Surrogate endpoints based on biomarkers have the potential to significantly shorten and reduce the complexity of clinical trials in some therapeutic areas such as rare disease, oncology and immunology. There have been multiple successes in the use of biomarker data as a surrogate endpoint, however there are significant challenges across the field for the successful implementation of and utilization of the biomarker data, including bioanalytical, biological, regulatory and clinical considerations. While some therapeutic areas are not well positioned for biomarker data use, new technologies such as next generation sequencing, proteomic approaches and high color flow cytometry assays have enabled us to provide key data for new therapeutic areas. This presentation will focus on these considerations and developments with a few examples of these implementations, both for internal decision making for a clinical assets, and as part of a pivotal clinical trial and submission package. The aim will be to show how we view biomarkers in clinical trials, their utility and potential issues that need to be addressed before using clinical biomarker data for decision making purposes or regulatory filings.
Upon completion, participant will be able to understand the uses and issues around clinical biomarker data in supporting clinical studies.
Upon completion the participant will be able to understand bioanalytical concerns for clinical biomarker data generation.
Upon completion the participant will be able to articulate Pfizer's approach to clinical biomarker assays and use.