EUFEMED-Healixia conference 2025 - Eufemed-Healixia Conference

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 5^th EUFEMED Conference (21-23 May 2025) and the 4^th 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’.

You are also kindly invited to join us for the social event (50 € fee) on Thursday evening at Salons van Dijck, Frederik de Merodestraat 33, 2800 Mechelen.

We look forward to meeting you in Mechelen, Belgium!

Wednesday, May 21, 2025 EUFEMED Pre-conference workshop: The most suitable participant for phase 1 clinical trials
12:30 - 13:00	Registration	Mechelen-Centraal
13:00 - 13:15	Welcome and Introduction	Room Alcazar
13:15 - 14:45	The most suitable participant for phase 1 clinical trials - Plenary Session	Room Alcazar
	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, investigator, 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 - Joop Van Gerven, CCMO, The Netherlands 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	Room Scala
15:15 - 16:15	Parallel breakout sessions:
	Who do you consider a healthy volunteer?	Room Begijnenzolder
	What is the population that you would include in phase 1 clinical trials?	Room Herten Aas
	Would you include non-oncology/non-ATMP patients in a First-in-Human trial?	Room Alcazar
16:15 - 16:45	Coffee break	Room Scala
16:45 – 17:30	Feedback from break-out sessions	Room Alcazar

Thursday, May 22, 2025 EUFEMED-HEALIXIA Joint Conference day
8:30 - 9:00	Registration			Mechelen-Centraal
9:00 - 9:15	Welcome and introductions – Jan de Hoon, EUFEMED & Erik Present, Healixia			Auditorium
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			Auditorium
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			Auditorium
10:45 - 11:15	Coffee break			Mechelen-Centraal
11:15 - 12:45	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 Joint Health Technology Assessment (HTA) in Europe: today and tomorrow? – Marc Van de Casteele, RIZIV-INAMI, Belgium Challenges in the development and registration of orphan drugs: a Regulator Perspective - Tim Leest, EMA’s Committee for Orphan Medicinal Products (COMP), Belgium Session chairs: Erik Present, Ingrid Theeuwes			Auditorium
12:45 – 13:45	Lunch			Mechelen-Centraal
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, Independant Researcher, Germany. Session Chair: Tim Hardman		Auditorium
15:15 – 15:45		Coffee break		Mechelen-Centraal
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		Auditorium
		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		Room Alcazar
17:30 - 18:00		Closing Keynote Presentation: Evolving a new framework to optimize drug development – Richard Hargreaves, Bristol Myers Squibb, USA Session chair: Jan de Hoon		Auditorium
19:00 - 22:00		Social Event with dinner at Salons Van Dijck, Mechelen 19:00 - Drinks & apetizers 20:00 - Welcome & Prize for best Poster Presentation 20:10 - Seated dinner with BBQ Buffet
Friday, May 23, 2025 EUFEMED Conference day 2
8:30 - 9:00			Registration	Mechelen-Centraal
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 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 CNS safety biomarkers in humans and their application in early-phase clinical drug development – Geert Jan Groeneveld, CHDR, The Netherlands Session chairs: Rob Zuiker, Erik Mannaert	Auditorium
10:30 – 11:00			Coffee break	Mechelen-centraal
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	Auditorium
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: Cristhyne Leon, Nova in Silico, France For regulator perspective: Flora Musuamba Tshinanu, FAMHP, Belgium Session chairs: Joachim Höchel, Tim Weglewski	Auditorium
13:15 - 13:30			Summary & End of conference – Ingrid Klingmann, EUFEMED	Auditorium
13:30 - 14:00			Farewell lunch	Mechelen-Centraal

Faculty Members	Program Committee	Local organizing committee
Varvara Baroutsou, IFAPP, Greece Keith Berelowitz, PatientRx Ltd, UK François Bompart, INSERM Ethics Committee, France Kerstin Breihaupt-Grögler, independant researcher, Germany Henri Caplain, Consultant, France Kim Denturck, AZ Delta, Belgium Philppe Detilleux, Sanofi, France Jan de Hoon, KU Leuven, Belgium Peter De Jaeger, AZ Delta, Belgium Yves Donazzolo, Eurofins, France Liam Eves, h-Bar consultants, UK Liesbet Geris,VPH Institute, Belgium Elfi Goesaert, VITO, belgium Geert Jan Groeneveld, CHDR, The Netherlands Olivier Harari, Regeneron Genetic Medicines, USA Richard Hargreaves, BMS, USA Joachim Höchel, Bayer, Germany Emmanuel Krupka, Sanofi, France Tim Leest, EMA’s Committee for Orphan Medicinal Products (COMP), Belgium Cristhyne Leon, Nova in Silico, France Thomas Lodeweyckx, SGS, Belgium Flora Musuamba Tshinanu, FAMHP, Belgium Olivier Roux, Sanofi, France Anna Rozova, Chiesi Rare Disease Unit, USA Greet Teuns, Johnson & Johnson, Belgium Hilde Vanaken, TCS, EFGCP, Belgium Philip Van Damme, KU Leuven, Belgium Marc Van de Casteele, RIZIV-INAMI, Belgium Joop Van Gerven, CCMO, The Netherlands Annelies Verbiest, UZA, Belgium Armand Voorschuur, pharma.be, Belgium	Nariné Baririan Sybille Baumann Henri Caplain Elke Debie Jan de Hoon Yves Donazzolo Tim Hardman Joachim Höchel Ingrid Klingmann Emmanuel Krupka Thomas Lodeweyckx Erik Mannaert Erik Present Sarah Tavernier Ingrid Theeuwes Siegfried Vanderbeke Frank Vanderdonck Tim Weglewski Rob Zuiker	Jan de Hoon Ingrid Klingmann Erik Present Sylvie Rottey

Program of the Conference

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

EUFEMED-HEALIXIA Joint Conference day

EUFEMED Conference day 2