ACoP11 Program (9 - 13 November 2020)



 9 Nov 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)
  Pre-Conference Session 1: Current Modeling Practices in Oncology  
  Translation in Oncology: Current Practices and Impact of PKPD Modeling on Guiding Decisions an Iterative Learning in Early Trials Owen Jones (AstraZeneca)
  Tumor Dynamic Modeling and Overall Survival Predictions Rene Bruno (Genentech)
  What can Pharmacometricians Learn from Mathematical Oncology? Kristin Swanson (Mayo Clinic)
  Pre-Conference Session 2: Emerging Modeling Approaches in Oncology  
  Model Based Meta-Analysis: Application to Drug Development Decisionmaking in Oncology Marion Bouillon-Pichault (Bristol Myers Squibb)
  Integration of Omics Data Sources to Inform Mechanistic Modeling of Immuno-Oncology Therapies Andrzej Kierzek (Certara)
  Approaches to Predict and Understand Drug Efficacy from Multi-omics Data: from Machine Learning to Logic Models Julio Saez-Rodriguez (Heidelberg Unversity)
   Pre-Conference Poster Session  
  Session 3: The FDA's MIDD Pilot Program and Oncology Case Studies  
  Role of Modeling in Oncology - MIDD Pilot Program Experience Rajanikanth Madabushi (FDA)
  The Use of Target Receptor Occupancy as an Exposure Endpoint to Guide Drug Development of Mosunetuzumab, a Bispecific for Non-Hodgkins Lymphoma Brendan Bender (Genentech)
  FDA-Sponsor Interactions Enable the Application of Modeling to Drug Development in Oncology and Beyond Luzelena Caro and Mallika Lala (Merck)
  ISoP Awards Brenda Cirincione  (Vertex) and Chris Penland (Astra Zeneca)
 10 -13 Nov

ACoP11 Welcome - President's Address and Opening Remarks

Navin Goyal, ACoP11 Chair 
Brenda Cirincione, ISoP President

  Keynote Address -   Transmission Dynamics and Control of Covid-19: What Have We Learned So Far ?
 Dr Neil Ferguson (Imperial College London)

How can Pharmacometrics help tackle Pandemics  

(Plenary Session on Covid-19)

Chairs: Daniele Ouellet (Pfizer) and Navin Goyal (GSK)
   Repurposing Existing and Developing Therapeutics: Rapid Communication, and Knowledge Management  Brian Corrigan (Pfizer)
  Modeling of Viral Dynamics Jeremie Guedj (INSERM)

QSP for COVID: repurposing  and combining models and drugs

Piet van der Graaf (Certara)
1A Applying Pharmacometrics and Model-Informed Drug Development (MIDD) to Global Health Challenges Chairs: Mark Lovern (Certara), Felix Boakye-Agyeman (Certara)
  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)
1B 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)
2A 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)
2B 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 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)
2C 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)
3A 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)
  Role of joint modelling for tumor size kinetics and survival data in oncology treatment decisions Solene Desmee (University of Tours)
  Improving Strategic Decision-Making with Early Prediction of Survival Outcomes in Oncology Clinical Trials Jonathan French (Metrum)
  Regulatory considerations for novel endpoints in oncology Lian Ma (FDA)
3B Advancing model-informed drug development (MIDD) of siRNA-based gene therapy: challenges and opportunities Chairs: Songmao [Ben] Zheng (Janssen), Varun Goel (Alnylam)
  Symposium Introduction: Advancing model-informed drug development (MIDD) of siRNA-based gene therapy: challenges and opportunities Songmao [Ben] Zheng (Janssen)
  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)
3C 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)
4A 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)
4B Understanding immune responses and viral infections: What can Immune-Viral Dynamics Modeling (I-VDM) teach us? Chairs: Wei Gao (Merck), Youfang Cao (Merck)
  Immune-Viral Dynamics Modeling for CMV Infection and Treatment Youfang Cao (Merck)
  Mechanistic Immune-Viral Dynamics Modeling for HIV Cure Drug Development. Daniel S. Rosenbloom (Merck)
  Predicting Influenza Kinetics and Disease Severity Amber M. Smith (University of Tennessee Health Science Center)
4C Hybrid QSP and machine learning modeling in cardiology and neuroscience drug discovery and development Chairs: James Kozloski (IBM Research), Carolyn Cho (Merck)
  Artificial intelligence for cardiac pharmacology Blanca Rodriguez, (Oxford)
  Reconciling prior knowledge with observational data in respiratory infection Gordon Broderick (Rochester General Hospital)
  Mapping clinical and experimental observations to the latent space of model parameters in analysis of cardiac mechanics and neuronal electrophysiology Viatcheslav Gurev (IBM Research)
  Network inference of omics data using machine learning to inform QSP model development Peter Bloomingdale & Sean Hayes (Merck)
  Alumni Event Chair: Sai Bathena (BMS)
5A Diving into the PDUFA VI Model Informed Drug Development Program Chairs: Jin Y. Jin (Genentech), Hao Zhu (FDA)
  Roche/Genentech experience - Crovalimab in Parxysmal Nocturnal Hemoglobinuria (PNH) Alexandre Sostelly (Roche)
  MIDD Pilot Program Showcase: Pfizer Perspective Daniele Ouellet (Pfizer)
  MIDD Pilot Program Showcase: Eli Lilly Perspective Sandy Karen Dickin (Eli Lilly)
  PDUFA VI Model-Informed Drug Development (MIDD) Paired Meeting Pilot: Program Update and Perspectives Rajanikanth Madabushi (FDA)
  Panel Discussion All Speakers + Yaning Wang (FDA), Jenny Chien (Eli Lilly)
5B 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)
5C 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)
  How useful is modeling & simulation in bridging different routes of administration for biologics? A journey of developing golimumab with a new route of administration. Jocelyn Leu (Janssen)
  A novel pharmacokinetic bridging strategy to support a change in the route of administration for biologics. Chandrahas Sahajwalla (FDA)
  PK-Based Clinical Bridging from IV to SC Route of Administration, the Industry Experience Whitney P. Kirschbrown (Genentech)
   Roller Coaster Sessions  
 Saving the PMx World... Chair: Rajendra Singh (GSK)
  Are PopPK analyses at risk in a gig economy? Peter Bonate (Astellas)
  No datapoint left behind: Rescuing biomarker information below the limit of quantification Daniel Rosenbloom (Merck)
  Learning from outside your therapeutic area: avoiding reinventing the wheel Mark Baker (ViiV Healthcare)
  Reverse Translation in Quantitative Systems Pharmacology Panagiota Foteinou (Sanofi)


Making Things Up, the Bad and the Good Chair: Pavan Vaddady (Merck)
  Some Things Just Don't Hold Water: Insights into Renal Function Estimation in Adults from Real World Evidence Nadia Noormohamed (Merck)
  Survival prediction and AI technologies Yuanfang Guan (University of Michigan)
  The role of open science in the development of regulatory endorsed clinical trial simulations tools for Alzheimer's disease, Parkinson's disease, and Huntington's disease Nathan Hanan (C-Path)
  Modelers are from Mars, Biologists are from ... Kathleen Morgan (Immunetrics)
  ACoP Trainee and Quality Abstract Awards Chair: Kenta Yoshida (Genentech)
  Social Event Chair: Mirjam Trame (AvroBio)

Tutorial #1 - Student/Trainee Tutorial : First in Human Dosing Determinations: From small molecules to cell-therapy

Chairs: Brian Cicali (UFL) and Rajendra Singh (GSK)

Tutorial #2 - Model Analysis Boot Camp for Pharmacometricians

Chairs: Helen Moore (Applied BioMath) and Craig Thalhauser (BMS)

Tutorial #3 - An open-source Pharmacometrician's workflow in R: from exploration (xGx) to model building (nlmixr) and diagnostics (ggPMX)

Chair: Souvik Bhattacharya (Novartis)