Day 1

28 March 2017, Tuesday

Registration Starts & Morning Coffee

IBC Opening & Ice Breaker

Chairperson Opening Remarks
Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiometabolism Risk Management and Anti-infectives (1), Bayer HealthCare Pharmaceuticals

Strategies for Transparency of Clinical Trials: Registration & Standardization of Data Management

  • What are the latest developments relating to the China Clinical Trial registration and its impact on transparency?  
  • What are the common drawbacks in clinical trials registration, and how can it be overcome?
  • Sharing of case studies to leverage best practices on implementation of clinical trial disclosure
  • Discussing data management standardization strategies

Wu Tai Xiang, Director, Chinese Clinical Trials Registry, China

Panel Discussion: Commercial, Regulatory and Operational Outlook for Clinical Trials in China 

  • Trends and expectations in Pharma spend for clinical trials in China
  • How conducive is the Chinese regulatory environment today to trials?
  • Can sites accommodate complex trials and meet global standards; and how site infrastructure caters patients enrolling in clinical trials?
  • Discussing issues related to patient population in China for different therapeutic areas
  • What’s the role of each stakeholder to improve the quality of clinical trials in China?
  • Return of investment vs. prioritising patients in trial

Simon Hedgecock, Regional ICRO Head, Novartis, China

Yao-Chang Xu, CEO, Abbisko Therapeutics Co., Ltd., China
Joe Zhou, CEO, Genor BioPharma, Walvax Bio Group and Visiting Professor, Peking University, China
Wu Tai Xiang, Director, Chinese Clinical Trials Registry, China
George Liu, Vice President, Early Development, Harbour Biomed, China

Morning Networking & Refreshment Break

Clinical Trial Protocol for Patients

Panel Discussion: Designing Patient-Centered Clinical Trial Protocol

  • What questions do stakeholders need to answer before the protocol is written?
  • Designing the flowchart to make the procedure feasible
  • Ensuring its design is accordance with regulations
  • How to measure the sample size?
  • Investigator’s information needs for technological support for eligibility criteria design
  • Other innovative approaches to clinical trial planning to minimize loss to follow-up over time

Jason Yang, MD, PhD.  Chief Medical Officer, CStone Pharmaceuticals, China
Chenguang Li, Clinical Study Manager, Evidence Generation & Clinical Research, RB, China
John L. Xu, Chief Scientific Officer, Mab-Venture Biopharm Co., Ltd, China
George Guo, GMO Country Head, Novartis Pharmaceuticals (China) Oncology, China

Regulation Updates for Precision Medicine

Progress in Regulating Next-Generation Sequencing Applications 

  • Regulatory oversight for NGS applications is especially challenging in cancer
  • One leading company has had success working with regulators to define a path forward
  • Recommendations for local companies (and regulators) will be discussed

James Creeden, Medical Director, Roche Molecular Information – APAC, Roche, China

Networking Lunch

Patient Selection & Recruitment Strategies
受试者选择 &招募策略

Case Study: Selection of Right Patients for Clinical Trials

  • Accelerating the recruitment rate
  • Sample size of the Chinese patient in multiple regional clinical trials
  • Financial consideration in recruitment
  • Meeting the timeline
  • What kind of strategies or methods to use: promotion material, social media etc.?

George Guo, GMO Country Head, Novartis Pharmaceuticals (China) Oncology, China

Comprehensive Genomic Profiling for Cancer Patient Selection in Adaptive Basket & Umbrella Studies

  • Overview of comprehensive genomic profiling and experience of Foundation Medicine in the US
  • Overview of basket and umbrella studies using genomic profiling and some examples of outcomes
  • Recommendations for such studies in China

James Creeden, Medical Director, Roche Molecular Information – APAC, Roche, China

Global Clinical Trials Trends

Improve Time to Market through Optimized End-to-End Supply Chain Management for Global Clinical Trials in Asia

  • Global Clinical Trials Overview – Trends and Developments
  • Optimizing End-to-End Clinical Trial Supply Chain Management to accelerate processes, lower cost and mitigates risk.
  • Strategies for Improving Clinical Trial Supply Chain Management in China

Peter Knapp, Vice President, Logistics and Global Expansion, Ancillare, LP, Singapore e Selection Strategies

Site Selection Strategies

Selecting the Right Subpopulation and Site for the Successful Clinical Trial

  • Heterogeneity of patient populations
  • Selecting patients based on pharmacogenomics or disease parameters
  • Significance testing the right patient population in a clinical trial

Lau Lit-Fui, President & Chief Operating Officer, CVie Therapeutics Limited, Taiwan

Afternoon Networking & Refreshment Break

What are the Key Factors in Selecting Pharmaceutical Trials?

  • Key considerations in selection of clinical trials from PI’s perspectives
  • Common areas to look out for in trial design
  • Conducting early phase studies

Dr Wang Ji Yao, Director, Division of Gastroenterology, Chair of Department of Internal Medicine, Zhong Shan Hospital, Fu Dan University, China 

New Approach for More Reliable Feasibility Assessment and Their Application in China

  • Optimizing data analytics, internal and external expertise to gather protocol and investigator intelligence
  • Holistic approach to assist high quality operation feasibility assessment

Rebecca Dai, Head Clinical Project Management – Primary Care & Women’s Healthcare, Clinical Development Operations, Bayer Pharmaceuticals, China

[Panel Discussion] How to Find the Right Site, Right Location?

  • Understanding the limitations of the clinical study, highly selective population and the workload involved
  • Managing expectations of collaborating partners for clinical research
  • Understanding the discrepancy in workload and educated personnel for coordinating global trials
  • Global clinical development – site compliance and connectivity to the industry inside and outside China

Paul Kong, Director of Clinical Operations, Fibrogen, China

Xin Zhang, Senior Director, Clinical Operations, Shanghai Henlius Biotech Co. Ltd, China
Wang Hao, Head of Clinical Operations, Bristol Myers Squibbs Pte Ltd, China
Helen Lin, Executive Medical Director, Amgen, China
Zhao Xianfeng, Head of Clinical and Nutrition Research, Abbott Nutrition R&D, China

Trial Support Quality

Quality Risk Management for Clinical Trials in China

  • What are the key considerations to ensure quality in clinical trials?
  • Carrying out high-quality clinical trials in a timely, transparent and efficient manner
  • Risk management for clinical trials in China

Yong Guo (Fred) Li, Vice President, Pharma R&D, Hua Medicine (Shanghai) Ltd, China

Chairperson’s Summary and End of Main Conference Day One

*Session outline may change to accommodate market-specific or company development.

Day 2

29 March 2017, Wednesday

Chairperson’s Opening Remarks
Eddy Wu, Executive Director, Medical and Scientific Affairs, Allergan, China

Site Operations and Management

[Panel Discussion] Ideal Clinical Trial Sites: Achieving a Balance Between Scientific Knowhow and Project Management Support
[小组讨论] 理想的临床试验点:在科学知识和项目管理支持之间实现平衡

  • Evaluating challenges in capability level, policy level and resource level
  • Understanding of the patient population, site health and local patient laws
  • Infrastructure support for trials of different therapeutic area – patient experience, administrative support and documentation capabilities
  • Support skills, specific inputs on protocols and quality of deliverables

Isabel Han, Executive Director, Clinical Operations, Denovo Biopharma, China

Rebecca Dai, Head Clinical Project Management – Primary Care & Women’s Healthcare, Clinical Development Operations, Bayer Pharmaceuticals, China
Wang Hao, Head of Clinical Operations, Bristol Myers Squibbs Pte Ltd, China
Laura Lin, Senior Portfolio Director, PAREXEL International, China

Patient Recruitment and Retention Strategies

Establishing Good Relationship with Principal Investigators to Help Profile & Recruit Patients

  • Current landscape and changes in the regulatory requirements
  • Transforming the clinical development by high technology
  • SWOT analysis of MNCs in China and the Asia Pacific area in the patient-centered clinical development
  • Incorporating the Patient Voice for Heightened Patient Participation
  • Discussing strategies and tactics

Jun Wang, Head of Clinical Operations, Takeda Development Center, China

Patient Safety & Informed Consent
受试者安全 &知情同意

Case Study: Best Practices on Informed Consent Process

  • Information and risk disclosure - How much information would be considered sufficient for the patient to make an informed consent?
  • Who should be taking the consent?
  • Language matters – practicing in an international setting

Dr C.S. Chen M.D., Ph.D., Executive Director - Cancer Center, Acting Chief of Medicine, Shanghai Jiahui International Hospital, China

Morning Networking & Refreshment Break

Case Study: Informed Consent Process – Managing Vulnerable Populations or Cognitive Impaired Populations
案例研究:知情同意流程 - 如何管理弱势群体或认知障碍群体

  • What are challenges in obtaining informed consent
  • The role of an investigator / delegated study personnel in obtaining personnel
  • Safeguarding the well-being of these group of populations

Jaclyn Yuen Yeng Ong, Senior Clinical Research Coordinator, Institute of Mental Health, Singapore

Innovative Practices in the Informed Consent Process

  • Informed consent as a process not a form
  • Role of education, multimedia and eConsents
  • Investigator responsibilities and integrity in consent

Barbara E. Bierer, Faculty Co-Director, Multi-Regional Clinical Trials Center of Harvard and the Brigham and Women’s Hospital (MRCT Center), and Professor of Medicine, Harvard Medical School, United States

Networking Lunch

Clinical Trial Quality

How to Ensure Data Integrity for Trial Sites in China?

  • Transparency in clinical trial Conduct confidentiality clauses
  • Electronic data procedures, core competencies of the databases and end-to-end processes
  • Data security/protection and integrity of data

Nellie Chen, Director of Clinical Operations, ASLAN Pharmaceuticals, China

[Co-presentation] How to Ensure Data Transparency for Trial Sites in China?

  • Pressure on sites from pharma and regulatory authority
  • Who owns the trial data? The sponsors who fund or sites who conduct?
  • Can sites withdraw data legally?

Dr Bian Zhaoxiang, Associate Vice-President, Professor of School of Chinese Medicine, Director of Clinical Division, Hong Kong Baptist University, Hong Kong
Wu Tai Xiang, Chairman, Chinese Clinical Trials Registry, China

What are the Quality Requirements in Phase I Centres?
阶段 I 中心有哪些质量要求?

  • Key considerations for inspection readiness and quality assurance in Phase I trials
  • Key considerations for trial sites for inspection readiness

Nie Zhao Hong, Head of Quality, Sihuan Pharmaceutical, China

e-Clinical Solution to Improve the Quality & Efficiency of Clinical Trial
Tong Guo, Head of Biostatistics, Africa/Asia, QuintilesIMS, China

Patient Data & Patient-Reported Outcome (PRO)
受试者数据 &受试者报告结果(PRO

Case Study: Identifying What Works & What Doesn’t for Patients through Comprehensive Real World Data

  • Patient-reported outcome (PRO) - Why to Bother?
  • How to use the results?
  • PRO measures in practice

Eddy Wu, Executive Director, Medical and Scientific Affairs, Allergan, China

Afternoon Networking and Tea Break

e-PRO: Increasing Patient Acceptability & Engagement
e-PRO:提高受试者的接受度 &参与度

  • Introduction to PRO and ePRO
  • Paper PRO vs ePRO
  • Identifying the pros and cons of ePRO

Na Guo, Principal Epidemiologist, GSK Shanghai R&D, China

Site as Partners

Vendor Oversight Implementation and GCP Quality Risk Management Framework

  • Improved processes, risk management frameworks and vendor oversight for clinical trials in Asia
  • Transparency and communication: CRO selection considerations: flexibility, expertise and transparency
  • Oversight of multiple vendors and data quality assurance

Jo Liu, Senior Business Operations Manager, Boehringer Ingelheim, China

Chairperson’s Summary and End of Main Conference

*Session outline may change to accommodate market-specific or company development.