The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

CDDF Dose optimization workshop 2023 – Recordings

CDDF Multi-Stakeholder workshop

Dose optimization in early oncology drug development

3 – 4 April 2023, Hybrid workshop

Presentations

SESSION 1: The challenges of dose optimization

Keynote Lecture: The need for dose optimization in early drug development – Mark J. Ratain (Uchicago Medicine, USA)

Clinician perspective – Elena Garralda (VHIO, ES)

Regulator’s perspective – Filip Josephson (Lakemedelsverket, SE)

Industry perspective – Harald Weber (Seagen, CH)

Session 1 complete

SESSION 2: Project Optimus and other Regulatory Initiatives

Goals and Status of Project Optimus – Stacy Shord, PharmD (FDA, US)

Patient contribution to Project Optimus – Dr. Hillary Stires (FOCR, US)

Session 2 complete

SESSION 3: Dose Optimization - methodological approaches

Using tumor evolutionary theory to inform optimal doses – Carter (Yanguang) Cao (UNC, US)

Biomarker consideration & Translational modeling – Weirong Wang (J&J, US)

New Statistical Concepts for Phase 1 and Phase 2 Studies – Ulrich Beyer (Roche, CH)

Session 3 complete

SESSION 4: Dose Optimization - Options for the path forward

Optimised Dosing – How to optimise the trade-offs? – Chunze Li (Roche, US)

Safety and Toxicity – Sophie Postel-Vinay (Gustave Roussy, FR)

Integrating Patient-Reported Outcomes – Chad Gwaltney (Gwaltney Consulting, US)

Academic Perspective (with case studies) – Johann de Bono (consultant in ICR, UK)

Industry Perspective (IQ, industry consortium, with case studies) – Divya Samineni (Roche, US) & Neeraj Gupta (Takeda, US)

Session 4 complete

SESSION 5: Wrapping up

Session 5 complete