We are pleased to announce our Keynote Presentations.
Topic 1: How to Release the Power of the Real World Data, When and How?|
by Shanmei Liao, BeiGene
Shanmei Liao, BeiGene
About Topic: With the growth of global awareness of the real world data use, many scenarios emergence trying to release the mysterious power of the asset. While within drug development, two most focused scenarios are serving as key evidence for regulatory approval and support effectiveness confirmation after regulatory approval, since both of the scenarios require high standard for the evidence which is still a dimension real world data need to demonstrate. The presentation will share few stories in these two areas to help us understand the current situation and shed lights to future development directions.
About Presenter: Shanmei Liao has about 15 years working experience in pharma/biotech industry. She worked for BMS US and Pfizer China and currently is the post approval and real world evidence global stat group lead in Beigene. She has worked/led about 6 China and US filings, and covered dozens of phase 1 to phase 4 clinical trials, in therapeutic areas as I/O, heme, I/I, neuro science, virology, CV/MED and biosimilar development. After taking the role of post approval stat lead in Beigene, she has led multiple China and exChina RWD studies design, PMC regulatory discussion, HTA and China NRDL package analyses and regulatory discussion, RWD and PRO analyses for post approval evidence generation, and quantitative monitoring for post marketing PV data. She is also served as the lead for China DIA RWD community and lecturer for both Yeehong Drug Development MBA program and National Medical Product Administration Institute of executive development (NMPAIED) with a focus on the RWD use in drug development. She got her Ph.D. from University of California at Davis and bachelor degree from Peking University, both in statistics.
Topic 2: Between now and the future - our mission and purpose|
by Ping-Chung Chang, Phastar
Ping-Chung Chang, Phastar, China
About Topic: Technologies are usually driven by unmet needs, and unmet needs are often represented by market trend data. This talk will focus on dissecting the industry spending & profit data, reviewing health care evolutions, summarizing the recent innovation hot topics and discussing our mission in this technology era. The goal is to provide audience a full-circle view of our industry’s movements on the innovation front and thus the purpose PharmaSUG serves.
About Presenter: Mr. Ping-Chung Chang is currently the Head of China Development and Global Delivery at Phastar. Ping has been a biostatistician in the clinical industry since 2002 and has had worked for pharmaceutical, biotech and CRO companies through the years. Ping is an experienced leader in regulatory submissions, large global team operations and CRO business management. While his current career focus is business optimization, Ping has also been greatly interested in innovations that lead to effort reduction or process improvements, and has been a vocal leader for virtual trials, data visualization and advanced data monitoring methods.
Topic 3: How Data and Insights Driven Drug Development
by Meng Chen, AstraZeneca
Meng Chen, AstraZeneca
About Presenter: Meng is currently Head of Biometrics in Astrazeneca R&D China. She leads a group of statisticians, programmers, data managers, medical writers together with business operation experts in AZ R&D China to help make innovative drugs available to the patients fast. She had over 16 years of industry experience having worked both in the US and China, on projects across many therapeutic areas and leading teams. Meng was trained as a statistician, and obtained her PhD in Statistics from University of Wisconsin-Madison.
|Topic 4: Sometimes newer is better, sometimes newer is just newer - How to pursue new technologies rationally!|