Zhaohui Su, VP of Biostatistics at Veristat, shared a post on LinkedIn:
This paper by Bradley Monk and colleagues offers a comprehensive overview of the journey oncology drugs take from discovery to approval. It addresses a variety of complex topics, including INDs, Phase I dose finding, dose optimization under Project Optimus, Phase II interpretability, FDA expedited approvals, diversity plans, and the evolving expectations for Phase III, all while remaining easy to read.
Specifically, this paper connects the entire development pathway into a coherent roadmap. It covers aspects from preclinical work and manufacturing controls to modern dose-finding designs like BOIN, and highlights the increasing significance of biomarkers, patient-reported outcomes (PRO), and decentralized trial considerations. Additionally, it sheds light on the challenges many sponsors face regarding regulatory expectations and emphasizes how thoughtful design choices can expedite development without compromising scientific rigor.
For those interested in oncology research, clinical operations, regulatory strategy, or drug development, this paper serves as a practical and accessible reference to understanding what it truly takes to bring new cancer therapies to patients today.”
Title: Development of anti-cancer medicines in the current era
Authors: Bradley J. Monk, Manish R. Patel, Sarper Toker , Vivek Subbiah, Lucio N. Gordan
Read the article here.
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