Cell and Gene Therapy

关于课程

As the cell and gene therapy (CGT) industry matures, more products are being released with a much higher frequency. Global pharmaceutical giants have also accessed the market in recent years, with nearly all the top 20 pharmaceutical competitors in Europe and the United States having made their way to CGT through mergers & acquisitions or cooperation. CGT has become a new frontier for the clinical research industry.

At the same time, CGT has met with many challenges in technology, R&D, clinical trials, industrialization, and regulations. Any problems that occur at any given stage in clinical research and development may affect the success of the final product.

作坊 Objective

  • Understand the entire process of new drug development as well as the key considerations and the impact of each stage
  • Acquire the special considerations on CGT (DNA-BLA) from CMC and clinical development perspective

Workshop Outline

  • Learn how to communicate with national regulatory bodies and apply for expedited programs
  • Case study and experience sharing on clinical research and development of CGT
程序 | Global Clinical Development Strategy Workshop Series

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