This order is A Pre-TACT meeting for study and milestone discussion for a BPN Biologics project. POP: 03/09/2023 to 03/08/2024
This order is A Pre-TACT meeting for study and milestone discussion for a BPN Biologics project. POP: 03/09/2023 to 03/08/2024
该订单是针对 BPN Biologics 项目进行研究和里程碑讨论的 Pre-TACT 会议。
批准号：
10946905
负责人：
金额：
$0.68万
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
项目状态：
已结题
起止时间：
2023-03-09 至 2024-03-08
关键词：
AddressAdvisory CommitteesAwardBiological ProductsDevelopmentDuchenne muscular dystrophyLeadNational Institute of Neurological Disorders and StrokeNeuromuscular DiseasesResearch PersonnelTherapeuticTherapeutics CommitteeU-Series Cooperative AgreementsUnited States National Institutes of HealthUniversitiesWorkmeetingsmemberprograms
中文摘要
翻译
根据BPN-Biologics计划授予的合作协议需要召开监管前会议，以讨论研究和里程碑，并有助于将有前途的治疗方法转移到IND使能工作。NMD治疗咨询委员会（TACT）会议是将神经肌肉疾病治疗推向IND申请的正式步骤。这次TACT前会议是准备TACT审查的重要准备步骤。西北大学将支持召集3名神经肌肉疾病和TACT会议专家，与NINDS支持的研究者和NIH领导开发团队的其他成员举行TACT前会议。
英文摘要
A cooperative agreement awarded under the BPN-Biologics program requires a pre-regulatory meeting to discuss studies and milestones and contribute to moving the promising therapeutic to IND-enabling work. The TREAT-NMD Advisory Committee for Therapeutics (TACT) meeting is an official step in moving therapeutics that address neuromuscular disorders towards IND applications. This pre-TACT meeting is an important preparatory step to prepare for TACT review. Northwestern University will support gathering 3 experts in neuromuscular disorders and TACT meetings to hold the pre-TACT meeting with the NINDS-supported investigator and other members of the NIH Lead Development Team supporting the investigator.
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