Friends of Cancer Research Public Meeting
The Future of Diagnostic Tests:
New Data & Modern Policy
Thank you to all that attended!
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Thursday, February 1st, 2024
10:00AM – 2:30PM ET
Washington Georgetown Marriott
1221 22nd St NW
Washington, DC 20037
Friends of Cancer Research (Friends) is proud to announce our next public meeting, The Future of Diagnostic Tests: New Data & Modern Policy
As technology rapidly advances and diagnostic tests continue to become more complex, it is critical that patients and providers receive accurate and consistent information to inform care decisions. Friends of Cancer Research (Friends) is collaborating with leading diagnostic developers to support assay innovation and harmonization. This meeting will further this work by sharing findings from the homologous recombination deficiency (HRD) Harmonization Project, the launch of the Digital Pathology Project, and a policy discussion focused on advancing diagnostic regulation and development.
Agenda
9:30 AM – Registration Opens
10:00 AM – Opening Remarks
10:05 AM – Opening Keynote Conversation
- Jeff Shuren, Director, CDRH, U.S. FDA
Session 1: Aligning on Approaches to Measuring HRD: Findings from the HRD Harmonization Project
The HRD Harmonization Project seeks to support the future use of assays that measure HRD status for treatment decision-making. Friends worked with diagnostic developers and other key stakeholders to identify sources of variability across HRD tests and opportunities for alignment. This session will review final findings from the HRD Harmonization Project and propose solutions to improve agreement in the future.
10:35 AM – Presentation: HRD Harmonization Project Findings
- Hillary Andrews, Friends of Cancer Research
10:45AM – Panel Discussion and Q&A
- Alexander Lazar, MD Anderson — Moderator
- Rebecca Arend, University of Alabama Birmingham
- Douglas Laird, Pfizer, Inc.
- Lisa McShane, National Cancer Institute
- Anand Pathak, CDRH, U.S. FDA
- Ethan Sokol, Foundation Medicine, Inc.
11:35AM – Break
Session 2: Supporting Digital and Computational Pathology: Launching a Demonstration Project
To support the application of digital and computational pathology platforms in oncology drug development, common reference standards and validation sets are needed. A common dataset to enable validation across different computational pathology platforms will enable reproducible, accurate, and reliable results. This session will describe the approach to a new Friends’ demonstration project to leverage data to generate an accessible digital pathology validation set to cross-evaluate different platforms to support robust development and validation.
11:50 AM – Panel Discussion and Q&A
- George Green, GA Green Consulting — Moderator
- Siraj Ali, Lunit, Inc.
- Brandon Gallas, CDRH, U.S. FDA
- Shahanawaz ‘DJ’ Jiwani, Frederick National Laboratory for Cancer Research
- John Longshore, AstraZeneca
- Satabhisa Mukhopadhyay, 4D Path
12:35 PM – Lunch
1:00 PM – Lunch Keynote Conversation
- Scott Gottlieb, Former Commissioner, U.S. FDA
- Lauren Silvis, Senior VP of External Affairs, Tempus AI Inc.—Moderator
Session 3: Navigating an Evolving Regulatory and Policy Landscape
Ensuring accuracy and reliability of diagnostic test results is critical to ensure patients receive the appropriate treatment. This discussion will explore existing regulatory paradigms, proposed policies aimed at enhancing diagnostic test development and review, and needs for emerging technologies.
1:30 PM – Panel Discussion and Q&A
- Kate Rawson, Prevision Policy — Moderator
- Michael Berger, Memorial Sloan Kettering Cancer Center
- Jochen Lennerz, BostonGene
- Carly McWilliams, Roche Diagnostics
- Lia Ridout, Patient/Survivor Advocate
- Brittany Schuck, U.S. FDA
- Anthony Sireci, Loxo@Lily
2:28PM Closing Remarks
2:30 PM – Meeting Concludes
