BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES

生物检测开发、资质/验证SME 生物检测开发顾问将被要求评估或开发生物检测。 制定开发计划并推荐策略和实验，以优化分析 和/或鉴定/验证分析，用于临床和非临床研究。生物测定法 可能会要求顾问协助建立与化验有关的里程碑 优化或验证。生物测定法可以用来测量药物产品。 制造性研究，和/或从临床和/或临床获得的血清或组织样本 非临床研究。美国国家卫生研究院可能会在设计和设计方面寻求顾问的指导 解释常用的体外分析方法，如生化和/或基于细胞的分析 化验。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求。与生物检测相关的咨询服务 可能需要在临时基础上或通过LDTS。 生物检测SME咨询公司将： 1)提供开发、鉴定/验证所需分析的专业知识，以支持 PK/PD、毒理学和临床安全性研究，以及制造/释放测试 《生物学》 2)协助建立与分析优化或验证相关的里程碑 3)担任化验开发专家，以确定潜在的发展 在现实的时间表上提出应对这些挑战的挑战并提出战略建议 4)与其他顾问、承包商和NIH工作人员合作， 战略性地规划和管理项目，以促进领导优化，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化验要求； 和后勤，从临床前阶段开始进行生物制品开发活动 一直到最初的临床阶段 6)合作设计调查性研究以支持生物制品 发展。 7)作为LDT的资源，满足化验要求和进行生物制品的后勤 从临床前阶段到临床初期的发展活动 生物检测中小型企业顾问的职责可能包括但不限于以下内容 职责和任务： A)审查和评论#年提出的生物测定方法的充分性 首席调查员(PI)和/或CMOS/CORS B)评价生物测定发展和/或鉴定/验证研究，每周或 双周制 C)担任团队生物分析专家，以确定潜在的产品开发 挑战并提出应对这些挑战的策略 D)协作设计研究以支持治疗学开发项目 E)与其他顾问、承包商和NIH工作人员合作， 战略性地规划和管理生物化验研究，以促进临床前评估 和安全性测试、研究新药(IND)提交和临床研究 F)通过电话和电子邮件促进LDT关于指定生物化验的讨论 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