IPP - DRUG DEVELOPMENT SUPPORT FOR CTEP

IPP - CTEP 的药物开发支持

• 批准号: 10874352
• 负责人: LAUREN MILLER
• 金额: $ 767.5万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10874352
• 关键词: Adverse event; Agreement; Antineoplastic Agents; Biological Markers; Cancer Therapy Evaluation Program; Clinical Trials; Contracts; Development; Infrastructure; Investigational Drugs; Monitor; Pharmacologic Substance; Preparation; Regulatory Affairs; Reporting; Safety; Services; drug development

The “Drug Development Support for the CTEP” contract provides support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a spectrum of support services. The main objective of this contract is to provide a technical and administrative infrastructure to support FDA regulatory sponsor compliance, to fulfill the terms of pharmaceutical collaborator agreements and to assist in the solicitation of clinical trials. The support tasks include: 1) the preparation, tracking, submission and distribution of CTEP drug development related documents and FDA submissions; 2) tracking information regarding investigational anti-cancer agents including biomarkers; 3) support safety monitoring and adverse event reporting; 4) support collaborator agreement activities and 5) provide general technical and administrative support for investigational agent development and regulatory activities.

“CTEP药物开发支持”合同为癌症治疗评估项目（CTEP）法规事务分支（RAB）和研究药物分支（IDB）提供一系列支持服务。 本合同的主要目的是提供技术和管理基础设施，以支持FDA监管申办者合规性，履行制药合作者协议的条款，并协助临床试验的征集。支助任务包括：1）准备、跟踪、提交和分发CTEP药物开发相关文件和FDA提交文件; 2）跟踪关于研究性抗癌药物的信息，包括生物标志物; 3）支持安全性监测和不良事件报告; 4）支持合作者协议活动; 5）为研究性药物开发和监管活动提供一般技术和行政支持。