Conference will also be streamed virtually

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Friends of Cancer Research (Friends) is hosting a meeting focused on driving innovation in diagnostics and regulatory policy. Key discussions will highlight evidence generation for novel technologies for diagnostic testing, including digital pathology and artificial intelligence (AI), along with strategies for developing diagnostic tests for rare biomarkers and addressing future regulatory considerations for cutting-edge tools. New data will be released from the ongoing Digital PATH Project, which leveraged a common dataset to evaluate variability across digital pathology platforms. This meeting brings together key thought leaders to explore how these innovations can accelerate progress in precision medicine and improve patient outcomes.

9:30AM: Breakfast & Registration Opens

10:00AM: Welcoming Remarks

• Jeff Allen, President & CEO, Friends of Cancer Research

Session 1: Evaluating Digital Pathology and AI in Diagnostics

Session 1 discussions will focus on new data from Friends’ Digital PATH Project, which evaluated the variability between AI-enabled digital pathology tools using a common dataset to inform future policies and advance the use of AI in diagnostic testing. The presentation will provide an overview of project findings and set the stage for panel discussions on strategies to advance regulatory frameworks for aligning AI-enabled pathology tools, including considerations for establishing common datasets for validation. Click to access the discussion document.

10:05AM: Session 1 Presentation – Digital PATH Project Findings

• Mark Stewart, Friends of Cancer Research

10:15AM: Session 1 Panel Discussion and Q&A

• Sarah Hersey, Bristol Myers Squibb — Moderator
• Santhosh Balasubramanian, PATH AI
• Mark Gustavson, AstraZeneca
• Joe Lennerz, BostonGene
• Joan Mancuso, Friends Advisory Advocate

11:15AM: Break

Session 2: Validating Diagnostic Tests for Rare Biomarkers

Session 2 builds on Friends’ previous White Paper that proposed solutions for co-developing therapies and companion diagnostics (CDx) targeting rare biomarkers as well as the need for regulatory flexibility and innovative strategies to support CDx development. The session discussions will focus on a new white paper exploring opportunities for regulatory flexibility, alternative data sources for diagnostic validation, and a proposed tool to support sponsor-regulator engagement. Click to access the session 2 white paper.

11:30AM: Session 2 Presentation – Innovative Processes for Validating Diagnostic Tests for Rare Biomarkers or Indications

• Megan Doyle, Eli Lilly & Company

11:40AM: Session 2 Panel Discussion and Q&A

• Jennifer Dickey, LabCorp Oncology — Moderator
• Megan Doyle, Eli Lilly & Company
• Elizabeth Mansfield, Foundation Medicine, Inc.
• Alain Silk, Tempus AI

12:35PM: Lunch

Session 3: Advancing Regulatory Frameworks and Policies for AI in Healthcare

Session 3 will explore the future of AI in diagnostics and drug development, focusing on innovative approaches for efficient and sustainable regulatory pathways that appropriately balance patient safety and innovation. Panelists will discuss collaborative strategies to support emerging policies for AI in healthcare.

1:05PM: Session 3 Panel Discussion and Q&A

• Rachel Sher, Manatt Health — Moderator
• Joe Franklin, Covington & Burling LLP
• Rohini Kosoglu, Fusion Fund
• Lauren Silvis, Tempus AI

1:55PM: Closing Remarks

2:00PM: Meeting Adjourned