CONTRACT KICKOFF MEETING AND PROJECT MANAGEMENT PLAN

合同启动会议和项目管理计划

• 批准号: 10721056
• 负责人: AMANDA BURNAUGH
• 金额: $ 1.15万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 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/10721056
• 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、专门的和战略性的服务，以支持国家卫生研究院的活动。美国国立卫生研究院要求一个研究机构支持NIH生物制剂开发项目，包括NIH蓝图神经治疗网络生物制剂（BPN-Biologics）项目、国家神经疾病和中风研究所（NINDS）超罕见基因治疗（URGenT）项目、帮助结束成瘾长期疼痛治疗开发项目（HEAL-PTDP）以及其他校外或校内NIH药物发现和开发项目。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，以提供对NIH广泛的生物医学和临床研究活动至关重要的支持，这些活动正在进行中，计划中和未预料到。