Clinical & Pharmaceutical Solutions through Analysis
Where Technology and Solutions Meet

CPSA 2011

Science and Technology Coming Together to Make a Difference

October 3 - 6, 2011
Buscks County Sheraton Hotel
Langhorne, PA

Conference Program

September 29, 2011

Monday, October 3

8:30 am - 4:00 pm

Short Courses - Bucks County Sheraton

Method Development for LC/MS: Traditional Approcahes and Emerging Trends
Instructors: Roger Hayes, Cetero Research; Shane Needham, Alturas Analytics

Small Molecule Biomarkers: Strategies for Method Development, Profiling and High Throughput Workflow Solutions in Drug Discovery
Instructors: Mark Hayward, Lundbeck Research; Ken Lewis, OpAns

Analysis of Peptides Peptides and Proteins: Sample Prep to Identification and Quantitation
Instructors: Nalini Sadagopan, Agilent Technologies; Gary Valaskovic, New Objective
Nathan A. Yates, Merck

9:00 am - 3:00 pm

CPSA Golf Outing - Makefield Highlands Golf Club, Yardley, PA
Don't miss your tee time! Contact Brad or Ken below for info and registration.
Organizers: Brad Coopersmith, Waters Corporation; Ken Imatani, Agilent Technologies
[Download Brochure]

12:00 pm - 4:00 pm

Pharmaceutical Sciences Workshop: Impurities and Degradants

Characterization of Impurities and Degradants in Biologics Discovery and Development
Guodong Chen, Bristol-Myers Squibb

Effective Use of LC-MSn Molecular Fingerprinting for the Rapid Structure Identification of Pharmaceutical Impurities
Min Li, Merck

Analytical Challenges in Controlling Genotoxic Impurities
David Liu, GlaxoSmithKline

To Isolate or Not: The Sometimes Circuitous Characterization of a Degradant
Gary Martin, Merck

4:30 pm - 5:30 pm

Sponsored Workshop & Social

6:00 pm - 9:00 pm

Reception & Sponsor's Dinner

New Chip to MicroLC Applications

New microfluidic cHiPLC Applications for Higher throughput
David Neyer, Eksigent part of AB SCIEX

Method development and transfer for a range of linear velocities suitable to scale down to 1mm column IDs and beyond
Rick King, PharmaCadence Analytical Services

Tuesday, October 4

7:30 am - 8:30 am

Registration & Continental Breakfast

7:30 am - 8:30 am

Sponsored Breakfast Workshop

Electronic Lab Notebook Special Interest Group

8:30 am - 9:00 am

Mike S. Lee, Milestone Development Services

Roger Hayes of Cetero Research will chair CPSA USA 2011
Meeting Overview
CPSA USA 2011 Chair
Roger Hayes, Ph.D.
Cetero Research

9:00 am - 9:45 am

Plenary Lecture
Secrets in Lipid Biochemistry Revealed by Mass Spectrometry
Robert C. Murphy, University of Colorado, Denver

10:00 am - 11:45 am

Parallel Sessions

Parallel Track I
Discussion Leader: Petia Shipkova, Bristol-Myers Squibb

Biomarkers for Toxicity
Don Robertson, Bristol-Myers Squibb

Lipid Analysis in Mitochondria and Serum Using High Resolution LC-MS and HCD Fragmentation
Susan Bird, Brighams and Womens Hospital

Coupling Static and Kinetic Biomarkers in Order to Unravel Dyslipidemia
Stephen Previs, Merck Research Laboratories

LC/MS Biomarker Assay Validation Using Surrogate Matrix and Surrogate Analyte Approaches
Gary Schultz, Advion Biosciences

Parallel Track II
Colloquium: The Science of Compliance
Discussion Leader: Chad Briscoe, PRA International

Holy #$%@! What Have We Gotten Ourselves Into?
Ray Farmen, Celerion

Carryover and Chromatographic Background Contributions: Are We Assessing Potential Bias Effects on Individual Sample Result and/or Batch Acceptance in Realistic (and Meaningful) Ways?
Rand Jenkins, PPD

Pitfalls of Whole Blood Stability and Hemolytic Plasma Assessment in Bioanalysis
Corey Ohnmacht, PRA International

The Role of Compliance in "Non-Regulated" Studies Conducted by the Pharmaceutical Industry
Rick Edom, Johnson & Johnson

Pre-Compliance in Early in vitro Drug Development
Joanna Barbera, Xenotech

12:00 pm - 1:00 pm

Sponsored Lunch / Roundtables

1:15 pm - 3:00 pm

Poster Session / Roundtables
Discussion Leaders: Jim Stephenson, Thermo Fisher; Matthew Szapacs, GlaxoSmithKline; Tracie Williams, Centers for Disease Control and Prevention; Donglu Zhang, Bristol-Myers Squibb

2:00 pm - 3:00 pm

Sponsored Workshops

LDTD with SelexION™ Technology and the QTRAP® 5500 System with Advanced Selectivity and High Throughput

Yves Leblanc, AB SCIEX

FTMS Small Molecule Imaging Workflow

M. Reid Groseclose, GlaxoSmithKline

Metabolism Optimization: Future Needs and Emerging Workflows

Workflows for Efficient Data Acquisition and Processing
Kevin Bateman, Merck

Application of Metabolite Identification Information for Drug Design
Roy Vaz, Sanofi-Aventis

Interactive Demonstration of Software Tools for Acquisition, Processing and Design
Ismael Zamora, Molecular Discovery

A QbD-based Approach to LC Method Development

Dominic Moore, Waters Corporation

Symposia & Rountable Discussion

3:00 pm - 4:30 pm

Metabolite Identification
Discussion Leaders: Joanna Pols, Merck; Ragu Ramanathan, Bristol-Myers Squibb

Use of High Resolution Mass Spectrometry for Correct Structure Elucidation of Metabolites
Natalia Penner, Biogen Idec

Advances in Metabolite Profiling Software: An Evaluation of Mass-Metasite
Diane Grotz, Merck & Co.

Streamlining the Drug Discovery Biotransformation Workflow: HRMS, On-the-fly-MDF and Metabolite Pilot Software
Xiaomei Gu, Bristol-Myers Squibb

A Comparison of Metabolic Profiles Following Targeted and Non-Targeted Analysis Using Q-Trap Technologies
Veronica Zelesky, Pfizer, Inc.

4:45 pm - 6:15 pm

Innovation in Regulated Bioanalysis: Fact or Fantasy?
Discussion Leader: Kevin Bateman, Merck

What is Innovation?
Kevin Bateman, Merck

The Case for Innovation in Drug Discovery Bioanalysis
Lucinda Cohen, Merck

The Case for Innovation in Regulated Bioanalysis
Chris Evans, GlaxoSmithKline

Group Arguement on Innovation in Bioanalysis
All attendees

6:30 pm - 9:00 pm

Sponsor Hospitality & Workshops

Beyond Sensitivity: New Solutions for Pharmaceutical Analysis

Ignatius Kass, Waters Corporation

Dried Blood Spot Summit

History, Properties, Issues and Scope of Applications for the Filter paper as a Matrix for Specimen Collection and Analysis
W. Harry Hannon (Retired), Centers for Disease Control and Prevention

New Technologies for the Direct Analysis of Analytes and Enzyme activities in Dried Blood Spots
David Millington, Duke University

The Dried "X" Spot - Beyond Newborn Screening
Donald Chace, Pediatrix Analytical

DBS Implementation Strategies
Olga Kavetskaia, Abbott Labs

Towards Full Yet Flexible Automation of Dried Blood and Matrix Spot Analysis
Shane Needham, Alturas Analytics

Wednesday, October 5

7:30 am - 8:30 am

Registration & Continental Breakfast

7:30 am - 8:30 am

Sponsored Breakfast Workshop

Isotope Solutions to Address Unmet Analytical Needs

8:30 am - 10:30 am

Symposia & Roundtables

Fast-to-Fail Paradigm
Discussion Leaders: Lucinda Cohen, Merck; Tim Olah, Bristol-Myers Squibb

Optimizing the Disposition Characteristics of New Chemical Entities Using HTS ADME Screens
Amit Kalgutkar, Pfizer

Biochemical and Assay Screening Using High Throughput Mass Spectrometry Detection
Jon Williams, GlaxoSmithKline

10:45 am - 12:15 pm

Parallel Sessions

Parallel Track I
Discussion Leaders: Jack Henion, Advion; Gary Valaskovic, New Objective; Nathan Yates, Merck

Don't forget the "LC" in LC-MS/MS
Jarrod Marto, Dana-Farber Cancer Institute

Moving Quantitative SRM-MS Toward a Faster Time-Frame: Evaluating Dual Columns and Microfluidic Chips for Peptide Quantification in Plasma
Susan Abbatiello, Broad Institute

Single Molecule Detection and Analysis with Nanostructures
Benjamin Cipriany, Cornell University

Parallel Track II
Colloquium: Globalization of Bioanalytical
Discussion Leaders: Mark Arnold, Bristol-Myers Squibb; Jerry Gromelski, QPS

Pharma Perspective on Globalizing Bioanalysis
Ajai Chaudhary, Merck

Globalizing Bioanalysis from a CRO Perspective: A Strategic Overview - Advantages and Challenges
Jaap Wieling, QPS

Global Bioanalysis Consortium - An Update of Harmonization Activities
Mark E. Arnold, Bristol-Myers Squibb

Immunogenicity Global Guidance Harmonization
Speaker TBA

12:00 pm - 2:15 pm

Exhibition - Where Technology and Solutions Meet!

12:15 pm - 2:15 pm

Lunch & Learn Sessions


Transitioning Qual/Quant Platforms from Small Molecules to Biologics
Matt Willetts, Bruker Daltonics

New Horizons for MALDI-TOF MS: The MALDI Biotyper for Microbial Identification in Pharmaceutical Microbiology
Gary Kruppa, Bruker Daltonics

Business Management and Science in the 21st Century

Ajai Chaudhary, Merck
Paul Corcoran, McKinley Scientific
Robyn Rourick, Genentech
Shane Needham, Alturas Analytics

High-Performance Nanospray: Technique & Technology

Efficient Fractionation Strategies for LC-MS/MS in Proteomics
Jarrod Marto, Dana-Farber Cancer Institute

Challenges of Dual Column Nanospray in Quantitative SRM-MS: Double the Speed or Double the Trouble?
Susan Abbatiello, The Broad Institute

Enabling Nanospray in Triple-Quad Mass Spectrometry
Kenneth Lewis, OpAns

Biologics Discovery & Characterization

Can LC-MS/MS Play a Role in Biologics Development Without Solving the Sample Preparation Issue?
Kevin Meyer, Perfinity Biosciences

Direct Characterization of Biotherapeutic Aggregation and Other Protein Interactions Using High Mass MS
Ryan Wenzel, Covalx

2:15 pm - 3:30 pm

Symposia & Rountable Discussion

Does LC/MS/MS Assay Have a Place in Biologics Development?
Discussion Leaders: Guodong Chen, Bristol-Myers Squibb; Gabriella Szekely-Klepser, Allergan, Inc.

The Rapid Integration of LC-MS-based Bioanalytical Methods to Quantify Peptides Therapeutics in Drug Discovery
Timothy Olah, Bristol-Myers Squibb

Challenges & Solutions in the Quantitative Analysis of Large Therapeutic Peptides
Fabio Garofolo, Algorithme Pharma

Large Therapeutic Proteins Quantification: The Best of Both Worlds
Jaap Wieling, QPS

Roundtable Discussion

3:45 pm - 5:30 pm

Vendor Session - "Five minutes of fame!"

Discussion Leaders: Mark Hayward, Lundbeck Research; Ragu Ramanathan, Bristol-Myers Squibb

5:30 pm - 6:30 pm

Exhibition & Social Hour
Where Technology and Solutions Meet!

6:30 pm - 9:00 pm

CPSA Dinner
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group


CPSA Shanghai 2012
Eric Yang, GlaxoSmithKline and Naidong Weng, Johnson & Johnson

Food Quality & Safety Summit
István Pelczer, Princeton University

Keynote Dinner Lectures

Liquid Chromatography-Mass Spectrometry in Pharmacology Research and its Transition to Clinical Applications
Ian Blair, University of Pennsylvania

Distinguished Analytical Scientist Award
Presented by Tom Covey, AB SCIEX and Rick King, PharmaCadence

A Scientific Adventure—LC/MS: From Academia to Entrepreneurship
Jack Henion, Advion BioSciences & Cornell University

Thursday, October 6

7:30 am - 8:30 am

Registration & Continental Breakfast

8:30 am - 4:00 pm

Short Course

Is Bioavailability in Early Drug Discovery a Problem and if so, How Can We Fix It?
Instructor: Ayman El-Kattan, Pfizer


8:30 am - 10:00 am

Symposia & Roundtables

CRO-Innovator Interface
Discussion Leaders: Chad Briscoe, PRA International; Ron Shoup, AIT Bioscience; Eric Woolf, Merck

Discovery and Development Bioanalysis Outsourcing: Similarities, Contrast, and Challenges
Ajai Chaudhary, Merck

Method Transfer Between Labs: The Challenges and Pitfalls
Yongdong Zhu, QPS

Bioanalytical Offshore Outsourcing - Strategies and Challenges
Pat Kadiyala, Bristol-Myers Squibb

Whose SOPs? Ours or Yours?
An Open Audience Debate

10:15 am - 11:45 am

New Technologies
Discussion Leaders: Kevin Bateman, Merck and Rick King, PharmaCadence

Towards Nanospray for High Throughput Mass Spectrometry
Gary Valaskovic, New Objective

Exploiting the Orthogonality of Differential Mobility in LC-MS Analysis
Yves LeBlanc, AB SCIEX

Cells Instead of Microsomes. Why the HepRG Cell Line is Going to Revolutionize DMPK Screening
Tom Rushmore, Life Technologies

The Emerging Role of Zebrafish Embryo Models in Toxicology
Jedd Hillegass, Lampire Biological Laboratories

12:00 pm - 1:15 pm

Sponsored Lunch & Roundtables

Coupled Workflows Enabled by HRMS:
Integrated Datasets to Facilitate Program Progression
Discussion Leader: Jonathan Josephs, Bristol-Myers Squibb

How Can We Acquire Integrated Datasets? Overview of Qual/Quant: What It Is and What It Is Not. A Specific Example.
Kevin Bateman, Merck

Informatics Considerations for Enabling Global Data Management
David Hardy, Waters Corporation

1:15 pm - 3:00 pm

Symposia & Roundtables

Clinical Diagnostics: From Biology to Analytical Chemistry
Discussion Leader: Kenneth Lewis, OpAns

Early Detection of Biomarkers for Pancreatic Cyst Management
Anthony Yeung, Fox Chase Cancer Center

Strategy, Specimens, Sensitivity, Selectivity and Success in the Development of Clinical Diagnostic Assays
Melissa Johnson, Duke University Medical Center

Life Lessons in a Clinical Diagnostic Lab
Bingfang Yue, NMS Labs

3:00 pm - 4:00 pm

Closing Event
Hosted by PharmaCadence

The Flavorful Chemistry of Chocolate
John P. Munafo, Ph.D.
Mars Global Chocolate Science and Technology, Hackettstown, NJ USA

The alluring aroma and complex taste of cocoa is a result of a collection of molecules that we perceive as they interact with our nasal olfactory epithelium and taste receptors in our oral cavity. In addition to its unique flavor, cocoa contains a wealth of phytonutrients known as cocoa flavanols, which are increasingly recognized for their beneficial effect on human health. Due to the complex nature and diversity of these molecules, different arrays of analytical techniques are required for their analysis. This talk will highlight chocolate flavor, the diversity of natural products found in cocoa, and several different analytical techniques used in studying the flavorful chemistry of chocolate.

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