Clinical & Pharmaceutical Solutions through Analysis
Where Technology and Solutions Meet

CPSA 2013

Connecting Patients and Subject Numbers Through Analysis

October 7-10, 2013
Sheraton Bucks County Hotel
Langhorne, PA


Preliminary Program

Updated October4, 2013

Monday, October 7

8:30 am - 4:00 pm

Short Courses - Sheraton Bucks County

Method Development for LC/MS: Traditional Approaches and Emerging Trends
Instructor: Shane Needham, Alturas Analytics

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

9:00 am - 3:00 pm

CPSA Golf Outing - Makefield Highlands Golf Club, Yardley, PA
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

12:00 pm - 4:00 pm

Molecular Discovery Users Meeting - University II Ballroom
Discussion Leader: Isma Zamora, Molecular Discovery

Plans for Cross Platform Assessment of Massmetasite
Kevin Bateman, Merck

Streamline of the MetSpot Workflow: From Sample Information in a Single Click
Wilson Shou, Bristol-Myers Squibb

How to Use Historical Data to Speed Up the Metabolite Identification Process
Natasha Penner, BiogenIdec (tentative)

Soft Spot Identification: How to Use the Data in Drug Discovery
TBA, AbbVie

MetabolitePilot and WebMetabase Integration: Expanding Metabolism Information
Eva Duchoslav, AB SCIEX

12:00 pm - 4:00 pm

From Screen Hit to Bedside Medicine: How Can We Maximize the Efficiency?
University I Ballroom

Discussion Leaders: Ron Kong, PTC Therapeutics; Fangbiao Li, Merck
Held in conjunction with the New Jersey Mass Spectrometry Discussion Group

Applying Nano Porous Silicon Technology to Affinity Kinetics and its Linkage to Mass Spectrometry
Keith Waddell, Silicon Kinetics

Caught in a Bind: Antibodies for Current and Emerging Technologies
Gordon R. Whiteley, NIH

Metabolomics in Drug Discovery: Lessons Learned and Path Forward
Petia Shipkova, Bristol-Myers Squibb

Target-Specific Protein Quantitation by LC-MS/MS
Bob Xiong, Tandem Labs

Thought on the Biomarker Pipeline
Randy Nelson, Arizona State University

Error Proofing: Maximizing Productivity by Getting it Right the First Time
Lucinda Cohen, Merck

4:30 pm - 5:30 pm

Executive Roundtable–Where Technology and Solutions Meet Business
University I/II Ballroom
Assessing the Effect of Medicinal Marijuana on Patient Care and Businesses Comprising (and on the Periphery of) the Pharmaceutical Industry
Discussion Leader: Timothy Olah, Bristol-Myers Squibb

Panel Discussion
Ken Lewis, OpAns; Joanna Pols, Merck; Bill Thomas, Compassionate Care Foundation

6:00 pm - 9:00 pm

Reception & Sponsor's Dinner - University I/II Ballroom

Opening Remarks - Disease is the Enemy!
Shane Needham, Alturas Analytics; Mike Lee, Milestone Development Services

CPSA Charitable Giving
Paul Corcoran, McKinley Scientific; Emily Ehrenfeld, Mozaic Solutions; Joe Fox, AB SCIEX; Shane Needham, Alturas Analytics; Robyn Rourick, Genentech; Tony Yeung, Fox Chase Cancer Center

Recent Applications of SelexION Technology
Yves Le Blanc, AB SCIEX

Distinguished Lecturer:
Dr. Richard Kibbey
Assistant Professor of Medicine (Endocrinology) and Cellular and Molecular Physiology
Yale University

Mitochondrial GTP Cycle: A Novel Metabolic Pathway Regulating Glucose Homeostasis

Tuesday, October 8

7:30 am - 8:30 am

Registration & Continental Breakfast - University Ballroom Lobby

8:30 am - 9:00 am

Opening Remarks - University I/II

Welcome
Mike Lee, Milestone Development Services

Objectives, Format, and Opening Remarks
Shane Needham, Alturas Analytics

9:00 am - 9:45 am

Plenary Lecture - University I/II Ballroom

Bioanalytical Strategy used for Ado-Trastuzumab Emtansine (T-DM1)
Ola Saad, Genentech

Clinical Development of T-DM1
Ellie Guardino, Genentech

9:45 am - 10:00 am

Break

10:00 am - 11:45 am

Parallel Sessions

Parallel Track I - Symposium Session - University I/II Ballroom

Cancer Metabolism
Discussion Leader: Roy Vaz, Sanofi

Stratifying ER + Breast Cancer Patients for Likelihood of Response to Tamoxifen and Identifying Potential Alternative Therapeutic Targets for Likely Non-Responders as Baseline
Renee Deehan-Kenny, Selventa

Glycolysis: Branch Points and Connections
Michelle Clasquin, Agios

Readily Accessible Boimarkers from the Fluids of Pancreatic Cancer Resection
Tony Yeung, Fox Chase Cancer Center

Parallel Track II - Colloquium Session - Princeton I/II Ballroom

Rapid Turn-Around Time of Bioanalytical Data
Discussion Leaders: Chad Briscoe, PRA International; Bruce Stouffer, Bristol-Myers Squibb; Eric Woolf, Merck

The Customer is Always Right.. Would You Like Quality Results with that Expedited Request? (The Impact of Adaptive Trial Design and Accelerated Clinical Programs)
Bruce Stouffer, Bristol-Myers Squibb

Samples, Samples, Who's Got the Samples - the Logistics of Regulated Bioanalysis
Eric Woolf, Merck

If NASA Can Put a Man on the Moon, We Can Develop Robust and Reliable Bioanalytical Methods
Chad Briscoe, PRA International

12:00 pm - 1:00 pm

Sponsored Lunch / Roundtables

Accelerating Therapeutic Antibody and Fusion Protein Development with an Integrated, Automated Sample Prep and Ultra Fast Mass Spectrometry Platform

1:00 pm - 3:00 pm

Poster Session / Roundtables - University Foyer
Discussion Leaders: Helene Cardasis, Matthew Szapacs, GlaxoSmithKline; Tracie Williams, Centers for Disease Control and Prevention; Sean Yu, Merck

3:00 pm - 3:15 pm

Break

3:15 pm - 4:45 pm

Parallel Sessions

Parallel Track III - Symposia Session - University I/II Ballroom

Fit for Purpose in the Clinical Laboratory
Discussion Leader: Donald Chace, Pediatrix; Tony Yueng, Fox Chase Cancer Center

Patient and Physician - Hungry for Quality in Lab Testing: Can Clinical Labs Serve the Quality?
Ravinder Singh, Mayo Clinic

Automated Direct Elution and LC/MS Bioanalysis of Dried Blood Spots Using Three Different Approaches
Jack Henion, Quintiles

The Black Box of Neonatal Nutrition and Metabolism - How New Testing Approaches Will Lead to Better Outcomes for Infants
Alan Spitzer, Pediatrix Analytical

The "Grade A" Laboratory: The CDS's Role in Assuring Quality in Newborn Screening Labs Worldwide
Victor DeJesus, CDC

Let Them Eat Cake!
Served in Princeton Ballroom Foyer

Parallel Track IV - Colloquium Session - Princeton I/II Ballroom

Boianalytical Laboratory Management
Discussion Leader: Mike Huang, Janssen Pharmaceuticals

Panelists: Chad Briscoe, PRA International; Shane Needham, Alturas Analytics; Naidong Weng, Janssen Pharmaceuticals; Eric Woolf, Merck

5:00 pm - 6:00 pm

Social Hour & Sponsored Workshops

Workshop - Princeton I Ballroom
Peptide Quantification on the QTRAP Mass Spectrometers with microflowLC: Bridging the Best of Small Molecule and Proteomics Analyses
Carmen Fernandez-Metzler, PharmaCadence Analytical Services

Workshop - Princeton II Ballroom
How Do Our Business Practices Have to Change to Enable Patient Focused Personalized Medicines?
Ajai Chaudhary, Merck; Tim Garrett, University of Florida; Ken Lewis, OpAns; Shane Needham, Alturas Analytics; Robyn Rourick, Genentech; Martin Steel, McKinley Scientific

Workshop - Villanova Amphitheater
Ion Mobility: Can You Do Without It?
Russell Mortishire-Smith, Waters Corporation

Workshop - Lehigh
TBA

6:30 pm - 9:00 pm

Sponsor Hospitality and Evening Workshops

Food Quality and Safety Summit - University I Ballroom

Discussion Leaders: István Pelczer, Princeton University; David Perlman, Princeton University

Profiling Bourbons and American Whiskeys using UHPLC/QTOF-MS
Tom Collins, Director of Research, Food Safety and Measurement Facility at UC Davis

Volatile Compounds and Sensory Perception of Aromatic Cocktail Bitters
Arielle Johnson, Dept. Viticulture & Enology, UC Davis

Overview of Regulatory Issue for Contaminants in Food
Steve J. Lehotay, Lead Scientist at the USDA Agriculture Research Service

New Methods for NMR Quantitation in Mixtures
David Russell, NMR Applications Scientist at Agilent

Beer-omics: Characterization and Quality Control of Beer
István Pelczer, Princeton University

Microsampling Summit - University II Ballroom

Discussion Leaders: Qin Ji, Bristol-Myers Squibb; Olga Kavetskaia, AbbVie

Assuring the Quality of the Filter Paper Matrix
Victor DeJesus, CDC

Designing Implementation Options for DBS in a Discovery Environment
Tim Olah, Bristol-Myers Squibb

DBS Sampling in Efficacy Study for Antimalarial Drug Candidate in Monkeys
Wenkui Li, Novartis

TBA
Chris Evans, GlaxoSmithKline

Panel Discussion: Victor De Jesus, CDC; Tim Olah, Bristol-Myers Squibb; Peter Bryan; Donald Chace, Pediatrix Analytical; Chris Evans, GlaxoSmithKline; Jim Kenney, Drummond Scientific; Wenkui Li, Novartis; Matt Rieser, AbbVie; Enaksha Wickremsinhe, Eli Lilly and Company; Yang Xu, Merck; Steve Lowes, Quintiles

Wednesday, October 9

7:30 am - 8:30 am

Registration & Continental Breakfast - University Ballroom Lobby

8:30 am - 10:00 am

Symposia & Roundtables - University I/II Ballroom
Mass Spectrometry in the Operating Room - The Urgency of Information and the Requirements of Diagnostics
Discussion Leaders: Andy Hoofnagle, University of Washington; Randy Nelson, Arizona State University

Real-Time Assays in the Operating Room
Zoltan Takats, Imperial College

Perspectives on Point-of-Care Assays with Very Short Turn-Around
Andy Hoofnagle, University of Washington

Extramural Workflows with Longer Turn-Around Times
Russ Grant, LabCorp

10:15 am - 11:45 am

Parallel Sessions

Parallel Track V - Symposium Session - University I/II Ballroom
Shared Workflows- From a Discovery Laboratory to Hospitals
Discussion Leaders: Rick King, PharmaCadence Analytical Services; Petia Shipkova, Bristol-Myers Squibb

The Role of Biomarkers in Translational Research
Dieter Drexler, Bristol-Myers Squibb

The Role of Non-Targeted, Comprehensive Molecular Profiling Approaches in Food and Beverage Research
Eric Milgram, PepsiCo

Metabolic Workflows in Basic and Translational Research: Untargeted Profiling and Targeted Mining of Small Molecule MS Data from Clinical Samples
Justin Cross, Memorial Sloan-Kettering Cancer Center

Parallel Track VI- Colloquium Session - Princeton I/II Ballroom
Regulations and Emerging Technology in the Clinical Sciences: The Impact on Research, Patients and Physicians
Discussion Leaders: Ken Lewis, OpAns; Robert Kennedy, University of Michigan

Implementing New Technologies for the Routine Clinical Laboratory - Challenges and Solutions
Lori Bachmann, Virginia Commonwealth University

Development and Applications of Biomarker Assays for Rare Metabolic Disorders
David Millington, Duke University

Opportunities and Challenges for Education in Clinical Testing
Tim Garrett, University of Florida

12:00 pm - 1:00 pm

Sponsored Lunch & Roundtables - Universtity I/II Ballroom
Utility of Data-Independent and Data-Dependent Acquisition to Increase Coverage of Nefazodone Metabolites from In-VivoMatrices
Jie Ding, Covance

1:15 pm - 2:15 pm

Social Hour & Sponsored Workshops

Workshop - Princeton I Ballroom

SWATH for Met ID: Smarter Data Acquisition and Intelligent Data Mining
Natasha Penner, BiogenIdec

Workshop - Princeton II Ballroom

Practical Tips for Success in Biotherapeutics Quantification
Erin Chambers, Waters Corporation

Workshop - Villanova Amphitheater

Innovation in High-Performance Microspray and Nanospray
Susan T. Weintraub, University of Texas Health Science Center, San Antonio; Shane Needham, Alturas Analytice; Gary Valaskovic, New Objective


Workshop - Lehigh

Next Generation Protein Digestion
Kevin Meyer, Perfinity Biosciences; Nick Herold, Perfinity Biosciences; Bob Ellis, Perfinity Biosciences

2:30 pm - 3:30 pm

Parallel Sessions

Innovator Award Session - University II Ballroom
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

Download Asbtracts

Graduate Student Session - Villanova Amphitheater
Clinical Sciences and Technology - Inspiring Career Paths for Young Scientists
Mentors: Susan Abbatiello, The Broad Institute; Brad Ackermann, Eli Lilly and Company; Steve Hofstadler, Abbott Labs; Kenneth Lewis, OpAns; Shane Needham, Alturas Analytics; Tim Olah, Bristol-Myers Squibb; Joanna Pols, Merck; Robyn Rourick, Genentech

Cellular Senescence and Its Altered Metabolism
Ken Durbin, Northwestern University

Targeted Proteomics and Biochemical Fractionation: New Tools for Deciphering the Synapse in Schizophrenia
Matt MacDonald, University of Pittsburgh

3:45 pm - 5:30 pm

Vendor Session - Princeton I/II
"Five Minutes of Fame!" - Watch Video
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group


Discussion Leaders: Mark Hayward, Active Ingredient Technologies; Matt Szapacs, GlaxoSmithKline; Nicole Donnelly, PharmaCadence Analytical Services

5:30 pm - 6:30 pm

Exhibition & Social Hour - Princeton Ballroom Lobby, University I and Ballroom Lobby
Where Technology and Solutions Meet!
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group

6:30 pm - 7:30 pm

CPSA Dinner Lecture & Distinguished Analytical Scientist Award- University I Ballroom
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group

Announcements

CPSA Brazil 2014
Paul Corcoran, McKinley Scientific; Daniel Lebre, CEMSA

CPSA Shanghai 2014
Eric Yang, GlaxoSmithKline; Naidong Weng, Janssen Pharmaceuticals

7:30 pm - 9:00 pm

Keynote Lectures & Awards - University I Ballroom

Innovator Award Presentation
Kevin Bateman, Merck

Program Chair Recognition
Mike Lee, Milestone Development Services

How Cloud Computing Can Extend the Power and Versatility of Mass Spectrometry from the Bench to the Bedside
Nathan Yates, University of Pittsburgh

Distinguished Analytical Scientist Award Presentation
Paul Corcoran, McKinley Scientific; Fred McLafferty, Cornell University

An Analytical Scientist's Comments on A Distinguished One
Fred McLafferty, Cornell University

From Inspiration to Belief, A Journey of Self-Discovery: Thinking Small, Ultra-Low Flow and Ultra-High Throughput Mass Spectrometry
Gary Valaskovic, New Objective

Thursday, October 10

7:30 am - 8:30 am

Registration & Continental Breakfast - Second Floor Lobby

8:30 am - 10:00 am

Symposia & Roundtables - Princeton I/II Ballroom
Biomarker and Emerging Technology in the Clinical Sciences: The Impact of Research, Patients and Physicians
Discussion Leader: Jim Shen, Bristol-Myers Squibb; Jianing Zeng, Bristol-Myers Squibb

Validation for Protein Therapeutics and Biomarkers
Binodh DeSilva, Bristol-Myers Squibb

Challenges in GXP Assay Robustness and Sensitivity: Case Studies in Protein Biomarker Assays
Elizabeth Groeber, Wil Research

Comparing LC/MS and Immunoassays for Clinical Biomarkers
Michael Lassman, Merck

10:15 am - 11:45 am

Tools for Data Sharing
Discussion Leaders: John Laycock, Amgen; Nathan Yates, University of Pittsburgh

CHORUS: A Community Based Solution for the Storage, Analysis, and Exchange of Mass Spectrometry Data and Information.
Nathan A. Yates, University of Pittsburgh

Streamlining High Throughput ADME: Data Sharing, Workflow Automation and High Speed/High Resolution Analytical Mass Spectrometry
Loren Olson, AB SCIEX

Automating Bioanalytical Sample Analysis Through Enhanced System Integration
John Laycock, Amgen

12:00 pm - 1:15 pm

Sponsored Lunch & Roundtables

Mass Spectrometry in the Operating Theatre, A Surgeon's Perspective
Laura Muirhead, Imperial College London

1:30 pm - 3:00 pm

Symposia & Roundtables - Villanova Amphitheater
New Alternative Instrumentation
Discussion Leader: Kevin Bateman, Merck; Rick King, PharmaCadence Analytical Services

Non-Analytical Technologies that will Alter Analytical Labs
Kevin Bateman, Merck; Rick King, PharmaCadence Analytical Services

CPSA - Where Technology and Solutions Meet

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