Mark Stewart
Vice President, Science Policy Friends of Cancer Research
Mark Stewart, PhD, is Vice President of Science Policy at Friends of Cancer Research, a Washington, DC-based organization that brings together stakeholders across the healthcare ecosystem to advance science, policy, and regulation in cancer care. He leads the organization’s research and policy agenda, overseeing multistakeholder initiatives that inform regulatory decision-making and accelerate the delivery of safe and effective therapies to patients. His work has helped advance the use of real-world evidence, improve clinical trial design, support biomarker development, and promote regulatory innovation to enable access to next-generation treatments.
Seminars
Wednesday 24th September 2025
Panel Discussion: Advancing Partnerships to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications
3:30 pm
- Determining a fit-for-purpose CDx strategy aligned with clinical trial endpoints
- When should biomarker advancement trigger formal CDx development efforts for harmonized drug-diagnostic codevelopment?
- How can collaborative, cross-functional teams streamline CDx integration into therapeutic development?
Wednesday 24th September 2025
Analytical & Translational Approaches Supporting Clinical Development of mRNA Based In Vivo CAR Products
12:40 pm
- Leveraging preclinical drug product mechanism of action data to inform on FIH clinical pharmacology analytical strategy
- Fit-for-purpose qualification and validation strategies for FIH to support a recommended dose regimen for Phase 2/ 3 evaluation
- Refinement of analytical approaches and translational strategy in Phase 2/ 3 to support regulatory activities
Wednesday 24th September 2025
Advancing AI-Driven HER2 Assessment: Findings from the Digital PATH Project
9:00 am
- Presenting novel findings from a multi-partner evaluation of AI-based HER2 scoring tools in breast cancer
- Demonstrating variability in model performance and the application of reference standards to evaluate consistency and reliability
- Exploring strategies to support validation and build regulatory confidence in AI-driven diagnostics for precision oncology
