American Conference on Pharmacometrics (ACoP)
Videotaped from The Grand Pequot at Foxwoods Resort
Mashantucket, CT
October 4-7, 2009
Cosponsored by the American College of Clinical Pharmacology

Welcome: Stacey Tannenbaum (View Slides)

Applications of Modeling over the Development Life Cycle of Biologics
Session Chairs: David D`Argenio & Don Mager

Anticipating human PK/PD data of biologics from preclinical data
Peiming Ma

Modeling and simulations for assessment of PK and PD of a G-CSF biosimilar
Wojciech Krzyzanski (View Slides)

Population PK-PD Modeling of Biological Agents: When Modeling Meets Reality
Diane Mould (View Slides)

Model and Data Sharing Initiatives
Session Chairs: Klaus Romero and Brian Corrigan

TI PHARMA
Meindert Danhof (View Slides)

CAMD Initiative for neurodegenerative diseases
Klaus Romero (View Slides)

OpenDiseaseModels.org: An Open Forum for Collaborative Model Building and Evaluation
Bill Gillespie (View Slides)

FDA Disease Models
Christoffer Tornoe (View Slides)

Dealing with Missing Data in Pharmacometrics
Session Chairs: Marc Gastonguay & Jonathan French

Introduction to Missing data and issues in pharmacometrics
Jonathan French

When Should We Be Concerned About Nonignorably Missing Data?
Dan Heitjan (View Slides)

The Impact of Missing Data on Model Evaluation
Marc Gastonguay (View Slides)

Lewis B. Sheiner Memorial Lecture
Introduction: Peter Milligan (View Slides) and Connecting to the Other Side Mats Karlsson (View Slides)

Where will the pharmacometricians of the future come from?
Session Chairs: Bernd Meibohm & Hartmut Derendorf

Panel Discussion: Sandra Allerheiligen, David Cadieu, Amita Joshi, Richard Lalonde

Development and Utlilization of Disease Models
Session Chairs: Mats Karlsson & Marc Pfister

A Mechanism-Based Disease Model for SGLT2 Inhibitors in Type 2 Diabetes Subjects
Chee Ng (View Slides)

Empirical Disease Progression Model for Ranibizumab in Age-Related Macular Degeneration
Satyendra Suryawanshi (View Slides)

The Antiviral Information Management System (AIMS): Leveraging prior knowledge to inform dose selection of new hepatitis C therapies
Lauren Neal (View Slides)

A Modeling Framework to Simulate Motesanib Efficacy in Thyroid Cancer
Rene Bruno (View Slides)

New Directions in Cardiovascular Modeling: From Biomarkers to Clinical Outcomes and Comparative Effectiveness
Session Chairs: Richard Lalonde & Christine Garnett

The RAAS Hypertension PhysioLab platform: A Systems Modeling Approach to Hypertension
Ramprasad Ramakrishna

Conceptual Framework for Evaluating The CV Risk Manifested By Drug-Induced Elevations in Systolic Blood Pressure
Raj Madabushi (View Slides)

Quantitative Approaches for Comparative Effectiveness and Pharmacoeconomics
Jens Grueger (View Slides)

Communication Through Graphics: Looking at Data, Models, and Results
Session Chair: Andreas Krause

Exploratory Data Visualisation: Taming the Technology
Richard Pugh

Visualizing PK/PD Models using Berkeley Madonna
Andreas Krause

Simulation Graphics to Enable Model-Based Decision Making
Kevin Dykstra

Event Driven/Non-continuous Data Models
Session Chairs: Raymond Miller & Celine Dartois

Exposure-Response Analysis for Spontaneously Reported Dizziness in Pregabalin Treated Patients with Generalized Anxiety Disorder
Kaori Ito (View Slides)

Impact of Dosing Regimens on Dropout Across Pregabalin Trials in the Treatment of Generalized Anxiety Disorder
Bojan Lalovic (View Slides)

Apnea of prematurity: A mixed effects modeling approach to disease resolution and pharmacologic intervention modeling
Christopher J Godfrey (View Slides)

Estimation of Mixed Hidden Markov Models with SAEM. Application to daily seizures data
Marc Lavielle (View Slides)

Who Wants to Be the First to Dose this Drug in Children?
Session Chair: Steven Kern (View Slides)

The Design and Analysis of Informative Pediatric Clinical Pharmacology Trials Based on Integrating Modeling and Simulation With Available Prior Knowledge
Jeff Barrett (View Slides)

No Experience, No Problem: Using Bottom-up Approaches to Guide First-in-Children Dosing
Andrea Edginton
(unfortunately, permission was not granted for videotaping)

Evaluation of Performance of a Pediatric Pharmacokinetic Study Using a Simulation Based Design
Manisha Lamba (View Slides)

PhRMA working group updates
Session Chairs: Julie Stone and Amit Roy

Adaptive Dose-Ranging Studies: An Update from the PhRMA Working Group
Jose Pinheiro (View Slides)

Optimizing TQT Studies through PK-PD: An OQT Working Group
Larisa Reyderman (View Slides)

Model-Based Drug Development PhRMA Initiative: Mapping the current status and future state for modeling and simulation in the pharmaceutical industry
Julie Stone (View Slides)

Closing Remarks