Registration Open

Short Courses

All short courses are held at the Sheraton Bucks County Hotel

Protein Identification, Quantification, and Biomarker Analysis
Instructors: Nalini Sadagopan, Agilent Technologies; Nathan Yates, University of Pittsburgh; Harris Bell-Temin, Bristol-Myers Squibb

Bioanalysis of Mix Modalities via Hybrid and Orthogonal Approaches
Instructors: Suzanne Cordovado, CDC; Barry Jones, Q2 Solutions; Linlin Luo, Bristol-Myers Squibb; Jim Shen, Bristol-Myers Squibb

Building a Better Clinical Mass Spectrometry Lab
Instructors: Don Chace, Medolac Laboratories; Tim Garrett, University of Florida; Mark Hayward, Active Ingredient Technologies; Kenneth Lewis, OpAns

Human Pharmacokinetic Prediction and Approaches to Identify Rate Determining Step of Drug Absorption and Elimination: Industrial Perspective
Instructors: Ayman El-Kattan, Pfizer; Yurong Lai, Gilead

Microsampling and Patient Centric Sampling – A journey through what it is and how you can incorporate it into your workflows
Instructors: Neil Spooner, Spooner Bioanalytical Solutions; Joe Siple, New Objective

CPSA Charity 5K Event

Contact Nicole Matz for more information.
Organizers: Nicole Matz, PRA Health Science; Guowen Liu, Agios; Naidong Weng, Janssen Research & Development; Helen Weng, Frontage Laboratories

CPSA Open Charity Golf Event

Organizers:John Butler, Agilent Technologies; Paul Corcoran, McKinley Scientific; Clark Williard, inVentiv Health Clinical Lab

Advanced Training in MassMetaSite / WebMetabase / MassChemSite Structure Elucidation Tools

Discussion Leaders: Ismael Zamora, Molecular Discovery

Executive Roundtable
Where Technology and Solutions Meet Business

Sponsored by McKinley Scientific

Discussion Leaders: Lucinda R. Hittle, Merck; Emily Ehrenfeld, New Objective

Panel Discussion:
Donald Chace, Medolac Laboratories
Binodh DeSilva, Bristol-Myers Squibb
Joanna Pols, Regeneron
Robyn Rourick, Genentech
Roy Vaz, Sanofi
Eric Yang, GlaxoSmithKline
Yi Zhang, SCIEX

Roundtables Archive

Reception & Sponsor's Dinner

Hosted by SCIEX

Opening Remarks

CPSA Charitable Foundation
Paul Corcoran, McKinley Scientific; Emily Ehrenfeld, New Objective

CPSA Institute
Naidong Weng, Janssen Research & Development; Tim Garrett, University of Florida

Distinguished Lecture Series

Registration & Continental Breakfast

Graduate Student/Mentor Breakfast
Discussion Leaders: Petia Shipkova, Bristol-Myers Squibb and Mike Lee, Milestone Development Services

Welcome & Opening Remarks

Opening Remarks – Disease is the Enemy!

Plenary Lecture

Parallel Sessions

TRACK I: Symposium Session

Informatics in the Clinical Laboratory
Discussion Leader: Timothy Garrett, University of Florida

Mass Spectrometry Innovations for Evaluating the Metabolic Signature of Parkinson’s Disease and Deep Brain Stimulation
Emily Gill, University of Florida

Multiomic Data Integration
Stephan Kang, Intero Life Sciences

Ion Mobility/Mass Spectrometry for Metabolomics and Clinical Analysis
Richard Yost, University of Florida

TRACK II: Colloquium Session

Data-Driven Decision Making in Non-Clinical Drug Development
Discussion Leader: Chad Briscoe, PRA Health Services

What Data is Required and How it is Used in Non-Clinical Regulatory Decisions
Chet Bowen, GlaxoSmithKline

Data Driven Decision Making for Non-Clinical Studies
Rick Briscoe, Merck

Ligand Binding Assay Formats in the Context of Reagent Availability – Discovery to IND Enabling Tox Journey
Jonathan Haulenbeek and Johanna Mora, Bristol-Myers Squibb

TRACK II-b: Colloquium Session

Introducing El-Maven:
Drug Discovery, Metabolomics and Flux

Rewired Metabolism of T-cells upon mTOR Inhibition: An Integrated Omics Approach
Darren Dumlao, Pfizer

MIMOSA: Characterizing the Flux in the TCA Cycle
Richard Kibbey, Yale University

Polly: A Cloud Based, Comprehensive Metabolomic Flux Platform
Abhishek Jha, Elucidata

Panel Discussion: Challenges and Opportunities of Integrating Call Metabolism in Drug Discovery
John Janiszewski, Pfizer

Sponsored Lunch & Roundtables

Sponsored by Shimadzu

Preliminary Evaluation of the Microsampling Wing™ by SHIMADZU (MSW2TM): A Micro Volume (2.8 µL/5.6 µL) Liquid Plasma Sampling Device
Lingling Xue, Merck

Next Generation Mass Spec Approach Towards Clinical Toxicology and Therapeutic Drug Testing from Oral Fluid Matrix
Manoj Tyagi, PhD., Captiva Labs

Poster Session & Roundtables

Discussion Leaders: Mark Cancilla, Merck; Helene Cardasis, Thermo Fisher Scientific; Scott Hottenstein, GlaxoSmithKline; Wenkui Li, Novartis; Enaksha Wickremsinhe, Eli Lilly & Co.; Matthew Szapacs, GlaxoSmithKline

Parallel Sessions

TRACK IV:Symposium Session

Marriage of Biochemistry and Molecular:
Clarifying or Confusing
Discussion Leaders: Don Chace, Medolac Laboratories; Suzanne Cordovado, Centers for Disease Control and Prevention

This Symposium session consists of presentations from Drs. Chace and Cordovado on the history of newborn screening and how metabolite and molecular testing have impacted the field. The presentations will be followed by a lively panel discussion describing the interplay of metabolomics, proteomics and genomics in laboratory medicine of the future.

Panelists:
Tim Garrett, University of Florida
Alla Kloss, Genzyme
Carla Cuthbert, Centers for Disease Control and Prevention
Binodh DeSilva, B ristol-Myers Squibb
Kostas Petritis, Centers for Disease Control and Prevention
Kyriakie Sarafoglou, University of Minnesota

TRACK V-a - Colloquium Session

Importance of Chromatography in Applied Sciences – Current Trends, Education, and Career Opportunities
Discussion Leaders (on behalf on Chinese American Chromatography Association): Yi He, John Jay College of Criminal Justice, CUNY & Naidong Weng, Janssen Research & Development

This colloquium session consists of podium presentations from both academia and industry. This session will highlight the importance of chromatography on applied sciences and the current trends. We will also discuss how to strengthen the chromatography education, training and career advance opportunities. Chinese American Chromatography Association, a volunteer-based non-profit organization, plays important role to promote and educate chromatography sciences among young scientists.

Advantages of Superficial Porous Particles in Chromatography
Chuping Luo, Advanced-Materials-Tech

Current Applications and New Trends of Liquid Chromatography – Mass Spectrometry in Forensic Toxicology
Marta Concheiro-Gisan, John Jay College, NY

Applying Chromatography to Resolve Real-world Pharmaceutical Challenges – A 30 Year Journey of An Accidental Chromatographer
Naidong Weng, Janssen Reasearch & Development

TRACK V-b - Colloquium Session

Bioanalytical Considerations in Biological Therapeutics
Discussion Leaders: Sophia Xu, Bristol-Myers Squibb and Weifeng Xu, Bristol-Myers Squibb

Insulin Glargine: Applying LC-MS to Assess Metabolite PK in Support of Biosimilar Studies
Yang Xu, Merck

Large Molecule Bioanalysis: Special Considerations for ADC and Biosimilars
Xiaoyan Cai, Wuxi AppTec

Critical Reagents in Bioanalysis: How Do We Know What We Are Measuring?
Jonathan Haulenbeek, Bristol-Myers Squibb

Immunogenicity Assay Design and Optimization for Support in Clinical Studies
Sharon Arrol, Alexion

Challenge to Current Acid-Dissociation Based Neutralizing Antibody Extraction and Detection and How We Can Solve It
Weifeng Xu, Bristol-Myers Squibb

TRACK V-c - Colloquium Session

Structure Identification
Discussion Leaders: David Detlefsen, Novatia and Mark Hail, Novatia

Let Them Eat Cake!
Donald Chace, Medolac Laboratories

Social Hour & Sponsored Workshops

WORKSHOP

Sponsored by SCIEX

Utilizing UHPLC Column Technologies for Solving Separation Challenges for Protein and Oligonucleotide Therapeutics
Michael McGinley, Phenomenex Inc

WORKSHOP
So You Want to Start a Business?

Sponsored by McKinley Scientific

Josh Mann, Meso Scale Discovery and Tim Garrett, University of Florida

This workshop will outline the key fundamentals and points of consideration when starting a biotech venture. This workshop will describe in more depth information on branding and business strategy as it relates to the biotech industry.

WORKSHOP
Patient Centric Blood Sampling and Analysis: What is it and will it become a reality?

Sponsored by Spooner Bioanalytical

Current approaches to the collection of blood samples for the quantitative determination of analytes are not fit for purpose. They are often inconvenient for patients, expensive for health systems and pharmaceutical companies and wasteful of the sample collected. This Workshop will highlight emerging technologies that could change this paradigm. Participants will discuss whether these approaches will warrant acceptance in the future for the generation of high quality data for clinical decision making. Various criteria will be considered including: Is the approach realistic? What technologies will we need? How might we better integrate high quality sampling with high quality analysis and data reporting, etc.?

WORKSHOP

Sponsored by Agilent Technologies

Sponsor Hospitality & Evening Workshops

Microsampling Summit

Sponsored by McKinley Scientific and Eli Lilly & Company

Workshop Leaders: Qin Ji, Bristol-Myers Squibb and Olga Kavetskaia, Pfizer

Panelists:
Tim Garrett, University of Florida
Jack Henion, Q2 Solutions
Wenkui Li, Novartis
John Lin, Frontage Laboratories
Laura Patrone, SK Life Science
Neil Spooner, Spooner Bioanalytical Solutions
Enaksha Wickremsinhe, Eli Lilly & Company
Yang Xu, Merck

Complete Biopharma Characterization

Sponsored by Thermo Fisher Scientific

Workshop Leader: Jonathan Josephs, Thermo Fisher Scientific

Registration & Continental Breakfast

CPSA 4 Corners Initiative Breakfast

Discussion Leaders: Mark Arnold, Covance; Lorin Bachmann, Virginia Commonwealth University

Download The Ethics of Business and Biomarkers presentation

Symposium Session & Roundtables

Development of New Biomarkers: A Focus on Disease Progression Biomarkers

Discussion Leader: Alla Kloss, Genzyme

Advancements in Protein Turnover Measurements and Protein Fractional Synthesis Quantification Utilizing Metabolic Labeling with Stable Isotope Tracers and High Resolution Mass Spectrometry
Thomas Angel, GlaxoSmithKline

An Integrated Mass Spectrometry-Based Analysis Pipeline for Determining Clinical Biomarker Signatures
Monica Lane, Sanofi

Kidney Toxicity Biomarkers
Wen Jianzhong, Merck

Parallel Sessions

TRACK VI: Symposium Session

A Bird’s Eye View from the Top: Analysis of Intact Proteins by Mass Spectrometry for In-Life Sample Sets
Discussion Leaders: Wenying Jian, Janssen Research & Development; John Kellie, GlaxoSmithKline

Comparison of HRMS Instrumentation for Intact PK Analysis of Biotherapeutics
Lisa Anne O’Callaghan, Merck Research Laboratories

Simultaneous Catabolite Identification and Quantitation of Therapeutic Proteins at the Intact Level
Wenying Jian, Janssen Research & Development

Subunit-Level and Intact Analyses of Antibodies from In-Life Samples: LC-MS Methods for Pharmacokinetic Quantitation, Critical Quality Attributes, and Biotransformation
John F Kellie, GlaxoSmithKline

TRACK VII-a:Colloquium Session

Emotional Intelligence in the Workplace
Discussion Leader: Lucinda Hittle, Merck

We have learned to recite the alphabet backwards from memory and even built towers out of 3x5 index cards. This year, our session will focus on small group discussion of Emotional Intelligence in the Workplace. The audience will actively participate in a brief individual assessment, then divide into 4 groups to discuss the 4 aspects of Emotional Intelligence: Self-awareness, Self-management, Social Awareness and Relationship Management. We will then have a report back to the group to discuss and provide an opportunity for further reflection. The session is based on the excellent book by Travis Bradberry and Jean Greaves Emotional Intelligence 2.0

TRACK VII-b:Colloquium Session

Metabolite Identification and Databases:
Industrial Workflows and Emerging Trends
Discussion Leader: Ismael Zamora, Molecular Discovery

Characterization of Metabolites of Different Molecular MOdalities using an Integrated LC/MS/MS and MassMetaSite/WebMetaBase™ Approach
Silvi Chacko, Bristol-Myers Squibb

Woulda-Coulda-Shoulda Acquired that Therapeutic Peptide Metabolite Identification Data
Christopher Kochansky, Merck

LC-HRMS vs NMR: The Dawn of Structure Elucidation
Elisabeth Ortega, Lead Molecular Design

TRACK VII-c:Colloquium Session

Patient Centric Blood Sampling and Analysis: Let’s Make this Happen!
Discussion Leader: Neil Spooner, Spooner Bioanalytical Solutions; Joe Siple, New Objective

Following-on from Tuesday evening's workshop, this Colloquium will bring together technology companies and thought leaders that are interested in positively moving forwards the agenda and expediting the time frame for developing and establishing patient centric blood sampling and analysis approaches with the public, media, regulators, etc., in order to increase the likelihood of acceptance of these technologies and the data arising from them.

Sponsored Lunch & Roundtable

Sponsored by Thermo Fisher Scientific

LC-MS Analysis of mAb and Bi-specifics in Plasma and Tissues: 1 ng/mL Sensitivity without Antibody Enrichment
Jun Qu, University at Buffalo

Social Hour & Sponsored Workshops

WORKSHOP

Sponsored by SCIEX

Confident and Powerful MetID for all Your Therapeutic Molecules
Shaw Xia, SCIEX

WORKSHOP
PicoChip and Metabolomics:
What's heat got to do with it?

Sponsored by New Objective

Timothy Garrett, University of Florida; Amanda Berg, New Objective; Emily Ehrenfeld, New Objective

WORKSHOP

Sponsored by Thermo Fisher Scientific

WORKSHOP
Elucidata User Group Meeting

Sponsored by Elucidata

Application of Flux in Drug Discovery
Thomas Roddy, Agios Pharmaceuticals

Democratizing Flux Capabilities through PollyPhi
Abhishek Jha, Elucidata

Parallel Sessions

Innovator Award Session
Session Leaders: Mark Cancilla, Merck and Daniel Spellman, Merck

Garbage in garbage out: how automated sample preparation can enable superior mass spec results
Steve Murphy, Agilent Technologies, Inc.

Multivariate solid phase extraction optimization using automated dispersive pipette extraction on robotic liquid handling system
L. Andrew Lee, Integrated Micro-Chromatography Systems, LLC (IMCS)

High-speed microfluidic CE-MS and CE-HPMS technology, and their opportunities in the pharma, biopharma and clinical domains
Chris Brown, 908 Devices Inc.

Nominated Vendor/ Sponsor Talk
TBD

Steven A. Hofstadler Graduate Student Session
Inspiring Career Paths in the Sciences for Young Scientists

Sponsored by New Objective

Session Leader: Petia Shipkova, Bristol-Myers Squibb

Mentors

Student Presentations

Online Hydrophobic Interaction Chromatography-Mass Spectrometry for Top-down Protein Analysis
Bifan Chen, University of Wisconsin

Characterization of Protein-Protein Interactions by Protein Cross-linking Capillary Electrophoresis at Increased Throughput
Claire Ouimet, University of Michigan

Quantitative Top Down Proteomics Temporally Defines Complexity of Aging Biomarkers
Peter Doubleday, Northwestern University

An Integrative Approach for Determining Biomarkers and Etiology of a Disease Leading to Mass Die Offs of Aquatic Life in South Africa
Jeremy Koelmel, University of Florida

Mentors:
Susan Abbatiello, Thermo Fisher Scientific
Bradley Ackermann, Eli Lilly & Company
Mark Arnold, Covance
Lori Bachmann, VA Commonwealth University
Amanda Berg, New Objective
Chad Briscoe, PRA Health Sciences
Don Chace, Medolac Laboratories
Paul Corcoran, McKinley Scientific
Ayman El-Kattan, Pfizer
Patrick Fromal, Shimadzu
Lucinda R. Hittle, Merck
Mark Hail, Novatia
Jonathan Josephs, Thermo Fisher Scientific
Steve Kang, Intero Life Sciences
Alla Kloss, Genzyme
Lisa Lorence, University of Pittsburgh
Josh Mann, Meso-Scale Discovery
Eric Milgram, PepsiCo
Shane Needham, Alturas Analytics
Timothy Olah, Bristol-Myers Squibb
Joanna Pols, Merck
Suma Ramagiri, SCIEX
Robyn Rourick, Genentech
Petia Shipkova, Bristol-Myers Squibb
James Small, Merck
Gary Valaskovic, New Objective
Roy Vaz, Sanofi
Naidong Weng, Janssen Research & Development
Anthony Yeung, Fox Chase Cancer Center

CPSA Announcements & Award Presentations

Sponsored by New Objective and McKinley Scientific

Local ACS Discussion Groups

CPSA Europe
Neil Spooner, Spooner Bioanalytical Solutions
Ismael Zamora, Molecular Discovery

CPSA Metabolomics
Timothy Garrett, University of Florida
Emily Ehrenfeld, New Objective

CPSA Shanghai
Xiao-Yan Cai, WuXi AppTec
Naidong Weng, Janssen Research & Development

CPSA Analytics
Nathan Yates, University of Pittsburgh

CPSA BRASIL
Carla Marshall-Waggett, New Objective
Martin Steel, McKinley Scientific

Innovator Award Presentation
Mark Cancilla, Merck
Daniel Spellman, Merck

Steven A. Hofstadler Graduate Student Award/Recognition
Emily Ehrenfeld, New Objective
Petia Shipkova, Bristol-Myers Squibb

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA USA 2018 Program Chair
Suzanne Cordovado, Centers for Disease Control & Prevention
Emily Ehrenfeld, New Objective

Keynote Dinner Lectures

Sponsored by New Objective and McKinley Scientific

Keynote Lecture

Distinguished Analytical Scientist Award

Sponsored by New Objective

Introduction and Presentation of Award
Renuka Pillutla, Bristol-Myers Squibb

Exhibition & Social Hour

Mix, mingle, nibble and visit with our participating vendors

Vendor Session - Five Minutes of Fame (5MOF)!

Discussion Leaders: Mark Hayward, ITSP; Matt Szapacs, GlaxoSmithKline

Registration & Continental Breakfast

Colloquia & Roundtables

Collaborative Research Models Between Pharma and CRO
Discussion Leader: Jim Shen, Bristol-Myers Squibb

Outsourcing bioanalysis of Clinical Biomarkers: Challenges and Opportunities
Yue Zhao, Bristol-Myers Squibb

Collaborating with Pharmaceutical Companies between 1 and 100,000 Employees: the CRO Perspective
Liam Moran, PhD, Charles River Laboratories

Be Careful What You Wish for… A Personal, CRO Perspective on CRO-Pharma Collaborations
Chad J. Briscoe, PhD, PRA Health Sciences

Parallel Sessions

TRACK VIII: Symposium Session

The Road to Regulation for Biomarker Qualification
Discussion Leader: Robyn Rourick, Genentech

Progress in Analytical Assay Validation for Biomarker Qualification: A Joint FDA/Critical Path Initiative
Steven Piccoli, Neoteric Consulting

Best Practices for Biomarker Methods Validation for LC/MS, AAPS White Paper Perspective
Carmen Fernandez-Metzler, PharmaCadence

Panel Discussion:
Mark Arnold, Covance
Chad Briscoe, PRA Health Sciences
Don Chace, Medolac Laboratories
Carmen Fernandez-Metzler, PharmaCadence
Steven Piccoli, Neoteric Consulting

TRACK IX: Colloquium Session

From Large to Small Molecules – Molecular-Level Characterization Strategies of API, Metabolites, Degradants and Everything in Between!
Discussion Leader: James Small, Merck

Probing the Relationship Between Small Molecule Drug Metabolites and Oxidative Degradants – Is there Really Something to Learn Here?
James Small, Merck

Sulfur-Centered Radicals and Degradation Mechanisms of Proteins – New Perspectives in the Regulation of Proteins and the Formation of Biologically Active Substances
Olivier Mozziconacci, Merck

Sponsored Lunch & Roundtables
Sponsored by New Objective and The University of Florida

My History in Analytical Technology in Biomarkers
Naidong Weng, Janssen Research & Development

Parallel Sessions

TRACK X: Symposium Session

Presentations from the Edge: Young Scientist Session
Discussion Leaders: Roy Vaz, Sanofi and Alla Kloss, Sanofi

A targeted LC-MS assay for the identification of new biomarkers of drug induced liver injury in plasma and dried blood microsamples
Michelle Robinson, Merck

Practical Approaches to Protein Biomarker Quantification by LC-MS: What Are We Actually Measuring?
Timothy Sikorski, GlaxoSmithKline

To be announced
Kristen Randall, Sanofi

Track XI: Colloquium Session

Alternative Instrumentation
Discussion Leaders: Kevin Bateman, Merck and Rick King, PharmaCadence Analytical Services

Adjourn