Cytel Consulting's Zoran Antonijevic
The key focus of precision medicine is identification of patients who would most benefit from a treatment. Proper enrichment of patient population greatly improves the probability of regulatory approval as well as product differentiation through improved efficacy and safety. Greater product differentiation leads to greater market access, as reimbursement is now a key driver to commercial success.
The process from observing a first signal of improved treatment response to demonstrating this in late stage clinical trials is very challenging, as described in the FDA Draft Guidance on Enrichment Strategies for Clinical Trials, published in December 2012. Zoran Antonijevic from Cytel Consulting will be presenting at the DIA Annual Meeting in a session “Predictive Enrichment: Design, Development Strategies, and Methodological Issues."
In his talk Zoran will go over considerations for incorporation of predictive biomarkers at late stage drug development. He will describe drug development strategies and clinical trial designs, including adaptive enrichment designs, that deal with this complex topic. Cytel Consulting has experience with both the methodology and the design of adaptive enrichment trials. Zoran’s presentation will illustrate one such case study.
In addition to his role as a Senior Director at Cytel Consulting, Zoran also chairs the DIA's Adaptive Design Scientific Working Group.
Related Items of Interest