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Re-Thinking Clinical Development
Session Chair(s)
Peter Mol, PharmD, PhD
CHMP member, NL
MEB, Netherlands
How can the best of big data and the randomised clinical trial be integrated to support regulatory decision making? In this DIALogue session four panelist will make their case in a 5-minute TED-style talk on how their solutions using e.g. Augmented Intelligence and wearables will improve trial efficiency and the chance of regulatory approval. The audience will be asked to express their enthusiasm or skepticism and suggest barriers and facilitators for the solutions proposed to support drug development. These barriers and facilitators will fuel further discussion between panelists and the audience.
Learning Objective : Listeners of this presentation will be able to apply their knowledge of AI on the development of new models for the regulatory process. We will compare various approaches and summarize the efforts that already have been made in this regard. How can the regulatory vision be reshaped to ultimately benefit patients.
Speaker(s)
Big Data: Moving from Artificial Trials to a Smarter Regulatory Process
Bruno Boulanger, PhD
PharmaLex, Belgium
Chief Scientific Officer
Value and Access: Managing Real-World Evidence Trials at scale
Jonathan Moshinsky
uMotif, United Kingdom
Head of Strategy
Advanced Analytics on Longitudinal Health Records
Frederik Floether, PhD, MA, MSc
IBM, Switzerland
Quantum Industry Consultant - Global Lead Life Sciences and Healthcare
Using Historical Data to Transform Clinical Trials
Alun Bedding, PhD
Roche Products Ltd, United Kingdom
Global Head of Methods, Collaboration and Outreach, PD Data Sciences
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