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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Global Regulatory Update

GUEST EDITOR: Dr Christiane Niederlaender, Senior Quality Assessor, Biologicals, MHRA

The past few years have witnessed an unprecedented increase in the range of expedited regulatory pathways potentially available to cell & gene therapy developers across the world. From RMAT to PRIME, and from Breakthrough Designation to the PMD Act, a weight of experience and insight now exists to help you capitalize on the benefits whilst avoiding the pitfalls.

  • Strategic pros/cons and practical considerations with accelerated development and conditional approval pathways
  • Keys to remaining nimble and flexible with clinical trial designs and parallel product/process development
  • Step-by-step guides to making successful pathway applications
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