Podium Presentations of ACoP6 Quality Awards and ACoP6 Trainee Awards
Hosted by Beesan Tan, ACoP6 Abstract Committee Chair
10:00 AM
12:00 PM
Session 3a: GPS for QSP: Where We have Been, Where We Are, and Where We are Headed
Sponsored by ISoP QSP Special Interest Group and AAPS Focus Group on QSP
History and current state of the science: an industry perspective
History and current state of the science: an academic perspective
History and current state of the science: a regulatory perspective
“Future Perspectives” roundtable discussion
Michael G Zager (Janssen), Cynthia Musante (Pfizer)
Sandra Allerheiligen (Merck)
Douglas Lauffenburger (MIT)
Darrell Abernethy (FDA)
Session 3b: A Novel Interdisciplinary Pharmacometric Approach: A Systems Approach to Support Pharmacology to the Payer
Why Pharmacology to the Payer (P2P)?
P2P case study – proof of concept
P2P case study linking to health economic outcomes
P2P planning for prime time and future applications
Robert Bies (Indiana University)
Craig Rayner (D3 Medicine)
Carl Kirkpatrick (Monash University)
Rich Nelson (Univ of Utah)
Patrick Smith (D3 Medicine)
12:00 PM
1:00 PM
Meet the QSP Special Interest Group (SIG) Lunch
[free, separate registration required]
Hosted by ISoP QSP Special Interest Group
12:00 PM
1:30 PM
Lunch/Posters/Exhibits
1:30 PM
2:30 PM
Sheiner Award Lecture
Hosted by Stephen Duffull (University of Otago)
Steven Shafer (Stanford University)
2:30 AM
3:00 AM
Break
3:00 PM
5:00 PM
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)
Robert Temple (FDA)
WEDNESDAY October 7th
7:30 AM
9:30 AM
Breakfast
Contributed Poster Session 3
Exhibits
9:45 AM
11:45 AM
Session 5a: Modeling and Simulations as Cornerstone in Drug Development for Rare Diseases: Challenges and Opportunities
Value of Pharmacometrics in rare disease drug development: A Regulatory viewpoint
Technical challenges and opportunities when applying modeling and simulation to rare disease drug development
An Industry perspective on the use of modeling and simulations in drug development for rare diseases
Role of Pharmacometrics in regulatory decisions for drugs to treat rare diseases: Case studies
Nitin Mehrotra (FDA), Marc Gastonguay (Metrum)
Andrew Mulberg (FDA)
C.J. Godfrey (Metrum)
Raj Pradhan (Alexion Pharmaceuticals)
Jingyu Yu (FDA)
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
The use of a hierarchical Bayesian approach and MCMC simulations to refine parameter estimates and variability within a PBPK framework
Importance of experimental determination of factors that reduce uncertainty and allow for identifiability of other parameters
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)
Fredric Bois (INERIS)
Anil Maharaj (University of Waterloo)
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)
Session 6c: A robust workflow, technical approaches, and software tools for application of QSP in model-based drug development
