What struck me most about many of the presentations at the recent DIA Pharmacovigilance and Risk Management Strategies conference (27-29 January in Washington DC) was that the future is already here, because change is already happening. For the last 2-3 years, many sessions at PV conferences focused on the potential of game-changers such as artificial intelligence, real-world evidence, personalised medicine and social media: Can we utilise these? What role do they play? Are they effective? It seems that the time is now for such concepts to be embraced by the industry and regulators alike in the pharmacovigilance world. And all of this against the backdrop of Brexit coming to fruition.
One particular initiative that caught my eye at the conference was the use of the MHRA’s ‘Yellow Card’ data to create a Biobank. After conducting a proof of concept with encouraging results, the agency Is now moving forward with this project in order to identify where genetics have a strong influence on who is most at risk of developing ADRs. From this, screening tests can be developed to optimise the use of medicines and reduce the number of ADR events. This Biobank is a world first, so this shows that the UK is still a global leader in pharmacovigilance, within or without Europe.
Updates from the regions highlighted that all are moving forward with the adoption of E2B R3. China is making the use of this format mandatory by July 2022 and the US FDA’s FAERS database will be able to accept the R3 format by the end of 2020. The EMA announced the week before the conference that E2B R3 will be mandatory in Europe from 30 June 2022. On the topic of ICH guidelines, I also learnt that the original E2D Guideline is being revised in order to account for changes in the industry, such as social media as a source of safety information. This is the first revision of this document that was originally published in 2003, and indeed a lot has changed since then. In a similar vein we should also expect a revision process to start on the E2A Guideline in the near future.
One update that I was pleased to hear was that CIOMS is now on to its Working Groups XI (patient involvement) and XII (benefit-risk balance), as well as another four active WGs in related areas such as MedDRA. I for one look forward to the outcomes of these WGs as some of CIOMS historical publications were my go-to reference sources.
Many of the regions reported a year-on-year increase in the volume of ADR reports, and, not unexpectedly, an increase in the number of reports coming directly from patients. That fact, along with improved accessibility of electronic health records, means that the need to make best use of AI technologies is growing. The US FDA is planning to use machine learning and natural language processing in its Sentinel system, in order to cope with the more than 70 million patients contributing data in medical records. The 5- year strategic plan includes implementing advanced analytics, in order to provide rapid answers to potential signals, and not having to wait months-years to identify them.
So we are now in a world where the exciting times are already happening and if you have not embraced them yet then be sure to catch that train before it leaves the station!