SCREENING OF INVESTIGATIONAL THERAPEUTICS TO TREAT, MODIFY OR PREVENT EPILEPSY FOR THE NINDS EPILEPSY THERAPY SCREENING PROGRAM (ETSP)

NINDS癫痫治疗筛查计划(ETSP) 该合同将支持对治疗癫痫和相关疾病的潜在治疗剂(小分子、天然产品、合成肽、生物制品，以下称为ETSP“研究化合物”)进行临床前药理学评估。合同还可能要求评估用于治疗癫痫和相关疾病的生物医学设备。本合同应要求承包商在以下表现领域开展评估研究化合物的研究：1)建立抗药性癫痫的工作流程；2)疾病预防和修改模型(抗癫痫)；3)药代动力学研究。此外，承包商应被要求执行辅助研究和可选任务，以支持ETSP不断变化的要求。 政府预计大部分工作将由主承包商完成。鉴于任务的复杂性、成果的统一性和一致性、知识产权保护和受控物质管理等因素，业务部门必须得到很好的协调和控制，如果工作在同一组织内进行，则更有可能成功完成。人们认识到，在承包商没有能力在内部执行某些任务的情况下，可能需要进行一些分包。无论如何，尽管使用了分包，承包商仍应负责全面、完整地履行工作说明书(SOW)的所有方面。

NINDS Epilepsy Therapy Screening Program (ETSP) This contract will support the conduct of preclinical pharmacological evaluations of potential therapeutic agents (small molecules, natural products, synthetic peptides, biologics and referred to hereafter as ETSP “investigational compounds”) for the treatment of epilepsy and related disorders. The contract may also require evaluation of biomedical devices for the treatment of epilepsy and related disorders. This contract shall require the Contractor to conduct studies evaluating investigational compounds in the following performance areas: 1) established workflow for drug resistant epilepsy, 2) models of disease prevention and modification (anti-epileptogenesis), and 3) pharmacokinetic studies. In addition, the Contractor shall be required to perform ancillary studies and optional tasks to support the evolving requirements of the ETSP. The government expects the preponderance of work to be performed by the prime Contractor. Given factors including the complexity of the tasks, need for uniformity and consistency of results, protection of intellectual property rights, and management of controlled substances, the operational pieces must be well coordinated and controlled which is more likely to be successfully accomplished when the work is performed within the same organization. It is recognized that some subcontracting may be required where the Contractor does not have the capability to perform certain tasks in-house. In any event, the Contractor, despite the use of subcontracting shall be responsible for full and complete performance of all aspects of the Statement of Work (SoW).