Session 1: Model Based Drug Development – Industry and Regulatory Scientists’ Views on Progress (Symposium)
Model Based Drug Development – The Current State of Affairs and Considerations for the Future
Exposure-Response – Does it have more to offer MBDD and how to get us there
Flying the plane whilst optimizing the control systems - Life in the real world of drug development:
Adaptive Trial Designs and Clinical Trial Simulations –Role of Pharmacometrics
Lokesh Jain (FDA), Chris Tornoe (Novo Nordisk)
Lokesh Jain (FDA)
Rune Viig Overgaard (Novo Nordisk)
John Davis (Genentech)
Brenda Gaydos (Eli Lilly)
12:00 PM
1:30 PM
Lunch/Posters/Exhibits
Student/Trainee Lunch & Networking [free; separate registration required]
Ashit Trivedi (ACoP Trainee Committee Chair)
1:30 PM
2:30 PM
State-of-the-Art Lecture "Predictive Biology through genome-scale models"
Bernhard Palsson (UCSD) Hosted by Robert Bies
2:30 PM
3:00 PM
Break
3:00 PM
5:00 PM
Session 2a: Dose selection in Oncology: Thinking beyond MTD? (Symposium)
Pharmacometrics in Oncology Drug Development
Exposure-Response in Regulatory Decision Making of Targeted Oncology Agents: Case Studies and Regulatory Expectations
Exposure-response modeling in oncology: technical challenges and proposed solutions
Oncology Drug Dosing: Often Precise But Not Necessarily Accurate
Anshu Marathe (FDA), Diana Wang (Pfizer)
Amit Roy (BMS)
Nitin Mehrotra (FDA)
Jonathan French (Metrum)
Mark J. Ratain (Univ. Chicago)
Session 2b: Quantitative Systems Pharmacology in Cardiovascular Disease: Applications and Approaches in Drug Development (Roundtable)
Mechanistic M&S to Support Design of Targeted Therapies for CV Tissue Protection and Regeneration
Mechanistic Physiological Modeling Elucidates in vitro and in vivo PCSK9 Effects on LDLR and LDL
QSP-based Approaches to Predict the Clinical Impact of Different HDL-Modifying Strategies on Reverse Cholesterol Transport, a Critical Mechanism for Plaque Clearance in Atherosclerosis
Archimedes Model: An Outcome-Based Model for Drug Development and Public Health Research for Cardiovascular Diseases
Saroja Ramanujan (Genentech); Matt Onsum (Silver Creek Pharmaceuticals)
Matt Onsum (Silver Creek Pharmaceuticals)
Christina Friedrich (Rosa and Co)
Kapil Gadkar (Genentech)
Tuan Dinh (Archimedes)
3:00 PM
5:00 PM
Session 2c: Variabilities in Accounting for Variability: Where does PK stops and PD start? (Symposium)
The Link between Pharmacodynamics and Physiologically Based Pharmacokinetic Models and the Sources of Variability in Response
The Added Value of Combining “Bottom-up” and “Top-down” Approaches in PK/PD Modelling
Combined analysis of PK and Efficacy Data of Preclinical Studies Improves IVIVE of Statins Response
Protein Binding as a Modulator of PK and PD Variability
Amin Rostami-Hodjegan (Univ. of Manchester)
Allen Forrest (SUNY Buffalo)
Masoud Jamei (Simcyp Ltd, a Certara company)
Evita van de Steeg (TNO)
Hartmut Derendorf (Univ. Florida)
7:30 PM
10:30 PM
Social Event
TUESDAY October 14th
7:30 AM
9:30 AM
Breakfast Contributed Poster Session 2 Exhibits
9:45 AM
11:45 AM
Session 3a: Translating Novel Pharmacological Concepts from Discovery to the Clinic (Symposium)
What is required to make systems pharmacology modeling and simulation a success?
Measurement, Definition, and Translation of Ligand Affinity, Efficacy, and Selectivity
What do We Need to Build Mechanism-based Receptor Models During the Translational Research Phase?
How can We Use Mechanism-based Receptor Models for Designing First in Human Studies?
Ted Grasela (Cognigen)
Ted Grasela (Cognigen)
William Clarke (Univ. Texas Health Sci Ctr)
Don Mager (Univ. Buffalo)
Richard Peck (Roche)
Session 3b: Adherence and Sampling Frequency: Practical Considerations in Understanding Therapeutic Failure (Symposium)
Bridging the Adherence Gap between use- and Method-effectiveness
Adherence Patterns in HIV, Modeling the Dosage Input Profile with or without Pharmacokinetic Measures
Adherence Patterns, a Joint Likelihood Based Model of Adherence and PK
Robert Bies (Indiana Univ)
Bernard Vrijens (MVW Healthcare)
Ayappa Chaturdevala (Mercer Univ.)
Mark Sale (Next Level Solutions)
Session 3c: Symposium: Mixed-Treatment Comparisons of Safety Events in Randomized Controlled Trials: Role and Impact of Pharmacometrics
Points for Consideration in Bayesian Mixed Treatment Comparison of Safety Endpoints: An Expert Viewpoint
Safety Contextualization for Rare Events: Considerations for Analysis and Decision Making in Drug Development
Model-Based Meta-Analysis of Safety Data to Support Drug Development
Jonathan French (Metrum Research Group), Sujatha Menon (Pfizer)
David Ohlssen (Novartis)
Pankaj Gupta (Pfizer)
Bill Gillespie (Metrum Research Group)
12:00 PM
1:30 PM
Lunch/Posters/Exhibits
Student/Trainee Mentoring Session with lunch [free; separate registration required]
Ashit Trivedi (ACoP Trainee Committee Chair)
1:30 PM
2:30 PM
Sheiner Award Lecture "Pharmacometrics at the edge of the world"
Stephen Duffull (University of Otago) Hosted by France Mentre
2:30 AM
3:00 AM
Break
3:00 PM
5:00 PM
Session 4a: Application of Pharmacometrics in Combination Products (Round Table)
Everolimus for Liver Transplantation: Industry Perspective
Everolimus for Liver Transplantation: Regulatory Perspective
Dose Justification Based on Risk/Benefit Balance for a Combination Product
Yaning Wang (FDA); Don Stanski (Astra Zeneca)
Thomas Dumortier (Novartis)
Yaning Wang (FDA)
Fang Li, Ph.D (FDA)
Session 4b: PKPD Modeling of Antibody-drug Conjugate (Symposium)
A preclinical and Translational Integrated Analyte Model Accounts for Drug-load Dependent Deconjugation and Clearance in PK of Thiomab ADC with Engineered Site-Specific Drug Conjugation
PK/PD Modeling and Simulation to Evaluate Alternative Dosing Strategies for SGN-CD19A, a Novel Anti-CD19 ADC
Approaches to Modeling Clinical PK of ADCs
Clinical Exposure Response and Toxicity Modeling for Anti-CD22-vc-MMAE ADC
Jin Yan Jin (Genentech); Saroja Ramanujan (Genentech)
ACoP5 Open Forum When Children are Just Small Adults: Examining Current Approaches in Extrapolation of Adult Efficacy Data for Pediatric Drug Development [separate registration and dinner fee required]
Current FDA perspective on extrapolation for pediatric drug development, and specific impact of Pharmacometrics
Organizational Experience of Utilization of Extrapolation for Pediatric Drug Development
Pharmacometrics and Pediatric Drug Development: Extrapolation is the Key Area of Focus?
Anasuya Hazra (Pfizer); Arnab Mukherjee (Pfizer)
Vikram Sinha (FDA)
Liping Zhang (Janssen), Amit Roy (BMS), Arnab Mukherjee (Pfizer)
Joga Gobburu (Univ. of Maryland)
WEDNESDAY October 15th
7:30 AM
9:30 AM
Breakfast Contributed Poster Session 3 Exhibits
9:45 AM
11:45 AM
Session 5: ISoP Standards and Best Practices Committee Report: Model Evaluation in Pharmacometrics (Round Table)
Introduction to ISoP Standards and Best Practices Committee, to MoEv and to the Symposium
Pros and Cons of Current Model Evaluation Tools
Guidelines from Industry on Model Evaluation: the ISop-MoEv wiki
Current FDA Perspective on Model Evaluation
Current EMEA Perspective on Model Evaluation
Panel Discussion
France Mentre (INSERM)
Rene Bruno (Pharsight)
Andrew Hooker (Univ. Uppsula)
Samer Moussaki (Certera)
Yaning Wang (FDA)
Flora Musuamba Tshinanu (Univ. London )
All presenters and Chair
11:45 AM
12:00 PM
Closing Remarks - meeting adjourns
Liping Zhang (Conference Chair)
12:00 PM
1:30 PM
Lunch & Meet the ISoP Board
1:30 PM
3:30 PM
ACoP6 meets ACoP5 [by invitation only]
1:30 PM
4:30PM
ACoP Tutorials [free; separate registration required]
Model Simplification - Application to Systems Pharmacology (2 hr)
Cloud Computing for Pharmacometricians (2hr)
Reproducible Research with R, Rmarkdown, Knitr and Git (3 hr)
Steve Duffull (Univ. of Otago); Vittal Shivva (Univ. of Otago); Shan Pan (Univ. of Otago)
Sachin Sanduja (Rudraya)
Devin Pastoor (Univ. Maryland)
THURSDAY October 16th
8:00 AM
5:00 PM
Post-meeting workshops
Model-Based Meta-Analysis (MBMA) Using R/S-PLUS (2-day)
Simulation Concepts and Strategies for Model-based Drug Development
How can Pharmacometrics be Leveraged to Support Key Regulatory Decisions: a Strategy Training Workshop
Leon Bax, Eugene Cox, Mark Lovern (Quantitative Solutions)
Marc R. Gastonguay, Jonathan French and colleagues (MetrumRG)
Joga Gobburu (Univ. Maryland)
FRIDAY October 17th
8:00 AM
5:00 PM
Post-meeting workshops
Population Analysis and Modeling with Monolix and Mlxtran (2-day)
Model-Based Meta-Analysis (MBMA) Using R/S-PLUS (2-day)
Marc Lavielle (Lixoft)
Leon Bax, Eugene Cox, Mark Lovern (Quantitative Solutions)
