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.

此要求的目的是获得复杂、专业和战略性的服务来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 (BPN-Biologics) 的生物制剂开发项目。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、帮助戒除成瘾长期疼痛治疗开发计划(HEAL-PTDP) 以及其他院外或院内 NIH 药物发现和开发项目，这需要能够提供全方位专业、战略、技术和运营服务的高素质和经验丰富的人员，以提供至关重要的支持。 NIH 正在进行的、计划中的和意外的广泛的生物医学和临床研究活动。 该合同的目的是通过提供以下内容来支持 BPN-Biologics、URGenT、HEAL-PTDP 和其他 NIH 项目： A. 制造服务包括但不限于： (1) 研发实验室规模工艺从研究机构到合同制造组织 (CMO) 的技术转让 (2) 生物治疗药物生产工艺开发 (3) 化学、制造和控制（CMC）开发 (4) 小规模生产、放大生产以及现行良好生产规范 (cGMP) 下的生产 (5) 灌装完成、放行测试、验证、稳定性测试和其他相关任务 (6) CMC 研究报告文件，使这些 NIH 项目的临床试验中的生物疗法能够进行监管备案和评估 B. 非临床服务包括但不限于： (1) 在体外、体内或离体模型中进行功效测试，包括使用患者来源的多能干细胞、或在疾病动物模型中、或在幼稚动物中、或在离体组织或小型外植体培养物中模拟神经系统疾病 (2)吸收、分布、代谢和消除(ADME)研究 (3) 药代动力学（PK）和药效学（PD）表征 (4) 毒理学研究，包括但不限于单剂量和/或重复剂量毒理学研究，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 (5) 非临床研究报告和文件，以便能够对这些 NIH 项目的临床试验中的生物疗法进行监管备案和评估。