Overview
As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to change the format of the upcoming DIA/FDA Biostatistics Industry and Regulator from "face-to-face" (in-person) to entirely virtual.
For more information, please review the list of Frequently Asked Questions
Forum: May 27-29
The DIA/FDA Biostatistics Industry and Regulator Forum is focused on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360-degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.
The forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.
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Program Committee
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Karen Lynn Price, PhD Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States -
Mat Soukup, PhD Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States -
Mouna Akacha, PhD Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland -
Brenda Crowe, PhD Associate Vice President, Statistics
Eli Lilly and Company, United States -
Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States -
Rima Izem, PhD Associate Director Statistical Methodology
Novartis, Switzerland -
Shiowjen Lee, PhD Deputy Director, Division of Biostatistics, OBPV, CBER
FDA, United States -
Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States -
Lei Nie, PhD Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
FDA, United States -
Frank W. Rockhold, PhD, MSc Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States -
William Wang, PhD President
Merck & Co, Inc, United States -
Aloka Chakravarty, PhD Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
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