Preclinical Development
Hannah Jones, PhD
Senior Vice President, Head of PBPK Consulting Services
Certara
Princeton, New Jersey
Description: This session will focus on how PBPK biosimulation software technology is used to ameliorate key challenges in drug discovery and pre-clinical stages to identify the most promising candidates and avoid later stage failure.
Many drug candidates fail in clinical studies, either because they do not effectively treat the condition for which they are being developed or the drug has too many side effects. Biosimulation is a proven approach for reducing that failure rate, beginning in drug discovery and supporting the translational stage prior to beginning human clinical studies. One of the key biosimulation technologies, encouraged by regulators and used by many biopharmaceutical companies is physiologically based pharmacokinetics (PBPK). Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of the biological and pharmacologic phenomena which determine in vivo PK in animals and humans. PBPK is a recognized game-changing technology for all stages of drug development, used by global regulators and hundreds of leading biopharmaceutical companies.
PBPK models are well-posed to make robust predictions of in vivo PK exposures, even when based on the limited data available during the initial stages of drug development. As such, PBPK approaches are being increasingly employed to strengthen the FIH dose rationale.
Simcyp has recently released a new software product based on its industry-leading Simcyp PBPK Simulator, for use by discovery and translational scientists. The software facilitates four important use cases: mechanistic first-in-human dose prediction, an essential step to achieving investigational drug approval (IND); compound prioritization in the discovery stage, including batch processing to identify the most promising drug candidates; drug-drug interaction screening to address safety issues before proceeding with a given compound; and early formulation assessment to strengthen the case for a molecule’s absorption in human subjects.