ACoP9 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) - Click for details  
7:00 AM 9:00 AM Breakfast and Registration for Pre-Meeting Workshops & Preconference  
7:30 AM 5:00 PM ACoP9 Pre-Conference:  Digital Health Technology, Machine Learning and Artificial Intelligence: The Future of Clinical Trials and Informative Therapeutic Decisions? (separate registration required) Co-Chairs:
Mirjam N. Trame (Novartis)
Puneet Gaitonde (Pfizer)
8:00 AM 5:00 PM CPT:PSP Editorial Board Meeting (by invitation only)    
8:00 AM 5:00 PM Pre-Meeting Workshops (separate registration required) - Click for details  
12:00 PM 5:30 PM ACoP9 Registration  
5:00 PM 5:30 PM ISoP Awards & Fellows Reception (invitation only)  
5:45 PM 7:30 PM Opening Session  
    Welcome/Conference Highlights C.J. Musante, ACoP9 Conference Chair
    Presentation of ISoP Awards & Induction of Fellows Hosted by:
Sihem Bihorel
Brenda Cirincione
    Lewis B. Sheiner Award Lecture  David D'Argenio
7:30 PM 9:30 PM Opening Reception  
7:00 AM 9:00 AM Registration /Breakfast / 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 2018: The Year in Review Jin Y. Jin, ISoP President
    ISoP 2019: The Year Ahead Justin Wilkins, ISoP President-Elect
9:45 AM 10:45 AM Keynote Lecture - Walter Woltosz Hosted by: Joy Hsu, ACoP9 Scientific Programming Chair
10:45 AM 11:00 AM Break  
11:00 AM 12:30 PM Concurrent Sessions 1  
    Session 1a:  AI and Pharmacometrics:  Time to Embrace, Capitalize and Advance? Chairs:  Ayyappa Chaturvedula (UNTHSC), Navin Goyal (GSK)
    Applying AI/ML/DL tools to accelerate drug development Stacie Clad-Thompson (GSK)
    Application of deep learning methods in drug repurposing efforts Nandu Gattu (Excelra)
    Machine learning methods for pharmacometrics model development Mark Sale (Nuventra)
    AI in pharmacometrics- regulatory perspective Chao Liu (FDA)
    Developing Machine Learning Algorithms using CATIE Schizophrenia Clinical Trial Data to Predict Reduction in Total PANSS Score and Identify Important Patient Outcome Predictors Poster Abstract Speaker - Jagdeep Podichetty (Indiana University School of Medicine)
    Session 1b:  Challenges and Opportunities for Cardiovascular QSP Modeling in Drug Development and Safety Evaluation Chairs:  Sergey Ermakov (Amgen), Anna Sher (Pfizer)
    Predicting QTc and Torsade de Pointes based on in vitro data - informing clinical development and drug labeling Derek Leishman (Eli Lilly)
    Identification and validation of therapeutic targets to improve myocardial mechanoenergetics in heart failure Daniel Beard (Univ. Michigan)
    Multiscale modeling of the failing heart: From cell to patient Andrew McCulloch (UCSD)
    A quantitative systems pharmacological study for risk assessment of astemizole-induced proarrhythmia Poster Abstract Speaker - Mikiko Nakamura (Chugai Pharmaceutical Co)
    Session 1c:  A Perspective on integrating Pharmacometrics and Quantitative Systems Pharmacology characteristics using examples Chairs:  Mirjam N. Trame (Novartis), Teun M. Post (LAP&P)
    iPSP Model with Underlying Network Analysis to Predict Clinical Endpoint Biomarkers in Anti-thrombotic Therapy Mirjam N. Trame (Novartis)
    Multi-scale iPSP Model of Physiologically-based Representations to Describe Bone Mineral Homeostasis and Interrelated Effects Matthew Riggs (Metrum)
    Application of an iPSP Model with Reduced Mechanistic Detail for a Disease System Analysis applied to Osteoporosis Teun M. Post (LAP&P)
    Development of a minimal PBPK-PD iPSP model for the HCV nucleoside inhibitor MK-3682 Matthew Rizk (Merck)
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: Yi Ting (Kayla) Lien, ISoP Student Community
2:00 PM 3:30 PM Concurrent Sessions 2  
    Session 2a:  From translational PKPD models to quantitative system pharmacology in neurodegeneration drug development Chairs:  Sreeraj Macha (Merck), Li Li (Eli Lilly)
    Quantitative Systems Pharmacology for Neuroscience drug discovery and development: current state, opportunities and challenges Piet van der Graaf (Certara)
    Quantitative systems pharmacology model for amyloid pathology investigation Tatiana Karelina (InSysBio)
    Mechanistic PKPD modeling to understand the uncertainty in predicting CSF target engagement Li Li (Eli Lilly)
    Turning the tide of failed trials. Re-engineering R&D using quantitative systems pharmacology Hugo Geerts (In Silico Biosciences)
    Disease progression model platform to inform efficient clinical trial design for Parkinson's Disease Poster Abstract Speaker - Malidi Ahamadi (Merck)
    Session 2b:  How pharmacometrics could significantly impact regulatory decision making process Chairs:  Joy C. Hsu (Roche), Nicolas Frey (Roche)
    Modifying "Dosage and Administration" section of vismodegib label based on Modeling & Simulation Pascal Chanu (Genentech)
    Pharmacometric Driven Post-Approval Nivolumab Dose Optimization Amit Roy (BMS)
    First-line alectinib approval in the U.S. and E.U. for ALK-positive NSCLC one year ahead of global trial readout based on Japanese trial findings: a M&S story Joy C. Hsu (Roche)
    A regulatory perspective on the application of model based analyses Yaning Wang (FDA)
    High Regulatory impact M&S: The EMA experience and outlook Efthymios Manolis (EMA)
    Session 2c:  Modeling Without Finish Line – Personalized Medicine by Quantitative Pharmacology In the Post-Approval Space Chairs:  Michael A Tortorici (CSL Behring), Melody Luo (J&J)
    Precision Medicine: Opportunity for Clinical Pharmacology/Pharmacometrics Joga Gobburu (Univ. Maryland)
    Herceptin in Gastric Cancer: Exposure response analysis for overall survival based on two dose levels Matts Kagedal (Genentech)
    Strategic Use of Information Technology Interventions to Affect Clinical Care Evolution Sandy Aronson (Partners HealthCare Personalized Medicine)
    reSET Digital Therapeutic for SUD Demonstrates Dose-Dependent Improvement in Outcomes Poster Abstract Speaker - Hilary Luderer (Pear Therapeutics)
3:45 PM 4:45 PM Contributed Posters Session 1 (afternoon)  
3:45 PM 4:15 PM MCS Poster Walk  
    Exhibits / Break  
4:00 PM 5:15 PM JPKPD Editorial Board Meeting (by invitation only)  
5:00 PM 5:05 PM WCoP 2020 Announcement Stacey Tannenbaum
5:05 PM 6:30 PM Innovation in Communication Hosted by:
Brenda Cirincione
Stacey Tannenbaum
6:30 PM 10:00 PM Social Event  
7:00 AM 9:00 AM Breakfast / 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:  Pharmacometrics in Big Data Era - Mission possible to find the needle in a haystack

(A Mathematical and Computational Science Special Interest Group Endorsed Symposium)

Chair:  Liang Zhao (FDA)
    Use of machine learning in pharmacometrics and to disentangle the effect of a single drug in combination therapy Tawanda Gumbo (Baylor)
    Big data to smart data in Brain disease: Real-world examples of advanced modeling and simulation Lee Lancashire (Cohen Veterans Bioscience)
    Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis Meng Hu (FDA)
    Drug-Induced Transcriptomics, Data  Integration, and Machine Learning to Accelerate Drug and Target Discovery Avi Ma'ayan (Mount Sinai)
    Session 3b:  Diagnostics and Methodologies for Evaluating QSP Models Chairs:  Jason Chan (Eli Lilly), Evan Wang (Eli Lilly)
    Towards Shared Technical Approaches and Best Practices for QSP Model Testing Saroja Ramanujan (Genentech)
    Evaluations of Scale: Lessons Learned While Developing and Extending a Mineral and Bone Health Multiscale Systems Pharmacology Model Matthew Riggs (Metrum)
    Qualification of QSP models during use and reuse: Case studies from a cardio-renal model K. Melissa Hallow (Univ. Georgia)
    Wavelet-based Approaches to Assessing the Predictive Performance of Multi-scale Models Donald Mager (Univ. Buffalo)
    Session 3c:  Advancing model-informed drug development (MIDD) of T cell-engaging bispecific antibodies through a multi-disciplinary lens: challenges and opportunities Chairs:  Shang-Chiung (Charles) Chen (Genentech), Chi-Chung Li (Genentech)
    Clinical population PK and PKPD Model Development of aCD3CD20, a bispecific antibody for treatment of Non-Hodgkin lymphoma (NHL) patients Brendan Bender (Genentech)
    Modelling binding kinetics of bispecific antibodies in a physiological context Linzhong Li (Certara)
    T Cell-Engaging Bi-Specific Antibodies: Promise and Complexities of the "New Magic Bullet" in Immunoncology Ronda Rippley (Regeneron)
    Pharmacokinetic/Target Engagement/Pharmacodynamic (PK/TE/PD) Modeling of T-Cell Redirecting Bispecific Antibodies Songmao Zheng (J&J)
    Generalizable Systems Pharmacology Model of Bispecific T-cell Engager (BiTE) Antibody Constructs: Case study of blinatumomab (CD19/CD3) in Non-Hodgkin Lymphoma Patients Poster Abstract Speaker - Vaishali Chudasama (Amgen)
10:30 AM 10:45 AM Break  
10:45 AM 11:45 AM State of the Art Lecture by  Andrew Lo :    P-Values vs. Patient Values: An Analytic Perspective  Hosted by: C.J. Musante, ACoP9 Conference Chair
11:45 AM 1:15 PM Lunch  
12:00 PM 1:00 PM Meet the QSP and SxP SIGs Lunches  
1:00 PM 2:00 PM Contributed Posters Session 2 (afternoon)   
2:15 PM 3:45 PM Concurrent Sessions 4  
    Session 4a:  Model-based Solutions to Complexities in Developing Drugs Exhibiting Target-Mediated Drug Disposition (TMDD) Chairs:  Scott A. Van Wart (Enhanced Pharmacodynamics), TBD (student)
    Translational PK-PD model for a monocolonal antibody combination product to neutralize S. aureus toxins in lung infection patients Christopher M. Rubino (ICPD)
    Translational pharmacokinetics and pharmacodynamics of lampalizumab in patients with geographic atrophy (GA) Jin Y. Jin (Genentech)
    Integrating TMDD and QSP models to accelerate the development of biological immunotherapy John M. Burke (Applied BioMath)
    Challenges and potential opportunities to better predict bioequivalence and switchability for biologics exhibiting TMDD Scott A. Van Wart (Enhanced Pharmacodynamics)
    Session 4b:  Selected topics that would benefit from enhanced collaboration between statisticians and pharmacometricians Chairs:  France Mentré (Inserm), Robert Bies (Univ. Buffalo)
    Introduction and overview of the SxP Pharmacometrician and Statistician Survey France Mentré (Inserm)
    Multiplicity issues with covariate analysis: strategies and perspectives on pre-specification of pharmacometric analyses Jose Pinheiro (J&J)
    What are the inferential (causal) limits or concerns regarding establishing inferences in observational data Jim Rogers (Metrum)
    Common concerns regarding the visualization of pharmacometric data Andreas Krause (Idorsia)
    Panel Discussion: strategies to enhance cross functional communication and education Panel - TBC
    Session 4c:  Parameter Variability Is Not a Crime: Virtual Patients Simulations with QSP Model Chairs:  Joshua F. Apgar (Applied BioMath), Tarek Leil (BMS)
    Parameter uncertainty and inter-individual variability as two sources of parameter variability for QSP model Joshua F. Apgar (Applied BioMath)
    Development of virtual populations for prediction of the response to treatments for non-alcoholic fatty liver disease Theodore Rieger (Pfizer)
    Virtual Patient Cohort Development and Virtual Population Calibration for a QSP Model of Immuno-Oncology Yougan Cheng (BMS)
3:45 PM 4:00 PM Break  
4:00 PM 5:30 PM Concurrent Sessions 5  

Session 5a:  Quantitative Systems Pharmacology (QSP) and Big data: How to integrate best of both worlds to advance drug development? 

(A Quantitative Systems Pharmacology Special Interest Group Endorsed Symposium)

Chairs:  Valeriu Damian (GSK), Loveleena Bansal (GSK)
    Cardiotoxicity caused by cancer therapeutics: using transcriptomics measurements to drive mechanistic simulations and improve predictions Eric Sobie (Mount Sinai)
    Towards Quantitative Cancer Systems Pharmacology by Integrating Big Data with Mechanistic Pan-Cancer Signaling Models Marc Birtwistle (Clemson Univ.)
    Fitting logic and causal reasoning models to diverse molecular data to unravel mechanisms of drugs’ toxicity Panuwat Trairatphisan (RWTH Aachen Univ.)
    Predicting ligand-dependent tumors from multi-dimensional signaling features Andreas Raue (Merrimack)

Session 5b:  Beyond Pharmacokinetics: Clinical Pharmacometrics for Optimizing Patient Outcomes in the 21st Century

(An ISoP/ACCP Clinical Pharmacometrics Special Interest Group Jointly Sponsored Symposium)

Chairs:  Daniel Wright (Univ. Otago), Amelia N. Deitchman (UCSF)
    State of the Art: Outcome-Based Therapeutics and Bedside Applications Amelia N. Deitchman (UCSF)
    Using QSP models to guide clinical care Steve Duffull (Univ. Otago)
    Stratified Medicine Approaches for Drug-Sensitive Tuberculosis Marjorie Imperial (UCSF)
    Towards an Improved Management of Psychiatric Patients: a Case for Monitoring Patient Adherence Through the Use of Reference Ranges An Vermeulen (Ghent Univ.)
    Clinical Trial Dose Optimization of Buprenorphine for Neonatal Abstinence Syndrome Using an Adaptive Monte Carlo Simulation Poster Abstract Presenter - Nicole Zane (Children's Hospital of Philadelphia)
    Session 5c:  Application of pharmacometrics in children with rare disease: experiences and future applications Chairs:  Wei Gao (Merck), Luning (Ada) Zhuang (FDA)
     Getting the dose right, first!  Challenges to pharmacometric approaches in children with rare diseases Lutz Harnisch (Pfizer)
    Optimizing modeling and simulation to bridge data for efficient pediatric drug development in rare diseases Xiang Gao (Alexion)
    Application of PBPK modelling for rationalizing dose selection in pediatric rare diseases Karen Rowland Yeo (Certara)
    Dosage considerations for FDA approval of canakinumab in pediatric rare diseases Luning (Ada) Zhuang (FDA)
5:30 PM 6:30 PM Alumni Receptions (by invitation only)  
6:30 PM 7:30 PM President's Reception (by invitation only)  
7:00 AM 9:00 AM Breakfast / Exhibit Hall Open  
8:00 AM 9:00 AM Contributed Posters Session 3 (morning)   
9:10 AM 9:15 AM PAGE 2019 Announcement Mats Karlsson
9:15 AM 10:45 AM Quality and Trainee Awards  Hosted by: Rui Zhu, ACoP9 Abstracts Committee Chair
10:45 AM 11:00 AM Break  
11:00 AM 12:30 PM Concurrent Sessions 6  
    Session 6a:  FDA Town Hall Update: Modeling and Simulation in GDUFA Regulatory Science Program Chairs:  Lanyan (Lucy) Fang (FDA), Lei Zhang (FDA)
    Overview of GDUFA-funded Modeling and Simulation grants/contracts Liang Zhao (FDA)
    Enhancing the reliability, efficiency, and usability of Bayesian population PBPK modeling Brad Reisfeld (Colorado State Univ.)
    Population pharmacokinetic and pharmacodynamic, dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs Joga Gobburu (Univ. Maryland)
    A predictive multiscale computational tool for simulation of lung absorption and pharmacokinetics and optimization of pulmonary drug delivery Narender Singh (CFD)
    Session 6b:  Leveraging big data science and technology to enable the development of QSP models for personalized medicine applications Chairs:  Karim Azer (Sanofi), Ioannis P. Androulakis (Rutgers)
    Big data and its role in biomedical research Philip Bourne (Univ. Virginia)
    Application of big data in systems pharmacology  Lei Xie (CUNY)
    How big data can enable and advance QSP models for personalized medicine applications Karim Azer (Sanofi)
    Dynamic models for personalized QSP Ioannis P. Androulakis (Rutgers)
    Combining machine learning and mechanistic modeling approaches to solve real life problems: assessment of the local tissue binding and its influence on the systemic exposure after topical application of drugs Poster Abstract Speaker - Sebastian Polak (Certara)
    Session 6c:  Effective Communication of Covariate Effects Chairs:  Yogesh Patel (Cognigen), Jill Fiedler-Kelly (Cognigen)
    Covariate selection – from biology to clinical use Steve Duffull (Univ. Otago)
    Forest plot - considerations to communicate covariate effects  Rajanikanth Madabushi (FDA)
    Determination and Communication of the Clinical Relevance of Covariate Effects: Examples from Industry Julie Stone (Merck)
    Population Kinetic/Pharmacodynamic (K/PD) Analyses of Daprodustat (Prolyl Hydroxylase Inhibitor) in Non-dialysis (ND) and Hemodialysis-Dependent (HDD) Anemia Patients with Chronic Kidney Disease (CKD) Poster Abstract Speaker - Kelly Mahar (GSK)
12:30 PM 2:00 PM Lunch  
12:45 PM 1:45 PM Meet the MCS and ClinPMx SIGs Lunches  
2:00 PM 3:00 PM Contributed Posters Session 3 (afternoon)   
3:15 PM 4:45 PM Concurrent Sessions 7  
    Session 7a:  Tumor Growth Dynamic Modeling: Applications in Oncology Drug Development, Submission, and Market Access Chairs:  Jennifer Sheng (BMS), Diansong Zhou (AstraZeneca)
    Comprehensive overview of Tumor-growth-dynamic Modeling: Descriptive and Predictive Power Peter Bonate (Astellas)
    Evaluation of Different Pattern of Tumor Dynamics with Immuno-Oncology (I-O) and Chemotherapy Agents Treatment by Utilizing Mixture Tumor Growth Dynamic Modeling Yan (Summer) Feng (BMS)
    De-convolving Response Evaluation Criteria In Solid Tumors (RECIST) in Non-small Cell Lung Cancer Using a Generalizable Bayesian Tumor Size Model  Hongmei Xu (AstraZeneca)
    Applications of TGD Modeling in Regulatory Decision-Making Jingyu Yu (FDA)
    Session 7b:  Application of modeling and simulation to accelerate drug development for parasitic tropical diseases: opportunities and challenges Chairs:  Yaning Wang (FDA), Sherwin K. B. Sy (Novartis)
    Towards establishment of quantitative framework to address drug development questions in global health setting Steve Kern (Bill and Melinda Gates Foundation)
    Translational mechanistic models to support anti-malarial drug developing and dosing Jurgen Bulitta (Univ. Florida)
    PK/PD modeling for malaria Jorg J. Mohrle (Medicines for Malaria Venture)
    Dosage considerations for FDA approval of benznidazole in children with Chagas disease Luning (Ada) Zhuang (FDA)
    Ebola viral dynamics in nonhuman primates: insights into virus immuno-pathogenesis and antiviral strategies Poster Abstract Speaker -Vincent Madelain (INSERM)
    Session 7c:  Current state of QSP in Industry:  Applications and Impact of QSP in Drug Discovery Chairs:  Marjoleen Nijsen (AbbVie), Erica Bradshaw-Pierce (Takeda)
    Welcome and Introduction to session  Marjoleen Nijsen (Abbvie), Erica Bradshaw-Pierce (Takeda)
    Educational presentation on current landscape of preclinical QSP modeling in the pharmaceutical industry  based on IQ QSP survey results as well as future opportunities and potential barriers for QSP modeling Jason Chan (Eli Lilly)
    Case Study 1: Target and Modality selection for autoimmune diseases using a QSP modeling of Complement Pathway  Loveleena Bansal (GSK)
    Case Study 2: Quantitative Systems Pharmacology Modeling Approach for Alzheimer’s Disease Diana Clausznitzer (AbbVie)
    Case Study 3: Development of a Preclinical Quantitative Systems Pharmacology Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy Edgar Schuck (Eisai)
5:00 PM 5:15 PM Closing Remarks  
5:30 PM 7:30 PM ACoP10 Meets ACoP9 (by invitation only)  
7:00 AM 9:00 AM Breakfast  
7:00 AM 12:00 PM Student/Trainee Event with Breakfast:  Your strategy to influence drug development decisions: hands-on experience with real-world cases (students/trainees only, separate registration required) Chairs:  Ghada Ahmed (AstraZeneca), Yi Ting (Kayla) Lien (Univ. Florida)
      Matt Rizk (Merck), Kyle Baron (Metrum), Lilly East (Biogen), Lisa Hendricks (Novartis)
8:00 AM 12:00 PM Tutorial Sessions (free, separate registration required)  
8:00 AM 12:00 PM Tutorial 1:  nlmixr: Population Modeling in R Chairs:  Matthew Fidler (Novartis), Wenping Wang (Novartis)
      Matthew Fidler (Novartis), Wenping Wang (Novartis), Teun M. Post (LAP&P), Justin Wilkins (Occams), Rik Schoemaker (Occams), Mirjam N. Trame (Novartis)
8:00 AM 12:00 PM Tutorial 2:  Evidence Synthesis from Drug Development to Health Technology Appraisal: Introduction to Network Meta-Analysis and Extensions to Model Based Network Meta-Analysis Chair:  Meg Bennetts (Pfizer)
    Introduction Meg Bennetts (Pfizer)
    Introduction to NMA: Assumptions, Networks and Consistency Nicky J. Welton (Univ. Bristol)
    Extension to MBNMA: Introduction to MBNMA Framework  Hugo Pedder (Univ. Bristol)
9:00 AM 12:00 PM Tutorial 3:  Best practices in calculating probability of success in drug development: Enhancing decision-making from a pharmacometric and statistical viewpoint Chairs:  Sandra Visser (GSK), Paolo Vicini (MedImmune)
     Quantitative and Qualitative Assessments of Probability of Study Success Stephen Ruberg (Analytix Thinking) 
     Probability of Success based on Pharmacological Principles (including Use of Priors) Stefano Zamuner (GSK)
    Estimating Probability of Technical (and Trial) Success with External Data: Applications of Model-Based Meta-Analyses (MBMA) Matt Zierhut (J&J)
     The Interplay of Decision Criteria, Operating Characteristics, Design, and Analysis in Proof of Concept and Beyond Brian Smith (Novartis) 
    Program-level simulation-based evaluation of PoS and expected NPV: a case study in neuropathic pain Jose Pinheiro (J&J)
12:00 PM 1:00 PM Lunch (not provided)  
 1:00 PM  5:00 PM Post-Meeting Workshops (separate registration required) - Click for details  
7:00 AM 8:00 AM Breakfast  
8:00 AM 5:00 PM Post-Meeting Workshops (separate registration required) - Click for details