Cell and gene therapy

Cell and gene therapies offer tremendous potential to treat disease, and to make dramatic changes to the way in which healthcare is provided.

The development and provision of cell and gene therapies is governed by a comprehensive legal and regulatory framework.  The regulatory strategy to be employed to take a product to market in this sector requires careful consideration, in conjunction with commercial and IP strategies.

We work with companies developing novel cell therapies and gene therapies, with hospitals, and with researchers.  Some examples of our work in this sector include:

  • Advising University College London Hospitals NHS Foundation Trust on arrangements with University College London for the production of viral gene therapeutic vectors for use in clinical trials for cancer patients
  • Advising in relation to the regulation of cell therapies by the Human Tissue Authority (HTA) and Medicines and Healthcare products Regulatory Agency (MHRA)
  • Advising in relation to the classification of Advanced Therapy Medicinal Products (ATMPs)
  • Advising in relation to the use of gene editing technologies in somatic cells and human embryos
  • Drafting and negotiating agreements regarding the procurement, processing, transfer, export and use of blood, cells, tissues and organs
  • Advising in relation to clinical trials of cell and gene therapies
  • Advising in relation to HTA licence applications and inspections
  • Acting for one of the parties to a public inquiry into human tissue retention in the nuclear industry
  • Advising in relation to non-consensual DNA analysis

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