By Isabelle de Zegher, VP Engineering, PAREXEL Informatics
DIA Europe Vienna is now in the books, and it was a very intensive 3 days with insightful panel discussions and many interesting presentations across several tracks. I served as the chair of Track 7: Digital Disruptors: Changing the Game along with Chris Walker from AMGEN. The track kicked off with a very well attended DIAmond session, then continued with 7 more sessions throughout the week – clarifying what we meant by digital disruptive technology; how it is changing the game for regulators, sponsors, sites; and the impact on patients as we progress toward new “connected” health care systems.
I have been attending technical tracks at DIA for several years now, and I was pleasantly surprised this year to see such a wide attendance in these sessions. Seems that the wheel is turning, and we as an industry finally understand the value of digitization in drug development – we must embrace new technology to increase speed of development, deliver more patient relevant data, and decrease uncertainty about our medicines.
As the meeting concluded, Chris and I took away the following messages:
Technology Disruption – The examples presented during the conference - coming from sponsors, vendors as well as regulators - show huge opportunity for greater efficiency and patient focus: eConsent, engagement apps, eCOA, sensors, bot-based patient assistant all technologies enabling virtual/remote trials; new applications such as ePIL and certainly AI & Blockchain. Many see the opportunity for a new type of products including medicine and technology-based services. In short, there is no doubt: our industry must embrace technology, define appropriate validation to trust these new applications, and focus on how to deploy them to solve healthcare problems.
Digital Data – New data will offer new insights; the volume and flow of data is evolving – with potentially very high volume. It may enable new endpoints as well as a greater reliance on RWE for real life outcomes.
Patient medical record is the yet unexploited gold mine – useful data will likely be coming from both structured and unstructured EHR with optimization of data curation through AI technology.
Legislative Framework - We are challenged to move away from sequential RCTs, towards a dynamic regulatory framework with increased collaboration across all stakeholders. Some disruption will require legislative change. It will certainly require new skill sets.
Enablers to Healthcare Disruption – Access to data (we need to solve our “data mess” as a priority), develop trust in new technologies; ensuring adequate skill sets and training and multi stakeholder agreement are key to success.
Thank you to all those who attended the sessions in Vienna for making this a dynamic and relevant discussion around the current state of digital transformation. As you move ahead on your own digital path, I encourage you to reach out so we can explore the path that is right for your organization.