Certara Investor Day Presentation Deck slide image

Certara Investor Day Presentation Deck

Increasing regulatory adoption 3 Incorporation of Biosimulation in FDA Guidances <2000 30+ FDA Guidances to Date PopPK Dose-response 5 Renal impairment Hepatic impairment 2000 - 2010 6 Pediatric HIV Animal QT interval prolongation 2011-2015 17 Pediatric rare diseases Drug-drug interaction PBPK Biosimilars Hypertension Ulcerative colitis Multi- regional clinical trials 2016-2020 MIDD applications in the report include: Predicting clinical outcomes Informing trial designs. ā— ā— 2021 FDA Focus Areas of Regulatory Science Model-informed product development aims to integrate information from diverse data sources to help decrease uncertainty and lower failure rates, and to develop information that cannot or would not be generated experimentally. Supporting evidence for efficacy Optimizing drug dosing Predicting product safety Drug Approvals https://www.fda.gov/science-research/advancing- regulatory-science/focus-areas-regulatory-science 16 Adoption Innovation Regulatory Guidances CERTARA
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