DAY 1 - Wednesday, July 22
OPEN MEETING

8:00 am   Hot American Breakfast

8:30 am   Welcome and Opening Remarks
                 John Mendelsohn (Committee Chair)

8:45 am   Panel Discussion 1:  Case studies of developing diagnostic-therapeutic combinations
                 Moderator: Hal Moses
                 Case A: I-Spy 2 trial
                 Anna D. Barker, Deputy Director, National Cancer Institute
                 Laura J. Esserman, UCSF Comprehensive Cancer Center
                 Donald Berry, M. D. Anderson Cancer Center
                 Daniel J. Sargent, Mayo Clinic Comprehensive Cancer Center
                 Elizabeth Mansfield, OIVD, CDRH

10:00 am   Case B: KRAS testing and therapeutic decision-making
                 Carmen J. Allegra, University of Florida-Gainesville
                 Daniel J. Sargent, Mayo Clinic Comprehensive Cancer Center
                 Robert Becker, Chief Medical Officer, OIVD, CDRH

10:45 am   Break

11:00am   Panel Discussion 2:  Case studies of testing therapeutic combinations
                 Moderator: Michael Carducci

                 Bristol-Meyers-Squibb Experience
                 Renzo Canetta, Vice President, Oncology Global Clinical Research

                 Genentech Experience 
                 Stuart Lutzker, Vice President BioOncology Exploratory Clinical Development, Genentech

                 Discussant:  Robert Justice, Director of the Division of Drug Oncology Products, CDER
                 Patricia Keegan, Director of the Division of Biologic Oncology Products, CDER
 

12:15 pm   Lunch

1:00 pm   Panel Discussion 3:  FDA perspective on cooperative group trials and oversight of oncology products
                 Moderator: Richard Schilsky
                 Janet Woodcock, Director, CDER
                 Richard Pazdur, Director, Office of Oncology Drug Products, CDER 
                 Robert Justice, Director of the Division of Drug Oncology Products, CDER
                 Patricia Keegan, Director of the Division of Biologic Oncology Products, CDER
                 Greg Campbell, Director, Division of Biostatistics, CDRH
                 Robert Becker, Chief Medical Officer, OIVD, CDRH
                 Elizabeth Mansfield, OIVD, CDRH
                 Peter Bross, Medical Review Officer, CBER

2:30 pm   Panel Discussion 4: OHRP and NCI oversight of cancer clinical trials
                 Moderator: Stephen Grubbs
                 Michael Carome, Director for Regulatory Affairs, OHRP
                 James Doroshow, Director, Division of Cancer Treatment and Diagnosis, NCI

3:30 pm   Break

3:45 pm   COMMITTEE DISCUSSION

4:45 pm   Wrap up – summary of Day 1
                 John Mendelsohn

5:00 pm   Adjourn Day 1

DAY 2 - Thursday, July 23

CLOSED MEETING

8:00 am   COMMITTEE DISCUSSION (Closed Meeting)

3:00 pm   Adjourn Day 2