Duration: 60 Minutes


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  • 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

Course Director: DR. STEFANO PERSIANI ‎

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. Dr. Persiani was later 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. Dr. Persiani in his current role applies translational approaches from drug discovery to registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies, serves on the review board of numerous professional journals, and acts as an external expert for the European Commission on the 7th Framework Program, HORIZON 2020, Marie Sklodowska-Curie Individual Fellowship Program, and Innovative Medicine Initiative. He also acts as an external expert for the La Caixa Foundation (Spain) and for the Research Agency of the Check Republic.

Specialities: Drug and biopharmaceutical discovery and development; from pre-clinical to clinical Phase I, and IIa. Dr. Persiani gives courses and consults in the above fields at the University of Milan Bicocca, University of Chieti, University of Bologna, University of Rimini, Thomson Reuter, IIR, Life Sciences Strategy, Informa life sciences, Health Communication Network, Vision in Business, Pharmaceutical Training International, GRC Educators, Trainning.com, and MPG Media.