Date: Thursday 6th June 2024
Time: 12:00-14:00 BST | 13:00-15:00 CEST
Location: Online via Zoom
Speakers: Daniel Rooks (Novartis), Wim Dartee (Novartis), Igor Knezevic (Bayer), Arne Mueller (Novartis) and Julia Chernova (Bayer).
Who is this event intended for? Statisticians and Data Scientists in early and late clinical drug development, and post-marketing. Anyone who is interested to learn more about digital measures development and integration in clinical trials.
What is the benefit of attending? Learn about challenges and possible solutions when developing and integrating digital measures/digital biomarkers in clinical development from experts in Regulatory and Data Science domains.
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Mobilise D is a consortium of academia, pharma and MedTech companies that come together to move forward development and integration of digital mobility assessments (also known as digital measures or digital biomarkers) in non-interventional and interventional clinical trials. We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you. Regulatory and Analytical experts will share the overview of their involvement and their insights when working with Mobilise D consortium.
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Speaker |
Biography |
Abstract |
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Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.
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Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
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Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception. |
The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project. |
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Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials. |
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Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints. |
Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups. |
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Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making. |
Introduction to Mobilise D Clinical Validation Study |
