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Quantitative Science Forum for Pharmaceutical Product Development

Oct 20 2013 8:30AM - Oct 21 2013 5:30PM

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Overview 

This forum held by DIA China and CDE, aims of this forum at providing a forum to discuss quantitative science (including statistics, data management, programming, and related disciplines) related topics in pharmaceutical product development in a regulatory context. It is expected that a dialogue among professionals from industry, government, and academia will examine top challenges and opportunities in the quantitative science areas.

To Register, click here for Chinese version

Featured Topics 

  • Local and multi-regional clinical development
  • E-source in clinical Data Management
  • Challenges in Chinese Traditional Medicine Developments
  • Innovative approaches and technical in clinical trial data management
  • Innovative statistical methods in drug development
  • Electronic submission & Data standards: i.e. CDISC, and implementation
  • Statistical issues in development of biosimilar products
  • Application of Surrogate endpoints in Drug Development
  • DMC and interim analysis
  • Endpoints in clinical development

Who Should Attend 

  • Statisticians
  • Clinicians
  • Data management professionals
  • Regulatory scientists
  • Quantitative scientists in academia
  • Quantitative scientists in regulatory agencies

Learning Objectives 

At the conclusion of this training, you should be able to:

  • Gain a better understanding of quantitative science and its roles in the regulated environment of pharmaceutical product development
  • Discuss key quantitative science issues in pharmaceutical product development, impacts of regulations, guidance and practices, technologies and standards
  • To improve collaboration and communication among industry, academia, and regulatory agencies.

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

Featured Speaker 

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Program Committee 

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Agenda  

Day 1 Sunday, October 20, 2013

  • 8:45AM - 10:30AM

    Plenary Session: Quantitative Sciences for Pharmaceutical Development Decision Making


    Session Chair(s):

    • No-image Qin Huang, PhD
      Deputy Director, Office of Biostatistics
      Center For Drug Evaluation, CFDA, China
    • No-image William WANG, PhD
      Head of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS)
      Merck Research Laboratories, Merck & Co., Inc., China

    Speaker(s):

    • Ling Su, PhD
      Strategic Advisor, Life Sciences
      Sidley Austin LLP, China
    • The Role of Quantitative Sciences in US Regulatory Decision-Making
      Lisa M. LaVange, PhD
      Director, Office of Biostatistics, Office of Translational Science, CDER
      FDA, United States
    • Statistical Review for Clinical Trials: Reality and Prospective in China
      Qin Huang, PhD
      Deputy Director, Office of Biostatistics
      Center For Drug Evaluation, CFDA, China
    • Roles of Academia Statisticians for Drug Review in China
      Feng Chen, PhD
      Professor, Dean
      School of Public Health, Nanjing Medical University, China
  • 1:30PM - 3:00PM

    Session 1: Local and Multi-regional Clinical Development (Strategy and Implementation)


    Session Chair(s):

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

    Speaker(s):

    • Ning Li, MD,PhD
      Vice President, GRA Head, Medical Policy, Asia
      Sanofi, China
    • Sample Size Considerations in Multi-regional Clinical Trials
      Luyan Dai, PhD
      Associate Director, Biostatistics
      Boehringer Ingelheim, Shanghai, China
    • Scientific Rigor in the Design of Simultaneous Global Drug Development - From Regulatory and Practical Perspectives
      Gang CHEN, PhD
      Johnson & Johnson, China
  • 1:30PM - 3:00PM

    Session 2: e-Source in Clinical Data Management


    Session Chair(s):

    • No-image Joanne Liu, MD,MBA
      Director, Asia Pacific, Global Data Management & Standard
      MSD R&D (China) Co., Ltd. , China

    Speaker(s):

    • Guang-Liang Wang, PhD
      Associate Director, Data Management
      Otsuka America Pharmaceutical, Inc., United States
    • ePRO and it Implementation
      Jean Paty, PhD
      Chief Scientific Officer
      ERT, United States
    • Electronic Data Capture: Why and How?
      Linzhou Li
      Senior Clinical Data Manager
      Merck Serono (Beijing) Pharmarceutical Co. Ltd, China
    • Electronic Source Data and Related Regulations
      Effie Ho
      R&G Pharmastudies Co., Ltd., United States
  • 3:20PM - 5:00PM

    Session 3: Challenges in Chinese Traditional Medicine Developments


    Session Chair(s):

    • Bingming Yi
      Director
      GSK, China

    Speaker(s):

    • Regulation, Evaluation, and Challenges in Traditional Chinese Medicine ~ (Chinese version only)
      BingLin Liu
      SFDA CDE, China
    • Challenges in Clinical Trials in Chinese Herbal Medicine Research
      Jianping Liu
      Director
      Beijing University of Chinese Medicine, China
    • Statistics in Clinical Trials in Traditional Chinese Medicine
      Jielai Xia, PhD
      Professor
      4th Military Medical University, China
  • 3:20PM - 5:00PM

    Session 4: Innovative Approaches and Technical in Clinical Trial Data Management


    Session Chair(s):

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

    Speaker(s):

    • Innovative approaches to risk-based monitoring
      Yutaka Sato
      Business Consultant
      Medidata Solutions K.K., Japan
    • Implementation of risk-based monitoring in data management
      Andrew Taylor
      Asia Pacific Head of Clinical Data Management
      Shanghai Roche Pharmaceuticals Ltd., China
    • Risk-Based Approach – How to Cooperate in Different Functions
      Yufeng Chen
      boehringer-ingelheim, China
    • Regulatory Information Management Solutions - Will 2013 be the year of Integration?
      Rasmus Nelund, MSc
      Consultant
      Nnit A/S, Denmark

Day 2 Monday, October 21, 2013

  • 9:00AM - 10:10AM

    Session 5: Innovative Statistical Methods in Drug Development

    Speaker(s):

    • Jerald S. Schindler, DrPH
      Vice President, Biostatistics and Research Decision Sciences
      Merck Research Laboratories, United States
    • Treatment of Missing Data in Clinical Trials: Past, Present, Future
      Shuyi Shen
      Senior Statistical Scientist
      Roche, China
    • SEARS:A Bayesian Seamless Phase I/II Adaptive Design
      Jielai Xia, PhD
      Professor
      4th Military Medical University, China
  • 9:00AM - 10:10AM

    Session 6: Electronic Submission & Data Standards: ie. CDISC and Implementation (Including Programming Related Issues)


    Session Chair(s):

    • No-image Yazhong Deng, MBA
      Director, Clinical Data, Analysis and Reporting organization
      Covance Pharmaceutical Research and Development (Beijing) Co., Ltd., China
    • Zibao ZHANG, PhD
      Associate Director
      PPD, China

    Speaker(s):

    • CDISC Implementation and Trend in Global
      Monika Kawohl
      Accovion, Germany
    • Early-Stage CDISC Adoption: Costs vs. Benefits
      Wenjun Bao
      SAS Software Co., Ltd., China
    • Victor Wu
      Senior Manager, Biostatistics
      Covance, China
    • Peter G Mesenbrink, PhD
      Executive Director Statistical Scientist
      Novartis Pharmaceuticals Corp., United States
  • 10:30AM - 12:00PM

    Session 8: Application of Surrogate Endpoints in Drug Development


    Session Chair(s):

    • Jacqueline Law, PhD
      Roche, China

    Speaker(s):

    • Modeling of Angiotensin II-Angiotensin-(1-7) Counterbalance in Disease Progression in Spontaneously Hypertensive Rats Treated With/Without Perindopril
      Wei LU
      Peking University, China
    • Driver genes in Lung Cancer and Precision Oncology in Trial design
      Shun Lu
      Director, Shanghai Lung Cancer Center
      Shanghai Jiaotong University, China
    • Surrogate Endpoints in Oncology Drug Development
      Nichole F. LI, PhD
      Associate Director
      Roche, China
  • 10:30AM - 12:00PM

    Session 7: Satistical Considerations in Development of Biosimilar Products


    Session Chair(s):

    • Roger (Peng) Qu, PhD
      Head of Clinical Statistics
      Pfizer China R&D Center, China

    Speaker(s):

    • Case Studies: Zarzio – a filgrastim biosimilar; Remsima – an infliximab biosimilar
      Eric M. Chi
      Executive Director
      Amgen, United States
    • Design and Analysis of Clinical Studies for Follow-on Biologics
      Shein-Chung Chow, PhD
      Professor, Department of Biostatistics and Bioinformatics
      Duke University School of Medicine, United States
    • Policies and Guidelines for Evaluation of Biosimilars EMA/WHO/FDA
      Eric M. Chi
      Executive Director
      Amgen, United States
  • 1:30PM - 3:00PM

    Session 9: DMC and Interim Analysis


    Session Chair(s):

    • Chen YAO
      Associate Director
      Peking University Clinical Research Institute, China
    • Tony Guo
      Associate Biostatistics Manager
      Sanofi-aventis (China) Investment Co., Ltd, China

    Speaker(s):

    • Practice of DMCs in clinical trials in China
      Chen YAO
      Associate Director
      Peking University Clinical Research Institute, China
    • How adaptive trial designs can increase efficiency in drug development: A case
      Joan SHEN, MD,PhD
      Chief Medical Officer
      Jiangsu Hengrui Medicine Co., Ltd., China
    • William WANG, PhD
      Head of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS)
      Merck Research Laboratories, Merck & Co., Inc., China
    • Jacqueline Law, PhD
      Roche, China
  • 1:30PM - 3:00PM

    Session 10: Endpoints in Clinical Development


    Session Chair(s):

    • No-image Yazhong Deng, MBA
      Director, Clinical Data, Analysis and Reporting organization
      Covance Pharmaceutical Research and Development (Beijing) Co., Ltd., China
    • Jie Chen, PhD
      Director, Global Biostatistics
      Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd., China

    Speaker(s):

    • FDA PRO Guidance and the Validation of a PRO
      Shanmei Liao
      senior biostatistician
      Pfizer(China) Research and Development Co., Ltd., China
    • Statistical aspects of PRO data analysis
      Ekkehard Glimm
      Biometrical Fellow
      Novartis, Switzerland
    • The application of PRO in TCM
      BaoYan Liu
      China Academy of Chinese Medical Sciences, China
  • 3:20PM - 5:00PM

    How to Improve Collaboration among Industry, Academia, and Agency Reviewers

Registration Fees 

Other Fees

Student
¥400.00

Member

Charitable Nonprofit/Academia Member
¥1200.00
Member Government
¥1200.00
Member Standard
¥1700.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥2000.00
NonMember Government
¥2000.00
NonMember Standard
¥2500.00
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