Workshop: (R)TTE analysis – MIDD applications, concept, methodology and NONMEM hands-on

Workshop introduction

Presentation 1:
Integration of model-based biomarkers and adverse effects with survival in oncology

Presentation 2:
From time to event joint models to competing risks in pharmacometrics

Presentation 3:
Integrating Time-To-Event Models: An industry insight into effective dose selection and regulatory submission

Day 1 closing remarks

Day 2 Introduction

Lecture 1:
Motivation for survival analysis

Lecture 2:
General concepts and theory

Lecture 3:
Data file format for estimation

Lecture 4:
Graphical exploration and data summary

Hands-on 1:
Graphical exploration and summary statistics

Lecture 5:
TTE and RTTE model estimation and NONMEM model code

Hands-on 2:
TTE and RTTE estimation

Break for Lunch

Lecture 6:
Model evaluation and interpretation of diagnostics

Hands-on 3:
Continued RTTE model estimation

Lecture 7:
Simulations

Hands-on 4:
Simulations and interpretation of graphical diagnostics

Lecture 8:
Communication of the results

Workshop closing remarks

• Co-founded Pharmetheus in 2012, advising in client projects and training Pharmetheus colleagues in pharmacometrics
• Expertise includes development of pharmacokinetic-pharmacodynamic models of desired and adverse effects in therapeutic areas such as oncology, infectious diseases, and neuroscience
• Experience as Professor of Pharmacometrics (2014-2021) and Pharmacokinetics and Pharmacodynamics (2021- ) at Uppsala University, Sweden, where she performs research and teaches in pharmacokinetics, pharmacodynamics, pharmacometrics, and drug development. Previously, she worked as Research Fellow and Associate Professor at Uppsala University, Sweden, and Postdoctoral Research Fellow at University of Queensland, Australia
• M.Sc. in Pharmaceutical Sciences (1997) and Ph.D. in Pharmacokinetics and Drug Therapy (2003) from Uppsala University, Sweden

• Collaborating with Pharmetheus since 2022, in the role as a Scientific Advisor
• Expertise includes Biostatistical Modelling and Pharmacometrics for treatment of Infectious Diseases, and development of the software PFIM for optimal design in pharmacometrics
• Currently Professor of Biostatistics at University Paris Cité, France, editor in Chief of CPT: Pharmacometrics and System Pharmacology since 2018, and co-founder of the Special Interest Group on Statistics and Pharmacometrics of ASA and ISoP
• M.Sc. in Mathematics (1984) from École Normale Supérieure, Ph.D. in Biomathematics (1984) from University Paris 6, M.D. (1993) from University Paris 7, France

• Currently serves as Senior Director & Distinguished Scientist in clinical pharmacology, modeling & simulation at Genentech/Roche, providing M&S scientific oversight for most of the non-oncology portfolio and ~40% of the oncology portfolio.
• Wide range of M&S experience and expertise for SMs and biologies in diverse therapeutic areas from Phase I to post-marketing, including rich global filing and health authority interaction experience.
• Previously worked as M&S consultant at Certara/Pharsight for ~ 13 years, most recently as Senior Director responsible for scientific oversight and business relationship management/expansion.
• Pharm.D. (2005) from Lebanese University, Lebanon and a Ph.D. in Pharmaceutical Sciences, Pharmacometrics (2013) from the University of Montreal, Canada