9th Annual Biomarkers Congress
Second Annual Putting Theory into Practice: Adaptive Clinical Trial Designs (Oct 16-17
Renaissance Toronto Hotel
1 Blue Jays Way
Toronto, Ontario
Cambridge Healthtech Institute
Second Annual Putting Theory Practice: Adaptive Clinical Trial Designs 

Schedule of Presentations:

Tuesday, October 16, 2007
11:30:00 Registration (11:30 - 12:30)
12:00:00 Luncheon Workshop or Lunch on your own (12:00 - 13:45)
13:45:00 SESSION I: LAYING THE GROUND WORK FOR EARLY DECISION MAKING (13:45 - 19:00) Jerald S. Schindler, Michelle J. Ballard, Jose Pinheiro, Tom Parke, Alastair Glass, Judith A. Quinlan, Graeme E. Archer, Weichung Joe Shih, Sumithra J. Mandrekar
13:45:00 SESSION I: Welcome to Toronto (13:45 - 13:50) Alastair Glass
13:50:00 SESSION I: Co-Chairperson’s Opening Remarks (13:50 - 14:00) Jerald S. Schindler
14:00:00 SESSION I: Setting the Stage for Adaptive Design Trials (14:00 - 14:30) Judith A. Quinlan
14:30:00 SESSION I: How Wyeth is Transforming R&D - The Learn and Confirm Model of Clinical Development (14:30 - 15:00) Michelle J. Ballard
15:00:00 SESSION I: The Use of Bayesian Methods in Go/No-Go Decision Making (15:00 - 15:30) Graeme E. Archer
15:30:00 SESSION I: Exhibit Viewing, Networking and Refreshment Break (15:30 - 16:00)
16:00:00 SESSION I: Evaluating Adaptive Dose-Ranging Studies: Conclusions and Recommendations from the PhRMA Working Group (16:00 - 16:30) Jose Pinheiro
16:30:00 SESSION I: Using Perturbed Unblinding for Sample Size Reassessment in Clinical Trials (16:30 - 17:00) Weichung Joe Shih
16:30:00 SESSION I: Adaptive Clinical Trials – Making Them Happen (16:30 - 17:00) Tom Parke
17:00:00 SESSION I: Adaptive Dose-finding Designs for Oncology Single and Dual Agent Combinations Using Accumulated Data from all Patients (17:00 - 17:30) Sumithra J. Mandrekar
17:30:00 SESSION I: Panel Discussion with Speakers (17:30 - 18:00)
18:00:00 SESSION I: Net Working Reception (18:00 - 19:00)
19:00:00 Close of Day 1
Wednesday, October 17, 2007
08:30:00 SESSION II: REGULATORY PERSPECTIVES AND LESSONS LEARNED FROM CONDUCTING STUDIES WITH ADAPTIVE TRIAL DESIGNS (08:30-11:15) Judith A. Quinlan, Jerald S. Schindler, Kathy Reinold, Dietlind Gardell, Tom Parke
08:30:00 SESSION II: Co-Chairperson’s Opening Remarks (08:30-08:45) Judith A. Quinlan
08:45:00 SESSION II: Regulatory Perspectives in Adaptive Trial Design (08:45-09:15) Dietlind Gardell
09:15:00 SESSION II: FDA's Perspective on Adaptive Trial Designs (09:15-09:45) Jerald S. Schindler
09:45:00 SESSION II: Adaptive Clinical Trials – Making Them Happen (09:45-10:00) Tom Parke
10:00:00 SESSION II: Exhibit Viewing, Networking and Refreshment Break (10:00-10:45)
10:45:00 SESSION II: Implementing Adaptive Clinical Trials - Tools of the Trade (10:45-11:00)
11:00:00 SESSION II: Technology Spotlight (11:00-11:15)
11:15:00 CASE STUDIES (11:15-14:45) Edie Owens, Evan Tzanis, Xiaoyin Frank Fran, Khaled El Emam, Judith A. Quinlan, Micheline Marshall
11:15:00 CASE STUDY: Operational Planning and Implementation with a Cardiovascular Trial Using an Adaptive Trial Design (11:15-11:45)
11:45:00 CASE STUDY: Luncheon Technology Workshop Adaptive EDC: Critical Steps for Managing Adaptive Trials (11:45-13:15) CASE STUDY Khaled El Emam
12:00:00 New Presentation Edie Owens
13:45:00 CASE STUDY: Acute Migraine POC Using CRM - The Power of Team Work and a Can Do Attitude... Overcoming Logistical and Operational Hurdles (13:45-14:15) CASE STUDY Judith A. Quinlan
14:15:00 Networking Refreshment Break (14:15-14:45)
14:45:00 CASE STUDY: Phase II Opioid Induced Constipation Dosing Study (14:45-15:15) CASE STUDY Evan Tzanis
15:15:00 CASE STUDY: Planning and Supplying Drug for Clinical Studies Using Flexible Designs(15:15-15:45) CASE STUDY Micheline Marshall
15:45:00 CASE STUDY: A Phase 2b Adaptive Dose-Finding Trial of a Novel Compound to Treat Acute Migraines (15:45-16:15) CASE STUDY Xiaoyin Frank Fran
16:15:00 Panel Discussion with Speakers (16:15-16:45)
16:45:00 Close of Putting Theory into Practice: Adaptive Clinical Trial Designs Conference
4th Annual Pharma R&D Asia Congress
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