The pharmaceutical industry’s productivity crisis is well known with >90% of drug candidates failing in clinical testing, primarily due to unexpected toxicity or lack of efficacy. Despite advances in high throughput ‘omics technologies and the large volume of information that is now amassed on new drug candidates, the probability of success for new molecules is not improving. Scannel and Bosney (2016) have pointed to a lack of predictive preclinical models as one of the key factors. New approaches using sophisticated human cell based systems are showing promise for replacing the use of animal models, particularly in cases where animal testing has failed to predict human effects. Dr. Berg will describe these new approaches and present a case study that successfully provided a mechanistic understanding of drug induced cardiovascular toxicity, an adverse effect of kinase oncology drugs. She will also discuss how phenotypic assay data can be incorporated into safety risk assessments through the adverse outcome pathway framework being developed for chemical safety testing.
About the Speaker:
Ellen L. Berg, PhD is an entrepreneur and scientific leader in drug discovery technology innovation. She is Chief Scientific Officer, Translational Biology for Eurofins Pharma Discovery Services and a principal at Alto Predict LLC. Dr. Berg was the lead inventor of the BioMAP® platform of human primary cell-based disease models, now successfully commercialized by Eurofins and serving the pharmaceutical and consumer products industries to deliver safer and more effective products. In previous positions, Dr. Berg was co-founder and CSO of BioSeek, Inc. and led a research team at Protein Design Labs, Inc. She received her PhD from Northwestern University and was a postdoctoral fellow at Stanford University, where she was a fellow of the American Cancer Society and a Special Fellow of the Leukemia Society of America. Dr. Berg has served in various positions with the Society of Laboratory Automation and Screening (SLAS), is a board member of the American Society for Cellular and Computational Toxicology (ASCCT), and a member of the Society of Toxicology (SOT) and Inflammation Research Association. Her research interests include human-based in vitro systems, drug and toxicity mechanisms of action, phenotypic drug discovery, and predictive methods for human efficacy and safety outcomes. She is currently focused on working with industry, academic and government stakeholders to incorporate non-animal, human-based in vitro and in silico predictive models into regulatory guidances. Dr. Berg holds several patents in the field of inflammation, and has authored over 80 publications.
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