Event Details

Overview

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.


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.


Timings

12:00-14:00 BST | 13:00-15:00 CEST

Speakers

  • Daniel Rooks (Executive Director, Translational Medicine at Novartis Biomedical Research of Novartis)

    Daniel Rooks

    Executive Director, Translational Medicine at Novartis Biomedical Research of Novartis

    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.

    view more
  • Wim Dartee (Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis)

    Wim Dartee

    Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis

    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.

    view more
  • Igor Knezevic (Global Regulatory Strategist at Bayer)

    Igor Knezevic

    Global Regulatory Strategist at Bayer

  • Arne Mueller (Associate Director & Principal Data Scientist in Clinical Digital Endpoint of Novartis)

    Arne Mueller

    Associate Director & Principal Data Scientist in Clinical Digital Endpoint of Novartis

    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.

    view more
  • Julia Chernova (Associate Director, Clinical Statistics (Digital Health) of Bayer)

    Julia Chernova

    Associate Director, Clinical Statistics (Digital Health) of Bayer

    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.

    view more

Tickets

PSI Member
Member Price Complimentary
PSI Non-Member
Standard Price Complimentary

Community

Connect with 90 people attending this event