Monday, June 24, 2024
Welcoming & Coffee
9:00 AM - 10:00 AM CEST
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Introduction
10:00 AM - 10:15 AM CEST

Frédéric Boiron, Director of the CHU Lille
Lise Alter, General Director of the French Health Innovation Agency

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Back to the needs
10:15 AM - 11:00 AM CEST
Plénière

Moderator : Alexis Génin  (Brain&Mind)
Speakers : François Lamy (AFM Telethon), David Devos (CHU Lille), Patrick Meshaka (Novartis)

Most “agile” methodologies for clinical research exist since decades and still are rarely used. What key cultural and technical factors are currently preventing their implementation (and how could this change) ?

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Parallel sessions a.m.
11:00 AM - 12:10 PM CEST
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Round-table #1 - External arm or hybrid: moving foward 3.0 clinical research ?
11:05 AM - 12:10 PM CEST
Table ronde

Moderator : David Perol (Unicancer)
Speakers : Remy Choquet (Roche), Louise Baschet (Horiana), Jean-Louis Fraysse (BOTDesign), Thomas Filleron, (Oncopole Toulouse), Valérie Denux (ANSM)

Will ultra-rare orphan patients remain without any treatments? How hybrid or external control arms can contribute to generate clinical evidence in ultra-rare/pediatric diseases or fragile populations?

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Roundtable #2 - Are patients affected by slowly progressing diseases condemned to remain without treatment ?
11:05 AM - 12:10 PM CEST
Table ronde

Moderator : Marc Bonneville (ARIIS)
Speakers : Cécile Ollivier (C-Path), Emmanuel Pham (Novadiscovery), Véronique Briquet-Laugier (Lab'FondaMental), Werner Rein (Theranexus), Gérard Raymond (France AssoSanté)

In which extent does Ph3 RCT find their limits for slowly progressing diseases? How can you demonstrate efficacy with non-subjective endpoints when you are investigating a disease that lasts more than 10 years? Are simulation and/or digital endpoints useful? Robust?

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Keynote #1 - For an ambitious regulation in line with evolution of health products and technologies
12:15 PM - 12:35 PM CEST
Plénière

Alexandre de la Volpillière (Deputy Director of ANSM)

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Keynote #2 - Is there a pilot in the rocket?
12:35 PM - 1:10 PM CEST
Plénière

Isabelle Rongier (Deputy Technical Director - Ariane Group)

Prospective keynote: how simulation became a standard for other areas. (Mind breaking parallel with other area eg Air Traffic Management and/or surgical practices and/or space technologies...)

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Lunchbreak
1:10 PM - 2:30 PM CEST
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Afternoon opening with Vincent Diebolt
2:30 PM - 2:40 PM CEST
Plénière

Vincent Diebolt (Director for the French Clinical Research Infrastructure Network)

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Round-table - Artificial intelligence, diagnosis, prediction, organization of care: how to move forward a personalized medicine - optimized healthcare system?
2:40 PM - 3:35 PM CEST
Plénière

Moderator : Stéphanie Allassonnière (PR[AI]RIE)
Speakers : Thierry Marchal (Ansys), Corinne Collignon (HAS), Vincent Sobanski (Professor Lille University), Tala Fakhouri (FDA)

Several AI based decision support systems are now already on the market. The emergence of digital twins and artificial data are opening new possibilities. In this panel, we will discuss the opportunities these new technologies are offering. At the same time, regulatory measures now need to evolve to take into account these developments. The FDA has proposed several guidelines for external control arms and AI based algorithms. We will now discuss on the next steps we all need to take to accelerate innovation.

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Parralèle sessions p.m.
3:40 PM - 4:35 PM CEST
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Round-table #1 - Digital Medical Devices : Where do we stand in their assessment and what healthtech stakeholders need to know?
3:40 PM - 4:35 PM CEST
Table ronde

Moderator : Line Farah (DNS, Ministry of Health)
Speakers : Jerome Fabiano (EIT Health), Corinne Collignon (HAS), Sarah Zohar (INRIA-INSERM), Dr Joris Giai (CHU Grenoble Inserm CIC 1406, Tech4Health), Stéphane Tholander (Agora Health)

The rapid evolution of digital medical devices, encompassing everything from wearable health monitors to AI-powered diagnostic tools, presents a new frontier in healthcare. This panel discussion aims to explore the current landscape of digital medical device assessment, addressing both the regulatory frameworks and the practical challenges faced by developers and healthcare providers.
This roundtable will not only delve into the current state of digital medical device assessment but also equip attendees with the knowledge they need to navigate this evolving landscape.

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Round-table #2 - Practical session : Emulated or simulated
3:40 PM - 4:35 PM CEST
Table ronde

Moderator : David Perol (Unicancer)
Speakers : Alison Antoine (Centre Léon Bérard) , Suzette Delaloge (Gustave Roussy Institute), Alexandre Templier (Quinten)

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Round-table #3 - Practical session : IA
3:40 PM - 4:35 PM CEST
Table ronde

Moderator : Raphaël Porcher (Université Paris Cité)
Speakers : Felix Balazard (Owkin), Stéphanie Allassonnière (PR[AI]RIE), Thomas Walter, (Institut Curie), Gautier Schreiner (HDH)

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Coffee break
4:35 PM - 4:50 PM CEST
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Round-table - Time to move on
4:50 PM - 5:40 PM CEST
Plénière

Moderator : Yann Maël Ledouarin (DGOS, Ministry of Health)
Speakers : Andrew Thomson (EMA), Tala Fakhouri (FDA), Sarah Zohar (INRIA-INSERM), Corinne Blachier-Poisson (Amgen)

Which roadmap to bring this future closer and real ? Discussion on the path to follow to create trust.

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Keynote #3 - Lionel Collet, Expert Witness of the day
5:40 PM - 6:00 PM CEST
Plénière

Lionel Collet, President of The French National Authority for Health – Expert witness of the day

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Wrap-up and Conclusion of the day - Dr Lise Alter
6:00 PM - 6:15 PM CEST
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