| \n Speake r \n | \n \n Biography \n | \n \n < p>Abstract\n | \n
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p> \n Daniel Rooks\n | \n \n Daniel Rooks\, PhD is Project Le ad of the Mobilise-D consortium and Head\, Endpoint Management in Translat ional 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 funct ion in drug development clinical trials. Prior to his current role\, he le d the Muscle Diseases and Neuromuscular Diseases groups in Translational M edicine and was the Early Clinical Lead of the bimagrumab program. His wor k with assessments in clinical trials at Novartis and before that at Harva rd Medical School includes traditional pen\, paper\, and stopwatch and dig ital measures. He co-developed the SPPB Guide mobile phone app th at standardizes administration and scoring of the Short Physical Performan ce Battery. He is a fellow of the American College of Sports Medicine. \n\; \n | \n \n Digital health technologies a nd digital outcome measures are increasingly used in clinical trials to as sess mobility in the real world. In 2019\, few digital mobility outcomes h ad been validated in multiple health conditions. The Mobilise-D consortium \, an Innovative Medicines Initiative (IMI) funded public-private partners hip\, 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 prese ntation will provide an overview of several key aspects of the Mobilise-D project. \n\; \n | \n
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Wim Dartee (Novartis) is Global Lead Regulatory Affairs\, Devices/ Sensors in Clinical Development at Novartis and has over 20 years&rsquo\; experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL)\, European\, US and Global regulatory affairs experience\, d irect interactions with all major Regulatory agencies (EMA\, key EU nation al health authorities\, FDA\, PMDA\, Swissmedic)\, and Notified Bodies BSI \, Tü\;vSü\;d. 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 op timize opportunities within the ever-changing regulatory framework. \nHis latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise\, cap italizing on opportunities in combining pharma development projects with i nnovative devices and digital\, and with particular focus on enabling the development of digital endpoints in drug clinical development. \nWim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception. \n | \n \n The Mobilise-D regu latory journey: key achievements and lessons learned \nThis presentation will focus on the regulatory strategy developmen t and the corresponding various Health Authority interactions that were un dertaken to establish what is needed to gain acceptance of digital mobilit y outcomes as part of the Mobilise-D project. \n | \n
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| \n \n \; \n | \n \n Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digit al biomarkers in clinical trials. \n | \n
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Dr. Arne Mueller\, a biologist by training\, obtained his Ph D in Bioinformatics from the University College London\, specializing in p rotein folding prediction. He gained industry experience through a Marie-C urie fellowship at Aventis Pharma\, focusing on Toxicogenomics. Dr. Muelle r's career progressed at Sanofi and Novartis\, where he transitioned from pre-clinical to clinical research\, with a particular focus on digital mob ility endpoints. \n | \n \n Technical validation of mobili ty endpoints \nHow do we know we measure what w e think we measure? The technical validation of Mobilise-D compares digita l mobility outcomes (DMOs) measured in the patient&rsquo\;s real world fro m lower limb-worn sensors against reference standards under different expe rimental conditions and in the patient populations. Challenges and methodo logies are presented: Terminology\, reference standards (incl. portable a reference)\, development of a benchmarking framework and the algorithm pip eline for deriving DMOs. Most DMOs can reliably be measured with a lower l imb-worn accelerometer\, but different algorithms must be deployed for dat a processing in different population groups. \n | \n
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| \n \n Quantitative data scientist with experience in to p-tier U.K. academia and international pharma. She received her PhD in Hea lth Data Science from Cambridge University designing methodology in estima ting diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical tr ials and is always excited to bring innovation in Drug development and pos t-marketing activities to support data-driven decision making. \n | \n \n
Introduction to Mobilise D Clinical Validation Study |
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