In May 2025, Mechelen will be the place for healthcare and life sciences professionals to network with colleagues and to exchange insights about the latest developments during our joint event: the 5th EUFEMED Conference (21-23 May 2025) and the 4th Annual Conference of Healixia (22 May 2025).
Both associations are celebrating an important anniversary, together at the Lamot Conference Centre in Mechelen, Belgium under the title ‘Mastering increasing complexity in developing innovative therapies’.
The presentations below are available as they are and remain the property of their original authors.
Publication, dissemination, modification, sharing without sourcing or commercial use of any of the presentations available below, even partial or modified, is strictly forbidden without the authorisation of their Original Authors. Unless stated otherwise, the opinions and statements in the presentations below are personal, and are not the ones of EUFEMED or the Authors' Related Organisations. Any of the material below can be removed at any time by EUFEMED, on request of their Original Owner or without justification. EUFEMED does not guarantee full time availability of those documents, and can amend or remove this webpage at their own discretion.
Wednesday, May 21, 2025
EUFEMED Pre-conference workshop: The most suitable participant for phase 1 clinical trials
| 12:30 | Registration | |
| 13:00 | Welcome and Introduction | |
| 13:15 | 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 | Download | |
| Which populations should be included in phase 1 clinical trials? Sponsor, investigator, regulator and ethics committee perspectives. | ||
| - The sponsor’s perspective – Joachim Höchel, Bayer, Germany | Download | |
| - The investigator’s perspective – Yves Donazzolo, Eurofins, France | ||
| - The regulator’s perspective - Joop Van Gerven, CCMO, The Netherlands | Download | |
| - Ethical perspective and the VolREthics initiative - François Bompart, INSERM Ethics Committee, France | Download | |
| What is the place of patients in First-In-Human trials? - Jan de Hoon, KU Leuven, Belgium | Download | |
| 14:45 | Coffee break | |
| 15:15 | 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 | Coffee Break | |
| 16:45 | Feedback from break-out sessions | |
| 17:30 | End of the Day |
Thursday, May 22, 2025
EUFEMED-HEALIXIA Joint Conference day
| 8:30 | Registration | |
| 9:00 | Welcome and introductions – Jan de Hoon, EUFEMED & Erik Present, Healixia | |
| 9:15 | Keynote Presentation - Genetic medicines: setting the scene for treatments of the future – Olivier Harari, Regeneron Genetic Medicines, USA Session chair: Jan de Hoon |
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| 9:45 | 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 | Download | |
| Challenges faced by the investigator: focus on the treatment of ALS as a rare disease – Philip Van Damme, KU Leuven, Belgium | Download | |
| The patient’s perspective as participant in a First-in-Human clinical trial - patient testimony | Download | |
| Session chairs: Jan de Hoon, Nariné Baririan | ||
| 10:45 | Coffee break | |
| 11:15 | Medicines Development for innovative therapies - challenges in regulation and reimbursement | |
| Challenges and opportunities from an industry perspective considering current/ upcoming changes – Armand Voorschuur, pharma.be, Belgium | Download | |
| Joint Health Technology Assessment (HTA) in Europe: today and tomorrow? – Marc Van de Casteele, RIZIV-INAMI, Belgium | Download | |
| Challenges in the development and registration of orphan drugs: a Regulator Perspective - Tim Leest, EMA’s Committee for Orphan Medicinal Products (COMP), Belgium | Download | |
| Session chairs: Erik Present, Ingrid Theeuwes | ||
| 12:45 | Lunch | |
| 13:45 | 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, Independant Researcher, Germany. Session Chair: Tim Hardman |
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| 15:15 | Coffee break | |
| 15:45 | 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 | Download | |
| The VolREthics Initiative – What will it change? – François Bompart, INSERM Ethics Committee, France | Download | |
| eConsent Done Right: A Fit-for-Purpose Study Framework – Hilde Vanaken, TCS, EFGCP, Belgium | Download | |
| 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 | Download | |
| The Federated Health Innovation Network: transform healthcare with data – Kim Denturck & Peter De Jaeger, AZ Delta, Belgium | Download | |
| The We Are Platform: a sustainable citizen-centric ecosystem for personal health data – Elfi Goesaert, VITO, Belgium | Download | |
| Session chairs: Geert Van Gassen, Elke Debie | ||
| 17:30 | Closing Keynote Presentation: Evolving a new framework to optimize drug development – Richard Hargreaves, Bristol Myers Squibb, USA Session chair: Jan de Hoon |
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| 19:00 | Social Event with dinner at Salons Van Dijck, Mechelen |
Friday, May 23, 2025
EUFEMED Conference day 2
| 8:30 | Registration | |
| 9:00 | Update on safety biomarkers in early clinical development | |
| Interest and use of emerging safety biomarkers in the drug development – Philippe Detilleux, Sanofi, France | Download | |
| Kidney safety biomarkers in human and approach to interpret emerging exploratory biomarkers – Emmanuel Krupka & Olivier Roux, Sanofi, France | Download | |
| Translational Approach of the Clinical and Nonclinical Evaluation and Qualification of Blood-based Biomarkers of Drug-induced Neurotoxicity: An IMI TransBioLine project – Greet Teuns, Johnson & Johnson, Belgium | Download | |
| CNS safety biomarkers in humans and their application in early-phase clinical drug development – Geert Jan Groeneveld, CHDR, The Netherlands | Download | |
| Session chairs: Rob Zuiker, Erik Mannaert | ||
| 10:30 | Coffee break | |
| 11:00 | Research in the spotlight: Poster pitches of selected abstracts and Audience Voting for best presentation award Session chairs: Thomas Lodeweyckx, Elke Debie |
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| 11:45 | Artificial Intelligence in Clinical Development: Buzzword, vision, or reality? With confirmed speakers:
Session chairs: Joachim Höchel, Tim Weglewski |
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| 13:15 | Summary & End of conference – Ingrid Klingmann, EUFEMED | |
| 13:30 | Farewell lunch |
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