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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Gene therapy (oncology)

Biopharmaceutical manufacturing and development program for a biotechnology company

An SME client engaged our services to lead the regulatory and clinical development of a gene therapy programme with the brief to progress the technology from pre-clinical proof-of-concept to Phase II oncology clinical trials. We worked alongside the client’s in-house Medical Director to successfully achieve the first gene therapy clinical trial approval by the Gene Therapy Advisory Committee for a genetically-modified adenovirus in the UK. This was a significant achievement in which new and highly complex development, quality and regulatory issues for ground-breaking technology were resolved. The complexities of the issues solved in this two-year assignment, and the lessons learned in the development of biopharmaceuticals, should not be underestimated in this landmark milestone for the Industry.

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