DIA Europe 2023: Digital Transformation in the EU Regulatory Space

The very well-attended “Digital Transformation in EU Regulatory Space” opened with speakers from the following entities offering their view of what is required to bring digital transformation to the regulatory environment at the EU. Session chair Rodrigo Palacios is an associate director in Regulatory Policy at Roche. Palacios introduced co-chair Zaïde Frias, head of the digital business transformation task force for EMA offered the current state of the EMA IT landscape describing it as “spaghetti.”

As such, her charge in the task force is significant, and she offered updates for the project, mostly around the training and upskilling for EMA purposes, as well as the current outline to implement transformational considerations.

Jan Geissler, founder and managing director of Patvocates, brought the patient view to the session, including the benefits of a digital transformation for access to trials, but all the challenges of technology, such as a sense of loneliness. But the large part centered on sharing and ownership around patient data, which he described as chickens sitting on their eggs. Chickens being academia and industry who are not willing to let go of their data or eggs.

The industry perspective came from Nick Sykes, senior director, Global Regulatory Sciences for Pfizer, where he offered a leveled a constructive criticism toward the European medicines regulatory network (EMRN) strategy 2025. Sykes believes it falls short on goals and deliverables; setting KPIs, as well as its ability to ensure the strategy announced in 2020 is actually staying up-to-date and adapting to the pace of technology. He also wondered if it was more of a regulatory strategy, rather than a stakeholder strategy.

However, Sykes noted that digitization in the pharma world could be used to help reform a static document strategy to a data focused one, which would be helpful for all parties. He also suggested that digital transformation be broken down to what should be a global collaboration, what should fall under national reformations, and the same for regional. For example, nation and regional interchangeability could help manage discord between EU priorities and national network members.

Lars Bo Nielsen, director general of the Danish Medicines Agency, praised the EMA’s EMRN for the ability to do so much in such a little time. He believes that the speed of digitization is primarily the nature of the reduction in computing and storage costs. Internal trends that are could be transformed by digital are the exponential growth in driving RWD for RWE; enhanced data analysis in assessment in pharmacovigilance and approval during assessment of marketing authorization, and the ability to have common IT systems and harmonization under EMA.

However, Nielsen also noted that the trends of citizen centric data generation and data sharing, along with social media could confound regulators in currently unforeseen ways. For example, he shared that in Denmark, an insurance company was considering an app to allow patients to rate the medicines. Nielsen noted the pressures on both drug makers and regulatory agencies would negatively impact of patients in their country.

Elena Bonfiglioli, lead for health and life sciences, Microsoft, Belgium brought the need for data, specifically AI, to be both responsible AI and generative AI. She said that data needs to be treated with dignity in order to fulfill its promise in health discovery and delivery.

She noted the three things to remember in digital transformation, which it should be

• User-experienced or user-centered.
• Be able to scale, using standards and skills
• Trust based, as a privacy-enhanced data collaboration.

From the non-profit side, Frank Nogueira, CEO of Accumulus Synergy, outlined his organization’s platform and collaborations that could enhance the data relationship and regulatory abilities for both sponsors and regulators.

Reference:

DIA Europe 2023, March 22-24, Basel, Switzerland. “Digital Transformation in EU Regulatory Space.”