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Delta Hotels Ottawa City Centre

Oct 18, 2022 1:00 PM - Oct 19, 2022 9:10 PM

101 Lyon Street North, Ottawa, ON K1R 5T9, Canada

Canada Annual Meeting

Session 8, Tracks A, B: Innovation and Collaboration in Oncology

Session Chair(s)

Oxana  Iliach, PhD

Oxana Iliach, PhD

Senior Director Regulatory Strategy

Certara, Canada

Marcia  Bailey, BSN, MHS, RN

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)

Krithika  Shetty, PhD

The FDA’s Project Optimus: The New Landscape Of Drug Dose Optimization in Oncology: Krithika Shetty, PhD

Associate Director

Certara, Canada

Melissa  Hunt, MSc

Health Canada’s Experience with Project ORBIS: Melissa Hunt, MSc

Director

Health Canada, Canada

Lauren Tesh Hotaki, PharmD

Project Orbis: Experiences and Updates: Lauren Tesh Hotaki, PharmD

Senior Regulatory Health Project Manager, Oncology Center of Excellence, CDER

FDA, United States

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