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Oncology (ONC)

Dose-Optimization in Oncology: Identifying Gaps and Opportunities

Friday, May 30, 2025
3:00 PM - 4:00 PM East Coast USA Time
Location: National Harbor 3

Session Description

Since the Project Optimus initiation by the U.S. Food and Drug Administration (FDA) in 2021, dose optimization in oncology has been a topic of great interest among drug developers, researchers, and regulators. Several guidance, public workshops, webinars, and previous ASCPT conference sessions have addressed the importance of dose optimization in oncology drug developments as we move away from traditional cytotoxic drug development.

However, it is still not clear whether dose optimization should be conducted for all modalities, when should dose optimization be conducted (phase 1, phase 2, phase 3 or later), what approach, clinical trial design, analyses, and population should be studied to select dosages, and what challenges had drug developers encountered while implementing dose optimization in existing or new drug development programs.

Learning Objectives

  1. Engage audience in reflecting oncology dose optimization strategies utilized in their organizations and compare their practice with the survey results from IQ Consortium on dose optimization in oncology drug development
  2. Identify current knowledge gaps in oncology dose optimization considerations
  3. Understand the pros and cons of different dose optimization strategies, including novel study designs and sophisticated modeling approaches in less well-established fields, such as novel modalities and combination therapies

Session Schedule

Introduction
Ya-Feng Wen, PharmD, PhD

Audience Survey on the Approaches for Oncology Dose Optimization
Naveen Mangal, PhD

A Panel Discussion on the Progress Made and Challenges that Lie Ahead in Dose Optimization in Oncology
Karthik Venkatakrishnan, PhD, Jeffrey Moscow, MD, and Lanre Okusanya, PharmD, MS