PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and Toxicology and Pharmacology Testing

Small Business Sources Sought Notice PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and Toxicology and Pharmacology Testing HHS-NIH-NCI-SBSS-TSB-75N91022R00012-18 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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government. Interested parties are expected to review this notice and the DRAFT Statements of Work (SOWs) to familiarize themselves with the requirement of these projects; failure to do so will be at your firm's own risk. Background: The NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT; http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program managed by the Division of Cancer Prevention (DCP) with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers toward clinical trials. The PREVENT program requires services under three (3) separate multiple-award IDIQ pools: 1) Preclinical Efficacy and Intermediate Endpoint Biomarkers, 2) Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and 3) Toxicology and Pharmacology Testing. Pool 1: Preclinical Efficacy and Intermediate Endpoint Biomarkers The objective of the - Preclinical PREVENT Cancer Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers Indefinite Delivery-Indefinite Quantity (IDIQ) contracts will be to continue evaluation of the efficacy of potential chemopreventive and immunopreventive regimens, as well as to identify pharmacodynamic and/or efficacy biomarkers which will enhance the development of these regimens for clinical trials. Resources from these contracts will be used to support development of several candidate cancer preventive agents. Pool 2: Preclinical Services for Biopharmaceutical Product Development and Manufacturing The - PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing (also referred to as PREVENT Current Good Manufacturing Practices or PREVENT CGMP) IDIQ contracts will provide a broad and flexible range of timely, proactive preclinical product development and manufacturing support services for promising biopharmaceutical products and diagnostic reagents to help investigators in various scientific disciplines obtain critical data needed to advance their agents further through the PREVENT pipeline, acquire additional funding from elsewhere, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and/or complete studies needed to apply for an Investigational New Drug (IND) and enter a Phase I trial. Pool 3: Toxicology and Pharmacology Testing The objective of the - Preclinical PREVENT Cancer Program: Toxicology and Pharmacology Testing IDIQ contracts will be to continue evaluation of the pharmacological and toxicological effects of potential cancer preventative agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents. Purpose & Objectives: The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns including HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; women-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. As a result of this SBSS notice, the NCI may issue a Request for Proposal (RFP) and a single RFP may be used to solicit for all three pools described above. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. Project Requirements & Objectives: Pool 1: Preclinical Efficacy and Intermediate Endpoint Biomarkers The overall requirements and objective of the current acquisition, designated as the PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, encompasses three main technical task areas: (1) Preclinical Evaluation of Cancer Preventive Efficacy; (2) Evaluation and Validation of Intermediate Endpoints for Chemopreventive Agents; and (3) Evaluation and Validation of Intermediate Endpoints for Immunopreventive Agents as described in detail in the attached DRAFT Statement of Work. The primary endpoint of the efficacy studies shall be to prevent the development of invasive cancers whereas the biomarker studies will identify and validate endpoints, which correlate with or represent the effectiveness of given chemopreventive agents, vaccines, or other immunopreventive agent. Pool 2: Preclinical Services for Biopharmaceutical Product Development and Manufacturing The overall requirements and objective of the current acquisition, designated as the PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing (PREVENT CGMP), encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacture related activities and documentation, as described in detail in the DRAFT Statement of Work. The key objective of the PREVENT CGMP acquisition is to provide preclinical product development and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing. Pool 3: Toxicology and Pharmacology Testing The overall requirements and objective of the current acquisition, designated as the PREVENT Cancer Preclinical Drug Development Program: Toxicology and Pharmacology Testing (PREVENT Toxicology Contract), encompasses four main technical task areas: (1) genotoxicity testing; (2) general toxicity in experimental animals; (3) reproductive toxicology studies in rodents and rabbits; (4) specialized studies, as described in detail in the attached DRAFT Statement of Work. The key objective of the PREVENT Toxicology/Pharmacology Testing contract is to support the conduct of regulatory toxicological and pharmacological studies with potential cancer preventive agents to enable or advance human clinical trials. Anticipated Period of Performance: It is anticipated that any awards that may result from this solicitation will be Indefinite Delivery/Indefinite Quantity (IDIQ) contract(s). Task orders issued under the IDIQ contract(s) are anticipated to be either cost-plus-fixed-fee (CPFF), cost-reimbursement (CR) or Firm Fixed Price (FFP). The duration of the IDIQ contract(s) is anticipated to be for a five (5) year period with two (2) one (1)-year option periods (for a total length of seven (7) years if all option periods are exercised). The anticipated start date is on or about November 2023. If a RFP is issued, the NCI anticipates that the following number of awards may result from the issuance of the RFP: Pool 1: Preclinical Efficacy and Intermediate Endpoint Biomarkers - up to ten (10) IDIQ awards estimated Pool 2: Preclinical Services for Biopharmaceutical Product Development and Manufacturing - up to five (5) IDIQ awards estimated Pool 3: Toxicology and Pharmacology Testing - up to ten (10) IDIQ awards estimated NAICS Code and Size Standard: In event an RFP is issued, the NAICS code for this acquisition is 541714 Research and Development in Biotechnology (except Nanobiotechnology), which has a size standard of 1,000 employees. Capability Statement/Information Sought: Sources are expected to furnish the necessary services, qualified personnel, materials, facilities, equipment and experience to meet the requirements in the attached, DRAFT SOWs. Respondents must be qualified and prepare a tailored capability statement that demonstrates a clear understanding of all Task Areas outlined in the attached, DRAFT SOWs. The Capability Statements will be evaluated based on the information provided in relation to the project requirements and the current capability and capacity to: Perform the work outlined in the Task Area(s) in the attached, DRAFT Statements of Work; Provide appropriate Personnel for the project; Access appropriate resources (e.g., Facilities & Equipment); and Implement appropriate Quality Management programs. Information Submission Instructions: Format: Interested, qualified small business organizations should submit a SEPARATE TAILORED CAPABILITY STATEMENT for each pool in which they are interested. Small businesses may submit between 1-3 separate Capability Statements (one per pool). Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single-sided pages excluding all attachments, resumes, charts, and other relevant supporting documentation (single spaced, 12 point font minimum) that clearly details the firm's ability to perform the aspects of the notice described above and in the DRAFT SOW. Tailored capability statements should also include an indication of current certified small business status. This indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible small business concern's name, point of contact, address and DUNS number. All pages must be numbered including attachments, resumes, charts, etc. Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Megan Osele, Contracting Officer at megan.osele@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-75N91022R00012-18 and clearly indicate which pool the Capability Statement is addressing. Please use the abbreviation - EFFICACY for Pool 1, - CGMP for Pool 2 and - TOXICOLOGY for Pool 3 within the email subject line. Common Cut-Off Date: Electronically submitted tailored capability statements are due no later than 2:00 PM (EDT) on Monday, March 7, 2022. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 SAM.gov. 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).