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.