第五届药物信息协会 (DIA) 中国年会 - eventdove.comeventdove.com/resource/20130325/1531_20130325162442693.pdf · ... best practices and ... Bioinformatic Tools in the Management

第五届药物信息协会 (DIA) 中国年会患者关爱与药物安全

5th DIA China 2013 Annual MeetingPatient Safety - A Sustained Focus from Scientific Ideas

to Innovative Medicines

中国 · 北京国际会议中心

Beijing International Convention Center, China

2013年5月12日 —— 专题培训 2013年5月13-15日 —— 会议报告、讨论、展览和论文壁报

May 12, 2013 - Pre-conference WorkshopsMay 13-15, 2013 - Conference, Exhibition and Posters

PRELIMINARY PROGRAM大会日程 ( 2 0 1 3 / 0 3 / 2 5 )

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

合办单位：

中国医药国际交流中心

http://cn13975.eventdove.com.cn

The 5th DIA China Annual Meeting with the theme of “Patient Safety – A

Sustained Focus from Scientific Ideas to Innovative Medicines” will be held at the

Beijing International Convention Center from May 12 to 15, 2013. The meeting

is co-sponsored by the China Center for Pharmaceutical International Exchange

(CCPIE) of the China Food and Drug Administration (CFDA).

The Annual Meeting is the largest meeting held by DIA in the Asia Pacific

region, featuring 14 themes with more than 40 sessions and 60 exhibitors and

bringing together about 1000 professionals from the pharmaceutical and bio-

pharmaceutical industries, contract research and service organizations, regula-

tory agencies, and academic institutes on a neutral global platform. The pro-

gram include the plenary and parallel sessions, preconference workshops, panel

discussions, scientific posters, exhibitions, networking opportunities, and more.

Attendees will share knowledge and experience focusing on better public health

protection, patient benefits, risk management, best practices and compliance in

alignment with science and regulations.

Simultaneous Translation Will be Available in Most Sessions

"Online RegistRatiOn Open", CliCk HeRe tO paRtiCipate!

5th DIA CHINA 2013 ANNUAL MEETING

PROGRAM VICE CHAIR


PROGRAM CO-CHAIR


PROGRAM CO-CHAIRS

Tingshi TAN, PhDGeneral Manager, Pfizer (China) R&D Co., Ltd.Vice President, Pfizer Worldwide Development Operations, China

Yajun ZHAODirector-General, China Center for Pharmaceutical International Exchange (CCPIE), China

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

http://en13975.eventdove.com

邓亚中工商管理硕士

科文斯（中国）临床数据分析与报告

负责人

Yazhong DENG, MBAHead of Clinical Data Analysis and Report-ing Organization (CDARO), Covance, China

陈之键博士

百济神州（北京）生物科技有限公司

首席医务官

George CHEN, MDChief Medical Officer, BeiGene (Beijing) Co., Ltd, China

Florence HOUN 美国FDA同仁会国际部联席主席

前美国FDA药物审评及研究中心三部部长

美国塞尔基因公司法规政策与战略副总裁

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association Inter-national Network (FDAAA)Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA

桂敏博士

百时美施贵宝全球注册科学部亚太区

CMC，中国CMC和运营部总监

Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Sci-ence, Bristol-Myers Squibb (BMS), China

黄彬

阿斯利康（中国）药物研发部药政事务和品

牌仿制药开发执行总监

Laurence HUANGExecutive Director, Regulatory Affairs and Branded Generics Development, RD De-partment, AstraZeneca, China

蒋皓媛医学博士

江苏恒瑞制药有限公司医学执行总监

Helen JIANG, MD, PhDExecutive Medical Director, Jiangsu Hengrui Medicine Co., Ltd., China

刘川博士

医药数据解决方案公司大中华地区发展

总监

Daniel LIU, PhDDirector, China Development, Medidata Solutions Worldwide, China

刘佳

爱恩希（北京）医疗科技有限公司北亚及

中国区总经理

Jessica LIU, MDGeneral Manager, China and North Asia, INC (Beijing) Medical Technology Co., Ltd., China

李宁医学博士

赛诺菲药学与医学政策亚洲区副总裁

Ning LI, MD, PhDAssociate Vice President, Asia/Regulatory and Medical Policy, Sanofi, China

李庆红

辉瑞医疗质量保证部亚洲地区负责人

Helen LI, MDEmerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China

刘宗范

默沙东（上海）医药咨询有限公司全球临床

数据管理中心亚太区总监

Joanne LIU, MDRegional Director, Asia Pacific Data Man-agement Center, Global Data Management & Standards, Merck & Co. Inc, China

梁冰

辉瑞（中国）研究开发有限公司安全监测及

风险管理/全球安全战略部总监

Vera LIANG, MDDirector, Associate Safety Risk Lead, Safety Surveillance and Risk Management, Worldwide Safety Strategy, Pfizer (China) R&D Co., Ltd., China

曲鹏博士

辉瑞（中国）研究开发有限公司统计部

高级总监

Roger QU, PhDHead of Clinical Statistics, Pfizer China R&D Center, China

任毅博士

罗氏研发（中国）有限公司药学部

高级总监

Yi REN, PhDSenior Director, Head of Chemistry, Manu-facturing and Control, Roche R&D Center (China) Ltd., China

大会组织委会 PROGRAM COMMITTEE

史力博士

上海泽润生物科技有限公司首席执行官

Li SHI, PhDCEO, Shanghai Zerun Biotechnology Co., Ltd., China

王捷博士

江苏省人民医院教授

江苏省临床医学研究院常务副院长

Jie WANG, MD, PhDExecutive Vice President, Academy of Clin-ical Research and Translational Medicine, Jiangsu Province Hospital, China

吴博士

第一三共（中国）投资有限公司医药开发总

部总经理

Yan WU, MDGeneral Manager, Division of Medical and Drug Development, Daiich Sankyo (China)Holding Co., Ltd., China

许俊才

上海医药临床研究中心副主任

Jack Xu, MDSenior Vice President, Shanghai Clinical Research Center, China

王春燕

圣犹达医疗用品（香港）有限公司亚太区

临床研究总监

Spring WANG, MDDirector, St Jude Medical Hong Kong Re-gional office, China

张迅博士

葛兰素史克（上海）医药研发有限公司

总裁

Xun ZHANG, PhDVice President, Head of Global Natural Product Business Unit, GSK R&D, China

徐宁医学博士,工商管理硕士

科文斯公司副总裁，中国临床研究事业部

负责人

Ning XU, MD, MBAVice President, Head of Clinical Develop-ment Service, Covance, China

闫小军工商管理硕士

拜耳医药保健有限公司全球注册战略发展

特药负责人

Wendy YAN, MD, MBAGlobal Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd. China

袁维颖博士

强生药物研发中国生物统计和统计程序部

门总监

Weiying YUAN, PhDSite Head of Biostatistics and Program-ming, China Pharmaceutical Research and Development, Johnson & Johnson, China

大会组织委会 PROGRAM COMMITTEE

王武保博士

默沙东研发(中国)有限公司默克研究院

生物统计与研究决策科学部-亚太执行总监

William WANG, PhDSite Head and Executive Director, Biosta-tistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co. Ltd., China

徐莉工商管理硕士

辉瑞公司肿瘤业务部肿瘤中国策略规划、贯

彻和全球运作部副总裁

Li XU, MD, MBAVice President, Oncology China Strategy, Implementation, and Oncology Opera-tions, Oncology Business Unit, Pfizer Inc., China

THANK YOU TO OUR PROGRAM COMMITTE FOR DEVELOPING A GREAT PROGRAM!

Ning XU (Chair)Laurence HUANG (ViCe Chair)

Yan CAILili CAOHannah CHENGeorge CHENPaul DAIAlicia DUYanhua GONGHaiyan LINing LIHelen LIShuting LIVera LIANGJessica LIUJoanne LIUDonglei MAOYi RENLi SHIJie WANGJingsong WANGPeng WANGWilliam WANGZhiang WUJack XUWendy YANRachel YANGSteve YANGTony ZHANG

中国区顾问委员会

Ad

viso

ry C

ou

nci

l of

Ch

ina

(AC

C)

中国区顾问委员会（ACC）由企业、学术界、医疗机构和政府部门的专家组

成。委员会针对DIA在中国地区开展的业务与服务，向理事会与执行总监提

供战略建议。此外，委员会还负责在中国地区发展并保持会员。

The Advisory Council of China (ACC) are made up of DIA volunteers who provide strategic input and feedback on DIA’s portfolio of prod-ucts and services in each region and play a vital role in identifying in-dustry trends and issues so that DIA can position itself best to serve its constituents globally. They also provide strategic input to the Board of Directors to help support the mission, vision, and strategic plan of DIA.

徐宁 (主席)

黄彬（副主席）

蔡琰

曹莉莉

陈华

陈之键

戴欣

杜英华

宫岩华

李海燕

李宁

李庆红

李树婷

梁冰

刘佳

刘宗范

毛冬蕾

任毅

史力

王捷

王劲松

王鹏

王武保

武志昂

许俊才

闫小军

杨佩蓉

杨青

张彦涛

DIA中国区顾问委员会

中国区顾问委员会成员：

Members of Advisory Council of China (ACC) :


主席

ADVISORY COUNCIL OF CHINA (ACC)CHAIR

徐宁医学博士,工商管理硕士

科文斯公司副总裁

中国临床研究事业部负责人

Ning XU, MD, MBAVice President, Head of Clinical Development Service, Covance, China

黄彬

阿斯利康（中国）药物研发部药政

事务和品牌仿制药开发执行总监

Laurence HUANGExecutive Director, Regulatory Affairs and Branded Generics Development, RD Department, AstraZeneca, China

Advisory Council of China (ACC)


副主席

ADVISORY COUNCIL OF CHINA (ACC)VICE CHAIR

6

FULL-DAY

08:30-17:30 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies

08:30-17:30 Drug Substance and Drug Product Stability Requirements and Practices

08:30-17:30 Data Management for Oncology Trials

08:30-17:30 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective

08:30-17:30 Global Clinical Trials in Drug Development - Principles and Case Studies

08:30-17:30 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs

SUNDAY, MAY 12, 2013 | PRE CONFERENCE WORKSHOPS ONLY

• To learn typical use patterns that have emerged focusing on the “patient identification/drill-down” reports, graphs, patient profile interactions of the system.

• To approaches for enhancing clinical R&D efficiency and quality.• To master transforming data to knowledge for better resource allocation

and risk-based decision making.• To learn the usage of the global dictionaries for coding of clinical trial and

safety data.

TARGETED AUDIENCE

Professionals in the following areas:• Clinical management and operation• Clinical IT and computing • Clinical trial data monitoring (CRAs, medical monitoring)• Data assurance and data quality control• Clinical informatics• Regulatory affairs • Data management and programming• E-clinical vendor management• Drug research and development

AGENDA

SESSION I | Bioinformatic Tools in the Management of Clinical Studies I

• Data review during the discovery phase

SESSION II | Bioinformatic Tools in the Management of Clinical Studies II

• Quality review process • Patient data tracking • CDISC standard data structures and approaches

SESSION III | Advanced Reporting and Analytics to Drive Clinical Development Efficiencies

• Enhancement of clinical R&D efficiency and quality• Allocation of resources• Studies planning and decision making

SESSION IV | Performing Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective I

• Signal detection and other methods for knowledge discovery• Transforming data to knowledge: the importance of consistent dictionaries

and terminologies

Full-Day Workshop 108:30 - 17:30 (12:00 - 13:00 Lunch) —— 2nd Floor, 201 B

ANALYSIS OF DATA PATTERNS TO MONITOR AND ASSESS OUTCOMES OF CLINICAL STUDIES

INSTRUCTORS

Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China

Eric S. HERBELPresident, Integrated Clinical Systems, Inc., USA

Yutaka SATOBusiness Consultant, Solutions Architecture, Medidata Solutions, Japan

Madeleine KRIEG, RPhProduct Manager,Uppsala Monitoring Centre, Sweden

Maria LINDQUIST, PhD Director & CEO,Uppsala Monitoring Centre, Sweden

DESCRIPTION

Over the past 10 years, the duration and complexity of clinical trials have steadily increased, Pharmaceutical R&D budgets are tighten and less resources on longer and more complex clinical trials have been observed. It becomes more critical to conduct clinical trials with more effective and innovative approaches. This workshop will discuss typical use patterns and best practices for data analysis of clinical studies. Topics include use patterns in support of ongoing medical monitor of clinical trials, use of CDISC data structure for risk-based monitoring, trial management during a clinical trial and post-approval clinical activities. A variety of approaches for reviewing clinical data, study planning, and decision-making based on the data accumulation will be discussed. The workshop will also cover topics such as a better allocation of resources to enhance clinical R&D efficiency and quality, benefits for patient data review, methods for outlier detection, and how to conduct signal detection.

LEARNING OBJECTIVES

• To understand when and how to use bioinformatic tools in reviewing clinical data.

7

SESSION V | Performing Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective II

• Use of the WHO Drug Dictionaries for coding of clinical trial and safety data

Full-Day Workshop 208:30 - 17:30 (12:00 - 13:00 Lunch) —— 2nd Floor, 201 C

DRUG SUBSTANCE AND DRUG PRODUCT STABILITY REQUIREMENTS AND PRACTICES

INSTRUCTORS

Joan RUAN, PhDAssociate Director, Analytical R&D Bristol Myers Squibb Co, USA

Xin (Amy) BU, PhDPrincipal Scientist, Analytical and Bioanalytical R&D Bristol Myers Squibb Co, USA

DESCRIPTION

Stability is a crucial quality attribute of pharmaceutical products; therefore, a stability program in compliance with current regulations is critical to all the phases of the drug development process and the new pharmaceutical product registration. Successful execution of stability programs requires a good understanding of global regulatory requirements, stability methodologies, and best practices. This session presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including regulatory and technical aspects to design global stability programs, which are cost effective and in compliance.

LEARNING OBJECTIVES

• To understand stability role in the drug development process• To design stability study based on ICH/WHO and global requirements• To execute global stability program effectively• To understand the importance of stability indicating methods• To manage global technology transfer• To interpret stability data

TARGETED AUDIENCE

• Pharmaceutical R&D scientists and managers • Regulatory affairs staff• Quality assurance and quality control professionals• Contract Research/Manufacturing Organization• Government health authority• Academic institution

AGENDA

SESSION I | Overview of Critical Regulatory Requirements for Drug Stability Program

• Stability role in the drug development process • Review of cGMP stability requirements• Review of ICH guidelines for stability• Requirements for global stability programs• Assignment of drug product shelf-life

SESSION II | Practice in Technical Aspects of Drug Stability

• Development of stability indicating methods• Design of forced degradation studies• Method validation and transfer• Evaluation of stability data

SESSION III | Discussion - Case Study

Full-Day Workshop 308:30 - 17:30 (12:00 - 13:00 Lunch) —— 2nd Floor, 201 D

DATA MANAGEMENT FOR ONCOLOGY TRIALS

INSTRUCTORS

Charles YAN, PhDTechnical Operations Lead, Clinical Data Services, Pfizer (China) R&D Center, China

Li XU, MD, MSD, MBAVice President, Oncology Strategy, Implementation, and Oncology Operations,Oncology Business Unit, Pfizer, USA

Fiona AN, MDDirector, Oncology Emerging Markets Clinical Development, Pfizer, USA

Wei ZHANG, PhDTA Lead, CDS, Pfizer (China) R&D Center, China

Sally ZHANGOncology TA Lead, CDS, Pfizer (China) R&D Center, China

Juan WANGData Manger, Oncology Group, CDS,Pfizer (China) R&D Center, China

Kiki WU Associate Director, Clinical Data Management, MSD R&D (China), China

DESCRIPTION

The full day workshop consists of two sessions: session I (basic) will introduce the fundamentals for professionals new to oncology clinical trials and session II (advanced) will focus on the data management activities at each phase of oncology trials.

LEARNING OBJECTIVES

• To introduce the basics in cancer definition, diagnosis/treatment, and the stages of oncology trials.

• To specify the characteristics for an oncology trial in design, efficacy endpoints, and safety monitoring.

• To understand data management activities at each phase of the oncology trials by focusing on CRF design, data cleaning, lab data handling, response data measurement, and long-term study management.

• To discuss the best practices in oncology trials regarding the key data points, SAE handling, and lab data review.

TARGETED AUDIENCE

This workshop is designed for clinical professionals who are new in oncology trials or new in oncology data management. It will also benefit the following professionals:• Clinical researchers• Trial project managers• Trial monitors• Biostatisticians• Trial programmers

AGENDA

SESSION I | Oncology Clinical Trial Basics Part I : Overview

• Drug Development• Oncology Standards of Care and Related Terminology

8

Part II : Trial Design and Endpoints

• Phases and Types of Oncology Trials• Endpoints (PFS, ORR, OS, RECIST 1.1)

Part III : Trial Conduction

• Informed Consent• Site Monitoring and Protocol Deviation

Part IV : Safety Monitoring

• Adverse Events and Serious Adverse Events• Common Terminology Criteria for Adverse Events (CTCAE)

Part V : Case Study

SESSION II | Basics for Oncology Data Manager

Part I : Study Initiation

• Understanding CRF design and database building for oncology trials• Understanding treatment cycle for oncology studies• Understanding efficacy data collection and measurement

Part II : Study Execution

• Cleaning response data from oncology studies• Handling local lab data with normal ranges• Understanding/supporting clinical review on response and toxicity data• 3rd Party review, challenges to DM• Handling external data with reconciliation

Part III : Study Completion

• Database lock for interim analysis for ongoing oncology studies• Managing long-term studies with follow-up

Part IV : Best Practices for Oncology Trials

• Critical data points in oncology trials• Data collection: needs vs. nice to have• SAE handling• Panic lab test data review• Tumor response

Full-Day Workshop 408:30 - 17:30 (12:00 - 13:00 Lunch) —— 3rd Floor, 301

APPLYING MedDRA IN CLINICAL SAFETY AND PHARMACOVIGILANCE PRACTICES: REGULATORY PERSPECTIVE

INSTRUCTORS

Anna ZHAO-WONG, MD, PhD, PMPDeputy Director, MedDRA Maintenance and Support Services Organization, USA

Sonja BRAJOVIC, MDMedDRA Coordinator, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, USA

DESCRIPTION

This workshop will focus on the application of MedDRA in clinical safety and pharmacovigilance, including a regulatory perspective. It will provide in-depth coverage of how to consistently and accurately encode clinical data with MedDRA and options to retrieve and present MedDRA-coded data as outlined in the ICH-endorsed “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents. The use of Standardised MedDRA Queries (SMQs) as tools to aid case identification and signal detection will be discussed. The implementation of MedDRA in US FDA Adverse Event Reporting System (FAERS) database will be described, including the current use of the terminology for coding and analysis of safety

data. Attendees are encouraged to bring questions about MedDRA coding, data retrieval/analysis to share and discuss.

LEARNING OBJECTIVES

• To describe the use of MedDRA terminology in coding adverse event data. • To demonstrate strategies for retrieval and subsequent analysis of MedDRA-

coded data in clinical safety and pharmacovigilance.• To understand how US FDA applies MedDRA in post-market

pharmacovigilance utilizing the FDA Adverse Event Reporting System (FAERS) and in analysis of clinical trial safety data in new drug review.

TARGETED AUDIENCE

This workshop is designed for the following professionals who already have a basic knowledge of MedDRA and wish to explore the implications of its use in clinical safety and pharmacovigilance: • Pharmacovigilance and clinical research professionals• Clinical data managers• Medical writers • Regulatory affairs professionals

AGENDA

SESSION I | MedDRA Introduction

SESSION II | MedDRA Coding and the ICH-endorsed Coding Guide: "MedDRA Term Selection: Points to Consider "

• Overview of MedDRA coding and the “MedDRA Term Selection: Points to Consider” document

• Data quality issues from US FDA perspective with coding examples • Coding exercises• Question & Answer

SESSION III | Analyzing MedDRA-Coded Data and the ICH-Endorsed Data Retrieval Guide: "MedDRA Data Retrieval and Presentation: Points to Consider"

• Overview of the “MedDRA Data Retrieval and Presentation: Points to Consider” document

• Developing queries using MedDRA• Query development exercise• Standardised MedDRA queries• Customized searches• FDA approach to MedDRA search strategies for signal detection: examples

from FDA AERS database and new drug safety review • Question & Answer

SESSION IV | MedDRA Versioning

Full-Day Workshop 508:30 - 17:30 (12:00 - 13:00 Lunch) —— 2nd Floor, 201 A

GLOBAL CLINICAL TRIALS IN DRUG DEVELOPMENT – PRINCIPLES AND CASE STUDIES

INSTRUCTORS

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

Qiong SHOU, PhDSenior Scientist, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP)Merck Research Laboratories / MSD R&D (China) Co. Ltd., China

9

Hsien-Ming James HUNG, PhDDirector, Division of Biometrics I, Office of Biostatistics OTS , Center for Drug Evaluation and Research (CDER), FDA, USA

Sue-Jane WANG, PhDAssociate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA

Yuki ANDO, MSSenior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

DESCRIPTION

In recent years, there was a significant increase of global clinical trials in pharmaceutical development. ICH guidance and/or local regulatory guidelines have set the basic scientific principles. The purpose of this workshop is to show the regulatory, statistical, clinical and operational principles through case studies in Cardiovascular (CV), Central Neurological System (CNS), anti-infective, oncology, and other therapeutic areas that may involve genomic factors. In each case study we will illustrate the disease, typical trial design, global development strategies, the global or regional clinical trial results, and regulatory review considerations.

LEARNING OBJECTIVES

• To review the regulatory, statistical, clinical and operational principles in global clinical trials.

• To learn various clinical development strategies for registration with different regulatory agencies through case studies.

• To review regulatory guidelines for regional registration through case studies.

TARGETED AUDIENCE

Professionals working in the following areas: • Quantitative science • Regulatory affairs• Pharmaceutical industry (preclinical, pre-market, post-market development)• Contract Research Organizations (CROs)• Government organizations • Academia and research institutes

AGENDA

SESSION I | Principle and Case Examples in the CV/CNS Areas

• Concepts of consistency and inconsistency (e.g. PLATO – acute coronary syndrome trial, and schizophrenia trials)

• Challenges and advantages of global versus regional trial strategy

SESSION II | Principles and Case Examples in Global/Regional Pharmacogenomics Trials

• Special features in design and analysis of pharmacogenomics trials (e.g. cancer, anti-viral, and other drug development influenced by genomic factors)

• Challenges versus advantages in global versus regional pharmacogenomics

SESSION III | Principles and Case Examples in Global/Asian Clinical Trials

• Development strategy and selection of trial design - Global/Asian/Regional• Evaluation of overall and regional results in global clinical trials

SESSION IV | Panel Discussion

Full-Day Round-Table Meeting08:30 - 17:30 (12:00 - 13:00 Lunch) —— 3rd Floor, 307

NATIONAL DRUG SAFETY AND ACTIVE PHARMACEUTICAL INGREDIENTS(APIs) IN CHINA: DEVELOPMENT OF RECOMMENDATIONS FOR THE REGULATION OF APIs

WELCOME REMARKS

CFDA OfficialLing SU, PhDPresident, DIA Board of DirectorsStrategic Advisor, Life Sciences, Sidley Austin LLP, China

Nicole Taylor SMITH, JDAssistant Country Director, US Food and Drug Administration, China Office

SESSION I | Summary of the 2012 Roundtable Discussion on the Regulation of APIs and Cooperation

Jeffrey GRENDirector, Office of Health and Consumer Goods, US Department of Commerce and US Co-Chair JCCT Pharmaceuticals Task Force, USA

SESSION II | Definition and Regulation of APIs and Chemical Manufacturing in the US and EU and the Role of APIs in Global Drug Safety

Discussion on the new EU API certification requirements and opportunities for international cooperation. Nicole Taylor SMITH, JDAssistant Country Director, US Food and Drug Administration, China Office

Patrizia TOSETTI, PhDScientific Officer, Health Directory of European Commission, France

SESSION III | Industry Perspectives on the Regulation of APIs

Guy VILLAXCEO, HOVIONE LLC, Representative of RX-360 Consortium, Portugal

Industry Speakers Invited

SESSION IV | Current Scope and Regulation of APIs in China, and Enforcement Approaches to Ensure Compliance

The session will discuss the regulation and oversight of APIs and bulk chemical manufacturers in China, including the potential evading of regulatory review by some bulk chemical manufacturers that produce APIs.

CFDA Official Invited

SESSION V | Inspection of API Manufacturing Facilities and Enforcement Cooperation to Address Unregulated Bulk Chemicals Patrizia TOSETTI, PhDScientific Officer, Health Directory of European Commission, France

Gang WANG, PhDUS Food and Drug Administration, China Office

10

MONDAY, MAY 13, 2013 | CONFERENCE DAY 1

REGISTRATION OPEN

07:30 - 16:00

OPENING PLENARY SESSION

13:30 - 17:30 2nd Floor, Convention Hall 1

OPENING REMARKS

Ling SU, PhDPresident, Board of Directors, DIAStrategic Advisor, Life Sciences, Sidley Austin LLP, China

AWARDS CEREMONY

WELCOME ADDRESSES

Lingshi TAN, PhDVice President, Pfizer Worldwide Development Operations;General Manager, Pfizer (China) R&D Co., Ltd., China

Yajun ZHAODirector-General, China Center for Pharmaceutical International Exchange (CCPIE), China

TEA BREAK

15:00 - 15:30

KEYNOTE SPEECH

Risk Management Planning Spurs Innovation and Enables Patient Safety

Patrizia A. CAVAZZONI, MDSenior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA

OPENING FORUM

SPECIAL RECEPTION

17:30 - 19:30 Exhibition Hall & Convention Hall 2

CHINA NIGHT ——DIA China 5th Anniversary Cerebration

SESSION VI | Role of Pharmacopeias Related to APIs in China, EU and US

CFDA Official InvitedSusanne KEITEL, PhDDirector General, Council of Europe, European Directorate for Quality of Medicines (EDQM), France

John HU, PhDVice President and General Manager, United States Pharmacopeia-China

SESSION VII | Legal and Policy Considerations to Ensure the Quality of APIs and Prevent the Sale or Export of Unregulated or Falsified APIs

Discussion and recommendations to prohibit and deter the manufacture and sale of unregulated bulk chemicals for use in pharmaceutical products, including potential suggestions for revisions to China’s Drug Administration Law, criminal code, and other statutes and regulations.

Chen YANG, LLMPartner, Sidley Austin, China

Academic Speaker Invited

SESSION VIII | Development of Specific Legal and Policy Recommendations

To address the manufacturing, sale and distribution of unregulated or counterfeit/falsified APIs that are intended for use as an API in a finished drug product that either originates from or is consumed in China.

OPEN DISCUSSION: MODERATORS: Jeffrey GRENDirector, Office of Health and Consumer Goods, US Department of Commerce, USA

CFDA Official

SESSION IX | Future Cooperation on the Implementation of Recommendations Discussed During the Roundtable

SESSION X | Concluding Comments and Next Steps

Session XI | Government to Government Discussion (By inVitation only)

11

TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2

THEME 1

CLINICAL RESEARCH & OPERATIONS

THEME 2

REGULATORY SCIENCE

THEME 3

DRUG SAFETY AND PHARMACOVIGILANCE

THEME 4

STATISTICS

THEME 5

VACCINES AND BIOLOGICS

THEME 6

CMC/cGMP

THEME 7

DEVELOPMENT AND REGULATIONS FOR

TRADITIONAL CHINESE MEDICINES (TCM)

08:30 - 10:00 PARALLEL THEMES

Session T 1-11st Floor, 5 C+F

Clinical Excellence When Involving China in Global

Clinical Development: Maximize Benefits and Minimize Risks

Session T 2-11st Floor, 5 A+B+G+H

Global Trends and China Development

Status on Fixed-Dose Combinations (FDCs)

Session T 3-11st Floor, 5 D+E

Pharmacovigilance during Pre-Approval–An Exciting Journey

of Investigation

Session T 4-11st Floor, 201 A

Safety Signal Detection and Quantitative

Assessment of Benefit/Risk Ratio

-Part I

Session T 5-12nd Floor, 201 B+C

Ensuring Innovation and Safety for Cell/Gene Therapy and

Blood Products

Session T 6-12nd Floor, 201 D

Evaluation of Generic Products

vs. Reference Products - The 2007 Conundrum - Part I

Session T 7-13rd Floor, 301

Development of Novel TCM Products for China and Global

Market

10:00 - 10:30 TEA BREAK

THEME 1


THEME 2

REGULATORY SCIENCE

THEME 3


THEME 4

STATISTICS

THEME 5


THEME 6

CMC/cGMP

THEME 7

DEVELOPMENT AND REGULATIONS FOR

TRADITIONAL CHINESE MEDICINES (TCM)



Coordination and Communication

among Stakeholders of Clinical Trials


New Biosimilar Regulation:

Challenges and Opportunities


Pharmacovigilance during Post-Approval

- Path to Success

Session T 4-21st Floor, 201 A

Safety Signal Detection and Quantitative

Assessment of Benefit/Risk Ratio

-Part II


Principles for Pandemic Influenza Preparedness

and Post-Marketing Vaccine Manufacturing

Changes


Evaluation of Generic Products

vs. Reference Products - The 2007 Conundrum - Part II


Case Studies and Good Practices in TCM Development

12:00 - 13:30 LUNCH BREAK

CFDA TOWNHALL MEETING THEME 5


THEME 8

TARGET-BASED ONCOLOGY DRUG

DEVELOPMENT


CFDA TOWNHALL MEETING1st Floor, Convention Hall 3


Cell Therapy Development, Opportunities, and Regulatory Considerations


Changing Paradigm in Cancer Diagnosis

and Treatment - Impact on Drug Development

15:00 - 15:30 TEA BREAK

CFDA TOWNHALL MEETING THEME 5


THEME 8

TARGET-BASED ONCOLOGY DRUG

DEVELOPMENT


CFDA TOWNHALL MEETING1st Floor, Convention Hall 3


Vaccine Product Qualification and Novel Hepatitis

Vaccine Development for China and the

World

Session T 8-22nd Floor, 201 DStrategies for Discovery and

Development of Target-Based Novel Cancer Medicines

12

WEDNESDAY, MAY 15, 2013 | CONFERENCE DAY 3

THEME 1


THEMES 2 & 3

REGULATORY AND SAFETY

(JOINT SESSION)

THEME 4

STATISTICS

THEME 6

CMC/cGMP

THEME 9

PHARM/TOX

THEME 10

eTOOLS AND DATA MANAGEMENT

THEME 11

INNOVATION FOR MEDICAL DEVICES

AND COMBINATIONAL PRODUCTS



GCP Clinics

Sessions T2-3 & T3-31st Floor, 5 A+B+G+H

Balancing Risk and Benefit during IND

Period


Overview of Meta-Analysis and Its

Application in Drug Development


Regulatory Perspectives on Botanical Drug

Products in China and the United

States


Pharm/Tox: From Animal to Human

Session T 10-12nd Floor, 201 A

Technology Advancement in the Landscape of Clinical Data Management


Innovation, Regulation and

Investment - Part I

10:00 - 10:30 TEA BREAK

THEME 1


THEME 2

REGULATORY AND

SAFETY(JOINT SESSION)

THEME 4

STATISTICS

THEME 6

CMC/cGMP

THEME 9

PHARM/TOX

THEME 10


THEME 11

INNOVATION FOR MEDICAL DEVICES

AND COMBINATIONAL PRODUCTS



Pharmacovigilance - QA Perspective

Sessions T2-4 & T3-41st Floor, 5 A+B+G+H

Balancing Risk and Benefit during NDA and Post-Marketing

Periods


Quantitative Sciences in Pharmaceutical

Development (QSPD)


Evolution of Global Biotherapeutic

Regulations – A CMC Perspective


GLP Regulatory Compliance for Data Quality and Integrity


Data Standards in Real World Clinical

Research


Innovation, Regulation and

Investment - Part II

12:00 - 13:30 LUNCH BREAK

THEME 1


THEME 2

REGULATORY SCIENCE

THEME 3


THEME 12

CONTRACT SERVICE ORGANIZATION

THEME 9

PHARM/TOX

THEME 10


THEME 13

PHARMACO- EPIDEMIOLOGY - DRUG

SAFETY AND BEST PRACTICES



Challenges and Opportunities at

Clinical Trial Sites/Institutions


Therapeutic Biologic Development in

China: CMC & Clinical Trial Design


Benefit-Risk: Getting It Right for Patients


How to Build Win-Win Relationship


Patient Safety: Toxicological

Evaluation and Risk Assessment in

Pharmaceutical R&D


Data Managers' Roles in Drug Safety


Pharmacoepidemiology - Drug Safety and

Best Practices

15:00 - 15:30 TEA BREAK

THEME 1


THEME 2

REGULATORY SCIENCE

THEME 3


THEME 12

CONTRACT SERVICE ORGANIZATION

THEME 14

POST-APPROVAL AND REAL WORLD

STUDIES



Ethics Committee Roles and

Development in China


Integration of an Innovative Labeling Hub in Asian with

Global Model


Does Risk Management

Planning Benefit Patients?


Value-Added Taskforce to Ensure

Patient Safety


Post-Approval and Real World Studies

13

TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2WEDNESDAY, MAY 15, 2013 | CONFERENCE DAY 3

Theme 1 | Clinical Research & Operations

Session T 1-1 | Tuesday, May 14, 201308:30 - 10:00 1st Floor, 5 C+F

CLINICAL EXCELLENCE WHEN INVOLVING CHINA IN GLOBAL CLINICAL DEVELOPMENT: MAXIMIZE BENEFITS AND MINIMIZE RISKS

SeSSion Chair

Vivian GUSenior Director, Clinical Operations, Bristol-Myers Squibb, China

To ensure success of clinical trials, it is important to identify critical factors and have a better understanding of risks and impacts on patient safety. The session will share experience and discuss clinical excellence.

Critical Success Factors in Clinical Trials

Jong Ran KIMVice President, Clinical Research, Asia Pacific, ICON, South Korea

Risk Identification and Risk-Based Monitoring

Elaine HAWKINGSExecutive Director, Regional Clinical Operation Head, Asiapac, Bristol-Myers Squibb, China

Risk and Benefit When Involving China and Asia in Global Clinical Trials

Koichi MIYAZAKI, MS, RPhAssociate Director, Clinical Operation, Daiichi Sankyo, Japan

PANEL DISCUSSION

Session T 1-2 | Tuesday, May 14, 201310:30 - 12:00 1st Floor, 5 C+F

COORDINATION AND COMMUNICATION AMONG STAKEHOLDERS OF CLINICAL TRIALS

SeSSion Chair

Yan WU, MDGeneral Manager, Division of Medical and Drug Development, Daiichi Sankyo (China) Holding Co., Ltd., China

ROUND-TABLE DISCUSSION

Speakers from clinical trial site, IEC/IRB, sponsor and CRO will discuss the focus of each side and how to build up smooth communication and coordination among them. The harmonization will lead a high efficiency in the clinical trial operation with patient safety and rights in mind.

PaneliStS

Benny Chung-Ying ZEE, Professor, PhDDirector, Division of Biostatistics, School of Public Health and Primary Care, Center of Clinical Trial, The Chinese University of Hong Kong, China

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

Vivian GUSenior Director, Clinical Operations, Bristol-Myers Squibb, China

Li CHEN, MDHead of Clinical Operations, ICON, China

Session T 1-3 | Wednesday, May 15, 201308:30 - 10:00 1st Floor, 5 C+F

GCP CLINICS

SeSSion Co-ChairS

Hannah CHEN, MDDirector, CQA/PV China, Jansen Pharm R&D QA, Johnson & Johnson, China


ROUND-TABLE DISCUSSION

GCP/ Quality issues that are commonly seen in clinical research will be discussed in this section. Experts from all parties involved in clinical research will provide insights and opinion, aiming to get a better understanding among stakeholders involved in clinical research and to facilitate future quality improvement.

PaneliStS


Paul DAI, MDSenior Director, Regional Head of ICRO, AMAC, Greater China Region, Beijing Novartis Pharma Co., Ltd., China

Helen LI, MDDirector, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China

CFDA Panelist Invited


PHARMACOVIGILANCE - QA PERSPECTIVE

SeSSion Chair

Helen LI, MDDirector, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China

Regulators are enhancing their oversight of pharmacovigilance with the ultimate aim to achieve patient safety. What are some of the lessons we have learned and experience gained from pharmacovigilance inspections and sponsor internal audits? Can we plan for the future and build quality and compliance into our Quality Management System and pharmacovigilance processes?

In this section, our discussion will focus on recent developments in EU Pharmacovigilance Legislation and common findings from PV inspections, and also share one sponsor’s experiences regarding how to build quality and compliance into the quality system and pharmacovigilance activities.

Recent Development in EU Pharmacovigilance Legislation and Common Findings from Pharmacovigilance Inspections

Anya SOOKOO, MSExpert Inspector, GCP & Pharmacovigilance, MHRA, UK

Sponsor Internal PV Audits: Build Compliance and Effectiveness into PV Process

Deborah DRISCOLL, PhDVice President, Medical Quality Assurance, Pfizer, USA

14


CHALLENGES AND OPPORTUNITIES AT CLINICAL TRIAL SITES/INSTITUTIONS

SeSSion Co-ChairS

Haiyan LI, MD, ProfessorDirector, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China


Clinical trials have increased greatly in recent years, and CFDA has paid more attention to quality than before through inspecting both sites and registration trials. Investigators are facing great challenge to ensure high quality of study conduct while runing many trials. How to cope with the challenge is the topic which will be discussed in this session.

The Guaranteed Role of Efficient Management Program for Subjects Involved in Clinical Research

Maozhi LIANG, ProfessorDirector, GCP Center, West China Hospital of Sichuan University, China

A Survey of Clinical Trial Sites and Analysis in 2012


The role of Clinical Trial Center in Drug Development in China

Haiyan LI, MD, ProfessorDirector, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China


ETHICS COMMITTEE ROLES AND DEVELOPMENT IN CHINA

SeSSion Chair: Haitao LIU, MD, MS of International Public HealthSenior Advisor, Clinical Development Quality Assurance Asia Pacific, Global Quality and Compliance, GSK R&D, China

The session focuses on the current ethical review practice and IEC construction in China: the strengths and challenges. It not only highlights the key areas of IEC construction in terms of infrastructure and system but also examines the existing paradigm defining the roles of EC, in terms of ensuring the protection of patient safety. It aims to develop an efficient review system and promote review quality.

Ensuring Patient Safety through Ethics Committee Oversight

Cristina E. TORRES, PhDAsian Regional Coordinator, Forum for Ethical Review Committees in Asia Pacific (FERCAP), Tailand

Challenge and Consideration in Ethical Review

Xiuqin WANG, PhDDeputy Director, Department of Science and TechnologyVice Chair, IRB, Jiangsu Province Hospital

PANEL DISCUSSION

Theme 2 | Regulatory Science

Session T 2-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H

GLOBAL TRENDS AND CHINA DEVELOPMENT STATUS ON FIXED-DOSE COMBINATIONS (FDCs)

SeSSion Chair

Wendy YAN, MDGlobal Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd. China

The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. They are being used in the treatment of a wide range of conditions e.g. HIV, hypertension and oral contraception, etc. There can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. In addition, the cost of an FDC finished pharmaceutical product may be less than that of separate products given concurrently. Improved medication compliance by reducing the pill burden of patients may be difficult to prove, but there could be additional benefit. In this session, speakers will share the experience of FDC development globally and its benefit to patients, CFDA/CDE speaker will discuss the general principles, regulatory requirements, and concerns on FDC development in China.

CFDA/CDE Speaker Invited

Industry Speaker Invited

Lisheng LIU, ProfessorFuwai Hospital, China

Session T 2-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H

NEW BIOSIMILAR REGULATION: CHALLENGES AND OPPORTUNITIES

SeSSion Chair

Ning LI, MD, PhDVice President, GRA Head, Medical Policy, Asia, Sanofi, China

Since US FDA released its biosimilar guidance in 2011, the issue surrounding how to conduct a regulatory acceptable study following the guidance becomes very critical. This session will focus on regulatory requirement and trial design of biosimilar development.

US FDA Biosimilar Guidance Considerations

John GONG, MD, PhDCEO, BL Pharma, China

How to Design A Biosimilar Clinical Study

Jian PENG, MDDirector, Clinical Research, Sanofi, China

CMC Related Issues in Biosimilars

HaiQing DUAN, PhDVice President, Medical Health Investment, Legendstar, China

Session T 2-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H

BALANCING RISK AND BENEFIT DURING IND PERIOD (JOINT SESSION)

SeSSionS Chair

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International Network (FDAAA)

15

Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA

Risk and benefit assessment is the foundation of the regulatory decision-making. Despite of significant progress made in the past decade in risk/benefit framework development, the challenge remains, especially in IND period where the benefit of a potential drug has not been adequately demonstrated. This is PART I of Risk/Benefit at US FDA, focusing on FDA’s use of clinical hold as an effective tool in managing risk during IND period.

Balancing the Benefits and Risks Management During IND Period at US FDA

Mark J. Goldberger, MD, MPH, FIDSAFormer Director, Office of Drug Evaluation IV, USFDA/CDER, Member of FDA Alumni Association, VP, AbbVie Regulatory Intelligence and Policy, USA

Clinical Hold – An Important Tool of Risk Management During IND at US FDA

Robert J. MEYER, MDFormer Director, Office of Drug Evaluation II, USFDA/CDER, Member of FDA Alumni Association, Assoc. Professor, Public Health Sciences , Director, Virginia Center for Translational and Regulatory Sciences, University of Virginia School of Medicine, USA

Statistical Considerations for Balancing the Benefits and Risks at US FDA

Ning LI, MD, PhDFormer Team Leader, Office of Biostatistics, US FDA/CDER, Member of FDA Alumni Association, Vice President, GRA Head, Medical Policy, Asia, Sanofi, China

Approving Clinical Trial Application - Benefits and Risks Considerations at CFDA/CDE


PANEL DISCUSSION


BALANCING RISK AND BENEFIT DURING NDA AND POST-MARKETING PERIODS (JOINT SESSION)

SeSSionS Chair

Mark J. GOLDBERGER, MD, MPH, FIDSAFormer Director, Office of Drug Evaluation IV, US FDA/CDERMember of FDA Alumni Association International Network (FDAAA)Vice President, AbbVie Regulatory Intelligence and Policy, USA

Risk and benefit assessment is the foundation of any regulatory decision-making. Despite of the progress made in the past decade, the significant challenge remains as we often witness the different opinions and decisions from regulatory agencies on same applications. This is PART II of Risk/Benefit at US FDA, focusing on FDA’s use of external experts and its building of Pharmacopidemiology capacity/capability in assisting risk/benefit analysis.

Overview of Benefit-Risk Assessment During the NDA Review and Post-Marketing Reassessment at US FDA

Robert J. MEYER, MDFormer Director, Office of Drug Evaluation II, USFDA/CDER, Member of FDA Alumni Association, Assoc. Professor, Public Health Sciences , Director, Virginia Center for Translational and Regulatory Sciences, University of Virginia School of Medicine, USA

Use of Public Advisory Committee in Risk/Benefit Assessment During NDA Review at US FDA

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International Network, Former Director, Office of Drug Evaluation III, US FDA/CDER, VP, Celgene Regulatory Policy and Strategy, USA

Approving Marketing Application - Benefits and Risks Considerations at TFDA/CDE

Lih-Jiuan HSU, MDDirector, Division of Clinical Science, TFDA/CDE, Taiwan

Post-Marketing Reassessment in China

Siyuan ZHAN, MDProfessor, Department of Epidemiology, Beijing University Medical School, ChinaPANEL DISCUSSION


THERAPEUTIC BIOLOGIC DEVELOPMENT IN CHINA: CMC & CLINICAL TRIAL DESIGN

SeSSion Chair

Janet LVHead of Regulatory, Roche Product Development in Asia Pacific, China

Therapeutic biologics play more and more important role to address unmet medical needs. To timely introduce new therapeutic biologics to China is also a shared goal of domestic industry and multinational companies (MNCs) in China. The session will focus on the best practices sharing in expediting CTA from CMC perspective and critical considerations to evaluate efficacy and safety of therapeutic biologics.

Specification Validation during CTA

Industry Speaker Invited

Critical Considerations for Designing A Clinical Trial to Evaluate Efficacy and Safety of Therapeutic Biologics

CFDA Speaker Invited

PANEL DISCUSSION


INTEGRATION OF AN INNOVATIVE LABELING HUB IN ASIAN WITH GLOBAL MODEL

SeSSion Chair

Rie MATSUIDirector, Regional Labeling Head for Asia, WSR International & Global Product Information, Pfizer

Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the Headquarters organization while local product documents and patient leaflets are handled by affiliates based in local offices. In 2012 Pfizer implemented a new regional Hub model designed to strengthen the voice of Asia in the global organisation, while bringing process efficiencies, cost benefits and increased focus on compliance to the region as a whole. The Asian Labeling Hub is now established, covering all Asian labels including Japan, China, ASEAN, Korea and India. This session will provide you with an overview of the Global Labeling System covering the CCDS, USPI and EU-SPC, as well as a discussion on the implementation of the Asian regional hub model and prospects for future development, including consideration on harmonization of labeling in the Asian region.

Global Safety Labeling System: CDS/US/EU countries

Speaker Invited

Innovative Labeling Implementation System in Asia Region

Speaker Invited

Theme 3 | Drug Safety and Pharmacovigilance

Session T 3-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 D+E

16

PHARMACOVIGILANCE DURING PRE-APPROVAL – AN EXCITING JOURNEY OF INVESTIGATION

SeSSion Chair

Feng (Richard) XIA, MD, MScMedical Director, Former Global Pharmacovigilance Lead, Safety Evaluation and Reporting, Worldwide Safety and Regulatory, Pfizer Worldwide Research & Development, USA

Pharmacovigilance has shifted toward earlier, proactive consideration of risks and potential benefits of drugs and has become an important aspect in the development of novel medicinal products, all the way to their market introductions. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also allowed a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. On the other hand, the pharmaceutical industry is evolving to actively respond to these new requirements and to ensure the upmost patient safety.

This session aims to provide a holistic view of safety in pre-approval stage, introducing the current thinking around pre-approval safety risk assessment, decision making, communication, and planning. The session will also bring practical examples from oncology clinical trials where unique considerations need to be taken around patient safety.

From First-in-Human (FIH) to Market Authorization: Critical Aspects of Safety in Developing Innovative New Medicinal Products (Assessment, Decision making, and Communication)

Dan ZHANG, MD, MPHChairman and CEO, Fountain Medical Development LTD., China

An Evolving Pharmaceutical Industry Model and Practical Experience to Ensure Upmost Patient Safety

Ayman AYOUB, MDSenior Director, Disease Area Head, Member of Pfizer Hepatic Injury Council, Safety Surveillance& Risk Management, Worldwide Research and Development, Pfizer, UK

Unique Considerations Around Patient Safety in Novel Oncology Clinical Trials

George CHEN, MD, MBAChief Medical Officer, BeiGene Co., Ltd, China

PANEL DISCUSSION TOPICS

• Clinical Safety Review for Marketing Applications • Practical Aspects of Pre-Approval Risk Assessment• Individual and Aggregate Safety Reports• Safety Communication During Pre-Approval

Session T 3-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 D+E

PHARMACOVIGILANCE DURING POST-APPROVAL - PATH TO SUCCESS

SeSSion Chair

XingMin QIU Director, World Safety and Regulatory, Pfizer China R&D Center, China

The decision to approve a drug is based on the information available at the time of approval. The knowledge related to the safety profile of the product can change over time through expanded use in terms of patient characteristics and the number of patients exposed. In addition to routine post-approval safety monitoring activities, the appropriate pharmacovigilance methods employed for products with special safety concerns have arisen. The best method chosen can vary depending on the product, the population, and the safety signal. Rigorously designed and conducted observational studies are well recognized as important

tools while active surveillance is the evolving area in pharmacovigilance. In this session, the overview, initiatives and practices of these methods for post-approval products will be deeply discussed.

Is Grandfather Product Necessarily Safe? - The Phenylpropanolamine (PPA) Experience

Yi TSONG, PhDDeputy Director, Division of Biometrics VI, Office of Biostatistics, CDER, FDA, USA

Active Surveillance of Drug Safety – Concept, Methodology, and Development

XiaoFeng ZHOU, PhDDirector, Worldwide Safety & Regulatory, Pfizer Inc., USA

Application of Active Surveillance – Practical Examples

Andy STERGACHIS, PhD, RPhProfessor, Epidemiology & Global HealthDirector, Global Medicines Program, School of Public Health, University of Washington, USA


• Post-Approval Safety Study – Which Way to Go• “Real World” Study• Challenge of Collecting Adverse Event Information in Post-Marketing • What Is the Lesson from the Critics on Under Reporting of 80,000 Adverse

Event Reports


BALANCING RISK AND BENEFIT DURING IND PERIOD (JOINT SESSION)


BALANCING RISK AND BENEFIT DURING NDA AND POST-MARKETING PERIODS (JOINT SESSION)

Session T 3-5 | Wednesday, May 15, 2013

13:30 - 15:00 1st Floor, 5 D+E

BENEFIT-RISK: GETTING IT RIGHT FOR PATIENTS

Session Co-Chairs

Hugues BERARD, MD, MBAVice President, Deputy Chief Medical Officer, IPSEN R&D, France

Gao GAO, MDAssociate Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China

Monitoring benefit-risk balance is critical at each stage across the life cycle of drug development, review and post-approval activities. A Benefit-Risk assessment framework is recognized as important from both an agency and a company perspective. It is a rapidly moving field involving a number of ongoing initiatives across regulatory agencies and companies. The session aims to:

• Present the progress made on defining and implementing a benefit-risk methodology framework

• Provide industry perspectives and address the issues within the benefit risk-framework adopted by industry and regulatory authorities

• Share real-life examples on how companies implement different methodologies and their learnings

• Discuss how to achieve a consensus on a scientifically accepted approach for making benefit risk decision and the role of benefit-risk framework in drug innovation

Practical Considerations When Approaching Benefit-Risk: A Case Study Showing The Benefit of A MAHs Collaborative Approach

17

Hugues Berard, MD, MBAVice President, Deputy Chief Medical Officer, Ipsen R&D, France

Benefit-Risk Assessment and Management in Drug Development in China

Hua MU, MD, PhDExecutive Vice President & Chief Medical Officer, Hutchison Medi Pharma, China

Global Initiatives on Benefit-Risk Framework and Implementation: European PROTECT Project

Juhaeri JUHAERI, PhDAssociate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA


• How to achieve a consensus on a scientifically accepted approach for making benefit risk decisions

• The role of benefit-risk framework in drug innovation

Session T 3-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 D+E

DOES RISK MANAGEMENT PLANNING BENEFIT PATIENTS?

SeSSion Co-ChairS

Lynn ZHOU, MD, MPHAssociate Director, International Pharmacovigilance Coordinator, PV Affiliate Relations, Global Pharmacovigilance & Epidemiology, Sanofi, China

Yun(Jackie) MAO, MD, MBADirector, Worldwide Safety & Regulatory, Pfizer China R&D Center, China

Effective risk management planning (RMP) has been playing a critical role in drug development and commercialization, while debates remain that RMP could be burdensome to the healthcare system and potentially limit the access of patients to medicines. On the other hand, global harmonization of RMP is underway but the value of adopting local perspectives is intensively discussed because risk identification/categorization and selection of tools to minimize or mitigate the risk can be largely affected by local patient population and the delivery of the healthcare. The success of a risk management plan should be measured with consideration of value to the patients.

This session aims to:

• Provide overview of RMP regulation worldwide with focus on asia regulation• Introduce CIOMS working group IX (effectiveness of risk minimization)• Share real-life examples on how to use epidemiology study to evaluation

effectiveness of risk minimization • Discuss how to harmonize risk management & toolkit and maintenance as

the science of risk management evolves

Risk Management Planning (RMP)– Where are We Heading to

William GREGORYSenior Director, Safety Strategy, Policy and Standards, Pfizer, USA

Risk Management in Asia: Experience in Japan

Stewart GEARY, MDChief Medical Officer, Vice President, Corporate Medical Affairs Headquarters, Eisai Co. Ltd., Japan

Observational Study for Risk Characterization and Assessment of Risk Minimization Tools

Juhaeri JUHAERI, PhDAssociate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA

PANEL DISCUSSION TOPICS• Can risk management plan and tools be harmonized? • How practical is it for China and Asia to adopt the RMP from EU and/or USA• How to measure effectiveness of risk minimization and mitigation tools in

China

Theme 4 | Statistics

Sessions T 4-1 & T 4-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 A

SAFETY SIGNAL DETECTION AND QUANTITATIVE ASSESSMENT OF BENEFIT/RISK RATIO

SeSSionS Co-ChairS

Weiying YUAN, PhD Site Head of Biostatistics and Programming, China Pharmaceutical Research and Development, Johnson and Johnson, China

Roger QU, PhDHead of Clinical Statistics, Pfizer R&D Center, China

Protection of patient safety is paramount in the drug development and medical treatment. Statistics plays an essential role in the identification of potential safety signals and quantification of benefit/risk ratio which is integral part of safety assessment. This session will focus on statistical application in both areas, from both regulatory and sponsor perspective.

Multiple Testing Issues in Thorough QTc Clinical Trials

Yi TSONG, PhDDeputy Director, Division of Biometrics VI, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA

Sequential GLR Tests for Signal Detection

Jie CHEN, PhDDirector, Global Biostatistics, Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., China

Statistical Considerations for Risk/Benefit

Marcia LEVENSTEIN, PhDVice President and Head of Global Statistics of Specialty Care Business Unit, Pfizer, China

Bayesian Shrinkage Estimator for Safety Signal Detection

Luyan DAI, PhDAssociate Director, Biostatistics, Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd., China

Safety in Pharmacogenomics

Sue-Jane WANG, PhDAssociate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA

PANEL DISCUSSION


OVERVIEW OF META-ANALYSIS AND ITS APPLICATION IN DRUG DEVELOPMENT

SeSSion Chair

Wei ZHANGRegional Head of Biometrics and Data Management, Asia/MENA, Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd., China

One of the most commonly used statistical methodologies in medical research and drug development is Meta-analysis, such as hypothesis generating, determination of effect margin for non-inferiority clinical trials, integrated analysis treatment effect based on large number of clinical trials. If conducts not appropriately, its value would be diminished by various sources of biases. This session will promote the good practice of meta-analysis and introduce its recent

18

development.

Meta-Analysis in Drug Safety Evaluation: Statistical Challenges and Best Practices

George QUARTEY, PhDPrincipal Statistical Scientist, Biostatistics, Genentech, USA

Meta-Analysis and Mixed Treatment Comparisons - Measuring and Reporting Direct and Indirect Evidence of Treatment Networks: Methodology, Software and Examples

Hendrik SCHMIDT, PhDAssociate Director, Boehringer Ingelheim, Germany


QUANTITATIVE SCIENCES IN PHARMACEUTICAL DEVELOPMENT (QSPD)

SeSSion Co-ChairS

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

Yang SONG, PhDSenior Principal Scientist, Biostatistics, Late Development Statistics, Biostatistics and Research Decision Sciences - Asia Pacific, MSD R&D (China) Co. Ltd., China

Quantitative Sciences in the pharmaceutical development encapsulate many disciplines such as biostatistics, epidemiology, health economics statistics, scientific programming, and data management. Collectively these scientific disciplines are playing increasing importantly roles in pharmaceutical development. These important roles are reflected not only in strategic design, execution, but also in regulatory submission and regulatory decision making; not only for pharmaceutical development in the developed regions but also in the emerging market regions. This session will examine the top challenges and opportunities facing the quantitative science professionals.

Emerging Issues with Quantitative Sciences in Drug Development

Hsing-Ming James HUNG, PhDDirector, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USAPANEL DISCUSSION TOPICS• Roles of Modeling and Simulation• Quantitative Benefit-Risk Assessment• Complex Clinical Trial Designs• Predictive or Prognostic Characteristics of Biomarkers• Utilities and Pitfalls of Integrated or Meta Analyses• Globalization

Panelists

Hsing-Ming James HUNG, PhDDirector, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA

Sue-Jane WANG, PhDAssociate Office Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA

Joan SHENSenior Director, Clinical Development, Pfizer, China

Yuki ANDO, MSSenior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Theme 5 | Vaccines and Biologics

Session T 5-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 201 B+C

ENSURING INNOVATION AND SAFETY FOR CELL/GENE THERAPY AND BLOOD PRODUCTS

SeSSion Chair

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International Network (FDAAA)Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA

A comprehensive presentation of the approaches to ensure quality, efficacy and patient safety for the blood supply, cell, tissue, and gene therapies at the US FDA’s Center for Biologics Evaluation and Research (CBER) and the China FDA/Center for Drug Evaluation (CDE).

Update from China CDE on Cellular/Gene Therapies Safety and Efficacy Requirements


Overview of FDA’s Requirements for Safety and Efficacy for Cell/Gene Therapies

Jinjie HU, PhD Member of FDA Alumni Association International Network (FDAAA)Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBERSenior Consultant, Biologics Consulting Group, INC., USA

Ensuring Safety and Efficacy of Blood Products in China

CFDA Speaker InvitedFDA Role in Blood Product Safety

Jinjie HU, PhD Member of FDA Alumni Association International Network (FDAAA)Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBERSenior Consultant, Biologics Consulting Group, INC., USA


PRINCIPLES FOR PANDEMIC INFLUENZA PREPAREDNESS AND POST-MARKETING VACCINE MANUFACTURING CHANGES

SeSSion Chair

Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International Network (FDAAA)Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA

Ensuring safety for vaccines is a difficult but necessary duty of all regulatory agencies to promote public health and responsibilities of the biologics industry. US FDA and China FDA have had many years of experiences to share. Ensuring vaccine safety and effectiveness by balancing the need to encourage the adoption of new technologies to advance quality and efficient manufacturing of vaccines with the need to demonstrate, through appropriate validation and/or clinical or non-clinical laboratory studies, the lack of adverse effect of the change on the safety and effectiveness of the product remains a challenge. An update on recent US and Chinese activities regarding influenza vaccine production and preparedness and safety will be presented.

FDA and WHO Pandemic Influenza Vaccine Preparedness Activities

Zhiping YE, MD, PhDSenior Investigator, Division of Viral Products (DVP), Office of Vaccines Review and Research (OVRR), Center of Biologics Evaluation and Research (CBER), FDA, USA

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Vaccine Applications at FDA: Regulations for Safety and Post-Marketing Changes

Sara E. GAGNETEN, PhDRegulatory Scientist, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research (CBER), FDA, USA

Advancing Vaccine Safety and Innovation in China



CELL THERAPY DEVELOPMENT, OPPORTUNITIES, AND REGULATORY CONSIDERATIONS

SeSSion Chair

Li SHI, PhDCEO, Shanghai Zerun Biotechnology, China

The new stage of biological product development and usage in treating diseases has been on biosimilars and cell therapeutics. These two areas are playing increase important rules in the current and future growth of biological based pharmacuticals. Cell therapy are facing not only technical but also regulatory challenges. For biosimilars, getting into regulated markets still needs great effort in meeting regulatory requirement. This session will review current status of cell therapy and biosimilar development, quality, safety and regulatory considerations.

Cell Therapy Development and Current Status in Its Application for Cosmetic Treatment

Ningwen ZHU, MD, PhDCEO, Cell & Tissue Eng, China

Safety Evaluation and Research in China for New Biologics by Following the International GLP Standard

Gene C HSU, PhD, DABTVice President and CSO, Innostar and National Shanghai Center for New Drug Safety Evaluation and Research, China

Expectation and Opportunities of Bringing Biosimilars from China to EU, from Regulatory Point of View

Hoss DOWLAT, PhDVice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany

Quality Control and Analysis of Novel Vaccine Development

CFDA Speaker invited


VACCINE PRODUCT QUALIFICATION AND NOVEL HEPATITIS VACCINE DEVELOPMENT FOR THE WORLD AND CHINA

SeSSion Chair

Li SHI, PhDCEO, Shanghai Zerun Biotechnology, China

Vaccine product qualification and novel hepatitis vaccine development have both been under the consideration in China vaccine industry. Supplying vaccine made in China to the world is one of the goals for China vaccine industry. WHO Pre-Qualification (PQ) activities and new GMP implementation have made it a more practical task. Hepatitis diseases are among the most awared diseases in Asian countries including China. This session will review WHO PQ practice and hepatitis vaccines effectiveness and new development.

The Challenges Faced in the Case of Novel Products

Nora DELLEPIANE, PhDScientist Quality, Safety and Standards, Vaccine Quality and Regulation Group

Leader, Essential Medicines and Health Products, WHO, Switzerland

Accurary of Titration Method for Detecting Live Attenuated Hepatitis A Vaccine

Xuanyi WANG, Professor Shanghai Medical College, Fudan University, China

New Generation of Hepatitis Vaccine Development with Novel Adjuvant for Improving Vaccine Efficacy

Tyler J. MARTIN, MDPresident and Chief Medical Officer, Dynavax, USA

Licensing/Collaborating with NIH in Both Infectious Diseases/Vaccines and Other Technologies

Peter A. SOUKASTechnology Transfer Officer, Public Health Service, National Institutes of Health, USA

Theme 6 | CMC/cGMP

Sessions T 6-1 & T 6-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 D

EVALUATION OF GENERIC PRODUCTS VS. REFERENCE PRODUCTS - THE 2007 CONUNDRUM

SeSSion Co-ChairS

Min GUI, PhDDirector, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China

Chi-wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA)Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDERExecutive Director, Global CMC, Pfizer, USA

CFDA kicked off an initiative in 2012 for the reevaluation of generic products approved before 2007 as one of the projects defined in the 12th Five Year Plan. This initiative was meant to resolve the 2007 conundrum in order to ensure safety, efficacy and quality of drug products for patients. More than 10,000 marketed products will be impacted, and this initiative may last up to 10 years. How to ensure a scientifically sounding process is in place to achieve the goal of resolving 2007 conundrum? What are the practical challenges faced by the Health Authority and industry, and how to overcome the identified issues? This session is designed to discuss this important CFDA initiative and associated challenges and concerns by the Health Authority and industry representatives. Current and former experts from the U.S. FDA will also share their experiences in bioequivalence evaluation and in using in vitro dissolution tests as a surrogate for bioequivalence studies where scientifically justified. CFDA Working Procedures for the Generic Product Reevaluation Initiative


Rule for Reference Product Selection and Guidance on Comparative Dissolution

CFDA/NIFDC Speaker Invited

Bioequivalence and In Vitro Dissolution Studies – A US Industry Perspective Xiaoxiong (Jim) WEI, MD, PhDMember of FDA Alumni Association International Network (FDAAA)Director, Clinical Pharmacology, Medpace, USA

PANEL DISCUSSION

Session T 6-3 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 D

REGULATORY PERSPECTIVES ON BOTANICAL DRUG PRODUCTS IN CHINA AND THE UNITED STATES

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SeSSion Chair

Chi-wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA)Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDERExecutive Director, Global CMC, Pfizer, USA

A botanical product is regulated as a dietary supplement or drug, depending on its intended use, in the U.S. The US FDA issued a guidance on Botanical Drug Products in 2004 to outline its recommendations on CMC information for different phases of clinical studies and for pre-NDA consideration. The guidance has enabled the industry and academia to begin studying botanical products for drug use, leading to the approval of the first botanical drug product in the U.S. in 2006. This session will introduce the brief regulatory history of botanical drug products and discuss the challenges in developing such products in the U.S. China’s long history and experience in regulating Traditional Chinese Medicines (TCM) will be presented as a comparison.

CFDA Requirements for Traditional Chinese Medicines (TCM)


Botanical Drug Products in the United States – Regulatory Background

Duu-Gong WU, PhDMember of FDA Alumni Association International Network (FDAAA)Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA

Regulatory Challenges in Developing Botanical Drug Products in the United States

David LIN, PhDMember of FDA Alumni Association International Network (FDAAA) Senior Consultant, Biologics Consulting Group, USA

PANEL DISCUSSION


EVOLUTION OF GLOBAL BIOTHERAPEUTIC REGULATIONS – A CMC PERSPECTIVE

SeSSion Co-ChairS

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

Min GUI, PhDDirector, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China

Over the past decades, the development and application of new technologies have transformed the biotherapeutic product development, and drive the evolution of biotherapeutic regulatory framework. This session will introduce the evolution of global biotherapeutic regulations and the emerging regulatory concepts that will change the regulatory framework in the US & EU, such as life-cycle management approach for process validation, CMC change management protocol, etc. Application of the new ICH Q11 principles in biotherapeutic drug substance development will also be discussed. In addition, this session will cover the platform manufacturing for biotherapeutic development and use cases to demonstrate its application.

Modular Viral Validation for Platform mAb Purification Process

Qi CHEN, PhDAssociate Director and Senior Scientist, Genentech, Inc., USA

Application of ICHQ11 Principles in Biotherapeutic Drug Substance Development

Anthony RIDGWAY, PhDSenior Regulatory Scientists, Biologics and Genetic Therapies Directorate, Health Products and Food Branch Health, Canada

Evolution of the Biotherapeutic Regulations in USA and Driving Force Behind

FDA Speaker Invited

Theme 7 | Traditional Chinese Medicines (TCM)

Session T 7-1 | Tuesday, May 14, 2013 08:30 - 10:00 3rd Floor, 301

DEVELOPMENT OF NOVEL TCM PRODUCTS FOR CHINA AND GLOBAL MARKET

SeSSion Chair


This session is to provide an overview of the R&D strategies and activities on the development of novel TCM products, as well as a forum for open discussion of the opportunities and challenges faced by the drug industry in its efforts to convert traditional herbal medicines into high quality, patent-protected, and clinically-proven products using global drug discovery and development technologies and standards.

TCM Industry Landscape

Junjie ZHOU, PhDGeneral Manager, Shanghai Hutchison Pharmaceuticals, China

R&D Strategy and Activity for New TCMs

Zuguang YE, ProfessorDirector, TCM Platforms, China National Academy of Sciences, China

TCM Globalization Opportunity and Challenge


Session T 7-2 | Tuesday, May 14, 2013 10:30 - 12:00 3rd Floor, 301

CASE STUDIES AND GOOD PRACTICES IN TCM DEVELOPMENT

SeSSion Chair

Jack XU, MDSenior Vice President, Shanghai Clinical Research Center, China

The regulatory requirements, experience, and practices for TCM development will be discussed with case studies at this session. The session will also discuss what criteria should be used for TCM clinical evaluations.

China Regulatory Guidelines and Updates about TCM


Update FDA IND and NDA Review about Botanical Medicine

FDA Speaker Invited

Clinical Research Update about TCMs in China

Jack XU, MDSenior Vice President, Shanghai Clinical Research Center, China

Theme 8 | Target-Based Oncology Drug Development Co-Organized By: US Chinese Anti-Cancer Association (USCACA)

Session T 8-1 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 D

CHANGING PARADIGM IN CANCER DIAGNOSIS AND TREATMENT - IMPACT ON DRUG DEVELOPMENT

SeSSion Co-ChairS

George CHEN, MD, MBA

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Chief Medical Officer, BeiGene (Beijing) Co., Ltd, China

Li XU, MD, MSD, MBAVice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA

This session will overview the current target based novel cancer drug development and review two successful cases of target based cancer drug development.

Overview and Introduction

Jorge PUENTE, MDPresident, Asia Pacific and Canada, Oncology Business Unit, Pfizer, USA

Case Study: Biomarker/Target Based Oncology Drug Development - Right Drug for the Right Patients at the Right Time

• Case 1 - Xalkori for ALK+ NSCLC

Maria KOEHLER, MD, PhDVice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA

• Case 2 - BRAF Inhibitor for BRAF V600e/k Mut Melanoma

Jun GUO, Professor, MD, PhDDirector, Department of Kidney & Melanoma Vice President of Hospital, Peking University Cancer Hospital & Institute, China

Session T 8-2| Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 D

STRATEGIES FOR DISCOVERY AND DEVELOPMENT OF TARGET-BASED NOVEL CANCER MEDICINES

SeSSion Co-ChairS

George CHEN, MD, MBAChief Medical Officer, BeiGene (Beijing) Co., Ltd, China

Li XU, MD, MSD, MBAVice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA

This session will discuss the strategies for discovering, developing and registering novel target-based cancer drugs with quality, speed and value. In addition, this session will also discuss what China needs to do to transit from participating to leading target-based cancer drug development.

Novel Cancer Target Identification and Validation

Jennifer YANG, PhDDirector, Johnson & Johnson Asia R&D Center, ChinaClinical Development Strategy - Selection of Right Target Population, Optimal Endpoints and Indications, and Study Execution

Hua MU, PhDExecutive Vice President and Chief Medical Officer, Hutchison Medi Pharma, China

Biomarker and Diagnostic Strategy- Regulatory Guidance and When/What/How And Cost/Benefit on BM Diagnostic Tool Development

Speaker Invited

Industry and Regulatory Agency Collaboration – Focusing on Strategy to Safely Speed Up The Drug Development and Registration


China’s Role in Participating and Leading Discovery and Development of Novel Oncology Medicine

Caicun ZHOU, PhD, ProfessorDirector, Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, China

Theme 9 | Pharm/Tox

Session T 9-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 B+C

PHARM/TOX: FROM ANIMAL TO HUMAN

SeSSion Chair

John GONG, MD, PhDMember of FDA Alumni Association International Network (FDAAA)CEO, BL Pharma, China

A comprehensive presentation of requirements for preclinical safety evaluations in the US FDA and China CFDA. Preclinical safety data analysis and interpretation, extrapolation of animal toxicity findings to humans, how to use animal data to predict potential human risk and support regulatory decisions.

FDA Requirements for Preclinical Safety Evaluations

Paul A. ANDREWS, PhDExecutive Director, Global Regulatory Affairs, Eisai Inc., USA

CFDA Requirements for Preclinical Safety Evaluations


PANEL DISCUSSION


GLP REGULATORY COMPLIANCE FOR DATA QUALITY AND INTEGRITY

SeSSion Chair

Dylan D. YAO, MD, PhDMember of FDA Alumni Association International Network (FDAAA)Senior Vice President and CSO, Joinn Laboratories, Inc., China

Comprehensive presentations regarding GLP compliance issues associated with preclinical data quality and integrity from the view point of both CRO and government regulatory agency, so that assures clinical subjects safety.

GLP Compliance Issues Impacting Data Quality and Integrity in Preclinical Studies - A CRO’S Point of View

Jane PEARSE, PhDDirector, Special Projects, Huntingdon Life Sciences, UK

Nonclinical Data Quality and Integrity in Preclinical Safety Evaluation with Reviewing Process


PANEL DISCUSSION


PATIENT SAFETY : TOXICOLOGICAL EVALUATION AND RISK ASSESSMENT IN PHARMACEUTICAL R&D

SeSSion Co-ChairS

Lijie FU, PhD, FELLOW ATSGeneral Manager, China Business, Senior Advisor of Regulatory, SNBLVice President, Chinese Society of Toxicology, China

Charles Y. WANG, PhD, DABTDirector, Safety Assessment, GSK R&D, China

This session focuses on toxicology in pharmaceutical safety evaluation and risk assessment, specifically the importance of pharmaceutical products and safety

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evaluation in China, as well as non-clinical risk assessment in compound license-in, which is a primary strategy for Chinese pharmaceutical industry.

Hazard vs. Risk - Toxicology Consideration

Lijie FU, PhD, FELLOW ATSGeneral Manager, China Business, Senior Advisor of Regulatory, SNBLVice President, Chinese Society of Toxicology, China

Safety Evaluation of Bio-pharmacuuticals: the Hot Topics and Key Concerns of Preclinical Studies in China

Jing MA, MD, PhD Director, National New Drug Safety Evaluation and Research Shanghai Center, China

Safety Evaluation of Chinese Traditional Medicines: Rhubarb and Its Major Constituents

Quanjun WANG, MD, PhD Assistant Director, Beijing Institute of Pharmacology and Toxicology, China

Non-Clinical Safety Assessment during Compound License-In

Charles Y WANG, PhD, DABTDirector, Safety Assessment, GSK R&D, China

Theme 10 | Clinical Data Management/eClinical

Session T 10-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 A

TECHNOLOGY ADVANCEMENT IN THE LANDSCAPE OF CLINICAL DATA MANAGEMENT

SeSSion Chair

Daniel LIU, PhDDirector, China Development, Medidata Solutions Worldwide, China

Technology is changing the clinical research landscape from protocol development, data acquisition and data exchange. Clinical Research is behind other industries in taking advantage of the uses of technology and information so it is important to know the trend such as cloud technology and tools to move the industry forward. This session will discuss the benefit of technologies to data managers and will provide a picture into the future of how it may impact our field.

Large Big Data Computing – Current Concept and Practice

Glen de VRIESPresident, Medidata Solutions, USA

Suitable Cloud Implementation for Life Sciences Research

Bagga ABHISHEKManager, Cognizant Technology Solutions, India

Bioinformatic Tools in Data Analysis and Management

Eric HERBALPresident, Integrated Clinical Systems, USA

PANEL DISCUSSION


DATA STANDARDS IN REAL WORLD CLINICAL RESEARCH

SeSSion Co-ChairS

Zibao ZHANG, PhDAssociate Director, Biostatistics, PPD, China

Yazhong DENG, MBA

Head of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China

Data Standard is a continued hot topic to streamline clinical research and modernize data and information flow in drug development. This session will focus on the added values of standardization and implementation approaches around the globe.

The audience will hear from experts who have been successful in their endeavors and learn how one could address the key challenges of integrating Standard into clinical trials. Updates of the CDISC standards implementation and regulatory considerations in China will be shared.

From HER/EMR to Clinical Database

Demetris ZAMBASExecutive Director, Global Data Management & Standards, MSD, USA

Case Studies with CDISC Standards: from CDASH to SDTM and AdaM

Victor WU, PhDSenior Manager, Statistics and Programming, Covance, China

Updates of CDISC Standards in China

Zibao ZHANG, PhDAssociate Director, Biostatistics, PPD, China

Regulatory Considerations of CDISC Standards


PANEL DISCUSSION


DATA MANAGERS' ROLES IN DRUG SAFETY

SeSSion Chair

Joanne LIUDirector, Global Clinical Data Management & Standard, MSD R&D (China) Center, China

This session will provide practical ideas on how to ensure the safety data quality through data validation plan, data review process and medical coding process. Hear from experienced speakers who have been successful in managing safety data and learn more about how you might address key challenges when managing safety data.

Considerations in Safety Data Validation and SAE Reconciliation

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

Safety Data Management in Phase I Study

Gang XU, MDDirector, Data Management, GSK R&D, China

Coding in Safety Data Management

Lobo LOOAssociate Director, China Data Management Center, MSD R&D, China

PANEL DISCUSSION

Theme 11 | Innovation on Medical Devices and Combinational Products

Sessions T 11-1 & T 11-2 | Wednesday, May 15, 2013 08:30 - 12:00 3rd Floor, 301

INNOVATION, REGULATION AND INVESTMENT - PART ISeSSion Co-ChairS

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Jie WANG, MD, PhDExecutive Vice President, Academy of Clinical Research and Translational Medicine, Jiangsu Province Hospital, China

Spring WANG, MDExecutive Director, St. Jude Medical Hong Kong Regional Office, Hong Kong, China

The session will cover topics of medical device innovation, registration and financing. With participations of senior and experienced experts, speakers will provide comprehensive review of the newly released medical devices GCP guideline by CFDA, innovations, roles of venture capital and cases studies on medical devices.

Innovation on Medical Devices

Peter CHEN, PhDPresident, Center for Innovation and Strategic Collaboration, China

The Draft GCP on Devices in China


Streamlining Medical Device Clinical Trial

XianQiang MI, ProfessorShanghai Advanced Research Institute, Chinese Academy of Science, China

Medical Device Innovation: A Case Study

Jie WANG, Professor Executive Vice President, Academy of Clinical Research and Translational Medicine, Jiangsu Province Hospital, China

Role of Venture Capital in Medical Device

Fay XING, MD, MBADirector, Decheng Capital, China

Theme 12 | Contract Service Organization


HOW TO BUILD WIN-WIN RELATIONSHIP

SeSSion Chair


In the journey of drug/device development, companies are not necessary to have all the scientific and operational capability and capacity to deliver all tasks, especially when it is related to patient safety or to the resolution to help patient out of disease suffering. The session will be emphasizing that the outsourcing decision is based on multiple factors besides money, with the aim to outline the various business need to CRO companies, including contribution to science/medicine, special area of service, delegated function services partner, in-sourcing people vs full service outsourced project.

Looking for CRO Solutions in China

Anfan WU, PhDRoche, China

A Successfully IND filed in US (Case Study)

Zaiqing WANGMDS, China

Collaboration to Win a Path to Success



CONTRACT SERVICE ORGANIZATION – VALUE-ADDED TASKFORCE TO ENSURE PATIENT SAFETY IN PHARMACEUTICAL DEVELOPMENT

SeSSion Co-ChairS

Yanhua GONG, MDVice President & Secretary General of CROU (CRO Union), China Association for Pharmaceutical and Medical Technology Exchange, China

Jessica LIU, MDGeneral Manager, China/North Asia, INC Research, China

The session will discuss how Contract Service Organizations(CSO) build infrastructure in China to develop high performing team.

Strategic Alliance on PvG to Support Patient Safety Management in Clinical Trial Conduct

Sheona STEVENSONAssociate Director of PVG, Head for AP region

Clinical Monitoring in China – Assuring Quality from the CRO Perspective

Emily TANExecutive Director, Clinical Research Asia Pacific, InVitive, PharmaNet, China

A Successful CRO in China: Size is not the Only Factor

Xiaoping YE, PhDVice President, Tigermed, China

PANEL DISCUSSION

Theme 13 | Pharmacoepidemiology - Best Practices and Drug Safety

Session T 13-1 | Wednesday, May 15, 2013 13:30 - 15:00 3rd Floor, 301

PHARMACOEPIDEMIOLOGY - DRUG SAFETY AND BEST PRACTICES

SeSSion Chair

Wei ZHOU, MD, PhDDirector, Epidemiology Asia Pacific Unit, Merck Research Laboratories, China

This session is to share the status and progress of pharmacoepidemiology in drug safety and risk management, as well as comparative-effectiveness research.

Introduction of Basic Pharmacoepidemiology Principles and Methods in Drug Development and Risk Management

Siyan ZHAN, Professory, MD, PhDDeputy Director, Department of Epidemiology and Bio-Statistics, Peking University Health Science Center, China

Regulatory Perspective and Progress of Pharmacoepidemiology and Drug Safety


Recent Progress of Pharmacoepidemiology Research - Using Large EMR and Claim Databases, and Comparative-Effectiveness Research on Drug Safety and Efficacy of Different Treatments and Drugs.

Arnold CHAN, MD, ScD, FISPEChief Scientist, Medical Research Department, National Taiwan University Hospital, Taiwan

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Theme 14 | Post-approval and Real World Studies


POST-APPROVAL AND REAL WORLD STUDIES

SeSSion Chair

Danyi ZHANG, MDFounder and the Chief Medical Officer, VitalStrategic Research Institute (VSRI), China

After a drug is approved for marketing, scientific and medical research continues. Numerous study methodologies and mechanisms are available to further study and evaluate its efficacy and safety in the real word setting as well as identify its potential new uses. The session will examine the trend and the practicality, issues, and possible solutions surrounding the application of these methods in China.

Overview

Danyi ZHANG, MDFounder and the Chief Medical Officer, VitalStrategic Research Institute (VSRI), China

Patient Registry

Yan XIAO, MD, PhDSenior Epidemiologist, Roche Pharma Development Center Asia Pacific, China

Investigator-Initiated Studies:

1. Case I :Frank FAN, MDSenior Medical Director, Sanofi, China

2. Case II:Yilong WANG, PhDVice Division Chief, Department of Internal Neurology, Beijing TianTan Hospital, China

三月

· 药品生产的风险管理：毒理评估和决策考量北京 3月9日

四月

· 临床研究中最佳伦理规范的理解与实践 - 研讨会南京 4月9-10日

五月

· 第五届药物信息协会(DIA)中国年会北京 5月12-15日

七月

· 首个人体临床研究：在中国的机会与挑战 - 研讨会北京待定

· 首个人体试验递增剂量的研究 - 研讨会北京待定

八月

· 如何准备成功地通过GMP检查 - 培训上海 8月28-29日

· CTD申报格式: 中国的法规要求与实践 - 研讨会上海 8月30-31日

九月

· 临床研究中发生偏离或违背的防范措施 - 研讨会上海 9月2-3日

· 临床研究机构的建设与管理 - 研讨会上海 9月4日

· 临床研究的项目管理-培训(中级班) 广州 9月16-18日

十月

· 临床试验中的生物统计学应用 - 研讨会武汉 10月25-26日

十一月

· 信号检测和数据挖掘 - 培训上海 11月11-12日

· 药物安全和警戒 - 培训上海 11月13日

十二月

· 医学事务研讨会系列1 北京 12月3-4日

· 有效的医学交流与论文撰写- 培训北京 12月5日

会议咨询，请联系DIA中国办公室

电话: +86.10.6260.2240 | 传真: +86.10.6260.2201 Email: [email protected]

2013年会议和培训 | DIA中国

MArch

· Risk-Based Manufacture of Pharmaceuticals: Toxicology and Critical Thinking - Training Beijing Mar. 9

APrIL

· Best Ethics Practices in Clinical Research - Training Nanjing Apr. 9-10

MAy

· 5th DIA China 2013 Annual Meeting Beijing May 12-15

JuLy

· First-in-Human Studies in China - Opportunities and Challenges - Workshop Beijing TBD

· First In Human (FIH) Dose Range Finding - Workshop Beijing TBD

August

· How to Prepare for Successful GMP Inspections - Training Shanghai Aug. 28-29

· CTD Dossier-Modules: China Requirements & Practices - Workshop Shanghai Aug. 30-31

sEPtEMbEr

· Root Cause Investigations and Corrective Actions for GCP Compliance - Workshop Shanghai Sep. 2-3

· Clinical Sites Development and Management - Training Shanghai Sep. 4

· Clinical Project Management- Part I (Intermediate Level) Guangzhou Sep. 16-18

OctObEr

· Biostatistical Applications in Clinical Trials - Workshop Wuhan Oct. 25-26

NOvEMbEr

· Signal Detection and Data Mining - Training Shanghai Nov. 11-12

· Drug Safety & Pharmacovigilance - Training Shanghai Nov. 13

DEcEMbEr

· Medical Affairs Training - Part I Shanghai Dec 3-4

· Effective Medical Communications & Medical Writing - Training Shanghai Dec 5

会议咨询，请联系DIA中国办公室

电话: +86.10.6260.2240 | 传真: +86.10.6260.2201 Email: [email protected]

2013 Meetings & trainings | DiaChina

Documents

第五届药物信息协会 (DIA) 中国年会 - eventdove.comeventdove.com/resource/20130325/1531_20130325162442693.pdf · ... best practices and ... Bioinformatic Tools in the Management