CONTRACT KICKOFF MEETING AND PROJECT MANAGEMENT PLAN

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(NIH)的活动。NIH需要一个研究机构来支持NIH生物制品开发项目，这些项目包括NIH蓝图神经治疗网络生物制品(BPN-Biologics)计划、国家神经疾病和中风研究所(NINDS)超稀有基因治疗(URCHET)计划、帮助结束成瘾长期疼痛治疗药物开发计划(Hear-PTDP)以及其他NIH外部或内部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、技术和运营服务，以提供对NIH正在进行的、计划内的和意外的广泛生物医学和临床研究活动至关重要的支持。 该合同的目标是通过提供以下内容来支持BPN-Biologics、紧急、治愈-PTDP和其他NIH计划： A.制造服务，包括但不限于： (1)技术-将研发实验室规模的流程从研究机构转移到合同制造组织(CMO) (2)生物疗法制造工艺开发 (3)化学、制造和控制(CMC)发展 (4)小规模制造、规模化生产和现行良好制造规范(CGMP)下的制造 (5)填充-完工、释放测试、验证、稳定性测试和其他相关任务 (6)CMC研究报告文件，将使这些NIH计划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)体外、体内或体外模型的有效性测试，包括使用患者来源的多能干细胞模拟神经疾病，或在疾病的动物模型中，或在幼稚动物中，或在体外组织或小的外植体培养中 (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，以便在这些NIH计划的临床试验中对生物疗法进行监管备案和评估。

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.