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Beijing Tangla Hotel

Jul 08, 2018 3:00 PM - Jul 09, 2018 11:00 PM

19 Fuxingmenwai Street, Chang’an Avenue West,, 100045 Beijing, China

2018 Quantitative Science Forum

Overview

With recent continuous developments and globalization in biotechnology and drug development, there is a high demand for data science innovation. This includes applying more innovative design and analysis methods to effectively assist the study design and decision making, and to improve the data science leadership in drug development. At the same time, as China just joined the ICH, the statistical review plays a more important role in regulations, with incorporating the international standards upon considering the present challenges of drug development in China as well. This year’s forum takes "Leadership in globalized drug development and data science innovation" as the theme, and provides an integrated platform for the quantitative scientists from regulatory agencies, academia, as well as domestic and international pharmaceutical enterprises. It also provides a view into the latest development of data science, statistical methods and regulations for other key participants in drug research and development, including clinicians, regulatory, and operations. Experts from health authorities, companies, the Chinese Clinical Trial Statistics Group (CCTS) and the China Clinical Data Management Committee (CDMC) will work with participants to discuss important topics, including innovative approaches for the development of immune oncology drugs, adaptive methods in early phase clinical studies, the application of advanced analytical tools in clinical research, and the use of real world data and artificial intelligence in drug development. The forum aims to deepen the discussions and promote quantitative science leadership, which is critical for the data-driven decision in drug research and development.

Who should attend?

  • Statisticians
  • Clinicians
  • Data Management Specialists
  • Regulatory representatives
  • Quantitative scientists

Learning objectives

  • Novel designs for immune-oncology drug development.
  • Latest development of adaptive design in confirmatory clinical trials
  • Basket trial, umbrella trial, and platform trial in drug development
  • Advanced data visualization in clinical research
  • Estimand and implementation in clinical trials
  • Quantitative pharmacology in drug research and development
  • Evaluation of biosimilars
  • Quantitative science in real-world study
  • Application of artificial intelligence and deep learning in clinical research
  • Pediatric drug development
  • Clinical trials under CDISC standards and new data management regulations
  • Progress in regulatory requirements and the opportunities for China with joining ICH

Program Committee

  • Feng Chen, PhD
    Feng Chen, PhD Professor, Dean
    School of Public Health, Nanjing Medical University, China
  • Tony Guo
    Tony Guo Executive Director, Head of Biometrics China
    BeiGene, China

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