Session 4a: Systems Pharmacology Approaches for Assessing Drug Safety
Mechanistic modeling of preclinical toxicities for translational safety assessment
Mathematical modeling of liver injury and dysfunction after acetaminophen overdose: early discrimination between survival and death
Modeling of liver injury in human patient populations using a mechanistic model of the liver
Mining adverse events databanks of adverse events to inform complex systems pharmacology models in drug safety
Jay Mettetal (AstraZeneca)
Jay Mettetal (AstraZeneca)
Chris Remien (University of Idaho)
Brett Howell (Hamner Institute)
Mirjam Trame (University of Florida)
Session 4b: Translational PK-PD and Pharmacometrics in Biologics Development
From Pop PK to PHC: Integrated modeling and biomarker strategies to accelerate the development of biologics
Model-based strategy in developing antibody-based biotherapeutics in pediatric populations
New methods to inform biologics development
Leveraging internal and literature data: application of PK/PD and MBMA in mAb drug development
Lorin Roskos (MedImmune)
Lorin Roskos (MedImmune)
Zhenhua Xu (Janssen)
Liang Zhao (FDA)
Nageshwar Budha (Genentech)
Session 4c: Mechanistic modeling for a complete oncology drug development cycle: translation, stratification, and feedback to discovery from the clinic
Multiscale Mechanistic Simulations of Tumor Targeting: Predicting whole animal to subcellular distribution
How do antigen number and shedding affect the delivery of antibody-based anticancer agents in solid tumors?
Preclinical-to-Clinical Translation of ADCs Using Mechanistic Modeling
Using Models of Cell Signaling networks in the Development of Tageted Anti-cancer Drugs
Brian Schmidt (BMS), Craig Thalhauser (BMS)
Greg Thurber (University of Michigan)
Byungkook Lee (NCI/NIH)
Dhaval Shah (University at Buffalo)
Daniel Kirouac (Genentech)
5:00 PM
6:00 PM
JPKPD Editorial Board Meeting
[by invitation only]
5:00 PM
7:00 PM
Posters / Exhibits
6:00 PM
7:00 PM
Presidential Reception
[by invitation only]
6:00 PM
7:00 PM
Alumni Receptions (TBD)
7:00 PM
10:00 PM
ACoP6 Open Forum: Global Regulatory Perspectives on the Role of Pharmacometrics in Drug Development and Registration [note: separate registration and dinner fee required]
Model informed drug development: EMA perspectives
Model informed drug development: FDA perspectives
Model building drug development (MBDD) bridging in Asia – Japanese regulatory perspectives
Using modeling and simulation in drug development and regulatory interaction: industrial perspective
The Role of Modeling and Simulation in Regulatory Decision Making: Physician’s Perspective
Rui Zhu (Genentech), Yaning Wang (FDA)
Ine Skottheim Rusten (MSWG, EMA)
Vikram Sinha (FDA)
Naomi Nagai (PMDA)
Sandra Allerheiligen (Merck)
Geoffrey Kim (FDA)
WEDNESDAY October 7th
7:30 AM
9:30 AM
Breakfast Contributed Poster Session 3 Exhibits
9:45 AM
11:45 AM
Session 5a:Translational Therapeutics through Computerized Platforms: Web, Mobile and Wearable Solutions for the Drug R&D and Clinical Use
A User Friendly Tool to Assist Clinicians in the Development of Limited Sampling Strategies
An Online Solution for the Clinical Recommendations for ADHD Treatment
Diagnosing and predicting cyclic neutropenia: An online solution for clinicians and modelers alike.
Fahima Nekka (University of Montreal), Jun Li (University of Montreal)
Olivier Barriere (inVentiv Health Clinical)
Philippe Robaey (CHEO Research Institute
Morgan Craig (University of Montreal)
Session 5b: Mechanistic Immune System Models Across Disease States: Shared Insights, Common Themes and Critical Distinctions
From low-level targets to engaging systemic host defenses: The evolving paradigm of quantitative systems pharmacology
Computational modeling of mucosal immune responses in infectious and autoimmune diseases
In silico evaluation and exploration of antibiotic tuberculosis treatment regimens
Recruiting the immune system against disease: Lessons for PK-PD and systems pharmacology
Craig Thalhauser (BMS), Brian Schmidt (BMS)
Ioannis P. Androulakis (Rutgers University)
Josep Bassagnanya-Riera (Virginia Tech)
Elsje Pienaar (University of Michigan)
Paolo Vicini (Pfizer)
Session 5c: Advances in Model Evaluation Methods for Pediatric Physiologically Based Pharmacokinetics
An overview of model validation, including identifiability and sensitivity, in systems biology with an emphasis on PBPK
Importance of experimental determination of factors that reduce uncertainty and allow for identifiability of other parameters
Exploring a Novel Mechanism of Atypical Nonlinear Plasma Protein Binding: A Sensitivity Analysis-Based Approach
Preclinical to clinical translation of Sorafenib pediatric PBPK models: a case study in model evaluation approaches.
John Carl Panetta (St. Jude Children’s Hospital), Burgess Freeman (St. Jude Children’s Hospital)
Brian Ingalls (University of Waterloo)
Anil Maharaj (University of Waterloo)
Amelia Deitchman (University of Florida)
John Carl Panetta (St. Jude Children's Hospital)
11:45 AM
12:00 PM
Closing Remarks - Meeting Adjourns
Brian Corrigan, ISoP President-Elect
Jin Yan Jin, ACoP6 Conference Chair
12:00 PM
1:00 PM
Student/Trainee Event with Lunch:
Effective Communication in Modeling and Simulation
[free, separate registration required]
Hosted by Charvi Nanavati, ACoP6 Trainee Committee Chair
12:00 PM
1:00 PM
Lunch
1:00 PM
4:00 PM
ACoP7 meets ACoP6
[by invitation only]
1:00 PM
4:00 PM
ACoP6 Tutorials
[free, separate registration required]
Session 6a: Building Pharmacometric Applications using R: R Shiny Tutorial
Brian Corrigan (Pfizer), Devin Pastoor (University of Maryland), Samer Mouksassi (Certara), Jinzhong Liu (FDA, Indiana University), Jessica Wojciechowski (University of South Australia)
Session 6b: Automated Model Selection
Mark Sale (Nuventra), Eric Sherer (Louisiana Tech University), Ken Kowalski (A2PG), and Andy Hooker (Uppsala University)
