ACoP5 Program

SATURDAY October 11th

8:00 AM

5:00 PM

Pre-meeting Workshops

R for Pharmacometrics (2-day)

 

Richard Pugh (Mango Solutions)

SUNDAY October 12th

8:00 AM

5:00 PM

Pre-Meeting Workshops

R for Pharmacometrics (2-day)


The Young, the  Diseased and the Elderly - PBPK Modeling of Special Populations

NONMEM7

Modeling Delays in Pharmacokinetics and Pharmacodynamics

 

Richard Pugh (Mango Solutions)

Martin Hobe and colleagues (Bayer)            

Bob Bauer (ICON)

Wojciech Krzyzanski (SUNY, Buffalo)

12:00 PM

5:00 PM

Registration

 

5:30 PM

9:00 PM

Awards (5:30-6:15)


 

Keynote Speech (6:15-7:30)
"The Clinical Pharmaceutical Sciences: Forty Years of Change"

 

ACoP Opening Reception (7:30-9:00)

Don Mager (ISoP President)
Kevin Dysktra (ISoP Awards Chair)



Leslie Benet (UCSF)
Hosted by Vikram Sinha (FDA)

MONDAY October 13th

7:30 AM

9:30 AM

Breakfast/Registration
Contributed Poster Session 1
Exhibits

 

9:30 AM

9:45 AM

President Address: Looking Ahead

Don Mager (ISoP President)

9:45 AM

11:45 AM

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)

Siddharth Sukumaran (Genentech)



 

Baiteng Zhao (Seattle Genetics)


Leonid Gibiansky (QuantPharm)

Dan Lu (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

Exhibitor/Sponsor/Vendor Reception [by invitation only]

 

7:00 PM

9:30 PM

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)