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Innovative Clinical Trial Designs for Diagnostic Co-registration
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
The registration study for a personalized biopharmaceutical therapy also serves as the registration study for the accompanying companion diagnostic, and it is often conducted in a small, molecularly-defined rare disease population. The frequent lack of available alternative treatment options in rare diseases makes it important for industry and FDA to reach a mutual understanding on the standards and evidentiary expectations needed for co-registration of novel personalized therapies in the rare disease setting with their companion diagnostics, so that safe and effective treatment options can be made available to patients as quickly as possible. In this session, a panel of experts from industry and government will discuss the latest innovations in registration study design for biomarker-defined rare diseases.
Speaker(s)
Speakers
Anne R. Pariser, MD
NIH NCATS, United States
Deputy Director, Office of Rare Diseases Research
Speakers
Michael Pacanowski, PharmD, MPH
FDA, United States
Div of Translational and Precision Medicine, OCP, CDER
Speakers
Axel Hoos, MD, PhD
GlaxoSmithKline, United States
Senior Vice President, Oncology R&D
Speakers
Boris Freidlin, PhD
National Cancer Institute (NCI), United States
Mathematical Statistician, Biometric Research Branch, DCTD
Speakers
Sue-Jane Wang, PhD, MA, MS
FDA, United States
Mathematician Statistician
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