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Timetable (OFB024)

Design of Experiments in Drug Development

Thursday 9th July 2015

Thursday 9th July 2015
10:00 to 10:15 J Toland (Isaac Newton Institute)
Welcome and Introduction
Session: Design of Experiments in Drug Development
INI 1
10:15 to 10:45 V Dragalin ([Janssen Pharmaceutical Companies])
Design of Experiments for IMI2 Strategic Research Agenda "The Right Prevention and Treatment for the Right Patient at The Right Time"
Session: Design of Experiments in Drug Development
INI 1
10:45 to 11:15 IDeAL (Integrated DEsign and AnaLysis of small population group trials) - a Collaborative Approach between Industry and Academia
Session: Design of Experiments in Drug Development
INI 1
11:15 to 11:30 Tea & Coffee
Session: Design of Experiments in Drug Development
11:30 to 12:00 Accounting for Parameter Uncertainty in Two-Stage Designs for Phase II Dose-Response Studies
Session: Design of Experiments in Drug Development
INI 1
12:00 to 12:30 Adaptive Dose Finding Designs in the Presence Of Model Uncertainty
Session: Design of Experiments in Drug Development
INI 1
12:30 to 13:00 Confirmatory Testing for a Beneficial Treatment Effect in Dose-Response Studies using MCP-Mod and an Adaptive Interim Analysis
Session: Design of Experiments in Drug Development
INI 1
13:00 to 13:45 Lunch & Networking
Session: Design of Experiments in Drug Development
13:45 to 14:15 Bayesian Adaptive Randomisation Revisited
Session: Design of Experiments in Drug Development
INI 1
14:15 to 14:45 Y Tymofyeyev ([Janssen Pharmaceutical Companies])
Brick Tunnel Randomization, Overcoming Inconvenient Allocation Ratio
Session: Design of Experiments in Drug Development
INI 1
14:45 to 15:15 Optimal Design of Clinical Trials with Censoring Driven by Random Enrollment
Session: Design of Experiments in Drug Development
INI 1
15:15 to 15:30 Tea & Coffee
15:30 to 16:00 Sequential Parallel Comparison Design for Trials with High Placebo Response: Overview and Case Studies
Session: Design of Experiments in Drug Development
INI 1
16:00 to 16:15 Regulatory Aspects of Adaptive Clinical Trial Designs: Perspectives from Scientific Advice to Marketing Authorisation Applications (Part 1)
Session: Design of Experiments in Drug Development
INI 1
16:15 to 16:30 Regulatory Aspects of Adaptive Clinical Trial Designs: Perspectives from Scientific Advice to Marketing Authorisation Applications (Part 2)
Session: Design of Experiments in Drug Development
INI 1
16:30 to 17:00 Open Discussion & Questions
Session: Design of Experiments in Drug Development
Chair: Vlad Dragalin
INI 1
University of Cambridge Research Councils UK
    Clay Mathematics Institute London Mathematical Society NM Rothschild and Sons