Joel Owen, Vice President of Pharmacometric Services, gives a brief introduction to the application of Modeling & Simulation in Phase 2 - questions to be addressed, speakers, and presentations.
Introduction to Post-Approval/Generics track with Ryan Franke
Ryan Franke, Director, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in the Post Approval/Generics phase - the value of modeling & simulation, speakers, and presentations.
Pharmacometrics in Phase 3 – Data Integration and Analysis to Support Dose and Labeling for the NDA
Phase 3 studeis typically involve 300 to 3,000 participants from patient populations for which the medicine is eventually intended to be used.
Optimizing sample size of a phase III trial with Simulx using a phase II popPD model
Goal: design of a bridging study
Panel Discussion: The Impact of Modeling in Drug Development
There is a rich, long-standing history of science and mathematical modeling that set the table for the current, rich MIDD environment
Keynote: Women in Pharmaceutical Science
Respect is a Simulations Plus Core Value
Pharmacometrics in Post Approval: Fulfillment of Requirements, Label Extension, and Life-Cycle Management
Aksana Jones, Associate Director, walks you through unleashing the full potential of model-informed drug development (MIDD) post-approval.
Pregnancy PBPK modeling, a necessary step towards safety and efficacy
Maxime LeMerdy, Senior Scientist discusses clinical trial and post-marketing information along with two case studies for Cefuroxime and Metronidazole.
Pharmacometrics Phase 2 Proof-Of-Concept Dose Selection Phase 3/Marketing
Sébastien Bihorel, Director, Pharmacometrics and Workflow Automation answers the question: "Where & how can pharmacometrics help?"
Impact of MIDD During Phase II New Drug Development a Regulatory Perspective
Yaning Wang, Division of Pharmacometrics, Office of Clinical Pharmacology, OTS/CDER/OMTP/FDA discusses the impact of MIDD during Phase 2 of New Drug Development
FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications
Banu Zolnik, from the Division of Biopharmaceutics/ONDP/OPQ/CDER/FDA, takes you through the FDA’s Perspective on PBPK Analyses for Biopharmaceutics Applications
Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity
Paul B. Watkins, Howard Q Ferguson Distinguished Professor, Director, Institute for Drug Safety Sciences and James Beaudoin, Scientist I present Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity.
Using Model Informed Drug Development and Model Integrated Evidence to Support Generic Drug Development and Assessment
Liang Zhao, Division of Quantitative Methods & Modeling, Office of Research and Standards, Office of Generic Drugs, CDER, FDA presents on using model-informed drug development and model integrated evidence to support generic drug development and assessment
Regulatory Perspectives for Reliable Model Informed Drug Development (MIDD)
Sarem Sarem, Biostat Unit, Office of Science Therapeutic Products Directorate, Health Canada, presents his thoughts on MIDD, Pharmacometrics, and Modeling & Simulation approaches in Phase III of drug development.
Mathematical Modeling with NAFLDsym® Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti FGFR1/KLB Bispecific Antibody
Zack Kenz, Scientist II, discusses collaborative work done with Genentech and previously presented at the AASLD in 2019.
The role of modeling and simulation in the approval of generic drug products
Pharmacometrics and Regulation
Efavirenz Physiologically Development and Validation as a Moderate CYP3A4 Inducer for Drug-Drug Interaction Predictions
Efavirenz is an antiretroviral medication used to treat and prevent HIV/AIDS.
Semi-Mechanistic PK/PD Model Effect Odanacatib, a Cathespin K Inhibtor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women
David Jaworowicz, Senior Director of Pharmacokinetics/Pharmacodynamics, presents objectives, study design, and data analysis for the semi-mechanistic PK/PD model of the effect of Odanacatib in Phase II studies of postmenopausal women
Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia
Pharmacometrician, Hannah Huang, presents "Population Pharmacokinetic and Concentration-QTc Analysis of Quizartinib in Patients With FLT3-ITD–Positive Relapsed/Refractory Acute Myeloid Leukemia"
2021 MIDD+ Awards
2021 MIDD+ Awards Presentation