Program of the Conference

Wednesday, May 21, 2025

EUFEMED Pre-conference workshop: The most suitable participant for phase 1 clinical trials

13:00 - 13:15

Welcome and Introduction

13:15 - 15:15

The most suitable participant for phase 1 clinical trials - Plenary Session

How did the healthy volunteer evolve over the last 10 years? - Thomas Lodeweyckx, SGS, Belgium

Which populations should be included in phase 1 clinical trials? Sponsor, regulator and ethics committee perspectives.

• The sponsor’s perspective – Joachim Höchel, Bayer, Germany
• The investigator’s perspective – Yves Donazzolo, Eurofins, France
• The regulator’s perspective (speaker invited)
• Ethical perspective and the VolREthics initiative - François Bompart, INSERM Ethics Committee, France

What is the place of patients in First-In-Human trials? - Jan de Hoon, KU Leuven, Belgium

14:45 - 15:15

Coffee break

15:15 - 16:15

Parallel breakout sessions:

• Who do you consider a healthy volunteer?
• What is the population that you would include in phase 1 clinical trials?
• Would you include non-oncology/non-ATMP patients in a First-in-Human trial?

16:15 - 16:45

Coffee break

16:45 – 17:30

Feedback from break-out sessions

Thursday, May 22, 2025

EUFEMED-HEALIXIA Joint Conference day

9:00 - 9:15

Welcome and introductions – Jan de Hoon, EUFEMED & Erik Present, Healixia

9:15 - 9:45

Keynote Presentation - Genetic medicines: setting the scene for treatments of the future – Olivier Harari, Regeneron Genetic Medicines, USA

Session chair: Jan de Hoon

9:45 - 10:45

Medicines Development for innovative therapies: challenges in early and late clinical development

• Navigating the Challenges of Clinical Development in Rare Diseases : lessons learned and hurdles to overcome – Anna Rozova, Chiesi Global Rare Disease, Canada
• Challenges faced by the investigator: focus on the treatment of ALS as a rare disease – Philip Van Damme, KU Leuven, Belgium
• The patient’s perspective as participant in a First-in-Human clinical trial - patient testimony

Session chairs: Jan de Hoon, Nariné Baririan

10:45 - 11:15

Coffee break

11:15 - 12:45

Medicines Development for innovative therapies - challenges in regulation and reimbursement

• Joint Health Technology Assessment (HTA) in Europe: today and tomorrow? – Marc Van de Casteele, RIZIV-INAMI, Belgium
• Perspective of industry (Speaker invited)
• Perspective of regulators (Speaker invited)

Session chairs: Erik Present, Ingrid Theeuwes

12:45 – 13:45

Lunch

 13:45 - 15:15

Oxford Debate - Diversity YES, but in Phase I? – With Keith Berelowitz, PatientRx Ltd, UK; Henri Caplain, Consultant, France; Liam Eves, h-Bar Consultants, UK; Kerstin Breithaupt-Grögler, Consultant, Germany.

Session Chair: Tim Hardman

15:15 – 15:45

Coffee break

15:45 - 17:15

Parallel session A: The new ethical framework

• Impact of the new versions of the Declaration of Helsinki, ICH-GCP E6 R3 and WHO guidance for the conduct of clinical trials – Varvara Baroutsou, IFAPP, Greece
• The VolREthics Initiative – What will it change? – François Bompart, INSERM Ethics Committee, France
• eConsent Done Right: A Fit-for-Purpose Study Framework – Hilde Vanaken, TCS, EFGCP, Belgium

Session chairs: Ingrid Klingmann, Yves Donazzolo

Parallel session B: Real World Data in Belgium: will Phase IV studies become obsolete?

• Transforming routinely-collected health data into real-world evidence – Annelies Verbiest, UZA, Belgium
• The Federated Health Innovation Network: transform healthcare with data – Kim Denturck & Peter De Jaeger, AZ Delta, Belgium
• The We Are Platform: a sustainable citizen-centric ecosystem for personal health data – Elfi Goesaert, VITO, Belgium

Session chairs: Geert Van Gassen, Elke Debie

17:30 - 18:00

Closing Keynote Presentation: Evolving a new framework to optimize drug development – Richard Hargreaves, Bristel Myers Squibb, USA

Session chair: Jan de Hoon

19:00 - 22:00

Social Event with dinner at Salons Van Dijck, Mechelen

Friday, May 23, 2025

EUFEMED Conference day 2

9:00 - 10:30

Update on safety biomarkers in early clinical development

• Interest and use of emerging safety biomarkers in the drug development – Philippe Detilleux, Sanofi, France
• Kidney safety biomarkers in human and approach to interpret emerging exploratory biomarkers – Emmanuel Krupka & Olivier Roux, Sanofi, France
• CNS safety biomarkers in human and approach to interpret emerging exploratory biomarkers: the preclinical perspective – Greet Teuns, Johnson & Johnson, Belgium
• CNS safety biomarkers in humans and interpretation of emerging signals– Geert Jan Groeneveld, CHDR, The Netherlands

Session chairs: Rob Zuiker, Erik Mannaert

10:30 – 11:00

Coffee break

11:00 - 11:45

Research in the spotlight: Poster pitches of selected abstracts and Audience Voting for best presentation award

Session chairs: Thomas Lodeweyckx, Elke Debie

11:45 - 13:15

Artificial Intelligence in Clinical Development: Buzzword, vision, or reality? With confirmed speakers:

• For academic perspective: Liesbet Geris, VPH Institute, Belgium
• For industry perspective: François-Henri Boissel, Nova in Silico, France
• For regulator perspective: Flora Musuamba Tshinanu, FAMHP, Belgium

Session chairs: Joachim Höchel, Tim Weglewski

13:15 - 13:30

Summary & End of conference – Ingrid Klingmann, EUFEMED

13:30 - 14:00

Farewell lunch