First, this week’s news is that the first Promising Innovative Medicine (PIM) designation has been issued to Northwest Bio. It is great that the Early Access to Medicines Scheme (EAMS) is moving forward and that its first user is a smaller company. This shows that it is open to all and hopefully it will be the first of many. This could present the opportunity for UK patients to be amongst the first in the world to be offered personalized immune therapy for brain cancer. It’s smart of nimble US companies like Northwest Bio to pioneer new regulatory flexibility alongside the clinical development they are doing at King’s College Hospital in the UK. We urge more companies to consider utilising the EAMS as a pathway to access and the BIA will be setting up more opportunities to learn more about the operation of the scheme later this year. Watch this space.
On the European front, the adaptive licensing pilot project is also moving in the right direction. Earlier this week the EMA confirmed that it has received and assessed 26 applications as part of its adaptive licensing pilot project. Seven of these have been selected for further discussion with the application. This news came as the EMA also published a useful Q&A document on the scheme. We anticipate a review from the EMA by the end of this year after which next steps will be set out.
Both these issues continue to be a key focus of our regulatory work. Early access is on the agenda at the UK Bioscience Forum and will also be discussed by BIA representatives at the EMA Information Day during Biotech Week.