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Keyword Search Criteria: Real World Evidence returned 12 record(s)
Sunday, 07/29/2018
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies
Shirley Wang
4:05 PM

A Glimpse into Industry Experience with RWE to Transform Pharmaceutical Research and Development
James Harnett
4:25 PM

Real World Evidence Demonstration Projects and Policy Development at FDA
Diqiong Xie, FDA; David Barrett Martin, FDA CDER OMP
4:45 PM

Monday, 07/30/2018
The Role of Real World Evidence in a Regulatory Environment: Focus on Safety
Estelle Russek-Cohen, US FDA CDER
8:35 AM

Learning Individualized Treatment Rules from Electronic Health Records Data
Yuanjia Wang, Columbia University
9:00 AM

Linking Medicare Current Beneficiary Survey (MCBS) to Augment Post-Market Real World Data from Medicare Claims: a Multiple Imputation Approach
Yun Lu, FDA; Xiyuan Wu, Acumen LLC; Yoganand Chillarige, Acumen LLC; Michael Wernecke, Acumen LLC; Hector Izurieta, FDA; Jeffrey Kelman, CMS; Richard Forshee , FDA
9:20 AM

Visual Analytics in the Real World Evidence Data Realm
Melvin Munsaka, AbbVie, Inc.; Kefei Zhou, Theravance Biopharma; Krishan P. Singh, GlaxoSmithKline
9:35 AM

Tuesday, 07/31/2018
Bayesian Methods in Real-World Evidence for Medicinal Product Development: Can Prior Distributions Provide a Platform for Creating Real-World Evidence?
John Loewy, Dataforethought


Wednesday, 08/01/2018
When Do We Really Need Randomized Clinical Trials?
Christopher Hane, OptumLabs; William Crown, OptumLabs


On Randomized Controlled Trials with Integrated Real World Evidence for Drug Development in Rare Diseases
Qing Liu, Amicus Therapeutics, Inc
11:15 AM

Thursday, 08/02/2018
Utilization of Historical Data and Real World Evidence in Clinical Trial Development - Case Studies in Rare Disease and Oncology
Florence H Yong, Pfizer Inc.; Ray Li, Pfizer Inc.; Steven Y Hua, Celgene - Receptos; Jeffery Palmer, Pfizer Inc.; Roberto Bugarini, Pfizer Inc.
8:50 AM

Deriving and Analyzing Endpoints from Electronic Health Record Data: a Case Study from Clinical Oncology
Sandra Griffith, Flatiron Health; Ariel Bourla, Flatiron Health; Bryan Bowser, Flatiron Health ; Geoff Calkins, Flatiron Health; Joe Chang, Flatiron Health; Rebecca Miksad , Flatiron Health ; Brian Segal, Flatiron Health; Elizabeth Sweeney, Flatiron Health ; Erin Williams, Flatiron Health ; Paul You , Flatiron Health ; Amy Abernethy, Flatiron Health
11:15 AM