Earlier this month we paired up with the MHRA to host our joint annual conference for the fifth year, and the first since their merger with NIBSC (the National Institute for Biological Standards and Control). Check out our pictures and summary of the event below.
As ever, our joint annual conference with the MHRA was a truly collaborative affair and a valuable forum for industry members, regulators and patient representatives to mingle and share updates. It was encouraging to hear from Chair of the MHRA, Professor Sir Michael Rawlins, on the evolving approaches in medicines regulation, including his recognition that alternative trial designs and alternative analyses are likely to be increasingly important. Several commentators noted how important it is that the FDA’s approach must fit with the progressive approach of UK and European regulators in order to truly streamline the regulatory requirements for companies.
Patient advocate speakers Emily Crossley from Duchenne Children’s Trust and Kathy Oliver from the International Brain Tumour Alliance helped to remind us of the reason we work in this industry and the importance of involving patients at every step of the development and regulatory process.
It was a delight to be hosted by the Wellcome Trust and to have their Head of Infection and Immunology, Professor Mike Turner, as a keynote speaker. In his presentation, Mike provided an overview of the key action taken by the Wellcome Trust during the Ebola outbreak, taking a less conservative approach by funding riskier projects and vastly accelerating their timeline, with a three week window to award a grant and just two weeks to ethics approval in the UK and Liberia. The Ebola vaccine development process was also outlined by Professor Adrian Hill, Director of the Jenner Institute.
Throughout the afternoon sessions – each focusing on the accelerated development and regulatory pathway in response to the Ebola epidemic towards the end of 2014 – collaboration emerged as a key theme.
We’ll be producing a report from the event over the coming months, so watch this space for more insights.