Registration Open

Short Courses

Protein Identification, Quantification, and Biomarker Analysis
Instructors: Nalini Sadagopan, Agilent Technologies; Gary Valaskovic, New Objective; Nathan Yates, University of Pittsburgh

New!! 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, Pediatrix Analytical; Tim Garrett, University of Florida; Mark Hayward, Active Ingredient Technologies; Kenneth Lewis, OpAns

Assessment of Oral Bioavailability in Preclnical Species and Human
Instructors: Ayman El-Kattan, Pfizer; Yurong Lai, Bristol-Myers Squibb

CPSA 5K Charity Event

Organizers:Nicole Matz, PRA Health Sciences; Guowen Liu, Agios Pharmaceuticals; 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

Microsampling: Isn't It Bleedin' Obvious?

Moderators: Neil Spooner, Spooner Bioanalytical Solutions; Joe Siple, Drummond Scientific

Participants/Panelists:
Kevin Bateman, Merck
Donald Chace, Pediatrix Analytical
Chris Evans, GlaxoSmithKline
Shane Needham, Alturas Analytics
Tim Olah, Bristol-Myers Squibb

Executive Roundtable
Where Technology and Solutions Meet Business

Sponsored by McKinley Scientific

Discussion Leaders: Lucinda R. Hittle, Merck and Emily Ehrenfeld, Mozaic Solutions

Panel Discussion:
Donald Chace, Pediatrix Analytical
Joanna Pols, Regeneron
Robyn Rourick, Genentech
Roy Vaz, Sanofi
Eric Yang, GlaxoSmithKline
Yi Zhang, SCIEX

Reception & Sponsor's Dinner

Hosted by SCIEX

Opening Remarks

CPSA Charitable Foundation
Paul Corcoran, McKinley Scientific; Shane Needham, Alturas Analytics; Emily Ehrenfeld, Mozaic Solutions

CPSA Institute
Paul Corcoran, McKinley Scientific; Emily Ehrenfeld, New Objective; Naidong Weng, Janssen Research & Development

Distinguished Lecture Series

Registration & Continental Breakfast

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

Graduate Student/Mentor Breakfast

Welcome & Opening Remarks
Welcome Letter

Opening Remarks – Disease is the Enemy!
Timothy Garrett, University of Florida; Jim Shen, Bristol-Myers Squibb; and Mike Lee, Milestone Development Services

Plenary Lecture

Parallel Sessions

TRACK I: Symposium Session

Clinical Mass Spectrometry: The Future's So Bright…
Discussion Leader: Timothy Garrett, University of Florida

Assay Design for the Clinical Laboratory: Solutions and Future Directions
Lorin Bachmann, Virginia Commonwealth University

The Lipidyzer™ Platform: A Revolutionary Tool for Understanding the Role of Lipids in Disease
Melanie Juba, SCIEX

Mass Detection: Population Screening in Metabolism
Donald Chace, Pediatrix Analytical

TRACK II: Colloquium Session

Clinical Dose Prediction: The Intersection of DMPK, Bioanalysis, Modeling and Clinical Sciences
Discussion Leader: Naidong Weng, Janssen Research & Development

Bioanalytical Challenge of Measuring Highly Protein Bound Drugs and Its Impact on Human Dose Prediction
Xu, Xiaohui, Bristol-Myers Squibb

Estimation of Volume of Nasal Secretion/Broncho alveolar Lavage Using Urea as Marker of Dilution
Yang Gao, Covance

Quantitative Translational Approach for Clinical Dose and Probability of ‘Technical Success’ Prediction in Early Development
Nahor Haddish-Berhane, Janssen Research and Development

Sponsored Lunch & Roundtables

Sponsored by Shimadzu

Addressing the Challenges of LC-MS Analysis in the Clinical Lab: Transport Particles using LC-MS/MS and PLIN2 Detection in Urine Using the Perfinity Workstation.
Fred Regnier, Novilytic

Poster Session & Roundtables

Discussion Leaders: Mark Cancilla, Merck; Helene Cardasis, Thermo Fisher Scientific; Wenkui Li, Novartis; Matthew Szapacs, GlaxoSmithKline

Parallel Sessions

TRACK III:Symposium Session

New Technologies/Approaches to Quantitation
Discussion Leader: Donald Chace, Pediatrix Analytical

Emerging Needs in the Pharmaceutical Industry
Alla Kloss, Genzyme

Application of High-Throughput Micro-Flow LC/MS/MS Metabolic Stability Screening Workflow
Brendon Kapinos, Pfizer

Differential Intensity Screening and Ranking of Unknown Protein Targets (DISRUPT): A Proteomic Method for the Rapid Identification of Novel Drug-Target Interactions
Harris Bell-Temin, University of Pittsburgh

TRACK IV-a - Colloquium Session

Fit for Purpose Biomarker Validation
Discussion Leader: Michael Lassman, Merck

Practical Considerations for Clinical LC-MS Biomarker Assay Validation
Derek Chappell, Merck

A Validated High Resolution LC/MS Assay for Oxyntomodulin in Human and Rat Plasma
Bradley Ackermann, Eli Lilly and Company

TRACK IV-b - Colloquium Session

Advanced Training in MassMetaSite/WebMetabase/MassChemSite Structure Elucidation Tools
Discussion Leader: Ismael Zamora, Molecular Discovery

Let Them Eat Cake!

Donald Chace, Pediatrix Analytical

Social Hour & Sponsored Workshops

WORKSHOP
A Streamlined Approach for Biotherapeutic Characterization

Sponsored by SCIEX

The Simpler and Faster Solution for Routine Biopharmaceutical Characterization
Bob Haufler, SCIEX

WORKSHOP
High Performance Meets Personalized Healthcare: The Prospects for Daily Performance Monitoring

Sponsored by McKinley Scientific

Mike Lee, Milestone Development; Tim Garrett, University of Florida; Nathan Yates, University of Pittsburgh

WORKSHOP
High Resolution Accurate Mass

Sponsored by Thermo Fisher Scientific

The use of High Resolution Accurate Mass (HRAM) to Drive Maximum Information and Confidence in the Characterization of all Therapeutic Modalities.
Jonathan Josephs, Thermo Fisher Scientific

Microsampling Summit

Sponsored by Drummond Scientific and McKinley Scientific

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

Panel Discussion:
Donald Chace, Pediatrix Analytical
Christopher Haynes, CDC
Kenneth Lewis, OpAns
Wenkui Li, Novartis
John Lin, Frontage Laboratories
Neil Spooner, Spooner Bioanalytical Solutions
Enaksha Wickremsinhe, Eli Lilly and Company
Yang Xu, Merck

Registration & Continental Breakfast

CPSA 4 Corners Initiative Breakfast
Discussion Leaders: Mark Arnold, Bioanalytical Solution Integration LLC and Lorin Bachmann, Virginia Commonwealth University

Download Overview (PDF)

Symposium Session & Roundtables

Protein/Clinical Biomarkers

Discussion Leaders: Brad Ackermann, Eli Lilly and Company and Randall Nelson, Arizona State University

Quantitative Immunoaffinity LC-MS/MS of Therapeutic Targets and Trafficking Proteins in Tissues and Primary Cells
Hendrik Neubert, Pfizer

Assessing Drug-Target Engagement in Tissue Biopsies Using Immunoaffinity LC-MS/MS
Tim Olah, Bristol-Myers Squibb

The Slow Embrace: A Personal Perspective on the Adoption of Mass Spectrometry in Clinical Practice
Mark Duncan, University of Colorado at Denver

High-Throughput, High-Precision Protein Assays Via Mass Spectrometry: Longitudinal Measurement of Protein Biomarker Panels in Dried Blood Spots
Leigh Anderson, SISCAPA

Parallel Sessions

TRACK V: Symposium Session

Data and Information Handling: The Invisible Puzzle Piece

Discussion Leader: Roy Vaz, Sanofi

Finding Potential Location Biomarkers for Cancer and the Advent of Computationally-Driven Experimentation
Robert F Murphy, Carnegie-Mellon University

Metabolomics in Pharmaceutical Research: An Information-Driven Approach
Harvey Lieberman, Sanofi/Genzyme

Untargeted Lipidomics: Applications and Warnings
Laura Goracci, University of Perugia

TRACK VI-a:Colloquium Session

A Focus on Phase I to Patient Trials: Enabling Technologies to Accelerate Drug Development

Discussion Leader: Chad Briscoe, PRA Health Sciences

Flow Cytometry and How Flow can be used to Demonstrate Target Engagement in Phase 1 Healthy Patient Studies
Barry van der Strate, PRA Health Sciences

Biomarker Applications in Phase 1
Chris Evans, GlaxoSmithKline

On the Use of Radioisotope Tracers in Early Phase Clinical Pharmacokinetics and Metabolism Research – Let’s Do More!
Ad Roffel, PRA Health Sciences

TRACK VI-b:Colloquium Session

Metabolite Identification and Databases: Industrial Workflows and Emerging Trends

Discussion Leader: Ismael Zamora, Molecular Discovery

Exploiting In Silico Techniques for Human Phase I Metabolism Prediction with Smartphone
Gabriele Cruciani, University of Perugia

Databasing Drug Metabolites to Influence the Design-Make-Test Drug Discovery Cycles
Christopher J Kochansky, Merck

Approaches for Small Molecule Metabolite ID in Discovery
Silvi A. Chacko, Bristol-Myers Squibb

Sponsored Lunch & Roundtable

High Resolution Accurate Mass

Sponsored by Thermo Fisher Scientific

High Resolution Accurate Mass Quantitation: Tools for Meeting Analyte Detection Challenges
Keeley Murphy, Thermo Fisher Scientific

Social Hour & Sponsored Workshops

WORKSHOP

Sponsored by SCIEX

The QTRAP® 6500+ System: Proven Performance & Quantitative Excellence, with No Compromise
Yi Zhang, SCIEX

Using Microflow LC-MS to Improve Sensitivity for the Quantitation of Biopharmaceuticals LC
Remco van Soest, SCIEX

WORKSHOP
All Roads Lead to PicoChip: Nanoflow, Microflow and Beyond

Sponsored by New Objective

Moderator: Timothy Garrett, University of Florida

The Reproducible Revolution- Label Free Mass Spectrometry and the Need for Chromatographic Excellence
Harris Bell-Temin, University of Pittsburgh

Low-Flow Doesn't Have to be Slow: Development and Optimization of High-throughput Micro-Flow LC
Brendon Kapinos, Pfizer

Separation of Peptides using PicoChip System
Cliff Phaneuf, Genzyme

WORKSHOP
Microsampling: Isn't it Bleedin' Obvious?

Sponsored by Drummond Scientific

Moderators: Neil Spooner, Spooner Bioanalytical Solutions; Joe Siple, Drummond Scientific

Participants/Panelists:
Kevin Bateman, Merck
Donald Chace, Pediatrix Analytical
Chris Evans, GlaxoSmithKline
Shane Needham, Alturas Analytics
Tim Olah, Bristol-Myers Squibb

Sponsored by TBA

Parallel Sessions

Innovator Award Session

Discussion Leaders: Mark Cancilla, Merck and Daniel Spellman, Merck

Steven A. Hofstadler Graduate Student Session

Discussion Leader: Petia Shipkova, Bristol-Myers Squibb

Sponsored by New Objective

Mentors:
Sue Abbatiello, Thermo Fisher Scientific
Brad Ackermann, Eli Lilly and Company
Lucinda Hittle, Merck
Paul Corcoran, McKinley Scientific
Patrick Fromal, Shimadzu
Jonathan Josephs, Thermo Fisher Scientific
Alla Kloss, Genzyme
Kenneth Lewis, OpAns
Eric Milgram, PepsiCo
Shane Needham, Alturas Analytics
Timothy Olah, Bristol-Myers Squibb
Joanna Pols, Regeneron Pharmaceuticals
Suma Ramagiri, SCIEX
Robyn Rourick, Genentech
Petia Shipkova, Bristol-Myers Squibb
James Small, Merck
Gary Valaskovic, New Objective
Anthony Yeung, Fox Chase Cancer Center

Miniaturized Sampling Probes and Microfluidic Devices for Monitoring Neurochemicals with High Spatio-Temporal Resolution
Thitaphat Ngernsutivorakul, University of Michigan

Investigating Metabolic Shifts from Exercise Routines
Michelle Reid, University of Florida

Translational Top-Down Proteomics From A Single Draw Of Human Blood
Timothy Toby, Northwestern University

CPSA Award Presentations

Sponsored by New Objective and McKinley Scientific

Keynote Lecture

Innovator Award Presentation
Mark Cancilla, Merck and Daniel Spellman, Merck

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

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA USA 2017 Program Chair
Timothy Garrett, University of Florida; Jim Shen, Bristol-Myers Squibb

Keynote Dinner Lectures

Sponsored by New Objective and McKinley Scientific

Keynote Lecture

Distinguished Analytical Scientist Award

Introduction and Presentation of Award
D. Holmes Morton, Central Pennsylvania Clinic

Exhibition & Social Hour

Participating Exhibitors
Exhibition Floorplan

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

Discussion Leaders: Mark Hayward, ITSP; Nicole Donnelly, PharmaCadence Analytical Services; Matt Szapacs, GlaxoSmithKline

Registration & Continental Breakfast

Colloquia & Roundtables

Bioanalysis of New Modalities Using LC-MS/MS

Discussion Leader: Guowen Liu, Agios Pharmaceuticals

Development of Highly Sensitive Immunoaffinity LC-MS/MS methods for Free and Total Cyno Monkey IP-10 Levels in Serum in Support of Target Engagement Studies in Drug Discovery
Hongwei Zhang, Bristol-Myers Squibb

Characterization of Pharmacokinetic Properties for a Site-specific Antibody Drug Conjugate (ADC) using Multiple-Platform Bioanalytical Assays
Jian Chen, Celgene

Considerations in Contracting Biomarkers Out: What are the Challenges, What to Ask, What to Expect, Where to Place even within the same CRO
Patrick Bennett, PPD

Parallel Sessions

TRACK VIII: Symposium Session

Biomarkers From Start to Finish

Discussion Leader: Alla Kloss, Genzyme

Technology Development for Biomarker Discovery in Limited Clinical and Biological Samples
Alexander Ivanov, Northeastern University

Metabolomic Correlates of Cardiometabolic and Age-Related Phenotypes in the Community
Susan Cheng, Brigham and Women’s Hospital

Exploring Target Identification Using the Cellular Thermal Shift Assay Approach
Clifford Phaneuf, Sanofi

TRACK VIII: Colloquium Session

Comparison of Traditional and Non-Traditional Strategies to Separate and Characterize Drug Metabolites

Discussion Leader: James Small, Merck

Impurity Isolations in Support of Drug Discovery
Ray McClain, Merck

Development of Relative Ion Mobility and Molecular Modeling (RIM3) as a Novel Approach to Metabolite Structural Identification
Ian Mcintosh, Merck

Recent Advances in the Complex Structure Elucidation of Drug Metabolites via High Resolution Solution NMR
James Small, Merck

Sponsored Lunch & Roundtables
Sponsored by New Objective, University of Florida and University Of Pittsburgh

Newborn Screening: A Balancing Act Full of Rewards
Carla Cuthbert, CDC

Symposium Session & Roundtables

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

Adjourn