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Course on Early Clinical Trials

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Course Info: Training Course on Early Phase Clinical Trials

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    This training course provides invaluable opportunity for people who wish to—
­    Become senior specialist designing and overlooking early phase clinical trials;
­    Master the effective methodology in making key decisions; and
­    Break through the bottleneck in drug development with enhanced capability in designing early clinical development.

[Course Description]
    The Training Course on Early Phase Clinical Trials is a joint product presented by the PUCRI and the Drug Clinical Trial Center of Peking University Third Hospital. It is one of the outcomes of the project titled “Construction of an International Technical Platform for Standardized Clinical Evaluation of New Drugs” sponsored by the National Science and Technology Major Projects in the 13th Five-Year Plan period. It is a course where domestic and foreign experts analyze – in an interactive manner – early clinical development strategies with case studies of successes and failures in the development of biologics and small molecules in tumor/non-tumor fields.

[Training Topics]
­    Pre-IND preparation: from preclinical to early clinical phases
­    Product risk management
­    Clinical development plan
­    FIH dose selection
­    Development and update of stopping rules
­    Dose escalation
­    Data to be obtained before PoC
­    End point selection
­    Go/No-Go decision
­    Preparation for later phases
­    Dose finding

[Core Lecturers]
(In alphabetical order)
­    Prof. HU Bei, professor of clinical pharmacology, Peking Union Medical College Hospital; visiting professor, the PUCRI
­    Prof. LI Haiyan, Chief of Cardiology and Director of Drug Clinical Trial Center, Peking University Third Hospital; adjunct professor, the PUCRI
­    Dr. LI Gailing, Senior Director of Clinical Pharmacology, China Janssen Pharmaceutical R&D
­    Dr. PENG Bin, Chief Medical Officer, EpimAb Biotherapeutics; visiting professor, the PUCRI
­    Dr. Joan Huaqiong SHEN, Chief Executive Officer, I-Mab Biopharma; visiting professor, the PUCRI
­    Dr. WANG Yaning, Director of the Division of Pharmacometrics, Office of Clinical Pharmacology, the United States Food and Drug Administration; visiting professor, the PUCRI
­    WANG Zaiqi, Chairman and Chief Executive Officer, InxMed
­    Dr. Sylvia Zhao, Executive Director and China/Japan Head of Pharmacokinetics Sciences (PK Sciences), the Novartis Institutes of Biomedical Research (NIBR)

[Trainee Feedback]
­    “With a well-designed syllabus, engaging teachers, and a combination of lectures and interactive discussions on case studies, experience in this course is truly a walk to remember.”
­    “The course is loaded with very good stuff, and the teachers are all veterans from regulatory authorities, clinical facilities or drug developers. I’ve learned a lot, and for that I am very grateful.”
­    “The case studies are real and extensive, ranging from cancer medications, to inhibitors, and to antibiotics.”

[Target Audience]
    People with backgrounds in clinical pharmacology, medicine, biology, toxicology, or early clinical development, who work with government agencies, hospitals or the industry.

[Contact Person]
Tel/Wechat: 13810653872
E-mail: sunwan_pucri@bjmu.edu.cn