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Session 8, Tracks A, B: Innovation and Collaboration in Oncology
Session Chair(s)
Oxana Iliach, PhD
Senior Director Regulatory Strategy
Certara, Canada
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director
GSK, Canada
Overall survival rates in oncology patients depend on access to safe and effective cancer treatments. Prompt approval of life-extending therapies is critical for this patient population. Initiatives such as Project Orbis and Project Optimus seek to help accelerate oncology drug access pathways through global collaborative review of oncology drug applications, and to help ensure oncology drug dose optimization during drug development. This session will provide an overview of these two initiatives and efforts.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the FDA Oncology Center of Excellence’s mission, vision, and initiatives
- Explain the principal benefits and challenges of Project Orbis
- Summarize the FDA’s expectations for oncology dose optimization in Project Optimus
Speaker(s)
The FDA’s Project Optimus: The New Landscape Of Drug Dose Optimization in Oncology
Krithika Shetty, PhD
Certara, Canada
Associate Director
Health Canada’s Experience with Project ORBIS
Melissa Hunt, MSc
Health Canada, Canada
Director
Project Orbis: Experiences and Updates
Lauren Tesh Hotaki, PharmD
FDA, United States
Senior Regulatory Health Project Manager, Oncology Center of Excellence, CDER