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.

该要求的目的是获得复杂，专业和战略服务，以支持美国国立卫生研究院（NIH）活动。 NIH需要一个研究组织，以支持NIH Biologint开发项目针对NIH蓝图神经治疗技术网络生物学（BPN生物学）计划，国家神经疾病和中风研究所（NINDS）超毛病基因治疗（紧急）计划，有助于内部的成瘾性临床治疗方法，以及其他及其临床的临床临床临床（As Intram），以及其他临床的临床临床临床（As Interry），并具有临床性的临床性临床。发现与开发计划。这需要能够提供全面的专业，战略，技术和运营服务的高素质和经验丰富的人员，以提供对NIH生物医学和临床研究活动至关重要的支持，计划和意外。 该合同的目的是通过提供： A.制造服务，包括但不限于： （1）从研究机构到合同制造组织（CMO）的研发实验室规模流程的技术转移 （2）生物疗法制造过程开发 （3）化学，制造和控制（CMC）开发 （4）在当前良好的制造实践（CGMP）下的小规模制造，扩展和制造 （5）填充填充，发布测试，验证，稳定性测试和其他相关任务 （6）CMC研究报告文档，该报告将在这些NIH计划的临床试验中对生物疗法的监管申请和评估 B.非临床服务，包括但不限于： （1）在体外，体内或体内模型中进行疗效测试，包括使用患者衍生的多能干细胞，疾病动物模型，幼稚的动物或在体内或体内组织或小型外展培养物中对神经系统疾病进行建模 （2）吸收，分布，代谢和消除（ADME）研究 （3）药代动力学（PK）和药效（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，以及/或新生儿和少年毒理学研究 （5）在这些NIH计划的临床试验中，将对生物疗法进行监管申请和评估的非临床研究报告和文档。