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Incorporating Pharmacogenomics in Clinical Studies

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September 25 - September 26 2006 | Hyatt Regency - Inner Harbor | Baltimore, MD

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Agenda Day One

Agenda Day One

DAY ONE: Monday September 25, 2006
8:00Conference Registration and Morning Coffee
8:30

Chairpersons' Welcome and Opening Remarks

Edward Abrahams, PhD, Executive Director,
PERSONALIZED MEDICINE COALITION STATE OF INDUSTRY KEYNOTE

8:45

Overview: How Pharmacogenomics Is Improving Drug Development Success

Nadine Cohen, PhD, Head of Pharmacogenomics and Senior Research Fellow,
JOHNSON & JOHNSON Pharmaceutical Research and Development East Coast and Europe

9:30

Case Study
Understanding How and Why to Incorporate Pharmacogenomics in Clinical Studies

Mark Watson, PhD, Clinical Pharmacogenetics,
GLAXOSMITHKLINE

10:15Morning Break
10:45

Applying Pharmacogenomics to the Drug Development Process for Safer More Effective Therapies

Moderated By:
David Johnston, PhD, Vice President, Chief Scientific Officer,
LABCORP

Nadine Cohen, PhD, Head of Pharmacogenomics and Senior Research Fellow,
JOHNSON & JOHNSON

Mark Watson, PhD, Clinical Pharmacogenetics,
GLAXOSMITHKLINE

11:30

Featured FDA Presentation
Collaborate on Novel Approaches to Diagnostics as They Evolve — FDA Recommendations for Pharmacogenomics

Courtney Harper, Associate Director for Toxicology, Division of Chemistry and Toxicology Devices,
CDRH, FDA

12:15Networking Luncheon
1:30

Assay Development and Validation
Evaluation of Analytical Methods for RNA Extraction and Validation of the Affymetrix Microarray Platform for Clinical Application

Sunil Kadam PhD, Principle Research Scientist Genomic Medicine, Laboratory of Experimental Medicine,
ELI LILLY AND COMPANY

2:15

Featured Case Study
The Irinotecan Example- From Research to Market with a New Diagnostic Test for Irinotecan

Luis Parodi, PhD, Director and Site Head, Clinical Pharmacogenomics,
PFIZER

3:00Afternoon Networking Break
3:30

Case Study
Development, Validation, and Clinical Study of Therapeutic and Diagnostic Oncology Biomarker

Ginette Serrero, PhD, President and Chief Scientific Officer,
A&G PHARMACEUTICALS

4:00

Genotyping Genetic Polymorphisms in Drug Metabolic Enzyme and Transporter Genes, Using the MegAllele Genotyping Platform

Carmen Dumaual, Associate, Diagnostic and Experimental Medicine,
ELI LILLY AND COMPANY

4:30

Panel Discussion
Incorporating Biomarker Validation and Qualification in Drug Development

Panelists:
Luis Parodi, PhD, Director and Site Head, Clinical Pharmacogenomics,
PFIZER

Ginette Serrero, PhD, President and Chief Scientific Officer,
A&G PHARMACEUTICALS

Carmen Dumaual, Associate, Diagnostic and Experimental Medicine,
ELI LILLY AND COMPANY

5:00

Day One Concludes



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