Friends of Cancer Research Annual Meeting 2024
Tuesday, November 12, 2024
10AM – 3PM ET
The Ritz Carlton
1150 22nd St NW, Washington, DC 20037
Conference will also be streamed virtually
This year’s annual meeting explored three different topics that focused on approaches for streamlining trial designs and data collection to support efficient regulatory processes and decision-making. Topics presented at the 2024 Annual Meeting addressed frequently encountered challenges that can impact the efficiency and conduct of clinical trials, and ultimately, the collection of evidence necessary to support new drug approvals. Click here to read the 2024 Annual Meeting recap.
Draft Agenda
10:00 AM: Opening Remarks
10:05 AM: Morning Keynote
- Ramsey Baghdadi, Prevision Policy (Moderator)
- Robert Califf, U.S. FDA
10:35 AM: Session 1 – Interim Overall Survival Evaluations and Implications for Trial Designs and Analysis Plans
Interim overall survival (OS) data, evaluated alongside early endpoints like progression-free survival and response rate, help assess the risk-benefit profile of new cancer drugs but can be confounded by factors like data maturity and study design features. This session discussed best practices for trial designs and analysis plans for interim OS analyses in cancer clinical trials as well as the formation of a multistakeholder consortium to conduct simulations, aiming to enhance the accuracy and reliability of interim OS data interpretation. Read the Session 1 White Paper here.
Session 1 Presentation (10 min)
- Geoff Oxnard, Eli Lilly and Company
Panel Discussion (40 min)
- Keith Flaherty, Mass General Cancer Center (Moderator)
- Nicole Gormley, U.S. FDA
- David Mitchell, Patient Advocate
- Geoff Oxnard, Eli Lilly and Company
- Lisa Rodriguez, U.S. FDA
- Antony Sabin, GSK
Audience Q&A (10 min)
11:35 AM: Break
11:50 AM: Session 2 – Enhancing Post-Marketing Studies with Pragmatism
Incorporating pragmatic elements into clinical trial designs can enhance the generalizability and efficiency of clinical trials. This session exploreed several case studies to inform incorporation of individual pragmatic elements into clinical trials after initial approval to answer specific research questions, enhancing their applicability and efficiency while maintaining regulatory rigor. Read the Session 2 White Paper here.
Session 2 Presentation (10 min)
- Paul Kluetz, U.S. FDA
Panel Discussion (40 min)
- Richard Schilsky, University of Chicago (Moderator)
- Allen Chen, AstraZeneca
- Trixia Camacho, Bristol Myers Squibb
- Eva May, Patient Advocate
- Neal J. Meropol, Flatiron Health
- Peter O’Dwyer, University of Pennsylvania
- Donna Rivera, U.S. FDA
Audience Q&A (10 min)
12:55 PM: Lunch
1:20 PM: Lunch Keynote
- Jeff Allen, Friends of Cancer Research (Moderator)
- Kimryn Rathmell, National Cancer Institute
1:50 PM: Session 3 – A Common Strategy for Using ctDNA as an Intermediate Endpoint in Prospectively Designed Trials
Friends has collaborated with various stakeholders to support using change in ctDNA levels as an intermediate endpoint in oncology drug development, demonstrating its association with OS. To standardize ctDNA measurement methodologies, this session discussed an aligned approach for assessing ctDNA changes, focused on using ctDNA in advanced non-small cell lung cancer (NSCLC) treated with immunotherapy. Read the Session 3 White Paper here.
Session 3 Presentation (10 min)
- Hillary Andrews, Friends of Cancer Research
Panel Discussion (40 min)
- Charu Aggarwal, Abramson Cancer Center, University of Pennsylvania (Moderator)
- Zoe June Assaf, Genentech, A Member of the Roche Group
- David Fabrizio, Foundation Medicine, Inc.
- Leon Freytor, Johnson & Johnson
- Anand Pathak, U.S. FDA
- Carol Vallett, Patient Advocate
- Paz Vellanki, U.S. FDA
Audience Q&A (10 min)
3:00 PM: Meeting Adjournment
