Leveraging Early Markers of Tumor Response in Model-Informed Drug Development to Aid in Go/No-Go Decisions: Are We There Yet?

Session Description

This session addresses a topic of highly emerging interest in the field of clinical pharmacology for cancer
therapeutics. Several markers of early tumor response ranging from tumor size to circulating tumor DNA have been known for a while, and model-informed clinical pharmacology approaches are tailor-made to incorporate such data to inform drug development. However, accomplishing the synergy is not without challenges: the quality and quantity of data collected, translatability to clinical response, and development of novel approaches to integrate the totality of data, being some of them. Regulatory guidance on how to leverage such markers at appropriate stages in the drug development paradigm is also a key emerging aspect. The objective of this session is to critically discuss where we are in leveraging early markers of tumor response in model-informed drug development and debate what further innovative disruptions would be needed to scale existing challenges. The session consists of three parts: Part 1 is comprise of a point vs. counter-point discussion, and Part 2 will address regulatory perspectives on this topic. A panel discussion will follow in Part 3.

Learning Objectives

1. To gain a good understanding of emerging markers of early tumor response in oncology clinical trials and understand the pros and cons in utilizing them in model-informed drug development decisions.

2. To learn regulatory perspective of utilizing early tumor kinetic and response data to enable decision making and carry out clinical and regulatory conversations on further development of novel approaches such as immunotherapy and combinations.

Session Schedule

12:15 PM - 12:17 PM ET
Introduction
Sathej Gopalakrishnan, PhD

12:17 PM - 12:30 PM ET
Opening Remarks
Rene Bruno, PhD and Don Mager, PharmD, PhD

12:30 PM - 12:51 PM ET
Point-Counterpoint

Discussion: Can We Depend on Early Markers of Clinical Response Such as Tumor Kinetic Data and Circulatory Tumor DNA to Enable Model Informed Decisions?
Sathej Gopalakrishnan, PhD and Sree Kasichayanula, PhD

12:51 PM - 1:06 PM ET
Regulatory Perspectives on Utilizing Emerging Markers of Early Anti Tumor Response in Decision Making: Decisions Clinical Pharmacologists Can Help Make
Lian Ma, PhD

1:06 PM - 1:15 PM ET
Panel Discussion, Live Q&A and Closing Remarks
All Speakers