Day One

Wednesday, 20th March, 2013

8.00 Registration, Coffee & Networking

8.55 Chair’s Opening Remarks

Stacey Tannenbaum, Director, Astellas Pharmaceuticals

Establishing The Link Between Drug Efficacy In Preclinical Models & In Humans

9.00 The PK/PD Pipeline; Ensuring That Your Preclinical Tools are as Predictive as Possible Moving Into the Clinic to Minimize Attrition Rates

• Overview of pharmacometric techniques applied in pharmaceutical drug development

• New strategies for refining current techniques to ensure better translation of data moving into the clinic

• Future challenges of PK/PD and the steps being taken to combat these

Damayanthi Devinen, Director, Johnson & Johnson

9.30 Integrating PK and PD Platforms to Remove the ‘Preclinical to Clinical’ Divide and Streamline Drug Development

• Defining PK/PD Strategy

• Understanding M&S to ensure robust translation of data into the clinic

• Creating the PK/PD testable hypothesis

Stacey Tannenbaum, Director, Astellas Pharmaceuticals

10.00 Applying PBPK to strengthen in vivo Extrapolations for Effective ADME Predictions in the Clinic

• Developing a PBPK model capable of accurately characterizing plasma and tissue PK

• Using PBPK to make better decisions moving into the clinic

• Moving towards a platform PBPK model to characterize plasma and tissue disposition

Alison Betts, Senior Principal Scientist, Pfizer

10.30 Introducing the Metabolizing Enzymes Module for PharmaPendium

Philip Maclauglin, Product Development Director, PharmaPendium

10.40 Speed Networking & Morning Refreshments

12.10 Devising more Predictive PK/PD Models to Ensure Success in the Clinic

• Case study of PK/PD prediction based on preclinical data

• Considerations for essential requirements to translate preclinical data into Phase I and IIa decision criteria

• Methods for better predicting drug efficacy using PK/PD

Tristan Maurer, Research Fellow, Pfizer

12.40 Mechanistic Modeling for the Prediction of Human Pharmacokinetics for Both Passive and Transporter Mediated Processes

• Identifying the success rate for human PK prediction using example applications

• Applications for compounds with passive and transporter mediated PK mechanisms

• Challenges and future directions for PBPK

Hannah Jones, Associate Research Fellow, Pfizer

1.10 Panel Discussion: Strategies for Selecting Better Mechanistic Models in Translational Drug Development

• Benefits and drawbacks of current modeling approaches

• Why mechanistic models are needed to make better PK/PD predictions

Harriet Kamendi, AstraZeneca; Lucy Lee, Eisai

1.40 Lunch

PK/PD Modeling Approaches To Identify & Validate Disease Specific Biomarkers

2.40 Integrating Functional Biomarkers and Efficacy to Support a Clinical Testable Hypothesis in the CNS

• Current approaches in identifying and validating disease specific biomarkers

• Optimizing PK/PD modeling to allow the identification of biomarkers cross-species

Patricia Schroeder, PK/PD Scientist, AstraZeneca

3.10 Identifying and Validating Translational Biomarkers to Ensure Better Decision Making Moving into the Clinic

• Reducing the risks throughout development from preclinical to clinical trials

• The benefits of the ‘Pharmacological Audit Trail’ in validating true biomarkers

• Case Study: PK/PD considerations for PARP and cMET

Lucy Lee, Clinical Pharmacologist, Eisai

3.40 Plato BioPharma (PBI) - An Experienced Discovery Partner for PK, Integrative Pharmacology, and Biomarker Analysis

• Overview of Plato BioPharma Inc. (PBI)
• Description of capabilities and services for PK/PD
• Partnering with Plato BioPharma

Glenn J Smits, Consultant, Plato BioPharma, Inc.

3.50 Afternoon Refreshments

Systems Pharmacology & PK/PD; The Potential To Streamline Drug Development

4.20 Bridging the Gap Between Systems Pharmacology and PK/PD to Enhance Drug Development

• Quantification of the minimum effective concentration

• Optimization of efficacy: Slower clearance vs. stronger affinity

• Modeling of competitive agonism

Wojciech Krzyzanski, Assistant Professor, University at Buffalo

4.50 PK/PD Approaches in the Stages of Drug Discovery

• Establishing IVIVC

• Applying semi-mechanistic models for more predictive results

• Translating biomarkers from preclinical to clinical development

Patrick Trapa, Senior Principal Scientist, Pfizer

5.20 Chair’s Closing Remarks

Stacey Tannenbaum, Director, Astellas Pharmaceuticals

5.25 Poster Session and Refreshments