3D Tissue Models
Adaptive Designs in Clinical Drug Development
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Schedule of Presentations:

Wednesday, February 2, 2011
08:30:00 Registration and coffee
09:00:00 Chairman's opening remarks
09:10:00 Implementing an adaptive design: the investigative site perspective Pierre Gervais
09:50:00 Adaptive design and operational impact Melissa Mitchener
10:30:00 Morning coffee
11:00:00 Co-ordination and trial planning: maximising the benefits of an adaptive design through effective management Catarina Mattsson
11:40:00 The question of ethics Jack Corman
12:20:00 Networking lunch
13:50:00 Developing internal regulatory guidance for adaptive trials Jennifer Dudinak
14:30:00 A perspective on the draft FDA adaptive designs guidance Marc Vandemeulebroecke
15:10:00 Afternoon tea
15:40:00 Statistical inference after an adaptive trial Chris Jennison
16:20:00 Detecting real treatment effects - an example from oncology Pavel Pisa
17:00:00 Chairman’s closing remarks and close of day one
Thursday, February 3, 2011
08:30:00 Re-registration and coffee
09:00:00 Chairman's opening remarks Marc Vandemeulebroecke
09:50:00 Majesty and misery of interim dose selection Eric Derobert, Fanny Windenberger
10:30:00 Morning coffee
11:00:00 Developing a simulation plan and simulation report David Manner
11:40:00 Get the dose right
12:20:00 Networking lunch
13:50:00 Group sequential tests for delayed response: a case study Lisa Hampson
14:30:00 Case study: combined phase I/PoC study with adaptive dose selection Paul Jordan, Annette Sauter
15:10:00 Afternoon tea
15:40:00 The use of efficient trial design in Phase II to choose the right dose in Phase III Alun Bedding
16:20:00 Case study: an adaptive design in oncology
17:00:00 Chairman’s closing remarks and close of conference
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