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 Workshops
May 25-27, 2015 - Conference, Exhibition and Posters

The 7th DIA China Annual Meeting
Innovation and Convergence - Building a Sustainable R&D Ecosystem
24-27 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
“Leavethestatisticstothestatisticians”–true,andbothstatisticians
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 CHAIR
Ouhong WANG, PhD
Director, Biostatistics, Amgen
KEY INSTRUCTORS
Luyan DAI, PhD
Associate Director Biostatistics, Biometrics and Data Management
at Boehringer-Ingelheim, Asia/META
Ping YAN, PhD
Associate Director, Clinical Statistics, Pfizer (China) Research and
Development Co.
Jack PENG, PhD
Associate Statistics Director, R&D Shanghai, GSK
Michelle WANG, PhD
Senior 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
DESCRIPTION
The 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 AUDIENCE
This 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 CHAIR
Daniel LIU, PhD
Chief Scientific Officer, Beijing Clinical Service Center
PROGRAM COMMITTEE
Tim WANG
Senior Manager, Clinical Data Management, Data Analysis and
Reporting Organization, Covance
Lily ZHAO
Senior Manager, Data Operations Leader, PAREXEL
John WANG
Principal Scientist, SAS Programming, Global Biostatistics, R&D,
Johnson & Johnson
AGENDA
Welcome and Opening Remark
Session 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 DESCRIPTION
The 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 CHAIR
Stacey FUNG, PharmD
Associate Director, Medical Communications, Genentech,
A Member of the Roche Group, USA
AGENDA
Session 1 | Developing Medical Information Strategy and Plans
SESSION DESCRIPTION
Pharmaceutical 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 CHAIR
David BOWERS
Director, Medical Communications, PPD
SPEAKERS
Elaine TSE
Regional Director, Medical Information Asia Pacific, Pfizer
Jianxiu YU
MI Director, Area Lead/Head of MI China, EMC, Pfizer
Provide to Patient Through Medical Function
Hugo YE
Medical 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 DESCRIPTION
Provision 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 CHAIR
Dannis CHANG, PharmD
Senior 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, MD
Medical Information Services, Novartis
A Journey to Globalization: Local Publication Practice Under
Global Guidelines And Regulations
Eric YU, PhD
Medical 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, MD
Director, Medical Science Excellence, Medical, Roche
Session 3 | The MSL Role across the Globe – Past,
Present and Future
SESSION DESCRIPTION
This 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-CHAIRS
Drew SCHEIFELE, PhD
Head of Medical, Asia Pacific Region, Biogen, Singapore
Lnyy BASS
JazzPharma
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-CHAIRS
Drew SCHEIFELE, PhD
Head of Medical, Asia Pacific Region, Biogen, Singapore
Lnyy BASS
JazzPharma
The MSL Role in Asia, a Perspective from China
Alex Condoleon, PhD
Vice 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 CHAIR
Huafei LI
Director, Medical Communication & Project Management,
Medical Affairs, Roche

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INVITED PANELISTS
Xuan HE , MBA
Head of Medical Communications, BHC China
Laura HUANG
Medical Governance Officer, GSK China Pharma
Jianxiu YU
MI Director, Area Lead/Head of MI China, EMC, Pfizer
Hugo YE
Medical Education Director, Eli Lilly and Company
Lizzy WANG
Medical Operations Director, Medical, Sanofi
Closing Remark
Stacey FUNG, PharmD
Associate Director, Medical Communications, Genentech, A
Member of the Roche Group, USA
LEAN: INNOVATIVE APPROACHES FOR AUTHORING CLINICAL,
CMC, AND NONCLINICAL REGULATORY DOCUMENTS
DESCRIPTION
The 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 CHAIR
Paul P. SOKOL, PhD
Senior Director, Neuroscience Regulatory Medical Writing
Janssen Research & Development, L.L.C., USA
PROGRAM COMMITTEE
Helle GAWRYLEWSI
Senior Director, Head Medical Affairs & Alliance Management,
Biometrics and Reporting, Janssen Research & Development, USA
Xing LI
Associate Director, Head of Janssen China R&D Medical Writing and
Translation Service Center, QS China, Janssen Research & Development
Paul P. SOKOL, PhD
Janssen Research & Development, LLC
KEY INSTRUCTORS
Yao YAO, PhD, RAC, CQA
Specially Invited Professor, IED, CFDA
Helle GAWRYLEWSI
Paul P. SOKOL, PhD
Senior Director, Neuroscience Regulatory Medical Writing
Janssen Research & Development, L.L.C., USA
AGENDA
Welcome and Opening Remark
Session 1 | Agenda for Workshop
Session 2 | Strategically Implement CTD Fundamental to CMC
and Nonclinical Document Writing
Session 3 | Introducing Lean Principles
Session 4 | Applying Lean Methodology to Authoring Clinical
Study Reports
Session 5 | Questions for Panel
Session 6 | Interactive Workshop Exercises for Subject
Disposition, Demography and Adverse Events
Session 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
INTRODUCTION
Haijun DONG, PhD, MBA
Senior Vice President and Managing Director, DIA Greater China
OPENING REMARKS
Barbara Lopez KUNZ
Global Chief Executive, DIA, USA
WELCOME ADDRESSES
Zili LI, MD, MPH
Senior Advisor, China R&D, Bill & Melinda Gates Foundation
Yajun ZHAO
Director-General, China Center for Food and Drug International
Exchange (CCFDIE)
WELCOME ADDRESSES FROM CFDA
CFDA Speaker Invited
KEYNOTE ADDRESS
Margaret A. HAMBURG, MD
Former Commissioner, FDA, USA
SPECIAL FORUM I :
BUILDING A SUSTAINABLE R&D ECOSYSTEM
Moderator
Steve YANG, PhD
Executive Vice President and Chief Operational Officer, Wuxi
Pharma Tech Inc.
Invited Panelists
Nancy MYERS, JD
Chair, the Board of Directors of FDA Alumni Association
President, Catalyst Healthcare Consulting, USA
Former Senior Policy Advisor to FDA Commissioner
Xianglin ZHANG, EMBA
Senior Engineer, President, Yeehong Business School, Shenyang
Pharmaceutical University
Yuwen LIU
Executive Director, Suzhou BioBay
Robert URBAN, PhD
Head, Johnson&Johnson Innovation Center, USA
Jin WANG
Partner, Mckinsey & Company
SPECIAL FORUM II :
INTERNATIONAL COLLABORATION IN PROMOTING AND
PROTECTING PUBLIC HEALTH
Moderators
Lin YUAN
General Director, Department of International Cooperation (Office
of Hong Kong, Macao and Taiwan Affairs), CFDA
Ling SU, PhD
Strategic 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/Affairs
BeiGene (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, PhD
Chief Executive Officer & Chief Scientific Officer
Shenzhen Chipscreen Biosciences Ltd.
Development of Conbercept Ophthalmic Injection in China
- A Chinese Story on a Global Scale
Yongzhong WANG, PhD
Deputy General Manager, Kanghong Pharmaceutical
Topic TBD
Speaker Invited
FUTURE DIRECTION OF GLOBAL DRUG DEVELOPMENT WITH
ICH E17 GUIDELINE FOCUSING ON MRCTS
Session Chair
Yoshiaki UYAMA, PhD
Director, Division of Epidemiology, Office of Safety I
Pharmaceuticals 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, PhD
Director, Division of Epidemiology, Office of Safety I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
How to Review MRCT Data for Drug Approval – From CFDA Perspective
Impacts of E17 Guideline for Drug Review and Approval in Taiwan
Lih-Jiuan HSU, MD
Senior 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, PharmD
Deputy 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, PhD
Dean, School of Business Administration
Shenyang 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 2
WEDNESDAY, 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 SHAO
Vice President and Director of R&D Center, Shanghai Fosun
Pharmaceutical (Group) Co., Ltd.
Innovation, Risk and Recognition: the Political Sociology for New
Drugs
Yinglian HU
Associate Professor, Chinese Academy of Governance
What Are We Still Lack of for New Drugs?
Ruilin SONG
Executive 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, PhD
Dean, School of Business Administration,
Shenyang Pharmaceutical University
New Drugs and Rational Medication
Luwen SHI, PhD
Professor, Peking University School of Pharmaceutical Sciences
PANEL DISCUSSION
All speakers from session 0105 & 0106
HOW OVERSEAS PRODUCTION SITE INSPECTION BE DONE
EFFICIENTLY AND EFFECTIVELY
Session Chair
Haifeng CAO, MBA
Head 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 KOTZAGIORGIS
Scientific 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, PhD
Director, 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, PhD
Director, 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 TRIALS
Session Chair
Shuting LI, MD
Director, 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 GUO
Global Monitoring Operation Country Head, China
Winnie XU
Senior Director, Clinical Operations, Quintiles
Huanling WANG, MD
Vice Director, Clinical Pharmacology Research Center, Peking
Union Medical College Hospital
Yongchuan CHEN
Director, GCP office, Southwest Hospital
Zhiqiang NING, MD, PhD
Vice President, R&D, Chipscreen Biosciences Ltd.
Tim SHI
Chief Representative for Global MD Organization China Office
THE FEASIBILITY OF INITIATING CLINICAL TRIALS BY SINGLE
IRB APPROVING IN CHINA
Session Chair
Shuting LI, MD
Director, 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 STRATEGY
Session Chair
Sunny ZHU, MD
Global 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, MD
Executive Director, Global Strategic Drug Development,
Center for Integrated Drug Development, Quintiles, Netherlands
ClinicalDevelopmentPlanConsiderationsforChinaLocalInnovations
Ning XU, PhD
Executive Vice President, Head of Clinical Development and
Regulatory
Affairs, Zai Laboratory
PANEL DISCUSSION:
Global vs China, MNC vs Local: Considerations in CDP
All Speakers and Invited Panelists
Zhi-Qiang NING, MD, PhD
Vice President, R&D, Shenzhen Chipscreen Biosciences Ltd.
Yuan LI, MD
Director, Product Development Strategy, Merck
Paul DAI, MD
Senior 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, MD
Senior 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, PharmD
Director, 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, PhD
Head of Clinical Pharmacology, Bayer R&D Center, China
Special Considerations for First-in-Man Studies
Peiming MA, PhD
Senior Director, Clinical Pharmacology, R&D Center, GSK China
CLINICAL OPERATION RISK BASED MONITORING
Session Chair
Vicky CHEN, MD
Senior 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 WILSON
Associate Director, Regional Clinical Operations, Bristol-Myers
Squibb, Canada
Elements of Successful Partnering to Execute Risk Based Monitoring
PJ CHEN
Executive Director, Area Head, North Asia Clinical Management,
PPD
DEBATE: Is Risk-Based Monitoring an Appropriate Methodology
for Clinical Trials in Emerging Region?
Moderators
Bo ZHENG
Head of Data Management, Statistics, Epidemiology and Data
Management, China Medicines Development, GSK
Bin LI
Managing Director, CMIC (Beijing) Pharmaceutical Services Co.,
Ltd.
Invited Panelists
Fanny 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 WIDE
Session Chair
Hualong SUN, MD, PhD
General 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 CHANG
Associate Director, Clinical Operations, Clinical Study Unit, Sanofi
Manage Key Project Millstones Involving Sponsor, Sites and CRO
Wenchi LIN
Senior Portfolio Director, Portfolio Leadership Phase II/III, PAREXEL
Challenges of Patients Enrollment and Compliance Management
from Investigator Sites
Laiping ZHONG, Professor
Department 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 TRIALS
Session Chair
Ouhong WANG, PhD
Director, 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, PhD
Manager, Biostatistics, Amgen
Flexible Modelling of Survival Curves for Censored Data in
Oncology Trial
Steve SU
Senior Biostatistician, Covance, Australia
Interval Censoring and Its Applications to Oncology Endpoints
Chao ZHU, PhD
Research Scientist, Eli Lilly and Co.
Statistical Considerations in Analyzing Recurrent Events
Fan XIA, PhD
Biostatistician, Roche
APPLICATION OF BAYESIAN METHODS FOR CLINICAL TRIALS
Session Chair
Bingming YI, PhD
Head 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, PhD
Director, 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, PhD
Senior Principal Scientist, Biostatistics, MSD R&D (China) Co. Ltd.

27
A Case Study for a Bayesian Approach to the Assessment of Safety
for Biosimilar and Its Application to Bridging Study
Jerry WANG, PhD
Head, GBS China, Merck Serono
EVOLVING CDM ROLE IN CLINICAL TRIALS
Session Chair
Li DING
Senior 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 CHEN
Head of Clinical Data Services, Pfizer China R&D Center
Evolving CDM Role Enabled by Technology – EDC
Tai XIE, PhD
President & 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 ZHANG
Regional Director, Clinical Data Management, Global Data
Management & Standard – Asia Pacific CT, MSD R&D (China) Co.,
Ltd.
QUALITY AND INTEGRITY OF CLINICAL TRIAL DATA
Session Chair
Daniel LIU, PhD
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, PhD
Summary Level Clinical Site Data for Data Integrity Review and
Inspection Planning in NDA and BLA Submission
Jingwei GAO
Regional Head, Regional Statistical Programming-Pan Asia META
Boehringer Ingelheim(China) Investment Co., Ltd.
STATISTICS AND DATA MANAGEMENT JOINT SESSION
- THE COLLABORATION OF DM AND STATISTICS (PART I)
Session Chair
Carina REINICKE
Biometrics 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, PhD
General manager, Meta Clinical Technology
Randomization in Clinical Trials: Implement and Randomization
Irregularity Control
Bob YAN, PhD
Head 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, MBA
Head 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, PhD
Senior Director, Data Management and Biometrics
Shanghai Hengrui Medicine Co, Ltd.
Quality by Design - Carved in Data Management and Statistics
Luyan DAI, PhD
Associate 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 DECISION
Session Chair
Yuan MENG, MD
Director, Safety Surveillance and Risk Management
Worldwide 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 AYOUB
Senior Director, SSRM DA Cluster Head, Pfizer, UK
Safety Science in Drug Development and Cases Study
Mason SHIH, PhD
Site 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, MBA
Director, 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 KHOURY
Vice President - Global Head, Research & Alliance Services, ICON
Commercialization & Outcomes, USA
Safety Use In The New Diabetes Medicines And Drug Safety
Management In Hospital
Yiming LI
Professor, Huashan Hospital of Fudan University

29
POST MARKETING SAFETY SURVEILLANCE
Session 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 WANG
Professor, Huashan Hospital of Fudan University
Signal Detection during Post-marketing Surveillance
Howe LI
CEO, Tigermed
ACTIVE SAFETY SURVEILLANCE
Session Chair
Min CHEN, RPh
Clinical Safety and Pharmacovigilance Expert, Pharmacovigilance
Consulting, LLC, USA
Former 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, RPh
Clinical Safety and Pharmacovigilance Expert, Pharmacovigilance
Consulting, LLC, USA
Former Director of Pharmacovigilance, Office of Surveillance and
Epidemiology, CDER, FDA
Opportunities and Challenges for Active Surveillance
Songlin XUE, MD, PhD
Executive Vice President, Head of Global Pharmacovigilance, Astellas
Experience of Active Surveillance in China
VACCINE SAFETY AND RISK MANAGEMENT
Session Chair
William WAN
Head, 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, MPH
Director, AEFI Surveillance, National Immunization Program,
Chinese Center for Disease Control & Prevention
The Safety of Vaccine: Scientific and Technological Discussion
Li SHI, PhD
Chief Executive Officer, Shanghai Zerun Biotechnology Co., Ltd.

30
HERBS SAFETY
Session Chair
Hellen ZHANG
Pharmacovigilance 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 GAO
Professor, Beijing University of Chinese Medicine
Chair Member of Drug Clinical Evaluation/Research Committee,
China Association Of Traditional Chinese Medicine
Practical Experience on TCM Product Safety
Hui CAO
Director, National Engineering Research Center For Modernization
Of Traditional Chinese Medicine
Member 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
Member
Former Deputy Director, Office of New Drug Quality Assessment,
CDER, FDA
Executive Director, Global CMC, Pfizer, USA
Melly LIN
Senior 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, PhD
Member of US FDA Alumni Association
Senior Consultant, Biologics Consulting Group, USA
Overview of Regulations and Guidelines on Post-Approval CMC
Changes for Biotechnological Products in the US
Duu-Gong WU, PhD
Member of US FDA Alumni Association
Director, Global Regulatory Consulting/Senior Consultant,
Pharmaceutical Product Development, USA
Post-Approval CMC Changes for Chemical Drugs in China
Zhen CHEN, PhD
Professor, Medicine College, Zhengzhou University
Former Deputy Director, CMC Division I, CDE, CFDA

31
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
Melly LIN
Ltd.
Chi-Wan CHEN, PhD
Member
CDER, FDA
Experience Sharing on Multiple Sites for Biologics
Jofeng CHI
Section 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
Chi-Wan CHEN, PhD
Member
CDER, FDA
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 TOWNHALL
Session Chair
Melly LIN
Regulatory Manager, Technical Regulatory Policy
Roche (China) Holding Ltd.
With the advent of globalization the need for harmonized
pharmaceuticalstandardshasbecomeincreasinglyurgent.InChina,
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 ZHANG
Secretary 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
Melly LIN
Ltd.
PANEL DISCUSSION
All Speakers
Theme 7
Biologic Development
NEW TREND/TECHNOLOGY IN BIOLOGIC DEVELOPMENT
Session Chair
Chengbin WU, PhD
Chief Scientific Officer, President of R&D
Shanghai 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, PhD
General Manager, Corporate VP of R&D
Amgen BioPharmaceutical R&D (Shanghai) Co., Ltd.
Topic TBD
Kang LI, PhD
Head of Biologics, BeiGene

32
Adagene’s Innovative Antibody Technology and Pipelines
Peter LUO, PhD
Co-founder and Chief Executive Officer, Adagene Inc.
SAFETY EVALUATION OF NEW TYPES OF ANTIBODIES
Session Chair
Jufeng WANG, PhD
Director, National Center for Safety Evaluation of Drugs
National 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, DABT
Senior 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, PhD
Director, General Toxicology, NCSED, CFDA
Preclinical Safety Evaluation of Therapeutic Monoclonal Antibody:
-Previous Experience and Future Direction
James YAN, MD, PhD
Executive Director and Site Lead, Early Development Business
Unit, 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, PhD
Head, 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, PhD
Head, 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

33
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 DENG
Vice President, Regulatory Affairs, AstraZeneca Investment(China)
Co., Ltd.
Biosimilar: Advantages in Regulatory Pathway
Weidong JIANG, PhD
Chief 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
BIOLOGICS
Session Chair
Haifeng SONG, PhD
Professor, 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, PhD
President and Chief Scientific Officer, Biologics Development Services
Navigating the Immunogenicity Regulatory Landscape
– Lessons Learned from Secukinumab BLA Submission
Eric LIANG, PhD
Group Manager/CNIBR DMPK-Biologics, Novartis
Topic TBD
Shalini GUPTA, PhD
Director, Clinical Immunology-PKDM, Amgen Inc.
Theme 8
Breakthrough with Innovative
Therapies- Therapeutic Driven
Drug Development
BREAKTHROUGH BY INNOVATIVE DISEASE THERAPIES
Session Chair
Xiaoxiang CHEN, PhD
Vice 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, PhD
Professor, People’s Hospital, Peking University
Overview Innovative Therapies in Year 2014 and Forecast of Year
2015
Xiaoxiang CHEN, PhD
Vice President, Medicine Development, Greater China,
Boehringer Ingelheim
BREAKTHROUGH OF INNOVATIVE CANCER THERAPIES AND
IMPACT ON LOCAL INNOVATION IN CHINA
Session Co-Chairs
Jian PENG, PhD
Scientific Advisor, Asia-Pacific R&D, Sanofi
Xianping LU, PhD
Chief 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

34
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, PhD
Professor, 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
Xianping LU, PhD
Chief Executive Officer & Chief Scientific Officer, Shenzhen
Chipscreen Biosciences Ltd.
BREAKTHROUGH THERAPIES IN DIABETES DISEASES
Session Co-Chairs
Yan GONG, MD, PhD
Senior Global Clinical Program Lead, Corporate Division of
Medicine, Boehringer-Ingelheim, Germany
Joan SHEN, PhD
Vice 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, MBA
Vice President, Clinical & Medical & Regulatory, Novo Nordisk
(China) Pharmaceuticals Co. Ltd.
Recent Advancement of Drug Development in Diabetes
- Synthetic Chemical Entity
Shuhua SHANG
Project/Clinical Research Director, AP R&D, Sanofi China
Outlook of Drug Development in Diabetes
– A Shift to “Glucose Plus”
Yan GONG, MD, PhD
Senior Global Clinical Program Lead, Corporate Division of
Medicine, Boehringer-Ingelheim, Germany
Status Quo, Challenges and Opportunities for Domestic Companies
in Diabetes Therapies
Eric HUA
Overseas Clinical Project Manager,
Gan & Lee Pharmaceuticalsd
Pipeline in Diabetes - From the Industrial Perspective
Chengyu GUAN, PhD
Medical 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, MD
Vice President, Clinical Development,
General Medicine BU, Asia-Pacific Region, INC Research
Lai WEI, PhD, MD
Director and Professor, Peking University Hepatology Institute
Vice 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, MD
Director and Professor, Peking University Hepatology Institute
Vice 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, PhD
Founder, President and CEO, Ascletis BioScience Co., Ltd.
How from Regulatory Perspective a China Component Should be
Embraced in the Clinical Development Plan
PohYeng THAI, PhD
Director, Regulatory Affairs, HCV Project in Asia Pacific Region,
Abbive, Singapore

35
Theme 9
Functional Specific Issues in
Drug Development
MEDICAL WRITING EVOLUTION AND EXPANSION: FROM
GLOBAL TO CHINA, FROM THE PAST TO THE FUTURE
Session Chair
Julia COOPER
Vice 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, PhD
Head, Clinical Operations / Medical Writing Europe,
Boehringer Ingelheim Pharma GmbH & Co. KG, Germmany
Medical Writing Evolution and Expansion in China
Nan WANG, PhD
Scientific 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 Pacific
Director, 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 JI
Senior 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 SELVASTINE
Manager, 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 FREDERICKSEN
Chief Science Officer, DITA Exchange, Denmark

36
WHY IS PROFESSIONAL MEDICAL WRITER NEEDED IN
BOOSTING SCIENTIFIC PUBLICATION IN CHINA?
Session Chair
Xiaoling WANG
Head 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 , RPh
Director, Asia-Pacific Medical Communications, Eli Lilly
Why Important and How to Do Successful Publication of China Data
Yang RUI, PhD
Senior Scientific Communication Manager, Novonordisk
Clinical Trial Data Sharing: A Publisher's Perspective
Huili CHEN
Business Development Manager, BMJ China
TECHNOLOGY LEADS TO NEW OPPORTUNITIES FOR MEETING
CUSTOMER MEDICAL INFORMATION NEEDS
Session Chair
Stacey FUNG, PharmD
The session will focus on the opportunities to engage customers in
newandimpactfulwaysasthenatureofhealthcarecommunications
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, PharmD
Does Size Really Matter?
Wendy HUO
Associate Director, Pfizer China Business Technology
Different Roles Using a Globalized MI System for Internal and
External Customers
Jack YU
Medical Information Manager, Medical Communication, Roche
REGULATORY WRITING: CTD, ICH E3-COMPLIANT CSR, AND
CHINA SUBMISSION DOSSIER PREPARATION
Session Chair
Hongbo ZHU, PhD
Head, 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, PhD
Team Leader, Medical Writing Europe,
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Clarifying ICH E3 - Clinical Study Report Guideline from Then to
Now
Helle GAWRYLEWSKI
PANEL DISCUSSION: Development of Submission Dossier for
China NDA/CTW
Yao YAO, PhD, RAC, CQA
Specially Invited Professor, IED, CFDA
Haidan WANG
Submission Manager, Oncology Developmment (Drug Regulatory
Affairs), Novartis Pharma
Hui GAO
Regulatory manager, Regulatory affair, Johnson & Johnson China
R&D

37
Kelly ZHANG
Regulatory Affairs Associate Director, MED-DRA, Boehringer
Ingelheim
Emma CHEN
Vice 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 DRISCOLL
Vice 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”Connell
Senior Director, Risk Management and External Engagement of
BRQC, Johnson&Johnson
Trial-Level Quality approach highlighting RBM, QBD and Perhaps
Risk Based Auditing
Brett WILSON
Associate Director, Global Development Operations, Bristol-Myers
Squibb, USA
CFDA Focus on Quality
PANEL DISCUSSION
All speakers and:
Hannah CHEN, MD
Director, AP/China R&D, Quality Assurance, Janssen Pharma R&D,
Q&C
Helen LI, MBA
QA Asia Lead, Emerging Market/PCO QA, Medical Quality
Assurance, Pfizer
SITE MANAGEMENT & SMO
Session Chair
Reako REN
Executive 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 LIU
Director, GCP Office, Shanghai Fudan University Cancer Hospital
Fast Site Start-up and Patient Enrollment with CRC
Maggie GU
Director, 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 GUO
Director, Clinical Development, Novartis Oncology
"Today and Future"- China SMO Development Trend/Model and
Operation Experience Share
Reako REN
Executive Director and Head of SMO Services, WuXi Apptec

38
INTERNATIONALIZATION OF CHINESE CRO IN CHINA
Session Chair
Bin LI
Managing 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, MD
Senior Director, Clinical Project Management, Quintiles Great China
Breakthrough Analytics within Clinical Trial Conduct
David KIGER
Vice 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, Professor
Chief 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, PhD
Pharmacologist, 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, PhD
Director, Tongren Tang Research Institute
Research and Development of Botanical Drug in China: The
Different Requirements for Traditional Chinese Medicine and
Natural Produc
Long CHENG, PhD
Professor, Director, Pharmaceutical Innovation and New Technology
ResearchOffice,ChinaNationalHealthDevelopmentResearchCenter
Former Senior Review, CDE, CFDA
DEVELOPING NEW DRUGS FROM TRADITIONAL CHINESE
MEDICINE FOR UNMET PUBLIC HEALTH NEEDS (PART II)
Session Chair
Lei ZHANG, PhD
Professor, Shanghai University of Traditional Chinese Medicine
Associate 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

39
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, PhD
Chief Scientific Adviser, Shanghai Innovative Research Center of
Traditional Chinese Medicine
Lab 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, PharmD
Director, Division of Clinical Pharmacology-3, Office of Clinical
Pharmacology, Office of Translational Sciences, FDA, USA
PANEL DISCUSSION
Tao DU, PhD
Chief Executive Officer, Humphries Pharmaceutical Consulting
Henry SUN, PhD
Vice President, Tasly Holding Group
WHO VACCINE SESSION (PART I): NEWER THAN NEW-
INNOVATIONS TO CREATE NEW HEALTH SOLUTIONS AND
DELIVERIES
Session Chair
Yiwu HE, PhD, MBA
Senior Program Officer, Global Health, Bill & Melinda Gates Foundation
WHO Vaccine Prequalification Program for High Burden Diseases/
WHO
Lance RODEWALD, MD
Expanded 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, PhD
Acting 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
DELIVERIES
Session Chair
Yiwu HE, PhD, MBA
Senior 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, PhD
Chief Medical Officer, P4 Medicine Institute, USA
A Practical View on Precision Immunotherapy: Engineering the
Body’s Immune System to Treat Cancer
Xiangjun ZHOU, PhD
Chief Scientific Officer, SYZ Cell Therapy Co.
GENERIC DRUG FORUM (PART I) – GLOBAL REQUIREMENTS
AND REGULATORY INITIATIVES
Session Chair
Shaoyu CHEN, JD
Member of FDAAA
Former Assistant Chief Counsel, Office of Chief Counsel,
Office of Commissioner, US FDA
Partner 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, JD
Director 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, RPh
Director, Pharmaceutical Science, CDE, TFDA, Taiwan
Generic Drug Development – PMDA Consideration and Practices
Toru YAMAGUCHI, MSc
Reviewer, Office of Generic Drugs, PMDA, Japan

40
GENERIC DRUG FORUM (PART II) - GLOBAL REQUIREMENTS
AND REGULATORY INITIATIVES
Session Co-Chairs
Ren YI, PhD
General Manager, China Region
Nanjing Medichem Bio-Pharmaceutical Development Co.
Jane CAI, PhD
Former 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 SUN
Director, China Quality Association for Pharmaceuticals (CQAP)
Bio-Equivalency Studies – FDA Consideration, Expectation and
Practices
Bing V. LI, PhD
Vice President, American Chinese Pharmaceutical Association,
USA
Consideration for Generic Product Development in Emerging Markets
Chao YE
Director, Asia Pacific OTC R&D Product Development, Shanghai
Johnson& Johnson Pharmaceuticals, Ltd.
GENERIC DRUG FORUM (PART III) - LESSONS LEARNED FROM
QUALITY AND COMPLIANCE INSPECTION
Session Chair
Lee KANG, PhD, MBA
Vice President and General Manager, Achlis Group
Consultant, 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, PhD
Assistant Country Director, FDA China Office
China and Beyond - Generic Drug Development and Quality
Management
Xuejie DOU
Senior Director, Quality, Xinhua Pharmaceutical
What We Learn from China and India Generic Drug Quality
Management
Lee KANG, PhD, MBA
Vice President and General Manager, Achlis Group
Consultant, The Perrigo Company, Hong Kong

41
PANEL DISCUSSION – WILL CHINA LEAD THE GLOBAL
DEVELOPMENT FOR GENERIC DRUGS?
Session Chair
Ruilin SONG, PhD
Executive President,
China Pharmaceutical Industry R&D Association (SINO-PhIRDA)
Invited Panelists
Keith FLANAGAN, JD
Director, and head of Office of Generic Drug Policy (OGDP), Office
of Generic Drugs, CDER, FDA
Bing LI, PhD
Vice President, American Chinese Pharmaceutical Association, USA
Gang WANG, PhD
Assistant Country Director, FDA China Office
Lee KANG, PhD, MBA
Vice President and General Manager,
Achlis Group Consultant, The Perrigo Company, Hong Kong
Guohua ZHANG, PhD
President and CEO, Novast Laboratories Ltd.
Shaoyu CHEN, JD
Member of FDAAA
Former Assistant Chief Counsel, Office of Chief Counsel,
Office of Commissioner, US FDA
Partner 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 ERA
Session Chair
Darren JI, PhD, MBA
Global 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, PhD
Chairman and Chief Executive Director, Zai Laboratories
Steve YANG, PhD, MBA
Executive Vice President and Chief Operating Officer, WuxiApptec
Jinzi WU, PhD
Founder, President and CEO, Ascletis Biosciences
Frank JIANG, PhD
Vice President and Head of Asia Pacific R&D, Sanofi
MONEY, TECHNOLOGY AND LEGAL STRUCTURE - PUT
TOGETHER THE JIGSAW PUZZLE FOR AN INNOVATIVE
PARTNERSHIP
Session Chair
Wendy PAN
Partner, 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, PhD
Chairman & Chief Executive Director, Innovent Biologics, Inc.
Xueming QIAN, PhD
Founder, Chairman and CEO, MabSpace Biosciences
Dadong CHEN
Managing Partner, BFC Group

2015 DIA China

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