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CPSA 2007

Influencing Scientific Decision-Making in Drug Discovery & Development via Integrated Analytical Sciences and Strategies
October 22-25, 2007

CPSA 2007

Overview
General Information
Call for Papers
Short Courses
Program
Registration
Job Postings
Sponsors
Photos

Past CPSA Digests
CPSA Digest 2000
CPSA Digest 2001
CPSA Digest 2002
CPSA Digest 2003
CPSA Digest 2004
CPSA Digest 2005
CPSA Digest 2006
CPSA 2007 Sponsors

Agilent Ad
Agilent Technologies
Alta Ad
Alta Analytical


alturas Ad
Alturas Analytical
Applied Biosystems Ad
Applied Biosystems


Bruker Daltonics Ad
Bruker Daltonics
ChemSpider Ad
ChemSpider


Eksigent Ad
Eksigent
Eurofins Ad
Eurofins Medinet


GL Sciences Ad
GL Sciences
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Indigo BioSystems


Ionics Ad
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McKinley Scientific


New Objective Ad
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Novatia Ad
Novatia


OpAns Ad
OpAns
Oxford Ad
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Quest Ad
Quest
Tandem Ad
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Thermo Ad
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Overview | General Information | Call for Papers | Short Courses | Program | Registration | Job Postings | Sponsors | Photos |

Preliminary Program Agenda

Monday, October 22
8:30 am - 4:30 pm Short Courses – Bucks County Sheraton Hotel
  • 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
5:30 pm - 7:30 pm Reception and Registration
Second Floor Lobby, Bucks County Sheraton Hotel
8:30 pm - 10:00 pm Sponsors Dinner Event
Tuesday, October 23
7:30 am - 8:30 pm Registration and Continental Breakfast
8:30 am - 8:35 am Welcome
Mike S. Lee, Milestone Development Services
8:35 am - 9:00 am Conference Overview: Objectives, Format & Opening Remarks
Nalini Sadagopan, Pfizer
9:00 am- 9:45 am Plenary Lecture

Why Can’t We All Just Get Along: An Integrated Approach to Solving ADME Issues
Jonathan L. Josephs, Bristol-Myers Squibb
9:45 am - 10:00 am Break/Roundtables
10:00 am - 11:15 am Biomarkers in Preclinical Development
Discussion Leaders: Dawn Dufield, Pfizer;
Nalini Sadagopan, Pfizer


Strategy for Translation in Biomarker Discovery and Application
Kevin L. Duffin, Eli Lilly and Company

Development of a Novel LC-MS/MS Assay - Translatable Biomarkers for Decision-Making
Dawn R. Dufield, Pfizer

LC/MS/MS Quantification of Neurotransmitter and Neuropeptide Biomarkers for Efficacy Measurements
David Budac, Lundbeck Research USA
11:15 am - 11:30 am Break/Roundtables
11:30 am - 12:45 pm Complimentary Lunch/Roundtables- Bioanalytical CRO Assay Transfers (University II Ballroom)
Discussion Leader: Robert A. Bethem, Alta Analytical Laboratory

Panelists: Steve Lowes, Advion BioSciences, Inc.;
Steve Unger, Bristol-Myers Squibb


  • Trust in partner relationships that the other had properly done their homework
    • Knowledge of failure rates?
    • Causes?
    • Stability?
  • Risks associated with assay changes
    • Are changes approved?
    • Are risks apparent?
    • What tests were done to assess ruggedness prior to assay validation?
  • Incurred samples
    • Whose SOP is used for random repeats?
    • Within and across studies for Xval?
    • Final test of assay transfer?
12:45 pm - 3:00 pm Poster Session/Roundtables (University I Ballroom)
Poster Session Chairs: James L. Stephenson, RTI International;
Eric Yang, GlaxoSmithKline


- New and Emerging Techniques

- High Throughput Assay Development

- Biomarkers of Disease
2:00 pm – 3:00 pm Workshop (Princeton I – 2nd Floor Boardroom Lobby Level)
Proteo-metabonomic Strategies in Drug Development - The Beauty and the Beast
Uwe Christians, Eurofins Medinet

Workshop (Princeton II – 2nd Floor Boardroom Lobby Level)
High Throughput Approaches – Fast Separations

Roger N. Hayes, Schering-Plough

Mark J. Hayward, Lundbeck Research USA

Ken Lewis, OpAns
3:00 pm - 4:15 pm Biologics
Discussion Leaders: Jean Lee, Amgen;
Gabriella Szekely-Klepser, Pfizer


Understanding the Landscape and Key Drivers of the Protein Therapeutics Market
Christine Smith, Pfizer

Biologics: Challenges in Delivering the Promise
Advait Badkar, Pfizer

Monitoring Quality Attributes of Biotechnology Products
Greg Flynn, Amgen
4:15 pm - 4:45 pm Break/Roundtables
4:45 pm - 6:00 pm Metabolomics and Metabonomics
Held in conjunction with the North Jersey ACS Chromatography and NMR Discussion Groups
Discussion Leader: István Pelczer, Princeton University

Spectroscopic Approaches in Biomarker Discovery and Molecular Systems Biology
Jeremy Nicholson, Imperial College

Integrated Metabonomic Studies
Nelly Aranibar, Bristol-Myers Squibb

Probing Dynamic Nuclear Polarisation Enhancement in NMR for Biological Applications
Ulrich Günther, University of Birmingham
6:00 pm - 8:00 pm Sponsor Hospitality - Evening Workshops
Held in conjunction with the North Jersey ACS Chromatography Discussion Group

Applied Biosystems/MDS Sciex (Princeton I) - New High Throughput Solutions for Modern Drug Discovery--Mass Spectrometry-Based Solutions
  • Mass Spectrometry Solutions for High-Throughput Modern Drug Discovery Workflows, Jean-Francois Alary, Product Manager, Applied Biosystems/MDS SCIEX
  • New Developments in Early-ADME Automated Candidate Optimization and Analysis-DiscoveryQuantTM Software, Jeff Miller, Product Applications Lab Sr. Manager Applied Biosystems/MDS SCIEX
  • Advantages of using the API 5000TM System to avoid matrix interference, Jenny Moshin, Field Applications Specialist Applied Biosystems/MDS SCIEX

Bruker Daltonics (Villanova Amphitheater)
  • High Specificity Screening with Accurate Mass ESI-q-TOF
  • MALDI Imaging: Improved Sample Prep, Biomarker ID & Small Molecule Localization
  • NALDI (Nano-Assisted Laser Desorption/Ionization) for Small Molecules

Eksigent Technologies (Princeton II) Oxford Instruments (Lehigh)
 
Wednesday, October 24
7:30 am - 8:30 am Registration & Continental Breakfast
8:30 am - 10:00 am Omics Technologies
Discussion Leader: Bradley L. Ackermann, Eli Lilly and Company

Assays for Candidate Biomarkers: Targeted MS Quantitation of Tryptic Peptides
N. Leigh Anderson, Plasma Proteome Institute

Applying Pharmacogenomics to Drug Discovery and Development
Keith Johnson, Pfizer
10:00 am – 10:30 am Break/Roundtables
10:30 am – 12:15 pm New Technologies and Trends in Bioanalysis
Discussion Leaders: Lucinda Cohen, Merck Research Laboratories
Eric Woolf, Merck Research Laboratories


Desorption Electrospray Ionization Mass Spectrometry Applied to High-Throughput Spot Sampling and Imaging of Drugs and Metabolites in Tissue Sections
Gary Van Berkel, Oak Ridge National Laboratory

MALDI Quantitation of Biological Samples
Dietrich Volmer, MRC Collaborative Centre for Human Nutrition Research

Exploring the Use of Elevated Temperatures for Small Particle LC Separations
Roger N. Hayes, Schering Plough Research Institute

Applications of Hydrophilic Interaction Chromatography in Clinical Bioanalysis
Rajesh Desai, Merck Research Laboratories
12:15 pm – 2:15 pm Exhibition Opens (University I Ballroom and Ballroom Foyer)

Complimentary Lunch & Learn and Poster Session (Villanova Amphitheater – 2nd Floor Boardroom Lobby Level) – Sponsored by Phenomenex

Structured Approach for Method Screening and Selectivity Optimization in Hydrophilic Interaction Liquid Chromatographic Separations
Carl Sanchez, Phenomenex

Poster Session/Roundtables (Boardroom Lobby - 2nd Floor)
Poster Session Chairs: James L. Stephenson, RTI International;
Eric Yang, GlaxoSmithKline


- New Developments and Instrumentation in Bioanalysis

- Metabolite Identification and Profiling in Drug Discovery and Development

- Quantitative Bioanalysis

- Biomarkers
2:15 pm – 3:30 pm Drug Metabolism in Preclinical and Clinical Development
Discussion Leader: Petia Shipkova, Bristol-Myers Squibb

Investigation of Equimolar Response in NanoESI for Metabolism Studies
Richard C. King, Merck Research Laboratories

Early Assessment of Metabolites in Clinical Studies: Potential Applications of NanoSpray Ionization Mass Spectrometry
Ragu Ramanathan, Schering Plough Research Institute

The Application of Metabonomics Approaches to Drug Metabolism
Mark Sanders, Bristol-Myers Squibb

3:30 pm – 5:30 pm Vendor Session
Held in conjunction with the North Jersey Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
Discussion Leader: Mark Hayward, Lundbeck Research USA

McKinley Scientific: Introducing Expanded Capabilities
Martin Steel, McKinley Scientific

Products and Services for In Vitro Drug Metabolism and Drug-Drug Interaction Studies
Jason Neat, XenoTech, LLC

Four Productivity Enhancers from Agilent
Tony Brand, Agilent Technologies

AM-PM; Analyze More–Process More. Quantitatiion Software Working for You!
Yves LeBlanc, Applied Biosystems

HALO HPLC Columns: Fused-Core Particle Technology for Ultra-Fast, Highly Efficient Separations
Carl Zimmerman, MAC-MOD Analytical, Inc.

Tandem Labs: A Multi-Dimensional Bioanalytical CRO
Patrick Bennett, Tandem Labs

Quantitative Determination of Oligonucleotide Drug Concentration by Hybridization-ELISA Assays for GLP PK/TK Analysis
LingSing Chen, Quest Pharmaceutical Services

Automated Off-Line 2D HPLC using the Dionex U3000 System
Michael DeMayo, Dionex Corporation

Meeting Analytical Challenges in Pharmaceutical Discovery and Development
Carl Sanchez, Phenomenex

New developments at Eksigent: Real-Time Reaction Monitoring and Eight Channel Method Development with the ExpressLC
Dave Neyer, Eksigent Technologies

New Developments in GC-TOF and GCxGC-TOF
Eric Nemec, LECO Corporation Separation Sciences

IONICS HSID++ INTERFACE FOR QSTAR: Control of Charge State Distribution using a Hot Source-Induced Desolvation (HSID) Interface - Application to Discovery of Bacterial Virulence Factors
Dragan Vuckovic, IONICS Mass Spectrometry Group

Reviewing Incurred Sample Reproducibility Using Rubicon
Randall Julian, Indigo BioSystems

Samples to Answers: An Optimized Process for Discovery
Ken Lewis, OpAns LLC

An Integrated Approach to Component Identification Using Quadrupole Ion Trap Mass Spectrometer
Robert Buco II, Shimadzu Scientific Instruments, Inc.

DARTing Ahead! Where We Are Now and Where We Are Going?
Chip Cody, JEOL USA

Evolution of DART Technology in the Pharmaceutical Lab
Brian Musselman, Ion Sense

Automated Chip-Based Online NanoLC and Direct Infusion with Active Spray Control
Sau LanTang Staats, Phoenix S&T, Inc.

Ultra-Performance NanoSpray: Enhanced Proficiency Through Digital Control
Gary Valaskovic, New Objective

Accurate Mass Is Not Enough To Get The Right Formula
Doug Boyd, Bruker Daltonics Inc.

TBA
Jeff Whitney, Novatia
5:30 pm – 6:30 pm Exhibition & Social Hour
Held in conjunction with the North Jersey Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
6:30 pm – 7:30 pm Dinner - North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
7:30 pm – 7:45 pm ACS Announcements

CPSA – Distinguished Analytical Scientist Award Presentation
7:45 pm – 9:00 pm Keynote Lectures
From Bioanalytical to Biomarkers - Using Quantitative Mass Spectrometry to Address Biological Bottlenecks
Bradley L. Ackermann, Eli Lilly and Company

Development and Applications of Improved Sample Handling and LC-MS Techniques for Comprehensive Proteome and Metabolome Analysis
Liang Li, University of Alberta
 
Thursday, October 25
7:30 am - 8:30 am Registration & Continental Breakfast
8:30 am - 10:00 am Driving Pharmaceutical Quality
Discussion Leader: Robyn Rourick, Kalypsys, Inc.

The Influence of Physico-Chemical Characterization and Solid Form Selection Strategies on Quality in Early Development
Sesha Neervanan, Allergan

Differentiation and Quantitative Determination of Surface and Hydrate Water in Lyophilized Mannitol Using NIR Spectroscopy
Nina Cauchon, Amgen

Leveraging High Quality Mass Spectral Data in Impurity Profiling
Don Richards, Pfizer
10:00 am – 10:30 am Break/Roundtables
10:30 am – 12:15 pm Biomarkers in Clinical Development
Discussion Leaders: Dawn Dufield, Pfizer;
Nalini Sadagopan, Pfizer


Translational Biomarkers as Early Decision Making Tools in Drug Development
Holly Soares, Pfizer

Quantitative Mass Spectrometry in Clinical Diagnostics - Yesterday, Today and Tomorrow
Russell Grant, Endocrine Sciences-Esoterix

Detection of Bloodstream Biomarkers Indicates the Red Blood Cell Should be a New Friend of Pharma
Dana M. Spence, Michigan State University
12:15 pm – 2:00 pm Lunch/Roundtables – ADME Strategies: Past, Present and Future
Discussion Leader: Ayman El-Kattan, Pfizer

Pharmacokinetic and Pharmacodynamics of Biologics: Challenges and Pitfalls
Bernd Meibohm, University of Tennessee

Roundtable Discussion – Moderated by Ayman El-Kattan, Pfizer

Panelists: TBA
2:00 pm – 2:15 pm Wrap Up & Adjourn
Nalini Sadagopan, Pfizer


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