Introduction

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention. The potential benefits of a biomarker in drug development are very significant. A careful identification of the context of use is necessary for a successful use of a biomarker. Biomarker use could benefit individual patients participating in clinical trials (e.g., earlier identification of toxicity with a safety biomarker) or general drug development and regulatory decision-making (e.g., a prognostic or predictive biomarker used to enrich a patient population could reduce the sample size needed to achieve statistical significance). This should ultimately reduce the duration and cost of clinical development and provide indication for a correct labelling for marketing of a new drug and this is applicable to both small molecules and biologicals.

Learning Objectives

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention. This definition encompasses diagnostic, prognostic and therapeutic applications. Biomarkers can be derived from molecular, histologic, radiographic, or physiologic characteristics. Therefore, biomarkers are not always direct measures of how a person feels, functions, or survives. When this is the case and approval from regulatory bodies is available, the biomarker belongs to a particular category, named “surrogate endpoint” that it is thus related to clinical outcomes assessment. The objectives of the course are to cover and explain all these aspects.

Area Covered In The Webinar

The topics that will be discussed during the webinar include the use of biomarkers during drug discovery and development and will provide information regarding the:

  • Definition of biomarkers
  • Classification and types
  • Surrogate endpoints as a special class of biomarkers
  • Biomarkers use
  • Role of biomarkers in drug discovery and development
  • Challenges
  • Case study

Why should you attend?

The difference between the various types of biomarkers and clinical outcome assessment is important, because the latter measures outcomes that are directly important to the patients and can be used to meet standards for regulatory approval of therapeutics, whereas biomarkers serve a variety of purposes, one of which is to link a measurement to a prediction of clinical outcome. Only when a biomarker is validated it can serve as the primary basis for regulatory approval for marketing. In this case, the biomarker is named “surrogate endpoint”. Only a very limited number of biomarkers are surrogate endpoints. Drug development without the use of biomarkers is considered at high risk of failure and all of those involved in this field should have at least a basic knowledge of this topic.

Who Will Benefit

  • Clinical research associates
  • Medicinal chemists
  • Pharmacologists
  • Toxicologists
  • Project managers
  • Business development managers
  • Medical writers

ENROLLMENT OPTIONS

On Demand
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Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post Know More

Dr. Stefano Persiani