08.30-09.00
Welcome coffee/tea
Morning Sessions
09.00-09.10
Welcome from the Club Phase 1 President
09.10-09.50
From biomarkers for patient selection to companion
diagnostic in drug development
Gérard Sanderink, Sanofi, France
09.50-10.30
Advances in ECG safety: Phase 1 studies supporting TQT
waivers
Pierre Maison-Blanche, Bichat University Hospital, APHP,
France
10.30-11.00
Break
11.00-11.40
Metabolite profiling in early clinical drug development:
Current status and future prospects
Mike Ufer, Idorsia Pharmaceuticals Ltd, Switzerland
11.40-12.30
PIPs’ experience after 10 years: Inclusion of the paediatric
development early is necessary when requested by regulation
Sylvie Benchetrit, French referent to the EMA PDCO, France
12.30-14.00
Lunch
Afternoon Sessions
14.00-14.30
Activity-based protein profiling reveals off-target proteins of
the FAAH inhibitor BIA 10-2474
Pr. Mario Van Der Stelt, Leiden University, The Netherlands
14.30-15.00
In silico tools for early phase side effect profiling and off
target prediction of potential drug candidates
Pr. Thierry Langer, Prestwick Chemical referent, Vienna
University, Austria
15.00-15.20
Panel discussion with Pr. Van Der Stelt, Pr. Thierry Langer and
the audience
15.20-15.50
Break
15.50-16.30
CAR T-cell: Engineering immune cells to treat cancer
Roman Galetto, Cellectis SA, France
16.30-17.10
Central Nervous System biomarkers with a special focus on
electrophysiology
Alain Patat, Biotrial, France
17.10-17.30
Conclusions and presentation of the next events of the Club
Phase 1
