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Program Overview

China and Asia over the decades has been playing an increasingly important role in the context of clinical research activities due to the significant scientific investment by multinational companies as well as rapidly booming China domestic R&D programs. In past few year, the China regulatory agency has also issued several regulations and initiatives to accelerate the review and approval and improve the quality of new drugs and medical devices. With the joining of ICH in 2017, the government is continuing to improve the regulatory standards and systems to promote innovation, enhance the R&D ecosystem. However, the drug development is fraught with all kinds of challenges which needs innovation, efficiency and collaboration. In return, the Clinical Development and Innovation Forum will gather leaders and scientists across pharma, biotech and academia for discussions and cases studies on the major topics including: Robust Clinical and Regulatory Strategy, Clinical Biomarkers and CDx, Immuno-Oncology and Cell & Gene Therapies, Rare Disease, Data Sciences and Digital Innovation, AI and Machine Learning, China Domestic R&D Innovation, Patient Strategies towards the Efficient and GCP-compliant Drug Development in the era of Precision Medicine.

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2021 Speaker Committee

  • Xingli Wang

    Vice President
    Novartis Global Drug Development (China)

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  • Johannes Nippgen

    Head of R&D Biopharma
    Merck Group (China)

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  • Hongjun Yang

    Founder and Co-Director, The Committee of Precision Medicine
    Chinese Society of Biotechnology

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  • Kai Wu

    Co-CEO
    Shanghai SIMR Bio

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  • Bin Ye

    Vice Precident, Clinical Biomarker & Precision Medicine
    Shenogen BioPharma

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  • Yukun Wang

    Head of Translational Medicine Oncology China
    Bayer Healthcare

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  • Junyuan Wang

    Co-Founder
    AnHeart Therapeutics

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  • Michael Lee

    Vice President, Head of Biometrics
    Harbour BioMed

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Program Key Discussions

Session 1: Clinical and Regulatory Strategy, Next Generation Clinical Trials
Session 2: Clinical Development for Biologics, Oncolytic Virus Therapy, Cell and Gene Therapies
Session 3: Clinical Biomarkers and Companion Diagnostics
Session 4: Early Clinical Development and Precision Oncology Trials
Session 5: China-initiated Global Drug Development: Opportunities and Challenges
Session 6: Clinical Data Management, Biostatistics and Virtual Trials
Session 7: Clinical Safety and Pharmacovigilance
Sesison 8: Big Data Analytics, AI and Machine Learning in Clinical Development
Session 9: Clinical Operation, Quality and Supply Management
Session 10: Clinical Outsourcing and Vendor Management

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Who would Attend

Approx. 450 senior R&D, Clinical, Medical and Regulatory executives and scientists are expected to attend the Clinical Development and Innovation Forum 2021. The participants will mainly come from the pharma/biotech, academia, investigational sites, regulatory agencies, CROs, technology and service providers with the main responsibilities including:

- Corporate Executives and Head of R&D
- Clinical and Regulatory Strategy
- Medical Sciences and Affairs
- Biomarkers, Companion Diagnostics and Translational Medicine
- Clinical Innovation and Strategy
- Clinical Data Sciences and Biostatistics
- Clinical Operation and Quality Management
- Clinical Procurement and Sourcing
- Principal Investigators