Network established to identify opportunities for regulation to support innovation within advanced therapies

A new network will foster collaboration among regulators, industry, and researchers to ensure there is a world-leading regulatory environment in the UK for advanced therapies that supports companies in the development, trial, and launch of these innovative treatments. Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, and the Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI) established the network with funding from Innovate UK and support from the MHRA.

The effective regulation of advanced therapies is vital to ensure that patients can access these transformative treatments promptly, to prepare the healthcare sector for the large-scale deployment of these therapies, and to ensure patient safety.

To help achieve this, the network will work with the UK regulators, predominately the MHRA, to identify effective and efficient regulatory strategies that address the unique challenges of these therapies. By sharing its recommendations with therapy developers and regulatory and healthcare stakeholders, it will support the UK to build a first-in-class regulatory ecosystem that welcomes and encourages healthcare innovation. This aims to enable the timely development of, and improved access to, safe and effective advanced therapies.

“As the number of advanced therapies requiring regulatory approval increases, it is essential that regulatory frameworks are developed that are fit-for-purpose. Our focus at Birmingham is understanding how the patient voice can help shape regulatory decision making and ensuring that we understand the risks and benefits of treatment from the patient perspective.”

Professor Melanie Calvert, University of Birmingham

The network is one of seven new Centres of Excellence in Regulatory Science and Innovation established by Innovate UK to help shape the development and approval of medical innovations in the UK.

Matthew Durdy, Chief Executive of the CGT Catapult, said: “Advanced therapies are both an opportunity for patients and an opportunity for the UK. This initiative is part of a drive to keep the UK as a leader in this field.”

Melanie Calvert, Deputy Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research, Professor of Outcomes Methodology at the University of Birmingham, NIHR Senior Investigator and co-lead of the NIHR Birmingham Biomedical Research Centre’s Patient Reported Outcomes research theme, said: “As the number of advanced therapies requiring regulatory approval increases, it is essential that regulatory frameworks are developed that are fit-for-purpose. Our focus at Birmingham is understanding how the patient voice can help shape regulatory decision making and ensuring that we understand the risks and benefits of treatment from the patient perspective. I am excited to leverage our extensive expertise in the field and work with our partners to provide patients with timely access to transformative treatments.”