CONTRACT KICKOFF MEETING AND PROJECT MANAGEMENT PLAN

合同启动会议和项目管理计划

• 批准号: 10721055
• 负责人: JANE MURAL
• 金额: $ 1.07万
• 依托单位: LEIDOS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721055
• 关键词: Adolescent; Animal Disease Models; Animals; Biological Products; Biological Response Modifier Therapy; Biomedical Research; Chemistry; Clinical Research; Clinical Trials; Complex; Contracts; Development; Documentation; Dose; Evaluation; Extramural Activities; Helping to End Addiction Long-term; Human Resources; In Vitro; Laboratories; Metabolism; Modeling; National Institute of Neurological Disorders and Stroke; Neonatal; Neurological Models; Pain; Patients; Pluripotent Stem Cells; Process; Program Development; Reporting; Research; Research Activity; Services; Technology Transfer; Testing; Tissues; Toxicology; United States National Institutes of Health; Validation; absorption; carcinogenicity; drug development; drug discovery; efficacy testing; experience; gene therapy; in vivo; manufacturing process development; manufacturing scale-up; meetings; nervous system disorder; pharmacokinetics and pharmacodynamics; programs; reproductive; research and development; research facility; stability testing; therapeutic development

The purpose of this requirement is to acquire complex, specialized and strategic services to support National Institutes of Health (NIH) activities. The NIH requires a research organization to support the NIH biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the National Institute of Neurological Disorders and Stroke (NINDS) Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP ), as well as other extramural or intramural NIH drug discovery and development programs. This requires highly qualified and experienced personnel capable of providing a full range of specialized, strategic, technical and operational services to deliver the support that is critical to the broad range of NIH biomedical and clinical research activities in-process, planned and unanticipated. The objective of this contract is to support the BPN-Biologics, URGenT, HEAL-PTDP and other NIH programs by providing: A. Manufacturing services including, but not limited to: (1) Technology-transfer of an R&D laboratory scale process from a research facility to the contract manufacturing organization (CMO) (2) Biological therapeutics manufacturing process development (3) Chemistry, manufacturing, and controls (CMC) development (4) Small-scale manufacture, scale-up, and manufacturing under current Good Manufacturing Practice (cGMP) (5) Fill-finish, release testing, validation, stability testing, and other associated tasks (6) CMC study report documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for these NIH programs B. Nonclinical services including, but not limited to: (1) Efficacy testing in in vitro, in vivo or ex vivo models, including modeling neurological disease using patient derived pluripotent stem cells, or in animal models of disease, or in naïve animals, or in ex vivo tissue or small explant cultures (2) Absorption, distribution, metabolism, and elimination (ADME) studies (3) Pharmacokinetic (PK) and pharmacodynamic (PD) characterization (4) Toxicology studies including, but not limited to single-dose and/or repeat dose toxicology studies, and/or reproductive toxicology and/or carcinogenicity studies, and/or neonatal and juvenile toxicology studies (5) Nonclinical study report and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for these NIH programs.

这一要求的目的是获得复杂的，专业的和战略性的服务，以支持美国国立卫生研究院（NIH）的活动。NIH需要一个研究组织来支持NIH蓝图神经治疗网络生物制剂的NIH生物制剂开发项目（BPN-Biologics）计划，国家神经疾病和中风研究所（NINDS）超罕见基因治疗（URGenT）计划，帮助结束成瘾长期疼痛治疗开发计划（HEAL-PTDP），以及其他校外或校内NIH药物发现和开发计划。这需要高素质和经验丰富的人员能够提供全方位的专业，战略，技术和业务服务，以提供支持，这是至关重要的广泛的NIH生物医学和临床研究活动的过程中，计划和意外。 本合同的目的是通过提供以下服务来支持BPN-Biologics、URGenT、HEAL-PTDP和其他NIH项目： A. 制造服务包括但不限于： （一） 从研究机构到合同生产组织（CMO）的研发实验室规模工艺的技术转移 （二） 生物治疗剂生产工艺开发 （三） 化学、生产和控制（CMC）开发 （四） 小规模生产、放大和根据现行药品生产质量管理规范（cGMP）生产 （五） 灌装-成品、放行检测、验证、稳定性检测和其他相关任务 （六） CMC研究报告文件，将使这些NIH项目的临床试验中的生物治疗剂能够进行监管备案和评价 B。 非临床服务包括但不限于： （一） 在体外、体内或离体模型中的功效测试，包括使用患者来源的多能干细胞建模神经疾病，或在疾病的动物模型中，或在未处理动物中，或在离体组织或小外植体培养物中 （二） 吸收、分布、代谢和消除（ADME）研究 （三） 药代动力学（PK）和药效学（PD）表征 （四） 毒理学研究，包括但不限于单次给药和/或重复给药毒理学研究，和/或生殖毒理学和/或致癌性研究，和/或新生儿和青少年毒理学研究 （五） 非临床研究报告和文件，将使监管备案和评价生物疗法的临床试验，这些国家卫生研究院计划。