ACT China 2014

November 21-23, 2014

In 2014, the fourth ACT China workshop was held in Shenzhen, China. The meeting concluded with the 2nd Annual Biomarkers Satellite Workshop.

Clinical trials play a vital role in improving the outcomes of cancer patients as well as in the drug development process. They account for a significant proportion of total research and development expenditure. Pharmaceutical companies today face an ever growing demand from regulators and patients to expand their clinical trial programs. While there are clear benefits for the conduct of clinical trials in China, it is also acknowledged that there are several key issues concerning clinical trials in China which need to be addressed. It is important that steps be taken to align Chinese clinical trial standards with those used internationally as this will enable more Chinese cancer centers and their investigators to participate in more international studies. This is where ACT China plays a crucial role.

STO and CSCO are grateful to the sponsors of this program.

Platinum Level/Founding Charter Sponsor: Sanofi
Jade Level Sponsor: Merck Serono
Additional Sponsors: Boehringer Ingelheim, AmoyDx
In-Kind Support: AlphaMed Press

Program Brochure
ACT China IV Agenda
Biomarkers Agenda

Video Lectures from ACT China IV 2014

The videos below are in English. You can watch these videos in Chinese.
请点击此处播放中文版演讲视频。

November 21, Morning Sessions

Welcome and Introduction
Yi-Long Wu, MD, PhD
Introduction to the Characterization and Validation of Biomarkers
Jin Li, MD, PhD
Pharmacokinetics, Pharmacodynamics, Drug-target Interactions, and Identifying Adverse Events in Phase II Biomarker Driven Clinical Trials
J. Jack Lee, PhD, MS, DDS
Rising Star of Clinical Studies: Phase II Biomarker Driven Clinical Trials
Xiaodong Zhu, MD
Phase II Biomarker Driven the Trial Development in Leukemia
Lin Qiu, MD, PhD
Panel Discussion: Phase II Biomarker Driven Clinical Trials, Including DMCs and/or Other Clinical Trial Committees
Jin Li, MD, PhD; Yi-Long Wu, MD, PhD; Lin Qiu, MD, PhD; Yang-Min (Max) Ning, MD, PhD and Iordanis Gravanis, MD, PhD

 

November 21, Afternoon Sessions

Development and Validation of Biomarkers as Clinical Tests
Monica M. Bertagnolli, MD
Statistical Considerations for Phase II Biomarker Driven Trials and Adaptive Design
J. Jack Lee, PhD, MS, DDS
Master Protocol Design Considerations and Endpoint Selection for Phase II Biomarker Driven Clinical Trials
Monica M. Bertagnolli, MD
Do We Need Phase II Trials in Biomarker Driven Study Era?
Yi Long Wu, MD, PhD
Panel Discussion: Use of Phase II Clinical Trials in the Era of Biomarker Driven Research
Jin Li, MD, PhD; Yi-Long Wu, MD, PhD and Monica M. Bertagnolli MD

 

November 22, Afternoon Sessions

Phase III Biomarker Driven Bridging Clinical Trials: Design Considerations and Real World Examples
J. Jack Lee, PhD, MS, DDS
Biomarkers in Oncology Drug Development and Tools for Accelerated Authorization: EU Regulatory Perspective
Iordanis Gravanis, MD, PhD
Tricks and Traps of Phase II Design
Yang-Min (Max) Ning, MD, PhD

 

The videos below are in Chinese. You can watch these videos in English.
请点击此处播放英文版演讲视频。

November 21, Morning Sessions

ACT CHina IV Welcome and Introduction (中文)
Yi-Long Wu, MD
Introduction to the Characterization and Validation of Biomarkers (中文)
Jin Li
Pharmacokinetics, Pharmacodynamics, Drug-target Interactions, and Identifying Adverse Events in Phase II Biomarker Driven Clinical Trials (中文)
J. Jack Lee, PhD, MS, DDS
Rising Star of Clinical Studies: Phase II Biomarker Driven Clinical Trials (中文)
Xiaodong Zhu, MD
Phase II Biomarker Driven the Trial Development in Leukemia (中文)
Lin Qiu, MD, PhD
Panel Discussion: Phase II Biomarker Driven Clinical Trials, Including DMCs and/or Other Clinical Trial Committees (中文)
Jin Li MD PhD, Yi-Long Wu MD PhD, Lin Qiu MD PhD, Yang-Min (Max) Ning

 

November 21, Afternoon Sessions

Development and Validation of Biomarkers as Clinical Tests (中文)
Monica M. Bertagnolli, MD
Statistical Considerations for Phase II Biomarker Driven Trials and Adaptive Design (中文)
J. Jack Lee, PhD, MS, DDS
Master Protocol Design Considerations and Endpoint Selection for Phase II Biomarker Driven Clinical Trials (中文)
Monica M. Bertagnolli, MD
Do We Need Phase II Trials in Biomarker Driven Study Era? (中文)
Yi-long Wu
Panel Discussion: Use of Phase II Clinical Trials in the Era of Biomarker Driven Research (中文)
Jin Li MD PhD, Yi-Long Wu MD PhD, Monica M. Bertagnolli MD

 

November 22, Afternoon Sessions

Phase III Biomarker Driven Bridging Clinical Trials: Design Considerations and Real World Examples (中文)
J. Jack Lee, PhD, MS, DDS
Biomarkers in oncology drug development and tools for accelerated authorization: EU regulatory perspective (中文)
Iordanis Gravanis, MD, PhD
Tricks and Traps of Phase II Design (中文)
Yang-Min (Max) Ning, MD, PhD