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PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE SOLICITATION NUMBER 75N95023R00064 TITLE CRO Support for NCATS Medicinal Chemistry for Lead Optimization CLASSIFICATION CODE AN11 - Health R&D Service... PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE SOLICITATION NUMBER 75N95023R00064 TITLE CRO Support for NCATS Medicinal Chemistry for Lead Optimization CLASSIFICATION CODE AN11 - Health R&D Services; Health care services; Basic Research NAICS CODE 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology RESPONSE DATE August 7, 2023 PRIMARY POINT OF CONTACT Giuliana Faller Contract Specialist giuliana.falller@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 ATTACHMENT 2 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 Medicinal Chemistry for Lead Optimization The following IDIQ contracts were awarded under Solicitation No. N01TR-19-2007: Contract No. 75N95019D00028 (Alchem Laboratories) Contract No. 75N95019D00029 (EUROFINS PANLABS, INC) Contract No. 75N95019D00030 (Lovelace Biomedical and Environmental Research Institute) Contract No. 75N95019D00031 (Regents of the University of Minnesota) Contract No. 75N95019D00032 (Organix Chemistry Solutions) Contract No. 75N95019D00033 (RTI International) Contract No. 75N95019D00034 (Southern Research Institute) Contract No. 75N95019D00035 (SRI International) Contract No. 75N95019D00036 (Southwest Research Institute) These modifications would extend the ordering period of the above IDIQ contracts by two years, through to September 25, 2026. There are no other changes to the contracts. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE Toxicology: The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 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 Medicinal Chemistry for Lead Optimization The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) conducts translational research in 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 Investigational New Drug (IND) is filed with the US Food and Drug Administration (FDA). 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 research and development (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 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. One of the DPI program requirements is to efficiently identify preclinical development candidates for rare and neglected diseases. To accomplish this endeavor, DPI has a need for a team of chemists; pharmacologists; absorption, distribution, metabolism, and excretion (ADME)/pharmacokinetics(PK) experts; and toxicologists working closely together to perform medicinal chemistry lead optimization. The objective of this contract is to support the DPI drug development programs by identifying preclinical drug candidates with improved efficacy, optimized ADME properties, and minimal predicted toxicity. While this Contract will be primarily in support of the DPI drug development programs. The Government reserves the right to allow other drug development programs at NIH to solicit task order proposals. As such, this Contract is not limited to rare or neglected disorders. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is to be as follows: CRO Support for NCATS Medicinal Chemistry for Lead Optimization: September 26, 2019 – September 25, 2024 (five years). This proposed modification will extend the ordering period through September 25, 2026. PLACE OF PERFORMANCE NCATS 9800 Medical Center Dr Rockville, MD 20850 Building B 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 TRND programs was 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 programs 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, August 7, 2023 and reference Notice No. 75N95023R00064 . Responses shall be emailed to the following: Drug Substance: All responses must be emailed to Giuliana Faller, Contract Specialist, at Giuliana.faller@nih.gov . All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.