Through a review of essential case studies, this webinar series, titled The Path to First-in-Human: Translating Discovery to the Clinic, will examine practical and scientific aspects relating to three key steps from discovery to initiating clinical trials.

Pipetting Considerations for Moving Your Program from Discovery to Safety

This webinar provides insight into the drug discovery process within the pharmaceutical and biotech environments with a focus on the importance of target engagement biomarkers and the role they can play from a translational efficacy and side effect liability perspective. An integrated project case study provides context as well as illustrates how Charles River’s multidisciplinary project teams transition projects for their partners seamlessly through discovery into GLP safety and toxicology studies.

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two scientists talking in laboratory settingHow to Design a Scientifically Robust Preclinical Program for Biological Therapeutics

This webinar addresses preclinical program designs for biological therapeutics. Using case studies, our speakers explore key areas to consider when building these complicated safety assessment packages in accordance with regulatory guidance and the 3Rs. Topics include target engagement, animal model selection, mechanism of action, species differences in response, immunogenicity, biomarker validation and the role of in vitro studies.

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researchers pipetting into a volumetric flaskFrom Mice to Men: Preclinical Safety Flags to Clinical Validations

This webinar will highlight common preclinical safety flags to consider in order to assist mitigating clinical trial risk, including recommendations from both FDA and EMA guidance documents. Our scientists will also discuss a tiered approach to clinical validations and tools to accelerate translation of preclinical data to the clinic through a brief overview of human PK profile projections, human equivalent dose predictions, and PK/PD modeling techniques.

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