Canada Annual Meeting

The Canada Annual Meeting offers three tracks, Regulatory, Clinical, Safety and Pharmacovigilance!

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Session 8, Track B: Statistical, Modeling and Dose Optimization Considerations for Trial Design

Session Chair(s)

Oxana Iliach, PhD

Senior Director Regulatory Strategy

Certara, Canada

Katalin Bertenyi, MSc

Manager, Centre for Blood, Blood Products and Biotherapeutics

Health Canada, Canada

This session will provide an overview of current approaches to optimization of doses with focus on oncology studies, statistical consideration for the studies with the small population and latest updates in this area from Health Canada.

Learning Objective : At the conclusion of this session, participants should be able to:
Describe project Optimus objectives and current status
Discuss statistical considerations for the design of the study with the small population

Explain latest Health Canada advancement and requirements for the statistical approaches in the clinical studies

Speaker(s)

Dose Optimization for Rare Cancers

Jade Huguet, PhD

Certara, Canada

Associate Director Clinical Pharmacology Clinical Pharmacology/Translational Med

Statistical Considerations for Trial Design in Rare Diseases: Examples from Duchenne and Becker Muscular Dystrophy

Utkarsh Dang, PhD

Carleton University, Canada

Associate Professor

Statistical Regulatory Challenges for the Design of Studies with Small Populations

Alex Bliu, PhD