Small Business Sources Sought - Needs Assessment SBIR.STTR.pdf

beta.sam.gov Notice Type: Sources Sought Notice

Notice Number: RFP-NIH-NICHD-OER-2020-10

Title of Requirement: Needs Assessment Program for the Department of Health and Human

Services (HHS) / National Institutes of Health (NIH) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Awardees

Agency: National Institutes of Health (NIH), Office of Extramural Research

(OER)

Notice Type: Small Business Sources Sought Notice

Introduction

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institutes of Health (NIH) Office of Extramural Research (OER).

This is a Small Business Sources Sought (SBSS) notice. It is not a Request for Proposal (RFP). No solicitation is available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according to the North American Industry Classification System (NAICS) code for the purposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible or if it is necessary to proceed through full and open competition. All size organizations are encouraged to respond. Small business organizations must have their size status certified by the Small Business Administration (SBA). The NAICS code is 541611 with a size standard of $15,000,000 in average annual receipts.

Description

National Defense Authorization Act for Fiscal Year 2019, passed by the 115th Congress and signed into law as Public Law 115-232, expanded the scope of support for the SBIR/STTR programs to improve the technical and business assistance (TABA) provided to Phase I and Phase II awardees. The NIH Office of Extramural Research (OER) created Small Business Education and Entrepreneurial Development (SEED), a new business unit, to oversee, coordinate and strengthen efforts to accelerate commercialization of academic innovations across all member institutes and centers within the agency. The SEED office will administer the NIH TABA program in coordination with liaisons from NIH institutes and centers.

The scope of this potential resultant contract is to provide Needs Assessment Reports, as part of the larger NIH TABA program, that prioritize the technical and business needs of selected companies that are developing products/services with NIH/HHS SBIR/STTR funding. Needs Assessment Reports provide summarized analyses of ten (10) commercialization areas from a life science industry perspective:

a) Target market attractiveness (need/size)

b) Technology/solution’s ability to address market need

c) Regulatory path

d) Business model profitability

e) Competition and Intellectual Property

f) Sales and marketing strategy

g) Management team

h) Strategic partners

i) Funding status/ Financial plan

j) Potential Exit Plan

The Needs Assessment Reports include analysis of the current state of the company and the life science product, identification of strengths and weaknesses for each of the commercialization areas (a-j) listed above, summary of the areas of highest priority that should be addressed by the company, and identification of appropriate resources and contacts for each of the commercialization areas (a-j) listed above that awardees can use to enhance the development of their life science product or service.

The contractor shall provide an experienced Project Manager for overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out under any subcontracts. The contractor shall also provide at least three (3) subject matter experts: A Medical Product Regulation subject matter expert, Life Science Industry Market Research subject matter expert, and Life Science Industry Business Development subject matter expert to manage and coordinate analysis of the commercialization areas listed above.

When responding to this notice, please describe your experience and knowledge of early stage life science industry market product regulation, market research, and business development across the NIH SBIR/STTR mission space such as:

• Subject matter expertise in medical product regulation, including the regulatory path for a wide variety of life science products (e.g. devices, drugs, biologics, diagnostics, and combination therapies);

• Subject matter expertise in life science industry (e.g. all modalities of therapeutics, diagnostics, and research tools) market research, including analysis of market attractiveness (need and size of the target market), intellectual property, and competitive landscape;

• Subject matter expertise in life science (e.g. all modalities of therapeutics, diagnostics, and research tools) business development, including early stage company partnering, investing and sales/marketing strategy;

• Project management of contract activities, including coordination of activities performed by subcontracts;

• Administrative program support (e.g., calendar management, meeting planning, information collection and tracking).

This work is for severable services to provide Needs Assessment Reports for selected NIH/HHS SBIR/STTR funded companies for up to the next 5 years (a base of 1 year with potential for options for 4 more years).

Capability Statements submitted as a result of this announcement should demonstrate the offerors’ qualifications, and experience, specifically providing evidence as to their capability to perform this requirement with particular attention to the areas below.

Information should be pertinent and specific in the technical area under consideration and will be assessed based on the following:

1. Personnel/Management: Adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. The following should be addressed:

• Ability to provide staffing to include name and professional qualifications of the individuals who will hold the roles of Project Manager, Medical Product Regulation subject matter expert, Life

Science Industry Market Research subject matter expert, and Life Science Industry Business Development subject matter expert. Extensive expertise in the early stage life science industry required. These individuals must have first-hand knowledge of the current standards and best practices and be able to provide recommendations that companies can use to progress to the next value inflection point for the life science product/service being developed.

• Ability to provide high-quality analysis of early stage life science companies and summarize that analysis in a clear, consolidated report.

• Ability to perform all tasks related to the management and coordination of the contract, including any subcontractors.

• Ability to perform analyses on life science companies across the entire NIH SBIR/STTR mission space (e.g. all modalities of therapeutics, diagnostics, and research tools across all NIH diseases) and products/services, including, but not limited to: market analysis (need/size), regulatory path, business model, competition and intellectual property, sales and marketing strategy, financial plan, and partnering/investment strategy.

2. Past Performance: Past performance is considered essential. In addition to demonstrating that the above qualifications have been met, interested parties must provide an outline of previous projects, specific work previously performed or being performed relevant to analysis of early stage life science products/services commercialization pathway. Documentation should include at least two (2) projects of similar size and complexity.

3. Other: Any other pertinent information, as pertains to this area of procurement, that would enhance the Government’s assessment of the information submitted.

Interested organizations that believe they possess the capabilities necessary to undertake this project should submit an electronic version of their response to this notice addressing the areas above. Capability statements must identify the organization’s DUNS number and business status as it correlates with SAM registration (i.e., educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity) and respond to the following questions:

a. Is your organization a small business under NAICS Code 541611?

b. Does your firm qualify as a small disadvantaged small business?

c. If disadvantaged, is your firm certified under section 8(a) of the Small Business Act?

d. Are you a certified HUBZone firm?

e. Are you a woman-owned or operated business?

f. Are you a certified Service-Disabled Veteran Owned or Veteran Owned?

Please limit responses to five (5) pages or less in MS Word or Adobe Portable Document Format (PDF). Any proprietary information should be so marked. Capability Statements sent in response to this notice must be submitted electronically via email to the Point of Contact identified below. The subject line must specify RFP- NIH-NICHD-OER-2020-10 and must be received no later than 2:00 PM April 15, 2020. Late responses will not be accepted. This notice is strictly market research and the Government will not entertain any questions. Respondents will not be notified of the results of the evaluation.

We appreciate your interest and thank you in advance for responding to this Small Business Sources Sought Notice.

Point of Contact

Jeremy White Contracting Officer jeremy.white@nih.gov mailto:jeremy.white@nih.gov