Preliminary ACoP11 Program



ACoP11 Pre-Conference: The Rising Role of Modeling in Oncology - From Translation to Confirmation (separate registration required) - Includes pre-conference poster session Co-Chairs: Heather Vezina (BMS), Peter Bonate (Astellas) and Mary Spilker (Pfizer)
State of the Art Lecture  
How can Pharmacometrics help tackle Pandemics Chair: Daniele Ouellet (Pfizer)
Applying Pharmacometrics and Model-Informed Drug Development (MIDD) to Global Health Challenges Chairs: Mark Lovern (Certara), Felix Boakye-Agyeman (Certara)
Model based approaches to enhance development and translation of anti-malarials Carl Kirkpatrick (Monash University)
Quantifying the Quality of Antimalarial Drugs in Ghana Felix Boakye-Agyeman (Certara)
Stratified Medicine Approaches to TB treatment Rada Savic (UCSF)
The new age of HIV therapy - making good ideas into therapies Mark Baker (ViiV Healthcare)
Bridging from mechanistic QSP models to subjective or complex clinical outcomes: challenges and approaches Chair: Michael C. Weis (Rosa)
Development of a mechanistic modeling platform of emesis to predict vomiting frequency in PONV Patients Sergio Iadevaia (Takeda)
Approaches to incorporating composite endpoints in autoimmune QSP models – a biologist’s perspective Jason R. Chan (Eli Lilly)
Modeling Fibrosis Progression in NAFLD/NASH Lyndsey Meyer (Pfizer)
Using mechanistic quantitative systems pharmacology (QSP) models to connect biomarkers to clinical disease activity scores – examples in dermatology and chronic inflammatory disease areas Vincent Hurez (Rosa)
 Semi-Mechanistic Modeling of Radiotherapeutics - Combining the Best of PBPK, QSP, and Population Approaches Chairs: Christian Claussen (Cognigen), Kevin Dykstra (Simulations Plus)
Population PBPK-radioactivity modeling of the disposition of a radiotherapeutic antibody in body tissues Christian Claussen (Cognigen)
A clinical population PBPD model to support the development of a radiotherapeutic antibody Anetta Claussen (Cognigen)
Supporting Translational Insights into Regulation and Recovery of Hematopoiesis through Creation of a Multi-Species Dynamic Platelet QSP Model Zackary Kenz (Dilisym)
 Abandoning RECIST: Rethinking decision paradigms in oncology with MIDD Chairs: Seth Robey (Merck), Jonathan French (Metrum)
Symposium Introduction: Moving Beyond Existing Endpoints Seth Robey (Merck)
Improving Strategic Decision-Making with Early Prediction of Survival Outcomes in Oncology Clinical Trials Jonathan French (Metrum)
Role of joint modelling for tumor size kinetics and survival data in oncology treatment decisions Solene Desmee (University of Tours)
Regulatory considerations for novel endpoints in oncology Lian Ma (FDA)
Advancing model-informed drug development (MIDD) of siRNA-based gene therapy: challenges and opportunities Chairs: Songmao [Ben] Zheng (Janssen), Varun Goel (Alnylam) 
A Drug-Drug Interaction Model of Cemdisiran & Eculizumab: How Combination Regimen of siRNA and mAb can transform treatment of Complement  Varun Goel (Alnylam) 
Preclinical-to-clinical translation of small interfering RNA (siRNA) using a multiscale PBPK/PD model: a case study with Fitusiran Vivaswath S. Ayyar (Janssen)
Identification of key factors in siRNA therapy design using a mechanistic PK-PD model Fulya Akpinar Singh (BMS)
Model-informed drug development for siRNA:  Regulatory perspectives Yaning Wang (FDA)
 When can parametric longitudinal modelling in drug development give benefit and when are other methods appropriate? Chair: Andrew Hooker (Uppsala University)
When is a longitudinal test better than a cross-sectional one? Björn Bornkamp (Novartis)
Opportunities and pitfalls in the use of nonlinear mixed-effects models for leveraging longitudinal information in drug development Andrew Hooker (Uppsala University)
Quantifying and addressing model uncertainty on longitudinal data in the design and analysis of clinical studies Tobias Mielke (Janssen-Cilag GmbH)
Using Markov Models When the Current Observation is Related to the Previous Observation Chairs: Virginia D Schmith (Nuventra), Cathrine Leonowens (Nuventra)
Markov Models in Longitudinal Data Analysis:  Needs and Opportunities Mats Karlsson (Uppsala University)
Markov Models at the Intersection of Pharmacometrics and Health Economics Marc R. Gastonguay (Metrum)
Use of a Markov Model to Describe Remimazolam Pharmacodynamics in Procedural Sedation  Jie [Jessie] Zhou (Nuventra)
State of the Art in Bayesian Methods for Mechanistic PBPK and QSP models: Concepts and Applications Chairs: Abhishek Gulati (Astellas), Frederic Bois (Certara)
Bayesian meta-analysis for pharmacokinetic parameters.  Witold Więcek (Certara)
Building a Bayesian modeling workflow for population PBPK. Box's loop offers a statistical paradigm for modeling: build, fit, criticize, and repeat.  Charles Margossian (Columbia)
Bayesian Mechanism-Based Pharmacometric Modeling: Concepts and Applications Tarek Leil (BMS)
Application of a Hierarchical Bayesian Machine Learning approach in Quantitative Systems Pharmacology Natnael Hamda (Astellas)
Immunogenicity for Immunoncology Modalities: Recent Advances in Modeling Chairs: Jennifer Sheng (BMS), Diansong Zhou (Astrazeneca) 
Comprehensive Overview of Immunogenicity for Immunoncology Modalities  Honghui Zhou (Janssen)
Pharmacometric Modelling of Immunogenicity of a PD-1 Inhibitor and Its Impact on PKPD  Lora Hamuro (BMS)
Pharmacometric Modelling for Immunogenicity of Bispecific Antibodies Donald Mager (University of Buffalo)
Current Thinking of Immunogenicity Assessment in Regulatory Space: Regulation and Modeling Strategy  Yaning Wang (FDA)
How to be Very Discrete, Yet Smoothly Effective:  Use of Published Discrete Trial Endpoint Data to Optimize Trial Designs Chairs: Jeffrey R Sachs (Merck), Jos Lommerse (Certara)
Plotting Go/No-Go Decisions:  Intuitive, Clear Visual Overlay of Data and MBMA or other NLME models with multiple covariates   Jeffrey R Sachs (Merck)
"Majority rule" testing can optimize design of trials with Discrete Endpoints Daniel Rosenbloom (Merck)
Closing the Gap: Using MBMA to Make Informed Decisions on Anti-RSV Drug Development    Brian Maas (Merck)
ALWAYS Count Your Chickens before They Hatch: Optimizing trial design for Quantitative Decision-Making  Nele Mueller-Plock (Certara)
Understanding immune responses and viral infections: What can Immune-Viral Dynamics Modeling (I-VDM) teach us? Chairs: Wei Gao (Merck), Youfang Cao (Merck)
Mechanistic Immune-Viral Dynamics Modeling for HIV Cure Drug Development. Youfang Cao (Merck)
Mechanistic Modeling of New Therapies for Chronic Hepatitis B Virus Infection Alan S. Perelson (Los Alamos National Laboratory)
Predicting Influenza Kinetics and Disease Severity Amber M. Smith (University of Tennessee Health Science Center)
Using Viral Dynamics Modeling to Inform Gene Therapy Clinical Development Pinky Dua (Pfizer)
Diving into the PDUFA VI Model Informed Drug Development Program Chairs: Jin Y. Jin (Genentech), Hao Zhu (FDA)
MIDD Pilot Program Showcase: Roche Perspective Alexandre Sostelly (Roche)
MIDD Pilot Program Showcase: Pfizer Perspective Daniele Ouellet (Pfizer)
MIDD Pilot Program Showcase: Eli Lilly Perspective Sandy Karen Dickin (Eli Lilly)
MIDD Pilot Program: FDA Perspective Rajanikanth Madabushi (FDA)
Panel Discussion All Speakers + Yaning Wang (FDA), Jenny Chien (Eli Lilly)
Scaling new heights in Systems Pharmacology: Integrated QSP and PBPK modeling to establish confidence in compound and target mechanism Chairs: Loveleena Bansal (GSK), Stephan Schaller (esqLABS)
A multi-scale mechanism-based model for characterizing Antibody-Dependent Cell-mediated Cytotoxicity in vitro and in patients  William Rittase (Janssen)
Evaluation of novel COPD targets using a QSP model of COPD progression linked with inhaled PBPK modeling  Cibele Falkenberg (GSK)
A PBPK platform model for T cell-dependent bispecific antibodies using PKSim/Mobi Monica E. Susilo (Genentech)
Pharmacokinetic based bridging approach to support a change in route of administration for biologics: thinking beyond traditional efficacy trials Chairs: Anshu Marathe (Novartis), Gerard Bruin (Novartis)
PK-Based Clinical Bridging from IV to SC Route of Administration, the Industry Experience Whitney P. Kirschbrown (Genentech)
A novel pharmacokinetic bridging strategy to support a change in the route of administration for biologics.  Chandrahas Sahajwalla (FDA)
How useful is modeling & simulation in bridging different routes of administration for biologics? A journey of developing golimumab with a new route of administration.  Honghui Zhou (Janssen)



There are several additional exciting events to attend throughout the conference duration:

  • Communication Challenge
  • Student/Trainee Mentoring Session
  • Poster Sessions and Walks
  • Exhibits
  • Alumni Receptions
  • Meet the ISoP Board
  • Quality and Trainee Awards
  • SIG Receptions