The first part of this session will discuss critical steps to be considered during late stages of preclinical development to ensure successful translation of preclinical biomarker testing into a clinical trial context. Focusing on targeted oncology treatments, the session will provide an overview of assay development criteria, to include specimen, analyte, and sample stability/integrity, and sample complexity. We will further examine the impact of sample acquisition and sample logistics on biomarker data quality.

On the topic of pharmacodynamic biomarkers, the session will provide following insights:

• Their value in the context of proof of target modulation of a therapeutic agent
• Their ability to support dose selection and schedule decision
• Consideration of testing in the target vs. surrogate tissue
• The utilization of proximal and distal pharmacodynamic markers

The first part of this session will conclude with a case study for how a biomarker defined population can support rationale drug development to potentially accelerate development timelines. The later part of this session will focus on regulatory considerations and requirements relevant to codevelopment efforts.

Initially, the regulatory portion of this session will provide an introduction to selected IVD regulatory frameworks. The basic understanding of the regulatory framework will then serve as the foundation of a discussion of regulatory considerations for trial conduct to include the elements of risk evaluation and regulatory implications. Moreover, elements to consider for trial design and implementation to facilitate future regulatory approval (such as specimen annotation and handling considerations) will be discussed.