药物信息协会(dia)第六届中国年会 -...

药物信息协会(DIA)第六届中国年会质量与合规 —— 满足患者需求的保证

6th DIA China Annual MeetingQuality and Compliance - Meeting Patients' Needs

中国 · 上海国际会议中心

Shanghai International Convention Center, China

2014 年 5 月 11 日 —— 会前专题研讨会 2014 年 5 月 12-14 日 —— 会议、展览和壁报

May 11, 2014 - Preconference WorkshopsMay 12-14, 2014 - Conference, Exhibition and Posters

PRELIMINARY PROGRAM会议手册 (2014-04-25)

W W W . D I A C H I N A . O R G

合办单位：

中国食品药品国际交流中心

主办单位：

药物信息协会

药物信息协会(DIA)第六届中国年会

6th DIA China Annual Meeting

2014 Shanghai

欢迎您 Tervetuloa � 반갑습니다

Accueil Welcome Welkom

Willkommen Bienvenidos 歓迎欢迎您

Willkommen Bienvenidos

반갑습니다Tervetuloa Welcome

歓迎

主办单位/ Hosts

药物信息协会 / DIA 中国食品药品国际交流中心 / CCFDIE

官方合作媒体 / DIA Media Partners

www.pharmachinaonline.com

www. b i o 1000 . c om

6TH DIA CHINA ANNUAL MEETING

6th DIA China Annual Meeting - "Quality and Compliance - Meeting Pa-

tients’ Needs" will be held on May 11-14 at the Shanghai International Convention

Center. This program includes plenary and concurrent sessions, preconference

workshops, forums, town hall meeting with the CFDA, poster presentations, an

exhibit hall, networking receptions, and more!

Held once a year in China, the DIA China Annual Meeting is expected to

attract 1400 participants. As the largest annual meeting held in the Asia Pacific

region, the DIA China Annual Meeting will provide a neutral platform for informa-

tion exchange, featuring speakers that include high-level representatives from

government, industry and academia in China and abroad.

6th DIA China Annual MeetingProgram Vice Chair


Program Co-Chair


Program Co-Chairs

Dayao ZHAO, MD, PhDHead of China R&D and Scientific Affairs Vice President, Janssen Pharmaceutical R&D, Johnson & Johnson, China

ZHAO YajunDirector-General, China Center for Food and Drug International Exchange (CCFDIE), China

LI Zili, MD, MPHDeputy Director, Research and Development, Beijing Representative Office, Bill & Melinda Gates Foundation

4

Director, Global Compliance, Celgene Corporation

Mark J. GOLDBERGER, MD, MPH, FIDSAMember of FDAAA International NetworkFormer Director, Office of Drug Evaluation IV, CDER, FDAVice President, Regulatory Affairs, AbbVie, USA

John GONG, MD, PhDMember of FDAAAVice President, BeiGene (Beijing) Co.

David LIN, PhDMember of FDAAASenior Consultant, Biologics Consulting Group, USA

WANG Gang, PhDAssistant Country Director, US FDA China Office

Jim WEI, MD, PhDMember of FDAAADirector of Clinical Pharmacology, Medpace, USA

WU Duu-Gong, PhDMember of FDAAADirector, Regulatory Consulting/Senior Consultant, Global Regulatory Consulting, Pharmaceutical Product Development (PPD), USA

Dylan YAO, MD, PhDGLP Compliance Officer of FDAAAFormer FDA Senior ReviewerSenior Vice President & Chief Scientist Officer, Joinn Laboratories, Inc.

DESCRIPTIONPreparing for GMP, GLP, GCP, PV/Risk Management inspections by stringent regulatory authorities, including from the FDA and WHO, is critical for meeting quality and safety standards. This workshop will allow participants to learn from instructors with backgrounds from regulatory agencies and industry, and with first-hand experience in conducting inspections and undergoing inspections. Both didactic and interactive learning will be provided.

Workshop 1 | Sunday, May 11, 201408:30 - 17:30 (12:00 - 13:30 Lunch) 5th Floor, 5D+E

CAREER DEVELOPMENT ROUND TABLE

Workshop 2 | Sunday, May 11, 201408:30 - 17:30 (12:00 - 13:30 Lunch) 5th Floor, 5B+C

PRINCIPLES FOR SUCCESSFUL GxP INSPECTIONS: A HANDS-ON INTERACTIVE APPROACH BASED ON FDA, WHO AND INDUSTRY EXPERIENCES

PROGRAM CO-CHAIRSFlorence HOUN,MD, MPH, FACPCo-Chair of FDAAA International NetworkFormer Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Regulatory Affairs, Celgene Corporation, USA

Li Zili, MD, MPHCo-Chair of FDAAA International NetworkDeputy Director, Research and Development, Beijing Representative Office, Bill & Melinda Gates Foundation

INSTRUCTORSCHEN Chi-Wan, PhDMember of FDAAA International NetworkFormer Deputy Director, Office of New Drug Quality Assessment, US FDA/CDERExecutive Director, Global CMC, Pfizer, USA

Shaoyu CHEN, JDMember of FDAAAFormer Assistant Chief Counsel, Office of Chief Counsel, Office of Commissioner, US FDAPartner and Managing Director, China Food and Drug Practice, Beijing and Shanghai Offices, COVINGTON & BURLING LLP

Bruce CLOSE

SUNDAY, MAY 11, 2014 | PRECONFERENCE WORKSHOPS

FULL-DAY

08:30-17:30 Career Development Round Table

08:30-17:30 Principles for Successful GxP Inspections: A Hands-on Interactive Approach Based on FDA, WHO and Industry Experiences

08:30-17:30 Early Clinical Development from First-in-Human (FIH) to Proof of Concept (POC) Simultaneous

Translation

08:30-17:30 Project Management in Clinical Data Management

08:30-17:30 Data Safety Monitoring Board Simultaneous

Translation

08:30-12:00 Individual Case Safety Report (ICSR) Medical Review

HALF-DAY

Preconference Workshop Registration Open: May 10, 13:00 - 20:00 and May 11, 07:00 - 17:30

5LEARNING OBJECTIVES• Understand the fundamental principles for success for GxP

compliance and inspection

• Experience learning through role playing, scenario discussion and review of mock inspection materials to identify opportunities to improve and correct processes, procedures, and measures of compliance

• Utilize perspectives on overcoming challenging situations to improve GxP compliance

• Learn about regulatory expectations on industry from FDA alumni, inspectors on behalf of WHO, and industry experts

TARGETED AUDIENCERegulatory and compliance personnel from industry, regulatory authorities, and other interested parties in GxP and compliance.

Suggested background of participants:

• Must have at least 5 years of industry or regulatory experience

• Must have basic familiarity with GxP requirements

• Fluent in English

AGENDA

SESSION 1 | Introduction

SESSION 2 | GMP Principles

SESSION 3 | GCP Principles

SESSION 4 | GLP: Regulations and Practices China vs. USA

SESSION 5 | Pharmacovigilance & Risk Management Principles

SESSION 6 | GMP Exercise

SESSION 7 | GCP Exercise

SESSION 8 | GLP Exercise

SESSION 9 | Pharmacovigilance & Risk Management

Workshop 3 | Sunday, May 11, 2014 Simultaneous Translation

08:30 - 17:30 (12:00 - 13:30 Lunch) 5th Floor, 5F

EARLY CLINICAL DEVELOPMENT FROM FIRST-IN-HUMAN (FIH) TO PROOF OF CONCEPT (POC)

PROGRAM CHAIRLI Gailing, PhDDirector, Head of Clinical Pharmacology, Janssen China Pharmaceutical R&D

INSTRUCTORSDennis BASHAW, PharmDDirector, Division of Clinical Pharmacology,Clinical Pharm & Drug Development, FDA, USA

PENG Bin, MD, PhDGlobal Head, OTM China, China Novartis Institutes for BioMedical Research Co., Ltd.

CHEN Chao, PhDHead of Neuroscience Therapy Area, Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, UK

XIE Rujia, PhDHead of Clinical Pharmacology & Pharmacometrics, Pfizer China R&D

Maikel RAGHOEBAR, PhDSenior Director, Head of Clinical Pharmacology Unit, Janssen Pharmaceutical R&D, Belgium

HU Pei, MD Center of Clinical Pharmacology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

DESCRIPTIONThe workshop is designed to meet the growing needs in China for training of drug early development from First-in-human (FIH) to Proof of Concept (POC), where the first evidence of clinical efficacy is demonstrated in the target disease of interest. How to safely and efficiently to manage this early phase of clinical development using clinical pharmacology principles, modelling & simulation approaches, innovative POC design, robust clinical operation and monitoring will be discussed. At the end of the workshop, a panel discussion will be organized with regards to current challenges and future perspectives in early clinical development in China.

LEARNING OBJECTIVES• Overview of FIH study including study design, selection of starting

dose, dose escalation and stopping rule.

• How is a POC trial normally designed and carried out with precedent /unprecedented mechanism of action (MoA)

• Importance of proof of pharmacology & utility of novel clinical technology for POC

• Modelling & simulation for human dose prediction and POC decision-making

• Safety/risk management in early clinical development

TARGETED AUDIENCE• Professionals in pharmaceutical R&D (Local & global MNCs)

• Staff & managers from Ph1 units

• Professionals in translation medicine or experimental medicine research

• Physicians/ healthcare professionals involved in the early clinical development

• Clinical pharmacologists

• Professionals interested in PK/PD modeling & simulation

• Healthy authorities

• Academic professionals in health science/pharmaceutics

AGENDA

Session 1 | Overview of Drug Development from FIH to POC

Session 2 | FIH Study

Session 3 | POC Study

Session 4 | Innovative Approaches to Inform POC Go/No Go Decision

Session 5 | Modelling & Simulation in FIH-POC

Session 6 | Safety & Risk Management /Operational Aspects in Early Clinical Development

Session 7 | Regulatory Perspective

6Session 8 | Panel Discussion: Early Clinical Development in China: Past and Future

Workshop 4 | Sunday, May 11, 2014 08:30 - 17:30 (12:00 - 13:30 Lunch) 5th Floor, 5J

PROJECT MANAGEMENT IN CLINICAL DATA MANAGEMENT

PROGRAM CHAIRCarrie ZHANGRegional Director, Asia Pacific, Global Data Management & Standard, MSD R&D China

INSTRUCTORSFAN YitengSenior Manager, Team Leader, Trial Operations, China Clinical Science & Operations, Sanofi China

Gracy LIU Lead Data Management Specialist, Global Data Management & Standard, MSD R&D China

DESCRIPTIONClinical trial data include various sources, can be collected via paper or electronically, either way has advantages and disadvantages in data quality, operation, project budget control, et al. Selecting the most suitable data collection approach, implementing well considered data quality control procedures and applying appropriate risk control via good project management, are extremely important for quality data collection starting from clinical trial planning stage to database lock. This one day workshop will discuss best approaches for EDC study related clinical data, central lab data, ePRO and IV/WRS quality data acquisition.

LEARNING OBJECTIVES• To share view of different data needs and challenges,

• To discussing best practices in project management during trial execution,

• To learning best approaches for EDC study related clinical data, central lab data, ePRO and IV/WRS quality data acquisition.

TARGETED AUDIENCE• Clinical trial data managers

• Clinical trial project managers and administrators

• Clinical trial monitors

• Clinical trial quality assurance and quality control professionals

• Clinical development professionals and study coordinators

• Clinical regulatory affairs professionals

AGENDA

Session 1 | Opening Remark

Session 2 | Overview of Project Management in Clinical Trial Data Handling • Main components in clinical trial data project management

• Key points in risk forecasting

• Good project management practice in clinical trial data management life cycle

• Quality control and implementation

Session 3 | Data Source and Possible Influence Factors Impacting Data Collection for Clinical Trial • Type of written sources defining data to collect: protocol,

questionnaire, etc.

• Type of possible factors impacting data collection: local lab data entering limitation, special compliance need, etc.

• Data collection challenges in EDC, external data upload, ePRO, paper source, etc.

Session 4 | CRF Data Collection: EDC or Paper Study, Why?Assuming you as Clinical Scientist or Medical Director, Clinical Operation staff, investigator, et al, discusses EDC or paper study challenges, risks and advantages. Good practice will be concluded from study level, database system level, data operation level and investigator site level.

Session 5 | Lab Data Collection: Central Lab or Local Lab, Why?As a team, each one will share your understanding and resolution to the risks, challenges, potential issues. Mitigation plan can be considered for every study phase. We will discuss and conclude the best practice to manage both local lab and central lab data.

Session 6 | Do We Want To Use IV/WRS or ePRO: Yes or No, Why?What is IV/WRS? What advantages can it bring to the trial? How to decide if we will invest to this tool to manage drug supply? How can ePRO transit study quality? Does it worth the cost? Group discuss will conclude the sensible points can be adopted in clinical trials.

Session 7 | If EDC Study, Central Lab, IV/WRS, ePRO All Selected for Your Trial, How Will You Manage Your Time Table, Project Risk and QualityAs a Clinical Data Manager, throughout study set up, in life, and close out stage, what should we require or provide to study team? How to define and control risks and challenges? How to perform quality control to ensure data quality?

Workshop 5 | Sunday, May 11, 2014 Simultaneous Translation

08:30 - 17:30 (12:00 - 13:30 Lunch) 5th Floor, 5 I

DATA SAFETY MONITORING BOARD

PROGRAM CO-CHAIRSRebecca H. LI, PhDExecutive Director, Multi-Regional Clinical Trials (MRCT) Center, Harvard University, USA

William WANG, PhDExecutive Director and Regional Head, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co., Ltd.

INSTRUCTORSSteven SNAPINN, PhDVice President of Global Biostatistical Science, Amgen, USA

YAO Chen, Professor Vice Director, Peking University Clinical Research Institute, Head of Department of Biostatistics, Peking University First Hospital

DESCRIPTIONThe DIA Data Safety Monitoring Board workshop will be led by Harvard Multi-Regional Clinical Trials Center and DIA. Faculty from Harvard, CFDA and representatives from industry will discuss various aspects of how clinical data can be monitored by an independent board – the DMC or DSMB. The format will be a workshop including lectures,

7discussion and case studies.

LEARNING OBJECTIVES• To gain understanding on what types of trial requires a DSMB to

monitor safety

• To understand the roles and responsibilities of the DSMB members

• To understand the regulatory guidance pertaining to monitoring trials using a DSMB

• Gain knowledge on how trials may be stopped for futility or efficacy

• Understand how multi-regional clinical trials are monitored for safety

TARGETED AUDIENCERegistration is open to attendees from industry, academia and government. Clinicians, biostatisticians, principal investigators, study coordinators, project managers, regulatory officers, bioethicists, and research nurses with clinical trial experience are welcome

AGENDA

Session 1 | Current DSMB Practices in China

Session 2 | Introduce the Harvard DSMB Program and Practices of DSMB

Session 3 | When Do You Need a DSMB and Responsibilities of DSMB Membership

Session 4 | Monitoring for Safety & Efficacy

Session 5 | Monitoring for Futility

Session 6 | Multi-regional Clinical Trials and Decision-making

Session 7 | Case Study

Session 8 | Panel Discussion

Upon Completion of the Course You Will Obtain:

• Data Safety Monitoring Board Training Course Registration

• A Certificate of Completion awarded jointly by DIA and the Harvard MRCT Center

• Potential Eligibility to serve on DSMBs for trials taking place in your country of residence

• Potential selection as a Harvard DSMB fellow Biographies of the Speakers

Workshop 6 | Sunday, May 11, 2014 08:30 - 12: 00 5th Floor, 5H

INDIVIDUAL CASE SAFETY REPORT (ICSR) MEDICAL REVIEW

PROGRAM CHAIRZHU Rong, MD, PhDMedical Director, Product Safety Surveillance and Reporting, Pfizer (China) R&D Ltd.

WANG Yuhong, MDSafety Science Leader, Global Safety Risk Management, Roche Product Development in Asia Pacific

INSTRUCTORSZHUANG Junyan, MD Medical Director, Product Safety Surveillance and Reporting, Pfizer (China) R&D Ltd.

CHEN Wenjuan, MDMedical Director, Product Safety Surveillance and Reporting, Pfizer (China) R&D Ltd.

ZOU Chen, MD, PhDSafety Risk Lead, Safety Surveillance and Risk Management, Pfizer (China) R&D Ltd.

ZHOU Lingyun, MDAssociated Director, International PV Coordinator, Global Pharmacovigilance and Epidemiology

DESCRIPTIONIndividual case safety report (ICSR) is fundamental in the safety surveillance of medicines. It is therefore important to capture information on ICSRs in a structured manner and to the highest possible quality standards to support accurate detection and analysis of drug safety signals. With the quick development of Chinese pharmaceutical companies and contract research organizations, there is an urgent need for our local reviewers to have both higher capacities and more experience in ICSR medical review, keeping the pace with the professionals around the world. Moreover, local pharmaceutical community will need to comply with the global standards of ICSRs reporting, such as major agencies’ requirement and ICH guidelines, to make the products approved globally, to improve the monitoring of the medicinal products already on the market, thereby to ensure the safety of patients using medicinal products.

The most common challenges in ICSR medical review are accurate event coding, expectedness and causality assessment. This workshop will provide the audience both introduction of global standards and practicing experience.

LEARNING OBJECTIVES• Know the points to consider for high quality event coding

• Learn how to perform the accurate expectedness assessment in individual cases

• Know the various methods for causality assessment in ICSRs and the requirement in FDA final rule

• Learn how to perform appropriate causality assessment using the method of Global Introspection based on FDA final rule

TARGETED AUDIENCE• ICSR reviewers

• Safety risk management of medicinal products

• Medical writers who develop CSRs

• Data managers and operators who need interact with ICSR medical reviewers

AGENDA

Session 1 | Introduction

Session 2 | Event Coding and Expectedness Assessment in ICSRs • Introduction of terminology used in event coding

• Points to consider for accurate event coding and MedDRA coding quality

• Event expectedness assessment – principles and experiences

Session 3 | Causality Assessment in ICSRs

8• Various methods for causality assessment in ICSRs

• How to perform appropriate causality assessment using the method of Global Introspection based on FDA final rule

Session 4 | Case Discussion and Q&A

9

The Role of Phase I Unit for Drug Development in China HU Bei, MD, Professor Director, Clinical Pharmacology Research Center, Beijing Union Medical College Hospital

Innovation of Clinical ResearchWANG Yongjun, MD, ProfessorVice President, Beijing Tiantan Hospital, Capital Medical University

Quality Control for Multi-Center Clinical TrialsJIANG Lixin, MD, PhD, FACC, ProfessorAssistant Director, National Centre for Cardiovascular Diseases (NCCD)Executive Deputy Director, National Clinical Research CentreCo-Director, China Oxford Centre for International Health ResearchFuwai Hospital, CAMS&PUMC

Session 0102 | Tuesday, May 13, 2014 Simultaneous Translation

10:30 - 12:00 1st Floor, Century Hall

DESIGN AND CONDUCT VALUE-ADDED AND HIGH QUALITY POST-MARKETING STUDIES

SeSSion Chair

Jane LIN, MDVice President, Strategic Medical Affairs, Johnson & Johnson Medical (China) Ltd.

Theme 1 | Clinical Research & Operations

Session 0101 | Tuesday, May 13, 201408:30 - 10:00 1st Floor, Century Hall

HOW TO BUILD A HIGH QUALITY CLINICAL RESEARCH CENTER

SeSSion Chair

LI Haiyan, MD, Professor Director, Drug Clinical Trial Center, Peking University Third Hospital Vice Director, Clinical Research Institute, Peking University

Successful drug development highly dependents on how to conduct high-quality clinical trials. Since the initiation of National Major Scientific and Technological Special Project for “Key New Drug Innovation Plan”, more than 60 hospitals nationwide in China have been funded to setup the high-quality GCP centers, which are designed to provide support for innovative drugs clinical research based on the China "11th Five-Year" and "12th Five-Year" development plans. This session will cover the mechanism for establishing collaborative innovation, training for professional training, technology platform support, and clinical studies capability enhancement.

MONDAY, MAY 12, 2014 | CONFERENCE DAY 1

Keynote Address Simultaneous Translation

SHI Yigong, PhDProfessor and Dean of School of Life Science, Director of Institute of Biomedicine, Tsinghua UniversityAcademician of Chinese Academy of SciencesAcademician of United States National Academy of SciencesAcademician of American Academy of Arts and Sciences

Jay P. SIEGEL, MDChief Biotechnology Officer and Head of Scientific Strategy and Policy,Johnson & Johnson, USAFormer Senior Official, US FDA Biologics Evaluation & Research (CBER)

Special Forum Simultaneous Translation

MOVING TOWARD A GIANT PHARMACEUTICAL COUNTRY – THE ROLES OF CHINESE INDUSTRY, SOCIETY AND GOVERNMENT

Networking Reception 17:30 - 19:00 1st Floor, Exhibition Hall

Opening Plenary Session Simultaneous Translation

13:30 - 17:30 7th Floor, Grand Ball Room

INTRODUCTIONDONG Haijun, PhDManaging Director, DIA China

OPENING REMARKSBarbara Lopez KUNZGlobal Chief Executive, DIA, USA

WELCOME ADDRESSESZHAO Dayao, MD, PhDHead of China R&D and Scientific Affairs, Vice President, Janssen Pharmaceutical R&D, Johnson & Johnson

ZHAO YajunDirector-General, China Center for Food and Drug International Exchange (CCFDIE)

TUESDAY, MAY 13, 2014 | CONFERENCE DAY 2

WEDNESDAY, MAY 14, 2014 | CONFERENCE DAY 3

Conference Registration Open: May 10, 13:00 - 20:00; May 11, 13:30 - 17:30; May 12 - 14, 07:30 - 17:30

10Post-marketing studies account for a large portion of studies in the product life cycle. The objectives and methodologies applied in the post-marketing phase are diversified. Different research method-ologies have their specific features, strengths and limitations, and are subject to different rules and regulations. As of today, there are no clear official guidelines in China to define these studies. In this ses-sion, speakers from industry and academia will discuss the scientific, operational and regulatory aspects of various methodologies and how these principles can be applied in China to enhance value, quality and compliance of post-marketing studies to maximize benefits and reduce risk to the patients.

Considerations In Design and Successful Execution of Observational ResearchAgnes RIVAILLE, PharmD Scientific Affairs Director, Late Phase Services, PRA, France

Observational Research to Enhance Innovative Medicines' Impact on Patients and SocietyDONG Wei, MD, PhDDeputy Site Head for Roche Global Product Development in Asia Pacific (PDY)

Using Outcomes Research for Product Life Cycle Management & Payer SupportNancy DREYER, MPH, PhDGlobal Chief of Scientific Affairs & Chief Vice President, Real-World and Late Phase Research, QuintilesAdjunct Professor, University of North Carolina at Chapel Hill, USA

Session 0105 | Wednesday, May 14, 201408:30 - 10:00 1st Floor, Century Hall

EVOLVEMENT IN DIABETES AND OBESITY PREVENTION AND TREATMENT - IMPACT ON DRUG DEVELOPMENT

SeSSion Chair

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

Diabetes and obesity special discussion will invite well-known Chinese diabetes expert to share the landscape of diabetes incidence in China and the research progress on preventing; Foreign experts on drug development will share their rich experience on designing diabetes drug development plan and the choice of assessment endpoints , eventually how to cooperate with the authorities on efficacy and safety requirements and evaluation.

Early Phase Clinical Research and Development for Diabetes and ObesityMarcus HOMPESCH, MDPresident & CEO, Profil Institute for Clinical Research, Inc. USA

New Model to Tackle the Operational Challenges in Diabetes Drug Clinical Development.Andreas KOESTER MD, PhDHead of Clinical Trial Innovation & External Alliances, Janssen R&D Pharma, Johnson & Johnson, USA

Regulatory Landscape for the Development and Approval of Anti-Obesity & Diabetes Drugs in the US and EUJim WANG, PhD, MBASenior Director, Global Regulatory Affairs, Novo Nordisk A/S, USA

Session 0106 | Wednesday, May 14, 2014 10:30 - 12:00 1st Floor, Century Hall

RISK BASED APPROACH TO CLINICAL TRIALS

SeSSion Chair

Qing ZURAW, MD, MBA Executive Medical Director, Clinical Development Services, Covance Inc., USA

The application of Risk-Based Monitoring (RBM) is a hot topic across the industry. How to better understand and implement regulatory guidance and what is the applicability to trial conduct in China?

This session will discuss how to increase risk awareness, take appropriate monitoring approaches, and manage quality for clinical studies.

Risk-Based Quality Management in Clinical Trials: A Risk Proportionate ApproachDavid COCKBURNHead of Manufacturing & Quality Compliance Service, Compliance & Inspections Department, European Medicines Agency (EMA), UK

Risk-Based Monitoring from the Global PerspectivesQing ZURAW, MD, MBA Executive Medical Director, Clinical Development Services, Covance Inc., USA

Risk-Based Monitoring in China: Current Practice and ChallengesJennifer HUANG, MDExecutive Director, Head of Global Clinical Trial Operation, Merck Research Laboratories R&D, China

Panel Discussion

PaneliStS

Speakers and:Jane LIN, MDVice President, Strategic Medical Affairs, Johnson & Johnson Medical (China) Ltd.

LI Shuting, MD, Associate ProfessorDeputy Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences

Session 0107 | Wednesday, May 14, 2014 Simultaneous Translation

13:30 - 15:00 1st Floor, Century Hall

JOURNEY TOWARD PROACTIVE GCP COMPLIANCE

SeSSion Chair

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

The journey toward proactive GCP compliance is long and challenging. In this session, the regulatory agencies from China, US, and Europe will share proactive approaches, requirements, and progress in GCP inspections, challenges, and trend in global initiative toward GCP compliance. FDA and EMA GCP inspection update will be shared and discussed.

CFDA Updates on GCP ComplianceCFDA Speaker Invited

11Update from FDA on GCP Compliance Leslie BALL, MDAssistant Commissioner and Deputy Director, Office of International Programs, FDA, USA

Facts and Figures of GCP Inspections Conducted - EMA PerspectiveDavid COCKBURNHead of Manufacturing & Quality Compliance Service, Compliance & Inspections Department, European Medicines Agency (EMA), UK

GCP Compliance, Challenges, Strategies and Experiences Vincent YEUNG, PhD, MBAGCP Operation Manager and Senior GCP Inspector, Medicines and Healthcare Products Regulation Agency (MHRA), UK

Session 0108 | Wednesday, May 14, 201415:30 - 17:30 1st Floor, Century Hall

PROMOTIONAL EFFECT OF EC ACCREDITATION ON CONSTRUCTION OF EC IN CHINA

SeSSion Chair

LI Shuting, MD, Associate ProfessorDeputy Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences

In recent years, some ECs in China have received accreditation by various international accreditation organizations. However, some questions have arisen such as what roles these accreditations play in EC work and do they really help in EC daily routines.

Three experts who have experience in ethics accreditations will present and join the discussion. It is expected that the changes brought by accreditations to the ethics review will be better understood and promote the ethics accreditation in China.

Management of Institutional Ethics Review System of Biomedical Research with Human ParticipantsXIONG Ningning, ProfessorDirector, Clinical Evaluation Research Room of TCM, Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of TCM

Effect on IRB Capacity Building in China by International Recognition Program WU Rong, ProfessorChair, Research Ethics Committee of Shanghai Medical Association; Vice Chair, IRB of Huashan Hospital Fudan University; Director, Office For Medical Planning Fudan University

AAHRPP Accreditation Promote Clinical Research in Youan HospitalWANG Meixia, Associate ProfessorAssociate Professor/Director, State Drug Clinical Trial Institution Office, Beijing Youan Hospital, Capital Medical University

Panel Discussion

Theme 2 | Regulatory Science

Session 0201 | Tuesday, May 13, 2014 08:30 - 10:00 3rd Floor, Yellow River Hall

THE PRACTICE OF NEW DRUG IN FIRST-IN-HUMAN STUDIES IN CHINA

SeSSion Chair

PENG Jian, PhDClinical Research Director, Sanofi China

First-in-Human (FIH) studies are part of the exploratory phase of drug development and represent significant milestone in the clinical development of new drugs. The session shares several practical considerations from CFDA/CDE experts’ point of view about the China FIH studies, as well as discusses regulatory and clinical issues and experience in FIH studies.

CDE Reviewer’s View on FIH StudiesCDE Speaker invited

Regulatory Requirements for FIH Clinical Studies Focus on GCP CFDA Speaker invited

Case Studies of FIH on Innovative Drug Development in China WU Yilong, ProfessorVice President of the Guangdong General Hospital, Guangdong Academy of Medical SciencesDirector, Guangdong Lung Cancer Institute.

Session 0202 | Tuesday, May 13, 2014 10:30 - 12:00 3rd Floor, Yellow River Hall

EXPERIENCE OF FORMAL CONSULTATION MEETINGS WITH CDE

SeSSion Chair

Wendy YAN, MBAGlobal Regulatory Strategist, Bayer HealthCare, Global R&D Center

Following the policies to encourage innovative drug development, the number of CDE formal consultation meetings (communication meetings) increased significantly and the topics covered most areas of new drug development. In this session, speakers from domestic and multinational pharmaceutical companies will share their experience about formal consultation meetings with CDE on various stage of new drug development. A speaker from CDE will give an overview about communication meetings with sponsors and provide suggestions on how to manage the communication meetings with CDE better.

A Formal Two-Way Communication Meeting with CDE on IND of a Novel Anti-Cancer Drug Using Innovative Development StrategyMU Hua, MD, PhDSenior Vice President & Global Head of Product Development Business Unit, WuXi AppTec

Effective CDE Consultation MeetingMary SUNAssociate Director, Regulatory Affairs, Pfizer Pharmaceutical Ltd.

12New IND Process for the First in Class Drug CTA Approval at China CDECHEN Li, PhDCo-Founder and CEO, Hua Medicine China

Topic TBDCDE Speaker Invited


13:30 - 15:00 3rd Floor, Auditorium

CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES UPDATE


13:30 - 15:00 3rd Floor, Auditorium

CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES UPDATE


08:30 - 10:00 3rd Floor, Yellow River Hall

THE CONSIDERATIONS OF AMENDMENT FOR DRUG ADMINISTRATION LAW (PART I)

SeSSion Chair

WU Zhiang, ProfessorDean, School of Business Administration, Shenyang Pharmaceutical University

China has initiated the amendment of drug administration law. What will be the key focus of the new law under the new environment? How significant will the changes be? The experts from government, academia, industry and pharmaceutical associations will share perspectives and exchange opinions with audience.

Innovation in Management of Drug Safety SystemCFDA Speaker Invited

Amendment of Drug Administration Law - The Perspective of Innovation in Drug Regulatory System SHAO Rong, ProfessorDean, School of International Pharmaceutical Business, China Pharmaceutical University(CPU)

Amendment of Drug Administration Law - The Perspective of Multinational Pharmaceutical Companies LI Weiping, MBAChair, Regulatory Work Group of R&D-Based Pharmaceutical Association Committee (RDPAC)Senior Director, Regulatory Affairs, Xi'an Janssen



THE CONSIDERATIONS OF AMENDMENT FOR DRUG ADMINISTRATION LAW (PART II)

SeSSion Chair

WU Zhiang, ProfessorDean, School of Business Administration, Shenyang Pharmaceutical University

Panel Discussion

PaneliStS

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

CHEN QiyuPresident, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

YANG Chen, LLM Partner and Head of Life Sciences, Sidley Austin LLP



INTERNATIONAL REGULATIONS - NEW INITIATIVES

SeSSion Chair

Janet LVHead of Regulatory Asia Pacific, Roche Product Development in Asia Pacific, Roche (China) Holding Ltd.

Adaptive licensing, break-through designation & approval in US, and the implementation of EU new Clinical Trials Regulation (CTR) are hot topics discussed by both regulatory agencies and industry. This session would provide the most recent updates on those initiatives and their impacts.

Adaptive Licensing Lisa TAN, PhDDeputy Director, Clinical Trials Branch, Health Products Regulation Group (HPRG), Health Sciences Authority, Singapore

US Breakthrough and Oncology New Regulations/PoliciesMichelle ROHRER, PhDHead of US Regulatory Affairs, Global Regulatory Affairs, Product Development, Roche

EU New InitiativesAnette HJELMSMARKSenior Regulatory Intelligence Manager, Regulatory Policies & Intelligence, Novo Nordisk A/S, Denmark



MULTI-REGIONAL CLINICAL TRIALS (MRCTS) – APEC UPDATE

SeSSion Chair

CFDA Official

Topic TBDCFDA Speaker Invited

MRCT Center at Harvard Data Monitoring Committee Training ProgramSteven SNAPINN, PhD Vice President of Global Biostatistical Science at Amgen, USA

MRCT Center at Harvard: Protocol Ethics and PI Competency InitiativesRebecca H. LI, PhDExecutive Director, Multi-Regional Clinical Trials (MRCT) CenterHarvard University, USA

Panel Discussion

13 Theme 3 | GxP Compliance Workshop


08:30 - 10:00 5th Floor, 5D+E

HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART I)

SeSSion Chair

Florence HOUN, MD, MPHCo-Chair of FDAAA International NetworkFormer Director, Office of Drug Evaluation III, CDER FDA Vice President, Global Regulatory Policy and Strategy, Celgene Corporation, USA

This session will illustrate key principles regarding regulators’ approach to how compliance issues with GxP impacts medical product application decision-making and how the application review impacts GxP inspections. These principles are based on FDA, industry, and CFDA experiences. Current and past decision makers on drug applications will share their views on how compliance with GxP affects their decision making based on previous cases in the public domain.

Key Principles on GxP Impact on Medical Product Review & Approval Decision-Making: The Medical Reviewer’s PerspectiveMark J. GOLDBERGER, MD, MPHMember of FDAAA International NetworkFormer Director, Office of Drug Evaluation IV, US FDA/CDERVice President, Regulatory Affairs, Abbvie, USA

Assuring Product Quality for New Drug Approvals: CMC Review and Pre-Approval InspectionCHEN Chi-Wan, PhDMember of FDAAA International Network Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDER Executive Director, Global CMC, Pfizer, USA

CFDA: Current and Future DirectionsCFDA Speaker Invited


10:30 - 12:00 5th Floor, 5D+E

HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART II)

SeSSion Chair

FENG YiSenior Advisor, Covington & Burling LLPFormer Associate Centre Director, Office of Management and Communication, CDE, CFDA

This session will build on the previous session and expand on key principles regarding the impact of GxP compliance on medical product decision-making based on FDA, industry, and TFDA experiences. Current and past decision makers on drug applications will share their views on how compliance with GxP affects their decision making based on previous cases in the public domain.

Biologics GMP Inspection - FDA's PerspectiveWANG Gang, PhDAssistant Country Director, US FDA China Office

How GLP Impacts the Medical Product Review and Approval Dylan YAO, MD, PhDFormer FDA Senior ReviewerGLP Compliance Officer of FDAAA Senior Vice President & Chief Scientist Officer, Joinn Laboratories, Inc.

TFDA Current and Future DirectionsLih-jiuan HSU, MDSenior Executive Officer, Office of Executive Director, CDE, TFDA

Theme 4 | Quantitative Science

Sessions 0401 | Tuesday, May 13, 2014 Simultaneous Translation

08:30 - 10:00 5th Floor, Yangtze River Hall

STATISTICAL LEADERSHIP IN PHARMACEUTICAL DEVELOPMENT AND BIOSTATISTICIAN'S ROLE IN REGULATORY ADVISORY MEETINGS

SeSSion Chair

Tony GUO, PhDDirector, Biostatistics, MSD R&D(China) Co., Ltd.

As pharmaceutical development relies increasingly on data driven and quantitative principles, statistical scientists are playing important roles not only in pharmaceutical development design and execution, but also in the regulatory submission and review process (including the critical advisory review meetings). In this session we will invite top statistical leaders from academia, government and industry to discuss the opportunities and challenges facing the profession.

Statistical Leadership in Regulatory Agency and AcademiaLisa LAVANGE, PhDDirector, Office of Biostatistics, OTS, CDER, FDA, USA

Statistical Leadership in Pharmaceutical IndustryJerry SCHINDLER, PhDVice President, Late Development Statistics, Merck & Co., Inc.

Panel Discussion

PaneliStS

Speakers and:CHEN Feng, PhD, ProfessorDean, School of Public Health, Nanjing Medical University Chair of China Association of Biostatistics (CABS) Chair of China Clinical Trial Statistics (CCTS) Working Group

Marcia LEVENSTEINVice President, CVMET Statistics Head, Global Innovative Pharmaceu-ticals Business Unit, Pfizer, USA

14Session 0402 | Tuesday, May 13, 2014 Simultaneous

Translation


STATISTICAL ISSUES IN INTERNATIONAL MULTI-REGIONAL CLINICAL TRIALS

SeSSion Chair

CHEN Gang, PhDSenior Director, Head of Quantitative Sciences, China R&D and Science Affairs, Johnson & Johnson

The impact of ethnic factors on efficacy, safety, and dosage of a new treatment has been described in the International Conference on Harmonization (ICH) guideline “Ethnic Factors in the Acceptability of Foreign Clinical Data” (ICH E5, 1998). In new drug development of China, the results from international multi-regional clinical trials (MRCT) alone are often inadequate to assess such impact due to small sample sizes and other statistical concerns. In this session we will discuss those potential statistical issues, the relationship between international MRCT and China registration clinical trials and possible solutions.

Panel Discussion• A bull in a china shop - How to spend the fragile Alpha

• A holistic view on global vs. local strategies

• Adaptive licensing on the MRCT or global development ?

• MRCT: Concept and concerns from statistical perspectives

• Why MRCT? Practical consideration from local registration perspectives

PaneliStS

XIA Jielai, PhDProfessor, Department of Medical Statistics, 4th Military Medical University

William WANG, PhDExecutive Director and Regional Head, Biostatistics and Research Decision Sciences (BARDS) – Asia Pacific, Merck & Co. Inc.

ZHAO Dayao, PhDHead of China R&D and Scientific Affairs, Vice President, Janssen Pharmaceutical R&D, Johnson & Johnson

TAN Ming, PhDProfessor and Chair, Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, USA

Sessions 0405 | Wednesday, May 14, 2014 08:30 - 10:00 5th Floor, Yangtze River Hall

STATISTICAL METHODOLOGIES FOR ONCOLOGY CLINICAL TRIALS

SeSSion Chair

Jacqueline LAW, PhDHead of Biometrics, Shanghai Roche Pharmaceuticals Ltd.

Oncology is one of the most active areas in new drug research and development, with significant unmet medical needs. Even with the advancement in the last decade in the development of personalized medicines, biomarker testing, computing technology and statistical methodologies, the design and analysis of oncology clinical trials still present many unique features and challenges. This session will focus on statistical methodologies in oncology clinical trials.

Evaluation of Confounding Effect on OS by Non-Protocol Therapies after Disease Progression in Oncology Clinical TrialsNicole F. LI, PhDAssociate Director of Biostatistics, Roche/Genentech

Treatment Effects on Disease Progression and Overall Survival in Oncology Clinical TrialsJIANG Qi, PhDExecutive Director, Global Biostatistical Science Amgen, California, USA

Use of Bayesian Augmented Control Design in Phase II Oncology Clinical TrialsZHU Chao, PhDAssociate Director, Asia-Pacific Statistical Sciences,Lilly Suzhou Pharmaceutical Co. Ltd.

Sessions 0406 | Wednesday, May 14, 2014 Simultaneous Translation


CURRENT GLOBAL REGULATORY STATUS AND TREND OF CLINICAL DATA MANAGEMENT

SeSSion Chair

Daniel LIU, PhDChief Scientific Officer, Beijing Clinical Service Center

In the past years, there are some new regulations and guidance published in the world, such as US FDA risk-based monitoring guidance, e-source guidance, EMA TMF guidance, CFDA clinical data management guidance etc. This session will give an overview of these new regulations and guidance related to the data monitoring and quality management of clinical studies. By these presentations and discussion, the audience may have further understanding of the global standard status and trends as well as differences on the data quality and integrity of clinical studies. Moreover, US FDA and EMA updated regulations and guidance related to the data management of clinical studies as well as CFDA guidance and expectations on data quality management will be overviewed.

Clinical Trial Regulation – UpdateVincent Yeung, PhD, MBAGCP Operation Manager and Senior GCP Inspector, Medicines and Healthcare Products Regulation Agency (MHRA), UK

Updated Regulations and Guidance of CDM by FDASunil G. SINGH President & CEO, DBMS Consulting, Inc. USA

Status and Trend of Clinical Data Management in China XIA Jielai, PhDProfessor, Department of Medical Statistics, 4th Military Medical University



DATA STANDARDIZATION IN CLINICAL RESEARCH: CDISC STANDARD AND ITS IMPLEMENTATIONS

SeSSion Chair

ZHANG Zibao, PhDAssociate Director, Biostatistics and Programming, PPD

15Data standardization is considered as a critical factor in improving the overall effectiveness and efficiency in clinical research and the regulatory review process. This session will provide an overview of commitments to the use of open, consensus-based data standards from regulatory, community and industry.

The topics will include the recent updates in data standardization from Chinese regulatory authority, and key issues, policy and guidance related to standardized study data; opportunities and challenges for regulatory and industry to ensure success in this area. Last, case studies will be shared by the standard development organization and the industry.

Clinical Data Standard Updates from Chinese Regulatory PerspectiveCDE Speaker Invited

Why CDISC Standards Make Difference in Clinical Data Quality and Efficiency?Becky KUSH, PhDPresident and CEO, CDISC, USA

Standard-Based Real Time Data Analysis and Reporting – Is It a Dream or Reality?Niklas MORTONVice President, Global Biostatistics, Programming & Medical Writing, PPD, USA



CLINICAL DATA MANAGEMENT (CDM) ROLE IN THE RISK-BASED MONITORING

SeSSion Chair

Andrew TAYLOR, Grad Dip (Biostatistics)Global Head, Database Design & Extraction (DDE) Asia-Pacific Head, Clinical Data Management, Biometrics Department

The Risk-Based Monitoring Approach makes use of central computerized review of clinical trial data and site metrics to determine if sites should receive more extensive quality review through on-site monitoring visits. This approach has a broad impact on almost all facets of clinical trial management, including people, process and technology as well as the quality and integrity of clinical data. What kind of challenges will this pose to data managers? What new role, responsibilities and skill sets will be needed for data managers to provide value in this approach? The speakers in this session will discuss real-life case study examples of risk-based monitoring and describe how to ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV from data manager perspective.

Data Management Approach in Risk Based MonitoringAndrew TAYLOR, Grad Dip (Biostatistics)Global Head, Database Design & Extraction (DDE) Asia-Pacific Head, Clinical Data Management, Biometrics Department

Late Phase Centralized Site Management - An Integrated Approach Toward Risk Based MonitoringHady KHOURYVice President, Global Head, Research & Alliance Services, ICON Peri-approval & Observational Research

Risk Based Monitoring: A Case Study from Initiation to CompletionCarina REINICKERegional Head of Clinical Data Management, Pan Asia/ Middle East,

Turkey and Africa, Boehringer Ingelheim Shanghai Pharmaceuticals Co, Ltd.

Theme 5 | Nonclinical/Early Phase Clinical Development

Sessions 0501 | Tuesday, May 13, 2014 08:30 - 10:00 5th Floor, 5F

PRECLINICAL RESEARCH - GLOBAL STANDARDS, CHALLENGES, OPPORTUNITIES AND THE PATH FORWARD

SeSSion Chair

Helen Han HSU, DVM, PhDVice President, Head of Preclinical Development and Safety, Asia Pacific & Global Business Development, Janssen Pharmaceutical Company

In recent years, there has been tremendous growth in Toxicology and DMPK that has strengthened China’s R&D capability in new drug development. Although successes were demonstrated in the submission of IND/CTA packages that contained preclinical data generated in China, still challenges existed preventing China generated preclinical data from being readily accepted by global regulatory authorities. As a country that is not part of MAD member countries, what kind of impact does this have on the acceptability of the data in supporting global clinical trials and registration? How is the data meeting international standards? What are the next steps? This program will review and explore the challenges and opportunities.

Current Challenges and Opportunities in Preclinical Development - GLP Data in ChinaHelen Han HSU, DVM, PhDVice President, Head of Preclinical Development and Safety, Asia Pacific & Global Business Development, Janssen Pharmaceutical Company

OECD “Mutual Acceptance of Data” - How can China Participate WU Xiaohuai, PhD Senior manager, GLP program, NO.5 Assessment Department, China National Accreditation Service for Conformity Assessment (CNAS)

Sessions 0502 | Tuesday, May 13, 2014 10:30 - 12:00 5th Floor, 5F

CRITICAL ELEMENTS IN BUILDING HIGH QUALITY TOXICOLOGY ASSESSMENT CENTERS - CASE STUDIES

SeSSion Chair

Helen Han HSU, DVM, PhDVice President, Head of Preclinical Development and Safety, Asia Pacific & Global Business Development, Janssen Pharmaceutical Company

In recent years, there has been tremendous growth in Toxicology and DMPK that has strengthened China’s R&D capability in new drug development. Although successes were demonstrated in the submission of IND/CTA packages that contained preclinical data generated in China, still challenges existed preventing China generated

16preclinical data from being readily accepted by global regulatory authorities. As a country that is not part of MAD member countries, what kind of impact does this have on the acceptability of the data in supporting global clinical trials and registration? How is the data meeting international standards? What are the next steps? This program will review and explore the challenges and opportunities.

Preclinical Data Integrity and Scientific Quality from a Regulatory Reviewer’s Perspective CDE Speaker Invited

FDA's Expectation on Nonclinical Data Integrity with Special Emphases on Data Generated by CROs - Case StudyDylan YAO, MD, PhDMember of FDAAAFormer Senior Toxicologist and GLP Reviewer, US FDA/CDER, Senior Vice President And Chief Strategy Officer, Joinn Laboratories, Inc.

Panel Discussion

Success Factors in Building a CRO that Meets Global Standards, and How the CROs are Facing the Challenges from the Recent Position from European Countries

PaneliStS Speakers and:BI Honggang, PhDCorporate Vice President and General Manager, Covance Inc.

Bob COLDRECKVice President, GLP QA, Wuxi Apptec (Suzhou) Co., Ltd.


13:30 - 15:00 5th Floor, 5B+C

QUANTITATIVE PHARMACOLOGY IN DRUG DEVELOPMENT

SeSSion Chair

LI Gailing, PhDDirector, Head of Clinical Pharmacology, Janssen China Pharmaceutical R&D

The session will focus on the state-of-the-art concepts, implementation and impact of model-based drug development (MBDD) in drug development, starting from an overview of MBDD in pharmaceutical industry; AP bridging strategy; and modeling and simulation in clinical practice.

An Overview of PK/PD Modeling & Simulation in Large & Small Molecule DevelopmentZHOU Honghui, PhDSenior Director and Janssen Fellow, Biologics Clinical Pharmacology, Janssen Pharmaceutical R&D, USA

Clinical Pharmacological Approaches to Deal with Ethnic Differences MA Peimin, PhDSenior Director, Clinical Pharmacology, China GlaxoSmithKline R&D

Modeling & Simulation in Clinic PracticeLU Wei, ProfessorChair of Department of Pharmaceutics, School of Pharmaceutical Science, Peking University

Modeling and Simulation - A "Toolkit" for Modern Drug DevelopmentCAPT E. Dennis BASHAW, PharmDDirector, Division of Clinical Pharmacology-3Office of Clinical PharmacologyOffice of Translational Sciences, FDA, USA

Sessions 0504 | Tuesday, May 13, 2014 15:00 - 17:30 5th Floor, 5H

PRECLINICAL DMPK: BUILDING QUALITY DATA AND SYSTEM

SeSSion Chair

Jeng-Pyng SHAW, PhDVice President of DMPK, BioDuro Co., Ltd.

Drug metabolism and Pharmacokinetics (DMPK) has played a critical role in drug discovery and development. How to get quality data and build a quality system for research and preclinical DMPK is essential for the China pharmaceutical industry. This session will start with using quality animals for in vivo PK/safety studies and building a quality system for bioanalysis. It will then discuss the importance of quality PK data for anti-body drug conjugate (ADC) drug development.

The Importance of the Quality of Animals in Conducting Tox/DMPK StudiesWANG Jianfei, DVM, PhDHead, Laboratory Animal Sciences, GlaxoSmithKline R&D

Building a Quality Program for BioanalysisXING JinSongVice President, Wuxi Apptec Co., Ltd.

Pharmacokinetic Consideration of ADC DrugCHENG Yuanguo, ProfessorAcademy of Military Medical Science

Theme 6 | Innovations and Talent Development to Support Value Creation


08:30 - 10:00 5th Floor, 5H

MEDICAL AFFAIRS, MEDICAL COMMUNICATION AND EDUCATION - VALUE PROPOSITION AND PRACTICES

SeSSion Chair

Zig LANG, MD, PhD, FAAPVice President, Medical Affairs and Pharmacovigillence, Bayer Healthcare Company

The current state of the medical affairs practices will be described and contrasted between China and the United States. Best practices will be shared.

Medical Affairs, Medical Communication and Education Framework and Good Practices in USPamela CYRUS, MDVP and Head, US Medical Affairs, Bayer Healthcare Pharmaceuticals, Inc., USA

17Medical Affairs, Medical Communication and Education Integration, Synergy and Value Proposition in China Avery INCE, MD, PhDVice President, Clinical Development & Medical Affairs, Xi'An Janssen Pharmaceuticals, Ltd., USA

Panel Discussion


INNOVATIONS AND TALENT DEVELOPMENT TO SUPPORT VALUE CREATION

SeSSion Chair

GU Chengming, MBAMedical Lead, China Medical, Pfizer Investment Co., Ltd

In this session, the role of MSL, medical education/communication and real life evidence collection (e.g. claim database analysis) will be discussed.

Understanding MSL Activities Across the Product LifecycleSpeaker Invited

Development and Utilization of Electronic Healthcare DatabaseLIU YanfangDirector, Epidemiology, Johnson&Johnson, Singapore

Innovations in Medical and Scientific Communications Justin Daniels, PhDHead & Global Medical Lead, Medical Affairs Oncology, Bayer Healthcare, USA


MEDICAL WRITING AND MEDICAL TRANSLATION

SeSSion Chair

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

Medical writing and medical translation are relatively new and promising areas in China. The writers and translators are playing a critical role to deliver scientifically correct and logically well-organized messages to audiences. The speakers from multinational pharmaceutical companies and academia will share their experience regarding role of medical writers in clinical development, and the future trend for professional translation (i.e. medical translation) .

Role of the Medical Writer in the Clinical Development Team and Professional Competencies Helle GAWRYLEWSKISenior Director, Head Medical Affairs & Alliance Management, Biometrics and Reporting Janssen Research & Development

Professional (Medical) Translation: Past, Present, and Future YAO Jinqing, ProfessorGraduate Institute of Interpretation and Translation (GIIT), Shanghai International Studies University (SISU)

Talent Development in Medical Affairs - McKinsey ReportZHANG FangningAssociate Principal, PMP, McKinsey & Company

Theme 7 | CMC and Quality


08:30 - 10:00 5th Floor, 5B+C

GENERIC DRUG DEVELOPMENT IN CHINA (PART I)

SeSSion Chair

REN Yi, PhDGeneral Manager, Nanjing Medichem Bio-Pharmaceutical Development Co.

Generic drugs represent >95% of the China drug market, and will continue to play a critical role in accessibility and affordability of medicines for patients. In this session, the national effort to evaluate quality consistency of generic drugs will be reviewed by regulators, and experience from industry will be shared. Directive on the EU 62 was implemented in mid 2013 which has significant impact to API export to EU market. Corresponding China polices and status of readiness of Chinese exporters will be reviewed. Generic drug approval process in China has long been a hot discussion topic. Important improvements have been made in many fronts in recent years. Areas that can be further improved to optimize the generic drug approval process in China will be discussed. The aspects of quality, regulatory review and approval process, affordability and accessibility of generics are key topics to be discussed by key opinion leaders in the country. This session will be of great interest to industry as well as respective government agencies.

Current Status of Generic Drug Consistency EvaluationLI Bo, PhDDeputy Director, National Institutes for Food and Drug Control

Effect and Implementation Status of No. EU62DONG Zuojun, PhDVice Director, Institute of Drug and Food Policy and Industry Development Research College of Pharmaceutical Science Zhejiang University of TechnologyFormer Deputy Director, Department of Drug Supervision, Zhejiang FDA

Drug Quality System and Its Expectation for Generic IndustryDaniel SONGDirector, CMC Regulatory Affairs, China R&D and Scientific Affairs, Janssen Pharmaceutical Company, Johnson & Johnson


10:30 - 12:00 5th Floor, 5B+C

GENERIC DRUG DEVELOPMENT IN CHINA (PART II)

SeSSion Chair

CHEN Chi-Wan, PhDMember of FDAAA International Network Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDER

18Executive Director, Global CMC, Pfizer, USA

Generic Drug Review and Approval System in ChinaCDE Speaker Invited

Panel Discussion


15:30 - 17:30 5th Floor, 5B+C

REGULATORY PERSPECTIVES ON DRUG-DEVICE COMBINATION PRODUCTS IN THE UNITED STATES AND IN CHINA

SeSSion Chair

CHEN Chi-Wan, PhDMember of FDAAA International Network Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDER Executive Director, Global CMC, Pfizer, USA

Drug-device combination products is a rapidly growing field of medical products designed to enable targeted drug delivery, reduce physiological barriers to drug transport, provide dosing convenience, and/or enhance patient compliance. These products range from simple pre-filled syringes to more complex products like transdermal delivery systems and drug-eluting stents. This session will introduce how drug-device combination products are regulated in the United States and discuss the technical and regulatory challenges in developing and approving these products for marketing. Product characterization, process controls, and quality assurance issues unique to pre-filled syringes, transdermal delivery systems, and drug-eluting stents will be presented.

Drug-Device Combination Products in USWU Duu-Gong, PhDMember of FDAAADirector, Regulatory Consulting/Senior Consultant, Global Regulatory Consulting, Pharmaceutical Product Development (PPD), USA

David LIN, PhDMember of FDAAASenior Consultant, Biologics Consulting Group, USA

Drug-Device Combination Products in ChinaSHI XinliDivision Chief, Division II, Center for Medical Device Evaluation, CFDA

Panel Discussion


08:30 - 10:00 5th Floor, 5B+C

GMP FORUM (PART I)

SeSSion Chair

David CHEN, PhDVice President, Quality and Regulatory Affairs, Zhejiang Jiuzhou Pharma

The pharmaceutical industry in China has been facing continuous pressure in striving for cost-effectiveness and high quality products in order to remain competitive in the market place. “Best Quality at Low Cost” is not only an expectation for pharmaceutical products from patients and consumers but also a goal for pharmaceutical companies. It is a challenge to comply with high quality standards while maintaining cost competitiveness. Tougher regulatory compliance requirements and enforcement provide another challenge as well. In this session,

the speakers from China, US and Europe regulatory agencies will share the current GMP compliance status, challenges, and also practices for meeting the cGMP compliance.

Current Status of Implementing China 2010 GMPYANG Wei Director General, Center for Certification of Drug, CFDA

US FDA’s Experience from Inspection of API Establishments in ChinaWANG Gang, PhDAssistant Country Director, US FDA China Office

Current Issues Relating to GMP from EU PerspectiveDavid COCKBURNHead of Manufacturing and Quality Compliance and Inspections Department, European Medicines Agency (EMA), UK


10:30 - 12:00 5th Floor, 5B+C

GMP FORUM (PART II)

SeSSion Chair

David CHEN, PhDVice President, Quality and Regulatory Affairs, Zhejiang Jiuzhou Pharma

Oversea GMP Inspection by CFDA: Current Status and Future OutcomeCHEN YanDivision Vice Chief, Inspection II, Center for Certification of Drug, CFDA

Comprehensive Quality Evaluation of Drugs Made in China: Future DirectionsWANG BoSenior Researcher, the Research Center of National Drug Policy and Ecosystem(NDPE)

Panel Discussion


13:30 - 15:00 5th Floor, 5B+C

CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGES (PART I)

SeSSion Chair

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

The biological industry in China has gone through rapid growth in recent years, which provides lots of challenges to the regulatory system in China. Currently, although there is no regulation or technical guideline on CMC requirements at different development stages in China, the regulatory expectation in China evolves quickly due to the quick development of local industry and exchange with multinational companies and other agencies.

The regulators from CFDA, Health Canada, and US FDA will clarify the regulatory expectation on CMC requirement at different clinical stages. Additionally, a case study to deep dive on process control and product control from Phase I to III will be discussed.

CMC Requirements for Therapeutic Biologics at Development StageCFDA Speaker Invited

19Regulatory Perspectives on Manufacturing Changes and Comparability Study for Biotechnology Products XU Lixin, MD, PhDProduct Quality Reviewer, Division of Monoclonal Antibody, Office of Biotechnology Products, CDER, FDA, USA

Regulatory Expectations for Specification Setting at Different Stages of Clinical DevelopmentWallace LAUZON, PhDActing Chief of the Cytokines Division, Centre for the Evaluation of Radio pharmaceuticals and Biologics, Biologics and Genetic Therapies Directorate, Health Canada


15:30 - 17:30 5th Floor, 5B+C

CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGES (PART II)

SeSSion Chair

WU Youling, PhDCEO, Zhejiang Teruisi Pharmaceutical Inc.

Process Evaluation/Validation from Phase I to Phase IIArmin KLEIN, PhDTechnical Regulatory Lead, Biologics Development New Products, Hoffmann-La Roche, Switzerland

The Manufacture and Quality Control of the Drug Investigated in Clinical TrialLI Xinyan, PhDExecutive Vice President, R&D, Medical and Regulatory Affairs, Zensun (Shanghai) Sci & Tech Co., Ltd.

Panel Discussion

Theme 8 | Pediatric Drug Development


13:30 - 15:00 5th Floor, 5D+E

HOW TO ENCOURAGE AND ACCELERATE CHINA PEDIATRIC DRUG DEVELOPMENT (PART I)

SeSSion Chair

CDE Official

With the theme of “ How to encourage and accelerate China Pediatric Drug Development ”, experts from Clinical, Industry, Academia and Regulatory will discuss pediatric renal disease medication comparison between China and foreign countries, challenges and opportunities in pediatric drug development in US and EU, ethical consideration in pediatric clinical trial, China pediatric drug development and evaluation strategy. The speakers and industry representatives will have a panel discussion around the topics. By various forums and interchange among the stakeholders, we sincerely expect to facilitate the China pediatric drug development and pediatric drug policies construction to really meet the pediatric medical needs.

Physician Perspective: Pediatric Renal Disease Medication Comparison Study Between China and Foreign Countries ZHONG Xuhui, MDPeking University First Hospital, Secretary of the Chinese Society of Pediatric Nephrology, secretary of IPNA Training Center (China), secretary of Pediatric Branch of China Medical Women's Association, member of Global Hygiene Council

Industry Perspective: Operational Challenges and Opportunities in Pediatric Drug Development in the US and EU Samuel MALDONADO, MD, MPD, FAAPVice President, CHILD – Child Health Innovation Leadership DepartmentChair, Pediatric Center of Excellence, Janssen Research & Development, USA


15:30 - 17:30 5th Floor, 5D+E

HOW TO ENCOURAGE AND ACCELERATE CHINA PEDIATRIC DRUG DEVELOPMENT (PART II)

SeSSion Chair

CDE Official

Academia Perspective: Ethical Considerations in Paediatric Clinical Trial Kalle HOPPU, MD, PhDDirector, Poison Information Center, Helsinki University Central Hospital WHO Expert Advisory Panel on Drug Evaluation, Finland

Regulatory Perspective: Considerations on China Pediatric Drug Development and EvaluationCDE Speaker Invited

Panel Discussion

Theme 9 | White Paper Showcase

Sessions 0901 | Tuesday, May 13, 2014 08:30 - 10:00 5th Floor, 5J

IATA DANGEROUS GOODS REGULATIONS ON INFECTIOUS SUBSTANCES CATEGORY B (BY TNT INTERNATIONAL EXPRESS)Understanding the IATA regulatory framework on shipping bio-medical samples by air

Knowing the regulations - getting your shipments delivered on time

Sessions 0902 | Tuesday, May 13, 2014 10:30 - 12:00 5th Floor, 5J

STRATEGIC INTEGRATION IN DRUG DEVELOPMENT: FROM PRE-CLINICAL TO POC (BY COVANCE)

Sessions 0905 | Wednesday, May 14, 2014 08:30 - 10:00 5th Floor, 5J

WHY RECRUITMENT? WHY CRC? - THE STATE OF PATIENT RECRUITMENT AND CRC IN CHINA (BY JSURE HEALTH INC.)

20 Theme 10 | Translational Medicine - Dreams and Approaches


08:30 - 10:00 5th Floor, 5F

SPEEDING UP DRUG DISCOVERY BY TRANSLATIONAL MODELING OF EFFICACY AND SAFETY (PART I)

SeSSion Chair

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

In recent years translational medicine is playing more and more important roles in drug discovery. With the accumulation of large sets of pre-clinical and clinical data, a lot of attention is being paid on how to translate this information to drug discovery and patient treatment.

The global experts will share experience on new technologies, new applications, development trends, and further discuss extended translational medicine activity in China in the near future.

To Explore the UnexplorableWANG Jun, PhDDirector, BGI

Ubiquitination-dependent Regulation of mTOR Signaling in Tumor Cell ProliferationGAO Daming, ProfessorProfessor, Institute of Biochemistry and Cell Biology, Shanghai Institute for Biological Sciences, Chinese Academy of Sciences

Patient-Derived Xenograft (PDX) Model and Improved Translatability in Drug DiscoveryWEN Danyi, MD, MBAPresident and CEO, Shanghai LIDE Biotech


10:30 - 12:00 5th Floor, 5F

SPEEDING UP DRUG DISCOVERY BY TRANSLATIONAL MODELING OF EFFICACY AND SAFETY (PART II)

SeSSion Chair

LI Cai, PhDDirector, In Vivo Pharmacology China Lead, Merck Research Laboratories, MSD

Interplay between Mesenchymal Stem Cells and Inflammation in the Tumor MicroenvironmentWANG YingAssistant Research Fellow, Institue of Health Sciences, SIBS, CAS

A New Frontier for Memory Enhancement Tim TULLY, PhDExecutive Vice President, Research & DevelopmentChief Science Officer and Founder, Dart NeuroScience

Ensuring the Smooth Translation of Pre-Clinical Data from Academia to IndustryMichael JAMIESON, DRSc.Associate Director, International Center for Regulatory Sciences Assistant Professor, Titus Family Department of Clinical Pharmacy

and Pharmaceutical Economics & Policy School of Pharmacy, University of Southern California

Theme 11 | Drug Safety and Pharmacovigilance


08:30 - 10:00 5th Floor, 5D+E

PRE-MARKETING RISK ASSESSMENT

SeSSion Chair

WANG Yuhong, MDSafety Science Leader, Global Safety Risk Management, Global Product Development in Asia-Pacific, Roche

Risk assessment occurs throughout a product’s lifecycle, from the early identification of a potential product, through the premarketing development process, and after approval during marketing. Premarketing risk assessment is particularly important as the assessment of underlying risks and benefits during the premarketing period is critical to the regulatory authority’s decision on product approval. Moreover, safety is the predominant reason why products are withdrawn from the marketplace, and Drug-Induced Liver Injury (DILI) remains the most common single cause of safety-related drug marketing withdrawals, as it has been for the past 50 years. This session is intended to share views from the perspective of industry, academia and regulatory authority on premarketing assessment of liver toxicity, provide an overview on DILI risk assessment and management in clinical development program, and give an update on the advances in DILI research worldwide and nationwide.

DILI Risk Assessment and Management in Clinical Development Program – Industry PerspectiveSean ZHAO, MD, PhDSenior Pharmaceutical Consultant, PV Quest, Inc., USA

Strengthening the Translational and Clinical Research on Drug-Induced Liver Injury (DILI) – Academic PerspectiveMAO Yimin, ProfessorRenji Hospital, School of Medicine, Shanghai Jiaotong University

Pre-marketing Risk Assessment – Regulatory PerspectiveCDE Speaker Invited

Panel Discussion

PaneliStS

All Speakers and:Joan SHEN, MD, PhDChief Medical Officer,Jiangsu Hengrui Medicine Co., Ltd.,


10:30 - 12:00 5th Floor, 5D+E

POST-MARKETING RESEARCHES/STUDIES-AS A TOOL FOR SAFETY

SeSSion Chair

GUO Xiaojun, PhD Head of Clinical Safety and Pharmacovigilance, GlaxoSmithKline R&D

21After a drug is authorized in the market, the knowledge of its safety will continue expanding with the wide use of the drug in the real world. Post-marketing research as well as other post-marketing surveillance activities play an important role to monitor drug safety. The session will introduce the requirement of post-marketing researches from the regulatory perspective and will also discuss why and how a company should select the best suitable type of post-marketing studies to study drug safety, as well as the considerations in conducting these types of studies.

Post-marketing Studies for Intensive Drug Monitoring: CDR PerspectiveCFDA Speaker Invited

Post-marketing Studies for Safety Evaluation Experience and Regulatory PerspectiveLI MinzhuPost-marketing Safety Expert

Panel Discussion

What are the Considerations when Conducting Post-Marketing Studies

PaneliStS

All Speakers and:CHENG GangNational ADR Center, CFDA

MO Jingping, MD, PhDSenior Director, Epidemiology, Pfizer Inc., USA

WANG DayouChief Pharmacist, Huashan Hospital Affiliated to Fudan University

SUN LeiSenior Study Manager Leader, R&D Shanghai, GSK


13:30 - 15:00 5th Floor, 5F

LABELING AND SAFETY RISK MANAGEMENT

SeSSion Chair

Vera LIANG, MDDirector and Global Safety Risk Lead, Safety Surveillance and Risk Management, Pfizer

Drug product labeling summarizes the essential scientific information needed for the safe and effective use of the drug and is the primary source of information about a drug’s safety and effectiveness. Multinational pharmaceutical companies develop the core label for each of their drug products, ensuring the consistent communication of safety information across the countries. The core label is a living document – the change will occur anytime when new information is identified, particularly the new safety information, leading to the downstream label updates in the countries where the product is marketed. On the other hand, there have been increased numbers of safety labeling changes requested by the Health Authorities - namely if the Agency becomes aware of “new safety information” that it believes “should be included in the labeling of the drug, ” then it may trigger a process to rapidly amend the labeling for the product. Our session aims to provide an overview on what constitutes the label, how the label evolves, and safety label updates in the context of the continuous benefit/risk assessment. Otherwise, we will touch upon the practical challenges faced by the multinational companies in implementing the company core label. Also, the audience will hear the perspectives of the Health Authorities in China and EEA countries on the role of the label in communicating product safety information.

Role of Labeling in Communicating Safety Risk Information – CFDA PerspectivesCFDA Speaker Invited

Role of Labeling in Communicating Safety Risk Information – EU PerspectivesRozalina KULAKSAZOVA, MSci.Pharm., Clin. Pharmacy SpecHead of Medicinal Information Division, Medicines Use Control, Bulgarian Drug Agency, Bulgaria

Company Core Data Sheet – The Importance to Ensure Uniform Communication of Safety InformationRie MATSUI, RPhDirector, Regional Labeling Head for Asia, International Labeling Group, WSR International & Global Product Information, Pfizer, Japan

Panel Discussion

PaneliStS

All Speakers and:CHENG GangNational ADR Center, CFDA

MO Jingping, MD, PhDSenior Director, Epidemiology, Pfizer Inc., USA


15:30 - 17:30 5th Floor, 5F

QUALITY IN PHARMACOVIGILANCE

SeSSion Chair

TANG XueCountry Safety Lead for China, Global Pharmacovigilance Office, WSRO, Pfizer

Pharmacovigilance (PV) is an integrated system which combined multi-science to collect, identify, evaluate, monitor and analyze an adverse event. To ensure it is operating effectively and with high quality, a set of examination measures is necessary in order to identify the issue and risk as well as to resolve the issue in the end. Internal audit within the enterprise and the inspection by health authority are activities to improve the quality management of the PV system. Europe and the US has taken the steps with experience, EMA has issued Good Pharmacovigilance Practice in its new legislation in July 2012 and defined the legal responsibility of both health authority and the enterprise to implement the audit/inspection of PV.

View from China Health AuthorityCFDA Speaker Invited

The Multinational Company ExperienceHelen LI, MD, MBAQA Asia Lead, Emerging Market/PCO QA, Medical Quality Assurance. Pfizer

Panel Discussion

PaneliStS

All Speakers and:YAO YuanHead of Drug Safety China, Drug Safety, Merck Group

22 Theme 12 | Project/Portfolio Management


08:30 - 10:00 5th Floor, 5H

PROJECT MANAGEMENT IN DRUG DEVELOPMENT

SeSSion Chair

LI Yuan, MD Director, Project Management, MSD R&D (China) Ltd.

This session will introduce the role of project leadership/management in drug development, values added to a cross-functional work in drug project team and the opportunities, and challenges faced by project management in drug development.

Overview of Project Management in Drug DevelopmentTimothy M. PHELANExecutive Director, Project Management, Merck & Co./ MSD, USA

Value Added Project Leadership in New Drug Development, Opportunity and ChallengeMaxwell J. KIRKBY, BSc Vice President, Global Product – IRESSA, AstraZeneca

Panel Discussion

How to Develop the Functionality and Talents of Project Management in China

PaneliStS

Speakers and:Clara GU Head of Global Project Management, General Medicine, Beijing Bayer Healthcare

Michael JIANG, MBAChief Operational Officer, Drug Development Medical Affairs Center, Lilly China

Kumar PENMETSA, PhDSenior Director, China R&D Project Management Office (PMO) and Strategic Operations, Bristol-Myers Squibb

Sessions 1208 | Wednesday, May 14, 2014 15:30 - 17:30 5th Floor, 5H

CLINICAL PROJECT MANAGEMENT (CPM)

SeSSion Chair

HU Ran Senior Manager, Trial Operations Clinical Sciences & Operations, Sanofi

Session Highlight:

• To introduce the role of clinical project manager (CPM) with challenges and opportunities of the role faced in China

• To share the working model of CPM

• To share the implementation of technical tools used by CPM and introduce the innovation technical tools in Project management

Challenge and Opportunity for CPM in ChinaNancy TICH, PhD Senior Director, Project Management, Covance, Hong Kong

Clinical Project Manager - A Core Role to Success SONG Biao Associate Director, Site Management & Monitoring, Asia AstraZeneca Pharmaceutical Co., Ltd.

Introduction of Working Model for CPMVivian CHANG Assistant Director, Clinical Operations, CSU (Clinical Study unit), Sanofi

Innovation Technology Tool for Project ManagementZHU Zheng Project Director, Project Management, Covance

Theme 13 | CRO and SMO – Quality Meets Technology

Sessions 1307 | Wednesday, May 14, 2014 13:30 - 15:00 5th Floor, 5D+E

ENHANCING CLINICAL TRAIL QUALITY WITH INTERNET TECHNOLOGIES

SeSSion Chair

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

This session will describe how to use internet technology to gradually change the traditional clinical trial management mode, which shows significant superiority for the subject recruitment, the process management of clinical trials, quality control and quality assurance, and information collection, etc. With the aid of internet technology, the quality of clinical trials should be improved and the efficiency of management should be increased. The specialist from hospital will show us how the informatics management system and the intelligent internet technology attribute and provide enhanced value to study sites. The big data transformation has revolutionized collaborations and how strategic partnerships between CROs and sponsors are formed. Discuss new tools and approaches to improve and centralized site management practices in late phase trials. We will also explore the “digital ecosystem” and showcase situations where digital, mobile and social channels have proven extremely effective in recruiting patients into clinical trials.

Improve Quality and Efficiency Through Information Technology ApplicationsTENG Zhi, PhD Senior Advisor, Life Science Solutions Division, Manufacturing & Distribution Industry Systems, Fujitsu Limited, Japan

Application of Informatics Management System and Intelligent Internet in Clinical Trials - Hospital PerspectiveLI Jingsong, Associate ProfessorDeputy President, Xinhua Hospital, School of Medicine, Shanghai JiaoTong University

23Fueling Clinical Trial Recruitment through an Analysis of the Digital EcosystemRamita TANDON, MD, MPHSenior Vice President and General Manager, InVentive Health/iCTRS, USA

A Procurement View of Clinical OutsourcingJames CHENNELLS Head, Global Strategic Sourcing, Pharma Development Services, Bayer Health Care Procurement, UK

Sessions 1308 | Wednesday, May 14, 2014 15:30 - 17:30 5th Floor, 5D+E

NEW COLLABORATION MODELS FOR HOSPITALS AND SMOs

SeSSion Chair

YANG LiDeputy Director, Drug Clinical Trial Center, Peking University Third Hospital

This session will describe the future development of SMOs in China. A new model for collaboration between Hospital and SMO optimizes site performance and ensures the high quality of clinical trial. Achieving success in Site/SMO new Collaboration, the traditional role of CRC has been changed into a practical site management and monitoring team. SMOs are also participating in patient recruitment to accelerate patient access in clinical trials. Panelists include speakers from both hospitals and SMOs, who will provide their perspectives and thoughts on the effective and efficient operational approaches to partnership management for site and SMOs.

The Future Development of SMO in ChinaLI Bin, MDGeneral Manager, Tigermed Co., Ltd., Canada

Investigation on the Cooperation Mode Between SMO, Sponsor and Drug Clinical Trial Center in ChinaWANG TianxunDeputy General Manager, undo International Pharmaceutical Research & Development Co., Ltd.

The Roles of Clinical Research Coordinators (CRCs) in Clinical TrialsWANG Xiuqin, PhD Professor, Vice Director of Scientific Research Department, Vice Chair of IRB, Jiangsu Province Hospital

The Exploration and Analysis on the Recruitment Methods of SMOWANG HongdongGeneral Manager, Beijing ASMO Medical Research Co., Ltd.

Theme 14 | Clinical Supply Chain


PATIENT FOCUSED CLINICAL SUPPLY MANAGEMENT (PART I)

SeSSion Chair

Lynn WANG, MBA Global Clinical Supply Regional Lead, Asia Pacific, Global Clinical Supply, Merck

One important factor in successfully conducting clinical studies is the efficient management of clinical trial supplies, particularly for those complex studies requiring detailed monitoring, precise planning, and coordination between many players.

The session will include the practices of providing the clinical supply during the planning, manufacturing, packaging and distribution process. It also will share the practice of drug supply management in conducting clinical trials at clinical sites. This session will provide the opportunity to learn from a variety of players, Multinational Companies, global and local CROs, domestic pharmaceutical companies to investigators, their experiences and challenges in managing drug supplies at clinical sites.

The Expectations from Investigator on Clinical Supply Management LI Shuting, MD, Associate ProfessorDeputy Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences

Investigational Medicinal Products Arrangement in Clinical TrialSONG Qingchun, MD General Manager, Proswell Medical Company

How Clinical Supplies Packaging will Drive Site Drug Accountability and Patient ComplianceJiunn Horng VOOSenior Manager, Clinical & Ancillary Supply Services (CASS) Asia Pacific, Covance (Asia) Pte Ltd., Singapore


PATIENT FOCUSED CLINICAL SUPPLY MANAGEMENT (PART II)

SeSSion Chair

Lynn WANG, MS, MBAGlobal Clinical Supply Regional Lead, Asia Pacific, Global Clinical Supply, Merck

The Patient Experience with Clinical MaterialsChristine MILLIGAN, PhD, MBAGlobal Director, Strategic Development Solutions, Catalent Pharma Solutions, UK

Panel Discussion

How Clinical Supply Chain Management Supports the Compliance at Sites and Patients Adherence to the Protocol?

24 Theme 15 | Biosimilar Workshop


08:30 - 10:00 3rd Floor, 3C+D

REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART I)

SeSSion Chair

LI Ning, MD, PhDMember of FDAAA Vice President, Head of Asia Regulatory and Medical Policy, Sanofi

The recent passage of law and publication of guidance in US provides a more defined pathway, as EU regulatory agencies did, for the development of biosimilar products by the pharmaceutical industry. However, unlike generic drugs of small molecules, the regulatory, scientific, and legal issues still present significant challenges due to the unique characteristics of individual biological products. This workshop will discuss the following:

• An update on the law and guidance for biosimilars and the newly approved products.

• The regulatory process for approval of biosimilars in US.

• The legal challenges pertaining to biosimilar products.

• The concept of comparability and the technical challenges related to biosimilar product development.

• Immunogenicity as an important issue for biosimilars.

Opening RemarksLI Ning, MD, PhDMember of FDAAAVice President, Head of Asia Regulatory and Medical Policy, Sanofi

Update on Regulatory Pathway and Scientific Considerations on Quality Comparability and Immunogenicity Issues WU Duu-Gong, PhDMember of FDAAADirector, Regulatory Consulting/Senior Consultant, Global Regulatory Consulting, Pharmaceutical Product Development (PPD), USA


10:30 - 12:00 3rd Floor, 3C+D

REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART II)

SeSSion Chair

LI Ning, MD, PhDMember of FDAAA Vice President, Head of Asia Regulatory and Medical Policy, Sanofi

The Biosimilars Challenge in the USGeorge YU, JD Counsel, Intellectual Property, Schiff Hardin LLP, USA

Quality and Regulatory Considerations for Biosimilar Product Development in ChinaScott LIU, PhDPresident and CEO, Shanghai Henlius Biophamaceuticals, Inc.

Panel Discussion

PaneliStS

All Speakers and:Shaoyu CHEN, JDMember of FDAAAFormer Assistant Chief Counsel, Office of Chief Counsel, Office of Commissioner, FDA, USAPartner and Managing Director, Covington and Burling LLP

CDE Speaker Invited

Special Session | China-Led Global Development

Special Session |Tuesday, May 13, 2014 Simultaneous Translation

08:30 - 12:00 3rd Floor, 3C+D

SeSSion Co-ChairS

MU Hua, MD, PhDSenior Vice President of Operations, Global Head of Product Development Service and Partnership Business Unit, WuXi AppTec

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

During the last few years, an increasing number of new drug development programs in China are driven by Chinese domestic companies. These companies include both large pharmaceutical companies with integrated R&D capabilities or specialized, smaller biotech companies. The products under development include both small and large molecules. While some of these development efforts are for China market, a few programs are positioned towards a China led early clinical development followed by subsequent global or Asian development. What is the future direction of China-led development programs? What are the learning from such efforts? We have invited R&D heads of the domestic pharmaceutical companies, chief executives of the Chinese biotech companies, and senior executives of major CRO company to reflect on their progress and share their insights on China-led local and global development. This special session will be the only forum in this DIA China annual meeting dedicated to Chinese domestic companies. Senior executives from Yangzijiang, Hengrui, Zhejiang Beta Pharma, Hutchison MediPharma, and leading CRO company such as Wuxi AppTec will share experience and openly discuss the global strategies for China new drug development.

New Drug R&D in China: Opportunities and ChallengesSU Weiguo, PhDExecutive Vice President and Chief Scientific Officer, Hutchison MediPharma

Icotinib, the Story of Developing New Drug in China, and Its Status Quo WANG Yinxiang, PhDCEO and CSO, Zhejiang Betta Pharmaceuticals Inc.

Panel Discussion

PaneliStS

All Speakers and:

25WU Jingzi, PhDFounder, President and CEO, Ascletis BioScience Co., Ltd.

YANG Dajun, MD, PhDAscentage Pharma Group Corp. Ltd

CHEN Li, PhDCo-Founder and CEO of Hua Medicine

LU Qiang, PhDChief Scientific Officer, Yangtze River Pharmaceutical Group

XU Li, MD, MSD, MBAHead of Oncology Business UnitVice President, Jiangsu Hengrui Medicine Co., LTD

WANG Peng, PhDPresident, Beijing Research Institute, Yabao Pharmaceutical Group

药物信息协会(dia)第六届中国年会 -...

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