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TransCelerate Shares Solution Insights During DIA Europe 2022

DIA Europe 2022 was back in person from March 29-31 after two years since the pandemic. Although it was a hybrid event, many attendees from the European region were present in-person with most traveling for the first time since COVID-19.

TransCelerate secured four sessions at DIA Europe surrounding Decentralized Clinical Trials, Intelligent Automation Opportunities in Pharmacovigilance, and Real World Data. Our presenters were a mix of in-person and virtual while delivering engaging and informative talks. Read on for our detailed session recap.

Our first session of the event featured Neal Grabowski (AbbVie), who led a talk on our Intelligent Automation Opportunities in Pharmacovigilance Initiative. The presentation titled “Case Studies for AI-Based Intelligent Automation in Pharmacovigilance” took attendees through the initial use cases of intelligent automation technologies (IAO), evaluating opportunities within the ICSR process steps, and sharing the technology benchmarking findings. Neal then spoke about the validation framework and shared the team’s findings that could lead to efficiencies to traditional processes and potentials for an opening of new channels of data for product insights. After his session, Neal passed it over to Minhaj Obeidullah (Novartis) along with two other speakers, Marc-André Giguére (Health Canada) and former TransCelerate contributor Jesper Kjaer (Danish Medicines Agency). 

The bulk of our sessions took place the next day with our first session dedicated to Decentralized Clinical Trials (DCT). After Rebecca Stanbrook (Novartis) introduced herself and everyone on the panel she passed it over to Dagmar Goertz (Janssen-Cilag GmbH) who gave an overview of TransCelerate and explained how she puts herself in the shoes of these patients which makes her work all the more passionate. Dagmar interacted with the crowd in-person as she engaged attendees and the panel on insights related to decentralized clinical trials. She also polled the audience to see what perspective they represent, and most were from biopharma but there were some from patient and academia groups. She then passed the talk over to Linda Rutgrink (Sanofi) who was also excited to talk through TransCelerate’s Modernization of Clinical Trials Initiative, why DCTs matter, how they have changed the clinical trial field, and how they benefit patients while providing solutions to common issues. 

Linda also mentioned our Diversity of Participants in Clinical Trials Initiative as she talked through the various solutions that TransCelerate has developed, including the recently launched US Regulatory Landscape: Diversity in Clinical Trials  The attendees then heard from three others on the panel and afterwards the session was opened for questions which provided rich dialogue.

The next session was focused on our Real World Data Initiative, “Developing a Quality Management Checklist to Support Audits of Real-World Data (RWD) Used in Regulatory Submissions,” with speakers Gracie Lieberman (Roche), Andre Araujo (GSK), John Concato (CDER/FDA), Ron Herings (PHARMO), and Frank Pétavy (European Medicines Agency).

Gracie started off the session in-person and shared her insights from TransCelerate’s Real World Data (RWD) Initiative. She then passed the microphone (virtually) off to Andre who introduced the overview of RWD and provided the RWD-related topics at TransCelerate. These topics included Health Authority Engagement, Audit Readiness, Pragmatic Clinical Trials, Rapid Signal Assessment Using RWD, Historical Trial Data Sharing, and Vulcan FHIR Accelerator. Andre then focused on the RWD Audit Readiness Initiative and its desired outcomes which include building trust, reducing barriers, and demonstrating fit-for-purpose use. He shared the Landscape Assessment Insights Framework with examples of documenting relevancy of RWD. Andre then explained the RWD survey outreach and ended the session with results of the survey

Frank Pétavy discussed the work the EMA is doing regarding data quality in Europe. John Concato led he session about RWD and approach to assessing this data. He anchored back to the FDA’s Real World Evidence (RWE) Framework from 2018 and then added the CDER/CBER RWE Draft Guidance from March 2022.

Our last session of the day ended with part two of the Decentralized Clinical Trials session with Dagmar Goertz (Janssen-Cilag GmbH). During Decentralized Trials-Part II, Dagmar was joined by two other TransCelerate contributors for this session, Co-Chair Rebecca Stanbrook (Novartis) and Susanne Norskov (Novo Nordisk A/S). Rounding out the other speakers were Gabriele Schwarz (BfArM), Frederik Grel NØrgaard (Danish Medicines Agency), and Lisbeth BregnhØj (Danish Medicines Agency).

Dagmar kicked off the session by summarizing the first session and mentioning how it was focused on industry, academia, and patients. This session targeted the regulators and the regulatory landscape. She had a poll to see who had also joined the first session, and a quarter of this audience also attended the first session.

Next up was Rebecca, who introduced the speakers and passed it to Gabriele Schwarz who previewed the regulations that are in play and then the second half of her talk about the factors that need to be considered in decentralized clinical trials.

Overall, it was another great conference that saw so many people from so many places and industries. TransCelerate would like to send its sincere thanks to DIA Europe and the Members who shared the work of so many colleagues across TransCelerate Member Companies. We are looking forward to our participation in next year’s event.

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