NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Thanks pgsd for sharing.

Dr June M Raine DBE

Chief Executive’s perspective on the year.

During this year of agency organisational evolution, we have not taken our eye off the ball. We have maintained as a top priority our strategy to facilitate patient access to innovative healthcare products, in full alignment with the Life Sciences Vision. A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches

MHRA Annual Report and Accounts
2022-2023

We have continued to support rapid and safe patient access to innovative medicines, by:

¦ Launching our Innovation Accelerator service, following consultation with stakeholders, to help provide innovators better access to our scientific expertise and regulatory guidance
¦ Continued operation and development of the Innovative Licensing Access Pathway (ILAP). The ILAP was recognised at The Organisation for Professionals in Regulatory Affairs (TOPRA) Human Medicines Symposium 2022 as a good example of how to create an end-to-end approach from discovery to deployment, involving both the regulator and health technology assessment bodies
¦ Creating a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalised cancer vaccines
¦ Developing guidelines, via an NHS programme, for acute myeloid leukaemia detection and creating better informatics tools for analysing patients’ genomic data
¦ Contributing to a scientific programme focusing on developing better tools to analyse the microbiome, to improve patient access to personalised treatments
¦ Developing a proposal and strategy for a risk-based approach to batch release testing to assure the quality of biological medicines, while maintaining the capability to independently monitor the quality of biological medicines not traceable by the risk-based approach

💊 729 new medicines approved in UK this year!

👨‍👩‍👧 Over the past 12 months, we’ve worked hard to assess the safety, quality and effectiveness of new medicines to enable access to UK patients.

To learn more, check out our Annual Report 👉 https://t.co/X0jxsQJFWV pic.twitter.com/UlmqLEj3mz

— MHRAgovuk (@MHRAgovuk) July 21, 2023