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100 * !
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Mon, 8/3/2020,
1:00 PM -
2:50 PM
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Virtual
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Statistical Innovations for Drug Approval and Reimbursement for Rare Disease — Invited Papers
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International Indian Statistical Association, Biopharmaceutical Section, Health Policy Statistics Section
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Organizer(s): Amit Bhattacharyya, Alexion Pharmaceuticals
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Chair(s): Amit Bhattacharyya, Alexion Pharmaceuticals
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1:05 PM
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On Analysis of Single Arm Trial with Natural History Controls
Qing Liu, Quantitative and Regulatory Medical Science, LLC
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1:25 PM
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Challenges in Rare Disease Clinical Trials: The PREVENT Trial for NMOSD
Fanny O'Brien, Alexion
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1:45 PM
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Predictive Models in Rare Diseases: Risks and Opportunities in Clinical Trials, with Examples in Amyotrophic Lateral Sclerosis (ALS)
Alex Karanevich, EMB Statistical Solutions
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2:05 PM
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Innovative Designs and Rare Diseases: Bridging Information Through Evidence Synthesis
Satrajit Roychoudhury, Pfizer Inc.
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2:25 PM
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Use Case Scenario: Indirect Comparisons to Enhance Reimbursement Negotiations in Rare Disease
Jinesh Shah, CSL Behring
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2:45 PM
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Floor Discussion
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