Preliminary ACoP10 Program


7:00 AM 9:00 AM Breakfast and Registration for Pre-Meeting Workshops  
8:00 AM 5:00 PM ISoP Board of Directors' Meeting (by invitation only)  
8:00 AM 5:00 PM Pre-Meeting Workshops (separate registration required)  
7:00 AM 9:00 AM Breakfast and Registration for Pre-Meeting Workshops & Preconference  
7:30 AM 5:00 PM

ACoP10 Pre-Conference: Clinical Pharmacometrics: Bringing Models to Patients (separate registration required)

Includes pre-conference poster session

Navin Goyal (GSK)
Elizabeth Lakota (Vertex)
8:00 AM 5:00 PM CPT:PSP Editorial Team Meeting (by invitation only)  
8:00 AM 5:00 PM Pre-Meeting Workshops (separate registration required)  
12:00 PM 5:30 PM ACoP10 Registration  
5:00 PM 5:30 PM ISoP Awards & Fellows Reception (invitation only)  
5:45 PM 7:30 PM Opening Session  
    Welcome/Conference Highlights Mirjam N. Trame (Novartis), ACoP10 Conference Chair
    Presentation of ISoP Awards & Induction of Fellows Hosted by:
Sihem Bihorel (University of Florida),
Heather Vezina (BMS)
    Lewis B. Sheiner Award Lecture  
7:30 PM 9:30 PM Opening Reception  
 8:00 PM  9:00 PM  ACoP10 Poster Walk  
7:00 AM 9:00 AM Registration / Coffee / Exhibit Hall Open  
8:00 AM 9:00 AM Contributed Posters Session 1 (morning)  
9:15 AM 9:45 AM President's Address/President-Elect's Address  
    ISoP 2019: The Year in Review Justin Wilkins (Occams), ISoP President
    ISoP 2020: The Year Ahead Brenda Cirincione (Vertex), ISoP President-Elect
9:45 AM 10:45 AM State-of-the-Art Lecture by Tareef Kawaf (RStudio): Open Source Data Science - A Look at the Possibilities Hosted by: Mirjam N. Trame (Novartis), ACoP10 Conference Chair
10:45 AM 11:00 AM Break  
11:00 AM 12:30 PM Concurrent Sessions 1  
    Session 1a: Quantitative Methods from Drug Development Impact Decision Making in Global Health Chair: Rukmini Kumar (Vantage Research)
    Joint longitudinal and time-to-event model for estimating risk of preeclampsia during pregnancy Samer Mouksassi (Certara)
    The derivation of standardized HAZ based growth metrics to be used as predictors for the variability of Wechsler Preschool and Primary Scale of Intelligence-III (WPPSI) Niclas Jonsson (Pharmetheus)
    Of “clever” models and “dumb” spreadsheets: what is more effective to drive policy change? Paolo Denti (University of Cape Town)
    Regulatory perspective on using MiDD for Global Health Jiang Liu (FDA)
    Session 1b: Integrated Pharmacometrics and Systems Pharmacology (iPSP) Modeling Without Borders: Opportunities and Challenges for Re-purposing iPSP Models Chairs: Anu Shilpa Krishnatry (GSK), Dan Kirouac (Applied BioMath)
    Repurposing the published models or model framework to address drug development and regulatory questions Dhananjay Marathe (Merck)
    QSP consortia impacting drug development: from open source to shared science towards re-purposing of iPSP models Piet H. van der Graaf (Certara)
    Extension of a liver safety modeling platform to NAFLD/NASH treatment, kidney toxicity, and pulmonary fibrosis treatment: making the most of a QST/QSP framework Scott Siler (DILIsym)
    Best practices to maximize the use and re- use of QSP models - recommendations from the UK QSP Network Lourdes Cucurull-Sanchez (GSK)
    Session 1c: Decision Analysis for Master Trials in Oncology Chairs: Amal Ayyoub (FDA), Nidal Al-Huniti (AstraZeneca)
    Bayesian approaches to clinical trials Lorenzo Trippa (Dana- Farber Cancer Institute)
    Statistical controversies in the decision analyses of platform trials Nidal Al-Huniti (AstraZeneca)
    How to detect an effective treatment under resource constraints: application in umbrella and basket trials Iris Wu (Merck)
    Combining BLRM and safety PKPD models to improve decision making in a phase I dose escalation study: Case study of PCA062, an antibody drug conjugate targeting P-Cadherin Jaeyoen Kim (Novartis) - Abstract Presenter
12:30 PM 2:00 PM Lunch / Exhibits  
12:30 PM 2:00 PM Student/Trainee Mentoring Session with Lunch (free, separate registration required) Hosted by: Ashwin Karanam (University of Minnesota), ISoP Student Community
2:00 PM 3:30 PM Concurrent Sessions 2  
    Session 2a:Novel Tools and Technologies: Is This Sustainable? Balancing Capability, Efficiency, Costs and Regulatory Acceptance Chairs: Navin Goyal (GSK), April Barbour (Incyte)
    Balancing capability while balancing budgets in a diversifying field Daniele Ouellet (Pfizer)
    A regulatory perspective on conducting and reviewing analyses which utilize emerging technologies Yaning Wang (FDA)
    Considerations for the development of free, open- source pharmacometric software Marc Gastonguay (Metrum)
    Training the future quantitative pharmacologist- casting a wide net or choosing an area of expertise Joga Gobburu (University of Maryland)
    Session 2b: QSP Modeling in Neuroscience: Novel Technologies and Methodologies Chairs: Peter Bloomingdale (Merck), William McCarty (Amgen)
    AD pathology QSP platform: studying the interactions between different toxicity modules through the junction of mechanistic submodels Tatiana Karelina (InSysBio)
    Assessment of drug-induced toxicity in the brain microphysiological system (MPS) using targeted and untargeted molecular profiling Murat Cirit (MIT)
    Computational phenotyping of psychiatric disorders using neuroimaging and digital devices Justin Baker (Partners HealthCare)
    Personalized brain network models for disease prediction Sarah Muldoon (University at Buffalo)
    Session 2c: Science of Passive Oral Absorption Modelling Chairs: Venkatesh Pilla Reddy (AstraZeneca), Gaohua Lu (GSK)
    Mechanistic oral absorption modelling: from early discovery to regulatory submissions - examples from Industry Gaohua Lu (GSK) and Venkatesh Pilla Reddy (AstraZeneca)
    Simcyp ADAM model for modelling passive drug absorption David Turner (Certara)
    GastroPlus ACAT model for modelling passive drug absorption Viera Lukacova (Simulations Plus)
    GI-Sim approach to modelling passive drug absorption Christer Tannergren (AstraZeneca)
3:45 PM 4:45 PM Contributed Posters Session 1 (afternoon)  
4:00 PM 4:30 PM MCS Poster Walk  
    Exhibits / Break  
3:45 PM 5:00 PM JPKPD Editorial Board Meeting (by invitation only)  
5:00 PM 5:05 PM WCoP 2020 Announcement Stacey Tannenbaum (Astellas)
5:05 PM 6:30 PM Innovation in Communication Hosted by:
Brenda Cirincione (Vertex)
Stacey Tannenbaum (Astellas)
6:30 PM 10:00 PM Social Event  
7:00 AM 9:00 AM Coffee / Exhibit Hall Open  
8:00 AM 9:00 AM Contributed Posters Session 2 (morning)  
9:00 AM 10:30 AM Concurrent Sessions 3  
    Session 3a: Challenges and Opportunities in Pharmacometric Analysis in Preclinical and Clinical Development of CAR-T Therapy Chairs: Aman P. Singh (Janssen), Xu Zhu (Novartis)
    Pharmacometrics analysis of cellular immuno-therapy Chao Liu (FDA)
    The cellular kinetics and anti-tumor dynamics of Kymriah Andrew Stein (Novartis)
    Measurement and Quantitative Characterization of Whole-Body Pharmacokinetics of Exogenously Administered T Cells in Mice Antari Khot (Pfizer)
    A Quantitative Relationship Between CAR-Affinity, Target Abundance, Target-Cell Depletion and Cytokine Release: Implications Towards Development of CAR-T cell-therapy Aman P. Singh (Janssen)
    Session 3b: Don’t Forget the Children: How Quantitative Systems Pharmacology can Reshape Extrapolation in Pediatric Drug Development Chairs: Tarek Leil (BMS), Scott Siler (DILIsym)
    Pediatric extrapolation: regulatory considerations Lynne Yao (FDA)
    QSP modeling of the Gaucher disease can substitute clinical trial efficacy data in pediatrics Satyaprakash Nayak (Pfizer)
    An integrated PB-QSP platform for the evaluation of the effects of age in diabetes Stephan Schaller (esqLABS)
    Using a QSP model of bile acid dynamics to investigate ursodiol dynamics in neonates Christina Friedrich (Rosa & Co.)
    Session 3c: Digital Measurements: Changing the Drug Development Paradigm Chairs: Daniela J. Conrado (Critical Path Institute), Jackson Burton (Critical Path Institute)
    Applications of digital measurements in drug development Daniela J. Conrado (Critical Path Institute)
    Modeling drug efficacy studies with digital endpoints Gregory Hather (Takeda)
    Lessons learned from using sensor-derived digital biomarkers Jonas Dorn (Novartis)
    Wearable sensors, smart phones, and machine learning: impact on clinical Care and research trials Arun Jayaraman (Shirley Ryan Ability Lab)
10:30 AM 10:45 AM Break  
10:45 AM 11:45 AM Keynote Lecture by Tim Wells (MMV): Optimizing Medicines for Malaria Control and Elimination: How does Modeling and Simulation Help Hosted by: Nahor Haddish-Berhane (Janssen), ACoP10 Scientific Programming Chair
11:45 AM 1:15 PM Lunch  
11:45 PM 1:15 PM Meet the QSP and SxP SIGs Lunches  
1:00 PM 2:00 PM Contributed Posters Session 2 (afternoon)  
2:15 PM 3:15 PM Sponsored Investigator Session Hosted by: Mirjam N. Trame (Novartis), ACoP10 Conference Chair, and Navin Goyal (GSK), ACoP10 Pre-conference Chair
    Building capacity for quantitative clinical pharmacology research in India Vikram Prakash (ACTREC, Tata Memorial Center, India)
    Pharmacometrics in Uruguay: fostering the quantitative framework to address local issues and vice versa Manuel Ibarra (Universidad de la Republica - Uruguay)
    Impact of Pharmacometrics in Cuba: its application to study nimotuzumab in patients with breast cancer Leyanis Rodriguez (University of Havana - Cuba)
3:15 PM 3:30 PM Break  
3:30 PM 5:00 PM Concurrent Sessions 4  
    Session 4a: Superbugs, Biologic Antibacterials and New Challenges in Application of Pharmacometrics Chairs: Parviz Ghahramani (Inncelerex), Tatiana Khariton (Inncelerex)
    Clinical perspective on application of pharmacometrics in development of biologic antibacterials compared to traditional small molecules Cara Cassino (ContraFect)
    Challenges and nuances in PK-efficacy modeling in animal models of infection Joannaellyn Chiu (Inncelerex)
    Challenges in PK-Efficacy Modeling and Clinical Dose Selection of Antimicrobial Peptides (AMPs) Parviz Ghahramani (Inncelerex)
    Population PKPD Analysis of 2-Way Interaction Between Plazomicin and Changes in Serum Creatinine: A Simultaneous PK/PD Model with a Feedback Loop Adekemi Taylor (Certara) - Abstract Presenter
    Session 4b: Putting Together the Puzzle: How Integrated Mechanistic Modeling Framework Enables Acceleration of the Drug Development of T cell-engaging Bispecific Antibodies Chairs: Xiaoying Chen (Pfizer), Chunze Li (Genentech)
    Translational modeling strategies to predict clinical starting and efficacious doses for CD3 bispecific molecules Alison Betts (Applied BioMath)
    A modeling framework to characterize cytokine release upon T-BsAb treatment: methodology and opportunities Xiaoying Chen (Pfizer)
    Quantitative pharmacology to inform a patient-centric dosing strategy of mosunetuzumab, a CD3/CD20 bispecific antibody for treatment of Non-Hodgkins Lymphoma Chi-Chung Li (Genentech)
    Considerations in development of T cell-engaging bispecific antibodies: experience, challenges and opportunities Min Zhu (Regeneron)
    Session 4c: FDA Science Forum: Model-based Approaches for Patient Pharmacokinetic Studies with Sparse Sampling Design Chairs: Liang Zhao (FDA), Lanyan (Lucy) Fang (FDA)
    Regulatory challenges and opportunities for model-based approaches for patient pharmacokinetic studies with sparse sampling design Lanyan (Lucy) Fang (FDA)
    Model-based statistical approaches for pharmacokinetic bioequivalence studies with sparse sampling and extension to two-stage designs France Mentre (Inserm)
    Development and comparison of model-based bioequivalence analysis methods on sparse data Andrew Hooker (Uppsala University)
    Model-based bioequivalence evaluation for ophthalmic products using model averaging approaches Xiaomei Chen (Uppsala University)
5:00 PM 6:00 PM Alumni Receptions (by invitation only)  
5:30 PM 7:00 PM QSP - SIG Reception  
6:00 PM 7:00 PM President's Reception (by invitation only)  
6:00 PM  7:30 PM  Clinical Pharm/MCS/SxP SIG Reception  
7:00 AM 9:00 AM Coffee / Exhibit Hall Open  
8:00 AM 9:00 AM Contributed Posters Session 3 (morning)  
9:00 AM 10:30 AM Quality and Trainee Awards Hosted by: Luning (Ada) Zhuang (FDA), ACoP10 Abstract Committee Chair
10:30 AM 10:45 AM Break  
10:45 AM 12:15 PM Concurrent Sessions 5  
    Session 5a: MIDD: Vaccine R&D Gets a Shot in the Arm from PMx Chairs: Nitin Mehrotra (Merck), Karim Azer (Bill & Melinda Gates Medical Research Institute)
    A dose of prevention for vaccine R&D: a regimen of PMx dosed at discovery, development, and post-licensure Jeff Sachs (Merck)
    QSP modeling efforts to advance global health: application to TB drugs and vaccines Karim Azer (Bill & Melinda Gates Medical Research Institute)
    MIDD in vaccines: application to TB and malaria vaccine clinical development Tawanda Gumbo (BSW Medical Center)
    CBER model informed drug development experience: Overview of PDUFA VI pilot program & application to vaccines Million A. Tegenge (FDA)
    Panel Discussion  
    Session 5b: Curing Diseases Through Genetic Manipulation: Advancements and Potential of Gene and Viral Therapy and Their Optimization with Model-Based Analysis Chairs: Abhishek Gulati (Astellas), Weirong Wang (Janssen)
    Viral gene therapy: the role of grug metabolism, pharmacokinetics (DMPK) and clinical pharmacology Nagendra Chemuturi (Novartis)
    QSP model for the development of oncolytic viral therapy Oleg Milberg (Janssen)
    QSP model of mRNA lipid nanoparticle for preclinical to clinical translation Joshua F. Apgar (Applied BioMath)
    Computational pharmacokinetic/pharmacodynamic (PKPD) modelling of DNA-based therapies for treatment of rare-diseases Inaki F. Troconiz (University of Navarra)
    Session 5c: Pharmacogenomics and Modeling Provide Great Opportunity for Developing Novel Therapies Chairs: Sharvari Bhagwat (Amgen), Mohamed Shahin (University of Florida)
    Genomics framework for improving target discovery and accelerating drug development Justin Wade Davis (Abbvie)
    Genetic approaches to discover drug targets for atrial fibrillation Sridharan Rajamani (Amgen)
    Systems modeling to understand the effects of genetic variants on responses to therapeutic interventions Kapil Gadkar (Genetech)
    Systems Pharmacology Modeling Identifies a Novel Treatment Strategy for Bortezomib-Induced Neuropathic Pain Peter Bloomingdale (Merck) - Abstract Presenter
12:15 PM 1:30 PM Lunch  
12:15 PM 1:30 PM Meet the MCS and ClinPMx SIGs Lunches  
1:30 PM 2:30 PM Contributed Posters Session 3 (afternoon)  
2:30 PM 3:30 PM Roller Coaster Session 1a Chair: Mirjam N. Trame (Novartis), ACoP10 Conference Chair and Navin Goyal (GSK), ACoP10 Pre-conference Chair
    Using machine learning to predict survival from biomarker dynamics Alex Yu (Janssen)
    QSP for checkpoint inhibitor combinations Andrew Stine (Immunetrics Inc.)
    Tracking Variability and uncertainty of QSP models: A Boolean Approach Implemented in Immuno-Oncology Matthew Putnins (Rutgers University)
2:30 PM 3:30 PM Roller Coaster Session 1b Chair: Nahor Haddish-Berhane (Janssen), ACoP10 Scientific Programming Chair and Craig Comisar (Certara)
    Overcoming technical borders in pharmacometrics: NLME modeling and simulation in R using NONMEM, MONOLIX, or NLMIXR in an exchangeable manner Anne Kuemmel (IntiQuan)
    A semi-mechanistic longitudinal dose-response model-based meta-analysis for weight loss Matt Zierhut (Janssen)
    Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology Gaurav Bajaj (Genmab)
3:30 PM 3:45 PM Break  
3:45 PM 5:15 PM Concurrent Sessions 6  
    Session 6a: Utility of Modeling in Development and Approval of Oligonucleotide Therapies Chairs: Varun Goel (Alnylam Pharmaceuticals), Ivan Nestorov (Biogen)
    Impact of modeling on describing PK, PK/PD, and disease progression properties of double stranded small interfering RNA enclosed lipid nano particle (LNP): Patisiran for treatment of hereditay transtherytin (hATTR) mediated amyloidosis Varun Goel (Alnylam Pharmaceuticals)
    Model and simulation to translate between in vitro and in vivo and to support pre-clinical and clinical research and development of oligonucleotides Xiao Shelley Hu (Wave Life Sciences)
    Development of a translational population PKPD model of mRNA-1944 encoding antibody against chikungunya virus in rats and non-human primates Husain Attarwala (Moderna Therapeutics) - Abstract Presenter
    Longitudinal PKPD analysis for urinary aminolevulinic acid (ALA) from phase I, II, and III clinical studies of givosiran in acute hepatic porphyria Sagar Agarwal (Alnylam Pharmaceuticals) - Abstract Presenter
    Session 6b: Beyond Visual Checks: Ways to Quantitatively Evaluate QSP Model Predictions Chairs: Helen Moore (Applied BioMath), Sietse Braakman (MathWorks)
    Simulation model verification, validation, and calibration: what's what? William Oberkampf (Sandia National Laboratories)
    When can we trust a complex biomedical model? Pras Pathmanathan (FDA)
    An overview of quantitative evaluation methods for QSP models Helen Moore (Applied BioMath)
    Panel Discussion All Speakers
    Session 6c: You Say To-MAY-to, I Say To-MAH-to What Statisticians Wish Pharmacometricians Understood (About Statistics) Chairs: Jonathan French (Metrum), Stacey Tannenbaum (Astellas)
    Panel Discussion Jim Rogers (Metrum) France Mentre (Inserm) Brian Smith (Novartis) Ken Kowalski (Pmetrics Consulting) Lei Nie (FDA)
5:15 PM 5:30 PM Closing Remarks  
5:45 PM 7:30 PM ACoP11 Meets ACoP10 (by invitation only)  
7:00 AM 9:00 AM Breakfast (only for tutorial attendees)  
7:00 AM 12:00 PM Student/Trainee Event with Breakfast: TBD (students/trainees only, separate registration required) Chairs: Ashwin Karanam (University of Minnesota), Birgit Schoeberl (Novartis)
    Quantitative Systems Pharmacology in Translational Drug Development John Burke (Applied Biomath), Kyle Baron (Metrum RG), Kapil Gadkar (Genentech), Jeff Kearns (NIBR), Hao Zhu (FDA)
8:00 AM 12:00 PM Tutorial Sessions (free, separate registration required)  
8:00 AM 12:00 PM Tutorial 1: The Role of Pharmacometrics in Advancing Quantitative Benefit-Risk Assessments for Drug Review and Approval Chairs: Arnab Mukherjee (Pfizer), Timothy Nicholas (Pfizer), Richard Lalonde (University of Florida)
    Innovations in benefit-risk analysis for decision-making GK Raju (LightPharma)
    Regulatory perspectives on the role of pharmacometrics in benefit risk analysis Hao Zhu (FDA)
    Application of benefit risk analysis in the cardiovascular therapeutic area WonKyung Byon (Pfizer)
    Clinical utility index for benefit risk evaluation Daniele Ouellet (Pfizer)
    The confluence of Statistical and Pharmacometric Approaches for Benefit Risk Analysis: a case study using Bayesian joint models for safety and efficacy Jonathan French (Metrum)
    Quantitative Benefit-Risk Assessment Using Model-Based Approaches: An Example in the Oncology Therapeutic Area Jin Jin (Genentech)
    Panel Discussion GK Raju, Yaning Wang, Daniele Ouellet, Jonathan French, Wonkyung Byon, Jin Y. Jin, Brian Corrigan, Kevin Dykstra, Hao Zhu
8:00 AM 12:00 PM Tutorial 2: The Use of Machine Learning in Drug Development with Regulatory Considerations Chair: Sarah Kim (University of Florida)
    Introduction to ML in drug development Hao Zhu (FDA) and Jackson Burton (Critical Path Institute)
    Hands-on tutorial Juan Francisco Morales (National University of La Plata) and Jagdeep Podichetty (Critical Path Institute)
8:00 AM 12:00 PM Tutorial 3: Pharmacometrics Goes Open-Source Chairs: Mirjam N. Trame (Novartis), Nahor Haddish-Berhane (Janssen)

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

Matt Fidler, Wenping Wang, Souvik Bhattacharya, Irina Baltcheva, Fariba Khanshan, Andrew Stein (All Novartis)
    A completely open-source pharmacometrics tool set: Moving from vision to reality with R, mrgsolve and Stan/Torsten Marc Gastonguay (Metrum), Bill Gillespie (Metrum)
    Open Systems Pharmacology community - an open access, open source, open science approach to modeling and simulation in pharmaceutical sciences Stephan Schaller (esqLabs)
12:00 PM 1:00 PM Lunch (not provided; for workshops only)  
1:00 PM 5:00 PM Post-Meeting Workshops (separate registration required)  
7:00 AM 8:00 AM Breakfast  
8:00 AM 5:00 PM Post-Meeting Workshops (separate registration required)