Date: Wednesday, 20 November 2019
Time: 15:30 – 17:00 GMT (16:30 - 18:00 CET)
Where: Online at your desk
Programme
Paradigm presentation:
Involving patient in medicines R&D is a smart idea, and therefore a topic of interest for all departments in pharmaceutical companies, and more particularly for research (of course!) but also the regulatory affairs. In an article in 2018 entitled ‘What do stakeholders expect from patient engagement: Are these expectations being met?’ it was found that ‘that policy makers / regulators are expected by other stakeholders groups to drive, create a framework and facilitate patient engagement, provide guidelines of good practices and connect stakeholders, but this expectations is not shared by the policy makers / regulators’.
The IMI-funded PARADIGM project aims to participate in the creation of a sustainable framework allowing systematic, meaningful and ethical patient engagement in medicines R&D to make patient engagement a greater reality.
Virtual Clinical Trial presentation:
Clinical trials are, and will remain, crucial in drug development and improving patient health. However, (s)low patient recruitment and low retention put pressure on the efficiency, generalisability and validity of traditional, clinical site-centred trials. Remote decentralised clinical trials (RDCTs) hold the promise of solving this problem. The RDCT approach is an operational strategy for technology-enhanced clinical trials, that are more accessible to patients by moving clinical trial activities to more local settings. RDCTs can be applied in all stages of the drug development process, to generate evidence on safety, efficacy (as traditionally obtained from controlled phase I to IV clinical trials) or effectiveness (as obtained from more pragmatic studies aimed at guiding prescribing in routine clinical practice).
The overall aim of Trials@Home is to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe.
Presenters
Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations).
Strong of 34 partners (patient organisations, pharmaceutical / biotech companies, regulators, HTA bodies and academic teams), PARADIGM (for Patients Active in Research and Dialogues for an Improved Generation of Medicines) will strengthen the understanding of stakeholders’ needs, the systems-readiness, ensure maximum synergies with other initiatives and develop an inventive and workable sustainability roadmap.
Previously, Mathieu worked for EURORDIS-Rare Diseases Europe since 2013. Mathieu was involved in activities to foster the access to innovation to patients.
Kim Hawkins, MPH, has 25 years of operational experience managing all phases of the drug development process. Kim has been with Sanofi for 6 years and is currently the Global Head of CSO Project Leaders. In addition to her portfolio responsibilities, Kim is leading several projects focused around the evolving clinical trial model to build innovation and digital technology into our trials and to further optimize clinical research for Sanofi and patients. As co-lead for the IMI Trials@Home project, she will work with the consortium to leverage telemedicine and other technologies to make clinical trials more accessible to patients.
Agenda
Gabriel Bohl - Chair of TOPRA IN FRANCE
- Intro TOPRA in France – 7 min
- Intro presenters and presentations – 7 min
Matthieu Boudes
- IMI presentation – 5 min
- Paradigm (Patient involvement) – 20 min
- Questions & answers – 15 min
Kim Hawkins
- Virtual Clinical Trial – Trial at Home – 20 min
- Questions & answers – 15 min
Space is limited, register your place today.
Prices
Members: Free