Biotech China 2014
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 Richard L Schilsky, Musa Mayer, Richard B GAYNOR, Kim H Lyerly, Joseph Gootenberg
08:40:00 Drug Discovery Jerry Collins
08:55:00 FDA Drug INDs Haleh Saber
09:00:00 Faculty Giuseppe Giaccone, Raj K. Puri, Neil Spector, Jerry Collins, Ashok Batra, Jorge Gomez, James Symanowski, William N Hait, Renzo Canetta, Ramzi Dagher, Richard Pazdur, Margaret Foti, Musa Mayer, James Doroshow, J. A. Zwiebel, Allen Lichter, H Kim Lyerly, Alex A Adjei
09:10:00 FDA Biologics INDs Andrew McDougal
09:25:00 Panel Discussion S. Leigh Verbois, Haleh Saber, Laura Andrews, Andrew McDougal, Jerry Collins
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 Neil Spector, David P Schenkein
12:00:00 Lunch
12:00:00 New Presentation
12:00:00 Challenges in Oncology Rajeshwari Sridhara
13:00:00 Endpoints and Types of Approvals Bhupinder Mann
13:45:00 Panel Discussion David P Schenkein, Peter Bross, Jeffrey S Abrams
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" Richard Pazdur, Paul Goldberg, Gardiner Harris
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 Susan Cummins, Julie Bullock, Robert DeLap, Malcom Smith, J Chang
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 Atiq Rahman, Sarah Bacus, Robert S. Becker
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 James Symanowski, James Zweibel, Daniel Lapadula, Gary Clark
14:30:00 Phase II Endpoints Virginia Kwitkowski
14:30:00 Preclinical Issues John Leighton
14:30:00 Cancer Vaccines and Immunotherapy Raj K. Puri, H Kim Lyerly
14:30:00 Drug Registration Strategies Richard Pazdur, Richard B Gaynor
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 Stephen H Friend, Diana Rowden, Tony Fiorino
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 Frank Calzone, Mark Gorman, Renzo Canetta, Richard Pazdur
12:00:00 Closed Session: Faculty Discussion and Course Evaluation
4th Annual Pharma R&D Asia Congress
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