Dose optimization has taken center stage in oncology in recent years with the formation of Project Optimus at the OCE. Striking the delicate balance between efficacy and safety is the key focus in the approval process of drugs. There have been several publications, a regulatory guidance document, workshops, sessions at conferences and meetings focusing on this topic. Our working group has been active with a dedicated subteam to further the research in this endeavor. Some of the activities undertaken by the team include responding with comments to the draft guidance, organizing a session at conferences and publishing a manuscript on the topic. We are thankful for the expertise and involvement of our team members in pushing the boundaries of what is possible. These efforts not only enhance our scientific rigor but also ensure that patients benefit from treatments tailored to their unique needs.

Detailed description of the content includes:

· Path to dose optimization – where are we now? By co-chairs Philip He and Laura Fernandes

· KOL Message: Dose Optimization: Current Approaches and Future Directions by Professor Ying Yuan

· When the Rubber Meets the Road: An Interview on FDA Guidance for Oncology Drug Dose Optimization by Fengyu Zhao, Jean Fan, Xiaoqiang Xue, and Philip He

· A Chronicle of Major Milestones Since Project Optimus Launch. By Gu Mi.

· Insights and Highlights: FDA-AACR Dose Optimization Workshop. By Arunava Chakravartty.

· Optimizing Oncology Doses: Recent Study Design Innovations by Philip He, Gu Mi, Zhiwei Zhang, Arunava Chakravartty, Patrick Mitchell, Haijun Ma, Gina D’Angelo, Kaushal Mishra, Pierre Colin, and Zhaohua Lu.

· FDA Oncologic Drugs Advisory Committee (ODAC) and FDA Oncology Approvals in Q3 and Q4, 2024. By Fengyu Zhao

· Upcoming Conferences and Workshops

· Biostat Bytes: Utility Function, Optimal Dose, and Admissible Doses. By Revathi Ananthakrishnan.

We hope this newsletter will be a valuable resource for all members of the Oncology Working Group.

You can access and download the newsletter at https://www.doi.org/10.5281/zenodo.14549660.