Friends of Cancer Research Virtual Meeting

Expediting Drug Development: Use of ctDNA as an Early Endpoint 

Wednesday, July 20, 2022
11:30AM EDT – 1:00PM EDT

Thank you to all that attended! 
Click HERE to Watch the Full Meeting

Click HERE to access the Meeting Discussion Document.

Friends of Cancer Research (Friends) is proud to announce a new virtual meeting, Expediting Drug Development: Use of ctDNA as an Early Endpoint.

The use of surrogate endpoints in oncology drug development has helped accelerate development of innovative therapies and brought life-saving treatments to patients quicker. As we continue to advance our biological and technological capabilities, other novel endpoints, such as the use of ctDNA, are emerging as important tools to help expedite development of the next generation of cancer therapies. To fully realize the potential of this endpoint and enable its use in oncology drug development, collaborative efforts to generate robust evidence are needed to ultimately validate ctDNA as an early endpoint.

This meeting builds on Friends’  multi-year, groundbreaking ctMoniTR Project and will highlight opportunities and strategies for validating ctDNA as an early endpoint. A new white paper will be released in advance of the meeting that outlines a roadmap to reach key evidentiary milestones that can help support the use of ctDNA as an endpoint for regulatory decision-making and strategies for using ctDNA in oncology drug development.

Register for the meeting above and scroll through below for the current agenda.

Agenda

11:30am – Welcome & Introductions

11:35am – Fireside Chat

• Patrizia Cavazzoni, Director, CDER, U.S. FDA
• Ellen Sigal, Friends of Cancer Research

11:40am – Panel 1: Leveraging Learnings from Recent Endpoint Validation Studies

• Moderator: Chris Abbosh, AstraZeneca
• Laleh Amiri-Kordestani, CDER, U.S. FDA
• Angela DeMichele, University of Pennsylvania
• Nicole Gormley, CDER, U.S. FDA
• Geoff Oxnard, Foundation Medicine Inc.

12:10pm – Panel 2: Developing an Evidentiary Roadmap for Use of ctDNA

• Moderator: Gary Pestano, Biodesix
• Julia Beaver, OCE, U.S. FDA
• Erik Bloomquist, OCE, U.S. FDA
• Aadel Chaudhuri, Washington University in St. Louis
• Mary Savage, GSK
• Alain Silk, Tempus Labs, Inc.

12:40pm – Q&A

12:58pm – Closing Remarks