FDA, ISoP Workshop Targets Oncology Dosage Optimization

Modeling and simulation outputs are moving closer to the center of oncology labeling decisions, and a joint workshop between the FDA Office of Clinical Pharmacology and the International Society of Pharmacometrics (ISoP) on November 9, 2023 formalized that trajectory. For regulatory affairs leads managing oncology portfolios, the session signals that quantitative methods are no longer supplementary to dose-finding, they are increasingly the primary evidentiary basis regulators expect to see.

The hybrid event, held at the Gaylord National Resort and Convention Center in National Harbor, Maryland, ran from 8:00 a.m. to 4:45 p.m. ET. Its stated objectives centered on three operational areas: embedding pharmacometric methods into clinical development of oncologic products, characterizing how dosage exploration shapes benefit/risk assessments, and applying model-based approaches to support dosing regimen selection when approved or investigational drugs move into new combinations or disease settings.

The benefit/risk framing is consequential for CMC and regulatory strategy teams. As modeling outputs increasingly inform recommended dosages in marketing applications and labeling, the documentation trail supporting those models, assumptions, validation datasets, sensitivity analyses, becomes subject to the same scrutiny as any other submission-critical evidence. Regulatory affairs professionals supporting IND and NDA packages for oncology assets should treat workshop guidance as directional signal for how CDER reviewers will weigh pharmacometric justifications against traditional dose-escalation data.

The primary audience named by FDA and ISoP included clinical pharmacologists, pharmacometricians, pharmacologists, toxicologists, statisticians, clinicians, and patient advocates, a cross-functional scope that reflects how broadly dosage optimization now cuts across development teams. Workshop materials, including recorded sessions, were made available via the ISoP website and linked YouTube recordings. Contact points for follow-up are Bernadette Johnson-Williams at FDA's Office of Clinical Pharmacology and Jennifer Pastore Monroy, Executive Director of ISoP.

Regulatory affairs teams with oncology assets in active development should review the workshop agenda and recorded sessions to assess alignment between their current modeling frameworks and the best practices discussed, particularly where new combination regimens or label expansions are under consideration.

Source: FDA What's New: Drugs RSS Feed via fda.gov, published August 28, 2026; workshop date November 9, 2023.