Mastering increasing complexity in developing innovative therapies
Schedule of the conference
| Day 1, Wednesday, May 21 | |
| 13:00 - 13:15 | Pre-conference workshop: The most suitable person for phase 1 clinical trials - Welcome and Introduction |
| 13:15 - 15:00 | Pre-conference workshop: The most suitable person for phase 1 clinical trials - 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 FIH trials? | |
| 15:00 - 15:30 | Coffee break |
| 15:30 - 16:30 | Parallel breakout sessions on the above topics |
| 16:30 - 17:00 | Coffee break |
| 17:00 - 18:00 | Feedback from break-out sessions |
| Day 2, Thursday, May 22 | |
| 9:00 - 9:15 | Welcome and introductions |
| 9:15 - 9:45 | Key Note - Genetic medicines: setting the scene for treatments of the future by Olivier Harari, Vice President at Regeneron Genetic Medicines, Tarrytown, NY, 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 | |
| -- Challenges faced by the investigator: focus on the treatment of ALS as a rare disease - Philip Van Damme, Belgium | |
| -- The patient’s perspective as participant in a First-in-Human clinical trial | |
| 10:45 - 11:15 | Coffee break |
| 11:15 - 12:45 | Medicines Development for rare diseases - challenges in regulation and reimbursement |
| -- Joint HTA (Health Technology Assessment) in Europe: today and tomorrow? – Marc Van de Casteele, RIZIV-INAMI | |
| -- Perspective of future marketing authorization holders | |
| -- Perspective or regulators | |
| 12:45 - 14:00 | Lunch |
| 14:00 - 15:30 | Oxford Debate - Diversity YES, but in Phase I? |
| 15:30 - 16:00 | Coffee break |
| 16:00 - 17:30 | Recent developments in ethical conduct of clinical trials |
| Real World Data in Belgium: will Phase IV studies become obsolete? | |
| 17:30 - 18:00 | Key Note |
| 19:00 - 22:00 | Conference Dinner at Salons Van Dijck, Mechelen |
| Day 3, Friday, May 23 | |
| 9:00 - 10:15 | Update on safety biomarkers in early clinical development |
| -- Interest and use of emerging safety biomarkers in the drug development | |
| -- Kidney safety biomarkers in human and approach to interpret emerging exploratory biomarkers | |
| -- CNS safety biomarkers in human and approach to interpret emerging exploratory biomarkers | |
| 10:15 - 10:45 | Coffee break |
| 10:45 - 11:30 | Oral presentation of the 3 best posters |
| 11:30 - 13:00 | AI in early clinical drug development |
| 13:00 - 13:15 | Summary & End of conference |
| 13:15 - 14:00 | Farewell lunch |
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From 16:00 to 17:30
Recent developments in ethical conduct of clinical trials
- Impact of the new versions of the Declaration of Helsinki, ICH-GCP and WHO guidelines for our future performance of clinical trials – Speaker TBC.
- The VolREthics Initiative – What will it change? - Speaker TBC
- The eConsent Initiative – A fit for purpose Study Framework - Hilde Vanaken, TCS, EFGCP, Belgium
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From 16:00 to 17:30
Real World Data in Belgium: will Phase IV studies become obsolete?
- Secondary use of data as a source of Real World Data/Evidence – Dr. Annelies Verbiest, UZA
- The FHIN Network: transform healthcare with data
- The We Are Platform: a sustainable civil-scientific ecosystem for personal health data - Elfi Goesaert, VITO