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Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
Session Chair(s)
Janet Jenkins-Showalter
Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States
FDA released a draft guidance in July 2011 that outlined the basics on developing targeted therapies and companion diagnostics, but it left many questions unanswered. This session will discuss potential approaches to address these remaining questions.
Learning Objective : Identify a regulatory development strategy for diagnostically selected populations; Recognize approaches to defining the diagnostically selected population; Formulate strategies for multi-marker diagnostic development.
Speaker(s)
Panelist
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
Panelist
Erling Thor Donnelly, PhD
Pfizer Inc , United States
Team Leader, Dacomitinib and Palbociclib, Oncology
Panelist
Shayesteh Fürst-Ladani, MBA, MS
SFL Regulatory Affairs & Scientific Communication, Switzerland
CEO
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