Paz Vellanki, Vice President Clinical Development at Precision for Medicine, shared on LinkedIn:
“I’m honored to be moderating a panel at the Friends of Cancer Research Annual Meeting on November 10 in Washington, DC.
Our session, ՛Incorporating Model-Informed Drug Development (MIDD) and AI to Optimize Oncology Dosing,՛ will explore how quantitative modeling and AI-enabled approaches can inform oncology dose selection building on principles from the International Council for Harmonisation (ICH) M15 guidance and within the framework of FDA’s Project Optimus.
Optimizing the dosage in oncology clinical trials must balance efficacy, safety, tolerability, and treatment exposure.
However, clinical evaluation of multiple dosages can be resource-intensive and might expose patients to dosages that offer limited benefit or unacceptable toxicity.
MIDD provides an opportunity to integrate diverse sources of evidence, quantify uncertainty, and support more efficient dosage optimization.
I’m looking forward to hearing perspectives from colleagues across FDA, industry, and patient advocacy on how these approaches can complement traditional clinical evidence and inform regulatory decision-making.
If you’ll be attending, I hope to see you there!
November 10 | 2:00 PM ET
The Ritz-Carlton, Washington, DC
Register։ Friends of Cancer Research Annual Meeting 2026․”
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