A EUFEMED achievement
I am a firm believer that we all strive to do our best at work. And yet, despite our best efforts, the best we can say about the outcomes of our daily slog is that we did our job. However, from time to time the circumstances align in such a fashion as to create something that stands out from ‘the norm’. Sometimes what we create is more than its constituent parts. Don’t get too carried away, it is often the result of a team effort – but still, it feels good to be part of something that is great.
Yesterday, the Journal Frontiers in Pharmacology published a piece of work that I had the good fortune to work on in collaboration with a group of industry leaders (open access read it here). The European Federation for Exploratory Medicines Development (EUFEMED) is a not-for-profit association that aims to improve the early phase clinical drug development process in Europe. On the 19 September 2018, EUFEMED organized a meeting in Leuven, Belgium entitled ‘The new FIH EMA guideline: Disruptive or constructive?’ to provide a forum for stakeholders to discuss the guideline’s operational impact. The revised EMA Guideline on strategies to identify and mitigate risks for First-in-Human and early clinical trials with investigational products was published on 20 July 2017. The idea itself was inspired in that it wanted to encourage dialogue between sponsors, agencies and service providers in the pharmaceutical industry.
As the guidelines came into operation on 1 February, 2018 it was assumed that by the date of the meeting many early phase stakeholders had gathered sufficient first-hand experience of working within the guideline to discuss their thoughts on its impact. The event welcomed over 100 attendees. The aim was for the audience to drive the program through the use of active directed polling employing the sli.do online tool. Electronic balloting of attendees continued throughout the meeting, with the organizers seeking their opinion, understanding and insights regarding the guidelines as well as any difficulties they may have experienced when they first started working with the updated recommendations.
The meeting format was open and discussions were informative, friendly and lively. My pen ran our while keeping a record of the meeting and a representative from the EMA, who was sitting next to me, commented on how he had never seen anyone write so much during a single meeting - there was just so much 'good stuff' being said.
In closing the meeting it was generally agreed that the necessary changes encompassed by new guidelines included both constru#ctive and disruptive aspects. However, the value of the meeting itself came from the continued dialogue throughout the day and the networking between groups that might otherwise see themselves as occupying different ‘camps’. It was generally accepted that stakeholders need to continue in a process of stakeholder engagement and discussion, particularly on critical safety issues. Such an approach allows partners to adopt a proactive approach to sharing best practice.
With the publication the outcome is that we have a useful record of the discussions and I have something to put in my ‘brag bag’. As Chairman of the AHPPI I am proud of the contribution made by our members who attended the meeting and those of the MHRA. Thank you to everyone who took part and contributed.
Tim Hardman is Managing Director of Niche Science & Technology Ltd., a bespoke services CRO based in the UK. He is also Chairman of the Association of Human Pharmacology in the Pharmaceutical Industry and an occasional commentator on science, business and the process of drug development.