ACoP8 Program

SATURDAY OCTOBER 14
7:00 AM 8:00 AM Breakfast and Registration for Pre-Meeting Workshops  
8:00 AM 5:00 AM Pre-Meeting Workshops (separate registration required)  
    Physiological modelling of therapeutic proteins and antibody-drug conjugates Simcyp/Certara
    Systems Pharmacology and PBPK modeling using PK-Sim and MoBi. A step by step lesson how to build and apply PBPK models - An Open Systems Pharmacology Workshop Michael Block (Bayer)
    New and Advanced Features of NONMEM 7.4 ICON
       
SUNDAY OCTOBER 15
7:00 AM 8:00 AM Breakfast and Registration for Pre-Meeting Workshops  
7:00 AM 8:00 AM Breakfast and Registration for ACoP8 Pre-Conference  
7:30 AM 8:30 AM ACoP8 Preconference Sunrise Session: “An Introduction to Systems Pharmacology” (preconference registration required) Valeriu Damian (GSK)
8:00 AM 5:00 PM Pre-Meeting Workshops (separate registration required)  
    Bridging PBPK with POPPK for Pediatrics Simcyp/Certara
    Advanced Use of Stan, rstan and Torsten for Pharmacometric Application Bill Gillespie (Metrum)
    Modeling Delays in Pharmacokinetics and Pharmacodynamics Wojciech Krzyzanski (University at Buffalo)
       
8:45 AM 5:00 PM ACoP8 Pre-Conference-
Systems Pharmacology: From Innovation to Impact (separate registration required)		 Co-chairs: Saroja Ramanujan (Genetech) and Cynthia J. Musante (Pfizer)
       
12:00 PM 5:30 PM Registration for ACoP8  
       
5:30 PM 7:15 PM Opening Session  
    Conference Opening: Conference Highlights Brenda Cirincione, ACoP8 Conference Chair
    ISoP Awards Presentation
ISoP Leadership Award:  Rik Schoemaker (Occams)
ISoP Innovation Award:  Donald Mager (University at Buffalo) ISOP Technical Manuscript Award:  Nidal Al-Huniti et al -
For Population Exposure-Response Modeling of Naloxegol in Patients With Noncancer-Related Pain and Opioid-Induced Constipation
ISoP Fellow Inductees		 Hosted by – Jonathan French (Awards Committee Chair)
       
    Lewis B. Sheiner Award Lecture Marc Gastonguay (Metrum)
       
7:30 PM 10:00 PM ACoP8 Opening Reception  
MONDAY OCTOBER 16
7:00 AM 9:00 AM Breakfast and Registration  
    Contributed Posters Session 1/Exhibits  
       
9:00 AM 9:45 AM President Address  
    ISoP 2017. The Year in Review René Bruno, ISoP President
    President-Elect Address
ISoP:  Looking Forward		 Jin Jin, ISoP President-Elect
    Programming Update Navin Goyal, ACoP8 Programming Chair
       
10:00 AM 11:30 AM Session 1a: Quantification of covariate effects for labeling Chairs: Elodie Plan (Pharmetheus) Mats Karlsson (Uppsala University)
    Points to consider when making inferences about covariates Marc Gastonguay (Metrum)
    Covariate model building mini-tutorial emphasizing covariate selection Malidi Ahamadi (Merck)
    Full model approaches with a focus on full random effects modeling Niclas Jonsson (Pharmetheus)
    Impact of Model-Based Covariate Effects on Regulatory Decisions Yaning Wang (FDA)
    Session 1b: Systems, Empirical or In-between: Bridging the Gap between Mechanism and Statistics Chairs: Ghada Ahmed (AstraZeneca) Matthew Rizk (Merck)
    When Mechanism Matters: Impacting Antibacterial Drug Development through Application of Mechanistic Models Matthew Rizk (Merck)
    Systems modeling of DGAT2 inhibition and application to drug development for non-alcoholic fatty liver Theodore Rieger (Pfizer)
    Pulling a model up by its bootstraps: evolving your way to QSP Frank Gibbons (AstraZeneca)
    A Quantitative Systems Pharmacology Approach For Predicting Pharmacological Interactions Between Antipsychotic Drugs.
Validation Using Electronic Health Records		 Abstract Speaker: Hugo Geerts (In-Silico Biosciences)
       
11:30 AM 1:00 PM Student/Trainee Mentoring Session with Lunch (free, separate registration required) Hosted by Kayla Lien, Trainee Committee Chair
11:30 AM 1:00 PM Lunch/Poster/Exhibit  
11:30 AM 1:00 PM Lunch and Learn - The application of pharmacometrics to the development of reversal agents for Direct Oral Anticoagulants Chairs: Takayo Ueno (BMS) Brenda Cirincione (Vertex)
    Challenges and Rewards in developing Reversal Agents: Industry perspectives Janet Leeds (Portola Pharmaceuticals)
    Application of PKPD modeling to optimization of andexanet treatment regimens for reversal of the anticoagulation effects of 3
direct fXa inhibitors		 Mark Lovern (Certara)
    Quantification of Dabigatran Anticoagulation Reversal: Bayesian Analysis of the Idarucizumab-Dabigatran PK Binding Model Julia Korell (Boehringer Ingelheim)
       
1:00 PM 2:00 PM State of the Art Lecture: Paul Watkins (University of North Carolina) Hosted by: Brenda Cirincione (ACoP8 Conference Chair)
       
2:00 PM 2:15 PM Break  
       
2:15 PM 3:45 PM Session 2a: Model-Based Drug Development of Therapeutic Proteins in Autoimmune Diseases Chair: Rong Shi (BMS)
    Using QSP to relate current therapeutic strategies to novel strategies: case studies from RA Craig Thalhauser (BMS)
    Implementing Pharmacometrics from Bench to Bedside in Autoimmune Diseases Diane Mould (Projections Research)
    How Model-Based Meta-Analysis Informs Drug Development in Autoimmune Diseases Mark R Lovern (Certara)
    Population Pharmacokinetic and Exposure-Efficacy/Safety Analyses for Selection of Optimal Dose Regimen of Tocilizumab in Patients With Giant Cell Arteritis (GCA) Abstract Speaker: Joy Hsu (Roche)
    Session 2b: Healthcare Analytics and Pharmacometrics - Bench to Bedside Progression- Opportunities for Synergy Chairs: Ayyappa Chaturvedula (UNTHSC)
      Navin Goyal (GSK)
    Expanding the Role of pharmacometrician in drug development: End to End influence Mike Fossler (Trevena)
    An Integrated Data Platform to Exploit Real-world data with M&S Deliverables Jeff Barrett (Sanofi Aventis)
    Pharmacoeconomic and outcomes research: where is the intersection for pharmacometrics Annesha White (UNTHSC)
    Clinical pharmacometrics and potential interfaces with healthcare analytics: Obstacles to successful implementation Michael Neely (USC)
    Using Bayesian Modeling to Optimize Antipsychotic Therapy Abstract Speaker: Mohamed Ismail (University at Buffalo)
    Session 2c: Advancing the Use of Quantitative Systems Pharmacology in Drug Development and Regulatory Decisions Chairs: Ananth Kadambi (Rosa) Matthew Riggs (Metrum)
    A future vision of multiscale systems pharmacology models in regulatory interactions Mark C. Peterson (Pfizer)
    Quantitative systems pharmacology: Regulatory Perspective Yaning Wang (FDA)
    Successful QSP Modeling In Drug Development Starts with the Right Questions Chi-Chung Li (Genentech)
    Systems Modeling of Left Ventricular Hypertrophy and Effect of Different Classes of Antihypertensive Therapies on Hypertrophy
Regression		 Abstract Speaker: Melissa Hallow (University of Georgia)
       
3:45 PM 4:00 PM Break  
       
4:00 PM 5:30 PM Session 3a: Effective application of modelling, simulation and knowledge sharing across quantitative disciplines Chair: Mike Smith (Pfizer)
    Adventures in Cross-Functional Study Design Michael Heathman (Lilly)
    Adaptive Borrowing of Adult Data for Pediatric Trials:  Collaborative Research at the Intersection of Pharmacometrics and Statistics Chyi-Hung Hsu (Janssen)
    Trial simulations to support Proof of Concept Study Design: Application to Immunology John Gibbs (AbbVie)
    Session 3b: Mechanistic joint models for longitudinal and time- to-event data: recent advances and specific applications in oncology drug development Chairs: Amit Roy (BMS) Hongmei Xu (AstraZeneca)
    Recent Innovation and Development in joint models for longitudinal and time-to-event data: An overview Ming-Hui Chen (University of Conn)
    Mechanistic joint models characterizing the relationship between nonlinear prostate specific antigen kinetics and survival in prostate cancer patients Jeremie Guedj (INSERM)
    Joint Modeling of Longitudinal data and Progression-Survival Analysis: Elotuzumab Amit Roy (BMS)
    Dynamic predictions of progression free survival and overall survival in Non-Small Cell Lung Cancer using tumor sizes: A longitudinal joint modeling approach for Gefitinib Nidal Al-Huniti (AstraZeneca)
    Session 3c: Bridging Toxicity and Efficacy: How QSP Models Can Incorporate Both Safety and Efficacy Endpoints for More Efficient Drug Development Chairs: Lisl Shoda (DILIsym Services) Jeff Woodhead (DILIsym Services)
    Using Systems Pharmacology Modeling to Understand the Pathophysiology of NAFLD and Response to Dietary Intervention in a Simulated Population Grant Generaux (DILIsym Services)
    QSP, IVIVE, PBPK, PKPD, MICE, CiPA, AP, QT, EAD,
pseudoECG, and CV - is it just a mess or a real step forward in the drugs cardiac safety assessment?		 Sebastian Polak (Simcyp)
    Applications and synergisms of a base QSP model of renal function in drug-induced renal injury and diabetic kidney disease Melissa Hallow (UGA)
    Model based analyses of the mechanisms of pi3k inhibitor induced GI toxicity Kapil Gadkar (Genentech)
    A Systems Pharmacology Approach to Support Translational Research in Immunotherapy and Its Combination with Chemotherapy Abstract Speaker: Emily Mick (University of North Carolina)
       
5:30 PM 6:30 PM Alumni Receptions (University of Florida; University at Buffalo, University of Minnesota, University of Maryland, University of North Carolina)
(By invitation only)		 Hosted by Heather Vezina, Alumni Committee Chair
       
6:00 PM 10:00 PM Social Event  
 
TUESDAY OCTOBER 17
       
7:30 AM 9:30 AM Breakfast and Registration  
    Contributed Posters Session 2/Exhibits  
    Statistics Spotlight Posters  
       
9:30 AM 10:30 AM Podium Presentation of ACoP8 Quality Awards and Trainee Awards Hosted by Wei Gao, Abstracts Committee Chair
    Joint modeling of time-evolving tumor load and survival: an approach to rationally design treatment sequencing, staging, and dosing strategies for oncology combinations (W-94) James Dunyak (Astra Zeneca)
    Bayesian formulation of a joint model of longitudinal tumor size and overall survival (OS) in Non-Small Cell Lung Cancer (W-96) Helena Edlund (Astra Zeneca)
    Shortening the duration of Acute Schizophrenia registration trials is a possibility (T-102) Mathangi Gopalakrishnan (University of Maryland)
    Grid search and chaos synchronization as a tool to uniquely estimate parameters of a chaotic pharmacological system (W-11) Nikhil Pillai (University at Buffalo)
    Modeling methods for analyzing tumor dynamic data from basket trials (M-13) Alanna Ocampo (Metrum)
    Quantification of postmenopausal osteoporosis population: An system pharmacology approach using bisphosphonates (W-53) Kayla Lien (University of Florida)
       
10:45 AM 12:15 PM Session 4a: Marriage between quantitative approaches and regulatory science: a reality check on where we are Chair: Liang Zhao (FDA)
    A brief introduction to GDUFA regulatory science research program: Pharmacometrics grant and contract opportunities Liang Zhao (FDA)
    Marriage between quantitative approaches and regulatory science: a reality check on where we are Lucy Fang (FDA)
    An Integrated Model-Informed Strategy to Assess Factors Influencing in Silico Bioequivalence Lawrence J. Lesko (University of Florida)
    Improved model-based bioequivalence strategies Andrew Hooker (Uppsala University)
    Session 4b: Adherence to Medications: A Crucial Missing Link in Quantitative Clinical Pharmacology Chairs: Michael Fossler (Trevena) Ayyappa Chaturvedula (UNTHSC)
    Understanding adherence to medications: Initiation, Persistence and Implementation Bernard Vrijens (WestRock Healthcare)
    Collection and interpretation of adherence and other behavioral data in clinical trials Jessica Haberer (Harvard)
    Utility of adherence data in pharmacometrics modeling and simulations Michael Fossler (Trevena)
    Markov models of adherence and identification of covariate effects in HIV prophylaxis Ayyappa Chaturvedula (UNTHSC)
    Session 4c: Mathematical Pharmacology: a distinct discipline of pharmacometrics Chairs: Wojciech Krzyzanski (Buffalo) Coen van Hasselt (Leiden)
    A biologist's reflections on and future perspectives of Mathematical Pharmacology Johan Gabrielsson (Swedish University)
    Building intuition for PK and binding models using lumped parameters, sensitivity analysis, and likelihood profiles Andy Stein (Novartis)
    Different approximations for pharmacokinetic models with target- mediated drug disposition Gilbert Koch (University of Basel)
    Mathematical updates of some classical pharmacological concepts in the context of nonlinearity Fahima Nekka (University Montreal)
       
12:15 PM 1:30 PM Lunch/Poster/Exhibit  
12:15 PM 1:30 PM Meet and Greet The SIGs luncheon  
12:15 PM 1:30 PM JPKPD Editorial Board Meeting (by invitation only)  
       
1:30 PM 2:30 PM Keynote Lecture: Julie Johnson (University of Florida) Hosted by Navin Goyal (ACoP8 Programming Chair)
       
2:30 PM 2:45 PM Break  
       
2:45 PM 4:30 PM Session 5a: Model informed Drug Discovery and Development (MID3): industry good practice, regulatory expectations, and technical gaps Chairs: Sandra Visser (Merck) Kevin Dykstra (qPharmetra)
    Overview of MID3 Good Practice Guidelines: Current Status & Challenges Scott Marshall (Pfizer)
    Reflection on Recent Good Practice Documents: Are the Expectations Fulfilled? Kevin Dykstra on behalf of Efthymios Manolis (EMA)
    Guidelines and Good Practices for Advancing Model-Informed Drug Development: Gaps and Opportunities Rajnikanth Madabushi (FDA)
    Panel Discussion  
    Session 5b: Optimal design: just nerdy or useful? Chairs: Elodie Plan (Pharmetheus) Stephen Duffull (Univ of Otago)
    Optimal design: the nerdy part made simple Sebastian Ueckert (Uppsala Univ)
    Optimal design with pharmacometric models Joakim Nyberg (Pharmetheus)
    Optimal design: challenges within the industry? Marylore Chenel (Servier)
    Optimal design: useful? Let’s discuss! Panel – France Mentré, Andrew Hooker, Tim Waterhouse, Yaning Wang
    Hands-on session  
    Session 5c:  System Pharmacology Approach to Facilitate Design of Combination Therapy for Effective Cancer
Immunotherapy		 Chairs: Weirong Wang (JnJ) Donald Heald (JnJ)
    Systems Pharmacology Modeling to Support Clinical Decisions in Immuno-Oncology:  Challenges and Applications Theresa Yuraszeck (Amgen)
    A Platform QSP Approach in Support of Combination Cancer Immunotherapy Brian J. Schmidt (BMS)
    Using PhysioPD Platforms to guide identification of I-O therapy responders/non-responders Michael J Reed (Rosa)
    Systematically Understanding Immunity Leading to CRPC Progression and Combination Therapy Xiaobo Zhou (Wake Forest University)
       
4:30 PM 4:45 PM Break  
       
4:45 PM 6:30 PM Innovative Communications Chairs: Stacey Tannenbaum (Astellas) Brenda Cirincione (Vertex)
       
6:30 PM 7:30 PM Presidential Reception (by invitation only) Hosted by René Bruno
       
WEDNESDAY OCTOBER 18
       
7:00 AM 9:00 AM Breakfast  
    Contributed Posters Session 3/Exhibits  
       
9:00 AM 10:30 AM Session 6a: Source Data Quality for Pharmacometric programming: Challenges and possible solutions Chairs: Neelima Thanneer (BMS) David Radtke (Eli Lilly)
    Challenges to data collection in clinical trials, how diverse approaches cause confusion at the site affecting data quality David Radtke (Eli Lilly)
    Bridging the data divide, assessing, monitoring, and hopefully resolving data issues between disparate data systems Alice Zong (JnJ)
    Rigorous and systematic process to create high quality pharmacometric data sets and data section of the report Neelima Thanneer (BMS)
    Update on the initiative for “Influencing Source - Data quality for Pharmacometric dataset creation” Harsha Reddy (Certara)
    Session 6b: Model-Aided Drug Development for Respiratory Diseases: Approaches & Applications Chairs: Kapil Gadkar (Genentech) Siddharth Sukumaran (Genentech)
    Understanding Asthma Pathophysiology at a Molecular Level Using Systems Modelling Oleg Demin (Inst of Sys Bio, Russia)
    Entrainment and synchronization of mitosis in asthma: An intervention target? Ioannis Androulakis (Rutgers University)
    A myriad of players in Asthma: what is the right target? Kapil Gadkar (Genentech)
    Application of QSP modeling in Immunology and inflammation Karim Azer (Sanofi)
    Session 6c: Data Needs and Model Qualification for Drug Safety Applications of QSP Chairs: Lisl Shoda (DILISym) Jeff Woodhead (DILISym)
    Use of systems toxicology modeling to investigate mechanisms of liver enzyme elevations mediated by macrolide antibiotics Jeff Woodhead (DILISym)
    QSP approaches allow for identification of cardiotoxic drugs and prioritization of drug-safety experiments Eric Sobie (Icahn, Mount Sinai)
    Ontology-Based Organization of Diverse Data Types to Develop and Inform Predictive Toxicology Models for Heart Failure Darrell Abernethy (FDA)
    Integrating Network-Based Strategy into QSP Models of Liver Safety Evan Wang (Eli Lilly)
       
10:30 AM 10:45 AM Break  
       
10:45 AM 12:15 PM Session 7a: Model-Aided Drug Development of Cancer Immunotherapeutics: Approaches & Applications Chairs: Siddharth Sukumaran (Genentech)
Kapil Gadkar (Genentech)
    Preclinical PK/PD Model-based starting dose selection for cancer immune therapeutics Haiqing Wang (BMS)
    Impact of Pharmacometrics in Immuno-Oncology: The Example of Pembrolizumab Rik de Greef (Quantitative Solutions)
    Quantitative Systems Pharmacology Modeling to Support Early Clinical Trials in Cancer Immunotherapy Benjamin Ribba (Roche)
    Dynamic Metrics-based Biomarkers to Predict Responders to Checkpoint Immunotherapy Abstract Speaker: Can Liu  (University of North Carolina)
    Session 7b: Neighbor’s Envy Owner’s Pride - Comparator Analysis for Drug Development and Market Access Chair: Pavan Vaddady (Merck)
    Model based meta-analysis and regulatory applications Yaning Wang (FDA)
    Application of systematic literature review and meta-analysis to demonstrate clinical benefit of new immunotherapies in head and neck cancer based on early clinical data Mallika Lala (Merck)
    MBMA for novel anti-diabetic drug development decision making Vikas Kumar (Pfizer)
    Post-approval decision-making supported by modeling and
simulation based on variety of data sources (meta-data, registry data, electronic medical records, and proprietary trial data)		 Marc Gastonguay (Metrum)
    Session 7c: Industrial-Strength Infrastructure for Pharmacometrics Chairs: Michael Heathman (Eli Lilly) Wenping Wang (Novartis)
    Infrastructure for Efficient and Massively Parallel NONMEM Execution Evan Wang (Eli Lilly)
    ePharmacology: Innovative Modeling Environment and Regulatory Compliant Repository for Pharmacometrics Model Development and
Simulation, Distributed Computation, and Reporting		 Thomas Tensfeldt (Pfizer)
    Infrastructure for Efficient and Effective Implementation of Modeling and Simulation in the Cloud William Knebel (Metrum)
    Pharmacometrics Infrastructure and Knowledge Management Nidal Al-Huniti (Astra Zeneca)
       
12:15 PM 12.30 PM Closing Remarks – Meeting Adjourns Brenda Cirincione, ACoP8 Conference Chair
Jin Jin, ISoP President-Elect
       
1:00 PM 2:00 PM Meet ISoP Board Hosted by ISoP Board Members
1:00 PM 2:00 PM Lunch/Poster/Exhibit  
1:00 PM 2:00 PM Student/Trainee Event with Lunch:
Making connections: How to build a professional network in graduate school and why you need one
(free, separate registration required)		 Hosted by Kayla Lien, Trainee Committee Chair
       
2:00 PM 4:30 PM ACoP9 meets ACoP8 (By invitation only)  
       
2:00 PM 5:30 PM ACoP8 Tutorials (free, separate registration required)  
       
    Tutorial 1: Building R Shiny Apps for Pharmacometrics Chairs: Pavan Vaddady (Merck) Bhargava Kandala (Merck)
    Tutorial 2: Modular QSP design - Approaches to speed up the QSP model development Chairs: Valeriu Damian (GSK) Andrzej Kierzek (Certara)
    Architecture of Immune Response Template: integration and representation of experimental data and knowledge in terms of immune cells' "passports" Oleg Demin Jr (Inst of Sys Bio, Russia)
    Modular design of QSP models? Examples in Immunogenicity and Immuno Oncology Andrzej Kierzek (Certara)
    Component Model Library - Immunetrics approach to QSP model building - Examples in acute inflammation Steve Chang (Immunetrics)
    Tutorial 3: Pharmacometrics + Applied Math = Better QSP Chairs: Cynthia Musante (Pfizer) Kevin Dystra (qPharmetra)
    Introduction & motivating questions Kevin Dykstra (qPharmetra)
    Understanding Your Model: Introduction to Dynamical Systems Theory Eduardo Sontag (Rutgers university)
    Phase Planes, Nullclines, Bifurcations: Concepts and Implementation Dean Bottino (Takeda)
    Identifiability: Concepts + Implementation Andy Stein (Novartis) and Andreas Raue (Merrimack)
   
    Tutorial 4: Student Tutorial: A: Communicate to Influence B: Elevator Pitch
(free, separate registration required)		 Chairs: Joga Gobburu (University of Maryland) and Kayla Lien (University of Florida)
       
THURSDAY OCTOBER 19
7:00 AM 8:00 AM Breakfast and Registration for Post-Meeting Workshops  
       
8:00 AM 5:00 PM Post-meeting Workshops (separate registration required)  
    R as a single-step platform for PK/PD and PBPK/QSP M&S:
integration of model estimation, optimization, simulation, and reporting. (Metrum)		 Kyle Baron (Metrum)
 
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