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WE'RE HIRING
"At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
VIEW ROLESCombination therapies are reshaping the future of oncology, but optimizing their dosing remains one of the field’s most complex challenges. This panel discussion explores how biotech and pharma teams can move beyond the traditional maximum tolerated dose (MTD) paradigm to embrace innovative, model-informed strategies that align with FDA’s Project Optimus.
Attendees will gain insights into designing effective combination trials, leveraging biomarkers and pharmacologic data and applying simulation tools to streamline the development process. Whether planning a first-in-human study or expanding a global trial, this session will equip attendees with the knowledge to navigate regulatory expectations and deliver better outcomes for patients.
Register now to explore how innovative trials are shaping the future of clinical research and enhancing patient outcomes.
Key takeaways:
- Understand the shift from maximum tolerated dose (MTD) to model-informed dose optimization and how this impacts trial design and regulatory expectations under FDA’s Project Optimus
- Learn how to design and operationalize combination therapy trials using innovative escalation models, biomarker strategies and global feasibility planning
- Explore how modeling and simulation tools can enhance decision-making in dose selection, reduce trial inefficiencies and improve patient safety and outcomes
- Obtain a Key Opinion Leader perspective on dose optimization with combinations with novel therapies – challenges and solutions
Speakers:
Jeff Hodge, MS, Vice President Early Phase Oncology, Hematology-Oncology Center of Excellence, IQVIA
Michael Brave, Vice President, Therapeutic Strategy, IQVIA
Howard “Skip” Burris, MD, President, Sarah Cannon Research Institute
Zheng Liu, Director of Quantitative Clinical Pharmacology, IQVIA
For more information and to register, click here.