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Wednesday, February 6 • 10:45 - 11:45
#S0401: Re-Thinking Clinical Development

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Component Type: Session

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.


Peter Mol, PhD, RPh


Big Data: Moving from Artificial Trials to a Smarter Regulatory Process
Bruno Boulanger, PhD

Advanced Analytics on Longitudinal Health Records
Frederik Floether, PhD, MA, MSc

Using Historical Data to Transform Clinical Trials
Alun Bedding, PhD

avatar for Peter Mol

Peter Mol

Principal Clinical Assessor, University Medical Center Groningen; Member SAWP, CBG-MEB (Dutch Medicines Evaluation Board)
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor at the University Medical Center Groningen... Read More →
avatar for Alun Bedding

Alun Bedding

Director, Biostatistics, Roche/Genentech
Alun Bedding has worked in the Pharmaceutical Industry for nearly 30 years and has experience in all areas of drug development, from pre-clinical to post registration. Alun currently works as a Director of Biostatistics in Roche, leading a team of statisticians working in early clinical... Read More →
avatar for Bruno Boulanger

Bruno Boulanger

Chief Scientific Officer, PharmaLex
Bruno has 25 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics. Bruno is... Read More →
avatar for Frederik Floether

Frederik Floether

IBM Q Consulting Global Life Sciences Leader, Quantum & AI, IBM
avatar for Jonathan Moshinsky

Jonathan Moshinsky

Head of Market Strategy, Umotif
Jonathan is responsible for Strategy and Marketing at uMotif. He has 10 years' experience in software strategy and management consulting for Life Sciences. Prior to uMotif, Jonathan was part of Veeva's Commercial strategy team, held senior consulting roles at IBM and was a Senior... Read More →

Wednesday February 6, 2019 10:45 - 11:45 CET
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  04 Modern Clinical Research, Session
  • Featured Topics Clinical Development
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