UCL has a particular interest and expertise in the development of novel gene and cell-based therapies. In recognition of this, and to ensure that the research support available keeps pace with the development of UCL science in these so-called advanced therapies, the JRO offers specialist regulatory expertise.
What is an Advanced Therapy Medicinal Product?
Advanced Therapy Medicinal Products (Advanced Therapies or ATMPs) are innovative, regenerative therapies which combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating; repairing or replacing damaged tissue/cells.
Specifically, an ATMP is a medicinal product which is either:
Gene therapy: Gene therapy is an experimental technique that uses genes to treat or prevent disease.
Somatic cell therapy uses living cells coming from the patient themselves, another human being or animals.
Tissue engineered product is a product that contains or consists of engineered cells or tissues and is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.
Where Can I Get Help?
Regulatory Managers – Advanced Therapies
The JRO’s Regulatory Managers for advanced therapy trials at UCL are available to provide specialist support for trials involving ATMPs at UCL. If you are planning a clinical trial involving an ATMP, even if you are still in the preclinical stages, it is recommended that you contact one of the Regulatory Managers to discuss the project, gain advice on requirements and identify the support and resources you may need.
Please contact firstname.lastname@example.org if you have any enquiries about UCL sponsorship for trials with advanced therapy medicinal products.