Tuesday, November 10, 2026
10:00AM – 3:00PM ET
The Ritz-Carlton 1150 22nd St NW,
Washington, DC 20037
Register
Friends of Cancer Research (Friends) is proud to host our 19th Annual Meeting on November 10, 2026. Since 2007, Friends has brought together leaders across federal health and regulatory agencies, academic research, industry, and patient advocates to advance evidence-based solutions to current challenges in drug development. This year’s topics converge on early-phase clinical trial development and offer an opportunity to apply risk-based and modern quantitative approaches that support efficient drug development while prioritizing patient safety. Explore the agenda below and stay tuned for updates.
AGENDA
9:30 AM – Networking Breakfast
10:00 AM – Opening Remarks
- Ellen Sigal, Friends of Cancer Research
10:05 AM – Opening Fireside Chat
10:35 AM – Setting the Stage: Modernizing Early Phase Drug Development
- Mark Stewart, Friends of Cancer Research
10:45 AM – Session 1 – Risk-Based Nonclinical Strategies to Support Early-Phase Development
Advances in modern therapeutics are challenging traditional approaches to nonclinical development and creating new opportunities to modernize evidence generation. This session will explore how risk-based, weight-of-evidence strategies can support fit-for-purpose evidence generation, and enable more efficient early-phase drug development, including through new approach methodologies (NAMs) and other human-relevant evidence sources.
- Liz Spehalski, Parexel International – Moderator
- Imein Bousnina, Genentech, a member of the Roche Group
- Nathan Coussens, Frederick National Laboratory for Cancer Research
- Carole Harbison, Takeda Pharmaceuticals
- Amy Pointon, AstraZeneca
- Tiffany Ricks, FDA
11:40 AM – Break
11:55 AM – Session 2 – Modernizing Expectations for Exploratory First-in-Human Studies
As innovative therapies continue to evolve, early clinical development requires approaches that are appropriately tailored to the scientific questions being addressed. This session will explore opportunities for fit-for-purpose regulatory expectations that support efficient development while maintaining patient safety.
- Michael Kalos, Next Pillar Consulting – Moderator
- Laleh Amiri Kordestani, FDA
- Ilaria Conti, Arvinas
- David Hong, University of Texas M.D. Anderson Cancer Center
- Arnoldo Rodriguez, Friends Advisory Advocate
- Donghua Yin, Pfizer Inc
12:50 PM – Lunch
1:30 PM – Lunch Panel Discussion
2:00 PM – Session 3 – Incorporating Model-Informed Drug Development (MIDD) and AI to Optimize Oncology Dosing
Emerging quantitative and AI-enabled approaches have the potential to strengthen dosage selection throughout oncology drug development. This session will explore where these tools can add value, how they can complement traditional evidence, and what is needed to support broader implementation.
- Paz Vellanki, Precision for Medicine – Moderator
- Jeff Barrett, Genmab Therapeutics
- Julie Bullock, GSK
- Jiang Liu, FDA
- Eva May, Friends Advisory Advocate
- Jatinder Mukker, EMD Serono
- Mirat Shah, FDA
2:55 PM – Closing Remarks and Meeting Adjournment
Content is subject to change.