ACT China III 2013

 

In 2013, the first Biomarkers Satellite Workshop was held prior to ACT China III by invitation only. Experts explored what is needed to deploy a nationwide testing of tumors for those molecular abnormalities that are likely to impact patient care. This Satellite Workshop brings together clinical oncologists, biomarker assay experts, and representatives of the CFDA of China, the FDA of the United States and Europe's EMA, to develop a plan for standardized cancer biomarker testing in China – for both clinical trials and for patient care.

[View Biomarkers Program]

Over the course of the 3-day ACT China III Workshop, a global faculty of experts addressed the current issues and challenges in carrying out Phase I, II and III clinical trials through a series of lectures, discussions, and workshops. We believe that the curriculum – covering ethics, preclinical studies, clinical trial design and conduct, statistics and regulatory considerations – will help transform oncology research in China for the benefit of cancer patients in China and around the world.

[View ACT China III Program]

Platinum Level/Founding Charter Sponsor: Sanofi Gold Level Sponsor: Shanghai Roche Pharmaceuticals Jade Level Sponsor: Bayer Healthcare Pharmaceuticals Pearl Level Sponsor: BTG International Canada, Quintiles In-Kind Support: ASCO, Conquer Cancer Foundation, AlphaMed Press

Video Lectures from ACT China IV 2013

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 22, 2013

You’re In Charge: Principal Investigator Responsibilities
Richard L. Schilsky, MD
Phase I Biomarker Driven Clinical Trials: Objectives, Design, Endpoints
Lillian L. Siu Phase, MD
Phase I Trials of Targeted Agent Combinations
Jin Li, MD, PhD
PK, Drug-Target Interactions, and Identifying AE’s in Phase I Biomarker-Driven Trials
Lillian L. Siu, MD
Phase I Biomarker Driven Clinical Trials
Panel Discussion

 

November 23, 2013

Development and Validation of Biomarkers as Clinical Tests
Lillian L. Siu, MD
Biomarker-driven Phase II Clinical Trials
Richard L. Schilsky, MD
Statistical Considerations for Phase II Biomarker Driven Trials and Adaptive Designs
J. Jack Lee, PhD, DDS
Do we need Phase II trials in the biomarker driven study era?
Yi-Long Wu, PhD
Use of Phase II Clinical Trials in the Era of Biomarker Driven Research
Panel Discussion
Phase I biomarker driven trial development (MLN0128)
Gong ji Fang, MD
Phase II biomarker driven clinical trial development in Lung Cancer
Shun Lu
Phase I biomarker driven clinical trial development (ipilimumab)
Caojun Ning, MD
Phase II biomarker driven clinical trial development in Gastrointestinal Cancers
Zhang Hau, MD
Statistical Considerations for Phase III Biomarker-Based Trials, Interim Analysis, and Data Monitoring
J. Jack Lee, PhD, MS, DDS
Panel Discussion on Global Regulatory Issues
Max Ning, Franceso Pignatti,
Chen-Yan Gao
Publishing Panel Discussion: Phase III Biomarker Driven Trials
Richard L. Schilsky, MD, Lillian L. Siu, MDYi-Long Wu, PhD J. Jack Lee, PhD, DDSJin Li, MD, PhD

 

November 24, 2013

What is the opportunity for cytotoxic therapy in the era of biomarkers and targeted agents?
Richard L. Schilsky, MD Yi-Long Wu, PhD
Opportunities and challenges in combining targeted therapies for breast cancer
Bi-Yun Wang, MD
ACT China III Summary Panel Discussion
Professor Shun Lu, Richard L. Schilsky, MD, Yi-Long Wu, PhD, J. Jack Lee, PhD, DDS, Jin Li, 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 22, 2013

(中文) You’re In Charge: Principal Investigator Responsibilities
Richard L. Schilsky, MD
(中文) Phase I Biomarker Driven Clinical Trials: Objectives, Design, Endpoints
Lillian L. Siu Phase, MD
(中文) Phase I Trials of Targeted Agent Combinations
Jin Li, MD, PhD
(中文) PK, Drug-Target Interactions, and Identifying AE’s in Phase I Biomarker-Driven Trials
Lillian L. Siu, MD
(中文) Phase I Biomarker Driven Clinical Trials
Panel Discussion

 

November 23, 2013

(中文) Development and Validation of Biomarkers as Clinical Tests
Lillian L. Siu, MD
(中文) Biomarker-driven Phase II Clinical Trials
Richard L. Schilsky, MD
(中文) Statistical Considerations for Phase II Biomarker Driven Trials and Adaptive Designs
J. Jack Lee, PhD, DDS
(中文) Do we need Phase II trials in the biomarker driven study era?
Yi-Long Wu, PhD
(中文) Use of Phase II Clinical Trials in the Era of Biomarker Driven Research
Panel Discussion
(中文) Phase I biomarker driven trial development (MLN0128)
Gong ji Fang, MD
(中文) Phase II biomarker driven clinical trial development in Lung Cancer
Shun Lu
(中文) Phase I biomarker driven clinical trial development (ipilimumab)
Caojun Ning, MD
(中文) Phase II biomarker driven clinical trial development in Gastrointestinal Cancers
Zhang Hau, MD
(中文) Statistical Considerations for Phase III Biomarker-Based Trials, Interim Analysis, and Data Monitoring
J. Jack Lee, PhD, MS, DDS
(中文) Panel Discussion on Global Regulatory Issues
Max Ning, Franceso Pignatti,
Chen-Yan Gao
(中文) Publishing Panel Discussion: Phase III Biomarker Driven Trials
Richard L. Schilsky, MD, Lillian L. Siu, MDYi-Long Wu, PhD J. Jack Lee, PhD, DDSJin Li, MD, PhD

 

November 24, 2013

(中文) What is the opportunity for cytotoxic therapy in the era of biomarkers and targeted agents?
Richard L. Schilsky, MD Yi-Long Wu, PhD
(中文) Opportunities and challenges in combining targeted therapies for breast cancer
Bi-Yun Wang, MD
(中文) ACT China III Summary Panel Discussion
Professor Shun Lu, Richard L. Schilsky, MD, Yi-Long Wu, PhD, J. Jack Lee, PhD, DDS, Jin Li, MD, PhD