CPSA

Chemical & Pharmaceutical Structure Analysis
Where Technology and Solutions Meet

CPSA 2008

The Value Proposition of Analytical Chemistry

October 27-30, 2008
Langhore, PA

Final Program

Monday, October 27

8:30 pm - 4:30 pm

Short Courses
Bucks County Sheraton Hotel
2nd Floor Boardroom Lobby

Method Development for LC/MS: Traditional Approaches and Emerging Trends
Roger Hayes, Schering-Plough
Shane Needham, Alturas Analytics

High Throughput Drug Discovery Support: LC/MS Strategies for Method Development, Profiling and Workflow Solutions
Mark Hayward, Lundbeck Research USA
Ken Lewis, OpAns

Is Poor Bioavailability in Early drug Discovery a Problem and If So, How Can We Solve It?
Ayman El-Kattan, Pfizer

Sample Preparation for Non-Traditional and Traditional Biological Matrices: Mass Spectrometry Quantitation from Organic Molecules to Peptides/Proteins
Min Chang, Biogen Idec
Qin Ji, Covance

5:30 am - 7:30 pm

Reception & Reigistration

8:30 am - 10:00 pm

Sponsors Dinner Event

Tuesday, October 28

7:30 am - 8:30 am

Reigistration & Continental Breakfast

8:30 am - 8:35 am

Welcome
Mike S. Lee, Milestone Development Services

8:30am - 8:45 am

Objectives, Format & Opening Remarks
Lucinda Cohen, Merck Research Laboratories

8:45 am - 9:45 am

Plenary Lecture

Mass Spectrometry of Synthetic Polymers: Some Challenges and Some Successes
Ian JDavid M. Hercules, Centennial Professor of Chemistry Emeritus, Vanderbilt University

9:45 am - 10:00 am

Break / Roundtables

10:00 am - 11:15 am

Excellence in Bioanalysis through Automation
Discussion Leader: Steven Michael, Pfizer

Process Improvement and Increased Productivity through the Introduction of Centralized, Automated Sample Preparation into a Generalist Model
Chris Holliman, Dave Weller, Max Tella, and Lisa Buchholz, Pfizer

Improving Bioanalytical Communication, Sample Handling, Data Reporting and Decision Making with a Custom Informatics Tool
John P. Walsh, Charles E. Taylor, Qiner Yang and Robyn A. Rourick, Kalypsys, Inc.

11:15 am - 11:30 am

Break / Roundtables

11:30 pm - 12:45 pm

Complimentary Lunch / Roundtables

Insourcing, Outsourcing and Offshoring
Discussion Leaders: Dieter Drexler, Bristol-Myers Squibb, and Min Zhong, Pfizer

Balancing Cost, Capacity, Quality and Innovation
Adrienne Tymiak, Bristol-Myers Squibb

Check List for Successful Offshoring Bioanalytical Studies
Zamas Lam, QPS

12:45 pm - 3:00 pm

Poster Session/Rountables
Session Chairs:
Michelle Dennehy, GlaxoSmithKline
James L. Stephenson, RTI International
Matthew E. Szapacs, GlaxoSmithKline
Tracie Williams, Centers for Disease Control & Prevention

2:00 pm - 3:00 pm

Rountable Workshop Sessions

Bringing Together an Integrated Strategy for Metabolite Identification Using High Mass Accuracy MSn Data/ Novel approaches to the comprehensive profiling of metabolites in lead discovery: integration of screening assays with ion-trap time of flight mass spectrometry
Neil Loftus, Shimadzu Scientific Instruments
Jon de Vlieger, Wilfried Niessen, Jeroen Kool, Hubertus Irth, VU University Amsterdam

Sensitivity, Sensitivity, Sensitivity ’Äì Throughput, Throughput, Throughput
Christopher Evans, GlaxoSmithKline
Reza Javahery, IONICS Mass Spectrometry Group
Daniel J. Magiera, Molecular MS Diagnostics

High Throughput Applications ’Äì Fast Chromatography
Roger N. Hayes, Schering-Plough
Mark J. Hayward, Lundbeck Research USA
Ken Lewis, OpAns
Shane R. Needham, Alturas Analytics

Small, Smaller, Tiny: Benefits and Drawbacks of Reduced Sample Size - North Jersey NMR Discussion Group
István Pelczer, Princeton University
David Russell, Varian

3:00 pm - 4:15 pm

Emerging Analytical Tools for Biologics
Discussion Leader: Gabriella Szekely-Klepser, Assay Designs, Inc.

Challenges to Safety Evaluation of Small Molecule Pharmaceuticals and Biologics
Rakesh Dixit, Medimmune

Critical Factors in the Assessment of Immunogenicity of Therapeutic Protein
Michael Mullenix, Assay Designs, Inc.

Multiplexed Immunoassay Technologies for the Detection of Clinical Biomarkers
Fizal Nabbie, Bristol-Myers Squibb

4:15 pm - 4:45 pm

Break / Roundtables

4:45 pm - 6:00 pm

"Nano" Applications to Small Molecule Analysis
Held in conjunction with the North Jersey ACS Chromatography and NMR Discussion Groups
Discussion Leader: Nalini Sadagopan, Agilent Technologies

Mass Spectrometry Imaging of Small Molecules Using Nanofeature-Assisted Laser Desorption Ionization Mass Spectrometry
Lin He, North Carolina State University

Application of Chip-Based Nanoflow LC in Combination with Triple Quadrupole MS for PK Quantitation Studies
Stephan Buckenmaier, Agilent Technologies

Nano Applications to Small Molecule Analysis
Jack Henion, Advion BioSystems

6:00 pm - 8:00 pm

Sponsor Hospitality - Evening Workshops
Held in conjunction with the North Jersey ACS Chromatography and NMR Discussion Groups

Eksigent Low flow LC/MS/MS for Quantitative Bioanalysis in a Discovery PK Laboratory - Eksigent
Heather Skor, Pfizer Global R↦D

Applied Biosystems

McKinley Scientific

Investigating Thermal and Instrumental Influences on sub 3 µm Columns - Phenomenex
Jason A. Anspach

Direct Injection of SPE Extracts into High pH Mobile Phases in LC-MS Analysis for Enhanced Throughput and Sensitivity - Phenomenex
Tivadar Farkas

Reducing the Complexity of Chiral Method Development for Pharmaceutical Compounds - Phenomenex
Tivadar Farkas

Wednesday, October 29

7:30 am - 8:30 am

Reigistration & Continental Breakfast

8:30 am - 10:00 am

Biomarkers in Preclinical and Clinical Development
Discussion Leader: Dawn Dufield, Pfizer

Urinary Stercobilin: A Potential Biomarker for Autistic Spectrum Disorders
Troy D. Wood, University of Buffalo

Differential Mass Spectrometry: Instruments, Analyses and Applications
Nathan A. Yates, Merck Research Laboratories

Assaying Low Abundance Candidate Protein Biomarkers by Targeted Mass Spectrometry
Eric Kuhn, The Broad Institute

10:00 am - 10:30 am

Break / Roundtables

10:30 am - 12:15 pm

Adding Another Dimension to the Quantitation of Peptides and Proteins
Discussion Leader: Ray Bakhtiar, Merck Research Laboratories

Challenges on Determination of PEGylated-Peptide in Human Plasma Using LC-MS/MS to Support Clinical Studies
Yang Xu, Merck Research Laboratories

Can We Learn How To Make More Stable Peptides From in vitro Metabolism Studies?: Quantification and Characterization Approaches by LC-MS
Constantin Tamvakopoulos, Biomedical Research Foundation of the Academy of Athens

LC-MS/MS Approach for Quantification of Therapeutic Proteins in Plasma Using a Protein Internal Standard and 2D-Solid-Phase Extraction Cleanup
Ziping Yang, Novartis Pharmaceuticals

12:15 pm - 2:15 pm

Exhibition Open

1:15 pm - 2:15 pm

Roundtable Workshop Sessions / Sponsored Lunch

McKinley Scientific
Instrument Leasing and Asset Management
Paul Corcoran, McKinley Scientific

Eurofins Medinet
Renal Dysfunction Molecular Markers’ÄîFrom Cage to Clinic
Jamie Bendrick-Peart, Eurofins Medinet

New Objective
High Performance Nanospray
Thomas R. Covey, MDS Analytical Technologies
Daniel J. Magiera, Molecular MS Diagnostics
Robyn Rourick, Kalypsys
Gary A. Valaskovic, New Objective

Alta Analytical Laboratory
Tissue Analysis
Lee Hamm, Alta Analytical Laboratory
Stanley C. Murakami, Alta Analytical Laboratory
Shane R. Needham, Alturas Analytics

Indigo Biosystems
Lies, Damned Lies, and Bioanalytical Statistics
Randall Julian, Indigo BioSystems
Christopher Kemper, Taylor Technology
Fred Lytle, Indigo BioSystems

2:15 pm - 3:30 pm

Leveraging Analytical Chemistry for Drug Metabolism Studies
Held in conjunction with the North Jersey ACS Drug Metabolism and Mass Spectrometry Discussion Groups and the Delaware Valley Drug Metabolism Discussion Group
Discussion Leader: Mingshe Zhu, Bristol-Myers Squibb

Industrialization of Metabolite Identification in Drug Discovery
Kevin Bateman, Merck Frosst Canada & Co.

Profiling Plasma Metabolites in First in Human Studies with High-Resolution LC/MS: A Challenging and Exciting Opportunity
Haiying Zhang, Bristol-Myers Squibb

3:30 pm - 5:30 pm

Vendor Session
Held in conjunction with the North Jersey ACS Drug Metabolism and Mass Spectrometry Discussion Groups and the Delaware Valley Drug Metabolism Discussion Group
Discussion Leaders:
Mark J. Hayward, Lundbeck USAResearch
Ragu Ramanathan, Bristol-Myers Squibb

5:30 pm - 6:30 pm

Exhibition & Social Hour
Held in conjunction with the North Jersey ACS Drug Metabolism and Mass Spectrometry Discussion Groups and the Delaware Valley Drug Metabolism Discussion Group

6:30 pm - 7:30 pm

Dinner
Held in conjunction with the North Jersey ACS Drug Metabolism and Mass Spectrometry Discussion Groups and the Delaware Valley Drug Metabolism Discussion Group
Co-sponsored by Applied Biosystems/MDS Analytical Technologies and McKinley Scientific

7:30 pm - 7:45 pm

Announcements

CPSA - Distinguished Analytical Scientist Award Presentation
Presented by:Tim Baker, Procter & Gamble

Using Mass Spectrometry in New Drug Discovery: Past, Present and Future
Walter A. Korfmacher, Schering-Plough Research Institute

7:45 pm - 9:00 pm

Keynote Lectures
Co-sponsored by Applied Biosystems/MDS Analytical Technologies and McKinley Scientific

Where Can We Go From Here? An Assessment of the Limits to Sensitivity of Electrospray and MALDI
Thomas R. Covey, MDS Analytical Technologies

Protein and Peptide Analysis Using Microfabricated Fluidic Devices
J. Michael Ramsey, University of North Carolina

Thursday, October 30

7:30 am - 8:30 am

Reigistration & Continental Breakfast

8:30 am - 10:00 am

Operational Excellence through IT and Hardware Solutions
Discussion Leader: Arkady Gusev, Pfizer

Improving Operation Efficiency of LC-MS Systems
Bernard Choi, Merck Research Labs

e-Lab Notebook Application to in ADME Studies: From ADME Data to ADME Knowledge
Dongyang He, Pfizer

An Integrated Turn-Key Solution for Large Scale Data Management
Randall Julian, Indigo BioSystems

10:00 am - 10:30 am

Break / Roundtables

10:30 am - 12:15 pm

Approaches to Overcome Poor Pharmacokinetic Properties for Lead Compounds
Discussion Leader: Ayman El-Kattan, Pfizer

Phosphate and other Prodrug Strategies in Drug Discovery and Development to overcome Poor Plasma Exposure
Tycho Heimbach, Novartis Pharmaceuticals

Understanding and Overcoming Solubility Issues in Oral Absorption
Shobha Bhattachar, Eli Lilly and Company

12:15 pm - 2:00 pm

Complimentary Lunch / Roundtables

Is There Life Beyond LC/MS?
Discussion Leader: Richard C. King, Merck Research Laboratories

2:00 pm - 2:15 pm

Wrap Up & Adjourn
Lucinda Cohen, Merck Research Laboratories

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