Accelerating Anticancer Agent Development and Validation Workshop
The Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
Bathesda, Maryland 20852
Accelerating Anticancer Agent Development and Validation Workshop
The Bethesda North Marriott Hotel and Conference Center

Schedule of Presentations:

Wednesday, June 18, 2008
07:30:00 Registration/Continental Breakfast
08:00:00 Introduction H Kim Lyerly
08:05:00 Panel Discussion: Obstacles to Development--Ten Barriers to Proving Agents are Effective and Safe Joseph Gootenberg, Kim H Lyerly, Richard B GAYNOR, Musa Mayer, Richard L Schilsky
08:40:00 Drug Discovery Jerry Collins
08:55:00 FDA Drug INDs Haleh Saber
09:00:00 Faculty Alex A Adjei, H Kim Lyerly, Allen Lichter, J. A. Zwiebel, James Doroshow, Musa Mayer, Margaret Foti, Richard Pazdur, Ramzi Dagher, Renzo Canetta, William N Hait, James Symanowski, Jorge Gomez, Ashok Batra, Jerry Collins, Neil Spector, Raj K. Puri, Giuseppe Giaccone
09:10:00 FDA Biologics INDs Andrew McDougal
09:25:00 Panel Discussion Jerry Collins, Andrew McDougal, Laura Andrews, Haleh Saber, S. Leigh Verbois
10:10:00 Break
10:30:00 Proof of Concept to Pre-Clinical Scientist George Daniel Demetri
10:45:00 Proof of Concept to the Clinical Investigator: What are Meaningful Endpoints in Early Stage Development Neil Spector
11:00:00 Proof of Concept to the Drug Developer David P Schenkein
11:15:00 Panel Discussion David P Schenkein, Neil Spector
12:00:00 Challenges in Oncology Rajeshwari Sridhara
12:00:00 New Presentation
12:00:00 Lunch
13:00:00 Endpoints and Types of Approvals Bhupinder Mann
13:45:00 Panel Discussion Jeffrey S Abrams, Peter Bross, David P Schenkein
14:30:00 Break
14:45:00 Case Study Discussion Groups #1
18:00:00 Cocktail Reception
18:30:00 Dinner
19:15:00 Dinner Panel: "Major Oncology Topics in the Press" Gardiner Harris, Paul Goldberg, Richard Pazdur
Thursday, June 19, 2008
08:00:00 Meet the Experts Breakfast
08:45:00 Clinical Pharmacology/QT Julie Bullock
09:00:00 Safety Reporting/Risk Management J Chang
09:15:00 Pediatrics Susan Cummins
09:30:00 Peri- and Post-marketing Studies Panel Discussion J Chang, Malcom Smith, Robert DeLap, Julie Bullock, Susan Cummins
10:15:00 Break
10:30:00 The Right Drug for the Right Patient: The Role of Biomarkers in Patient Selection Sarah Bacus
10:45:00 Pharmacogenomics Atiq Rahman
11:00:00 Imaging as a Biomarker
11:15:00 Biomarkers Panel Discussion Robert S. Becker, Sarah Bacus, Atiq Rahman
12:00:00 Meet the Experts Lunch
12:00:00 New Presentation
13:00:00 Statistical Considerations in Phase I Studies James Symanowski
13:15:00 Improved Phase I Design Issues/Phase I Studies in Healthy Volunteers
13:30:00 Harmonization of International Standards for Oncology Products Daniel Lapadula
13:45:00 Panel Discussion Gary Clark, Daniel Lapadula, James Zweibel, James Symanowski
14:30:00 Drug Registration Strategies Richard B Gaynor, Richard Pazdur
14:30:00 Preclinical Issues John Leighton
14:30:00 Phase II Endpoints Virginia Kwitkowski
14:30:00 Cancer Vaccines and Immunotherapy H Kim Lyerly, Raj K. Puri
16:00:00 An Investor's View of Drug Development Tony Fiorino
16:15:00 Decision-Making in Oncology Drug Development Stephen H Friend
16:30:00 Advocacy and Drug Development for Special Populations/Diseases Diana Rowden
16:45:00 Panel Discussion Tony Fiorino, Diana Rowden, Stephen H Friend
17:30:00 Adjourn (dinner on your own)
Friday, June 20, 2008
07:30:00 Continental Breakfast
08:00:00 Case Study Discussion Groups #2 (repeat of Day 1)
10:45:00 Break
11:00:00 Panelists Richard Pazdur, Renzo Canetta, Mark Gorman, Frank Calzone
12:00:00 Closed Session: Faculty Discussion and Course Evaluation
3D Tissue Models
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