Introduction

Biomarkers can be considered tools to be qualified in close association with individual submissions for drug approvals. The U.S. Food and Drug Administration (FDA) Drug-Diagnostic Co-development Concept Paper [1] described a specific example of this association, where the approval of a drug and a test are closely linked with each other in both their product concepts and the timelines of their regulatory approvals. Several examples of biomarkers approved through this co-development process are shown in the FDA's Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels [ 2] ' Biomarkers in this table include both genetic and translational entries. Genetic biomarkers are often integrated in drug development as clinical or nonclinical markers of drug efficacy or safety for the purpose of patient selection in clinical trials, response prediction through stratification or enrichment, or dose optimization. Translational biomarkers have applications similar to those of genetic biomarkers but may also be useful for response monitoring and as early indicators of toxicity or adverse reactions.

Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.

Novel approaches are being tested continuously for the successful integration of biomarkers in drug development. Their applications range from early compound selection through postmarketing applications. However, integration of these novel biomarkers into routine nonclinical and clinical practice, and regulatory submissions, have often been slow. Hesitation in the application of these tests is often associated with fear not only about how comprehensive data supporting these applications are but also about the regulatory interpretation of the context of use for these applications [3]. Biomarker tests can be integrated into drug development when we have a consensus about the context in which we are measuring the biomarker and the evidence supporting this measurement. These levels of consensus need to be reflected in the regulatory review of biomarker data.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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