SBIR-STTR-CAP_Sources_Sought_Notice__(2).doc

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. PLEASE NOTE THAT THIS IS NOT A REQUEST FOR PROPOSAL (RFP). NO SOLICITATION EXISTS AT THIS TIME.

This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service- disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code is 541611—Administrative Management and General Consulting Services with a small business size standard of $14.0 million.

The National Institutes of Health, National Library of Medicine (NLM) is conducting a market survey to help determine the availability and technical capability of qualified small businesses, HUBZone small businesses, service-disabled veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, and small disadvantaged businesses capable of serving the needs identified below.

Background Information

The purpose of the National Institutes of Health (NIH) Commercialization Assistance Program (CAP) is to help NIH Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase II awardees accelerate the transition of their NIH-funded technologies under the SBIR and STTR programs into the marketplace. CAP is designed to provide participants with individualized assistance toward accomplishing the following goals:

· Developing or improving strategic business planning

· Developing or improving market identification, definition, and research capabilities

· Developing or improving marketing materials

· Developing a roadmap for and establishing licensing opportunities

· Developing a roadmap for and establish strategic and/or investment partnerships

· Seeking regulatory and/or reimbursement approvals

CAP is a mentoring and training program that includes one-on-one business counseling organized around topics that will contribute to the development of a strategic action plan, business plan, or a licensing or go-to-market strategy. Additionally, the CAP seeks to provide robust strategic and technical assistance to program participants seeking help with the Food and Drug Administration (FDA) regulatory and approval processes, typically representing a significant proportion of companies funded by the NIH SBIR and STTR programs.

Period of Performance

The anticipated period of performance shall be a 12-month base period with () additional 12-month option years. The proposed contract type will be a performance based fixed price contract.

Purpose and Objectives of the Procurement

Small business participation in the training activities will span a period of nine (9) months with a targeted start date in January 2014. The program shall be customized to meet the needs of early stage or advanced companies and be divided into three: (1) an emerging track, (2) an advanced track, and 3) a regulatory track. The emerging track will be comprised of training and informational workshops and individual (one-on-one) mentoring and consulting sessions led by an advisor assigned by the contractor. The advanced track will focus on the completion of task(s) specifically designed to assist the more advanced business savvy companies with overcoming critical issues that are hindering their commercialization progress. The regulatory and reimbursement track will provide individual (one-on-one) mentoring and consulting sessions led by an advisor assigned by the contractor aimed at helping companies navigate the Federal regulatory pathway and reimbursement approval processes.

CAP participation is at no direct charge to the selected companies; however, participants are responsible for their travel and lodging expenses associated with attending CAP-related events. Eighty (80) companies in total will be selected to participate. However, given the anticipated rate of attrition, the number of participants could decrease. Companies will be assigned into an appropriate track based on their needs and commercialization readiness upon application review conducted jointly by the NIH and the selected Contractor.

EMERGING TRACK SPECIFICS:

Over a nine-month period, participants will:

· Participate in an initial kickoff workshop

· Participate in virtual webinars

· Work closely on a regular, monthly basis with the selected Contractor on the company’s business and commercialization strategic plan or process

· Develop a management toolkit, or set of customized materials that may be used in commercialization efforts

· Participate in a feedback workshop that allows for constructive criticisms about the participant’s commercialization strategy

· Participate in a Next Steps/Closeout Meeting at which time participants will present their 18-month Strategic Action Plans to NIH

· Provide program feedback and commercialization progress tracking reports to NIH

ADVANCED TRACK SPECIFICS:

Over a nine-month or less period, participants will:

· Participate in a kickoff workshop

· Identify one or two specific outcomes that are achievable within the program’s timeframe and resources.

· Upon NIH approval of targeted outcomes, each participant will work one-on-one with a designated advisor and other business experts as needed to achieve the desired commercialization outcome

· Participate in virtual webinars

· When appropriate, present their business opportunity at an outside partnering/investment event

· Upon completion of their targeted outcomes, provide a close-out webinar presentation to NIH on achieved outcomes and strategies for carrying their technology forward.

· Provide program feedback and commercialization progress tracking reports to NIH.

REGULATORY TRACK SPECIFICS:

Over a nine-month or less period, participants will:

· Participate in a kickoff workshop

· Identify one or two specific outcomes that are achievable within the program’s timeframe and resources.

· Upon NIH approval of targeted outcomes, each participant will work one-on-one with a designated advisor and other business experts as needed to achieve the desired commercialization outcome related to the FDA approval process

· Participate in virtual webinars

· Upon completion of their targeted outcomes, provide a close-out webinar presentation to NIH on achieved outcomes and strategies for carrying their technology forward.

· Provide program feedback and commercialization progress tracking reports to NIH.

Contractor Requirements

DELIVERABLES:

TASK 1: Develop a web-based project management system that (1) accepts applications from interested participants, and (2) tracks program participants’ progress.

The Contractor will establish a secure web-based project management system that will document the progress of each CAP participant. The system should also have the ability to accept on-line applications from those interested in applying to the program. The system must be accessible by both the Contractor and the National Institutes of Health. Upon the completion of the CAP, all program-related and developed materials are to be uploaded and the system turned over to NIH for retention.

TASK 2: Evaluate applications and recommend participants to NIH.

NIH will notify its SBIR and STTR Phase II award recipients funded in the past five (5) years of the opportunity to participate in this program, however, priority will be given to new applicants. The Contractor shall develop an on-line application process for interested prospective participants. The Contractor shall review and evaluate the applications and forward their recommendations to NIH for consideration. NIH will then make the final selection of 80 participants and assignments to one of the three tracks.

Participants:

· Selected companies must meet the current SBIR/STTR eligibility requirements and have received an NIH SBIR or STTR Phase II or a Fast-Track award (grant, contract, or cooperative agreement) in the past five (5) years. NIH will verify the eligibility of each applicant.

· The technology targeted for commercialization in the CAP must have been developed with an NIH SBIR or STTR Phase II award.

· It is expected that participants may be at different points along the commercialization spectrum, and therefore individualized technical assistance must be offered to each participant by an advisor provided by the Contractor. Participants will include both “emerging companies” (those making their first debut into the commercial marketplace) and “seasoned companies” (those who may have some experience and/or track record with commercialization). The Contractor must have the expertise to handle this wide range of commercialization experience and assist the companies with identifying the most appropriate strategy for commercialization.

· NIH supports a wide range of biomedical and health science technologies including the development of clinical technologies, basic research tools, and healthcare/IT type products. The Contractor shall demonstrate a substantial understanding of the diversity of the NIH SBIR/ STTR funded technologies and must have the ability to provide commercialization assistance for the entire range.

· The program is designed for those seeking investments, strategic alliances, licensing deals, business strategy, or regulatory and reimbursement guidance. The program is not intended for those companies seeking only sales, contacts prospects, or business development. Accordingly, each applicant will be expected to provide as part of the application an executive summary outlining core business operations, company vision, business strategy to date and key challenges to be addressed in the CAP.

Task 3: Develop and coordinate the “Kickoff Workshop” (All tracks)

The Kickoff Workshop is the first of two CAP-sponsored events for all participants. The Contractor shall develop and coordinate this 2-day in-person workshop. The workshop will be held at a single location at a date to be determined by the NIH Project Officer. The workshop will enable participants to meet with their assigned advisor, network with fellow CAP participants, meet other key NIH and industry people who may be associated with the program, and attend commercialization training seminars. Seminar topics may include but are not limited to the following:

· An Introduction to the NIH CAP Program

· Intellectual Property Management

· Financing Life Science Companies

· Strategic Alliances and Partnerships

· Strategic Business Planning

· Navigating the FDA regulatory process

· Reimbursement considerations and strategies

· Leveraging Social Media and Networking

· Marketing Your Company: Putting Your Best Foot Forward

· CEO Roundtable: Commercialization Success Stories from previous Cap participants

· Understanding your customer

· Session Targeting Healthcare IT/Education /Media Companies

[NOTE: Please be advised on the HHS Policy on Efficient Spending (below)]

Task 4: Work one-on-one with emerging track program participants to: (1) provide business and strategic planning; (2) develop a management toolkit; and (3) connect participants with potential partners and/or investors. (Emerging track only)

Business and Strategic Planning: During the Business and Strategic Planning phase, the Contractor shall provide an advisor to work one-on-one on a regular basis with each of the participants to develop or tease out their business model, improve or enhance their understanding of the target market (the “addressable market”), create a strategic action plan (including possible timelines), and develop some of the necessary marketing materials to implement the strategy. Participants may work with their advisors to identify potential partners, licensees and/or investors and develop an approach on making the proper connections at the right time. Participants will be coached and mentored at face-to-face meetings or via remote communication tools, e.g., phone, email, Internet.

A get-to-know, two-hour face-to-face meeting between each participant and their advisor will be scheduled early in the program. Depending on the logistics, this may be done prior to attending the kickoff workshop or at the workshop itself. The meeting will include an in-depth discussion of the company’s status, suitability of the CAP, commercialization needs, and a work plan. By the end of this meeting, the Contractor shall have communicated a clear understanding of all program details, a customized commercialization approach, and obtained a firm commitment from the selected participant to invest the required time and effort to the CAP. Note that advisors are not to do the work for the participants, but will mentor, guide, and assist.

At the end of the business and strategic planning phase of the CAP, each participant is expected to have a solid understanding of the commercial value of their technology, how it fits in to the current market landscape (positioning), the technology’s competitive advantage, what gaps remain to be addressed, a plan to address such gaps, and the optimal strategy for achieving the previously-identified goals. In addition, and if appropriate, participants may develop with their advisors’ assistance, a set of specific strategic or investment targets and a list of realistic prospects that the participants may wish to approach.

Management Toolkit: During the Business and Strategic Planning Phase of the program, the Contractor shall assist each participant with the development of a Management Toolkit that will include materials useful for implementing the commercialization plan both during and after the program ends. Because it will be customized for each participant’s needs, it may include any number of the following components:

1. 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 events such as investment forums, conferences, or trade.

2. Business Case Presentation: This 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.

3. Virtual Showcase Materials: A virtual on-line showcase will be set up to market the business opportunities and technologies of all CAP participants. The materials may be posted on an NIH website in the form of a quad chart and may include the specific business opportunity, a company description, and a brief description of the product and its current state of development. These materials may also be used by the company for their marketing endeavors both during and after the CAP.

4. Strategic Action Plan: At the end of the program, each company will have a list of strategic tasks and milestones with a timeline looking forward for the next 18 months. This tool is meant for managing and tracking the participant’s commercialization progress and successful outcomes after the CAP.

Connecting with Potential Investors, Strategic Partners and Licensees: Preparing for and accessing investors, licensees and strategic partners is an important element of the program and will be emphasized throughout the course of CAP. The Contractor shall solicit “Wish lists” of potential strategic partners and investors from the participating companies when CAP begins and as stated previously, the Contractor shall help prepare a roadmap and tools to assist CAP participants in approaching them. The Contractor may also help in identifying new investors, licensees and partners.

If a participant is ready and the Contractor is able to garner the interest of desired investors, licensees and partners, the Contractor shall help the participant approach them. These introductions are to be made only if a participating company is truly ready and only if the Contractor has reason to believe the potential partners, licensees and investors are appropriate, as contacting potential partners and investors too early or inappropriately may be detrimental to the participant’s future prospects with these resources. The Contractor’s advisors shall counsel the participants regarding the best possible time to approach. The Contractor shall coordinate scheduling close-out presentations and ensure participation of appropriate advisors and mentors at the end of the program.

Task 5: Provide individualized mentoring for advanced track participants only

An advisor/mentor who will serve as a facilitator and aide and as a sounding board for the participants is to be assigned to each of the fifteen advanced track participants. With the assistance of the advisor/mentor, a work plan will be documented describing the participant’s most critical commercialization need/gap and the desired outcome that is deemed to be possible during the program. This document will guide the course of work to be performed by the participant and their advisor/mentor. Experts in business areas such as accounting, FDA and CMS processes, or intellectual property protection will be brought in as needed to assist the participant and their advisor//mentor. The Contractor shall facilitate such connections with industry experts for up to 5 hours of pro bono counseling by each expert. Because each strategic plan will be unique and participant-specific, participants may spend varying amounts of time working toward their desired outcome. Some may complete the program in perhaps only a few months while others may be working toward their outcome until the scheduled program completion in September.

Connecting with Potential Investors, Strategic Partners and Licensees: Preparing for and accessing investors, licensees and strategic partners is an important element of the program and will be emphasized throughout the course of CAP. The Contractor shall solicit “Wish lists” of potential strategic partners and investors from the participating companies when CAP begins and as stated previously, the Contractor shall help prepare a roadmap and tools to assist CAP participants in approaching them. The Contractor may also help in identifying new investors, licensees and partners.

If a participant is ready and the Contractor is able to garner the interest of desired investors, licensees and partners, the Contractor shall help the participant approach them. These introductions are to be made only if a participating company is truly ready and only if the Contractor has reason to believe the potential partners, licensees and investors are appropriate, as contacting potential partners and investors too early or inappropriately may be detrimental to the participant’s future prospects with these resources. The Contractor’s advisors shall counsel the participants regarding the best possible time to approach.

When the desired outcomes are completed, each advanced track company will present to NIH strategic outcomes accomplished in the program including a timeline looking forward for the next 18 months. This tool is meant for managing and tracking the participant’s commercialization progress and successful outcomes after the CAP. The Contractor shall coordinate scheduling close-out presentations and ensure participation of appropriate advisors and mentors.

A final report for each participant will be prepared and uploaded into the project management system. This report will include the companies’ progress, their end results, and comments concerning if the desired outcome was reached. If not reached, the key issues that prevented the outcome from occurring are to be included.

Task 6: Provide individualized mentoring for regulatory track participants only

An advisor/mentor who will serve as a facilitator and aide and as a sounding board for the participants is to be assigned to each participant in the regulatory track. With the assistance of the advisor/mentor, a work plan will be documented describing the participant’s most critical and desired outcome that is deemed to be possible during the program that relates to the Food and Drug Administration (FDA) approval process. This document will guide the course of work to be performed by the participant and their advisor/mentor. Experts in business areas such as accounting, FDA and CMS processes, or intellectual property protection will be brought in as needed to assist the participant and their advisor//mentor. The Contractor shall facilitate such connections with industry experts for up to 15 hours of pro bono counseling by each expert. Because each strategic plan will be unique and participant-specific, participants may spend varying amounts of time working toward their desired outcome. Some may complete the program in perhaps only a few months while others may be working toward their outcome until the scheduled program completion.

Assistance provided by the advisor/ mentor may include but are not limited to:

· Identification of the company’s goals for its product – based on discussion with the company, the advisor/ mentor will assess what is the company’s expected product, its intended use and indications for use.

· Identification of the regulatory path –based on the company’s goal(s), the advisor/ mentor will recommend a specific regulatory path that should be taken. This will be applicable also to companies that have previously submitted materials to the FDA, received rejection or otherwise encountered challenges with their path to submission or approval.

· Development of regulatory strategy – the advisor/ mentor will work with the company to address regulatory hurdles the company will likely face given its product, the regulatory path and the company’s current approach to navigating the regulatory landscape.

· Assessment of the success of the chosen regulatory path- the Contractor shall devise metrics to be used for assessment for the likelihood of the success of the recommended regulatory path.

Task 7: Develop and lead the feedback workshop(s)

The feedback workshop is the second CAP-sponsored event, however requires in-person participation from the companies. A minimum of two regional feedback workshops will be organized and led by the Contractor at locations based on the demographics of the participants. The Contractor shall develop and lead this feedback workshop which is comprised of scheduled closed business meetings between the company and industry experts. To accommodate travel preferences of the participating companies and also to cultivate local networking, CAP feedback workshops may be held in several locations including Washington, DC.

Participants are required to attend only one day at one location. Each will be scheduled for a 2-hour meeting where the company will present their business opportunity to a group of mentors and life science industry experts who will provide honest and objective feedback of the company’s commercialization strategy and pathway. They will also critique the presentation for content and presentation style. The Contractor is responsible for assuring that appropriate mentors and industry experts will be available for each meeting.

Task 8: Provide written and oral program progress reports.

Written Reports—Progress and final reports will be provided in writing by the Contractor to the NIH SBIR Project Officer. Monthly progress reports will be due on the 8th of each month. These reports shall include, but are not limited to, details of work completed, problems encountered, steps taken to resolve the problems, and any other pertinent issues and concerns.

Upon completion of the program, the Contractor shall prepare a final report that will include a summary of the progress and actions taken during the program as well as suggestions for improving the program.

Oral Presentations—The Contractor will come to the NIH campus a minimum of once during the program to give a presentation on the program and its progress. The date will be negotiated with NIH SBIR Project Officer but depending on the need, will be either during the latter part of the business and strategic planning portion of the program, or at the conclusion of the program.

Task 9: Track participants’ commercialization progress and provide statistical analysis of results.

Throughout the course of the program, the Contractor shall track and collect commercialization data from the participants from the beginning to the completion of the program.

Collected data must include but are not limited to investor/partnership/licensing introductory activities, changes to overall business strategy or components thereof, progress toward securing strategic investments or alliances, activities toward developing a comprehensive regulatory or reimbursement plan, and whether the program was perceived to have impacted the companies’ commercialization progress. For those companies choosing to commercialize without third party involvements, data will also be collected concerning their sales volume related to the CAP project, and whether any debt was incurred in order to further commercialization.

The Contractor shall analyze the statistical data and provide written summary report for each participating company indicating if there was commercialization progress as part of the final progress report described in Task 8. The Contractor must, therefore, have the expertise to conduct statistical analysis and strong writing skills required in compiling the company-specific commercialization tracking reports. The Contractor will provide these reports to NIH before the end of the contract base year and, thereafter, before the end of each subsequent option years 1, 2, 3, and 4 of the contract.

Advanced Understandings:

In general, the Contractor will be expected to provide timely responses to CAP-related inquiries from the Project Officer and participating companies.

Program Timeline Based on Deliverables and Program Milestones

Example 12-month Base Year of CAP (in months)

Deliverable/

Task #

Tasks 3, 4, 5, 6, 8

Tasks 7, 8

Tasks 4, 5, 6, 8 Tasks 8, 9

The proposed acquisition will be procured in accordance with the policies and procedures under FAR Part 12 and 13.5. All responsible sources may submit a capability statement which will be considered by the National Library of Medicine. This Sources Sought Notice is not a Request for Quote (RFQ), nor is a RFQ available. Documents in response to this Sources Sought Notice should incorporate the following instructions:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain enough sufficient detail for the Government to make an informed decision regarding your capabilities; however, the statement should not exceed ten (10) pages, excluding cover page, appendices, and resumes.

(b) The capability statement should include references, key personnel, and any teaming arrangements needed to fulfill the requirements. It must identify the responder’s small business type and size; DUNS number; NAICS code; and technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

(c) All capability statements must be submitted electronically no later than 12:00 PM EST on Monday, December 30, 2013 to Reggie Brown at reginald.brown3@nih.gov.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).