Tom Oakley
Tom Oakley is Principal Consultant at Somerville Development Partners.
JournalThe EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams
The EU’s Health Technology Assessment Regulation (EU-HTAR) demonstrates a significant transformation in how health technologies are evaluated across EU member states (MS). The regulation, which came into effect on 12 January 2025, establishes a partnership between the European Medicines Agency (EMA) and national Health Technology Assessment (HTA) bodies through introducing joint clinical assessments (JCAs) and joint scientific consultations (JSCs).
JournalThe first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Patients with transfusion-dependent β-thalassemia and severe sickle cell disease suffer the burden of repeated blood transfusions and vaso-occlusive crises, respectively. Casgevy (exagamglogene autotemcel) consists of autologous CD34+ haematopoietic stem and progenitor cells edited, ex vivo, by CRISPR-Cas9 technology. Gene editing using Casgevy results in reduced expression of the BCL11A gene, ...