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Workshop Programme

for period 16 Aug 2011

Pharmaceutical Day

16 Aug 2011


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
Other Seminars
Seminars in the University
National and International Scientific Research Meetings

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