United to Beat Disease: Partners in Healthcare, Partners in Science, Partners in Technology and Innovation

Meeting Program     Monday | Tuesday | Wednesday | Thursday

Updated October 13, 2018

Monday OCTOBER 15

7:30 am

Princeton Lobby
2nd Floor

Registration Open

Coffee and Continental Breakfast

Short Courses

All short courses are held at the Sheraton Bucks County Hotel

8:30 am - 4:00 pm

Protein Identification, Quantification, and Biomarker Analysis

Instructors: Weixun Wang, Merck; Harris Bell-Temin, Bristol-Myers Squibb; Nalini Sadagopan, Agilent Technologies; Nathan Yates, University of Pittsburgh

8:30 am - 4:00 pm

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

8:30 am - 4:00 pm

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

8:30 am - 4:00 pm

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

12:00 pm - 4:00 pm

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; Kevin Bateman, Merck; Tim Olah, Bristol-Myers Squibb; Enaksha Wickremsinhe, Eli Lilly & Co.

Download Microsampling Course Presentation

8:30 am - 4:00 pm

Integrating Technologies for High Throughput, Industrialized Drug Discovery

Instructor: Abhishek Jha, Elucidata

7:30 am - 9:30 am

Makefield Highlands Golf Club, Yardley, PA

CPSA 5K Charity Event

Organizers: Nicole Matz, PRA Health Sciences; Guowen Liu, Agios; Naidong Weng, Janssen Research & Development; Helen Weng, Frontage Laboratories

10:00 am - 3:00 am

Makefield Highlands Golf Club, Yardley, PA

CPSA OPEN Charity Golf Event

Organizers: John Butler, Agilent Technologies; Clark Williard, inVentiv Health Clinical Lab

12:30 pm - 4:30 pm

University I/II


Molecular Discovery Users Meeting:
WebMetabase 4.0 World Wide Premier

Discussion Leader: Ismael Zamora, Molecular Discovery

4:30 pm - 5:30 pm

University I/II

Executive Roundtable

Where Technology and Solutions Meet Business

Big Ideas, Big Data: Where Do We Go From Here?

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

  • Look at science topics through business lens
  • How the different information for multiple analytical sources fits together
    • How to weave together pieces of info
    • Big data – how to leverage what we already know/make useful
  • The world beyond small molecules
    • More than just large molecules
    • What is cost/quality of life of prolonged life
  • When THC goes legit
    • Methods available
    • Labs will need to test/treat like alcohol

Brad Ackermann, Eli Lilly and Company
Abhishek Jha, Elucidata
Robyn Rourick, Genentech
Neil Spooner, Spooner Bioanalytical Solutions
Eric Yang, GlaxoSmithKline

6:00 pm - 9:00 pm

University I/II

Opening Reception & Sponsor's Dinner

Opening Remarks

CPSA Institute
Naidong Weng, Janssen Research & Development
Tim Garrett, University of Florida
Neil Spooner, Spooner Bioanalytical Solutions

CPSA Charitable Foundation
Alla Kloss, Sanofi
Emily Ehrenfeld, New Objective

Introducing ALD Connect:
Raising Awareness, Creating Community, & Empowering Patients to Find a Cure for ALD
Florian Eichler, Harvard Medical School and Mass General Hospital
Kathleen O'Sullivan-Fortin, ALD Connect
Jesse Torrey and Jack Torrey: Connect to the Patients

Distinguished Lecture Series

Hui Zhang

The Next Generation HT BioAnalytical Platform for Drug Discovery: ADE-OPP-MS
Hui Zhang

Tuesday OCTOBER 16

7:30 am - 8:30 am

University Foyer


Coffee and Continental Breakfast

7:30 pm - 8:30 pm

University I/II


Discussion Leaders: Petia Shipkova, Bristol-Myers Squibb and Mike Lee, Milestone Development Services

8:30 am - 9:00 am

University I/II

Welcome & Opening Remarks

Opening Remarks - Disease is the Enemy!

Mike Lee

Mike S. Lee
Milestone Development Services

Alla Kloss

Format, Objectives, Opening Remarks
Alla Kloss

9:00 am - 9:45 am

University I/II

Plenary Lecture

Transformative Partnerships in Rare Neurological Diseases: the Case of Adrenoleukodystrophy

Florian Eichler

Florian Eichler
Harvard Medical School
Massachusetts General Hospital

10:00 am - 11:45 am

Parallel Sessions

Princeton I

Track 1: Symposium Session
Leveraging Government/Industry Partnerships to Build a Better Bassinet in Newborn Screening

Discussion Leader: Suzanne Cordovado, Centers for Disease Control and Prevention

CDC’s Newborn Screening Translation Research Initiative: An Ongoing Public-Private Partnership through the CDC Foundation
Robert Vogt, Centers for Disease Control and Prevention

Molecular Testing and DNA Sequencing in Newborn Screening: Working with Partners to Ensure Accurate Testing from Dried Blood Spots
Suzanne Cordovado, Centers for Disease Control and Prevention

Past, Present and Future of Newborn Screening for Metabolic Disorders: Global Harmonization of Screening Results
Kostantinos Petritis, Centers for Disease Control and Prevention

Princeton II

Track 2: Colloquium Session
Metabolomics to Biomarkers: Seeing Disease Clearly

Discussion Leaders: Michelle Clasquin, Pfizer and David Pirman, Agios Pharmaceuticals

Metabolomics in Basic Biomedical Research
Caroline A. Lewis, Whitehead Institute for Biomedical Research

Probing Metabolic Heterogeneity Using Imaging Mass-Spectrometry
Shawn M. Davidson, Princeton University

Transaminase Inhibition by 2-Hydroxyglutarate Impairs Glutamate Biosynthesis and Redox Homeostasis in Glioma
Sam McBrayer, Dana-Farber Cancer Institute


Track 3: Colloquium Session
A Private Endeavour to Deliver the Future Analytical Tools for All; Foolhardy or Grand?

Discussion Leader: Stephen Tomisich, Trajan Scientific & Medical

  • Investing in the Workflow Solutions of the Future
  • Smart Chemistries; Selective Sample Processing; Faster, Cheaper, Better
  • Analytically Credible Micro-Sampling Tools
  • Workflow Automation, Centralized vs Remote, Sampling vs POCT

Stephen Tomisich, Trajan Scientific & Medical
Andrew Gooley, Trajan Scientific & Medical

General Discussion


Track 4: Colloquium Session
Joint Session with Chinese American Chromatography Association (CACA)

Discussion Leaders: Chuping Luo, Advanced Materials Technology; Naidong Weng, Janssen Research & Development

A Closer Look at the Retention Mechanism in Hydrophilic Interaction Chromatography (HILIC)
Yong Guo, Fairleigh Dickinson University

The Advancement and Application of Hydrophilic Interaction Chromatography (HILIC) Technique in Today’s Bioanalytical Science
Yang Lu, Frontage Laboratories

Recent Advances and Optimization in Reversed Phase Separation Technology for mAb Analysis
Chuping Luo, Advanced-Materials-Tech

12:00 pm - 1:00 pm

University I/II

Sponsored Lunch & Roundtables

Inflammation Potentially Modulates the Efficacy of Antibody Therapeutics
Yoshinobu Koguchi, Earle A. Chiles Research Institute

1:00 pm - 3:00 pm

University Foyer

POSTER SESSION & Roundtables

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

3:15 pm - 4:45 pm

Parallel Sessions

University I

Track 5: Symposium Session
Meet All Omics

Discussion Leader: Monica Lane, Sanofi

Multi-omic Study to Identify Novel Biomarkers of Pompe Disease
Kelly George, Sanofi

Utilization of High-Throughput LC-MS and CE-MS in Plasma Biomarker Discovery for Infectious Diseases
J. Will Thompson, Duke University

Fast Sensitive Method for Trisaccharide Biomarker Detection in Mucopolysaccharidosis
Alexei Belenky and Drew Tietz, Sanofi

University II

Track 6: Colloquium Session

Discussion Leaders: Wenying Jian, Janssen Research & Development; Naidong Weng, Janssen Research & Development

7-Alpha-Hydroxy-4-Cholesten-3-One (C4) as a Potential Biomarker for Glucagon Receptor (GCGR) Activation
Lijuan Kang, Janssen

Impacts of Biomarker Bioanalysis on Drug Development And Translational Medicine
Yue Zhao, BMS

Biomarkers and the New BMV Guidance
Barry Jones, Q2 Solutions


Track 7: Colloquium Session
Metabolomics and Standardization

Discussion Leader: Tim Garrett, University of Florida

Approaches to Enable Longitudinal Metabolomic Data Mining in Drug Discovery
Dave Pirman, Agios Pharmaceuticals

Metabolomic and Fluxomic Biomarkers for the Fasted/Refed Transition
Irwin Kurland, Albert Einstein College of Medicine

Development of Reference Method Systems to Improve Patient Care
Lorin M. Bachmann, VCU Health System


Track 8: Colloquium Session
Advancing Analytical and Engineering Techniques in Pharmaceutical Sciences

Discussion Leader: James Small, Merck; Yongchao Su, Merck

Characterizing the Impact of Modifications in CDRs of mAbs on Structure-Function by Hydrogen-Deuterium Exchange Mass Spectrometry and Functional Assays
Hui Wei, Bristol-Myers Squibb

Predictive Physical Stability Enabling Pharmaceutical Package Selection
Michael McNevin, Merck & Co, Inc.

Utilizing Imaging Techniques, such as Scanning Electron Microscopy and Energy Dispersive Spectroscopy, to Enabled Drug Development
James D. Ormes, Merck & Co, Inc.

Session Overview

4:45 pm - 5:15 pm

Princeton Lobby
2nd Floor

Let Them Eat Cake

Donald Chace, Medolac Laboratories

5:00 pm - 6:00 pm

Social Hour & Sponsored Workshops

Princeton I



Princeton II




6:30 pm - 9:00 pm

Sponsor Hospitality & Evening Workshops

University I

Microsampling Summit:
Connecting Workflows from The Patient to Outcomes

Workshop Leaders: Kevin Bateman, Merck; Qin Ji, Bristol-Myers Squibb; Olga Kavetskaia, Pfizer; Timothy Olah, Bristol-Myers Squibb; Joe Siple, New Objective; Neil Spooner, Spooner Bioanalytical Solutions; Enaksha Wickremsinhe, Eli Lilly & Co.

Patient Centric Sampling – It Really is Bleedin’ Obvious
Neil Spooner, Spooner Bioanalytical Solutions

Bleeding at Home... Impact on Clinical Trial Patients
Enaksha Wickremsinhe, Eli Lilly & Co.

"A pint of sweat, saves a gallon of blood." (George S. Patton) Let's Get to Work Now!
Timothy Olah, Bristol-Myers Squibb

Bringing the Trial to the Patient
Kevin Bateman, Merck

Wednesday OCTOBER 17

7:30 am

University Foyer

Registration Open

Coffee and Continental Breakfast

7:30 am - 8:30 am

University I/II

CPSA Four Corners Initiative breakfast Meeting

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

8:30 am - 10:00 am

University I/II

Symposium Session & Roundtables

Lions Don’t Hunt Chipmunks:
The Unique and Important Role of Quantitative Mass Spectrometry for the Analysis of Tissue-Based Protein Biomarkers

Discussion Leader: Brad Ackermann, Eli Lilly and Company

Hunting for Inflammatory Cytokine Expression in Atopic Dermatitis Skin Biopsies Using Multiplexed Online Immunoaffinity LC/MS/MS
Jay Johnson, Pfizer

Why Assume When You Can Actually Detect? Comprehensive Insight into the Complexities of Disease and Identifying Effective Treatment
Timothy Olah, Bristol-Myers Squibb

Targeted Mass Spectrometry to Quantify Drug Targets in Cancer Immunotherapy
Dan Liebler, Protypia/Adjunct Professor, Vanderbilt University

10:15 am - 11:45 am

Parallel Sessions


TRACK 1: Colloquium Session
Patient Centric Blood Sampling and Analysis:
Let’s Make this Happen!

Discussion Leaders: Neil Spooner, Spooner Bioanalytical Solutions; Joe Siple, New Objective

Princeton I/II

Track 2: Colloquium Session
Targeting Parkinson's Disease

Discussion Leader: Pablo Sardi, Sanofi

Parkinson’s Progression Marker Initiative (PPMI): Identifying Progression Biomarkers for Therapeutic Development
Samantha Hutten, Michael J Fox Foundation

Parkinson’s Disease: Time to be Precise
Pablo Sardi, Sanofi

Identifying CSF Markers of Parkinson’s Disease and Progression with Mass Spectrometry
Daniel Chelsky, Caprion Biosciences, Inc.


Track 3: Colloquium Session
Metabolite Identification and Databases:
Industrial Workflows and Emerging Trends

Discussion Leader: Ismael Zamora, Molecular Discovery

Unlocking the potential of Ion Mobility for Drug Metabolite Identification - partnering with Lead Molecular Design
Mark Wrona, Waters

UNIFI/MassMetaSite Integration. How to Use Ion Mobility Data Using the UNFI 3rd Party API
Ismael Zamora, Molecular Discovery

Structural Elucidation in Chemistry: MS and NMR Join Forces for an Automatic Workflow
Elisabeth Ortega, Molecular Discovery


Track 4: Colloquium Session
Innovation Bootcamp

Discussion Leader: Lucinda Hittle, Merck

12:00 pm - 1:00 pm

University I/II

Sponsored Lunch & Roundtables

1:15 pm - 2:15 pm

Social Hour & Sponsored Workshops

Princeton I/II

Leading High-Performance Nanoflow and Microflow LC-MS into the Future

Bernhard Nemec, ProLab
Andrew Lee, IMCS
Abhishek Jha, Elucidata

Simplifying Targeted Biomarker Panel Analysis
Monica Lane, Sanofi

Development of an LC-MS Based Protein Quantitation Assay to Support Discovery of Liver Function Biomarkers
Michelle R. Robinson, Merck


Maven User Meeting

Workshop Leader: Abhishek Jha

2:30 pm - 3:30 pm

Parallel Sessions

Princeton I/II

TRACK 5: Sympoium Session
Clinical Biomarkers:
Business or Science or the Business of Science

Discussion Leaders: Arkady Gusev, Novartis and Olga Kavetskaia, Pfizer

Introduction to Clinical Biomarkers and the Business of Science
Olga Kavetska, Pfizer

Business of Fit for Purpose: From sample management to validation to final sample analysis data
Iman Jilani, Pfizer

Business of Synergies: From clinical sites to central lab, CROs and beyond
Arkady Gusev, Novartis

LC-MS Biomarker Bioanalysis Outsourcing Business Models: Challenging the PK Precedence
Stephen Lowes, Q2 Solutions


TRACK 6: Colloquium Session
Frontiers of Innovation, Technology and Solutions

Discussion Leaders: Alla Kloss, Sanofi; Ganesh S. Moorthy, Children's Hospital of Philadelphia

Microsampling Assays for Pediatric Clinical Trials: Opportunities and Challenges
Ganesh S. Moorthy, Children's Hospital of Philadelphia

Recent Trends with the Transfer from LBA to LC/MS assays: Microflow LC/MS Applications for Large Biomolecules
Shane Needham, Alturas Analytics

Integrative Proteomics to Producing a Large Versatile Repertoire of Therapeutic Nanobodies
Yi Shi, University of Pittsburgh

High-Frequency Longitudinal Analysis of Macro- and Micro- Inflammation Processes Using Dried Blood Microsamples and SISCAPA Protein Panel Assays
Leigh Anderson, SISCAPA Assay Technologies

University II

Innovator Session

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

Fast HPLC Injections, Rethought
Bernhard Nemec, Prolab Instruments

Rapid Purification, Characterization and Manipulation of Antibodies using High Capacity Capturem Membranes
Christian Hoppmann, Takara Bio USA


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

Session Leaders: Petia Shipkova, Bristol-Myers Squibb and Emily Ehrenfeld, New Objective

Student Presenters:

Uncovering New Fungal Natural Products and Their Biosynthetic Pathways Using FAC-MS Technology
Matt Robey, Northwestern University

Deciphering the Human Heart Proteome by Top-down Proteomics
Trisha Tucholski, University of Wisconsin

Mass-Activated Droplet Sorting for Label Free, High-Throughput Enzyme Screening at the Nanoliter Scale
Dan Holland-Moritz, University of Michigan

Improving quantitation of 25-hydroxyvitamin D in human serum using ion mobility coupled with liquid chromatography and mass spectrometry
Nick Oranzi, University of Florida

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
Ayman El-Kattan, IFM
Patrick Fromal, Shimadzu
Lucinda R. Hittle, Merck
Mark Hail, Novatia
Jonathan Josephs, Thermo Fisher Scientific
Alla Kloss, Genzyme
Lisa Lorence, University of Pittsburgh
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
Roy Vaz, Sanofi
Naidong Weng, Janssen Research & Development
Anthony Yeung, Fox Chase Cancer Center

3:45 pm - 5:30 pm

Princeton I/II


"5MOF" - 5 Minutes of Fame

A unique CPSA USA tradition not to be missed!

5:30 pm - 6:30 pm

University I
University Foyer

Social Hour & Exhibition

Munch, mix and mingle with our sponsors and vendors

6:30 pm - 7:30 pm

University II

CPSA Dinner, Announcements & Awards


Local ACS Discussion Groups

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

CPSA Metabolomics
Timothy Garrett, University of Florida

CPSA Shanghai
Emily Ehrenfeld, New Objective
Naidong Weng, Janssen Research & Development

CPSA Analytics
Amanda Berg, New Objective
Alla Kloss, Sanofi

Carla Marshall-Waggett, New Objective


Innovator Awards
Mark Cancilla, Merck; Dan Spellman, Merck

Steven A. Hofstadler Graduate Student Award/Recognition
Petia Shipkova, Merck and Emily Ehrenfeld, New Objective

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA USA 2019 Program Chair Announcement
Alla Kloss, Sanofi

7:30 pm - 9:00 pm

University II

Keynote Dinner Lecture
Distinguished Analytical Scientist Award

Keynote Lecture


Smart Trials: Moving from Site-Centric to Patient-Centric Clinical Trials
Kevin Bateman

Distinguished Analytical Scientist Award

Introduction and Presentation of Award
Matt Barfield, GlaxoSmithKline

Neil Spooner

Patient Centric Blood Sampling and Quantitative Bioanalysis – A Personal Journey
Neil Spooner
Spooner Bioanalytical Solutions

Thursday OCTOBER 18

7:30 am

Princeton Lobby
2nd Floor

Registration Open

Coffee and Continental Breakfast

8:30 am - 10:00 am

Princeton I/II

Colloquia & Roundtables

Collaborative Research Models Between CRO and Pharma

Discussion Leader: Jim Shen, Bristol-Myers Squibb

A Hitchhikers Guide to the 2018 FDA BMV Guidance: Don’t Panic
Steve Lowes, Q2

FDA’s Last Frontier: 5-Year Mission to Revise the BMV Guidance
Linlin Luo, Bristol-Myers Squibb

Open Discussion

10:15 am - 11:45 am

Parallel Sessions


TRACK 9: Symposium Session
Bioanalytical Aspects in Biological Therapeutics

Discussion Leaders: Sophia Xu, Bristol-Myers Squibb and Weifeng Xu, Bristol-Myers Squibb

Strategies and Challenges for Peptide Quantification in Regulated BA with Case Studies
Yang Xu, Merck

CRISPR, Cell and Gene Therapies: Bioanalytical Expectations and Challenges
Robert Dodge, Novartis

The Secrets to Robust Bioanalytical Method Development
Jonathan Haulenbeek, Bristol-Myers Squibb


TRACK 10: Colloquium Session
Updates on the Road to Regulation for Biomarkers

Discussion Leader: Robyn Rourick, Genentech; Brad Ackermann, Eli Lilly and Company

Biomarker Assay Validation Challenges and the Current BMV
Carmen Fernandez-Metzler, PharmaCadence Analytical Services

Juggling 101: Satisfying Regulatory, Client and Internal Compliance and Performance Requirements for Biomarker Assays in the CRO Environment
Tom Oglesby, PPD Laboratories

When Do GLP, GCLP, GCP or CLIA Apply for Biomarkers
Mark Arnold, Covance


TRACK 11: Colloquium Session
Pushing the Boundaries of Analytical Chemistry through Novel Applications

Discussion Leader: James Small, Merck

Applying SepQuant DropletProbe for Rapid Tissue Distribution and On Tissue Metabolite Identification in Drug Discovery and Development
Bingming Chen, Merck & Co.

Problem Solving in a Pharmaceutical Forensic Services Laboratory—Who We Are; What We Do and How We Do It
Janine Brouillette, Merck & Co, Inc.

12:00 pm - 1:15 pm


Sponsored Lunch & Roundtables

Micro-Column Separation in Metabolomics:
How Do We Grow Small?

Discussion Leader: Emily Ehrenfeld, New Objective; Tim Garrett, University of Florida

LC/MS-based Workflows for Targeted Protein Quantitation in Biopharmaceutical R&D: Automation, Micro and NanoFlow Chromatography and Integrated Data Analytics
Dan Spellman, Merck

1:30 pm - 3:00 pm

Parallel Sessions

Princeton I/II

TRACK 12: Symposium Session
Presentations from the Edge: Young Scientist Session

Discussion Leader: Roy Vaz, Sanofi

New Strategies to Facilitate Efficient Discovery of Permeable Therapeutic Peptides
Tanvi Desai, Merck

Strategies to Address Stability Issue in Biomarker Quantitation
Zhuo Chen, GlaxoSmithKline

Mass Spectrometry Imaging Reveals Drug Disposition and Facilitates Biomarker Discovery
Cristina Silvescu, Bruker


TRACK 13: Colloquium Session
New Alternative Instrumentation

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

3:00 pm


Alla Kloss, Sanofi
Mike Lee, Milestone Development Services