- A biomarker is a dynamic and informational biological variable (i.e., cellular, biochemical, molecular, genetic, protein, metabolite, specific post-translational modification or physiological or physical sign) that can be objectively measured and evaluated as an indicator of normal biological process, pathogenic processes and their progression or the pharmacologic responses to a therapeutic intervention.
- Biomarkers enable the characterization of patient populations and quantitation of the extent to which new drugs reach intended targets, and alter the disease phenotype to achieve clinical outcomes.
- Biomarkers are also divided into wet (laboratory) and dry (imaging, questionnaires) biomarkers.
- Biomarkers can stratify patient populations and are therefore required to inform regulatory and therapeutic decision making regarding candidate drugs and their indications in order to streamline the drug discovery and development programs.
- Relatively few biomarkers are defined as “surrogate endpoints”. A surrogate endpoint is expected to predict clinical outcome (benefit or harm, or lack of benefit) based on epidemiologic, therapeutic, pathophysiologic or other scientific evidence, and independent validation.
- Drug discovery and development without the use of biomarkers is considered nowadays at a higher risk of failure.
- The webinar will provide the basic concepts of biomarkers and their use in drug discovery and development and will describe how biomarkers have been used successfully by reviewing a case study.
Why You Should Attend:
- You will get a better understanding of the different definitions of biomarkers.
- You will explore the optimal use of biomarkers and how this will streamline and add value to the drug discovery and development programs.
- You will learn how the pharmacological data in preclinical disease models and the safety signals during toxicological studies, including the evaluation of the safety margins, can benefit from the use of biomarkers.
- You will learn how biomarkers are essential to obtain a proof of mechanism in pre- and clinical studies (i.e. after administration, the drug is reaching the intended target at sufficiently high concentrations).
- You will learn how biomarkers in clinical development support dose selection, endpoints selection, comparison with competitors, and safety.
- You will learn how biomarkers help in selecting the target patient population and in examining time-response relationships.
Areas Covered in the Session :
- Definition of Biomarker
- Classification and Types of Biomarkers
- Surrogate Endpoints
- Biomarkers Use
- Role of Biomarkers in Drug Discovery and Development
- Challenges in Biomarkers Use
- Biomarkers Case Study
Who Should Attend:
- R&D Scientists
- Preclinical Scientists
- Clinical Scientists
- Clinical Research Associates