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) 筛选用于治疗、改变或预防癫痫的研究性治疗方法

• 批准号: 10787983
• 负责人: KAREN WILCOX
• 金额: $ 550.24万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-23 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10787983
• 关键词: Ancillary Study; Area; Biological Products; Contractor; Contracts; Devices; Disease; Disease model; Drug Kinetics; Epilepsy; Epileptogenesis; Evaluation; Event; Government; Intellectual Property; Intractable Epilepsy; Modification; National Institute of Neurological Disorders and Stroke; Natural Products; Performance; Property Rights; Therapeutic; Therapeutic Agents; Work; disorder prevention; pharmacologic; pre-clinical; prevent; screening; screening program; small molecule; synthetic peptide

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).

NINDS癫痫治疗筛查计划（ETSP） 该合同将支持对用于治疗癫痫和相关疾病的潜在治疗药物（小分子、天然产物、合成肽、生物制剂，以下称为ETSP“研究化合物”）进行临床前药理学评价。 合同还可能要求对治疗癫痫和相关疾病的生物医学设备进行评估。本合同应要求承包商在以下性能领域进行研究，以评估研究化合物：1）耐药性癫痫的既定工作流程，2）疾病预防和改善（抗癫痫发生）模型，以及3）药代动力学研究。 此外，应要求承包商进行辅助研究和可选任务，以支持ETSP不断变化的要求。 政府期望主要工程由主承包商完成。 考虑到各种因素，包括任务的复杂性、结果的统一性和一致性、知识产权的保护以及受控物质的管理等，必须很好地协调和控制业务部分，当工作在同一组织内进行时，更有可能成功完成。 人们认识到，如果承包商没有能力在内部执行某些任务，可能需要进行某些分包。 在任何情况下，尽管采用分包，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。