5th Annual FDA/DIA Statistics Forum
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road North Bethesda, MD 20852
Bethesda, Maryland
   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
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
3D Tissue Models
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