Eliza Slawther

Cell and gene therapy manufacturers based in Europe should speak to local regulators to understand how to demonstrate compliance with EU-level good manufacturing practice guidelines, as each country will apply the rules differently, an expert explains.

The European Medicines Agency should be responsible for the regulatory oversight of AI in the drug development process in the EU and provide clarity on its “risk-based” approach to governance, pharma industry federation EFPIA says.

The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas' gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.

Regulators do not have the resources to “double check” that companies are using AI appropriately, meaning that manufacturers must ensure the AI tools they use meet relevant standards, says an EU regulatory expert.

The UK's drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.

Experts working in the advanced therapy sector tell In Vivo how novel solutions can empower cell and gene therapy manufacturers to reduce costs, improve scalability and optimize their processes – improving the clinical profile and commercial viability of products.

Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration's Tala Fakhouri.

While many companies demonstrated an interest in the UK’s licensing and access pathway for innovative medicines, few made use of the various benefits the scheme had to offer, the MHRA said.

The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca's director for data and AI policy says.

The European Medicines Agency has given stakeholders until 18 December to give their opinion on its proposed platform for addressing gaps and research needs in regulatory science.