CRO Support for NCATS Bioanalytical Method Development for Biologics and Reagent Generation for Bioanalytical Method Development on Biologics Extensions

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE SOLICITATION NUMBER 75N95024R00063 TITLE CRO Support for NCATS Bioanalytical Method Development for Biologics and Reagent Generation for Bioanalytical Method Development on Biologics CLASSIFICATION CODE AN11 - Health R&D Services; Health care services; Basic Research NAICS CODE 325411 - Medicinal and Botanical Manufacturing RESPONSE DATE March 27, 2024 PRIMARY POINT OF CONTACT Nick Niefeld Contract Specialist nick.niefeld@nih.gov (301) 827-2094 DESCRIPTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). There are more than 6,500 identified rare and neglected diseases, yet only about 250 treatments are available for these conditions. The limited numbers of patients can make gathering information and designing drug studies difficult. As a result, scientists often know

little about the symptoms and biology of these conditions. Also, some private companies may find it difficult to justify the cost of developing drugs for such small rare disease markets. The National Center for Advancing Translational Sciences (NCATS) Therapeutics for Rare and Neglected Diseases (TRND) program is designed to combat these challenges. Its mission is to encourage and speed the development of new treatments for diseases with high unmet medical needs. TRND stimulates therapeutic development research collaborations among NIH and academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses. The program provides expertise and resources, working with research partners to move therapeutics through preclinical testing, including plans for clinical trials and submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). These efforts effectively “de-risk” therapeutic candidates and make them more attractive for adoption by outside business partners. The TRND program aims to encourage and speed the development of new treatments for rare and neglected diseases. The program is designed to advance the entire field of therapeutic development by encouraging scientific and technological innovations to improve success rates in the crucial preclinical stage of development. The National Institute on Drug Abuse (NIDA) Office of Acquisition, on behalf of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), intends to negotiate and award modifications to the following multiple award indefinite-delivery, indefinite-quantity (IDIQ) contracts for the following TRND programs: CRO Support for NCATS Bioanalytical Method Development for Biologics The following IDIQ contracts were awarded under Solicitation No. N01TR-17-2004: Contract No. HHSN271201800007I (PPD Development LP) Contract No. HHSN271201800008I (SRI International) These modifications would extend the ordering period of the above IDIQ contracts by two years, through March 31, 2028. There are no other changes to the contracts. Reagent Generation for Bioanalytical Method Development on Biologics The following IDIQ contracts were awarded under Solicitation No. N01TR-18-2006: Contract No. HHSN271201800010I (A&G Pharmaceuticals) These modifications would extend the ordering period of the above IDIQ contracts by two years, through May 31, 2027. There are no other changes to the contracts. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE Drug Substance: The intended procurement is classified under NAICS code 325411 with a small business size standard of 1,000 employees. Toxicology: The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees. Drug Product: The intended procurement is classified under NAICS code 325412 with a small business size standard of 1,250 employees. REGULATORY AUTHORITY The resultant modifications will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the current Federal Acquisition Circular (FAC). STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a) (1) under provisions of the statutory authority of FAR Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. DESCRIPTION OF REQUIREMENT BACKGROUND, PURPOSE AND OBJECTIVES CRO Support for NCATS Bioanalytical Method Development for Biologics The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Science (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI’s model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA). For certain drug development programs, DPI will support its candidate’s development up to human Phase IIB studies if and when determined by DPI management team as necessary to achieve DPI’s mission. DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer (PO) is responsible for the overall planning, execution, and reporting of the program. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of technical areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program. The objective of this contract is to support the DPI drug development programs by: (1) developing and validating sensitive and bioanalytical methods to quantify concentrations of novel biologics; (2) developing assays for measurement of anti-drug antibodies; and (3) providing bioanalytical support for drug concentration and anti-drug antibodies measurements for samples collected from not only animal pharmacokinetic (PK), biodistribution, toxicokinetic (TK) and efficacy studies but also human clinical trials. Under this contract, novel biologics include, but are not limited to, the following: mAbs, recombinant human proteins, Fc-fusion proteins, bio-functional proteins, PEGylated or other engineered peptides, protein fragments, antibody-drug conjugates (ADC), engineered human genes and carries, in plasma/serum, tissue homogenates, and CSF. To accomplish this objective and ensure adequate CRO and CMO support is provided to DPI, and out of a recognition that it is unlikely that a sufficient number of contractors will have the requisite capabilities to satisfy the objectives of this acquisition, this Statement of Work has been divided into four technical areas: Technical Area 1: Reagent Generation; Technical Area 2: Bioanalytical Method Development for Novel Biologic Drugs; Technical Area 3: Bioanalysis of Novel Biologic Drugs in Biologic Matrices; and Technical Area 4: Determination of Anti-Drug Neutralizing Antibodies. To qualify for award, organizations must have capabilities in at least one technical area. Organizations must respond fully to all technical areas they wish to be considered for. Reagent Generation for Bioanalytical Method Development on Biologics The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI’s model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA). For certain drug development programs, DPI will support its candidate’s development up to human Phase IIB studies if and when determined by the DPI management team as necessary to achieve DPI’s mission. DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non- profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer (PO) is responsible for the overall planning, execution, and reporting of the program. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program. To accomplish this objective and ensure adequate CRO support is provided to DPI, NCATS issued RFP No. N01TR-18-2006, “CRO Support for NCATS Bioanalytical Method Development for Biologics,” on January 26, 2017. In that RFP, the Statement of Work was divided into four technical areas: Technical Area 1: Reagent Generation; Technical Area 2: Bioanalytical Method Development for Novel Biologic Drugs; Technical Area 3: Bioanalysis of Novel Biologic Drugs in Biologic Matrices; and Technical Area 4: Determination of Anti-Drug Neutralizing Antibodies. To qualify for award, organizations had to demonstrate capabilities in at least one technical area. NCATS received no responses in Technical Area 1. Therefore, it is issuing a new RFP soliciting responses to the reagent generation requirement. II. Scope and Objectives The objective of this contract is to support the DPI drug development programs by generating reagents (e.g. polyclonal and monoclonal antibodies) that will be used in bioanalytical assay development to quantify concentrations of novel biologics and anti-drug antibody (ADA) in biological samples (e.g. plasma, serum, and tissue homogenate) collected from pharmacology, pharmacokinetic and toxicokinetic studies. Under this contract, novel biologics include but are not limited to the following: mAbs, recombinant human proteins, Fc-fusion proteins, PEGylated or other engineered peptides, antibody-drug conjugates (ADC). Note: (1) the development of bioanalytical assay reagents is a non-GLP/non-GMP activity; (2) no human materials are involved in this work. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is to be as follows: CRO Support for NCATS Bioanalytical Method Development for Biologics: April 1, 2018 - March 31, 2025 (seven years) This proposed modification will extend the ordering period through March 31, 2028. Reagent Generation for Bioanalytical Method Development on Biologics: June 8, 2018 - May 31, 2025 (seven years) This proposed modification will extend the ordering periods through May 31, 2027 PLACE OF PERFORMANCE NCATS 9800 Medical Center Dr Rockville, MD 20850 CONTRACT TYPE Task orders awarded under these IDIQ contracts for each TRND program will be Firm- Fixed-Price or Cost-Plus-Fixed-Fee, in accordance with the contract terms and conditions of the IDIQ contracts. REASON FOR THE NON-COMPETITIVE ACTION The above IDIQ contracts for the two TRND programs were originally awarded based on full and open competition. FAR Part 15 source selection procedures were used during the pre-award process, including: an independent peer review, an internal review by NCATS of both the technical and cost proposals submitted, and discussions with the Offerors regarding their proposals. Modifying the aforementioned IDIQ contracts for each TRND program specified herein to extend the ordering period is the only efficient and effective way to ensure continuation of these services. NCATS is actively planning and preparing for a new acquisition for these services, but due to changes in requirements, it was not possible to have the new acquisition begin with sufficient time to avoid a gap in the ordering periods. The mission of the NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions, with the goal of getting more treatments to more patients more quickly. The TRND program advances the mission of NCATS by encouraging and accelerating the development of new treatments for diseases with high unmet medical needs. The services performed under the above IDIQ contracts are vital to the TRND program and advancing the mission of NCATS, and a gap in the ordering periods would severely impact both. The contractors listed in the Introduction above have specific qualifications to provide the services for these requirements and are the only organizations that can perform this specific work at this time without unacceptable delays. For the time period contemplated for these actions, modifications to extend the ordering periods are the only way to avoid lapses in the ordering periods and a lapse in NCATS’ ability to obtain these critical services in a timely fashion. CLOSING STATEMENT This notice of intent is NOT a request for competitive proposals; however, interested parties may identify their interest and capability to respond to this notice. Responses to this notice must contain sufficient information to establish the interested parties’ bona-fide capability of fulfilling the requirements described herein. The statement must also include the contractor’s Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), and its certification of business size. All offerors must have an active registration in the System for Award Management (SAM), which can be accessed at www.sam.gov. A determination by the Government not to compete these proposed contract actions based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement for these two TRND programs. The determination whether to proceed with the proposed IDIQ contract modifications for these two TRND programs is solely within the discretion of the Government. All responses must be received by 5:00 PM Eastern Time, March 27, 2023 and reference Notice No. 75N95024R00063. Responses shall be emailed to the following: Drug Substance: All responses must be emailed to Nick Niefeld, Contract Specialist, at nick.niefeld@nih.gov . All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.