ACoP8 Program

SATURDAY October 14th

7:00 AM

8:00 AM

Breakfast and Registration for Pre-meeting Workshops

 

8:00 AM

5:00 PM

Pre-Meeting Workshops (separate registration required)

 

     Physiological modelling of therapeutic proteins and antibody-drug conjugates: Simcyp/Certara  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  (Bayer)

 Michael Block (Bayer)
   

New and Advanced Features of NONMEM 7.4 (ICON)

 ICON

SUNDAY October 15th

7:00 AM 

8:00 AM

Breakfast and Registration for Pre-meeting Workshops 

 

7:00 AM

8:00 AM

Breakfast and Registration for ACoP7 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

 

   

Bridging PBPK with POPPK for Pediatrics:  (Simcyp/Certara)

 Simcyp/Certara
   

Advanced Use of Stan, rstan and Torsten for Pharmacometric Applications (Metrum)

 Bill Gillespie (Metrum)
   

Modeling Delays in Pharmacokinetics and Pharmacodynamics (U of Buffalo)

 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

 

 

 

(5:30 - 6:30)

Conference Opening - Conference Highlights

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:

Brenda Cirincione, ACoP8 Conference Chair

 

Awards Presentation hosted by – Jonathan French (Awards Committee Chair)

   

Sheiner Award Lecture:

 Marc Gastonguay (Metrum)

7:30 PM

11:00 PM

ACoP8 Opening Reception

 

MONDAY October 16th

7:30 AM

9:00 AM

Breakfast/Registration/Contributed Poster Session 1/Exhibits

 

9:00 AM

9:45 AM

President Address - ISoP 2017. The Year in Review

President-Elect Address - ISoP:  Looking Forward

Programming Update

 René Bruno, ISoP President

Jin Jin, ISoP President Elect

Navin Goyal, ACoP8 Programming Chair

10:00 AM

11:30 AM

Session 1a: Quantification of Co-variate Effects for Labeling

Points to consider when making inferences about covariates

Covariate model building mini-tutorial emphasizing covariate selection

Full model approaches with a focus on full random effects modeling

Impact of Model-Based Covariate Effects on Regulatory Decisions

Chairs: Elodie Plan (Pharmetheus) , Mats Karlsson (Uppsala University)

 Marc Gastonguay (Metrum)

Malidi Ahamadi (Merck)

Niclas Jonsson (Pharmetheus)

Yaning Wang (FDA)

   

Session 1b: Systems, Empirical or In-between: Bridging the Gap between Mechanism and Statistics

When Mechanism Matters: Impacting Antibacterial Drug Development through Application of Mechanistic Models

Systems in Balance:  The Case for Physiologically-Influenced Empirical Models

Pulling a model up by its bootstraps: evolving your way to QSP

A Quantitative Systems Pharmacology Approach For Predicting Pharmacological Interactions Between Antipsychotic Drugs. Validation Using Electronic Health Records

Chairs: Ghada Ahmed (AstraZeneca) , Matthew Rizk (Merck)

Matthew Rizk (Merck)

William Denney (Human Predictions)

Frank Gibbons (AstraZeneca)

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

 

 

Lunch/Posters/Exhibits

 
   

Lunch and Learn - The application of pharmacometrics to the development of reversal agents for Direct Oral Anticoagulants

Challenges and Rewards in developing Reversal Agents: Industry perspectives

Application of PKPD modeling to optimization of andexanet treatment regimens for reversal of the anticoagulation effects of 3 direct fXa inhibitors

Quantification of Dabigatran Anticoagulation Reversal: Bayesian Analysis of the Idarucizumab-Dabigatran PK Binding Model

Chairs: Takayo Ueno (BMS) , Brenda Cirincione (Vertex)

Janet Leeds (Portola Pharmaceuticals)

Mark Lovern (Certara)

Julia Korell (Boehringer Ingelheim)

1:00 PM

2:00 PM

State-of-the-Art Lecture: Dr 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

 Using QSP to relate current therapeutic strategies to novel strategies: case studies from RA

Implementing Pharmacometrics from Bench to Bedside in Autoimmune Diseases

Utility of Model-based Approaches in Assessing and Strategizing Drug-Drug Interactions for Therapeutic Biologics

How Model-Based Meta-Analysis Informs Drug Development in Autoimmune Diseases

Population Pharmacokinetic and Exposure-Efficacy/Safety Analyses for Selection of Optimal Dose Regimen of Tocilizumab in Patients With Giant Cell Arteritis (GCA)

 Chairs: Rong Shi (BMS) , Honghui Zhou (Janssen)

Craig Thalhauser (BMS)

Diane Mould (Projections Research)

Honghui Zhou (Janssen)

Mark R Lovern (Certara)

 

Abstract Speaker: Joy Hsu (Roche)

 

 

Session 2b: Healthcare Analytics and Pharmacometrics - Bench to Bedside Progression- Opportunities for Synergy

Expanding the Role of pharmacometrician in drug development: End to End influence

An Integrated Data Platform to Exploit Real-world data with M&S Deliverables

Pharmacoeconomic and outcomes research: where is the intersection for pharmacometrics

Clinical pharmacometrics and potential interfaces with healthcare analytics: Obstacles to successful implementation

Using Bayesian Modeling to Optimize Antipsychotic Therapy

Chairs: Ayyappa Chaturvedula (UNTHSC), Navin Goyal (GSK)

Mike Fossler (Trevena)

Jeff Barrett (Sanofi Aventis)

Annesha White (UNTHSC)

Mike Neely (USC)

Abstract Speaker: Mohamed Ismail (University at Buffalo)

 

 

Session 2c: Advancing the Use of Quantitative Systems Pharmacology in Drug Development and Regulatory Decisions

A future vision of multiscale systems pharmacology models in regulatory interactions

Quantitative systems pharmacology: Current scope and potential opportunities

Successful QSP Modeling In Drug Development Starts with the Right Questions

Systems Modeling of Left Ventricular Hypertrophy and Effect of Different Classes of Antihypertensive Therapies on Hypertrophy Regression

Chairs: Ananth Kadambi (Rosa),  Matthew Riggs (Metrum)

Mark C. Peterson (Pfizer)

Nitin Mehrotra (FDA)

Chi-Chung Li (Genentech)

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

Adventures in Cross-Functional Study Design

Adaptive Borrowing of Adult Data for Pediatric Trials:  Collaborative Research at the Intersection of Pharmacometrics  and Statistics

Trial simulations to support Proof of Concept Study Design: Application to Immunology

Chair: Mike Smith (Pfizer)

Michael Heathman (Lilly)

Chyi-Hung Hsu (Janssen)

 

John Gibbs (AbbVie)

 

   

Session 3b: Mechanistic joint models for longitudinal and time-to-event data: recent advances and specific applications in oncology drug development

Recent Innovation and Development in joint models for longitudinal and time-to-event data: An overview

Mechanistic joint models characterizing the relationship between nonlinear prostate specific antigen kinetics and survival in prostate cancer patients

Joint Modeling of Longitudinal data and Progression-Survival Analysis: Elotuzumab

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

Chairs: Jennifer Sheng (BMS), Hongmei Xu (AstraZeneca)

Ming-Hui Chen (UConn)

Jeremie Guedj (INSERM)

Jennifer Sheng (BMS)

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

Using Systems Pharmacology Modeling to Understand the Pathophysiology of NAFLD and Response to Dietary Intervention in a Simulated Population

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?

Applications and synergisms of a base QSP model of renal function in drug-induced renal injury and diabetic kidney disease

Model based analyses of the mechanisms of pi3k inhibitor induced GI toxicity

A Systems Pharmacology Approach to Support Translational Research in Immunotherapy and Its Combination with Chemotherapy

Chairs: Lisl Shoda (DILIsym Services), Jeff Woodhead (DILIsym Services)

Grant Generaux (DILIsym Services)

Sebastian Polak (Simcyp)

Melissa Hallow (UGA)

Kapil Gadkar (Genentech)

Abstract Speaker: Emily Mick (University of North Carolina)

5:30 PM

6:30 PM

Alumni Receptions

[by invitation only]

 Hosted by Heather Vezina, Alumni Committee Chair

6:00 PM

10:00 PM

Social Event

 

TUESDAY October 17th

7:30 AM

9:30 AM

Breakfast/Registration/Contributed Poster Session 2/Exhibits

 

9:30 AM

10:30 AM

Podium Presentation of ACoP7 Quality Awards and Trainee Awards

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)

 Bayesian formulation of a joint model of longitudinal tumor size and overall survival (OS) in Non-Small Cell Lung Cancer (W-96)

Shortening the duration of Acute Schizophrenia registration trials is a possibility (T-102)

Grid search and chaos synchronization as a tool to uniquely estimate parameters of a chaotic pharmacological system (W-11)

Modeling methods for analyzing tumor dynamic data from basket trials (M-13)

Quantification of postmenopausal osteoporosis population: An system pharmacology approach using bisphosphonates (W-53)

Hosted by Wei Gao, Abstracts Committee Chair

James Dunyak (Astra Zeneca)

 

Helena Edlund (Astra Zeneca)

Mathangi Gopalakrishnan (University of Maryland)

Nikhil Pillai (University at Buffalo)

Alanna Ocampo (Metrum)

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

A brief introduction to GDUFA regulatory science research program: Pharmacometrics grant and contract opportunities

Marriage between quantitative approaches and regulatory science: a reality check on where we are

An Integrated Model-Informed Strategy to Assess Factors Influencing In Silico Bioequivalence

Improved model-based bioequivalence strategies

Chair: Liang Zhao (FDA)

Liang Zhao (FDA)

Lucy Fang (FDA)

Lawrence J. Lesko (Univ Florida)

Andrew Hooker (Uppsala University)

   

Session 4b: Adherence to Medications: A Crucial Missing Link in Quantitative Clinical Pharmacology

Understanding adherence to medications: Initiation, Persistence and Implementation

Collection and interpretation of adherence and other behavioral data in clinical trials

Utility of adherence data in pharmacometrics modeling and simulations

Markov models of adherence and identification of covariate effects in HIV prophylaxis

Chairs: Michael Fossler (Trevena), Ayyappa Chaturvedula (UNTHSC)

Bernard Vrijens (WestRock Healthcare)

Jessica Haberer (Harvard)

Michael Fossler (Trevena)

Ayyappa Chaturvedula (UNTHSC)

   

Session 4c: Mathematical Pharmacology: a distinct discipline of pharmacometrics

A biologist's reflections on and future perspectives of Mathematical Pharmacology

Building intuition for PK and binding models using lumped parameters, sensitivity analysis, and likelihood profiles

Different approximations for pharmacokinetic models with target-mediated drug disposition

Mathematical updates of some classical pharmacological concepts in the context of nonlinearity

Chairs: Wojciech Krzyzanski (Buffalo), Coen van Hasselt (Leiden)

Johan Gabrielsson (Swedish Univ)

Andy Stein (Novartis)

Gilbert Koch (University of Basel)

Fahima Nekka (Univ Montreal)

12:15 PM

1:30 PM

Lunch/Posters/Exhibits

 

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: Dr Julie Johnson (University of Florida)

 

 Hosted by Navin Goyal (ACoP8 Programming Chair)

2:30 AM

2:45 AM

Break

 

2:45 AM

 4:30 PM

Session 5a: Model informed Drug Discovery and Development (MID3): industry good practice, regulatory expectations, and technical gaps

Overview of MID3 Good Practice Guidelines: Current Status & Challenges

Reflection on Recent Good Practice Documents: Are the Expectations Fulfilled?  

Guidelines and Good Practices for Advancing Model-Informed Drug Development: Gaps and Opportunities

Panel Discussion

Chairs: Sandra Visser (Merck),  Kevin Dykstra (qPharmetra)

Scott Marshall (Pfizer)

Efthymios Manolis (EMA)

Rajnikanth Madabushi (FDA)

   

Session 5b: Optimal design: just nerdy or useful?

Optimal design: the nerdy part made simple

Optimal design with pharmacometric models

Optimal design: challenges within the industry?

Optimal design: useful? Let’s discuss!

Chairs: Elodie Plan (Pharmetheus) , Stephen Duffull (Univ of Otago)

Sebastian Ueckert (Uppsala Univ)

Joakim Nyberg (Pharmetheus)

Marylore Chenel (Servier)

Panel – France Mentré, Andrew Hooker, Tim Waterhouse, Ine Skottheim Rusten

   

Session 5c:  System Pharmacology Approach to Facilitate Design of Combination Therapy for Effective Cancer Immunotherapy

Systems Pharmacology Modeling to Support Clinical Decisions in Immuno-Oncology:  Challenges and Applications

A Platform QSP Approach in Support of Combination Cancer Immunotherapy

Using PhysioPD Platforms to guide identification of I-O therapy responders/non-responders

Systematically Understanding Immunity Leading to CRPC Progression and Combination Therapy

Chairs: Weirong Wang (JnJ) , Donald Heald (JnJ)

Theresa Yuraszeck (Amgen)

Brian J. Schmidt (BMS)

Michael J Reed (Rosa)

Xiaobo Zhou (Wake Forest Univ)

 

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 Rene Bruno, ISoP President

WEDNESDAY October 18th

7:00 AM

9:00 AM

Breakfast/Contributed Poster Session 3/Exhibits

 

9:00 AM

10:30 AM

Session 6a: Source Data Quality for Pharmacometric programming: Challenges and possible solutions 

Challenges to data collection in clinical trials, how diverse approaches cause confusion at the site affecting data quality

Bridging the data divide, assessing, monitoring, and hopefully resolving data issues between disparate data systems

Rigorous and systematic process to create high quality pharmacometric data sets and data section of the report

Update on the initiative for “Influencing Source - Data quality for Pharmacometric dataset creation”

Chairs: Neelima Thanneer (BMS) , David Radtke (Eli Lilly)

David Radtke (Eli Lilly)

Alice Zong (JnJ)

Neelima Thanneer (BMS)

Vishak Subramoney (Certara)

 

   

Session 6b: Model-Aided Drug Development for Respiratory Diseases: Approaches & Applications

Understanding Asthma Pathophysiology at a Molecular Level Using Systems Modelling

Entrainment and synchronization of mitosis in asthma: An intervention target?

A myriad of players in Asthma: what is the right target?

Application of QSP modeling in Immunology and inflammation

Chairs: Kapil Gadkar (Genentech) , Siddharth Sukumaran (Genentech)

 Balaji Agoram (MedImmune)

Ioannis Androulakis (Rutgers Univ)

Kapil Gadkar (Genentech)

Karim Azer (Sanofi)

   

Session 6c: Data Needs and Model Qualification for Drug Safety Applications of QSP

Use of systems toxicology modeling to investigate mechanisms of liver enzyme elevations mediated by macrolide antibiotics

QSP approaches allow for identification of cardiotoxic drugs and prioritization of drug-safety experiments

Ontology-Based Organization of Diverse Data Types to Develop and Inform Predictive Toxicology Models for Heart Failure

Integrating Network-Based Strategy into QSP Models of Liver Safety

Chairs: Lisl Shoda (DILISym) , Jeff Woodhead (DILISym)

Jeff Woodhead (DILISym)

Eric Sobie (Icahn, Mount Sinai)

Darrell Abernethy (FDA)

Jim Stevens (Eli Lilly)

10:30 AM 10:45 PM

Break

 

10:45 PM

12:15 PM

Session 7a: Model-Aided Drug Development of Cancer Immunotherapeutics: Approaches & Applications

Preclinical PK/PD Model-based starting dose selection for cancer immune therapeutics

Impact of Pharmacometrics in Immuno-Oncology: the Example of Pembrolizumab

Quantitative Systems Pharmacology Modeling to Support Early Clinical Trials in Cancer Immunotherapy

Chairs: Siddharth Sukumaran (Genentech) , Kapil Gadkar (Genentech)

Haiqing Wang (BMS)

Rik de Greef (Quantitative Solutions)

Benjamin Ribba (Roche)

 

   

Session 7b: Neighbor’s Envy Owner’s Pride - Comparator Analysis for Drug Development and Market Access

Model based meta-analysis and applications: What can it entail?

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

MBMA for novel anti-diabetic drug development decision making

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)

 

Chairs: Pavan Vaddady (Merck) , Nitin Mehrotra (FDA)

Nitin Mehrotra (FDA)

Mallika Lala (Merck)

Vikas Kumar (Pfizer)

Marc Gastonguay (Metrum)

   

Session 7c: Industrial-Strength Infrastructure for Pharmacometrics

Infrastructure for Efficient and Massively Parallel NONMEM Execution

ePharmacology: Innovative Modeling Environment and Regulatory Compliant Repository for Pharmacometrics Model Development and Simulation, Distributed Computation, and Reporting

Infrastructure for Efficient and Effective Implementation of Modeling and Simulation in the Cloud

Pharmacometrics Infrastructure and Knowledge Management

Chairs: Michael Heathman (Eli Lilly) , Wenping Wang (Novartis)

Evan Wang (Eli Lilly)

Thomas Tensfeldt (Pfizer)

William Knebel (Metrum)

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

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

 

 

Lunch & Meet ISoP Board and Posters

 Hosted by ISoP Board Members

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 Shiny Apps for Pharmacometrics

Chairs: Pavan Vaddady (Merck)

Bhargava Kandala (Merck)

   

Tutorial 2: Modular QSP design - Approaches to speed up the QSP model development 

Architecture of Immune Response Template: integration and representation of experimental data and knowledge in terms of immune cells' "passports"

Modular design of QSP models? Examples in Immunogenicity and Immuno Oncology

Component Model Library - Immunetrics approach to QSP model building - Examples in acute inflammation

Chairs: Valeriu Damian (GSK) , Andrzej Kierzek (Certara)

Oleg Demin Jr (Inst of Sys Bio, Russia)

Andrzej Kierzek  (Certara)

Steve Chang (Immunetrics)

   

Tutorial 3: Pharmacometrics + Applied Math = Better QSP 

Introduction & motivating questions

Understanding Your Model: Introduction to Dynamical Systems Theory

Phase Planes, Nullclines, Bifurcations: Concepts and Implementation

Identifiability: Concepts + Implementation

Chairs: Cynthia Musante (Pfizer) , Kevin Dystra (qPharmetra)

Kevin Dykstra (qPharmetra)

Eduardo Sontag (Rutgers univ)

Dean Bottino (Takeda)

Andy Stein (Novartis) and Andreas Raue (Merrimack)

   

Tutorial 4: Student Tutorial:

A: Communicate to Influence

B: Elevator Pitch

Chairs: Joga Gobburu (University of Maryland) and Kayla Lien (University of Florida)

THURSDAY October 19th

7:00 AM

8:00 AM

Breakfast and Registration for Post-meeting Workshops

 

8:00 AM

5:00 PM

Post-meeting workshops

 

   

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)