Friends of Cancer Research Public Meeting

Establishing Evidence: New Advancements Using ctDNA

Thank you to all that attended! Click through the relevant links below related to the meeting:

Click HERE to watch the Full Meeting
Click HERE for the Meeting One Pager
Click HERE to access the Session 1 Presentation
Click HERE to access the Session 2 Presentation

Tuesday, July 11th, 2023
10:30 AM – 3:00 PM EST
Washington Georgetown Marriott
1221 22nd St NW
Washington, DC 20037
The meeting will also be streamed virtually

Friends of Cancer Research (Friends) is proud to announce our next public meeting, Establishing Evidence: New Advancements Using ctDNA.

Circulating tumor DNA (ctDNA) shows major promise as a tool to improve treatment for patients with cancer. In July 2022, we hosted a meeting, Expediting Drug Development: Use of ctDNA as an Early Endpoint, that laid out an evidentiary roadmap to using ctDNA as an early endpoint for regulatory decision-making. The meeting in July 2023 includes data readouts for two initiatives that support this roadmap. The first is ctMoniTR Module 1 data demonstrating relationships between ctDNA and outcomes in aNSCLC patients treated with TKI. The second project was identified as a knowledge gap in the evidentiary roadmap exercise and includes data of baseline ctDNA levels across cancer types, stages, and assays. In addition to discussing findings from these projects, we will also discuss regulatory considerations and potential updates to the evidentiary roadmap.

Register for in-person or virtual attendance above and stay tuned for additional details.

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Agenda

10:00AM — In-Person Check-In Begins

10:30AM — Welcoming Remarks

10:35AM — Morning Keynote featuring Patrizia Cavazzoni, U.S. FDA, and Lee Fleisher, CMS, and moderated by Jeff Allen, Friends of Cancer Research

11:05AM — Session 1: Evaluating ctDNA measurements across cancer types and stages

Objectives: Key initial findings from the Friends’ collaborative initiative comparing trends in baseline ctDNA levels between cancer types and stages across assay developers will be presented prior to the panel discussion focused on the clinical and regulatory implications of these findings.

Panel:

-Mark Sausen, Personal Genome Diagnostics — Moderator

-James Chen, Tempus

-Greg Jones, NeoGenomics Laboratories

-Anand Pathak, U.S. FDA

-Eric Peters, Genentech, a member of the Roche Group

12:05PM — Networking Lunch

12:30PM — Lunch Keynote with an introduction from Ellen Sigal, Friends of Cancer Research, and featuring moderator Richard Pazdur with Valerie Jensen and Harpreet Singh, U.S. FDA

1:00PM — Session 2: Changes in ctDNA levels as an early indicator of outcomes in advanced NSCLC treated with TKI (ctMoniTR Module 1)

Objectives: This session will focus on new data findings from Module 1 of the project, highlighting key considerations for current and future work, and discussing next steps for the ctMoniTR project.

Panel:

-Nevine Zariffa, NMD Group, LLC — Moderator

-Carin Espenschied, Guardant Health

-Minakshi Guha, Takeda Pharmaceutical Company

-Geoff Oxnard, Foundation Medicine, Inc

-Diana Vega, AstraZeneca

-Paz Vellanki, U.S. FDA

2:00PM — Session 3: Regulatory considerations for using ctDNA as an early endpoint 

Objectives: Based on new data presented, and regularly advancing evidence regarding the use of ctDNA, panelists will consider potential adjustments to the ctDNA roadmap. Discussions will focus on how the new data influences future evidentiary needs and opportunities for continued data generation.

Panel:

-Amy McKee, Parexel — Moderator

-Ken Billett, Patient Advocate

-Nicole Gormley, U.S. FDA

-Vladimir Jankovic, Regeneron Pharmaceuticals, Inc

-Minetta Liu, Natera

-Reena Philip, U.S. FDA

-Christian Rolfo, Ichan School of Medicine at Mount Sinai