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Validity : 25th May'23 to 04th Jun'23
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:
Biomarkers are a key medical product development tool capable of facilitating the 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 protection.
The potential benefits of a biomarker in drug development are very significant. Careful identification of the context of use is necessary for the 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 an indication for the correct labeling for marketing of a new drug and this is applicable to both small molecules and biologicals.
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 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.
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.