Biomarkers are a key medical product development tool capable of facilitating development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treatments by reducing the time and cost of clinical trials while maintaining patient protections.

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.

Why Should You Attend

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 direct measures of how a person feels, functions, or survives—a category of measure known as a clinical outcome assessment. This difference between 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.

Webinar Takeaway

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

Who Will Benefit

  • Clinical research associates
  • Medicinal chemists
  • Pharmacologists
  • Toxicologists
  • Project managers
  • Business development managers
  • Medical writers
FDA Faculty Dr. Stefano Persiani

Faculty Dr. Stefano Persiani 

Internal & External Innovation, Director Translational Sciences and Pharmacokinetics at Rottapharm Biotech


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-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology

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