Workshop Programme
for period 16 Aug 2011
Pharmaceutical Day
16 Aug 2011
Timetable
| Tuesday 16 August |
| 09:25-09:30 |
Welcome from Dragalin, V & INI Director Designate |
DAE |
| Chair: Vlad Dragalin |
| Session: Dose ranging: Methodology |
| 09:30-10:00 |
Dragalin, V (Aptiv Solutions, USA) |
DAE |
| |
Adaptive Dose-Ranging Designs with Two Efficacy Endpoints | Sem 1 |
| Chair: Vlad Dragalin |
| 10:00-10:30 |
Pronzato, L (CNRS) |
DAE |
| |
Penalized optimal design for dose finding | Sem 1 |
| 10:30-11:00 |
Jennison, C (Bath) |
DAE |
| |
Jointly optimal design of Phase II and Phase III clinical trials: an over-arching approach | Sem 1 |
| 11:00-11:30 |
Morning coffee |
DAE |
| 11:00-12:30 |
DAE informal discussion |
DAE |
| 11:30-12:00 |
Wang, S-J (FDA) |
DAE |
| |
Utility and pitfals of dose ranging trials with multiple study objectives: fixed or adaptive | Sem 1 |
| Session: Dose ranging: Industry challenges |
| 12:00-12:30 |
Pinheiro, J (Johnson & Johnson) |
DAE |
| |
Improving dose-finding methods in clinical development: design, adaptation, and modeling | Sem 1 |
| 12:30-14:00 |
Lunch Break |
DAE |
| 14:00-14:30 |
Bretz, F (Novartis) |
DAE |
| |
Response-adaptive dose-finding under model uncertainty | Sem 1 |
| Chair: Vlad Dragalin |
| Session: Dose ranging: Applications |
| 14:30-15:00 |
Thygesen, H (Lancaster) |
DAE |
| |
Dose Escalation using a Bayesian Model: rational decision rules. | Sem 1 |
| 15:00-15:30 |
Neuenschwander, B (Novartis Pharma AG) |
DAE |
| |
Bayesian approaches to Phase I clinical trials: methodological and practical aspects | Sem 1 |
| 15:30-16:00 |
Leonov, S (GlaxoSmithKline) |
DAE |
| |
Application of model-based designs in drug development | Sem 1 |
| Session: Panel Discussion |
| 16:45-18:00 |
Krams, M (Johnson & Johnson) |
DAE |
| |
Design of Experiments in Healthcare, dose-ranging studies, astrophysics and other dangerous things | Sem 1 |