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Challenges with Biological Medicines
Session Chair(s)
James Matcham
Head, Early Clinical Development Biometrics
AstraZeneca, United Kingdom
Many biologic medicines are being developed with the expectation that they may only be effective in a subgroup of patients. Planning a development programme investigating the utility of companion diagnostics and considering the subsequent population enrichment, is an active area of research. This session will provide an opportunity to hear about the current views and activities in the development of companion diagnostics and in population enrichment designs
Speaker(s)
Current Thoughts in the Design of Population Enrichment Studies
Andrew Peter Grieve, DrSc, PhD, MSc
Aptiv Solutions, Germany
Senior Vice President Clinical Trial Methodology
Can a Treatment be Licensed on the Basis of Post Treatment Predictive Biomarkers?
Andrew Stone, MSc
AstraZeneca, United Kingdom
Head of Statistical Innovation
Regulatory Review of The Early Years of Biosimilar Product
David Brown, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of Statistics Team, Healthcare, Quality and Access
Using Multiple Statistical Approaches to Establish the Safety of Vaccines
Suzie Seabroke, PhD, MSc
MHRA, United Kingdom
Senior Pharmacoepidemiologist, Vigilance and Risk Management Division
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