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