Monday, October 1

8:30 am - 4:00 pm

Short Courses - Sheraton Bucks County

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

NEW! Targeted Metabolomics: The Art & Science of Measuring Drug Efficacy
Instructors: Mark Hayward, Active Ingredient Technologies; Kenneth Lewis, OpAns

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

Assessment of Oral Bioavailability in Preclinical Species and Human: Impact of Physicochemical, Biopharmaceutical and Physiological Factors
Instructor: Ayman El-Kattan, Pfizer

NEW! Self Innovation
Instructor: Lucinda Cohen, Merck

9:00 am - 3:00 pm

CPSA Golf Outing - Makefield Highlands Golf Club, Yardley, PA
Don't miss your tee time! This year we've expanded the fun with prizes for closest to the pin and for longest drive. Contact Brad, Ken or Paul below for information, registration and/or sponsorship opportunities.
Organizers: Brad Coopersmith, Waters Corporation; Ken Imatani, Agilent Technologies; Paul Corcoran, McKinley Scientific
[Download Brochure]

12:00 pm - 4:00 pm

Pharmaceutical Sciences Workshop: A Focus on Biomarkers
Sponsored by the North Jersey ACS Mass Spectrometry Discussion Group and Frontage Laboratories
Moderators: Ron Kong, PTC Therapeutics and Fangbiao Li, Merck

Biomarker Development and Validation–Our Practices and Experiences
Shawn Li, Frontage Laboratories, Inc.

Biomarkers Utilization in Early Stage Development
Omar F. Laterza, Merck Research Laboratories

Using Physiologically-based PK/PD Modeling to Impact Drug Development Decision Making
Emile Chen, GlaxoSmithKline

Innovative Biomarker Assay for the Quantitation of D3 Creatinine and Creatinine Using LC-MS/MS
Michael Leonard, GlaxoSmithKline

12:00 pm - 4:00 pm

Molecular Discovery User Meeting

Development of a Higher Throughput Metabolite Screening Assay in Early ADME Profiling Using Generic HRMS Acquisition and Automated Data Processing
W. Shou, A. Paiva, Bristol-Myers Squibb

High-Throughput MetID Workflow for Early Drug Discovery
JianweiShen, Abbott Labs

Workflows for Efficient Data Aquisition and Processing
Kerry Fillgrove, Merck

Use of MassMetaSite in a Discovery Setting: Processing Microsomal Metabolism Data from Different Instruments
Natasha Penner, Biogen Idec

Solving Bottlenecks in Metabolite Identification Using AB SCIEX TripleTOF™ Technology and MetabolitePilot™ Software
Shaw Xia, AB SCIEX

4:30 pm - 5:30 pm

Executive Roundtable–Where Technology and Solutions Meet Business
Discussion Leeder: Timothy Olah, Bristol-Myers Squibb

6:00 pm - 9:00 pm

Reception & Sponsor's Dinner
Hosted by AB SCIEX

Tuesday, October 2

7:30 am - 8:30 am

Registration & Continental Breakfast

Welcome
Mike Lee, Milestone Development Services

9:00 am - 9:45 am

Plenary Lecture

Navigating the Waters from Scientist to Administrator in an Ever-changing Environment: a 25-year Journey in the Pharmaceutical Industry
Lisa A. Shipley, Vice President, Pharmacokinetics
Pharmacodynamics & Drug Metabolism
Merck

9:45 am - 10:00 am

Break

10:00 am - 11:30 am

Parallel Sessions & Roundtables

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

Application of LC/MS Biomarker Assays in Drug Discovery
Joelle Onorato, Bristol-Myers Squibb

Measuring the Dynamics of Low Abundant Proteins: Clinical Studies
Michael Lassman, Merck

Chemoplexing: Another Step Toward Digitization of Biology
Rick King, PharmaCadence Analytical Services

Parallel Track II
Colloquium: Regulatory Issues and Industrial Workflows
"Regulatory Compliance Can be a Real Drag, like Being Married for 22 Years!?"
Discussion Leaders: Chad Briscoe, PRA International and Robyn Rourick, Genentech

From Anything Goes to GLPs and CROs
Ken Dammers, Celgene Corporation

Navigating Through a Merger - Regulated Bioanalysis in the "New Merck"
Eric Woolf, Merck

Finding Common Ground. A European CRO’s Perspective on the Implementation of Varied Expectations of Regulators and Clients from around the World
Edwin Hooijschuur, PRA International

Do You See What I See? Regulatory Perspective on Bioanalysis
Chongwoo Yu, Food & Drug Administration

12:00 pm - 1:00 pm

Sponsored Lunch / Roundtables
Implementing Automation Workflows in Drug Discovery
Sponsored by Agilent

1:00 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

3:00 pm - 3:15 pm

Break

3:15 pm - 4:45 pm

Parallel Sessions & Roundtables

Parallel Track III
Trends in Metabolite Profiling and Identification
Discussion Leader: Natalia Penner, Biogen Idec

What is the Purpose of Human ADME Studies?
Ronald White, XenoBiotic Laboratories

Current Strategic Leverage of Radiolabel Metabolism Studies: Human-Only? Rat-Early? Active Metabolites, Reactive Metabolites, and MIST
Scott Obach, Pfizer

Maximizing the Value of Drug Metabolism Studies–Where To Go From Here?
Russell Mortishire-Smith, Janssen Pharmaceutica

Parallel Track IV
Measuring and Mitigating Transporter Effects on the Disposition of New Drugs
Discussion Leaders: Mark Hayward, Active Ingredient Technologies; Ayman El-Kattan, Pfizer

Incorporation of Transporter Data into Drug Discovery Screening Cascades
Matt Soars, Bristol-Myers Squibb

Predicting Unbound Intracellular Drug Concentrations in the Presence of Transporters
Swati Nagar, Temple University

Prediction of Human Pharmacokinetics for Compounds that are Substrates for OATP Transporters
James Gosset, Pfizer

Transporter Related Assays / Decision Trees / Regulations / Product Mitigation in Drug Development: 'Bad Times' Are Opportunities to be Good Learners
Sid Bhoopathy, Absorption Systems

5:00 pm - 6:00 pm

Social Hour & Sponsored Workshops

Workshop
Future Workflows Connecting Business and Science Globally
Sponsored by McKinley Scientific

Shane Needham, Alturas Analytics
Robyn Rourick, Genentech
Ajai Chaudhary, Merck
Martin Steel, McKinley Scientific

Workshop
Protein Quantitation: When SRM Alone Isn't Selective Enough
Sponsored by PharmaCadence Analytical Services

Improving LC-MS Selectivity using the Qtrap MS³ Scan
Carmen Fernández-Metzler, PharmaCadence Analytical Services, LLC

Using Ion Mobility to Enhance Selectivity for Protein Quantitation
Yves LeBlanc, AB SCIEX

Sample Prep Methods to Enhance Selectivity in Protein Quantitation
Angela Goodenough, Bristol-Myers Squibb

Workshop
Metabolite Identification
Sponsored by Molecular Discovery

The Evolution of Metabolite Identification Workflows in Drug Discovery
Kevin Bateman, Merck

Automated ID for Uncorking the Quan/Qual Bottleneck: Drip or Deluge?
Jonathan Josephs, Bristol-Myers Squibb

WebMetabase: From Data to Information and From Information to Knowledge
Ismael Zamora, Molecular Discovery, Ltd.

6:30 pm - 9:00 pm

Sponsored Hospitality & Evening Workshops

Food Quality & Safety Summit
Sponsored by Agilent Technologies
István Pelczer, Princeton University and David Perlman, Princeton University

Analytical Methods for Detailed Analysis of Complex Mixtures
Mike Reily, Bristol-Myers Squibb

Phosphoprotein Phosphatase 2A (PP2A) Regulation and the Pharmacology of Coffee, Tea, and Chocolate
Jeffry B. Stock, Princeton University

Recent Regulatory Advances for Food Quality Control, and Analysis of Heavy Metals in Food and Food Ingredients
Mark Beaumont, Firmenich

DR BENCE: A Highly Portable Method to Determine Absolute Concentration of Components by NMR; Application to Selected Beverages
Jeffrey R. Fardink, Princeton University

Is it the Real Thing, or is it Adulterated or Contaminated? Quantitative Analysis of Honey by High-Sensitivity NMR
István Pelczer, Princeton University and Joseph G. Lelinho, Hilltop Honey

Dried Blood Spot Summit
Sponsored by McKinley Scientific and Drummond Scientific
Discussion Leaders: Qin Ji, Bristol-Myers Squibb and Olga Kavetskaia, Abbott Labs

IQ/FDA Interactions
Chris Evans, GlaxoSmithKline

Challenges and Solutions
Leimin "Perry" Fan, Abbott Labs

DBS Clinical Studies
Shane Needham, Alturas Analytics

Panel Discussion
David Boulton, Bristol-Myers Squibb
Peter Bryan, Celgene
Donald Chace, Pediatrix Analytical
Chris Evans, GlaxoSmithKline
Leimin (Perry) Fan, Abbott Labs
Jim Kenney, Drummond Scientific
Wenkui Li, Novartis
Shane Needham, Alturas Analytics
Patricia Zane, Sanofi-Aventis

Wednesday, October 3

7:30 am - 8:30 am

Registration & Continental Breakfast

8:30 am - 10:00 am

Symposia & Roundtables
Clinical Diagnostics
Discussion Leaders: Donald Chace, Pediatrix Analytical and Tony Yeung, Fox Chase Cancer Center

Companion Diagnostics - A Reference Laboratory Experience
Alan Wookey, LabCorp

Measuring Proteins by LC-MS in Clinical Samples
Andy Hoofnagle, University of Washington

Detection and Characterization of Clinical Pathogens - Casting a Broad Net with PCR-MS
Steve Hofstadler, IBIS Biosciences, an Abbott Company

10:15 am - 11:45 am

Parallel Sessions

Parallel Track V
Bridging the Gap Between Pharmacokinetics and Pharmacodynamics Through Quantitative LC-MS
Discussion Leader: Lucinda Cohen, Merck

Ultra-Sensitive Cytokine Quantitation in Serum and Tissues by Immunoaffinity nano-LC-MS/MS
Joe Palandra, Pfizer

Strategies to Augment and Troubleshoot Ligand Binding Assays with Fit-For-Purpose LC/MS/MS Methodology: Case Studies
Erick Kindt, Pfizer

Measuring De Novo Lipogenesis in Human Plasma by LC-MS
Bernard Choi, Merck

Focusing on Core Analytical Capabilities to Support an Expanding Need for Clinical Biomarker Analysis and the Development of Companion Diagnostics
Brad Ackermann, Eli Lilly and Company

Parallel Track VI
Colloquium: Regulatory Issues and Industrial Workflows
Innovation in Regulated Bioanalysis: Yes it is Happening!
Discussion Leaders: Shane Needham, Alturas Analytics and Naidong Weng, Janssen Pharmaceuticals

Science and Process in Regulated Bioanalysis
Roger Hayes, MPI Research

Innovative Bioanalytical Approach for Protein Biomarkers
Wenying Jian, Janssen Pharmaceuticals

Regulation Does Not Hamper Innovation: Incorporating New Technologies and New Approaches Into Regulated Bioanalysis
Anne-Françoise Aubry, Bristol-Myers Squibb

Microflow LC/MS/MS in Regulated Bioanalysis - Is It Possible?
Shane Needham, Alturas Analytics

12:00 pm - 1:00 pm

Sponsored Lunch & Roundtables
Perfinity LIVE: Protein to Peptides - Proof without burden in 15 minutes flat!
Sponsored by Shimadzu

Join us for a live interactive lunchtime demonstration and discussion to introduce the Perfinity iDP, a quick and seamless protein sample digestion platform for LC-MS workflows.

1:15 pm - 2:15 pm

Social Hour & Sponsored Workshops

Workshop
Cutting Edge Performance. Compliant Ready. Networked. Complete. An Holistic Solution for DMPK
Sponsored by Waters Corporation

Ignatius J. Kass, Waters Corporation

Workshop
Innovative Workflows for High-Performance: Microspray and Nanospray
Sponsored by New Objective

Update on Multi-channel NanoLC: The PicoChip Platform
Nathan Yates, University of Pittsburgh

Microflow Capillary LC for Bioanalysis
Shane Needham, Alturas Analytics

Molecular MS Plate Reader:
Combining Ultra-low Flow and Ultra-high Throughput with Nanospray
Gary Valaskovic, New Objective

2:30 pm - 3:30 pm

NEW! Innovator Award Session
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
Discussion Leader: Kevin Bateman, Merck

Evaluation of a Microsampling System for Accurately Controlling Dried Blood Spot Volumes
Jim Kenney, Joe Siple, Drummond Scientific

PicoSlide Multichannel Nanospray: So Easy a Caveman Can Do It!
Gary Valaskovic¹, Ben Ngo¹, Amanda Berg¹, Nathan Yates² 1) New Objective Inc. Woburn, MA; 2) University of PIttsburgh, Pittsburgh, PA

Rapid Analysis Using High Performance Ion Mobility Spectrometry
Ching Wu, Clinton Krueger, Carol Moraff, Excellims Corporation

Metabolite Identification: From Data to Information and From Information to Knowledge
Ismael Zamora¹, Luca Morettoni², Xavier Pascual¹, Blanca Serra¹, Fabien Fontaine¹, Guillem Plasencia¹, Stefania Dragoni³, Gabriele Cruciani³; 1) Lead Molecular Design, S.L; 2) Molecular Discovery, Ltd; 3) University degli Study di Perugia

An Interdependent LC/MS/MS Solution for Urine Testing for Detection and Quantification of Drugs-of-Abuse and Pain Management
Martin Steel, McKinley Scientific

3:30 pm - 5:30 pm

Vendor Session
"Five minutes of Fame!"
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
Hosted by Merrill Lynch
Discussion Leaders: Mark Hayward, Active Ingredient Technologies; 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 Lecture & Distinguished Analytical Scientist Award
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group

Announcements
CPSA Shanghai 2013

Innovator Awards
Chair: Kevin Bateman, Merck

Keynote Dinner Lectures

Mass Spectrometry: Convenient Characterization of Complex Compounds with Colossal Content of Cool Comprehension
Fred W. McLafferty, Cornell University

Weigh Every Protein
Neil L. Kelleher, Northwestern University

How to Keep Your Mass Spectrometer Alive:
A Manual of Step-by-Step Procedures for the Complete Idiot
Nathan A. Yates, University of Pittsburgh

Thursday, October 4

7:30 am - 8:30 am

Registration & Continental Breakfast

8:30 am - 10:00 am

Symposia & Roundtables
Outsourcing: Science, Interaction and Collaboration
Discussion Leader: Jim Shen, Bristol-Myers Squibb

The Role of Bioanalytical CRO in the Global Setting
John Lin, Frontage Laboratories

From R&D to Production: Problems Encounted During Assay Transfer for the Quantitation of Clopidogrel Active Metabolites in Human Plasma
Moucun Yuan, PPD

Panelists:
Bruce Stouffer, Bristol-Myers Squibb
Mike Huang, Janssen Pharmaceuticals
Ron Shoup, AIT Bioscience

10:15 am - 11:45 am

Symposia & Roundtables
Perspectives on the Quantification of Peptides and Proteins by Mass Spectrometry
Discussion Leader: Susan Abbatiello, The Broad Institute of MIT and Harvard

Exploiting Chemical and Analytical Technologies for Fast, Robust, and Sensitive Quantitation of Peptides and Proteins in Biological Samples
Susan Abbatiello, The Broad Institute of MIT and Harvard

Quantification of Proteins Targeted by Biotherapeutics using Immuno-affinity LC-MS/MS
Mireia Fernandez-Ocaña, Pfizer

Using Mass Spectrometric Immunoassay (MSIA) in Biomarker Development
Randy Nelson, University of Arizona

12:00 pm - 1:15 pm

Sponsored Lunch & Roundtables

Workshop:
Implementing High Resolution Quan/Qual in an Industry Setting
Sponsored by Waters Corporation
Discussion Leader: Mark Wrona, Waters Corporation

An Integrated in vitro Qual/Quan Story: How We Got Here and Where We Are Going
Jonathan Josephs, Bristol-Myers Squibb

Real World Experiences with In Vivo Quan/Qual
Russell Mortishire-Smith, Janssen Pharmaceutica

1:30 pm - 3:00 pm

Symposia & Roundtables
Alternative Instrumentation
Discussion Leader: Kevin Bateman, Merck

Gary Van Berkel, Oak Ridge National Laboratory
Scott Tanner, DVS Sciences
Dan Murnick, Rutgers University

3:00 pm - 4:00 pm

Closing Event
Sponsored by PharmaCadence Analytical Services

Innovation at Crayola
Dave Rowan, Crayola

Dave Rowan, Chemist and Research & Development Manager for Crayola will present a short program on the use of chemistryin launching colorful new products to delight children around the world.