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FTHMH Regulatory Strategies investigates the development of regulatory approaches and frameworks for the manufacture and delivery of advanced biotherapeutics, such as cell and gene therapies.
Personalised medicines that are based on cells, genes, or tissues, known as Advanced Therapy Medical Products (ATMPs) in the UK and EU, offer great opportunities for the treatment of serious illnesses and rare diseases. The Regulatory Strategies project, part of the Future Targeted Healthcare Manufacturing Hub (FTHMH), is investigating the evolution and impact of new regulatory frameworks and pathways aimed to foster these unique innovations in healthcare while maintaining similarly high standards of quality, safety and efficacy as established for conventional medicines.
Specifically, research in the project aims to:
- Evaluate the implications of the creation of adaptive or facilitating pathways for the marketing approval of ATMPs, such as the establishment of additional requirements in the post-approval phase of cell and gene therapies (e.g. risk management requirements, challenges of post-approval changes in manufacture on classification, comparability, optimisation), and the implications these have on several key stakeholders such as developers and healthcare providers
- Mapping and evaluating the regulatory challenges for point-of-care manufacture of advanced biotherapeutics
- Identify standardisation and regulatory compliance challenges resulting from regulatory change due to Brexit and other sector changes (e.g. new products).