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: H&E-Based Molecular Profiling: From Bench to Bedside in the Era of Precision Medicine & AI
12:10 pm
- AI-enabled H&E-based molecular profiling has the potential to transform the diagnosis and treatment pathway for cancer and beyond by overcoming key challenges of traditional wet lab methods – such as high cost, time-consuming processes, limited scalability, and variability in reproducibility – through rapid, scalable, and data-driven analysis
- The panel will discuss the enormous potential of utilising AI-enabled H&E-based molecular profiling in Clinics, Drug development and Drug discovery/Research
Wednesday 24th September 2025
Panel Discussion: Advancing Partnerships to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications
3:30 pm
- When should biomarker advancement trigger formal CDx development efforts for harmonized drug-diagnostic co-development?
- Determining a fit-for-purpose CDx strategy aligned with clinical trial endpoints
- How can collaborative, cross-functional teams streamline CDx integration into therapeutic development, adoption and launch planning and market access?
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
