached, the final outcomes report will specify the key issues that prevented the outcome from occurring.
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
The NIH SBIR CAP is offered by the National Institutes of Health and is managed by Larta Institute, 606 South Olive Street, Suite 650, Los Angeles, CA, 90014; www.larta.org; tel. (213) 694-2826. For all matters related to this program, please contact:
NIH
Ms. Kay Etzler
NIH SBIR CAP Program Manager
Office of Extramural Programs
Ph: (301) 435-2713
E-Mail: etzlerk@od.nih.gov
Larta Institute
Ms. Judy Hsieh
Programs Manager
Larta Institute
Ph: (213) 538-1444
E-Mail: jhsieh@larta.org |
