Interventional Agents Safety and Pharmacokinetic Services

The aim of this solicitation is to create a multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract. The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remains a high public health priority. To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical and non-clinical development support for promising therapeutic candidates that emerge from academia, the private sector, or other sources. The suite of services will encompass those activities commonly associated with the development of interventional products for infectious disease required for New Drug Applications (NDA), Biologic License Applications (BLA), and/or Investigational New Drug (IND) applications.For the purposes of

this contract, an Interventional Agent is a chemical or biological agent for control of diseases caused by pathogens or toxins. The provided services shall be directed at the following:Diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (NIAID) Emerging Infectious Diseases/Pathogens list (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens)Emerging and re-emerging infectious diseasesAntimicrobial-resistant and multi-drug-resistant infectionsBacterial infectionsFungal infectionsViral infectionsParasitic diseasesNIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that demonstrate capability to fulfill the technical requirements of at least one (1) of the technical Task Areas listed below plus required Task Area F. A contract may be awarded to an organization proposing to fulfill any number or combination of the technical Task Areas plus Task Area F. The Government anticipates making awards to those organizations with the best qualifications in each Task Area. Subpar evaluation in one technical Task Area will not exclude the organization from or negatively impact consideration for award in another Task Area. Organizations will be considered for contracts only in the Task Area(s) they include in the proposal. Sample Task Order solicitations will be provided in the RFP solely for evaluative purposes and do not represent actual work being solicited at this time. Task Order solicitations for actual work will be issued after the award of the Parent Contract.Task Area A – Product Development Planning and EducationTask Area A will support products by review, evaluation, or development of Product Development Plans (PDP) or their individual components, with respect to feasibility of design, development, manufacture, assay development, stability, preparation for clinical trials to include required documents, materials, and data for IND. This Task Area also supports conducting, reviewing, and evaluating technical feasibility or regulatory compliance of planned preclinical or nonclinical studies. Task Area A supports the development of Section 508-compliant educational materials including white papers, technical reviews, technical guidance documents, classes, and workshops. Task Area B – Non-GLP in vitro Preclinical Safety StudiesTask Area B will support the testing of candidate interventional agents in in vitro preclinical microbiological and safety studies.Task Area C – Non-GLP in vivo Preclinical Microbiological, Safety, Toxicology, and Pharmacokinetics ServicesTask Area C will support the preclinical safety, toxicity, and pharmacokinetic studies of interventional agent candidates in relevant small and large animal models. This activity includes all such non-GLP in vivo tests that are needed for drug development, toward the IND. The Contractor is responsible for the acquisition, housing, and care of animals, and must provide access to an Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited (or equivalent) animal facility and the capacity (appropriate cage space, etc.) as required to fulfill the required services.Task Area D – GLP Preclinical Microbiological, Safety, Toxicology, and Pharmacokinetics (PK) ServicesTask Area D will support the preclinical safety, toxicity, and pharmacokinetic studies of interventional agent candidates against in vitro, or relevant small and large animal models. This activity includes all such tests that are required to support clinical use in humans. Testing must be sufficient to meet requirements for IND/NDA/BLA filing and shall be performed under Good Laboratory Practice (GLP requirements (21 CFR 58). The Contractor is responsible for the acquisition, housing, and care of animals, and must provide access to an AAALAC-accredited (or equivalent) animal facility and the capacity (appropriate cage space, etc.) as required to fulfill the required services. Task Area E – Commercial Off-the-Shelf Screening for Absorption, Distribution, Metabolism, and Excretion (ADME), Safety, and Pharmacokinetics (PK)Task Area E will support the non-GLP in vitro and in vivo screening style assays for Adsorption, Distribution, Metabolism, and Excretion (ADME), Safety, and Pharmacokinetics (PK) in a fixed format requiring minimal customization or protocol development. The scope of Task Area E animal studies includes small animal PK and tolerability studies using traditional routes of administration and standard timepoints and bioanalysis. Task Area E does not include the following: (1) Good Laboratory Practice (GLP) studies of any kind; (2) Non-GLP animal studies requiring protocol development, customization, large animals or non-traditional species, non-traditional routes of administration, extended observation or data collection periods, or multiple dosing per animal.Task Area F – Contract Kick-Off MeetingTask Area F will support the planning and participating in the parent contract kick-off meeting.Project requirementsNIAID recognizes that a single organization or institution may not have the full spectrum of expertise or facilities required to perform all activities set forth in the Statement of Work. Offerors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through subcontracts, partnership or consortia agreements, and/or use of consultants. However, Offerors shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.NIAID will issue a Request for Task Order Proposal (RTOP) after the determination of a specific need which will be articulated in a Statement of Work (SOW) included in the RTOP. Specific activities within the Task Areas will depend on requirements developed by NIAID in conjunction with the status of the individual interventional agents as part of an overall product development plan. The Offer shall develop a response including a technical proposal in which the Offer specifies the scientific approach and methods it will employ to accomplish the key components of the RTOP and a business proposal detailing the associated costs or pricing structure as appropriate to the Task Order type. Compliance with applicable parts of 21 CFR (e.g. Good Laboratory Practices, and Electronic Records) may be required as determined by needs, funding, product maturity, and timelines of the product as specified in the Task Order.For the purposes of this contract, the following definitions apply:Therapeutic - A drug (synthetic or natural product) or a biotechnology product (e.g., monoclonal antibody) intended for use in the cure, mitigation, or treatment of disease.Anticipated period of performance This is an IDIQ Contract with a seven-year ordering period. The anticipated start date is on/or about May 1, 2025.