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409 Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Complex Innovative Approaches in Emerging Neurodegenerative / Neuroimaging Drug Developments — Topic Contributed Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Section on Statistics in Imaging
Organizer(s): Tristan Massie, FDA
Chair(s): Sue-Jane Wang, FDA
1:05 PM A ROC Surface Methodology in Diagnosing Early Stage Neurodegenerative Diseases for Early Interventions
Chengjie Xiong, Washington University in St Louis; Jingqin Luo, Washington University in St. Louis
1:25 PM Alternatives to MMRM for Preclinical Alzheimer’s Clinical Trials
Michael C Donohue, University of Southern California; Gopalan Sethuraman, University of Southern California; Oliver Langford, University of Southern California; Wenyi Lin, University of California, San Diego; Philip S Insel, Lund University; Wesley Thompson, University of California, San Diego; Rema C Raman, University of Southern California; Reisa Sperling, Harvard Medical School; Paul S Aisen, University of Southern California
1:45 PM Comparative Performance of Some Testing Approaches in Two-Arm Studies with Count Data Potentially Highly Skewed
Sue-Jane Wang, FDA; Zhipeng Huang, U.S. Food and Drug Administration (Intern); Hai Zhu, The University of Texas Health Science Center at Houston
2:05 PM Statistical Issues and Challenges Seen in Drug Development for Neurodegenerative Diseases
Tristan Massie, FDA
2:25 PM Floor Discussion