ACoP6 Program

SATURDAY October 3rd

7:00 AM

8:00 AM

Breakfast and Registration for Pre-meeting Workshops

 

8:00 AM

5:00 PM

Pre-meeting Workshops 

 

   

Modeling Delays in PK and PD

Wojciech Krzyzanski (Univ at Buffalo)   

   

Advanced Features of NONMEM7 Workshop

Robert Bauer (ICON)

   

Introduction to R

Richard Pugh (Mango Solutions)

   

Systems Pharmacology and Model Coupling -A Step-by-step Lesson How to Build Integrated PBPK/PD Models for Combination Therapies

Martin Hobe (Bayer)

SUNDAY October 4th

7:00 AM 

8:00 AM

Breakfast and Registration for Pre-meeting Workshops 

 

7:00 AM

8:00 AM

Breakfast and Registration for ACoP6 Pre-conference

 

8:00 AM

5:00 PM

Pre-Meeting Workshops

 

    R for Pharmacometrics Richard Pugh (Mango Solutions)
    Physiological Modeling of Therapeutic Proteins and Antibody-drug Conjugates Lingzhong Li (Simcyp - A Cetara Company)
       

8:15 AM

4:00 PM

ACoP6 Pre-conference

“Enabling environments in which pharmacometrics and biostatistics help produce robust development and regulatory strategies”

Co-chaired by Vikram Sinha (FDA) and Brian Smith (Novartis)

12:00 PM

5:30 PM

Registration for ACoP6

 

5:30 PM

7:30 PM

Opening Session

 

 

 

(5:30 - 6:15)

Conference Opening

ISoP Awards Presentation:

Leadership Award - Larry Lesko

Innovation Award - Marc Lavielle

Jin Yan Jin, ACoP6 Conference Chair; Donald Mager, ISoP President

 

Kevin Dykstra, ACoP6 Awards Committee Chair

   

(6:15 - 7:30)

Keynote Speech: 

Transitioning from Basic PK/PD Towards Systems Pharmacology Models

Hosted by Robert Bies, ACoP6 Scientific Programming Committee Chair

William J. Jusko (Univ. at Buffalo)

7:30 PM

9:00 PM

ACoP6 Opening Reception

 

MONDAY October 5th

7:30 AM

9:30 AM

Breakfast/Registration
Contributed Poster Session 1
Exhibits

 

9:30 AM

9:40 AM

Conference Highlights

Jin Yan Jin, ACoP6 Conference Chair

9:40 AM

10:00 AM

President Address: The Journey of ISoP

President-Elect Address: Looking Ahead 

Donald Mager, ISoP President


Brian Corrigan, ISoP President-Elect

10:00 AM

12:00 PM

Session 1: Is There a Role of Big Data in Drug Development Decisions?

Linking Genomic Markers to Disease using Computational Methods

Leveraging Real World Data for Development and Use of Medicines: An Industry Persepective on Big Data

Computational Biology Tools for Identifying Drug-Drug Interactions 

A Pharmacometrician's perspective for utilization of Big Data

Arnab Mukherjee (Pfizer), Robert Bies (University of Buffalo)


Sean Mooney (University of Washington)


Josephine Sollano (Pfizer)

 

Lang Li (Indiana University)


Marc Gastonguay (Metrum)

12:00 PM

1:30 PM

Student/Trainee Mentoring Session with Lunch 

Click here to view mentor bio-sketches

[free, separate registration required]

 Hosted by Charvi Nanavati, ACoP6 Trainee Committee Chair

12:00 PM

1:30 PM

Lunch/Posters/Exhibits

 

1:30 PM

2:30 PM

State-of-the-Art Lecture


The Calculus of Calories: Quantitative Physiology of Human Metabolism and Body Composition Dynamics

Hosted by Mirjam Trame, ACoP7 Scientific Programming Committee Chair

Kevin Hall (NIH/NIDDK)

2:30 PM

3:00 PM

Break

 

3:00 PM

5:00 PM

Session 2a: Modeling and Simulations as Cornerstone in Drug Development for Rare Diseases: Challenges and Opportunities

Rare Diseases Drug Development: Perspectives of CDER's Rare Diseases Program

Technical challenges and opportunities when applying modeling and simulation to rare disease drug development

An Industry perspective on the use of modeling and simulations in drug development for rare diseases

Role of Pharmacometrics in regulatory decisions for drugs to treat rare diseases: Case studies

 

Nitin Mehrotra (FDA), Marc Gastonguay (Metrum)

 

Jonathan Goldsmith (FDA)

 

C.J. Godfrey (Metrum)

 



Raj Pradhan (Alexion Pharmaceuticals)

 

Jingyu Yu (FDA)

 

 

Session 2b: Pharmacometric Approaches for Analysis of Categorical Safety Data for Improved Risk Assessment

Introduction and overview of pharmacometric approaches for analysis of categorical safety 

Adaptive Switching from Non-inferiority to Superiority in CV Outcome Study 

Longitudinal analysis for categorical safety data

Analysis of Longitudinal ordering catagorical muscle spasm data- a comparison among different models 

Cecilia Fosser (Cytel), Matts Kagedal (Genentech)

 


 Matt Hutmacher (A2PG)



Lingyun Liu (Cytel)

 

 Mats Karlsson (Uppsala University)


 Tong Lu (Genentech)

 

 

Session 2c: Meeting in the Middle: Bridging PBPK and QSP Modeling


Systems-based PK/PD Modeling for Anti-cancer Drugs

Systems Pharmacology Modeling and Simulation for the Development of Integrated Microphysiological Systems

Mechanistic understanding of translational pharmacokinetic-pharmacodynamic relationships in nonclinical tumor models

Combining knowledge of in vitro drug properties, population and genetic variability for the prediction of QTc prolongation

 Masoud Jamei (Simcyp - A Certara Company), Ben Small (Simcyp - A Certara Company)

James Gallo (Mount Sinai School of Medicine)

Jiajie Yu (MIT)



Mary Spilker (Pfizer)


 

Sebastian Polak (Jagiellonian University/Simcyp -A Certara Company)

7:30 PM

10:30 PM

Social Event

 

TUESDAY October 6th

7:30 AM

9:00 AM

Breakfast/Registration
Contributed Poster Session 2
Exhibits

 

9:00 AM

10:00 AM

Podium Presentations of ACoP6 Quality Awards and ACoP6 Trainee Awards

 Hosted by Beesan Tan, ACoP6 Abstract Committee Chair

10:00 AM

12:00 PM

Session 3a: GPS for QSP: Where We have Been, Where We Are, and Where We are Headed

Sponsored by ISoP QSP Special Interest Group and AAPS Focus Group on QSP

History and current state of the science: an industry perspective

History and current state of the science: an academic perspective

History and current state of the science: a regulatory perspective

“Future Perspectives” roundtable discussion

 

 Michael G Zager (Janssen), Cynthia Musante (Pfizer)

 

 

Sandra Allerheiligen (Merck)


Douglas Lauffenburger (MIT)


Darrell Abernethy (FDA)

   

Session 3b: A Novel Interdisciplinary Pharmacometric Approach: A Systems Approach to Support Pharmacology to the Payer

Why Pharmacology to the Payer (P2P)?

P2P case study – proof of concept


P2P case study linking to health economic outcomes

P2P planning for prime time and future applications

 Robert Bies (Indiana University)




Craig Rayner (D3 Medicine)


Carl Kirkpatrick (Monash University)


Rich Nelson (Univ of Utah)


Patrick Smith (D3 Medicine)

12:00 PM

1:00 PM

Meet the QSP Special Interest Group (SIG) Lunch

[free, separate registration required]

Hosted by ISoP QSP Special Interest Group

12:00 PM

1:30 PM

Lunch/Posters/Exhibits

 

1:30 PM

2:30 PM

Sheiner Award Lecture 

Hosted by Stephen Duffull (University of Otago)

Steven Shafer (Stanford University)

2:30 AM

3:00 AM

Break

 

3:00 PM

 5:00 PM

Session 4a: Systems Pharmacology Approaches for Assessing Drug Safety

Mechanistic modeling of preclinical toxicities for translational safety assessment

Mathematical modeling of liver injury and dysfunction after acetaminophen overdose: early discrimination between survival and death

Modeling of liver injury in human patient populations using a mechanistic model of the liver

Mining adverse events databanks of adverse events to inform complex systems pharmacology models in drug safety

Jay Mettetal (AstraZeneca)



Jay Mettetal (AstraZeneca)



Chris Remien (University of Idaho)





Brett Howell (Hamner Institute)



Mirjam Trame (University of Florida)

   

Session 4b: Translational PK-PD and Pharmacometrics in Biologics Development

From Pop PK to PHC:  Integrated modeling and biomarker strategies to accelerate the development of biologics

Model-based strategy in developing antibody-based biotherapeutics in pediatric populations

New methods to inform biologics development

Leveraging internal and literature data: application of PK/PD and MBMA in mAb drug development

 Lorin Roskos (MedImmune)



Lorin Roskos (MedImmune)




Zhenhua Xu (Janssen)



Liang Zhao (FDA)


Nageshwar Budha (Genentech)

   

Session 4c: Mechanistic modeling for a complete oncology drug development cycle: translation, stratification, and feedback to discovery from the clinic

Multiscale Mechanistic Simulations of Tumor Targeting: Predicting whole animal to subcellular distribution

How do antigen number and shedding affect the delivery of antibody-based anticancer agents in solid tumors?

Preclinical-to-Clinical Translation of ADCs Using Mechanistic Modeling

Using Models of Cell Signaling networks in the Development of Tageted Anti-cancer Drugs

Brian Schmidt (BMS), Craig Thalhauser (BMS)




Greg Thurber (University of Michigan)



Byungkook Lee (NCI/NIH)




Dhaval Shah (University at Buffalo)

 

Daniel Kirouac (Genentech)

5:00 PM

6:00 PM

JPKPD Editorial Board Meeting

[by invitation only]

 

5:00 PM

7:00 PM

Posters / Exhibits

 

6:00 PM

7:00 PM

Presidential Reception

[by invitation only]

 

6:00 PM

7:00 PM

Alumni Receptions (TBD)

 

7:00 PM

10:00 PM

ACoP6 Open Forum: Global Regulatory Perspectives on the Role of Pharmacometrics in Drug Development and Registration
[note: separate registration and dinner fee required]

Model informed drug development: EMA perspectives

Model informed drug development: FDA perspectives

Model building drug development (MBDD) bridging in Asia – Japanese regulatory perspectives

Using modeling and simulation in drug development and regulatory interaction: industrial perspective

The Role of Modeling and Simulation in Regulatory Decision Making: Physician’s Perspective

Rui Zhu (Genentech), Yaning Wang (FDA)





Ine Skottheim Rusten (MSWG, EMA)

Vikram Sinha (FDA)


Naomi Nagai (PMDA)



Sandra Allerheiligen (Merck)



Geoffrey Kim (FDA)

WEDNESDAY October 7th

7:30 AM

9:30 AM

Breakfast
Contributed Poster Session 3
Exhibits

 

9:45 AM

11:45 AM

Session 5a: Translational Therapeutics through Computerized Platforms: Web, Mobile and Wearable Solutions for the Drug R&D and Clinical Use

A User Friendly Tool to Assist Clinicians in the Development of Limited Sampling Strategies

An Online Solution for the Clinical Recommendations for ADHD Treatment

Diagnosing and predicting cyclic neutropenia: An online solution for clinicians and modelers alike.

 

Fahima Nekka (University of Montreal), Jun Li (University of Montreal)

 


Olivier Barriere (inVentiv Health Clinical)


Philippe Robaey (CHEO Research Institute


Morgan Craig (University of Montreal)

   

Session 5b: Mechanistic Immune System Models Across Disease States: Shared Insights, Common Themes and Critical Distinctions

From low-level targets to engaging systemic host defenses: The evolving paradigm of quantitative systems pharmacology

Computational modeling of mucosal immune responses in infectious and autoimmune diseases

In silico evaluation and exploration of antibiotic tuberculosis treatment regimens

Recruiting the immune system against disease: Lessons for PK-PD and systems pharmacology

 

Craig Thalhauser (BMS), Brian Schmidt (BMS)



Ioannis P. Androulakis (Rutgers University)

 

Josep Bassagnanya-Riera (Virginia Tech)


Elsje Pienaar (University of Michigan)


Paolo Vicini (Pfizer)

   

Session 5c: Advances in Model Evaluation Methods for Pediatric Physiologically Based Pharmacokinetics

An overview of model validation, including identifiability and sensitivity, in systems biology with an emphasis on PBPK

Importance of experimental determination of factors that reduce uncertainty and allow for identifiability of other parameters

Exploring a Novel Mechanism of Atypical Nonlinear Plasma Protein Binding: A Sensitivity Analysis-Based Approach

Preclinical to clinical translation of Sorafenib pediatric PBPK models: a case study in model evaluation approaches. 

John Carl Panetta (St. Jude Children’s Hospital), Burgess Freeman (St. Jude Children’s Hospital)

Brian Ingalls (University of Waterloo)



 Anil Maharaj (University of Waterloo)

 

Amelia Deitchman (University of Florida)



John Carl Panetta (St. Jude Children's Hospital)

11:45 AM

12:00 PM

Closing Remarks - Meeting Adjourns

Brian Corrigan, ISoP President-Elect

Jin Yan Jin, ACoP6 Conference Chair

12:00 PM

1:00 PM

Student/Trainee Event with Lunch: 

Effective Communication in Modeling and Simulation 

[free, separate registration required]

Hosted by Charvi Nanavati, ACoP6 Trainee Committee Chair

12:00 PM

1:00 PM

Lunch

 

1:00 PM

4:00 PM

ACoP7 meets ACoP6

[by invitation only]
 

 1:00 PM

 4:00 PM

ACoP6 Tutorials 

[free, separate registration required]

 

   

Session 6a: Building Pharmacometric Applications using R: R Shiny Tutorial

Brian Corrigan (Pfizer), Devin Pastoor (University of Maryland),  Samer Mouksassi (Certara), Jinzhong Liu (FDA, Indiana University), Jessica Wojciechowski (University of South Australia)

   

Session 6b: Automated Model Selection

Mark Sale (Nuventra), Eric Sherer (Louisiana Tech University), Ken Kowalski (A2PG), and Andy Hooker (Uppsala University)

   

Session 6c: A robust workflow, technical approaches, and software tools for application of QSP in model-based drug development

Sponsored by ISoP QSP Special Interest Group

Saroja Ramanujan (Genentech), Sergey Ermakov (Amgen), Craig Thalhauser (BMS), and Kapil Gadkar (Genentech)

THURSDAY October 8th

7:00 AM

8:00 AM

Breakfast and Registration for Post-meeting Workshops

 

8:00 AM

5:00 PM

Post-meeting workshops

 

   

Modern R (2-day)

Devin Pastoor (University of Maryland-Baltimore)

   

MONOLIX Suite Workshop (2-day)

Marc Lavielle (Lixoft)

   

Getting Started with Bayesian PK/PD Modeling Using Stan: Practical use of Stan and R for PKPD applications

Bill Gillespie (Metrum)

   

Modeling Biologics with Target Mediated Disposition

Leonid Gibiansky (QuantPharm)

FRIDAY October 9th

7:00 AM 8:00 AM

Breakfast and Registration for Post-meeting Workshops

 
8:00 AM 5:00 PM

Post-meeting workshops

 

   

Modern R (2-day, continued)

Devin Pastoor (University of Maryland-Baltimore)
   

MONOLIX Suite Workshop (2-day)

Marc Lavielle (Lixoft)