Mastering increasing complexity in developing innovative therapies
Schedule of the conference
| Day 1, Wednesday, May 21 | |
| 13:00 - 13:15 | EUFEMED PRE-CONFERENCE WORKSHOP: THE MOST SUITABLE PERSON FOR PHASE 1 CLINICAL TRIALS - Welcome and Introduction |
| 13:15 - 15:15 | Plenary Session |
| How did the healthy volunteer evolve over the last 10 years? | |
| Which populations should be included in phase 1 clinical trials? Sponsor, regulator and ethics committee perspectives. | |
| What is the place of patients in First-In-Human trials? | |
| 15:15 - 15:45 | Coffee break |
| 15:45 - 16:45 | Parallel breakout sessions on the above topics |
| 16:45 - 17:00 | Coffee break |
| 17:00 - 18:00 | Feedback from break-out sessions |
| Day 2, Thursday, May 22 | |
| 9:00 - 9:15 | EUFEMED-HEALIXIA JOINT CONFERENCE DAY: Welcome and introductions |
| 9:15 - 9:45 | Keynote Presentation - Genetic medicines: setting the scene for treatments of the future by Olivier Harari, Regeneron Genetic Medicines, USA |
| 9:45 - 10:45 | Medicines Development for rare diseases: challenges in early and late clinical development |
| -- Challenges faced by the sponsor: lessons learned and hurdles to overcome (Speaker invited) | |
| -- 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 (Speaker invited) | |
| 10:45 - 11:15 | Coffee break |
| 11:15 - 12:45 | Medicines Development for rare diseases - challenges in regulation and reimbursement |
| -- Joint Health Technology Assessment (HTA) in Europe: today and tomorrow? – Marc Van de Casteele, RIZIV-INAMI, Belgium | |
| -- Perspective of future marketing authorization holders (Speaker invited) | |
| -- Perspective or regulators (Speaker invited) | |
| 12:45 - 13:45 | Lunch |
| 13:45 - 15:15 | Oxford Debate - Diversity YES, but in Phase I? - With Keith Berelowitz, PatientRx Ltd, UK and Henri Caplain, Consultant, France |
| 15:15 - 15:45 | Coffee break |
| 15:45 - 17:15 | Parallel session A: The new ethical framework |
| Parallel session B: Real World Data in Belgium: will Phase IV studies become obsolete? | |
| 17:30 - 18:00 | Closing Keynote Presentation: Evolving a new framework to optimize drug development by Richard Hargreaves, Bristel Myers Squibb, USA |
| 19:00 - 22:00 | Social Event with dinner at Salons Van Dijck, Mechelen |
| Day 3, Friday, May 23 | |
| 9:00 - 9:05 | EUFEMED CONFERENCE DAY 2: Welcome & introductions |
| 9:05 - 10:15 | Update on safety biomarkers in early clinical development |
| -- Interest and use of emerging safety biomarkers in the drug development by Philippe Detilleux, Sanofi, France | |
| -- Kidney safety biomarkers in human and approach to interpret emerging exploratory biomarkers by Emmanuel Krupka & Olivier Roux, Sanofi, France | |
| -- CNS safety biomarkers in human and approach to interpret emerging exploratory biomarkers (Speaker invited) | |
| 10:15 - 10:45 | Coffee break |
| 10:45 - 11:30 | Research in the spotlight: Poster pitches of selected abstracts and Audience Voting for best presentation award |
| 11:30 - 13:00 | Artificial Intelligence in Clinical Development: Buzzword, vision, or reality? (Speakers invited) |
| 13:00 - 13:15 | Summary & End of conference |
| 13:15 - 14:00 | Farewell lunch |
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From 15:45 to 17:15
Parallel session A: The new ethical framework
- Impact of the new versions of the Declaration of Helsinki, ICH-GCP and WHO guidelines for our future performance of clinical trials - Barbara Baroutsou, IFAPP, Greece
- The VolREthics Initiative – What will it change? - François Bompart, INSERM Ethics Committee, France
- The eConsent Initiative – What It Is, What It Isn’t, and Tools to Implement eConsent - Hilde Vanaken, TCS, EFGCP, Belgium
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From 15:45 to 17:15
Parallel session B: Real World Data in Belgium: will Phase IV studies become obsolete?
- Secondary use of data as a source of Real World Data/Evidence – Annelies Verbiest, UZA, Belgium
- The Federated Health Innovation Network (FHIN): transform healthcare with data (Speaker invited)
- The We Are Platform: a sustainable civil-scientific ecosystem for personal health data - Elfi Goesaert, VITO, Belgium