Biomarkers in Drug Discovery and Development
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About this webinar:
Biomarkers have been defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes and pharmacologic responses to therapeutic intervention. In drug discovery and development, biomarkers carry the promise of allowing better decision making, identifying unfavourable properties (safety biomarkers) or confirming the expected efficacy profile of new drugs (efficacy biomarkers) early in the development before the progression to human studies. The drug development process is often associated with high levels of attrition, since many drug candidates fail because of preclinical or clinical safety issues.
The need for good biomarkers is therefore essential to identify preclinical effects that could be translated into humans (translational biomarkers); in addition, biomarkers can often be used in the approval process for a drug or treatment, as part of the risk assessment definition. Aptuit can provide analytical and biological biomarkers validation (e.g. by using different animal models or setting up specific studies) as well as measurement of biomarkers in several animal species by using different platforms: the interpretation of data is provided by using a multidisciplinary approach in which biomarkers results are related to other end-points (histopathology, histo/immunostaining, morphometric evaluations, toxicokinetic data, clinical signs, electron microscopy, gene expression, etc.) measured in complex studies.
Dr. Federica Crivellente
Research Investigator, Biomarkers and Applied Immunology Laboratory
Aptuit - Verona, Italy
Dr Federica Crivellente is Research Investigator, Biomarkers & Applied Immunology Laboratory at Aptuit, Verona, Italy. Prior to joining Aptuit as a Research Investigator in 2010, Dr Crivellente was Clinical Pathology Manager in GlaxoSmthKline (from 2001). Starting with a degree in Biology from the University of Padua, she completed her PhD (1996 -1999), supervised by Prof. Franco Tagliaro, at the Dept. of Public Health and Community Medicine, Unit of Forensic Medicine, University of Verona, investigating the role of carbohydrate deficient transferrin (CDT) as a marker of chronic alcohol abuse in humans and setting up a method for its determination by mean of capillary electrophoresis. Following this, she completed 1 and ½ year post-doctoral fellowships on the development of new methodologies for forensic DNA analysis by capillary electrophoresis with Prof. Bruce McCord at Ohio University, Ohio, USA (2000-2001). She then joined GSK and earned a Specialization in Biochemistry and Clinical Chemistry at the University of Brescia in 2002. Dr Crivellente has a wide experience in safety biomarker validation by mean of different analytical methods and Clinical Pathology data analysis and interpretation in General Toxicology studies (both GLP and non-GLP); she acted also a Safety Assessment Project Representative and was involved in many GSK worldwide projects on safety issues. She is a Member of the American Society of Veterinary Clinical Pathology and is a co-author of about 30 full publications in international journals/books.
Dr Elena Vicentini is a Scientist working in the Biomarkers and Applied Immunology Laboratory at Aptuit, Verona, Italy. She graduated in Agro-Industrial Biotechnology at the Verona University in 1999. She joined GlaxoSmithKline in 2000 working on the generation of transgenic mouse models for the study of mood disorders and on the biochemical characterization of preclinical stress models. She has driven and progressed preclinical programs to the screening phase of drug discovery working in the Translation Biology group and acquiring deep experience in biomarker analysis to provide in vivo pharmacodynamic assays to the disease models for the robust characterization of lead molecules and candidates to be integrated in the pharmacological and behavioural package in order to facilitate decision making. She has experience in the validation and analysis of acute stress, metabolic and inflammatory markers by using different platforms in complex biological matrices in preclinical species (non-GLP and GLP studies). She is a co-author of full publications in international journals/books.