Biotech China 2014
5th Annual FDA/DIA Statistics Forum
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road North Bethesda, MD 20852
Bethesda, Maryland
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=24168&eventType=Meeting
   An Open Forum to Discuss Important Statistical
   Issues Associated with the Development and Review of Therapeutic Drugs
   and Biologics

   Event Code 11008

Schedule of Presentations:

Monday, April 11, 2011
08:45:00 WELCOME AND OPENING REMARKS Stephen E. Wilson , Barry H. Schwab
09:00:00 KEYNOTE ADDRESSES Robert T. O'Neill, Jesse L. Goodman, Nancy L Geller
11:00:00 SESSION 1 | Report from the NAS Panel on Missing Data | Overview and Recommendations Dionne Price , David Ohlssen
11:15:00 Session Description Roderick J Little, Thomas J. Permutt , Jay P. Siegel
13:30:00 SESSION 2 | Feedback and Comments on the NAS Missing Data Panel Report | Regulatory and Industry Views Gouxing Soon , Camille Logue Orman
14:00:00 Session Description Karen Higgins , David J. Wright , James Henry Roger, Douglas C. Throckmorton
15:30:00 SESSION 3 | Panel Discussion on the NAS Missing Data Panel Report Joan K Buenconsejo, Jose C. Pinheiro
16:00:00 Session Description Karen Higgins , Michael Kenward, Roderick J Little, Thomas J. Permutt , James Henry Roger, Jay P. Siegel, Douglas C. Throckmorton, David J. Wright
Tuesday, April 12, 2011
08:30:00 SESSION 4 | Bayesian Applications in the Device Industry, CDRH Guidance, and Bayesian Approaches Telba Irony
09:00:00 Session Description Gregory Campbell , Telba Irony, Nitin R Patel
10:30:00 SESSION 5 | Bayesian Applications in the Pharmaceutical and Biotech Industries Ram Tiwari
11:00:00 Session Description Beat Neuenschwander, James Stamey, Ram Tiwari
12:00:00 LUNCH AND AWARD CEREMONY Greg Enas
13:15:00 SESSION 6 | Bayesian Applications: Panel Discussion Ram Tiwari
14:00:00 Session Description Gregory Campbell , Telba Irony, Beat Neuenschwander, Robert T. O'Neill, Nitin R Patel, James Stamey, Ram Tiwari
15:00:00 SESSION 7 | Data Monitoring Committee Experiences in Multi-Regional Clinical Trials Bruce Binkowitz, Sue-Jane Wang
16:00:00 Session Description Janet Wittes, Jay Herson
Wednesday, April 13, 2011
08:30:00 SESSION 8 | Meta-Analysis | Efficacy and Safety Jerald S. Schindler, Aloka Chakravarty
09:30:00 Session Description George Rochester, Sanjib Basu, Scott H Korn
10:30:00 SESSION 9 | Risk and Benefit Assessment Approaches Baruch Fischhoff , Christy Chuang-Stein , Ralph B. D'Agostino
13:00:00 SESSION 10 | Clinical Case Studies
14:30:00 SESSION 11 | Panel and Floor Discussion Ralph B. D'Agostino, Baruch Fischhoff , Robert T. O'Neill, Christy Chuang-Stein
4th Annual Pharma R&D Asia Congress
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