IN VITRO STRATEGIES LIMITED LIABILITY COMPANY:1198212 [16-014035]IGF::CL::IGF

体外策略有限责任公司：1198212 [16-014035]IGF::CL::IGF

• 批准号: 10383377
• 金额: $ 2.55万
• 依托单位: IN VITRO STRATEGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-05 至 2021-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383377
• 关键词: Achievement; Address; Biochemical; Biological Assay; Cells; Chemistry; Clinical; Clinical Research; Clinical Trials; Consult; Consultations; Contractor; Contracts; Data; Data Analyses; Development; Discipline; Drug Kinetics; Electronic Mail; Experimental Designs; Feedback; Formulation; Future; Hour; In Vitro; Individual; Investigational Drugs; Lead; Logistics; Modeling; Peer Review; Pharmaceutical Chemistry; Preparation; Process; Protocols documentation; Reporting; Research Design; Resources; Role; Services; Shapes; Strategic Planning; Teleconferences; Telephone; Time; United States National Institutes of Health; Validation; Work; assay development; base; design; drug development; drug discovery; drug metabolism; experience; experimental study; in vitro Assay; innovation; interest; lead optimization; meetings; member; pre-clinical; preclinical safety; programs; small molecule; symposium

Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on programs and projects to the NIH and to BPN LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. General Requirements Consultants may serve on BPN LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs. A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held once or twice per month to discuss programmatic issues of broad interest. Specific Discipline Requirements 1. Bioactivity Assay Bioactivity Assay consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. Bioactivity Assay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Assay-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Bioactivity Assay consultant may include but is not limited to the following responsibilities and tasks: • In partnership with other consultants, contractors, and NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND-enabling studies, and clinical studies. • Serve as a resource to LDT for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage • Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges. • Collaborate on design of investigative studies in support of development compounds. 2. Drug Metabolism and Pharmacokinetics Drug Metabolism and Pharmacokinetics (DMPK) consultants may be required to evaluate PK study protocols and data, assist with study design, and advise NIH staff on the establishment of milestones related to DMPK. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. DMPK-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Drug Metabolism and Pharmacokinetics consultant may include but is not limited to the following responsibilities and tasks: • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage pharmacokinetic (PK) programs to facilitate assay development, exploratory chemistry, lead optimization, formulation activities, IND enabling, and clinical studies. • Serve as the PK expert in order to identify potential drug discovery and development challenges such as lead identification and lead development and suggest strategies to address these challenges. • Collaborate on design of investigative PK studies, PK/PD strategy, experimental design, data analysis and interpretation for discovery and translational projects in support of NIH drug discovery and development projects.

根据这一要求聘请的顾问不仅将为通过严格的同行评审过程选择的有前途的药物发现和开发项目做出重大贡献，他们还将帮助塑造一个创新的，备受瞩目的项目，该项目可能成为未来NIH药物发现工作的典范。 合同顾问将通过电话会议和电子邮件向NIH和BPN LDT成员提供有关计划和项目的反馈和指导。顾问可临时担任或作为最不发达国家小组的成员。预计顾问将就项目里程碑、开发战略、研究设计和数据解释提供投入。具体的咨询责任将取决于个别顾问的专业知识和个别项目和计划的需要。 BPN目前有处于探索性到临床前安全性阶段的项目。部分项目将进入新药研究（IND）和临床试验阶段。项目的延续将取决于具体项目里程碑的实现和项目组合的管理。自2011年以来，有15个项目进入了业务方案网络，5个项目仍在进行中。新项目每年审查两次，得分最高的项目可能会被纳入该计划。 总要求 顾问可以在BPN LDTs上服务，这需要每周3-10个小时的固定时间，包括会议和准备时间。每个LDT每1-2周通过电话会议召开约2小时的会议。可请顾问担任最不发达国家小组的联合主席。 担任LDT联合主席的顾问应促进LDT讨论，通过电子邮件和电话与NIH项目经理合作，维护并向其他LDT成员传达整体项目策略，并就里程碑报告的编制向PI提供建议。最不发达国家小组的联合主席是根据专门知识的广度和以前担任类似职务的经验挑选的。 每月与所有咨询人举行一次或两次电话会议，讨论广泛关心的方案问题。 具体纪律要求 1.生物活性测定 生物活性测定顾问可能需要评估生物活性测定，并推荐策略和实验，以优化和/或验证用于药物化学活动的测定。可能要求生物活性测定顾问协助建立与测定优化或验证相关的里程碑。NIH可能会就常用体外试验（如生化和细胞试验）的设计和解释向顾问寻求指导。具体的咨询责任将取决于个别咨询人的专门知识和个别项目的需要。可能需要临时或在LDT上提供化验相关咨询服务。 生物活性测定顾问的职责可能包括但不限于以下职责和任务： ·与其他顾问，承包商和NIH工作人员合作，提供建议，战略规划和管理计划，以促进铅优化，IND使能研究和临床研究。 ·作为LDT的分析要求和物流资源，从临床前阶段到初始临床阶段进行小分子化合物的药物开发活动 ·作为分析专家，以确定潜在的发展挑战，并提出解决这些挑战的策略。 ·合作设计调查研究，以支持开发化合物。 2.药物代谢和药代动力学 可能需要药物代谢和药代动力学（DMPK）顾问评估PK研究方案和数据，协助研究设计，并就DMPK相关里程碑的建立向NIH工作人员提供建议。具体的咨询责任将取决于个别咨询人的专门知识和个别项目的需要。DMPK相关咨询服务可能需要临时提供或在LDTs上提供。 药物代谢和药代动力学顾问的职责可能包括但不限于以下职责和任务： ·与其他顾问，承包商和NIH工作人员合作，提供建议，战略规划和管理药代动力学（PK）计划，以促进分析开发，探索性化学，铅优化，制剂活动，IND启用和临床研究。 ·担任PK专家，以确定潜在的药物发现和开发挑战，如先导化合物识别和先导化合物开发，并提出应对这些挑战的策略。 ·合作设计调查性PK研究，PK/PD策略，实验设计，数据分析和解释，以支持NIH药物发现和开发项目的发现和转化项目。