Agenda at a Glance

Monday, April 26, 2010
8:30	Registration and Morning Coffee
9:00	Chairperson’s Welcome
9:15	Solutions Summit Meet & Greet
9:30	In Search of a Better Decision Criterion in Phase II Randomized Oncology Trials Morning Session Leaders Jane Fridlyand, Biostatistics, GENENTECH Ionel Mitrica, Director, Clinical Development, GLAXOSMITHKLINE
10:30	30-Minute Morning Networking Break
11:00	In Search of a Better Decision Criterion in Phase II Randomized Oncology Trials – Session Resumes
12:00	Expert Exchange Luncheon
1:15	The ABC’s of Designing and Conducting an Adaptive Trial Afternoon Session Leader Scott Berry, Ph.D., President and Senior Statistical Scientist, BERRY CONSULTANTS
3:00	30-Minute Afternoon Networking Break
3:30	Cutpoint Determination for a Continuous Valued Diagnostic Test and Implications for Drug Development Howard Mackey, Senior Statistical Scientist, Clinical Biostatistics, GENENTECH
4:15	TARGET Solutions Summit Discussion
4:45	Day One Deep Dive Rehash
5:15	Day 1 concludes

Tuesday, April 27, 2010
8:00	Morning Coffee
8:30	Chairperson’s Recap of Day One
8:35	Case Study Practical Considerations in Successful Implementation of Exploratory Imaging in Early Phase Trials Haren Rupani, M.D, Global Head, Oncology Clinical Imaging, NOVARTIS
9:00	Case Study Challenges, Solutions, and Lessons Learned for Utilizing Independent Review of Scans as a PFS Endpoint Suman Bhattacharya, PhD, Senior Scientist, Bio-Oncology, GENENTECH
9:30	Case Study Overcoming Issues When Utilizing Independent Review of Scans in Oncology Trials Ionel Mitrica, Director, Clinical Development, GLAXOSMITHKLINE
10:00	TARGET Solutions Summit Discussion
10:30	15-Minute Morning Networking Break
10:45	INTERACTIVE ROUND TABLE DISCUSSIONS Table 1 Protocol Design Strategies & Patient Recruitment Considerations Table 2 Predictive Modeling & Early Phase Designs Table 3 Insights to RECIST v 1.1 vs. Alternative Measurement Standards
11:30	Day Two Deep Dive Rehash
12:00	Conference Concludes