How fantastic it was to be able to meet old friends, colleagues and customers face to face at a conference again for the first time in many years. While Zoom, Teams and Slack have certainly fared well in providing a make-do alternative to in-person communication during the pandemic, nothing can beat being surrounded by interesting individuals, discussing and exchanging ideas, learning about new initiatives, and building new relationships. It was a wonderful feeling getting to experience this once again at DIA Europe in March.
And what a great conference it was! My thanks to the Drug Information Association (DIA) and the conference organisers for bringing together such a great range of speakers and topics for discussion. Opening the conference was Dr. Junaid Bajwa, Chief Medical Scientist at Microsoft with a fascinating vision of how technology and specifically AI will play a crucial role in meeting our ever-evolving healthcare needs, from the drug discovery process through to delivery and provision of front-line care service.
Gravitate Health – empowering patients with meaningful information
Dr. Bajwa’s opening discussion set the tone for a fascinating series of presentations about ongoing initiatives like the Identification of Medicinal Products (IDMP), SPOR and electronic Product Information (ePI). Having personally worked on the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) for a number of years, it was easy to become disillusioned with the concept of “data led” submissions. It seemed like so much effort had gone into creating new workloads, with no real discernible benefit for anyone at all, other than perhaps those who calculate Pharmacovigilance fees! When I first learned about IDMP all those years ago, my first reaction was “here we go again” – more pain, more work, another system. If this resonates with some of you today, then I encourage you to check out the work of Gravitate Health (find out why below) and the European Medicines Agency’s ePI initiative.
The highlight of the conference for me was to hear from Anne Moen of the University of Oslo, and Catherine Chronaki of the HL7 Europe Foundation who presented on Gravitate Health’s mission, to “equip and empower citizens with digital information tools that make them confident, active and responsive in their patient journey, specifically encouraging safe use of medicines for better health outcomes and quality of life”. One of the ways this will be achieved is through the development of the G-Lens (or Gravitate Lens), an application which will pull relevant information from the ePI and the International Patient Summary (IPS) to provide meaningful and appropriate information to the patient.
As mentioned in my presentation at the GPRAS in Berlin, the G-Lens project from Gravitate Health is a commendable and ambitious effort in addressing the shortcomings of the Patient Information Leaflet (PIL), the current main vehicle through which information is presented to patients. The reason there is such a fundamental need for improvement on this format is because according to a 2014 EU Health Literacy Survey, 27.5 percent of respondents found understanding the PIL either fairly or very difficult. An obviously concerning statistic highlighting the need for a solution that has patients’ health literacy at its core. The development of electronic Product Information will be the backbone for a lot of the work that Gravitate Health is doing, and Generis are going to support the creation of ePI by utilising CARA’s Structured Content Authoring functionality, which we are further developing this year. Unlike paper PILs, it will be possible to rapidly update ePI with the latest authorised information, meaning patients using ePI can be confident that they hold the latest information about benefits, risks, and use.
What struck me most about Moen and Chronaki’s presentation was the call to industry to get involved in the development of this crucial work via the HL7 “Connectathons”. These Connectathons allow implementers and developers to come together to hold technical discussions that advance the Fast Healthcare Interoperability Resources (FHIR) specification, develop FHIR-based solutions, and exchange data with other FHIR interfaces. It seems to be a truly collaborative effort, bringing together industry, patient groups, academic and research groups, and even Health Authorities.
Developments on the implementation of PMS
In a session on SPOR Implementation in Europe, it was announced early on that the 2-step implementation of PMS has been replaced by a “DADI-first” approach.
The EMA’s position is now that it is yet to decide on the best approach for implementing the PMS (whether a two-step approach is still relevant), and when to phase out the Article 57 requirement (before or after all forms have been replaced by the new eAF portal (i.e. Variation, MAA, Renewal). Such a change of strategy might not have been completely unforeseen, but I have to say I was a little bit surprised to hear of this during a DIA presentation. It can be a little frustrating at times waiting to be drip-fed information about DADI and the PMS. The DADI webinars hosted by EMA were extremely well attended, and people are eager to know more about how this new process will take shape. It’s clear that EMA needs to do a better job of ensuring people are kept up to date with latest developments, especially those which represent a change in strategy or direction.
I had a fantastic time at the conference, filled with inspiring discussion and thought leadership from an excellent selection of speakers. It can be easy to get caught up in the intricacies of new policies and initiatives, but while we wait for further developments to shape the future of the industry, it is critical that our focus is maintained on the overall vision: the improvement of health outcomes for patients in Europe and across the globe.
Mark Willoughby is Head of Life Sciences at Generis Corporation, where he is responsible for the overall strategy of the CARA Life Sciences platform. He has experience across various roles in Quality and Regulatory affairs, at large, mid-size and small-cap pharmaceuticals; both at innovators and generics. Before joining Generis, his most recent role was as Head of Systems and Data Management at ADVANZ PHARMA, where he was responsible for the design and implementation of the Operations systems strategy.
His areas of expertise are electronic Submissions and Data Management, including eCTD, RIM, XEVMPD, and IDMP; Master Data Management; Quality Management Systems and Computer Systems Validation.