Eliza began reporting on health and medical science in 2018 while completing her Master’s degree in Journalism at City, University of London. During her degree program she interned at C+D and on the London Evening Standard’s health desk. In the years since, Eliza has written about everything from mid-stage drug development to market access for medicines and devices in the EU and beyond. Her work explores the trials and tribulations of securing reimbursement for medical products in Europe, and Eliza is particularly interested in the challenges of funding innovation in health care. Eliza has lived in London since 2017 and is originally from Cheshire, in the north west of England. She has a BA in English Literature from the University of Manchester and is in the process of completing a second undergraduate degree in Biomedicine from Birkbeck College, an evening university that is part of the University of London.
Latest from Eliza Slawther
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.
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.
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 UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country’s medicines regulator, the MHRA, says the framework is the “first of its kind in the world.”
The UK’s drug regulator has approved Eli Lilly’s early Alzheimer’s drug Kisunla, but England’s health technology assessment agency NICE said that the product “does not currently demonstrate value” for the National Health Service.
EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.