旧金山湾区，明天的讲座；CLINICAL DEVELOPMENT HIGHLIGHTS

[Tlexander]

https://www.cabsweb.org/events/5668347/ ... ighlights/


What does it take to bring clinical evidence to obtain market approval? This workshop is designed to gain a “big picture” of the entire drug development process from IND to NDA/BLA. It will highlight regulatory requirements, the framework for robust study design, medical monitoring and benefit & risk assessment, and elements of clinical operations and CRO program management. Key principles and concepts will be illustrated with case studies. This workshop will provide an opportunity for CABS members who are interested in expanding professional networks to clinical development for career development, industry partnerships or strategic collaborations.

Presentation Titles and Speakers:

1. Presentation Title: Brief introduction of clinical development

Speaker: Wei Dong, MD, PhD, VP and Head of Drug Safety at Denali, 2010-2011 CABS President

2. Presentation Title: Regulatory overview: the journey from IND to NDA/BLA including case examples

Speaker: Wen Liu, PhD, VP of Regulatory Affairs, Lyell Immunopharma

3. Presentation Title: Statistical considerations in clinical trial designs

Speaker: Jing Yi, PhD, Head of Data Science and Global Development Team Leader, CARGO Therapeutics

4. Presentation Title: Clinical operations and CRO program management

Speaker: Angela Wang, Commercial Director at Novotech

5. Presentation Title: Clinical Monitoring Priorities and Responsibilities

Speaker: Harry Liu, MD, MPh, MBA, Executive Director, Clinical Development, ALX Oncology

6. Presentation Title: The science and practice of drug safety

[Tlexander]

本周六SF旧金山湾区的workshop：clinical development plan，感兴趣的小伙伴一起去哈，https://www.cabsweb.org/events/5668347/ ... ighlights/，共包括6个内容的专题：临床开发简介，从IND到NDA/BLA的监管概览，临床试验设计中的统计考虑，临床运营与CRO项目管理，临床监测的优先事项与责任，药物安全的科学与实践。