Commercialization Accelerator Program (CAP)
For Phase II SBIR & STTR Awardees
Market & Customer Discovery and Development • Business Strategy and Outcomes •
Regulatory & Reimbursement Strategies
THE APPLICATION PERIOD FOR THE 2019-2020 NIH CAP COHORT IS NOW CLOSED. PLEASE CHECK BACK IN SUMMER 2020 FOR NEXT YEAR.
What is the Commercialization Accelerator Program (NIH CAP)?
An Information Session Webinar will be held Thursday, August 8th from 12:30PM EDT (9:30AM PDT) to 2:00PM EDT (11:00AM PDT). You may register HERE 
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NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.
Note: The NIH CAP is not intended to be a substitute for your business development activities nor to serve as a source for private capital and funding.
Applicants are selected via a competitive process for up to 80 slots in the program. The 2019-2020 Program kicks off at the end of September 2019 and spans nine (9) months, ending in June 2020.
Funded by NIH and managed through a contract with Larta Inc., (www.larta.org ) of Los Angeles, CA, the CAP provides selected participants with individualized assistance toward accomplishing key commercialization goals.
"The level of expertise through the LARTA NIH-CAP program is essential to any small business attempting to commercialize a technology. Insightful feedback helped us position ourselves within our market niche which was very useful as we began commercialization efforts with two major players in the rapid diagnostics arena. LARTA mentors provided clarity and critical perspective on how to speak the language of private industry (vs. academia) and how to cater to private industry expectations.”
"As a startup, I feel like I am on a life boat on the open sea, but with CAP, I have seasoned captains with me on the boat to navigate.”
Results Directly Attributed to NIH CAP since 2004
NIH CAP Overview
The program brings expert mentors with deep life sciences domain expertise and experience, a network of life sciences industry executives, and functional experts in many areas of commercialization. Based on your background and experience, your company will be assigned into one of these three tracks:
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Commercialization Transition Track (CTT): Relevant for the majority of HHS SBIR/STTR Phase II companies, this track offers tools and customized approaches to commercialization. It will help your company develop and execute on plans and activities critical to commercialization of your technology. The degree of customization enables the Program to work with you to address issues specific to your company’s stage, level, and background. You also have an opportunity to receive, in an in-person live session, direct feedback from executives and experts drawn from the life sciences industry, investment community, regulatory affairs, and research.
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Advanced Commercialization Track (ACT): ): If you are more experienced in commercialization, and have a history of running a company, developing products, generating sales and revenues, and have customers, the ACT may be suitable. You should be focused on addressing a specific “gap” or issue, which resolution is crucial or critical to your continued success.
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Regulatory/Reimbursement Training Track (RTT): Similar to ACT, this track is applicable to those applicants with previous commercialization experience. This track will apply to a selected group of HHS-funded companies seeking regulatory approval by the Food and Drug Administration (FDA) or seeking reimbursement from CMS (Centers for Medicare & Medicaid Services) and private insurance to achieve payment for products/services provided.
For this 2019-2020 cohort year, NIH CAP is also working on continuing to pilot a new feature, namely “FDA Day.” The NIH has long worked collaboratively with its sibling HHS Agency, the U.S. Food and Drug Administration (FDA), on many programs and projects. Recognizing that certain small businesses will need to work with the FDA for federal approval(s) prior to their product being commercialized on the market, “FDA Day” is being planned and intended to be an opportunity for selected CAP participant companies of the 2019-2020 cohort to learn more about FDA approval processes, reviews, and requirements as these relate to the small business’ technology/product.
Graduates of the program can enjoy, in perpetuity, continued support from Larta’s world-class resources, including access to its well-regarded Larta Portal, introductions to its Industry Advisory board and professional network, live webinars and a library of past webinars, notification of investment and collaboration opportunities, publicity and promotion through Larta’s social media and public relations channels, and more.
Program Event Dates
- Application Deadline: Friday, August 22, 2019, 11:59pm PDT
- Information Session: August 8, 2019 from 12:30pm EDT (9:30am PDT) to 2:00pm EDT (11:00am PDT)
- Commercialization Training Workshop (CTW)* (KickOff event): November 13-14, 2019 – Los Angeles, CA
- FeedForward™ Sessions*: March 18-19, 2020 (CA); April 1-2, 2020 (DC): For CTT participants only.
- Closeout Webinar: April – June 2020
- Program Feedback and Tracking: Summer 2020 and on
Larta's Advisors
You will be paired with a Principal Advisor (PA) who brings deep industry, entrepreneurial experience, and technology and business expertise. Your PA will be a team member advising you on your commercialization plan and strategy during your participation in the program.
"Our Principal Advisor has been incredibly helpful in the presentation development and introducing us to experts (e.g. CMO, DOD funding expert) that will further help us with our commercialization efforts." - 2017-18 company on its assigned Principal Advisor
Program Timeline
Events Descriptions
CTW: Official In-Person Kickoff. The companies meet with their assigned Principal Advisor, attend interactive sessions comprised of program training and commercialization topics, and enable participants to network amongst fellow CAP participants, panel speakers, and HHS/NIH staff. In-person attendance required of ALL participants.
FeedForward™ Sessions: For CTT participants only. Private in-person working meetings for participants to present their strategy to invited external experts and solicit feedback and further guidance. A high-impact, distinguishing feature of this program.
Closeout Webinar: A virtual session where participants discuss with NIH program staff, Larta professionals and external experts their progress and accomplishments in the program, and outline their next steps.
Program Feedback and Tracking: NIH will collect data from companies at pre-designated points throughout the Program, to evaluate the Program’s impact on the companies’ commercialization efforts and outcomes.
Who is Eligible to Participate?
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Companies whose NIH SBIR and STTR Phase II, Phase IIB, or Phase II portion of Fast-track award is current or was active in the past 5 fiscal years. Awardees from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) can also apply.
(NOTE: Projects that ended before August 2014 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.
- Small businesses that have previously participated in the program no more than two (2) times may participate again providing they have a different qualifying Phase II award. Companies may be accepted in the program no more than three (3) times. Due to the limited number of slots available, first time applicants to the CAP will be given priority.
How Much Time Does CAP Require?
- The commitment of time and resources by company management is vital.
- Company CEO participation is highly encouraged and expected in this program. The CAP is a 9-month program. It is not a curriculum-based approach.
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You work at your pace with an assigned industry expert called your Principal Advisor (PA)
- The program is aimed at assisting participants with evaluating and managing your commercialization options based on your specific technologies. These may include the investment readiness of the company (technology), pursuit of strategic partnership/s, development of licensing opportunities, and an 18-month commercialization roadmap.
Is there a Cost to Participate in CAP?
Much of the program is virtual (interactions occur remotely). Two exceptions should be noted, where in-person participation is mandatory.
- A CAP launch event, called the Commercialization Training Workshop, or CTW, to be held in the Los Angeles, CA area on November 13-14, 2019. Required for ALL participants (CTT, ACT, and RTT).; and
- One of the FeedForward™ Sessions or “FFS” held in Los Angeles, CA (on March 18-19, 2020), and Washington, DC (on April 1-2, 2020). Applies only to participants in the Commercialization Transition Track (CTT).
CAP participation is free of charge for the selected companies
- Participants pay for their own travel and lodging expenses in attending the mandatory events.
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Participants with a current, active Phase II SBIR-STTR award may re-budget funds if it does not result in a change of scope or is otherwise prohibited by their grants.
- Selected companies are encouraged to contact their funding NIH institute program officer for inquires in this regard. For an active SBIR contract, you will need to confer with your contracting officer.
- Please remember that participation in the NIH CAP is a business commitment like any other commitment that your small business makes.
NIH expects that each applicant company that is accepted into the program will honor these commitments. Accordingly, please be certain your small business can and will commit to the CAP if accepted, e.g., attending required meetings, and complying with program deliverables and deadlines (e.g., as described at http://sbir.nih.gov/cap), through completion of the program.
Where Can I Find the Application?
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Application to the NIH CAP is done online, and should take less than one hour; once you log on to the application portal, detailed instructions will guide you through the process. Please note that access to the portal is secured behind a password protected firewall. To apply, click HERE .
About the Application
Where Can I Find the Application?
THE APPLICATION PERIOD FOR THE 2019-2020 NIH CAP COHORT IS NOW CLOSED.
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Application to the NIH CAP is done online, and should take less than one hour; once you log on to the application portal, detailed instructions will guide you through the process. Please note that access to the portal is secured behind a password protected firewall. To apply, click HERE .
Who is Eligible to Participate?
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Companies whose NIH SBIR and STTR Phase II, Phase IIB, or Phase II portion of Fast-track award is current or was active in the past 5 fiscal years. Awardees from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) can also apply.
(NOTE: Projects that ended before August 2014 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.
- Small businesses that have previously participated in the program no more than two (2) times may participate again providing they have a different qualifying Phase II award. Companies may be accepted in the program no more than three (3) times. Due to the limited number of slots available, first time applicants to the CAP will be given priority.
What is the Selection Process?
- Reviews of completed applications will be conducted by a committee comprising NIH SBIR-STTR program managers and Larta Inc. staff who are directly involved with the CAP.
- The most successful applicants will be those committed to the commercialization of the technology, and to the realistic expression and development of the current business model (whether or not it is built around a single technology). Applicants should also be clear in their expression of commercialization goals, the identification of gaps and deficiencies, and the understanding of the resources that may be needed in commercializing a product or service.
CAP Data
Following the completion of the program, SBIR/STTR CAP participants are tracked for an 18-month period in two 9-month intervals. Commercialization data from a baseline period which spans the duration of the program is also collected. These reports provide progress tracking results for each year’s participants and are only summaries of the data. Quantifiable data such as number of deals and partnerships, revenue, and growth in equity funding are included as well as data indicating the participants' perceived impact the program had on their commercialization progress.
To view some of this data and other highlights from the CAP program, please view the NIH CAP Progress Reports:
baseline
1st tracking interval
NIH CAP: Breeding success, one company at a time 2004-2013
See information about the commercialization progress previous CAP participants made between 2004 and 2013. This data was collected at the conclusion of each year's program and again at two nine-month intervals.
NIH CAP Virtual Showcase
The technologies showcased are those which have been developed through the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program. Each company listed has participated in the NIH SBIR Commercialization Assistance Program (CAP). Potential strategic partners and investors are encouraged to peruse the business opportunities offered here and contact the companies directly for those of interest.
Disclaimer Note: Information contained on this site neither constitutes nor should be inferred to be an endorsement or recommendation by NIH.
Participants:
- 2018-19 (PDF - 711 KB)
- 2017-18 (PDF - 521 KB)
- 2016-17 (PDF - 8.84 MB)
- 2015-16 (PDF - 521 KB)
- 2014-15 (PDF - 1.8 MB)
- 2012-13 (PDF - 1 MB)
- 2011-12 (PDF - 1 MB)
- 2010-11 (MS Word - 194 KB)
- 2009-10 (MS Word - 232 KB)
- 2008-09 (MS Word - 270 KB)
- 2007-08 (MS Word - 258 KB)
- 2006-07 (MS Word - 346 KB)
- 2005-06 (MS Word - 320 KB)
- 2004-05 (MS Word - 288 KB
CAP in Detail
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 contracting vendor, 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.
The application period for NIH SBIR/STTR Phase II awardees is currently closed and expected to open sometime in 2014. All applications will be competitively reviewed, and participants will be notified if they’ve been accepted. This year we expect to accept 75 companies into the program. The assistance through CAP spans nine (9) months.
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.
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:
- Participate in an Orientation Webinar
- Be Assigned a Dedicated Principal Advisor and Develop a Work Plan
- Participate in a Commercialization Training Workshop
- Perform Business and Strategic Planning and develop a Management Toolkit
- Develop a Quad Chart and Keywords
- Participate in a mid-point Feedback Session
- Provide Program Feedback and Tracking
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
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
- Discussion concerning program expectations
Principal Advisor Assignments and Work Plan Development
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
(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. 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
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 earlier 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 –
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
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
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. 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
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:
- Participate in the ACT Orientation Webinar
- Be Assigned a Dedicated the Principal Advisor and Develop an Outcome Proposal
- Participate in a Commercialization Training Workshop
- Develop a Transaction-Oriented Work Plan
- Develop a Quad Chart and Keywords
- Submit a Final Outcome Report
- Provide Program Feedback and Tracking
CAP Timeline ACT Companies
The following are the key identifiable phases of the ACT track, in sequence.
ACT Orientation Webinar
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
- Discussion concerning program expectations
Principal Advisor Assignments and Outcome Proposal Development –
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.
Commercialization Training Workshop
(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.
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
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
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
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
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.
Contact
NIH
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.
NIH SBIR/STTR Program Manager and
NIH Extramural Data Sharing Policy Officer,
Office of Extramural Programs (OEP),
Office of Extramural Research (OER),
National Institutes of Health (NIH)
Telephone: (301) 435-0189
Email: jpkim@nih.gov
Larta, Inc.
Judy Hsieh
Senior Program Manager
Larta, Inc.
Ph: (213) 538-1444
jhsieh@larta.org
