演讲题目
Driving Clinical Strategy & Optimized Design with RWD and Clinical Patient-level Data

付萌

3D Medicine 临床开发部副总经理

Over 15 years extensive international clinical and pre-clinical experiences and outstanding proven track records in Asia and US
? Strong global clinical trial development and operational experiences
? Diverse knowledge, skill sets and training in medicine, clinical science, public health, regulation. Broad combinations of clinical practice and clinical/pre-clinical researches, medicine and business management, precision medicine and public health.
? Develop and manage global trials across multiple therapeutic areas and at different development phases
. Strong FDA submission and inspection handling experience.

Speech Abstract :
Value of Real World Data
? Essential for patient centric drug development
? Fill the efficacy-to-effectiveness gap
? Critical for product value story
? Business/Research Question Driven
? Always start with a question, not a particular real world data source
? Use a staggered approach
? Leverage data driven process with continuous learning over the lifespan of a product
? Start the journey early
? Consider RWE and ‘on-market’ learning as part of their development journey, and to take it seriously so we can produce high quality results