BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES

生物测定开发、确认/验证SME 生物测定开发顾问将被要求评估或开发生物测定 开发计划并推荐策略和实验以优化分析 和/或鉴定/验证所述测定，用于临床和非临床研究。生物测定 可能会要求顾问协助建立与分析相关的里程碑， 优化或验证。生物测定法可用于测量制剂， 生产研究和/或从临床和/或临床试验中获得的血清或组织样品中， 非临床研究。NIH可能会寻求顾问对设计的指导， 解释常用的体外试验，如生物化学和/或基于细胞的 测定。具体的咨询责任将取决于个人的专业知识 顾问和个别项目的需要。生物测定相关咨询服务 可能需要在临时基础上或通过LDTs。 生物测定SME顾问将： 1)提供开发、鉴定/验证检测试剂盒的专业知识，以支持 PK/PD、毒理学和临床安全性研究，以及 生物 2)协助建立与分析优化或验证相关的里程碑 3)作为试验开发专家，以确定潜在的开发 挑战，并提出在现实的时间表内应对这些挑战的战略 4)与其他顾问，承包商和NIH工作人员合作，建议， 战略规划，并管理程序，以促进铅优化，IND 使能和临床研究执行 5)作为资源，领导开发团队成员满足检测要求， 从临床前阶段开始进行生物制剂开发活动 直到临床初期 6)合作设计支持生物制品的调查性研究 发展 7)作为LDT的分析要求和物流资源，以进行生物制剂 从临床前阶段到初始临床阶段的开发活动 生物测定SME顾问的职责可能包括但不限于以下内容 职责和任务： a）审查并评论提出的生物测定方法的充分性 主要研究者（PI）和/或CMO/COR B）每周或 每两周 c）担任团队生物测定专家，以确定潜在的产品开发 挑战，并提出应对这些挑战的战略 d）合作设计研究，支持治疗开发项目 e）与其他顾问、承包商和NIH工作人员合作，提供建议， 战略规划和管理生物测定研究，以促进临床前评价 和安全性测试，新药临床试验（IND）提交和临床研究 f）通过电话和电子邮件促进LDT关于指定生物测定的讨论 努力

Bioassay Development, Qualification/Validation SME Bioassay development consultants will be required to evaluate or develop bioassay development plans and recommend strategies and experiments to optimize assays and/or qualify/validate the assays, for use in a clinical and nonclinical studies. Bioassay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. Bioassays may be used to measure drug product in manufacturing studies, and/or in serum or tissue samples obtained from clinical and/or nonclinical studies. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and/or cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Bioassay-related consultation services may be required on an ad hoc basis or through LDTs. Bioassay SME Consultants will: 1) Provide expertise in developing, qualifying/validating assays required to support PK/PD, toxicology, and clinical safety studies, and manufacturing/release testing of the biologic 2) Assist in the establishment of milestones related to assay optimization or validation 3) Serve as the assay development expert in order to identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines 4) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies execution 5) Serve as a resource to lead development team members for assay requirements, and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage 6) Collaborate on the design of investigative studies in support of biologics development. 7) Serve as a resource to LDT for assay requirements and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage The role of the Bioassay SME consultant may include, but is not limited to, the following responsibilities and tasks: a) Review and comment on the adequacy of bioassay approaches proposed by Principal Investigators (PIs) and/or CMOs/CORs b) Evaluate bioassay development and/or qualification/validation studies on a weekly or biweekly basis c) Serve as the team bioassay expert in order to identify potential product development challenges and suggest strategies to address these challenges d) Collaborate on design of studies in support of therapeutics development projects e) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage bioassay studies to facilitate preclinical evaluation and safety testing, Investigational New Drug (IND) submissions, and clinical studies f) Facilitate LDT discussions via telephone and email regarding assigned bioassay efforts