Project management and oversight

WP1

Description

WP1 deals with overall Project Coordination, Project Management, Financial Management, and Risk Management.

In addition, it focuses on development of strategies and long-term project plans, and ensures that work complies with national and EU Health and Safety regulations and Ethical Guidelines.

Objectives

Establish management committees and guidelines for their operation

Establish technical and financial reporting guidelines, monitoring and reporting

Administration of Consortium Agreement

Delivery of all necessary reports including periodic and final project reports

Academic Lead
null

Lynn Rochester

Professor of Human Movement Science, Institute of Neuroscience

Newcastle University

Project Manager
null

Mike Jackson

Project and Business Development Manager

iXscient

EFPIA Co-Lead
null

Ronenn Roubenoff

MD, MHS, Global Head, Translational Medicine Discovery & Profiling, Global Head, Musculoskeletal Disease Translational Medicine

Novartis

EFPIA Project Manager
null

Tilo Hache

Strategy & Planning Lead, Translational Medicine Discovery & Profiling

Novartis

Algorithm development and technical validation

WP2

Description

WP2 will produce a validated ‘device-algorithm pair’ and associated technical, clinical and patient specific standards for clinical validation in WP4.

A comprehensive approach will be adopted to achieve a robust technical validation, including validation on real world data. Current state of the art modelling of human gait will be combined with advanced processing techniques to increase the specificity and accuracy of algorithms. A range of human factors will be assessed related to sensor and protocol acceptability.

Objectives

Create a database of existing real-world and laboratory data and algorithms for the quantification of digital mobility outcomes

Optimise algorithms for digital mobility outcomes and confounding factors from different mobility sensors and locations

Provide a validated device-algorithm pair to be used in WP4

Assess additional factors, such as user characteristics and comfort, wearability and protocol acceptability, for the chosen mobility sensor solution

Provide protocols, standards, manuals, technical validation datasets, sensor requirements and algorithm specifications

Academic Lead
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Claudia Mazzà

Professor of Biomechanics, Department of Mechanical Engineering, Insigneo Institute of in silico Medicine

University of Sheffield

EFPIA Co-Lead
null

Arne Mueller

Data Scientist, Clinical Digital Endpoints

Novartis

Database development and data management

WP3

Description

WP3 will be responsible for design and implementation of the end-to-end data storage and management platform.

It will primarily underpin and enable the activities of WP2 and WP4, as the principal aim of WP3 is to provide a facility for managing and storing the data generated during these WPs.

Objectives

Define and implement the standard for clinical and technical data acquisition, anonymisation, quality check and processing

Specify and develop end-to-end multimodal data hosting, management and maintenance platform

Implement and test the database management and data processing platform

Provide a data management platform that meets the specific needs for data security, privacy and secure data transfer

Produce and maintain the suite of software tools that are required for successful data capture in WP4

Academic Lead
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Brian Caulfield

Professor of Physiotherapy, Director INSIGHT Centre for Data Analytics

University College Dublin

EFPIA Co-Lead
null

Marie McCarthy

Senior Director of Product Innovation Information Technology

ICON

Definition and validation of digital mobility outcomes against clinical endpoints

WP4

Description

WP4 will carry out the clinical validation where digital mobility outcomes are linked to clinical end-points. This will be achieved through the Mobilise-D prospective longitudinal cohort study that incorporates four disease cohorts: chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD), multiple sclerosis (MS) and proximal femoral fracture (PFF).

Digital mobility outcomes will be tested as predictors of mobility, disability, falls, hospitalisation, nursing home admission and mortality.

Objectives

Finalise the network of disease cohorts for recruitment into the Mobilise-D cohort study

Refine the clinical assessment protocol for each disease cohort and the harmonised
protocol for the Mobilise-D cohort

Complete recruitment and longitudinal data collection in prospective Mobilise-D
cohort study

Establish clinical validity of digital mobility outcomes to predict clinical end-points
in each disease cohort and the global Mobilise-D cohort

Provide clinical expertise in the planning of data analysis and data interpretation

Academic Lead
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Clemens Becker

MD, Head of Department Geriatric Medicine, Orthogeriatrics and Geriatric Rehabilitation, Research Group Clinical Gerontology

Robert Bosch Gesellschaft Fur Medizinische
Forschung

EFPIA Co-Lead
null

Ram Miller

Senior Translational Medicine Expert, Musculoskeletal Disease

Novartis Institutes for BioMedical Research

EFPIA Co-Lead
null

Paolo Pirano

Expert Biomarker & Data Insights

Bayer AG

Regulatory, HTA and payer consensus over operational definitions

WP5

Description

WP5 aims to foster acceptance by global health authorities, and health technology assessment bodies of the routine use of wearable mobility sensors in the safety and efficacy testing of new medicinal products, and in the clinical practice as a technology to support medical decision and management of individual patients

Objectives

Pursue with the competent authorities (e.g. the European Medicines Agency in Europe, the Food & Drugs Administration in USA) the regulatory qualification of Digital Mobility Outcomes obtained with wearable sensors for the use in the regulatory evaluation of new drugs. 

Engage with national and European authorities to demonstrate how the use of digital mobility outcomes can help to better evaluate the socioeconomic impact of new drugs.

Academic Lead
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Marco Viceconti

Professor of Computational Biomechanics, Department of Industrial Engineering

Alma Mater Studiorum – Università di Bologna

EFPIA Co-Lead
null

Wim Dartee

Global Lead Medical Devices and Combination Products, Regulatory Affairs Innovation

Novartis Pharma AG, Basel

EFPIA Co-Lead
null

Hubert Truebel

Head of Clinical Sciences within Translational Sciences
Bayer

Statistical analysis, evaluation of results and data availability

WP6

Description

WP6 will analyse and validate digital mobility outcomes for the disease cohorts assessed and followed in WP4, with the aim to provide complete information for regulatory qualification.

The validation will cover construct validity, predictive capacity, responsiveness, ability to detect changes and identify a minimal important difference for improvement or worsening of the digital mobility outcomes.

Objectives

Test construct validity of the digital mobility outcomes in large samples of patients with COPD, MS, PD and PFF assessed under real life conditions

Assess predictive capacity and thresholds of digital mobility outcomes for prediction of clinical outcomes, in prospective cohorts of patients with COPD, MS, PD and PFF

Assess responsiveness to potential interventions and ability to detect changes and define minimal important difference (MID) in digital mobility outcomes in patients with COPD, MS, PD and PFF

Characterise real-world walking behaviour in patients with COPD, MS, PD and PFF

Academic Lead
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Judith Garcia-Aymerich

Research Professor, Head of the Non-Communicable Diseases and Environment Research Programme

Fundacion Privada Instituto De Salud Global

EFPIA Co-Lead
null

Hans Guehring

Medical Director in Global Clinical Development

Merck KGaA

Stakeholder information and results dissemination and exploitation

WP7

Description

WP7s main goals are to drive public awareness of the project by disseminating, teaching, and spreading the outcomes and results of the project. To promote access and use of project results, we will create and implement procedures to make data, standards, and software openly accessible.

To ensure sustainability after the life of the project, a digital mobility assessment module will be developed and provided that will enable external researchers and industry to include real-world mobility assessment in future studies and trials.

Objectives

Drive public awareness of the Mobilise-D project by disseminating, teaching,
and spreading the outcomes and results of the project

Engage the community and create a project Stakeholders Network

Organise and participate in events to inform the relevant stakeholders and public
at large about project results and outcomes

Create procedures to make data, standards, and software openly accessible

Develop a strategy for exploitation and translation of project results into practice

Ensure optimal exploitation and sustainability by providing user-friendly mobility
assessment modules

Academic Lead
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Beatrix Vereijken

Professor of Human Movement Science, Department of Neuromedicine and Movement Science

Norwegian University of Science and Technology

EFPIA Co-Lead
null

Valdo Arnera

MD, Scientific Advisor and General Manager
ERT Geneva
EFPIA Co-Lead
null

Nadir Ammour

Global Lead Clinical Innovation and Partnership, Patients and Sites

Sanofi