BIOACTIVITY ASSAY DEVELOPMENT CONSULTING SERVICES

生物活性测定开发咨询服务

• 批准号: 10721045
• 负责人: FRANK PREUGSCHAT
• 金额: $ 0.76万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-10 至 2023-08-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721045
• 关键词: Address; Biochemical; Biological Assay; Biological Products; Biological Testing; Cells; Clinical; Clinical Research; Consult; Consultations; Contractor; Development; Development Plans; Electronic Mail; Helping to End Addiction Long-term; Individual; Investigational Drugs; Lead; Logistics; Measures; Pain; Pain management; Pharmaceutical Preparations; Principal Investigator; Published Comment; Qualifying; Resources; Role; Serum; Services; Speed; Strategic Planning; Telephone; TimeLine; Tissue Sample; Toxicology; United States National Institutes of Health; Validation; assay development; base; clinical pain; design; evaluation/testing; experimental study; in vitro Assay; lead optimization; member; pharmacokinetics and pharmacodynamics; pre-clinical; preclinical evaluation; product development; programs; safety study; safety testing; therapeutic development; validation studies

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 “This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management.”

生物测定开发、资格/验证中小企业 需要生物测定开发顾问来评估或开发生物测定 开发计划并推荐策略和实验以优化检测 和/或鉴定/验证测定，以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检测相关的里程碑 优化或验证。生物测定可用于测量药物产品 制造研究，和/或从临床和/或获得的血清或组织样本中 非临床研究。 NIH 可能会寻求顾问的设计和指导指导 解释常用的体外测定，例如生化和/或基于细胞的测定 化验。具体的咨询职责将取决于个人的专业知识 顾问和个别项目的需求。生物测定相关咨询服务 可能需要临时或通过 LDT。 生物测定中小企业顾问将： 1) 提供开发、鉴定/验证支持所需检测的专业知识 PK/PD、毒理学和临床安全性研究以及制造/发布测试 生物的 2) 协助建立与测定优化或验证相关的里程碑 3) 担任检测开发专家，以识别潜在的开发潜力 挑战并提出在现实的时间表内应对这些挑战的策略 4) 与其他顾问、承包商和 NIH 工作人员合作，提出建议， 战略规划和管理计划以促进先导化合物优化、IND 启用和临床研究执行 5) 作为资源引导开发团队成员满足检测要求， 和物流从临床前阶段进行生物制剂开发活动 直至初始临床阶段 6) 合作设计支持生物制剂的调查研究 发展。 7) 作为 LDT 的资源，满足检测要求和进行生物制剂的后勤工作 从临床前阶段到初始临床阶段的开发活动 生物测定中小企业顾问的角色可能包括但不限于以下内容 职责和任务： a) 对生物测定方法的充分性进行审查和评论 首席研究员 (PI) 和/或 CMO/COR b) 每周或每周评估生物测定开发和/或资格/验证研究 每两周一次 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策略 d) 合作研究设计以支持治疗开发项目 e) 与其他顾问、承包商和 NIH 工作人员合作，提出建议， 战略性地规划和管理生物测定研究以促进临床前评估 和安全测试、研究性新药 (IND) 提交和临床研究 f) 通过电话和电子邮件促进有关指定生物测定的 LDT 讨论 努力 “这项研究是 NIH 帮助结束成瘾长期 (HEAL) 计划的一部分，旨在加快科学解决方案的速度，以了解疼痛的基础并加强临床疼痛管理。”