Please check back for regular program updates - EventDoveen15975.eventdove.com/resource/20150302/1531_20150302170630361.… · • Overview of SDTM concepts • SDTM-based domain

The 7th DIA China Annual MeetingInnovation and Convergence - Building a Sustainable R&D Ecosystem24-27 May, 2015 | Shanghai International Convention Center | Shanghai

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Please check back for regular program updates

Workshop 1 | Sunday, 24 May, 13:30-17:30

ESSENTIAL BIOSTATISTICS CONCEPTS MADE EASY DESCRIPTION“Leave the statistics to the statisticians” – true, and both statisticians and non-statisticians agree. However, statisticians don’t operate in isolation. Communication and teamwork are essential for modern drug development. A basic understanding of how each other works can make everyone more effective. This short course is designed specifically for that purpose. We aim to equip you with the basic statistical concepts relevant to non-statisticians’ work, and demonstrate how such knowledge can improve your own performance. No formulae or Greek letters – guaranteed!

TARGETED AUDIENCE• Medical Researchers• Study Managers• Data Managers• Regulatory Scientists• Programmers

AGENDA• The magic number is not magic

▪ The truth of p-value• The necessary devil

▪ Variability• The shining waterdrop

▪ Sample size and power made easy• Why can’t I take a peek?

▪ Multiple testing concepts• What can make you talk like a genius

▪ Understanding confounding• Fitting a squared peg through a round hole

▪ The importance of assumption checking• We will find you!

▪ Selection bias/publication bias that can make or break your reputation (including randomization/blinding concepts)

• Science or art? ▪ How to display data in tables and graphs


HOW TO COMPLETE A CDISC-COMPLIANT CRF ANNOTATION DESCRIPTIONThe annotated CRF (a-CRF) will document the tables, variable item names, forms, visits and any other objects as well as code lists in clinical trials. It is one of important tools to specify the information about the structure of clinical database/CRF and each datasets. The a-CRF is also required in a submission of trial outcomes for review by regulatory authorities. When a clinical data management processes a CRF, he should appropriately understand how to handle the data collected in the CRF. Thus, CRF annotation is essential to guide CDM to interpret and program definitions of data set recorded in CRF. This workshop is designed to provide the unique opportunity to hear from a variety of perspectives on the challenge and goal of successful CRF annotation. The topics will cover overview of CRF annotation, two types of a-CRF, methodology of CRF annotation, data standards of CDISC/CDASH/SDTM overview, diabetes case examples of two type’s a-CRF etc. The interactive small group discussions will be included for attendees to have an opportunity to discuss real-life problems and solutions in day-to-day CRF annotation.

SUNDAY, 24 MAY, 2015 | PRECONFERENCE WORKSHOPS

Preconference Workshop REGISTRATION OPEN: 23 May, 13:00 - 20:00 and 24 May, 07:00 - 13:30

Workshop 1 (Half Day) | 13:30 - 17:30 | Essential Biostatistics Concepts Made Easy

Workshop 2 (Full Day) | 08:30 - 17:30 | How to Complete a CDISC-Compliant CRF Annotation

Workshop 3 (Full Day) | 08:30 - 17:30 | Exploring Medical Communications Services to Support Patient Care Decisions

Workshop 4 (Full Day) | 08:30 - 17:30 | Lean: Innovative Approaches for Authoring Clinical Regulatory Documents


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Join the conversation: #DIA中国 DIAChina

LEARNING OBJECTIVE• ICH/GCP/FDA requirements to CRF annotation• General rule and challenge of CRF annotation• Relationship of CDISC standards to CRF annotation• CDASH based annotated CRF for implementation purpose• SDTM based annotated CRF for submission purpose• QA/QC practice during the CRF annotation

TARGETED AUDIENCEThis training program is a “must” for those interested and involved in CRF annotation, including but not limited to:

• Clinical Project Management Professionals• Clinical Data Management Professionals• Clinical Data Professionals• Clinical SAS Programmers • Clinical Database Builder • Clinical Study Professionals• Clinical Research Associates• Quality Assurance and Quality Control Professionals• CRF/Data Standardization Professionals

PROGRAM CHAIRDaniel LIU, PhDChief Scientific Officer, Beijing Clinical Service Center

PROGRAM COMMITTEETim WANGSenior Manager, Clinical Data Management, Data Analysis and Reporting Organization, Covance

Lily ZHAOSenior Manager, Data Operations Leader, PAREXEL

John WANGPrincipal Scientist, SAS Programming, Global Biostatistics, R&D, Johnson & Johnson

AGENDAWelcome and Opening RemarkSession 1 | Overview of CRF Annotation• Significance of CRF annotation• The process of CRF annotation• Role and responsibility for CRF annotation• Methodology of CRF annotation• ICH/GCP/FDA requirements in the submission of annotated

Session 2 | The Relationship and Difference between CDASH and SDTM Based a-CRF• Two types of annotated CRF• For implementation – CDASH based a-CRF• For submission – SDTM based a-CRF

Session 3 | Data Standards – CDISC Overview• Overview of CDISC core principles CDISC• Overview of CDISC main foundational CDISC• CDISC organization and values CDISC• CDISC in China – the present and the future CDISC

Session 4 | Data Standards – CDASH Overview• Overview of CDASH CDASH• Purpose and basic concepts of the CDASH standard• Relationship between CDASH and the other CDISC standards• Conformance rules for CDASH implementations CDASH• Challenges of collecting data in de-normalized structures• CDASH best practice recommendations for data collection

Session 5 | Data Standards – SDTM Overview• Overview of SDTM concepts• SDTM-based domain models for human clinical data,

relationship tables, and trial design• SDTM and the SDTM implementation guide for clinical data• Regulatory requirements status in each of location/regional

for SDTM

Session 6 | Starting to CRF Annotation• CFAST therapeutic area standards program• Overview of diabetes therapeutic area data standard user

guide V1• Annotation content requirements in CDASH and SDTM• General rules of naming• Similarities and differences for variables naming between

CDASH and SDTM

Session 7 | Case examples in Diabetes of CDASH based Annotated CRF and practice• Case examples and interactive practices

Session 8 | Case examples in Diabetes of SDTM based Annotated CRF and practice• Case examples and interactive practices• The reused annotation variables from CDASH to SDTM• Summary and wrap up


EXPLORING MEDICAL COMMUNICATIONS SERVICES TO SUPPORT PATIENT CARE DECISIONS

AGENDASession 1 | Technology Leads to New Opportunities for Meeting Customer Medical Information NeedsSESSION DESCRIPTIONThe session will focus on the opportunities to engage customers in new and impactful ways as the nature of healthcare communications continues to evolve. Understanding how customers want to receive information (including self-service tools) and connect is the first step. The next step is navigating the future for how tools will be utilized. Discussions will highlight opportunities and lessons learned in the utilization of technology (including mobile applications, websites, and social media tools) as enablers for communication with external customers. Examples from specific companies will be shared to highlight outcomes and experiences across Medical Communications. In addition, challenges relating to successful implementation will be discussed as it relates to legal/regulatory concerns, AE reporting, off-label information


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dissemination, and how to partner successfully with internal teams. Additional topics include how to raise awareness of new tools so customers know they are available.

LEARNING OBJECTIVES• Compare experiences and discuss development of

information technology tools that bring the greatest value to your organization

• Discuss how to partner and collaborate effectively with internal and external stakeholders while ensuring compliance with regulatory guidelines

SESSION CHAIRStacey FUNG, PharmDAssociate Director, Medical Communications, Genentech, A Member of the Roche Group, USA

SPEAKERSStacey FUNG, PharmDAssociate Director, Medical Communications, Genentech, A Member of the Roche Group, USA

Jianxiu YUMI Director, Area Lead/Head of MI China, EMC, Pfizer

Jack YU Medical Information Manager, Roche

Session 2 | Developing Medical Information Strategy and Plans SESSION DESCRIPTIONPharmaceutical companies are exploring new ways to develop their Medical Information function, including centralized, decentralized, and regionalized models. As the Medical Information function evolves it is becoming clear that one size doesn’t fit all and consequently there are now almost as many Medical Information models as there are companies!

This session will explore the different strategies and plans that pharmaceutical companies use to deliver Medical Information services in China, the Asia Pacific Region, and Globally. The discussions will look at the different approaches taken by different organizations.

This session will explore globalization and regionalization as well as Chinese strategies for providing medical information to customers.

LEARNING OBJECTIVES• Identify the components of an effective medical information

strategy• Discuss models for the contact center and the medical

information team • Understand local and global best practices for providing

medical information to customers

SESSION CHAIRDavid BOWERSDirector, Medical Communications, PPD

SPEAKERSElaine TSERegional Director, Medical Information Asia Pacific, Pfize

Jianxiu YUMI Director, Area Lead/Head of MI China, EMC, Pfizer

Hugo CHENMedical Education Director, Eli Lilly and Company

Session 3 | Comparing Regulatory Guidance for Medical Information Worldwide: Are There any Differences as to the Way We Respond to Healthcare Providers and Patients Globally?

SESSION DESCRIPTIONProvision of medical information, publication planning, and medical liaison services within biopharmaceutical companies have existed in one form or another for about 50 years. Over the years, these services have been introduced to countries areas across the globe. With popularity comes the potential for regulation. This session will review some of the different types of medical communication models, review related regulatory guidelines in place, and discuss the implications for the globalization of medical information, MSLs, and publication planning organizations.

LEARNING OBJECTIVES• Describe the various models used to provide medical

information, publications and medical liaison services• List the similarities and differences between regulatory

guidelines worldwide covering medical information, publication planning, and medical liaisons

• Assess existing corporate policies and procedures to determine if action is needed to meet regulatory expectations

SESSION CHAIRDannis CHANG, PharmDMedical Communications Scientist, Genentech Inc.A Member of Roche Group, USA

Medical Information Role and Processes for Medical Inquiry Management

Xuan ZHENG, MDMedical Information Services, Novartis

A Journey to Globalization: Local Publication Practice Under Global Guidelines And Regulations

Eric YU, PhDPublications, Roche

Globalization of Medical Information, Publication Planning, and Medical Science Liaisons: A Comparison Of Guidance and Practice Differences

Ping FENG, MDMSL Oncology, Roche



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Session 4 | Panel Discussion: Medical Science Liaison - Global Guidance and China Practice and Patients Globally?


LEAN: INNOVATIVE APPROACHES FOR AUTHORING CLINICAL REGULATORY DOCUMENTS DESCRIPTIONThe purpose and structure of the CTD (Common Technical Document) are presented, which serve as an introduction to the documents that form the basis of health authority regulatory submissions. Key principles of “lean methodology” are introduced, outlining value for efficient document generation. The application of “lean methodology” to authoring a specific CTD document, ie, the CSR (clinical study report), is presented along with practical exercises.

LEARNING OBJECTIVE• Structure of the CTD• Principles underlying “Lean Methodology or Thinking”• Practical application of “Lean” to authoring CSRs

TARGETED AUDIENCE• Pharmaceutical Industry Professionals• Pharmaceutical Research & Development Professions• Medical Writers• Nonclinical and Clinical Scientists• Clinical Pharmacologists• Regulatory Affairs Professionals• Reviewers from Regulatory Agencies• Life Science, Pharmaceutical & Medical Graduates

PROGRAM CHAIRPaul P. SOKOL, PhDJanssen Research & Development, LLC

PROGRAM COMMITTEEHelle GAWRYLEWSISenior Director, Head Medical Affairs & Alliance Management, Biometrics and Reporting, Janssen Research & Development, USA

Xing LIAssociate Director, Head of Janssen China R&D Medical Writing and Translation Service Center, QS China, Janssen Research & Development

Paul P. SOKOL, PhDJanssen Research & Development, LLC

KEY INSTRUCTORSYao YAO, PhD, RAC, CQASpecially Invited Professor, IED, CFDA

Helle GAWRYLEWSISenior Director, Head Medical Affairs & Alliance Management, Biometrics and Reporting, Janssen Research & Development, USA

Paul P. SOKOL, PhDJanssen Research & Development, LLC

AGENDAWelcome and Opening RemarkSession 1 | Agenda for WorkshopSession 2 | Strategically Implement CTD Fundamental to CMC and Nonclinical Document WritingSession 3 | Introducing Lean Principles Session 4 | Applying Lean Methodology to Authoring Clinical Study ReportsSession 5 | Questions for PanelSession 6 | Interactive Workshop Exercises for Subject Disposition, Demography and Adverse EventsSession 7 | Closing Remarks from Panel



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Theme 1

Understanding China Regulatory Landscape - Advancing Regulatory Science Expert Panels and Presentations

Session 0101 | Tuesday, 26 May, 08:30-10:00

SUCCESSFUL STORIES OF BRINGING INNOVATIVE PRODUCT INTO CHINA MARKET SeSSion Chair

Wendy YAN, MD, MBA Senior Vice President, Head of Regulatory/AffairsBeiGene (Beijing) Co., Ltd.

Encouraging innovation is one of the most important initiatives for Chinese government. Many experts in pharmaceutical industry are eager to develop innovation drugs in China. However, there are few successful cases to bring innovative drug into China market due to the characteristics such as high technology, high investment, high risks and extremely uncertainty, etc. during innovative drug development. In this session will invite several representatives from

industry to share their successful cases, experiences, and lessons learned from the innovative drugs’ development. CDE reviewer will be invited (tbc) to present from reviewer’s perspective. Hopefully this session could be of assistance and guidance to the industry peers.

Registration of Chidamide for an Orphan Disease, PTCL, in China

Xianping LU, PhDChief Executive Officer & Chief Scientific OfficerShenzhen Chipscreen Biosciences Ltd.

Development of Conbercept Ophthalmic Injection in China - A Chinese Story on a Global Scale

Yongzhong WANG, PhDDeputy General Manager, Kanghong Pharmaceutical

Topic TBD

Speaker Invited


MONDAY, 25 MAY, 2015 | CONFERENCE DAY 1

Conference REGISTRATION OPEN: 23 May, 13:00 - 20:00; 24 May, 13:30 - 17:30; 25 - 27 May, 07:30 - 17:30

Opening Plenary Session | Monday, 25 May, 13:30-17:30

INTRODUCTIONHaijun DONG, PhD, MBASenior Vice President and Managing Director, DIA Greater China

OPENING REMARKSBarbara Lopez KUNZGlobal Chief Executive, DIA, USA

WELCOME ADDRESSESZili LI, MD, MPHSenior Advisor, China R&D, Bill & Melinda Gates Foundation

Yajun ZHAODirector-General, China Center for Food and Drug International Exchange (CCFDIE)

WELCOME ADDRESSES FROM CFDACFDA Speaker Invited

KEYNOTE ADDRESS

KEYNOTE ADDRESS IN DEVELOPMENT

SPECIAL FORUM: R&D ECOSYSTEM

SPECIAL FORUM IN DEVELOPMENT

Networking Reception | Monday, 25 May, 17:30-19:00

TUESDAY, 26 MAY, 2015 | CONFERENCE DAY 2WEDNESDAY, 27 MAY, 2015 | CONFERENCE DAY 3


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FUTURE DIRECTION OF GLOBAL DRUG DEVELOPMENT WITH ICH E17 GUIDELINE FOCUSING ON MRCTSSeSSion Chair

Yoshiaki UYAMA, PhDDirector, Division of Epidemiology, Office of Safety IPharmaceuticals and Medical Devices Agency (PMDA), Japan

ICH is currently working for establishing E17 guideline focusing on Multi-Regional Clinical Trials. This session presents the latest situation of E17 guideline development and discuss how the guideline affects regulatory review and drug development at global level.

Update of ICH E17 Guideline Development

Yoshiaki UYAMA, PhDDirector, Division of Epidemiology, Office of Safety IPharmaceuticals and Medical Devices Agency (PMDA), Japan

How to Review MRCT Data for Drug Approval – From CFDA Perspective

CFDA Speaker Invited

Impacts of E17 Guideline for Drug Review and Approval in Taiwan

Lih-Jiuan HSU, MDSenior Executive Officer, Office of Executive Director, Center for Drug Evaluation, Taiwan

MRCT Data Submission to Multiple Regulatory Agencies: Impacts of ICH E17 Guideline – From Industry Perspective

Patrick K. BRADY, PharmDDeputy Vice President, Scientific & Regulatory Affairs, The Pharmaceutical Research and Manufacturers of America (PhRMA), USA

Session 0105 | Wednesday, 27 May, 08:30-10:00

HOW FAR AWAY IS THE INNOVATIVE MEDICINE TO CHINA PATIENTS? (PART I)SeSSion Chair

Zhi’ang WU, PhDDean, School of Business AdministrationShenyang Pharmaceutical University

SESSION IN DEVELOPMENT


HOW FAR AWAY IS THE INNOVATIVE MEDICINE TO CHINA PATIENTS? (PART II)SeSSion Chair

Zhi’ang WU, PhDDean, School of Business Administration, Shenyang Pharmaceutical University



HOW TRANSPARENCY EVOLVE IN KEY AUTHORITY AND HOW IT HELPS INDUSTRY R&D CAPABILITY BUILD UPSeSSion Chair

Haifeng CAO, MBAHead of Regulatory Affairs, GSK

CFDA is realizing the importance of transparence and issued some policy in recent years. However there is more they can do. By introducing FDA and EMA related important policy and their influence to industry. It is to help CFDA understand how to develop policy for future to increase transparency and facilitate industry development. Keeping transparency also helps agency to work more efficiently as well.


Session 0108 | Wednesday, 27 May, 15:30 - 17:30

HOW MULTIPLE-DISCIPLINARY DEPARTMENT IN AUTHORITY WORKS COLLABORATIVELY TO MANAGE/REGULATE PRODUCT QUALITY SeSSion Chair

Hengxu WEI, PhDDirector, CMC Regulatory Affairs, GSK

The aim for the presentation is to help China CDE, National lab and CHP to work together to address quality of products, rather than each department works independently to issue new policy/guideline. There is a real case for antibiotics quality control in China which creates difficulty to industry. CDE requires all antibiotics product specifically to meet EMA/CHMP/QWP/199250/2009 - Setting Specifications for Related Impurities in Antibiotics, which requires any unknown impurity to be either controlled at <0.2% in product or to be identified. However it is clearly indicated by EMA this guideline is not retrospective so only applicable to new registration, and all existing product just needs to comply with EP. It reflects insufficient communication between ChP and CDE.




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Theme 2

China Food and Drug Administration (CFDA) Town Hall

Session 0203 & 0204 | Tuesday, 26 May, 13:30 - 15:00

CHINA FOOD AND DRUG ADMINISTRATION (CFDA) TOWN HALL

CFDA Townhall this year is intended to communicate with the audiences on the hot topics related to drug review & approval system reform, which might include integrated reform plan on drug review & approval, DAL amendment timeline and its key considerations, unannounced and overseas inspection with regard to GMP and GCP compliance, and the international collaboration.


Theme 3

Clinical Science and Clinical Trial Operation


THE RESPONSIBILITIES TO SPEED UP CLINICAL TRIALSSeSSion Chair

Shuting LI, MDDirector, GCP Center, the Cancer Hospital of Chinese Academy of Medical Sciences

It is shown that only 60% of the time is used for subjects’ enrollment during the clinical trial, and the other 40% is wasted on the approving issues by government departments, sponsors, CRO, ECs and site management offices. Being a participant of the trial, everyone has the reason for using the time on reviewing, negotiating and bargaining with EC, legal departments and so on, these kinds of process will waste time from 2 months to 6 months and even longer. In this session we will invite some experts representing various fields to discuss, from different aspects, how to speed up the clinical trial, to develop effective methods to solve the problems we have met.

Topic TBD

George GUOGlobal Monitoring Operation Country Head, China

Topic TBD

Winnie XUSenior Director, Clinical Operations, Quintiles

Topic TBD

Huanling WANG, MDVice Director, Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Topic TBD

Yongchuan CHENDirector, GCP office, Southwest Hospital

Topic TBD

Zhiqiang NING, MD, PhDVice President, R&D, Chipscreen Biosciences Ltd.

Topic TBD

Tim SHIChief Representative for Global MD Organization China Office


THE FEASIBILITY OF INITIATING CLINICAL TRIALS BY SINGLE IRB APPROVING IN CHINASeSSion Chair

Shuting LI, MDDirector, GCP Center, the Cancer Hospital of Chinese Academy of Medical Sciences

In multicenter clinical trials, each clinical trial will undergo an initial full-board review, subsequent annual reviews and so on by IRBs varying from several to hundreds. These multiple IRB reviews create a largely redundant, time-consuming workload. Last year NIH issued a draft policy to promote the use of single institutional review boards or IRBs to reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.

Is it time for us to use single IRB in China? What kind of crisis may meet if single IRB is used? In this session we will invite some experts from several fields to discuss on the feasibility of ethical review by single IRB in China.

All Speakers from Session 0301


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CINICAL SCIENCE (PART I) - DEVELOPMENT STRATEGYSeSSion Chair

Sunny ZHU, MDGlobal Clinical Lead, Global Clinical Development, Bayer Healthcare Company

• What is Holistic approach for Clinical Development Plan (CDP)? • How to do a CDP? • Challenges and opportunities for China in a global CDP?• Considerations in CDP strategy from a local innovation company • Any difference and characters in CDPs development across

region or companies?

Holistic Approaches for A Clinical Development Plan

Theo J HOOFWIJK, MDExecutive Director, Global Strategic Drug Development,Center for Integrated Drug Development, Quintiles, Netherlands

Clinical Development Plan Considerations for China Local Innovations

Ning XU, PhDExecutive Vice President, Head of Clinical Development and RegulatoryAffairs, Zai Laboratory

Panel Discussions: Global vs China, MNC vs Local: Considerations in CDP

Panelists Invited


CLINICAL OPERATION RISK BASED MONITORING SeSSion Chair

Vicky CHEN, MDSenior Director, Clinical Development, Greater China, INC Research

The conduct of clinical trials requires the sponsors to monitor clinical trials in order to ensure an adequate protection of research subject rights, safety and welfare as well as to ensure the quality and integrity of the data collected that is going to be submitted with the purpose of marketing applications. With the increased complexity of studies, there is a need to focus on the most critical data elements using a risk-based approach to monitoring. The effective integration of data sources and its analysis are key enablers for the innovation aimed at improving efficiencies. The use of computerized systems and the continued digitalization offer unique opportunities for data driven decisions and quality oversight. The aim of this session is to explore the challenges and opportunities for the risk based monitoring strategies in emerging regions such as Latin America and Asia. The complex regulatory framework, increased communication technology tools, cultural diversity and the increasingly globalized approach for the conduction of clinical trials create unique difficulties for sites, and sponsor/CROs in diverse geographies when implementing risk based monitoring strategies.

Topic TBD

Qing’an JIAO , MDSenior Director, Head of GCO China Global Clinical Operations, Xi’an Janssen Pharmaceuticals Ltd.

A Long Way to Go – Risk-Based Approach to Monitoring in China

Kevin LIManaging Director, CMIC (Beijing) Pharmaceutical Services Co., Ltd.

DETABE: Is Risk-Based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Region?

All Speakers and Invited Detabers


CINICAL SCIENCE (PART II) - IMCT LATEST GUIDANCE POPULATION PK VALUE IN DEVELOPMENT SeSSion Chair

Paul DAI, MDSenior Director, Regional Head of ICRO, AMAC/Greater China Region (Asia Pacific, Middle East and African Countries/Greater China Region), Beijing Novartis Pharma Co., Ltd.

Early Development and Population PK and Its Value

CAPT. E. Dennis BASHAW, PharmDDirector, Division of Clinical Pharmacology III, Office of Clinical Pharmacology, Office of Translational Sciences, FDA, USA

Topic TBD

Speaker Invited

Topic TBD

Speaker Invited


PROJECT MANAGEMENT - STUDY WIDESeSSion Chair

Hualong SUN, MD, PhDGeneral manager, Meta Clinical Technology

The session will discuss the issues and challenges based on different points of views from sponsor, investigator and CRO when conducting clinical trials.

CRO Selection and Management

Vivian CHANGAssociate Director, Clinical Operations, Clinical Study Unit, Sanofi

Manage Key Project Millstones Involving Sponsor, Sites and CRO

Wenchi LINSenior Portfolio Director, Portfolio Leadership Phase II/III, PAREXEL


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Challenges of Patients Enrollment and Compliance Management from Investigator Sites

Laiping ZHONG, ProfessorDepartment of Oral & Maxillofacial-Head & Neck Oncology, the 9th People’s Hospital, School of Medicine, Shanghai Jiao Tong University

Panel Discussion - How to Make a Good Communication between Sponsors, CROs, and Investigator Sites

All Speakers

Theme 4

Quantitative Science - Addressing Critical Clinical and Regulatory Questions


STATISTICAL METHODS FOR ONCOLOGY CLINICAL TRIALSSeSSion Chair

Ouhong WANG, PhDDirector, Biostatistics, Amgen

Oncology clinical trials have unique challenges compared with non-oncology trials: The unmet medical needs are greater which demand speedier clinical trial conduct. Biomarkers are usually a consideration that drives patient selection and treatment strategy. The clinical endpoints are often time-to-event measures that require special analysis methods beyond the familiar ones for continuous or categorical variables. Also endpoint censoring is a feature that can miss valuable information if not properly handled. Statistical methodology utilized in the oncology area is therefore unique and requires special study. In this session, several statistical issues relevant to oncology will be presented and discussed. Real examples and potential applications are employed whenever possible.

An Adaptive Seamless Phase II/III Design for Oncology Trials with Subpopulation Selection Using Correlated Survival Endpoints

Jerry WUManager, Biostatistics, Amgen

Flexible Modelling of Survival Curves for Censored Data in Oncology Trial

Steve SUSenior Biostatistician, Covance, Australia

Interval Censoring and Its Applications to Oncology Endpoints

Chao ZHUResearch Scientist, Eli Lilly and Co.

Statistical Considerations in Analyzing Recurrent Events

Fan XIA, PhDBiostatistician, Roche


APPLICATION OF BAYESIAN METHODS FOR CLINICAL TRIALSSeSSion Chair

Bingming YI, PhDHead of Statistics, Epidemiology, and Data Management, GlaxoSmithKline (Shanghai) R&D

With the increasing cost and declining efficiency in pharmaceutical research and development, it becomes more and more important to leverage sophisticated statistics tools such as Bayesian methods to enhance decision making, study designs, and data analysis and interpretation. This session aims to present on latest development in the application of Bayesian methodology, including optimizing the end-to-end drug development strategy; enhancing decision making via interim analysis; evaluating Probability of Success. It will also provide an insight on future trend of Bayesian methods.

Maximizing Return on Investment in Designing Phase II Clinical Trials

Cong CHEN, PhDDirector, Late Development Statistics, Oncology, Merck Research Labs, Merck & Co., Inc., USA

A Bayesian Prediction Model between a Biomarker and the Clinical Endpoint for Dichotomous Variables

Yang SONG, PhDSenior Principal Scientist, Biostatistics, MSD R&D (China) Co. Ltd.

A Case Study for a Bayesian Approach to the Assessment of Safety for Biosimilar and Its Application to Bridging Study

Jerry WANG, PhDHead, GBS China, Merck Serono


INVOLVING CDM ROLESeSSion Chair

Li DINGSanofi



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QUALITY AND INTEGRITY OF CLINICAL TRIAL DATASeSSion Chair

Daniel LIU, PhDChief Scientific Officer, Beijing Clinical Service Center

Quality and integrity of clinical data are directly associated with efficacy and safety reliability of NDA drugs. All of regulatory bodies worldwide have been enhancing their efforts on the quality and integrity of clinical data. One of good examples is that FDA recently established an Office of Pharmaceutical Quality. As a developing country of pharmaceutical landscape, China should learn and master regulatory standard and dynamic state of clinical data quality and integrity, keeping up with the global expectation and requirements. This session will focus on the regulatory requirements and trends of quality and integrity of clinical trial data oversea and domestically, making clinical data professionals to control and improve quality of clinical trial data better.

Regulatory Standard and Expectation of Clinical Data Quality


An Emerging Regulatory Landscape Impacting Quality and Integrity of Clinical Data Submission: Trial Master File

Daniel LIU, PhDChief Scientific Officer, Beijing Clinical Service Center

Summary Level Clinical Site Data for Data Integrity Review and Inspection Planning in NDA and BLA Submission

Jingwei GAORegional Head, Regional Statistical Programming-Pan Asia METABoehringer Ingelheim(China) Investment Co., Ltd.


STATISTICS AND DATA MANAGEMENT JOINT SESSION - THE COLLABORATION OF DM AND STATISTICS (PART I)SeSSion Chair

Carina REINICKEBiometrics and Data Management (BDM) Pan Asia/META, Boehringer Ingelheim Shanghai Pharmaceuticals Co, Ltd.

With fast scientific advancement and development of computer technology, the expectation of speedy drug development is more than ever nowadays. Managing the dual expectation of both speed and quality becomes more and more a challenge for the pharmaceutical industry. The integrity of clinical trials results is built upon the quality and accuracy of both statistical analysis and the very fundamental basis of the analysis, data quality. Quality data is essential for the validity of study analysis and results, safeguarding the safe use of the treatment and wellbeing of the patients. This session will focus on the very basic issue of data collection, management, statistical methodologies in the handling of data issues, and the impact on the statistical analysis and interpretation of the study results. Real world cases will be used to

enhance the understanding and discussion of the session.

Design CRF to Meet SAP Requirement

Hualong SUN, MD, PhDGeneral manager, Meta Clinical Technology

Randomization/Blinding: Theory and Practices (for Setup, Testing and Review)

Bob YAN, PhDHead of Biostatistics and Programming, Sanofi

Implementing Metrics Management for Improving Data Management and Statistics Performance (Quality, Efficiency, Timeline and Timeliness) from CRO Aspect

Yazhong DENG, MBAHead of Clinical Data Analysis and Reporting Organization (CDARO), Covance


STATISTICS AND DATA MANAGEMENT JOINT SESSION - THE COLLABORATION OF DM AND STATISTICS (PART II)SeSSion Chair

Charles YAN, PhDSenior Director, Data Management and BiometricsShanghai Hengrui Medicine Co, Ltd.


Theme 5

Risk Assessment, Management & Communication - An End to End and Comprehensive Perspective


CLINICAL DEVELOPMENT - BENEFIT AND RISK BASED DECISIONSeSSion Chair

Yuan MENG, MDDirector, Safety Surveillance and Risk ManagementWorldwide Regulatory and Safety, Pfizer



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POST MARKETING SAFETY SURVEILLANCE SeSSion Chair

Lijun CAONovartis



ACTIVE SAFETY SURVEILLANCESeSSion Chair

Songlin XUE, PhDAstalas



EFFECTIVE RISK MANAGEMENTSeSSion Chair

Joy LI, MD, PhD, MBADirector, Pharmacovigilance and Medical Information, BMS China R&D



VACCINE SAFETYSeSSion Chair

Yuan YAOHead of Drug Safety China, Drug Safety, Merck Group



HERBS SAFETYSeSSion Chair

Helen HEDirector, Pharmacovigilance, Bayer


Theme 6

CMC and Quality System


MANAGING POST-APPROVAL CMC CHANGES IN A GLOBAL MARKET SeSSion Chair

Chi-Wan CHEN, PhD FDA Alumni Association International Network Planning Committee MemberFormer Deputy Director, Office of New Drug Quality Assessment, CDER, FDAExecutive Director, Global CMC, Pfizer, USA

This session will compare the regulations and policies on post-approval CMC changes among the US, EU, and China. The MNCs face tremendous challenges in ensuring that they are in compliance with the regional or country-specific regulations and policies while maintaining the drug supply to patients throughout the product lifecycle. These challenges, including stability testing and shelf-life setting for post-approval changes, will be illustrated in case studies covering both chemical drugs and biologics. Lastly, the China regulations and guidelines on post-approval CMC changes and review experience will be discussed from a former CDE official’s perspective.

Overview of Regulations and Policies on Post-Approval CMC Changes for Chemical Drugs in the US, EU, and China

Chi-Wan CHEN, PhD FDA Alumni Association International Network Planning Committee MemberFormer Deputy Director, Office of New Drug Quality Assessment, CDER, FDAExecutive Director, Global CMC, Pfizer, USA

Topic TBD

Duu-Gong WU, PhDMember of US FDA Alumni AssociationDirector, Global Regulatory Consulting/Senior Consultant, Pharmaceutical Product Development, USA

How Multi-National Companies (MNCs) Manage Post-Approval CMC Changes in a Global Market? - Case Studies

David LIN, PhDMember of US FDA Alumni AssociationSenior Consultant, Biologics Consulting Group, USA


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Post-Approval CMC Changes in China – A Former CDE Official’s Perspective

Zhen CHENFormer Deputy Director, CMC Division I, CDE, CFDA


CHP TOWNHALLSeSSion Chair

Melly LINRegulatory Manager, Technical Regulatory Policy, Roche (China) Holding Ltd.

With the advent of globalization the need for harmonized pharmaceutical standards has become increasingly urgent. In China, more and more local pharmaceutical manufacturers are exploring foreign market. Having a same international quality standard is one of the key factors in opening the door of foreign market. In this session, we will hear the efforts from Chinese pharmacopoeia in global harmonization.

In addition, ChP 2015 was just published in Feb 2015. It is important for the industry to know the major revisions in ChP 2015, evaluate the potential impacts and implement the changes.

The Role of Chinese Pharmacopoeia in Global Pharmacopeia Harmonization

Wei ZHANGSecretary General, Chinese Pharmacopeia

Update of ChP 2015

Chinese Pharmacopeia Speaker Invited

The Measures Taken by ChP to Improve the Working Model and the Collaboration with Industry

Chinese Pharmacopeia Speaker Invited


MULTIPLE SITES FOR BIOLOGICALS IN CHINA (PART I)SeSSion Chair

Melly LINRegulatory Manager, Technical Regulatory PolicyRoche (China) Holding Ltd.

Currently only one Manufacturing Site is allowed to be registered for biological drug substances/drug products in China. With the rapid development of China biological industry and acceleration of internationalization, the existing manufacturing capacity cannot meet the increasing market demands. Additional manufacturing sites/facilities will become a necessary option during the development of local biological industry. From drug supply perspective, multiple sites provide safety back up in case one site cannot produce materials for various unexpected reasons. In this session, regulators and industry will share their experience on

managing multiple biological sites and discuss potential challenges in managing multiple sites.

US FDA's Experience on Multiple Manufacturing Sites for Biological Products: History, Technical and Regulatory Consideration

Andrew CHANG, PhDVice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk, USA

Regulatory Consideration on Multiple Sites for Biologics


Experience Sharing on Multiple Sites for Biologics - From TFDA Perspective

TFDA Speaker Invited


MULTIPLE SITES FOR BIOLOGICALS IN CHINA (PART II)SeSSion Chair

Melly LINRegulatory Manager, Technical Regulatory PolicyRoche (China) Holding Ltd.

Use of Multiple Manufacturing Sites for Recombinant Products: Comparability Requirements for Site Transfer and Long Term Monitoring

Wassim NASHABEHGlobal Head, CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Roche, Switzerland

PANEL DISCUSSION

All Speakers from Session 0603 & 0604


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Theme 7

Biologic Development


NEW TREND/TECHNOLOGY IN BIOLOGIC DEVELOPMENTSeSSion Chair

Chengbin WU, PhDChief Scientific Officer, President of R&DShanghai CP Guojian Pharmaceuticals Co. Ltd.

Recent advancements in antibody drug development have demonstrated breakthroughs in the treatment of cancer and other disease. This session will focus on new technologies and recent clinical success in the biologics field.

Bispecific T-Cell Engaging Antibodies for Cancer Immunotherapy

Mingqiang ZHANG, PhDGeneral Manager, Corporate VP of R&DAmgen BioPharmaceutical R&D (Shanghai) Co., Ltd.

Topic TBD

Kang LI, PhDHead of Biologics, BeiGene

Topic TBD

Peter LUO, PhDCEO, Adagene


SAFETY EVALUATION OF NEW TYPES OF ANTIBODIESSeSSion Chair

Jufeng WANG, PhDDirector, National Center for Safety Evaluation of DrugsNational Institutes for Food and Drug Control

Topic TBD

Rod PRELLTherapeutic Area Leader for Cancer Immunotherapy, Genentech

Topic TBD


Topic TBD

James YANChief Scientific Officer, Covance, China


DEVELOPMENT OF BIOSIMILARS IN CHINA: INTERPRETATION OF BIOSIMILAR GUIDANCE, OPPORTUNITIES AND CHALLENGES (PART I)SeSSion Chair

Joe ZHANG, MD, PhDHead, Center of Medical and Translational Sciences, Shanghai CP Guojian Pharmaceuticals Co. Ltd.

With a rapid growth of the biotechnology sector in China and the expiration of numerous patents of originator biologics, development of biosimilars becomes an attractive area of growth for biopharmaceutical industry in China. However, due to the unique characteristics associated with each individual biologics, development of biosimilars poses great challenges for both sponsors and regulators. The newly published draft technical guidance on Biosimilars by Center for Drug Evaluation of CFDA provides a more defined pathway for biosimilar development in China, a thorough understanding of the guidance is essential for both sponsors and regulators to better use the guidance to guide biosimilar development in China. Experts from both CFDA and industry will share their interpretation of the guidance and discuss the scientific and regulatory challenges faced by biosimilar industry in China in the 2 consecutive sessions. A panel discussion at the end of the 2 sessions will provide an opportunity for audience to interact with speakers of the sessions.

Quality Challenges to Development and Evaluation of Biosimilars


Nonclinical Challenges to Development and Evaluation of Biosimilars


Clinical Challenges to Development and Evaluation of Biosimilars



DEVELOPMENT OF BIOSIMILARS IN CHINA: INTERPRETATION OF BIOSIMILAR GUIDANCE, OPPORTUNITIES AND CHALLENGES (PART II)SeSSion Chair

Joe ZHANG, MD, PhDHead, Center of Medical and Translational Sciences, Shanghai CP Guojian Pharmaceuticals Co. Ltd.

With a rapid growth of the biotechnology sector in China and the expiration of numerous patents of originator biologics, development of biosimilars becomes an attractive area of growth for biopharmaceutical industry in China. However, due to the unique characteristics associated with each individual biologics, development of biosimilars poses great challenges for both sponsors and regulators. The newly published draft technical guidance on Biosimilars by Center for Drug Evaluation of CFDA provides a more defined pathway for biosimilar development in


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China, a thorough understanding of the guidance is essential for both sponsors and regulators to better use the guidance to guide biosimilar development in China. Experts from both CFDA and industry will share their interpretation of the guidance and discuss the scientific and regulatory challenges faced by biosimilar industry in China in the 2 consecutive sessions. A panel discussion at the end of the 2 sessions will provide an opportunity for audience to interact with speakers of the sessions.

Science Based Biosimilar Development and Regulatory Pathway

Irene DENGSenior Director and Head of China DRA, Roche

Biosimilar: Advantages in Regulatory Pathway

Weidong JIANG, PhDChief Strategy Officer and Senior Vice President, Henlius

PANEL DISCUSSION

All Speakers from Session 0703 & 0704

Session 0705 | Wednesday, 27 May 08:30-10:00

DETECTION AND EVALUATION OF IMMUNOGENICITY OF BIOLOGICSSeSSion Chair

Haifeng SONG, PhDProfessor, Academy of Military Medical Sciences, China

Immunogenicity of biologics has been a hot topic in recent years. This session provides an opening platform to discuss the issues with high attentions in immunogenicity, mainly focusing on technologies and regulatory rules of immunogenicity evaluation, and better understanding of the impact of immunogenicity on biologics.

Recommendations from the AAPS LBABFG Biosimilars Action Program Committee on the Development and Validation of ADA assays for Biosimilar Drug Development

Michael ANDERSON, PhDPresident and Chief Scientific Officer, Biologics Development Services

Navigating the Immunogenicity Regulatory Landscape – Lessons Learned from Secukinumab BLA Submission

Eric LIANG, PhDGroup Manager/CNIBR DMPK-Biologics, Novartis

Topic TBD

Shalini GUPTA, PhDDirector, Clinical Immunology-PKDM, Amgen Inc.

Theme 8

Therapeutically Specific Issues in Drug Development

Session 0801 & 0802 | Tuesday, 26 May, 08:30-12:00

BREAKTHROUGH IN DISEASE THERAPIESSeSSion Co-ChairS

Xiaoxiang CHEN, PhDVice President, Medicine Development, Greater China, Boehringer Ingelheim

Kezhou ZHANG, PhDGeneral Manager, China R&D, Novonordisk

Innovative therapy is the driving factor to address the unmet medical needs and improve clinical outcome for patients. Despite the enormous challenges, there have been exciting breakthroughs in multiple therapeutic areas in recent years. This session will highlight some of the key achievements for the last year with renowned experts from pharmaceutical industry, academia, and regulatory agency. The outlooks for select areas and the roles and opportunities of China will also be discussed.

Advances in Diabetes Therapies

Gong YAN, PhDAssociate Director, Global Clinical Development/Diabetes

Topic TBD

Speaker Invited

Breakthrough Therapies for Cardiovascular Diseases

James HE, PhDVice President, Medicine, Novartis

Advances in Infectious Diseases

Zhangjing CHEN, PhDVice President, Medicine Novartis


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Session 0803 & 0804 | Tuesday, 26 May, 13:30-17:30

HOW IS DAA ERA CHANGING THE CHRONIC HCV MANAGEMENT - EFFICIENT CLINICAL DEVELOPMENT FOR INNOVATIVE HCV TREATMENT SeSSion Co-ChairS

Jessica LIU, MDVice President, Clinical Development, General Medicine BU, Asia-Pacific Region, INC Research

Lai WEI, PhD, MDDirector and Professor, Peking University Hepatology InstituteVice President, Medical Service, Peking University People's Hospital

In the past few years, with the rapid development of direct acting antiviral agents (DAAs), treatment of chronic hepatitis C infection has been revolutionized. Most of the chronic hepatitis C patients can now be cured with interferon-free pan-oral therapy with a short duration of therapy. However, clinical data on the use of these DAAs is grossly lacking in Chinese. And there are also important clinical issues, such as duration of therapy, pharmaco-economic, patients with advance liver diseases that drive physicians, scientists, pharmacologists for the continuous efforts with even move innovative clinical development plan.

Hepatitis C in China and Unmed Needs

Lai WEI, PhD, MDDirector and Professor, Peking University Hepatology InstituteVice President, Medical Service, Peking University People's Hospital

HCV Anti-Viral Drug Clinical Development Plan: Industry Considerations, Development Strategy, Decision-Making Process/Mechanism and Competitor Landscape

Speaker Invited

All oral DAA Regiments Development by Chinese Companies: Past, Now and Future

Jinzi J. WU, PhDFounder, President and CEO, Ascletis BioScience Co., Ltd

How to Optimize Cinical Development in China? – From the Agency Perspective


Theme 9

Functional Specific Issues in Drug Development


MEDICAL WRITING EVOLUTION AND EXPANSION: FROM GLOBAL TO CHINA, FROM THE PAST TO THE FUTURESeSSion Chair

Julia COOPERVice President, Head of Global Medical Writing Services, PAREXEL

The development of medical writing worldwide will be presented, with focus on China. The difference in work scope and key competencies between medical writers globally and in China will be discussed. This session will also discuss the roles of medical writing during the preparation of different types of document. By the end of the session, attendees will be able to answer 2 main questions:

1. Who are we as medical writers, both globally and in China?2. How can we help the project team to achieve their objective to

prepare quality, compliant documents on-time?

Medical Writing Evolution and Expansion in Global Environment

Speaker Invited

Medical Writing Evolution and Expansion in China

Nan WANG Bayer

Target Profile for a Medical Writer In China: How to Develop a Good Medical Writer in China

Roselynn TIEN PARAXEL


EMBRACE THE DYNAMIC ENVIRONMENTAL CHANGE: INNOVATIONS LEAD TO NEW OPPORTUNITIES AND SOLUTIONS SeSSion Chair

Joan AFFLECKAssociate Vice President, Global Head of Clinical Documentation, Sanofi

In this session, we are going to focus on the challenges and opportunities in an evolving environment. It is crucial to understand the critical changes and the trend around the industry in this evolving environment. In this session, we will work together to explore the nature of the challenges we are facing now and identify


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the new opportunities through the aids of innovative tools.

We are going to introduce the updated health agency’s requirements regarding clinical trial transparency and their impact on our business. Our experience on documents contents reuse management to improve efficiency and quality will be shared. Per the CFDA requirements, all submission documents have to be in Chinese. We would like to promote a computer-aided translation tool in helping us in writing local documents in a timely manner and with a good quality.

Starting at the Beginning: How the Protocol Drives Documentation and Why the Common Protocol Template is a Critical Change in the Industry

Speaker Invited

A Transparent World: How the Growing Commitment to Sharing Clinical Trial Information, Results and Data with a Broad Public is Changing the Scope and Responsibilities of Medical Writers

Speaker Invited

Tools of the Trade: How Shifting from a Document - Centric to Content - Focused Mindset and Toolset Supports the Standards, Speed and Scope of Today’s Medical Writing World

Speaker Invited


WHY IS PROFESSIONAL MEDICAL WRITER NEEDED IN BOOSTING SCIENTIFIC PUBLICATION IN CHINA?SeSSion Chair

Yang RUIScientific Communication Manager, Novonordisk

Pharmaceutical companies have an obligation to provide the results of their medical studies to HCPs and public. Scientific publication is a convincing and competitive platform for scientific communication. This session will clarify ethical requirement and MW’s responsibility for publication; the status of global and China’s scientific publication; What we should do to leverage scientific publication in China and how.

Publication Ethics and Medical Writer’s Role

Yuko KOJIMAEli Lily, Japan

Why Important and How to Do Successful Publication of China Data

Yang RUIScientific Communication Manager, Novonordisk

Clinical Trial Data Sharing: A Publisher's Perspective

Huili CHENBMJ


TECHNOLOGY LEADS TO NEW OPPORTUNITIES FOR MEETING CUSTOMER MEDICAL INFORMATION NEEDSSeSSion Chair

Stacey FUNG, PharmDAssociate Director, Medical Communications, Genentech, A Member of the Roche Group, USA

The session will focus on the opportunities to engage customers in new and impactful ways as the nature of healthcare communications continues to evolve. Understanding how customers want to receive information (including self-service tools) and connect is the first step. The next step is navigating the future for how tools will be utilized. Discussions will highlight opportunities and lessons learned in the utilization of technology (including mobile applications, websites, and social media tools) as enablers for communication with internal and external customers. Examples will be shared to highlight outcomes and experiences across Medical Communications. In addition, challenges relating to successful implementation will be discussed as it relates to legal/regulatory concerns, AE reporting, off-label information dissemination, and how to partner successfully with internal teams. Additional topics include how to raise awareness of new tools so customers know they are available.

Utilization of Technology Tools to Provide Medical Information to Customers

Stacey FUNG, PharmDAssociate Director, Medical Communications, Genentech, A Member of the Roche Group, USA

Does Size Really Matter?

Wendy HUOAssociate Director, Pfizer China Business Technology

Different Roles Using a Globalized MI System for Internal and External Customers

Jack YUMedical Information Manager, Roche

PANEL DISCUSSION


REGULATORY WRITING: CTD, ICH E3-COMPLIANT CSR, AND CHINA SUBMISSION DOSSIER PREPARATIONSeSSion Chair

Judith CALDERWOODOncology Submission Management, Novartis, Switzerland

In this session, international experts from the US and EU will introduce the historical context of CTD, ICH E3 Guideline (Clinical Study Report), global challenges, and recommended best practice. In addition, national speakers from multinational pharmaceutical companies will share their experiences in preparing clinical


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dossiers for China Health Authority submissions, i.e., challenges, creative working and collaboration models, and template & dossier structure tailored for successful China submissions.

The Regulatory Medical Writer’s Role in CTD Preparation

Speaker Invited

Clarifying ICH E3 - Clinical Study Report Guideline from Then to Now

Helle GAWRYLEWSKISenior Director, Head Medical Affairs & Alliance Management, Biometrics and Reporting, Janssen Research & Development, USA

PANEL DISCUSSION: Development of Submission Dossier for China NDA/CTW


INNOVATIVE APPROACHES TO ENSURING QUALITY IN CLINICAL TRIALS AND COMPLIANCE TO GOOD CLINICAL PRACTICE (GCP)SeSSion Chair

Helen LIAsia Lead, Pfizer Medical Quality Assurance

A quality management system (QMS) is an integrated framework through which organizations can systemically plan and achieve their quality objectives. While ICH Q10 provides clear guidance for QMS in the pharmaceutical manufacturing sector, no existing guidance describes a framework that provides an enterprise-wide view of achievement of clinical quality objectives; that is capable of being customized to fit an organization’s unique circumstances; and that accommodates the variability inherent in clinical development. In the absence of such guidance, clinical QMS vary dramatically across industry, sometimes resulting in over-engineered, cumbersome systems that are not adaptable or fit for-purpose. Without change in industry perceptions, a Clinical QMS will continue to be viewed as rigid and as a barrier to innovative approaches in clinical development and to delivery of medicinal products to patients in need.

This session will invite our CFDA officials to share their expectations of quality and clinical QMS in China in the future. We will describe ongoing activities of a TransCelerate workstream evaluating clinical QMS. Panelists will discuss ongoing development of a concept paper describing a progressive clinical QMS framework designed to provide a consistent, streamlined, and proactive quality approach across all stages of clinical research. The concept paper will be supplemented with more tactical guidance for issue management and knowledge management; panelists will also review these workstream activities. The concept paper and associated guidance will assist industry in moving from what regulators have described as a one-size-fits-all, traditional quality approach to an innovative, streamlined quality model focused on preventing “errors that matter.”

Clinical QMS- High Level Quality Framework

Speaker Invited

Trial-Level Quality approach highlighting RBM, QBD and Perhaps Risk Based Auditing

Speaker Invited

CFDA Focus on Quality



INTERNATIONALIZATION OF CHINESE CRO IN CHINASeSSion Chair

Kavin LIManaging Director, CMIC (Beijing) Pharmaceutical Services Co., Ltd.

The session is focused on the CRO business development at the technical level. The speakers from global and local CROs will share their experiences from project manager, clinical trials comparison between Australia and China and role of medical imaging perspectives.

The Beauty of Project Delivery: Project Manager Empowerment

Johnathan LEE, MDSenior Director of Clinical Operation, Quintiles China

Clinical Trials – Why Australia? Asia-Pacific Perspective

Christina CHENSenior Director, Clinical Operation, Tigermed Australia

Medical Imaging in a Key Role to Advance Quality Clinical Trials

Luxia LIANG General Manager, Fantastic Bioimaging Co. Ltd.


SITE MANAGEMENT & SMO SeSSion Chair

Reako RENExecutive Director and Head of SMO Services, WuXi Apptec.

SMO has been widely and deeply involved in current China clinical research site operation, and it takes important role on improvement of project progress and quality. However, under uncertain regulation environment and complicated medical environment, it exists a lot of arguments in SMO operation model, SMO-site collaboration model, how to properly use of SMO in clinical projects etc. That's why SMO/CRC has become a hot "topic" at recent industry conferences. The industry players have common belief that more extensive discussion on this topic would help more build reasonable cooperation model with SMO, benefit compliance of SMO operation, then finally improve China clinical research industry.


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On this session, we will heard voices from study site, SMO and sponsor, together share experience and resolutions to the complicated clinical site operation environment, eventually improve the efficiency and quality of China site operation.

Site Perspective on CRC Administration and SMO Development Trend

Shuting LIDirector, GCP Center, the Cancer Hospital of Chinese Academy of Medical Sciences

Fast Site Start-up and Patient Enrollment with CRC

Maggie GUDirector, Clinical Development, AstraZeneca

CRC's Role in Global Clinical Trial: Experience Sharing of EMA Inspection in China

George GUODirector, Clinical Development, Novartis Oncology

"Today and Future"- China SMO Development Trend/Model and Operation Experience Share

Reako RENExecutive Director and Head of SMO Services, WuXi Apptec

Theme 10

China and Beyond - WHO PQ, Generic Drug and Botanic Drug Pathway


WHO VACCINE (PART I): GLOBAL REGULATORY AND PROCUREMENT REQUIREMENTS SeSSion Chair

Yiwu HE, PhD, MBABill & Melinda Gates Foundation

Topic TBD

National Institutes of Health Speaker Invited

The UNICEF Procurement Program for Pharmaceutical Products

Speaker Invited

Going to the New Market - Pharmaceutical Manufacturing and Marketing in Africa

Speaker Invited


WHO VACCINE (PART II): GLOBAL REGULATORY AND PROCUREMENT REQUIREMENTS SeSSion Chair

Yiwu HE, PhD, MBABill & Melinda Gates Foundation

New Approaches to Develop HIV Vaccines

Speaker Invited Breakthrough Immunotherapies: Engineering the Body’s Immune System to Treat Cancer

Speaker Invited

mRNA - A New Class of Drugs

Speaker Invited

Ebola Vaccine Development

Speaker Invited


DEVELOPING NEW DRUGS FROM TRADITIONAL CHINESE MEDICINE FOR UNMET PUBLIC HEALTH NEEDS (PART I)SeSSion Chair

William JIA, ProfessorChief Scientific Adviser, Shanghai Innovative Research Center of Traditional Chinese Medicine,Lab Director, Associate Professor, Centre for Brain Health, University of British Columbia, Vancouver, Canada

Naturally derived complex mixtures, like most of herbal medicines, are eligible to be developed as new drugs without further purification in not only China, but also US, Canada, and European countries. Despite the differences in when a particular set of quality and safety data may be required by the respective regulatory agencies, the ultimate clinical usefulness of the botanical or other natural mixtures for treating (or diagnosing) of certain diseases needs to be demonstrated, through well designed clinical trials (US) and/or long years of human experience demonstrating adequate safety and effectiveness.

The invited speakers include experts in quality control of Chinese herbal medicines and new drug target development in China and botanical drug review and guidance development at US FDA. Panel discussion will invite speakers and experts with expertise covering key areas of new drug development, including safe and effective use of Chinese herbal medicines to promote and protect human health for domestic and international consumers.

The Significance of US FDA’s Botanical Drug Guidance and Botanical Drug Approvals

Jinhui DOU, PhDPharmacologist, Botanical Review Team, Office of Pharmaceutical Science, CDER, FDA, USA


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Selection of Quality Raw Herbs to Build a Solid Foundation for Formulated Chinese Medicine Products

Yuming CHI, PhDDirector, Tongren Tang Research Institute

Research and Development of Botanical Drug in China: The Different Requirements for Traditional Chinese Medicine and Natural Produc

Lei ZHANG, PhDProfessor, Shanghai University of Traditional Chinese MedicineAssociate Director, Traditional Chinese Medicine Patent Prescription Committee, China Association for Traditional Chinese Medicine


DEVELOPING NEW DRUGS FROM TRADITIONAL CHINESE MEDICINE FOR UNMET PUBLIC HEALTH NEEDS (PART II)SeSSion Chair

Lei ZHANG, PhDProfessor, Shanghai University of Traditional Chinese MedicineAssociate Director, Traditional Chinese Medicine Patent Prescription Committee, China Association for Traditional Chinese Medicine

Naturally derived complex mixtures, like most of herbal medicines, are eligible to be developed as new drugs without further purification in not only China, but also US, Canada, and European countries. Despite the differences in when a particular set of quality and safety data may be required by the respective regulatory agencies, the ultimate clinical usefulness of the botanical or other natural mixtures for treating (or diagnosing) of certain diseases needs to be demonstrated, through well designed clinical trials (US) and/or long years of human experience demonstrating adequate safety and effectiveness.

The invited speakers include experts in quality control of Chinese herbal medicines and new drug target development in China and botanical drug review and guidance development at US FDA. Panel discussion will invite speakers and experts with expertise covering key areas of new drug development, including safe and effective use of Chinese herbal medicines to promote and protect human health for domestic and international consumers.

TCM Bioinformatics and Post-Metabolism Compounds as Innovative Approaches for New Drug Development

William JIA, PhDChief Scientific Adviser, Shanghai Innovative Research Center of Traditional Chinese MedicineLab Director, Associate Professor, Centre for Brain Health, University of British Columbia, Canada

Clinical Pharmacology Studies for Botanicals in Different Phases of New Drug Development

CAPT E. Dennis BASHAW, PharmDDirector, Division of Clinical Pharmacology-3, Office of Clinical Pharmacology, Office of Translational Sciences, FDA, USA

PANEL DISCUSSION

All Speakers and Invited Panelists


GENERIC DRUG FORUM (PART I) – GLOBAL REQUIREMENTS AND REGULATORY INITIATIVES SeSSion Chair

Shaoyu CHEN, JDPartner; Managing Director, China Food and Drug PracticeCOVINGTON & BURLING LLP, Shanghai, China

Patients in the world need innovative drugs as well as generic drugs. How to balance the competing interests and maintain a healthy development of innovative and generic drugs has become one of the top challenges for the industry and the regulators globally. This session will look at how the US FDA, Taiwan FDA, India Pharmaceutical, and Japan PMDA regulate generic drugs, focusing on the latest of the scientific and regulatory requirements.

US FDA’s New Initiatives and Update on GDUFA

Keith FLANAGANDirector and Head of Office of Generic Drug Policy (OGDP), Office of Generic Drug, CDER, FDA, USA

Regulations and Challenges in Generic Drug Development – What Taiwan Pharma have Learn from?

Chia-Ling HSIAO, PhD, RPhDirector, Pharmaceutical Science, CDE, TFDA, Taiwan

Generic Drug Development in India - Best Practices and Challenges

Indian Pharmaceutical Association Speaker Invited

Generic Drug Development – PMDA Consideration and Practices

Toru YAMAGUCHI, MScReviewer, Office of Generic Drugs, PMDA, Japan


GENERIC DRUG FORUM (PART II) - GLOBAL REQUIREMENTS AND REGULATORY INITIATIVES SeSSion Co-ChairS

Ren YI, PhDGeneral Manager, China RegionNanjing Medichem Bio-Pharmaceutical Development Co.

Jane CAI, PhDFormer Director, DIA China

A quality management system (QMS) is an integrated framework through which organizations can systemically plan and achieve their quality objectives. While ICH Q10 provides clear guidance for QMS in the pharmaceutical manufacturing sector, no existing guidance describes a framework that provides an enterprise-wide view of achievement of clinical quality objectives; that is capable



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of being customized to fit an organization’s unique circumstances; and that accommodates the variability inherent in clinical development. In the absence of such guidance, clinical QMS vary dramatically across industry, sometimes resulting in over-engineered, cumbersome systems that are not adaptable or fit for-purpose. Without change in industry perceptions, a Clinical QMS will continue to be viewed as rigid and as a barrier to innovative approaches in clinical development and to delivery of medicinal products to patients in need.

This session will invite our CFDA officials to share their expectations of quality and clinical QMS in China in the future. We will describe ongoing activities of a TransCelerate workstream evaluating clinical QMS. Panelists will discuss ongoing development of a concept paper describing a progressive clinical QMS framework designed to provide a consistent, streamlined, and proactive quality approach across all stages of clinical research. The concept paper will be supplemented with more tactical guidance for issue management and knowledge management; panelists will also review these workstream activities. The concept paper and associated guidance will assist industry in moving from what regulators have described as a one-size-fits-all, traditional quality approach to an innovative, streamlined quality model focused on preventing “errors that matter.”

Bio-Equivalency Evaluation for the Quality of Generic Drugs in China

Xinsheng SUNDirector, China Quality Association for Pharmaceuticals (CQAP)

Bio-Equivalency Studies – FDA Consideration, Expectation and Practices

Bing V. LI, PhDVice President, American Chinese Pharmaceutical Association, USA

Consideration for Generic Product Development in Emerging Markets

Chao YEDirector, Asia Pacific OTC R&D Product Development, Shanghai Johnson& Johnson Pharmaceuticals, Ltd.


GENERIC DRUG FORUM (PART III) - LESSONS LEARN FROM QUALITY AND COMPLIANCE INSPECTIONSeSSion Chair

Lee KANG, PhD, MBA Vice President and General Manager, Achlis GroupConsultant, The Perrigo Company, Hong Kong

Since US FDA issued in 2004 the "risk based factory inspection," it effectively managed its limited resources to ensure the compliance of all domestic manufacturers. However, the US has found multiple quality incidents involving imported foods and drugs from overseas. In 2008 US FDA has established overseas branches as part of the international program to strengthen its oversight beyond the border. Today, US FDA has local offices in Beijing, Shanghai,

and Guangzhou to manage issues related to exports to the US. In 2009 and 2010, US Congress enacted FDA Globalization Act and Drug Safety and Accountability Act, respectively, to provide additional control of drugs that are imported from overseas. This has significant impact on Chinese pharmaceutical companies as China accounts for a large part of pharmaceutical raw materials and products exporting to the US. In recent years, China has had several quality issues that drew attention from the world. As the trade continued to grow, regulatory agencies in both the US and EU countries have increased their inspections in China as the supply chain becomes greatest challenge. This session focuses on quality and compliance inspections and quality regulations. Through case studies and analysis, the speakers from both regulatory authorities and industry will present from their respective points of view and real-life experiences in quality and compliance requirements, how to establish quality system and specifications, and best practice and the risk management. It aims to provide coherent overview of how Chinese companies can work collaboratively with regulators and to achieve quality standards to ensure safety and best interest for consumers.

FDA Inspection of Generic Drug Companies in China – Practices and Case Studies

Gang WANG, PhDAssistant Country Director, FDA China Office

China and Beyond - Generic Drug Development and Quality Management

Xuejie DOUSenior Director, Quality, Xinhua Pharmaceutical

What We Learn from China and India Generic Drug Quality Management

Lee KANG, PhD, MBAVice President and General Manager, Achlis GroupConsultant, The Perrigo Company, Hong Kong


PANEL DISCUSSION – WILL CHINA LEAD THE GLOBAL DEVELOPMENT FOR GENERIC DRUGS?

All Speakers and Invited Panelists



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Theme 11

Innovative Partnership and Business Model for Drug Development in China Beyond


PARTNERSHIP STRATEGIES AND CREATIVE FRAMEWORKS IN THE NEW ERASeSSion Chair

Darren JI, PhD, MBAGlobal Head and Vice President Asia and Emerging Markets Partnering, F. Hoffmann-La Roche

More than 50% of innovative drugs in the future will come from partnered assets. External collaboration and partnering are becoming the central agenda for major pharma and biotech companies. What are the evolving strategies for partnering today? What does it take to win a deal? What are major challenges? What new and creative framework we see today?

The current session will focus on the learnings from the world’s leading deal-makers in pharma and biotech companies. It provides an inspirational forum to carefully dissect what are behind the deals and how to prepare to win a great deal in the competitive environment today.

PANEL DISCUSSION

Samantha DU, PhDFounder and CEO, Zai Laboratories

Steve YANG, PhD, MBAExecutive Vice President and Chief Operating Officer, WuxiApptec

Jinzi WU, PhDFounder, President and CEO, Ascletis Biosciences

Frank JIANG, PhDGlobal R&D Head and Vice Presedent, China R&D, Sanofi-Aventis


MONEY, TECHNOLOGY AND LEGAL STRUCTURE - PUT TOGETHER THE JIGSAW PUZZLE FOR AN INNOVATIVE PARTNERSHIPSession Chair

Wendy PANPartner, OMM



CHINESE PHARMA/BIOTECH FROM LOCAL TO GLOBAL: FROM STRATEGIES TO TACTICS SeSSion Chair

Frank CHIU, MD, PhDGeneral Manager, Boon Pharmaceutical Research Ltd.

This session focuses on regulatory requirements for clinical study conduct and marketing application in the US for Chinese pharma and biotechnology companies.

The Trends of Early Phase Clinical Development in China: From International to Domestic Pharmas

Ge Zhang, MD, PhD Medical Director, Jiangsu Hengrui Medicine Co., Ltd.

Conducting the China Sponsored IND Clinical Trials in US

James FAN MD, MBS Senior Medical Director, Medical and Safety, Services/Asia Pacific Area and Japan, ICON Clinical Research Pte. Ltd.

Regulatory Strategic Approach to US Market for Chinese Pharmaceutical Companies

Yao YAO, PhD, RAC, CQA Specially Invited Professor, IED, CFDA

Successful Stories of Local Chinese Pharma/Biotech Sponsored INDs in the US - A Pragmatic Approach: A Time and Cost Effective Approach

Frank CHIU, MD, PhDGeneral Manager, Boon Pharmaceutical Research Ltd.


CASE STUDIES AND PANEL DISCUSSION



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Theme 12

Hot Topics and Late Breaker


INNOVATION: WHY SHOULD I CARE ? - HOW TO CREATE EFFICIENT COMMUNICATIONS FOR STAKEHOLDERS OF DRUG R&D CHAINSeSSion Chair

Donglei MAO

Who is benefiting most from drug innovation? What’s the core value accepted by all stakeholders involved in drug innovation process? How to establish ethical standards and social and legal environment that every innovators should adhere to? In this session, we invite key opinion leaders from local media, foreign media, industry and association to debt on this topic. Through the discussion we have today, we hope we can build up a foundation of a wiser thought for the future drug innovation in China.

How to Cover Drug Innovation and Access for Public from Trade Media Perspective

Shuming MAJournalist, Y-LP

FDA Reform History and How to Communicate with the Public from Experts Perspective

Speaker Invited

The Role of Foreign Trade Media: Promote Innovation and Bridge Pacific

Jialing DAI Chief Editor, PharmaDJ

How to Communicate with Patients and the Public by Leveraging Internet Tools

Steve YANG, PhDExecutive Vice President and Chief Operational Officer, Wuxi Pharma Tech Inc.


GLOBAL EXPEDITED DEVELOPMENT, ACCESS AND APPROVAL PATHWAYSSeSSion Chair

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International NetworkFormer Director, Office of Drug Evaluation III, CDER, FDAVice President, Global Regulatory Intelligence, Strategy and Policy, Celgene Corporation, USA

Health authorities and industry must balance the need for patient access to promising medical products which nonetheless have uncertainties about safety and efficacy as full development programs may not be complete. Also, national emergencies such as pandemics, emerging drug resistance, and bioterrorism necessitate regulatory mechanisms to both spur innovation and product development as well as provide public access to potentially useful products should crises develop. This session will discuss both the regulatory constructs that exist around the world to expedite access, development, and approval of these types of important therapies.

Meeting the Challenge of Ebola – Innovation in Development, Access, and Approval

Murray (Mac) LUMPLIN, MD Deputy Director, Regulatory Affairs, Lead for Global Regulatory Systems Initiatives, Global Health, The Bill and Melinda Gates FoundationFormer Deputy Commissioner, FDA, USA

Overview of Regulatory Flexibility – FDA’s Expedited Processes and Emergency Use Authorization

Mark J. GOLDBERGER, MD, MPHMember of FDA Alumni AssociationFormer Director, Office of Drug Evaluation IV, CDER, FDA, USA

Regulatory Initiatives at the CFDA: Expedited Process and Emergency Considerations



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MEDICAL AFFAIRS - HOW TO DELIVER THE LATEST MEDICAL KNOWLEDGE TO THE HEALTH PROFESSIONALSeSSion Chair

Victoria ELEGANT, MBBS, DRCOG. FFPMVice President, Medical and Regulatory Affairs, Baxter Healthcare, Asia Pacific Region

Non promotional education of health professionals is becoming increasingly important as medicine gets more and more complex. On the other hand, HCPs have less time to devote to education. This session focuses on the roles of the medical department on providing best and innovative methods of education to HCPs in order to help them get best outcomes for their patients.

Aligning Medical Strategy to Provide Best Outcomes

Alex CONDOLEONVice Presedent, Medical Affairs, Sanofi China

Innovation on Delivery of the Latest Medical Knowledge to HCPs'

Frances CHANG, PhDVice Presedent, Medical Affairs, Roche ChinaSuccessful Delivery of Medical Education Through Various Media and Channels

Chengming GU, MBASenior Medical Director, Pfizer


ON THE WAY - CHINA INNOVATIVE PHARMACEUTICAL COMPANYSeSSion Chair

Dan ZHANG, MD, MPHChairman and CEO, Fountain Medical Development Ltd.

SESSION IN DEVELOPMENTSession 1207 | Wednesday, 27 May 13:30-15:00

DRUG-DIAGNOSTIC CO-DEVELOPMENT AND REGULATORY REQUIREMENT AND CHALLENGES FOR COMPANION DIAGNOSTIC TESTSeSSion Chair

Jinjie HU, PhD Member of the FDA Alumni Association International NetworkFormer Senior Reviewer, Office of Blood Research and Review, CBER, FDASenior Consultant, Biologics Consulting Group, INC., USA

