The InSilicoWorld consortium works with a large Multi-stakeholder Advisory Board (MAB) to form a community of Practice around In Silico Trials, where academics, industry experts, regulators, clinicians, and patients can develop consensus around Good modeling Practices.
In a project of this kind, the role of the Advisory Board is more important than usual. To remove barriers to the adoption of In Silico Trials, the InSilicoWorld project cannot work in isolation, and extensively engage with representatives of all relevant stakeholders:
- Researchers are represented by experts from very large institutions active in the field, public-private partnerships, and possibly other funders. This stakeholder group also includes higher education institutions, for the educational and retraining aspects.
- The industry is represented by healthcare industry trade organizations, and by individual experts from large medical companies (both pharma and medical devices), simulation software companies, as well as Small and Medium Enterprises (SMEs) active in both fields.
- Medical Professionals are represented by medical and allied profession associations;
- Regulators are represented by experts from EMA and from national regulatory agencies and notified bodies. The ISW consortium will also invite experts from USA FDA, due to the engagement of this extra-European regulator with the topic in subject;
- Policy Makers are represented by members of the European Parliament part of the ITRE committee and by organizations working to reduce animal experimentation;
- Payers are represented by and by national or regional healthcare authorities in charge of orienting healthcare spending, insurances, HTA authorities, and organizations;
- Citizens are represented by organizations of patients and other social groups with specific interests in healthcare such as elders;
The primary engagement of the MAB is for the regulatory aspects and for the information on the risks and benefits of using In Silico Trials. However, the MAB is also periodically informed and consulted on the main activities, as they may impact the stakeholder groups here represented. The MAB will act as consulting and advisory Board to influence and impact the implementation of specific parts of the project and to provide a final evaluation of the project outputs.
Composition of the MAB
- Rossana Alessandrello – Agency for Health Quality and Assessment of Catalonia
- Alberto Bardajì de Quixan – TUV SUD
- Patrick Boisseau – Director of EU Research & Innovation Partnership Policies of MedTech Europe
- Antoine Bril – EFPIA
- Francois Busquet – Altertox Academy
- Vincenzo Costignola – European Medical Association
- Jacques Demotes – Director-General of ECRIN
- Matthias Fink – TUV SUD
- Judith Garcia Aymerich – Lead Epidemiologist, Barcelona Institute of Global Health
- Christian Kaddick – EndoLab Mechanical Engineering GmbH
- Ingrid Klingmann – Chairperson of the Board, European Forum for Good Clinical Practice
- Thierry Marchal – Program Director for Healthcare Solutions at Ansys Inc., and Chair of the Avicenna Alliance
- Matthias Mondon – TUV
- Mark Palmer – Distinguished Scientist at Medtronic responsible for computational modelling
- Blanca Rodriguez – Professor of Computational Medicine, University of Oxford
- Elena Toschi – Istituto Superiore di Sanità; IT contact person for ECRIN (CT infrastructure, lot of CROs)
- Barry Walker – Tuberculosis Vaccine Initiative
- John Wilkinson – Former Director (retired) of Medical Devices at UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
- Matthias Woiczinski – Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
- Andrew Worth – JRC
The overall aim of the In Silico World project is to accelerate the uptake of modeling and simulation technologies for the development and regulatory assessment of all kinds of medical products. This will be achieved by supporting the trajectory of a number of In Silico Trials solutions through development, validation, regulatory approval, optimization, and commercial exploitation.
These solutions, already developed to different stages, target different medical specialities (endocrinology, orthopaedics, infectiology, neurology, oncology, cardiology), different diseases (osteoporosis, dynapenia-sarcopenia, tuberculosis, multiple sclerosis, mammary carcinoma, arterial stenosis, etc.), and different types of medical products (medicinal products, medical devices, and Advanced Therapeutic Medicinal Products).