2015 DIA China

第七届药物信息协会(DIA)中国年会

The 7th DIA China Annual Meeting

2015年5月24-27日 | 上海国际会议中心 | 中国

24-27 May 2015 | Shanghai International Convention Center | China

主办单位 / Host

会议手册

Preliminary Program

2015 年 5 月 24 日 —— 会前专题研讨会 2015 年 5 月 25-27 日 —— 会议、展览和壁报

May 24, 2015 - Preconference WorkshopsMay 25-27, 2015 - Conference, Exhibition and Posters

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

PROGRAM CHAIROuhong WANG, PhDDirector, Biostatistics, Amgen

KEY INSTRUCTORSLuyan DAI, PhDAssociate Director Biostatistics, Biometrics and Data Management at Boehringer-Ingelheim, Asia/META

Ping YAN, PhDAssociate Director, Clinical Statistics, Pfizer (China) Research and Development Co.

Jack PENG, PhDAssociate Statistics Director, R&D Shanghai, GSK

Michelle WANG, PhDSenior Scientist, Biostatistics, BARDS, Merck

AGENDA• The necessary evil

▪ Variability

• What can make you talk like a genius ▪ Understanding confounding

• The shining waterdrop ▪ Sample size and power made easy

• Why can’t I take a peek? ▪ Multiple testing concepts

• The magic number is not magic ▪ The truth of p-value

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

• What can break your reputation ▪ Bias

• Fitting a squared peg through a round hole ▪ The importance of assumption checking

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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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.

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


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EXPLORING MEDICAL COMMUNICATIONS SERVICES TO SUPPORT PATIENT CARE DECISIONS

OVERALL DESCRIPTIONThe Medical Communications pre-conference workshop will focus on communications that contribute to advance product development in a global market; optimize scientific communications with health care professionals and patients; and enhance and foster patient care by ensuring appropriate use of medicines and medical products.

The pre-conference workshop will cover key issues relevant to professionals working in Medical Information, Medical Communications, Medical Science Liaisons, and Medical Affairs roles. The content will be of particular interest to managers and leaders of Medical Information Services and Medical Science Liaison Teams.

The Medical Communications pre-conference workshop is organized by the Medical Communications Community and Medical Science Liaisons Community.

LEARNING OBJECTIVES• Discuss the impact of the Medical Communications (medical

information, MSL, and publications) roles on the delivery of effective medical information to healthcare providers and consumers

• Understand the capabilities across various communications team roles and factors that influence the roles

• Discuss the tools and technology available to support Medical Communications roles.

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

AGENDASession 1 | 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, Pfizer

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

Provide to Patient Through Medical Function

Hugo YEMedical Education Director, Eli Lilly and Company

Session 2 | 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, PharmDSenior Medical Communications Scientist,Genentech Inc. A Member of Roche Group



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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, PhDMedical Publication Manager, MC&PM, Medical Division, Shanghai Roche Pharmaceuticals Ltd.

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

Ping FENG, MDDirector, Medical Science Excellence, Medical, Roche

Session 3 | The MSL Role across the Globe – Past, Present and Future

SESSION DESCRIPTIONThis session will explore the influence of local healthcare dynamics, stakeholder needs, and compliance considerations on the MSL role. Different types of MSL roles and their unique contributions will be highlighted along with the skills and technologies needed for success. As an important externally facing role in many companies the session will also discuss compliance considerations for MSL roles and metrics to communicate performance.

LEARNING OBJECTIVES• Understand the unique capabilities across various MSL roles

and factors that influence the roles (e.g. communication, Pharmacoeconomic/HEOR, research, etc.)

• Differentiate the MSL roles from Commercial roles.

• Understand what capabilities, skill sets, training and technology considerations are needed for the role.

• Understand basic compliance factors and some feasible performance metrics

SESSION CO-CHAIRSDrew SCHEIFELE, PhDHead of Medical, Asia Pacific Region, Biogen, Singapore

Lnyy BASSJazzPharma

Welcome, Introduction and MSL Background

Andrew BRUCE

Appropriate Use of MSLs Throughout the Product Lifecycle and MSL Core Attributes and MSL Management

Andrew BRUCE

MSL Roles as a Function of the Healthcare Market and Needs of HCP, Patients, Caregivers, and Business

Stephanie DANANDJAJA

Session 4 | Understanding MSL Activities across the Product Lifecycle

SESSION DESCRIPTION This session will explore the various activities MSL roles contribute across the product lifecycle. Case studies/examples will be given for MSL contributions in development, pre-launch, launch, through to loss of exclusivity. Specific focus will be given in established products, generics, late stage drugs, and activities with government payers.

LEARNING OBJECTIVES• Understand how MSL can work effectively with established

products, generics and late stage drugs

• Understand how MSL can work effectively with government payers and cost/outcome driven discussions

SESSION CO-CHAIRSDrew SCHEIFELE, PhDHead of Medical, Asia Pacific Region, Biogen, Singapore

Lnyy BASSJazzPharma

The MSL Role in Asia, a Perspective from China

Alex Condoleon, PhDVice President, Medical Affairs, Sanofi

MSL Section Faculty Q&A/ Interactive Panel

Session 5 | Panel Discussion: Medical Communication in China - Opportunity and People Development

KEY QUESTIONS FOR DISCUSSION• How do you see the Medical Communication/Medical

Information function in China in next 5 years?

• What's the most important competencies that Medical Information should be develop today to embrace the change in future?

• Possible career development path for Medical Communication/Medical Information staff?

• What's your key take aways from today's workshop?

SESSION CHAIRHuafei LIDirector, Medical Communication & Project Management, Medical Affairs, Roche



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INVITED PANELISTSXuan HE , MBAHead of Medical Communications, BHC China

Laura HUANGMedical Governance Officer, GSK China Pharma

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

Hugo YEMedical Education Director, Eli Lilly and Company

Lizzy WANGMedical Operations Director, Medical, Sanofi

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


LEAN: INNOVATIVE APPROACHES FOR AUTHORING CLINICAL, CMC, AND NONCLINICAL 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, PhDSenior Director, Neuroscience Regulatory Medical WritingJanssen Research & Development, L.L.C., USA

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, PhDSenior Director, Neuroscience Regulatory Medical WritingJanssen Research & Development, L.L.C., USA

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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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 ADDRESSMargaret A. HAMBURG, MDFormer Commissioner, FDA, USA

SPECIAL FORUM I : BUILDING A SUSTAINABLE R&D ECOSYSTEM

Moderator

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

Invited Panelists

Nancy MYERS, JDChair, the Board of Directors of FDA Alumni AssociationPresident, Catalyst Healthcare Consulting, USAFormer Senior Policy Advisor to FDA Commissioner

Xianglin ZHANG, EMBASenior Engineer, President, Yeehong Business School, Shenyang Pharmaceutical University

Yuwen LIUExecutive Director, Suzhou BioBay

Robert URBAN, PhDHead, Johnson&Johnson Innovation Center, USA

Jin WANGPartner, Mckinsey & Company

SPECIAL FORUM II : INTERNATIONAL COLLABORATION IN PROMOTING AND PROTECTING PUBLIC HEALTH

Moderators

Lin YUANGeneral Director, Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs), CFDA

Ling SU, PhDStrategic Advisor, Life Sciences, Sidley Austin LLP

In today’s world where drug R&D and supply chain are very much globalized, how the regulatory agencies should and can better collaborate to protect and promote public health. This special designed forum will focus on the specific area to discuss is how China may play a more important role in the global regulatory area.

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


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Theme 1

Regulatory Science: Advancing the Best Practice in China via Understanding and Sharing the New Development and the Real World Experience Globally

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.

Meet the Clinic Need and CFDA Approval of the First Orphan Drug Designation for Chinese Innovative Drug Epidaza (Chidamide)

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


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

In connection with the current situation in China: how far away is the innovative medicine to us in term of technology? How far away is it to us in terms of the health care system? In pricing? Regulatory system? In optimal utilization? etc.

In this session, the "we" could be the consumers, industry, government, hospitals and other stakeholders related to new drugs.


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


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The guest experts will present their views, exchange opinions and explore wisdom ideas in this session.

The Plight for New Drugs to Achieve Their Values

Ying SHAOVice President and Director of R&D Center, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Innovation, Risk and Recognition: the Political Sociology for New Drugs

Yinglian HUAssociate Professor, Chinese Academy of Governance

What Are We Still Lack of for New Drugs?

Ruilin SONGExecutive President, China Pharmaceutical Innovation and Research Development Association (PhIRDA)

Topic TBD



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

New Drugs and Rational Medication

Luwen SHI, PhDProfessor, Peking University School of Pharmaceutical Sciences

PANEL DISCUSSION

All speakers from session 0105 & 0106


HOW OVERSEAS PRODUCTION SITE INSPECTION BE DONE EFFICIENTLY AND EFFECTIVELYSeSSion Chair

Haifeng CAO, MBAHead of Regulatory Affairs, GSK

In past 4-5 years, CFDA started to arrange overseas site inspection for overseas applicant. Current inspection is focused on selected ones based on reasons, no routine pre-approval inspection for every application although it has been implemented for every domestic new drug approval. So we can foresee more and routine overseas inspection related to drug approval in future. So overseas site inspection will be on the critical path for new import drug approval in future in China. It is critical to have the effective and efficient inspection from both agency and applicant perspective

to ensure patient’s early access to innovative drug. By organizing this session, we can share both EMA and CFDA experience and both Agency’s expectation on applicant to support domestic and overseas applicant to better prepare the inspection.

EMA’s Experience to Perform Efficient and Effective Overseas Production Site Inspection and Their Expectation on Overseas Applicant

Evangelos KOTZAGIORGISScientific Administrator, Specialized Scientific Disciplines Department, European Medicines Agency (EMA)

CFDA’s Experience to Perform Efficient and Effective Overseas Production Site Inspection and Main Activities in the Coming Years


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.

How Multiple-Disciplinary Department in EU Works Together Collaboratively to Manage/Regulate Product Quality


China Regulatory System on Managing Product Quality

Daniel SONG, PhDDirector, CMC Regulatory Affairs, China R&D and Scientific Affairs, Janssen Pharmaceutical Companies, Johnson & Johnson Product Quality


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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.

SESSION IN DEVELOPMENT...

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.

PANEL DISCUSSION

George GUOGlobal Monitoring Operation Country Head, China

Winnie XUSenior Director, Clinical Operations, Quintiles

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

Yongchuan CHENDirector, GCP office, Southwest Hospital

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

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 Panelists from Session 0301


CINICAL SCIENCE (PART I) - DEVELOPMENT STRATEGYSeSSion Chair

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

This session will focus on discussing for the below areas:• 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


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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 DISCUSSION: Global vs China, MNC vs Local: Considerations in CDP

All Speakers and Invited PanelistsZhi-Qiang NING, MD, PhDVice President, R&D, Shenzhen Chipscreen Biosciences Ltd.

Yuan LI, MDDirector, Product Development Strategy, Merck

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.


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

Early Phase Development Strategy & Population PK’s Value to Entire Process of Drug Development

Hartmut BLODE, PhDHead of Clinical Pharmacology, Bayer R&D Center, China

Special Considerations for First-in-Man Studies

Peiming MA, PhDSenior Director, Clinical Pharmacology, R&D Center, GSK China


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.

RBM Methodology Overview and Some Experience Sharing

Brett WILSONAssociate Director, Regional Clinical Operations, Bristol-Myers Squibb, CanadaElements of Successful Partnering to Execute Risk Based Monitoring

PJ CHENExecutive Director, Area Head, North Asia Clinical Management, PPD

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

ModeratorsBo ZHENGHead of Data Management, Statistics, Epidemiology and Data Management, China Medicines Development, GSK

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

Invited PanelistsFanny FENG Senior Process Manager, Clinical Development, Site Management & Monitoring, Asia, AstraZeneca

Yajun TANG Associate Clinical Project Manager, Development East Asia & Network, UCB Pharma


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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

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 WU, PhDManager, 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 ZHU, PhDResearch 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.


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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


EVOLVING CDM ROLE IN CLINICAL TRIALSSeSSion Chair

Li DINGSenior Director, Trial Operation China Site Head and AP Coordinator, CSO China Site Deputy Head, Sanofi

Clinical Data Managers (CDMs) play an important role to ensure the quality of a clinical database, on which regulatory decisions are made before new products are put on the market. Over the last few decades, the roles and responsibilities of a CDM in a clinical trial have evolved. In this session, we invited leaders in this field to discuss the changes and challenges CDMs have faced and their opportunities in the future.

Overview of Evolving CDM Role

Jessie CHENHead of Clinical Data Services, Pfizer China R&D Center

Evolving CDM Role Enabled by Technology – EDC

Tai XIE, PhDPresident & Chief Executive Officer, Brightech International/Chengdu Ming Ke

Evolving CDM Role Driven by Outsourcing Business Model

John TANG, PhD

Evolving CDM Role with Expertise Development in China – Contribution from China to the World

Carrie ZHANGRegional Director, Clinical Data Management, Global Data Management & Standard – Asia Pacific CT, MSD R&D (China) Co., Ltd.


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.

CRF Design to Meet Requirement of Statistical Analysis Plan

Hualong SUN, MD, PhDGeneral manager, Meta Clinical Technology

Randomization in Clinical Trials: Implement and Randomization Irregularity Control

Bob YAN, PhDHead of Biostatistics and Programming, Sanofi


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Implementing Metrics Management for Improving Data Management and Statistics Analysis Performance in Clinical Trials

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.

Quality by Design - Carved in Data Management and Statistics

Luyan DAI, PhDAssociate Director Biostatistics, Biometrics and Data Management at Boehringer-Ingelheim, Asia/META

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

PANEL DISCUSSION

All Speakers from 0407 & 0408

Theme 5

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


DRUG SAFETY IN CCLINICAL DEVELOPMENT – BENEFIT / RISK BASED DECISIONSeSSion Chair

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

We started to shape the drug benefit and risk in human during clinical development process. Signal detection; risk analysis, evaluation, communication and minimization are throughout the clinical development. This section will focus on safety evaluation and decision making in development plan level, target organs level, and safety evaluation from regulator perspective during CTA/NDA reviewing.

Safety Evaluation in Drug Development – Development Plan Level Considerations

Ayman AYOUBSenior Director, SSRM DA Cluster Head, Pfizer, UK

Safety Science in Drug Development and Cases Study

Mason SHIH, PhDSite Head, Drug Safety, Asia Pacific, Genentech, a Member of Roche Group

Safety Data Evaluation During CTA/NDA Reviewing



EFFECTIVE RISK MANAGEMENT SeSSion Chair

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

Pharmacovigilance is one of the important part in product Life cycle management. It’s not only interest for the drug company, but also draw very attention to the hospital physicians and RA officials. How HCP think about the pharmacovigilance and how implementation in the hospital in their daily routine work and share the best practice.

Late Phase interventional and observational research has applied various aspects of study risk management over the last couple of decades or so. Nevertheless, there is a continuous need to streamline both process and expectations across the industry in light of the recent regulatory guidelines, papers and initiatives that have been developed. Quality by design, risk assessment and risk management comprehensively secure an adequate study risk-quality balance that ultimately provides cost efficiency and economies of scale around how late phase research can be managed. What impact would an integrated centralized site management and robust risk management process have on the outcome of late phase research?

Evolution of Risk Management in Peri-Approval & Observational Research

Hady KHOURYVice President - Global Head, Research & Alliance Services, ICON Commercialization & Outcomes, USA

Safety Use In The New Diabetes Medicines And Drug Safety Management In Hospital

Yiming LIProfessor, Huashan Hospital of Fudan University


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POST MARKETING SAFETY SURVEILLANCESeSSion Chair

Ivy WANG, MD, PhD Associate Director, Safety Surveillance & Risk Management, Pfizer

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

When a new medicinal product is approved for marketing, demonstration of safety and efficacy is generally based on data from a limited number of patients. In clinical practice, a broader range of patients are treated (e.g., age, co-morbidities, concomitant medications, genetic differences), and events too rare to occur in clinical trials may be observed (e.g., severe liver injury). The continuous analysis of relevant safety, efficacy, and effectiveness of a medicinal product throughout the lifecycle is needed. This section will discuss about the post-marketing studies, safety signal evaluation and benefit-risk assessment during post-marketing surveillance.

Thinking of Post-marketing Drug Safety Studies Dayou WANGProfessor, Huashan Hospital of Fudan University

Signal Detection during Post-marketing Surveillance

Howe LICEO, Tigermed


ACTIVE SAFETY SURVEILLANCESeSSion Chair

Min CHEN, RPhClinical Safety and Pharmacovigilance Expert, Pharmacovigilance Consulting, LLC, USAFormer Director of Pharmacovigilance, Office of Surveillance and Epidemiology, CDER, FDA

In the emerging globalized medical product development, there has been an increasing emphasis on product safety in premarketing safety assessment, risk management, and postmarketing surveillance to assure product safety for patient use. Many tools of postmarketing surveillance methods and approaches are available in different countries. An overview of the US postmarketing requirements in new drug approvals in 2014 gives the current scope of the safety surveillance based on the knowledge of risks already identified at time of approval. The updated US Sentinel initiative that utilizes large claims databases and specific Drug-Induced Liver Injury Network (DILIN) will be provided for the US current active surveillance activities. From the industry’s perspective, there are many opportunities and challenges for active surveillance. Most importantly, the most current thinking and experience of active surveillance in China will be presented for

more complete discussions.

Overview of Postmarketing Requirements in 2014 US FDA New Drugs Approvals, and Updates on Sentinel and DILIN

Min CHEN, RPhClinical Safety and Pharmacovigilance Expert, Pharmacovigilance Consulting, LLC, USAFormer Director of Pharmacovigilance, Office of Surveillance and Epidemiology, CDER, FDA

Opportunities and Challenges for Active Surveillance

Songlin XUE, MD, PhDExecutive Vice President, Head of Global Pharmacovigilance, Astellas

Experience of Active Surveillance in China



VACCINE SAFETY AND RISK MANAGEMENTSeSSion Chair

William WANHead, Pharmacovigilance, Baxter

Due to the success of immunization (vaccine), some diseases are no longer perceived as a threat. Like drug pharmacovigilance, risk communication is a really important part of the success of pharmacovigilance to ensure the minimization of negative effects to individuals. The PV communication of vaccine is somehow similar like drug pharmacovigilance, however definitely some special for vaccine safety communication, e.g. communication to support the immunization program. In recent years, misleading and alarming drug safety information, including vaccine safety information, spread via web sites and new social media. This may impact public health. How to deal this? In this section, we are talking the safety of vaccine, risk communication.

Safety of Vaccine – from the CDC Perspective

Dawei LIU, MPHDirector, AEFI Surveillance, National Immunization Program, Chinese Center for Disease Control & Prevention

The Safety of Vaccine: Scientific and Technological Discussion

Li SHI, PhDChief Executive Officer, Shanghai Zerun Biotechnology Co., Ltd.


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HERBS SAFETYSeSSion Chair

Hellen ZHANGPharmacovigilance Country Head, Bayer

Traditional Chinese medicine (TCM) enjoys a history of thousands of years. However, TCM is generally described as “every medicine has its side-effect” when referring to its safety. In recent years, more and more attention goes to the safety issue of TCM, and meantime comes misunderstandings. To develop and internationalize TCM, the bottle neck is the insufficiency of study data. With the evolving of drug safety and pharmacovigilance system, there will be a long way to go for healthcare authority, medical institutions, and pharmaceutical companies to establish a system for TCM safety. In this session, we are going to invite the TCM officers from CFDA, experts on TCM and representatives from TCM companies to join the discussion.

Traditional Chinese Medicine Enterprises' Responsibilities on TCM PV


Interpretation on TCM Product Safety

Xuemin GAOProfessor, Beijing University of Chinese MedicineChair Member of Drug Clinical Evaluation/Research Committee, China Association Of Traditional Chinese Medicine

Practical Experience on TCM Product Safety

Hui CAODirector, National Engineering Research Center For Modernization Of Traditional Chinese MedicineMember of Chinese Pharmacopoeia Commission

Theme 6

CMC and Quality System


MANAGING POST-APPROVAL CMC CHANGES IN CHINA AND THE US (PART I)SeSSion Co-ChairS

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

Melly LINSenior Regulatory Manager, CMC Policy, Roche (China) Holding Ltd.

In this session, current and former officials from CFDA, TFDA, and US FDA will describe the regulatory systems for post-approval CMC changes to chemical drugs and biologics in each country. The regulatory filing mechanisms, types and levels of change, data requirements (including stability data), shelf-life setting, utility of stability commitment, use of comparability protocol, application of ICH Q5E principles, acceptability of multiple manufacturing sites, and other issues will be discussed. Case studies will be presented to illustrate the challenges facing multi-national companies as they comply with the country-specific regulations and policies without disrupting the drug supply to patients in a global market during the product lifecycle.

Overview of Regulations and Guidelines on Post-Approval CMC Changes for Chemical Drugs in the US

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

Overview of Regulations and Guidelines on Post-Approval CMC Changes for Biotechnological Products in the US

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

Post-Approval CMC Changes for Chemical Drugs in China

Zhen CHEN, PhDProfessor, Medicine College, Zhengzhou UniversityFormer Deputy Director, CMC Division I, CDE, CFDA


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Overview of Regulation and Guideline on Post-Approval CMC Changes for Biologics in China



MANAGING POST-APPROVAL CMC CHANGES IN CHINA AND THE US (PART II)SeSSion ChairS



Experience Sharing on Multiple Sites for Biologics

Jofeng CHISection Chief , Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan

Managing Post-Approval CMC Changes for Chemical Drugs in a Global Market – Case Studies


Managing Post-Approval CMC Changes for Biologics in a Global Market – Case Study

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

Session 0605 | Tuesday, 27 May, 8:30 - 10:00

CHP TOWNHALLSeSSion Chair

Melly LINRegulatory Manager, Technical Regulatory PolicyRoche (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 manufacturer are exploring foreign market. Having a same international quality standard is one of the key factors in open 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 revision in ChP 2015, evaluate the potential impact and implement the change.

Change of ChP 2015 and Future Direction

Wei ZHANGSecretary General, Chinese Pharmacopeia

USP Perspective: Pharmacopeia Harmonization and Collaboration between Pharmacopeia and Industry

Kevin CAO Director, User Relationship Management, USP

Industry Perspective: Pharmacopeia Harmonization and Collaboration between Pharmacopeia and Industry


PANEL DISCUSSION

All Speakers

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


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Adagene’s Innovative Antibody Technology and Pipelines

Peter LUO, PhDCo-founder and Chief Executive Officer, Adagene Inc.


SAFETY EVALUATION OF NEW TYPES OF ANTIBODIESSeSSion Chair

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

Because of their good specificity and significant effects,monoclonal antibody drugs are called “biological missile” and become a research hotspot of biopharmaceutical companies. With the development of biotechnology,a variety of monoclonal antibody derivatives are generated, including antibody-drug conjugates, small molecular antibodies and bispecific antibodies, etc. During the development of new types of antibodies, the safety evaluation of antibodies is one of the most challenges for the researchers. In this session, Dr. Jufeng Wang, Director of National Center for Safety Evaluation of Drugs (NCSED), National Institutes for Food and Drug Control (NIFDC), invites 3 speakers to give talks on the progress and prospect of the Safety Evaluation of New Types of Antibodies. They are: Dr. Rod Prell from Genentech, Dr.Yan Huo from NCSED of NIFDC and James Yan from CSO, Covance China.

Current Challenges and Opportunities in Toxicity Assessment of Bispecific Antibodies

HONG WANG, MD, PhD, DABTSenior Scientist/Oncology Therapeutic Area Leader,Toxicology, Safety Assessment, Genentech, a Member of Roche Group

Non-Clinical Safety Evaluation of New types of Antibodies

Yan HUO, PhDDirector, General Toxicology, NCSED, CFDA

Preclinical Safety Evaluation of Therapeutic Monoclonal Antibody: -Previous Experience and Future Direction

James YAN, MD, PhDExecutive Director and Site Lead, Early Development BusinessUnit, Covance Pharmaceutical R&D (Shanghai) Co., Ltd.


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.

Challenges Related to Development and Evaluation of Biosimilars


Regulatory Considerations for Marketing Biosimilars in EU by Chinese Companies



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 DENGVice President, Regulatory Affairs, AstraZeneca Investment(China) Co., Ltd.

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

Breakthrough with Innovative Therapies- Therapeutic Driven Drug Development


BREAKTHROUGH BY INNOVATIVE DISEASE THERAPIES SeSSion Chair

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

Innovative therapy is crucial factor of clinical progression to address the unmet medical needs and improve clinical outcome of patients. Even with the long, complicated pathway, the science of drug discovery is back on script, there have been exciting breakthrough in disease therapies. The sessions 0801/0802/0803/0804 will invite the senior experts from pharm, clinical academia and also agency to tackle the major advances in the past year and upcoming year of 2015, and also the roles and opportunities of China to participate and even lead in such innovative wave.

Medical Advancement with Innovative Disease Therapies

Linong JI, PhDProfessor, People’s Hospital, Peking University

Overview Innovative Therapies in Year 2014 and Forecast of Year 2015

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


BREAKTHROUGH OF INNOVATIVE CANCER THERAPIES AND IMPACT ON LOCAL INNOVATION IN CHINA SeSSion Co-ChairS

Jian PENG, PhDScientific Advisor, Asia-Pacific R&D, Sanofi

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

Cancer has been the leading threat to people’s life worldwide, with constantly increasing mobility and mortality in China it becomes a serious burden to our public healthcare system. In the meantime, we are facing a new generation of exciting breakthrough therapies with all emerging technologies. During this session the experts from pharm, academia will help lead the audience to tackle all


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the major advances in clinical cancer research which deem to lead the revolutionary changes of treatment choices of cancer patients globally and also the great opportunities we have been facing in China.

Clinical Landscape of Innovative Cancer Therapies

Caicun ZHOU, PhDProfessor, Director, Medical Oncology, Shanghai Pulmonary Hospital, Tongji University

The Transformations of Year 2015 for Innovative Cancer Therapies by Targets

Jimmy JIN, MD, PhD Director, Translational Medicine Programs Lead, TSU Asia-Pacific, Sanofi R&D

Local Innovations in China for Cancer Therapies and Their Strategy



BREAKTHROUGH THERAPIES IN DIABETES DISEASES SeSSion Co-ChairS

Yan GONG, MD, PhDSenior Global Clinical Program Lead, Corporate Division of Medicine, Boehringer-Ingelheim, Germany

Joan SHEN, PhDVice President, Chief Medical Officer, Jiangsu Hengrui Medicine Co., Ltd, China

Overview of recent advancement of diabetes therapies; outlook of future development focusing on new mechanisms and a shift in target product profile; challenges and opportunities for domestic innovative companies.

Recent Advancement of Drug Development in Diabetes - Biological Entity

Kezhou ZHANG, MD, PhD, MBAVice President, Clinical & Medical & Regulatory, Novo Nordisk (China) Pharmaceuticals Co. Ltd.

Recent Advancement of Drug Development in Diabetes - Synthetic Chemical Entity

Shuhua SHANGProject/Clinical Research Director, AP R&D, Sanofi China

Outlook of Drug Development in Diabetes – A Shift to “Glucose Plus”

Yan GONG, MD, PhDSenior Global Clinical Program Lead, Corporate Division of Medicine, Boehringer-Ingelheim, Germany

Status Quo, Challenges and Opportunities for Domestic Companies in Diabetes Therapies

Eric HUAOverseas Clinical Project Manager, Gan & Lee Pharmaceuticalsd

Pipeline in Diabetes - From the Industrial Perspective

Chengyu GUAN, PhDMedical Director, Jiangsu Hengrui Medicine Co., Ltd, China


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 from Regulatory Perspective a China Component Should be Embraced in the Clinical Development Plan

PohYeng THAI, PhDDirector, Regulatory Affairs, HCV Project in Asia Pacific Region, Abbive, Singapore


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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

Thomas SCHINDLER, PhDHead, Clinical Operations / Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Germmany

Medical Writing Evolution and Expansion in China

Nan WANG, PhDScientific Medical Writer, Global Medical Writing, Bayer

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

Roselynn TIEN, PhD Director, Medical Writing Services Asia PacificDirector, Global Resource Management, PAREXEL, Singapore


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

Mary MCKENNA Director, Electronic Document Management, Sanofi, USA

In this session, we will focus on the challenges and opportunities in an evolving environment and how they impact medical writers. We will explore changes that are specific to China and others that span the globe, some related to content, some to format, some to tools - all of which are critical to preparing compliant deliverables in the most efficient and forward-thinking ways.

Particular attention will be given to the importance of the eCTD and its future implementation in China ; the rapidly growing field of disclosure with its applications for study information and results; and a look at technological applications that are shifting the landscape of document and content management, particularly in the area of the common protocol template developed by TransCelerate Biopharma Inc.

eCTD in China: implications for its adoption for medical writers and regulatory strategists in China and beyond

Handsome JISenior Publishing Team Manager, Worldwide Regulatory Operations, Pfizer

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

Selvaraj SELVASTINEManager, Medical Writing Service, PAREXEL, India

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

Steffen FREDERICKSENChief Science Officer, DITA Exchange, Denmark



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

Xiaoling WANGHead of clinical documentation, Clinical Science Operation, Sanofi R&D

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 KOJIMA , RPhDirector, Asia-Pacific Medical Communications, Eli Lilly

Why Important and How to Do Successful Publication of China Data

Yang RUI, PhDSenior Scientific Communication Manager, Novonordisk

Clinical Trial Data Sharing: A Publisher's Perspective

Huili CHENBusiness Development Manager, BMJ China


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, Medical Communication, Roche


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

Hongbo ZHU, PhDHead, Medical Writing Asia, Boehringer Ingelheim

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 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

Sybille Eibert, PhDTeam Leader, Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co KG, Germany

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

All Speakers and Invited PanelistsYao YAO, PhD, RAC, CQA Specially Invited Professor, IED, CFDA

Haidan WANGSubmission Manager, Oncology Developmment (Drug Regulatory Affairs), Novartis Pharma

Hui GAORegulatory manager, Regulatory affair, Johnson & Johnson China R&D



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Kelly ZHANGRegulatory Affairs Associate Director, MED-DRA, Boehringer Ingelheim

Emma CHENVice President, Biostatistics, R&G PharmaStudies Co., Ltd.


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

Deb DRISCOLLVice President, Global Medical Quality Assurance, Pfizer

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

Ann Meeker-O”ConnellSenior Director, Risk Management and External Engagement of BRQC, Johnson&Johnson

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

Brett WILSONAssociate Director, Global Development Operations, Bristol-Myers Squibb, USA

CFDA Focus on Quality


PANEL DISCUSSION

All speakers and:

Hannah CHEN, MDDirector, AP/China R&D, Quality Assurance, Janssen Pharma R&D, Q&C

Helen LI, MBAQA Asia Lead, Emerging Market/PCO QA, Medical Quality Assurance, Pfizer


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.

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

Yanfei LIUDirector, GCP Office, Shanghai Fudan University Cancer Hospital

Fast Site Start-up and Patient Enrollment with CRC

Maggie GUDirector, Site Management & Monitoring, China/HongKong, Clinical Development, AstraZeneca Investment (China) Co., Ltd.

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


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INTERNATIONALIZATION OF CHINESE CRO IN CHINASeSSion Chair

Bin 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, Clinical Project Management, Quintiles Great China

Breakthrough Analytics within Clinical Trial Conduct

David KIGERVice President, Product Strategy, PAREXEL Informatics, USA

Medical Imaging in a Key Role to Advance Quality Clinical Trials

Luxia LIANG General Manager, Fantastic Bioimaging Co. Ltd.

Theme 10

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


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

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

Long CHENG, PhDProfessor, Director, Pharmaceutical Innovation and New Technology Research Office, China National Health Development Research Center Former Senior Review, CDE, CFDA


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


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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

Tao DU, PhDChief Executive Officer, Humphries Pharmaceutical Consulting

Henry SUN, PhDVice President, Tasly Holding Group


WHO VACCINE SESSION (PART I): NEWER THAN NEW-INNOVATIONS TO CREATE NEW HEALTH SOLUTIONS AND DELIVERIESSeSSion Chair

Yiwu HE, PhD, MBASenior Program Officer, Global Health, Bill & Melinda Gates Foundation

WHO Vaccine Prequalification Program for High Burden Diseases/ WHO

Lance RODEWALD, MDExpanded Program on Immunization Team Lead, China Country Office, World Health Organization

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

Richard WANG Chairman, Yichang Humanwell Pharmaceuticals

The National Center for Advancing Translational Sciences: A Collaborative Vehicle to Enable Translational Therapeutics Development

Anton SIMEONOV, PhDActing Scientific Director, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health


WHO VACCINE SESSION (PART II): NEWER THAN NEW-INNOVATIONS TO CREATE NEW HEALTH SOLUTIONS AND DELIVERIESSeSSion Chair

Yiwu HE, PhD, MBASenior Program Officer, Global Health, Bill & Melinda Gates Foundation

New Approaches to Develop HIV Vaccines

Shan LU, MD, PhD Professor, University of Massachusetts Medical School, USA

Aiming STEM Cells with Precision Medicines to Treat Colorectal Cancer

Edward LIN, PhDChief Medical Officer, P4 Medicine Institute, USA

A Practical View on Precision Immunotherapy: Engineering the Body’s Immune System to Treat Cancer

Xiangjun ZHOU, PhDChief Scientific Officer, SYZ Cell Therapy Co.


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

Shaoyu CHEN, JDMember of FDAAAFormer Assistant Chief Counsel, Office of Chief Counsel, Office of Commissioner, US FDAPartner and Managing Director, Covington and Burling LLP

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 FLANAGAN, JDDirector 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 – PMDA Consideration and Practices

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



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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 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 LEARNED 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


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

Ruilin SONG, PhDExecutive President, China Pharmaceutical Industry R&D Association (SINO-PhIRDA)

Invited PanelistsKeith FLANAGAN, JDDirector, and head of Office of Generic Drug Policy (OGDP), Office of Generic Drugs, CDER, FDA

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

Gang WANG, PhDAssistant Country Director, FDA China Office

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

Guohua ZHANG, PhDPresident and CEO, Novast Laboratories Ltd.

Shaoyu CHEN, JDMember of FDAAAFormer Assistant Chief Counsel, Office of Chief Counsel, Office of Commissioner, US FDAPartner and Managing Director, Covington and Burling LLP

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, PhDChairman and Chief Executive Director, Zai Laboratories

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

Jinzi WU, PhDFounder, President and CEO, Ascletis Biosciences

Frank JIANG, PhDVice President and Head of Asia Pacific R&D, Sanofi


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

Wendy PANPartner, OMM

How to obtain new product/technology to accelerate internal R&D? How to obtain money to fund development of new products/technologies without losing control or upside of the technology? How to create win-win partnerships where partners can each benefit from the collaboration? What would be the optimal structure for a collaborative partnership, joint ventures or license arrangements? The esteemed members of this panel will share their real life stories in how their structured collaborative partnerships to achieve their goals.

PANEL DISCUSSION

Michael YU, PhDChairman & Chief Executive Director, Innovent Biologics, Inc.

Xueming QIAN, PhDFounder, Chairman and CEO, MabSpace Biosciences

Dadong CHENManaging Partner, BFC Group



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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

Yan WU, MD, PhD Head, Clinical Operation and Drug Safety, Hutchison MediPharma

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

SESSION IN DEVELOPMENT...

Theme 12

Hot Topics and Late Breaker


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

Donglei MAOChief Editor, DrugRNDer

Qiang LAIVice Executive Chief Editor, HealthCare Executive

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, HealthCare Executive

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

Zheng ZHAOAssistant, Center for Pharmaceutical Information and Engineering Research, Peking University

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

Jialing DAI Chief Editor, PharmaDJ

From Community to Communities – Experiences Sharing from Ding Xiang Yuan

Tiantian LIFounder, Ding Xiang Yuan

How NGOs Play Their Role to Enhance the Innovation in China

Changxiong CHENGeneral Secretary, China Pharmaceutical industry Research and Development Association


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How to Communicate with Internal and External Stakeholders by Leveraging Social Media Tools

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

Closing Remarks

Yi FENGSenior Advisor, Covington and Burling LLPFormer Associate Center Director, Office of Evaluation Management and Communication, CDE, CFDA


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



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

Harris XIAAssociate Director, CV AstraZeneca


ON THE WAY - CHINA INNOVATIVE PHARMACEUTICAL COMPANYSeSSion Chair

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

This session would take a global view on China’s innovative approach in pharmaceutical/biotech industry. Global Economy would ask for a global approach for R&D collaboration, in the form of project-based collaboration, licensing deals or JV, as well as redeploy of human capitals. Speakers would share their experiences on managing their innovative R&D activities in China from global perspectives.

Early Clinical Development in Global Market

John OYLERChief Executive Officer, BeiGen Co. Ltd.

Global Phase III Pivotal Trial Sponsored by Chinese Firm

Henry SUN, PhDVice President, Tasly Holding Group

International Partnership in China: a New Model

Jingwu ZANG, PhDChief Scientific Officer, Simcere Pharmaceutical Inc.



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Pharmaceutical Innovation in China

Jin WANGPartner, Mckinsey & Company

PANEL DISCUSSION

All Speakers and Invited PanelistsYi FENGSenior Advisor, Covington and Burling LLPFormer Associate Center Director, Office of Evaluation Management and Communication, CDE, CFDA



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

Topic TBD

Zhiyang ZHANG, MD MBAChief Executive Officer, 3gBio

Putting Personalized Healthcare into Practice

James CREEDEN, PhDDirector, Medical Science, Roche

CFDA Current Regulatory Policy and Guidance on Companion Diagnostic


Theme 13

White Paper Showcase


PATIENT AND THERAPEUTIC CENTRIC CLINICAL MATERIALS (BY CATALENT)

The industry is interested in the Patient Centricity movement to improve recruitment and retention. Clinical sites are facing more challenges with the number, complexity and product specifications of clinical materials. Patients, for whom the investigational product is priority, are looking for patient friendly kits and logistics to help them comply with the study protocol. The presentation will include:

• Patient friendly packaging and labelling solutions and case studies to meet specific therapeutic challenges;

• Demand led supplies;• Direct to Patient supplies; • Integrated clinical material management.

Christine MILLIGAN, PhD, MBAGlobal Director, strategic development solutions, Catalent Pharma Solutions


RISK BASED SAFETY MONITORING (BY PROSWELL MEDICAL COMPANY)

Risk based safety Monitoring (RBSM) in clinical trials is widely credited for protecting human subjects during a clinical trial and ensuring integrity of study. Although the process of RBSM various significantly among pharmaceutical companies, the common elements include (1) commit to protect human subjects and integrity of safety information in the clinical trials – the organizational culture ensures that all the members of the organization give priority to patient safety; (2) understand hazards and evaluate risk – the foundation of a risk-based approach; (3) manage risk – the ongoing execution of RBSM; and (4) evaluation of effectiveness of RBSM system - learn from experience via metrics, incidents, audits and management reviews, provide direct feedback on the workings of the system, and improve it.

Zefei JIANG, PhD Director of Breast Oncology Department, Proswell Medical Company

Zheng BOHead of Data Management, China Medicines Development, GSK Shanghai R&D


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Danhua LINDirector, Oncology Business Department,Proswell Medical Company


MODERNIZING DRUG DEVELOPMENT: HOW THE VOICES OF PATIENTS, RESEARCHERS, DRUG DEVELOPERS, AND REGULATORS HAVE CONVERGED TO BRING INNOVATION TO THE CLINICAL TRIALS PROCESS, HOW THAT IS CHANGING VIEWS OF DATA COLLECTION TODAY, AND WHAT IS COMING NEXT (BY MEDIDATA SOLUTIONS)

Innovation and modernization of the drug development process is needed all over the world. There is a lot of unmet medical need. There are 7000 rare diseases classified in the U.S., but fewer than 500 treatments have ever been approved by the FDA, in spite of large annual investment in drug development. This problem is greater when we look at common disease that has no cure. This presentation examines the role of patients, researchers, drug developers, and regulators working together to improve drug development. It gives examples of how modern approaches are being implemented today in clinical trials, when patients are enrolled, data is collected, and in meetings with regulators to discuss data, and paths to approval.

Steve SmithSenior Director, Patient Value, Medidata Solutions

Gaoqiang XIE, PhD Program Manager, Clinical Research Institute, Peking University


BRINGING DRUG TO PATIENTS SOONER: PARALLEL GLOBAL CLINICAL DEVELOPMENT IN THE AGE OF PERSONALIZED MEDICINE (BY COVANCE)

With world’s fastest growing pharmaceutical market in China, Chinese pharma and biotech companies have an advantage for simultaneous development and approval of new innovative products in China and the US/EU, reducing the drug gap for global products developed by Chinese companies. There are also opportunities for global companies to partner with Chinese companies to leverage this simultaneous development advantage, creating new possibilities of international partnerships with Chinese companies and bringing important new medicines to Chinese patients sooner than ever before.

Kenneth SOMBERG, MD, MBAChief Medical officer, Covance Inc.

Honggang BI, PhDCorporate VP, Covance Inc. & General Manager, Covance China

Xiaoning GUO, PhD Director, Molecule Development Group, Asia Pacific, Covance Inc.

Peter VARNEYGlobal Vice President, Alliance Management, Covance Inc.

Beatriz ROCHA, MD, PhDExecutive Director, Head of Clinical Global Regulatory Affairs Strategy, Covance Inc.

Tufail SYED, MDSenior Director, Laboratory Operations , Asia Pacific, Covance Inc.


OPPORTUNITIES AND CHALLENGES FACING R&D IN CHINA (BY CGP CLINPLUS)

Regardless of medicine or medical device, clinical trials or post marketing studies, there are both challenges and opportunities facing R&D in China. We’d like to share with you our expertise and the best practices through our real-world experiences and case studies

• Best practices in conducting PMS studies on time and within budget

• CRC Landscape in China• Navigating through the new Medical Device regulations for

easier access to Chinese market



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Special Session

Brain Storm - Discussion in Depth of

China SMO Practice

Special Session | Wednesday, 27 May, 10:30-12:00

BRAIN STORM - DISCUSSION IN DEPTH OF CHINA SMO PRACTICESeSSion Co-ChairS

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

Luke LUBusiness Operation Manager,Third Party Management, Lilly China Medical Develop Unit

A Clinical Research Coordinator (CRC) is a specialized research professional working with the principal investigator and GCP regulations. First deployment in the late 90’s, this role as has become widely used in clinical studies in China. “SMO Association”, a member of DIA, was established by the end of 2014.

Increased involvement of CRCs in clinical studies, as improved quality levels to that of established trial markets like U.S. or Europe. However, there are still a lot of challenges in the CRC business. How must companies continue to invest in development of CRCs, improve collaborations, uphold ethics and integrity in the workplace.

Key Discussion Questions:• What’s the Best Practice of Collaboration (Contracting &

Payment) and Management (Reporting Line, KPI, etc.) Among Sponsor, Investigator, and SMO

• How to Evaluate the Workload of the CRC and the Cost Elements of the Pricing Structure in order to Ensure the Fairness amount Different Parties

• What is the Most Challenging Points to You? - From the Different Perspectives

Invited Panelists

Leon ZHANGVice President, Clinical Coordination, Beijing Linkstart Medical Technology Development Co.,Ltd

Xiaojing CHENCovidien

Mingli XUBeijing HMO Medicine Technology Co.,Ltd

Xiaochun CAOTigerMed

Shuyan CHENClinical Research Coordinator Associate Director, Site Management Service, Kun Tuo Medical Research & Development (Beijing) Co., Ltd.

Cindy LUBusiness Operation Management Manager, Eli Lilly Company

Fei XIEDaiichi Sankyo Company Limited

2015 DIA China

Documents

Transcript of 2015 DIA China