Getting Medicines to Patients Faster by Eliminating the Bottlenecks in Drug Discovery and Development

Preliminary Program     Monday | Tuesday | Wednesday | Thursday

Updated September 24, 2015

Monday October 5

7:30 am - 8:30 am
Princeton Foyer

Registration Open

8:30 AM - 4:00 PM

Princeton I

Short Courses

Protein ID and Biomarker Analysis by Mass Spectrometry: Challenges and Solutions for Quantification and Differential Analysis
Instructors: Nalini Sadagopan, Agilent Technologies, Gary Valaskovic, New Objective, Nathan Yates, University of Pittsburgh

Princeton II

New! How to Teach an Old Dog New Tricks; The Use of Traditional and Novel Methods, Practices, Technologies to Quantify Protein Therapeutics in a Regulated Environment
Instructors: Shane Needham, Alturas Analytics, Jim Shen, Bristol-Myers Squibb and Dave Abramowitz, SCIEX


Building a Better Clinical Mass Spectrometry Lab:
Clinical Diagnostics is Growing in the Use of Mass Spectrometry and Especially in the Implementation of New Techniques

Instructors: Timothy Garrett, University of Florida; Mark Hayward, Active Ingredient Technologies; and Kenneth Lewis, OpAns


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

7:30 AM - 9:30 AM
Tyler State Park
Newtown, PA

NEW! CPSA Charity 5K Event

Contact Nicole Matz for more information.
Download Registration Form
Organizers: Nicole Matz, PRA Health Science; Guowen Liu, Bristol-Myers Squibb; Naidong Weng, Janssen Research & Development; Helen Weng, Frontage Laboratories

10:00 AM - 3:00 PM
Makefield Highlands Golf Club, Yardley, PA

CPSA Charity Open Golf Event

Tee Time - 10:00 AM
Contact Brad, John or Paul below for information, registration and/or sponsorship opportunities.
Organizers: Brad Coopersmith, Waters Corporation; John Butler, Agilent Technologies; Paul Corcoran, McKinley Scientific

12:00 pm - 4:00 pm
Villanova Amphitheater

Molecular Discovery Users Meeting

Discussion Leader: Ismael Zamora, Molecular Discovery

Automated Soft-Spot Identification: Success Rate, Limitations, Code Logic and Functionality
John Janiszewski, Pfizer

To be announced
Christopher Kochansky, Merck

What is Molecular Discovery Working on Now in Order to Get More Knowledge from the Same Data
Ismael Zamora, Molecular Discovery

4:30 pm - 5:30 pm
University I/II

Executive Roundtable
Where Technology and Solutions Meet Business

Discussion Leaders: Lucinda Cohen, Merck and Shane Needham, Alturas Analytics
6:00 pm - 9:00 pm
University I/II

Sponsor's Reception & Dinner

Distinguished Lecture Series

Doug Lewis

Fetal Alcohol Exposure - A 30 Year Search for a Reliable Biomarker
Douglas Lewis
United States Drug Testing Laboratories, Inc.

Tuesday October 6

7:30 am - 8:30 am
University Foyer

Registration & Continental Breakfast

7:30 am - 8:30 am
University I/II

Graduate Student/Mentor Breakfast

8:30 am - 9:00 am
University I/II

Welcome & Opening Remarks

Opening Remarks – Disease is the Enemy!
Chad Briscoe, PRA Health Sciences; Naidong Weng, Janssen Research & Development and Mike Lee, Milestone Development Services

Mike Lee

Mike S. Lee
Milestone Development Services

Chad Briscoe

Format, Objectives, Opening Remarks
Chad Briscoe
PRA Health Sciences

Naidong Weng

Naidong Weng
Janssen Research & Development

9:00 am - 9:45 am
University I/II

Plenary Lecture

David Evans

Mechanism Based Drug Disposition – Building Quality into Our Product Pipeline
David Evans
Janssen Research & Development

10:00 am - 11:45 am

Parallel Sessions

Villanova Amphitheater

TRACK I: Symposium Session

Future Needs of Mass Spectrometry in Clinical Sciences

Discussion Leaders: Timothy Garrett, University of Florida and Kenneth Lewis, OpAns

Achieving Widespread Adoption of MS in the Clinical Laboratory: What Will It Really Take?
Lori Bachmann, VCU

Using MS to Screen Multiple Metabolites: How to Design Your Assay for the Clinic
Don Chace, Pediatrix Analytical

Digitized LC-MS as an Enabling Tool on the Path to Precision Healthcare
Gary Valaskovic, New Objective

Understanding Complex Lipid Metabolism through Quantitative Lipidomics
Yi Zhang, SCIEX

Princeton I/II

TRACK II: Colloquium Session

PBPK Modeling
Discussion Leader: Avijit Ghosh, Janssen Research & Development

PBPK Model Guided Drug Development and Labeling Optimization
Alice Ke, Certara/Symcyp

A Systems Platform to Predict Pharmacokinetics of Liver Transporter Substrates
Rui Li, Pfizer

Minimal Physiologically-Based Pharmacokinetic (mPBPK) Model for a Monoclonal Antibody against Interleukin-6 in Mice with Collagen-Induced Arthritis
Xiling Jiang, Janssen Research & Development

12:00 pm - 1:00 pm
University I/II

Sponsored Lunch & Roundtables

LCMS-8060: Changes Everything
David Colquhoun, Shimadzu Scientific Instruments

Quantitative Determination of Opioids in Whole Blood using Fully Automated Dried Blood Spot Desorption Coupled to On-line SPE-LC-MS/MS
Ruth Verplaetse, Q2 Solutions

1:00 pm - 3:00 pm
University Foyer

Poster Session & Roundtables

Discussion Leaders: Mark Cancilla, Merck; Helene Cardasis, Thermo Fisher Scientific; Matthew Szapacs, GlaxoSmithKline; Tracie Williams, CDC

3:15 pm - 4:45 pm

Parallel Sessions

University I

TRACK III: Symposium Session

A Tough Nut to Crack: Bringing New Analytical Approaches to the Clinic Successfully
Discussion Leader: Don Chace, Pediatrix Analytical

Translating Global Metabolomics to Clinical Diagnostics
Tim Garrett, University of Florida

Simplifying Complex Proteomic Workflows for Larger Scale and Speed
Nathan Yates, University of Pittsburgh

From Discovery to Patient – A Case Study
Roy Vaz, Sanofi

University II

TRACK IV-a - Colloquium Session

Tiered Approach/Scientific Validation in Bioanalysis – Reaching out our Stakeholders in QA, Clinical and Preclinical PK
Discussion Leaders: Eric Woolf, Merck and Philip Timmerman, EBF/Janssen Research & Development

Introduction and aim
Eric Woolf, Merck

Principles and Status Update of Scientific Validation/Tiered Approach in Bioanalysis
Philip Timmerman, EBF/Janssen R&D

Contribution related to a QA Perspective on Scientific Validation/Tiered Approach
Karen Hencken, Merck

Fit-for-Purpose Bioanalytical Data in Preclinical Phase
Debra R Luffer-Atlas, Eli Lilly and Company

Contribution Related to a Clinical PK Perspective on Scientific Validation/Tiered Approach
Jan de Jong, Janssen R&D

Panel Discussion


TRACK IV-b - Colloquium Session

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

Isolation and Structure Elucidation in the Development Environment within Pharma
Brian Marquez, Mestrelab Research

Challenges in Impurity Isolation and Identification at a Contract Research Lab
Ken Ray and Dan Petrillo, Novatia

4:45 pm - 5:15 pm
2nd Floor Lobby
Let Them Eat Cake!

Don Chace, Pediatrix Analytical

5:00 pm - 6:00 pm

Social Hour & Sponsored Workshops

Princeton I

Options and Considerations in Biologics Bioanalysis – When to Try Something Different

Large Molecule Bioanalysis: LC-MS or ELISA?
A Case Study
Zamas Lam, QPS

Improving Sensitivity in Bio-Analysis using microLC
Remco Van Soest, SCIEX

Princeton II

High Performance Meets Personalized Healthcare: Daily Performance Monitoring

Daily Performance Monitoring
Martin Steel, McKinley Scientific and Mike Lee, Mozaic Solutions

Differential Mass Spectrometry Platform for Personalized Healthcare
Nathan Yates, University of Pittsburgh

Infinite Speed and LC/MS Throughput with Digital LC Technologies
Gary Valaskovic, Mozaic Solutions

Informatics for Personalized Healthcare
Andrey Bondarenko, InfoClinika

Villanova Amphitheater

Multimodal Omics Workflows for Translational Research

David Heywood, Waters Corporation


Improved Workflows for Protein Digestion

IAC and Digestion with a Single Reagent
Carmen Fernandez-Metzler, PharmaCadence Analytical Services, LLC

A Controlled Flow 96 Well Plate for Full Automation of Antibody Capture and Protein Digestion Workflow
John Laycock, SPEware Corporation

6:30 pm - 9:00 pm

Sponsor Hospitality & Evening Workshops

University I

High Resolution Accurate Mass Quantitation Summit

Discussion Leaders: Jack Henion, Q2 Solutions and Jonathan Josephs, Thermo Scientific

Past Present and Future of Interrogating Biological Samples: How HRAM has Become an Essential and Integral Component of the Analytical Arsenal
Jack Henion, Q2 Solutions

Panel Discussion
Chaired by Jack Henion, Q2 Solutions and Jonathan Josephs, Thermo Scientific

University II

Microsampling Summit

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

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs
Yang Xu, Merck

Small samples with a BIG impact; where is microsampling today?
Chris Evans, GlaxoSmithKline

Comparative Studies for Dried Blood Spot Sampling: Design, Conduct and Statistical Data Analysis
Qin Ji, Bristol-Myers Squibb and Carol Gleason, Bristol-Myers Squibb

Donald Chace, Pediatrix Analytical
Chris Evans, GlaxoSmithKline
Kenneth Lewis, OpAns
Wenkui Li, Novartis
Tim Olah, Bristol-Myers Squibb
Fred Regnier, Novilytic LLC
Enaksha Wickremsinhe, AbbVie
Yang Xu, Merck

Wednesday October 7

7:30 am - 8:30 am
University Foyer

Registration & Continental Breakfast

8:30 am - 10:00 am
University I/II

Symposia & Roundtables

The Future of Mass Spectrometry for Clinical Protein Biomarker Determination (20/20 Vision)

Discussion Leader: Randall Nelson, Arizona State University

Next Horizon of Immunoaffinity LC-MS/MS for Protein Biomarkers
Hendrik Neubert, Pfizer

The Future is Now - Monitoring Insulin Levels for Diabetes Clinical Care With High Precision Using Mass Spectrometry
Mary Lopez, Nuclea Biotechnologies

Mass Spectrometric Immunoassays for Discovery, Verification, and Validation of Proteoform Biomarkers
Dobrin Nedelkov, Arizona State University

10:15 am - 11:45 am

Parallel Sessions

Villanova Amphitheater

TRACK V: Symposium Session

Rare Diseases
Discussion Leaders: Michelle Clasquin, Agios Pharmaceuticals and Roy Vaz, Sanofi

Gaucher Disease and Parkinsonism: Insights from a Rare Disease
Ellen Sidransky, National Institutes of Health

Analytical Aspects of Phenotypic Screening in Drug Discovery for Rare Diseases
Alexei Belenky, Genzyme

A Pediatrician's Perspective: Insight into the Diagnosis and Treatment of Metabolic Diseases - Amino Acids & Organic Acids as Biomarkers.
Holmes Morton, Clinic for Special Children

Princeton I/II

TRACK VI-a: Colloquium Session

Innovation Boot Camp
Discussion Leader: Lucinda Cohen, Merck

Tim Olah, Bristol-Myers Squibb

Jim Yergey, Yergey Consulting


TRACK VI-b: Colloquium Session

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

Optimized Workflow for a Metabolic Soft Spot Identification Assay
Wilson Shou, Bristol-Myers Squibb

How to Fit the DMS Dimension into Fluxomic Workflows
Richard Kibbey, Yale University

To be announced
Gary Martin, Merck

12:00 pm - 1:00 pm

Sponsored Lunch & Roundtable

University I & II

Stereospecific Drug Metabolite Analysis Using 2D LC/MS Q-TOF and SFC/QQQ
Smriti Khera, Agilent Technologies

1:15 pm - 2:15 pm

Social Hour & Sponsored Workshops

Princeton I

Differential Ion Mobility – Pushing the Boundaries of Selectivity in Biotherapeutics

Detect More Selectively with SelexION® Technology
Yves LeBlanc, SCIEX

Princeton II

6 Minutes of Science: Success from Qual to Quan with High-Performance Nanospray and LC-MS

Nathan A. Yates, University of Pittsburgh

Shane Needham, Alturas Analytics

The Potential of Nanospray and Digitization to Improve Metabolomic Workflows
Tim Garrett, University of Florida

Villanova Amphitheater

Using Ion Mobility Separation to Enhance Drug Metabolism Studies - New Approaches for Data Analysis

Advances in IMS-enabled Workflows For Qualitative and Quantitative DMPK Studies
Mark Wrona, Waters Corporation

Processing HDMS(e) Data in Mass-Metasite
Ismael Zamora, Molecular Discovery and Paul Rainville, Waters Corporation

2:30 pm - 3:30 pm

Parallel Sessions

University II

Innovator Award Session
Discussion Leader: Kevin Bateman, Merck

The Effects of Heat Stabilization and Euthanasia Methods on Free Fatty Acid Measurements in Rat Tissues
Camilla Sivertsson, Denator

A Lab Mobile Mass Spectrometer for High Fidelity Mass Analysis Around the Pharmaceutical Facility
Brian Musselman, IonSense

Identifying Proteins to which Small-Molecule Probes and Drugs Bind
Nathan Yates, University of Pittsburgh

Differential Mass Spectrometry Workflow Leveraging Cloud Based Technologies
Andrey Bondarenko, InfoClinika

Use of Cerex SPE cartridge technology for simplified IAC sample preparation
Bonnie Baker, PharmaCadence

Development and Application of the MASSPEC Algorithm for Structural Elucidation Utilizing Mass Spectral Data
Marshall Siegel, MS Mass Spec Consultants

Villanova Ampitheatre

Steven A. Hofstadler Graduate Student Session

Inspiring Career Paths in the Sciences for Young Scientists

Sue Abbatiello, Thermo Fisher Scientific
Brad Ackermann, Eli Lilly and Company
Hong Cai, GlaxoSmithKline
Lucinda Cohen, Merck
Paul Corcoran, McKinley Scientific
Patrick Fromal, Shimadzu
Jonathan Josephs, Bristol-Myers Squibb
F rank Kero, Biotage
Alla Kloss, Genzyme
Kenneth Lewis, OpAns
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
Anthony Yeung, Fox Chase Cancer Center

Direct Sampling of Adherent Cells Using Laser Ablation Electrospray Ionization Mass Spectrometry
Rachelle Jacobson, The George Washington University

Identification of Sirtuin 5 Modulators by Droplet Microchip Electrophoresis
Erik Guetschow, University of Michigan

Lipidomics of Liver Disease
Rainey Patterson, University of Florida

Higher Insight in Cellular Senescence: Defining a New Mass Window for Top Down Quantitative Proteomics
Peter Doubleday, Northwestern Universtiy

3:45 pm - 4:15 pm
Princeton I/II

CPSA Award Presentations

Innovator Award Presentation
Kevin Bateman, Merck

Steven A. Hofstadler Graduate Student Award/Recognition
Presented by the Mentors

Program Chair Recognition
Mike Lee, Milestone Development Services

4:15 pm - 5:45 pm
Princeton I/II

Keynote Lecture and
Presentation of the Distinguished Analytical Scientist Award

Keynote Lecture

"Kicking it Up a Notch” with New Spices in Clinical Chemistry: Multiple Metabolite, Micro Sampling and LC/MS

Don Chace

Don Chace
Pediatrix Analytical

Distinguished Analytical Scientist Award Presentation
Presented by Russell Grant, LabCorp

Pigs 'n Blankets: Mass Spectrometry and the Continuum of Human Health

Andy Hoofnagle

Andy Hoofnagle
University of Washington

5:45 pm - 6:45 pm
University I & Lobby, 2nd Floor Lobby
6:45 pm - 9:00 pm
University II

Vendor Session - "Five Minutes of Fame"

Discussion Leaders: Mark Hayward, ITSP Solutions, Inc.; Matt Szapacs, GlaxoSmithKline; Nicole Donnelly, PharmaCadence

Thursday October 8

7:30 am - 8:30 am
2nd Floor Lobby

Registration & Continental Breakfast

8:30 am - 10:00 am
Princeton I/II

Colloquia & Roundtables


Discussion Leaders: Wenying Jian, Janssen Research & Development and Jim Shen, Bristol-Myers Squibb

The Role of Mass Spectrometry in Supporting the Development of Therapeutic Antibodies and Antibody-Drug Conjugates (ADC’s)
Michael Peddicord, Bristol-Myers Squibb

ADC Bioanalysis by Immuno-Capture LC-MS/MS Hybrid Assays
Ang Liu, Bristol-Myers Squibb

Next-Generation Drug Conjugates Using the Centyrin Alternative Scaffold
Shalom Goldberg, Janssen Research & Development

10:15 am - 11:45 am

Parallel Sessions

Villanova Amphitheater

Track VIII: Symposium Session

Biomarkers From Start to Finish

Discussion Leader: Alla Kloss, Genzyme

X-Linked Adrenoleukodystrophy: Biomarkers for Newborn Screening and Development of New Therapies
Ann Moser, Kennedy Krieger Institute

Isotopic Labeling Strategies for Biomarker Discovery in Metabolomics
Tim Garrett, University of Florida

PD Biomarker Measurement by LC/MS/MS – Technological Advancements to Address Sensitivity and Throughput Challenges
Barry Jones, Quintiles


Track VIII: Colloquium Session

Traditional and Non-Traditional Strategies to Generate Drug Metabolites for Analytical Characterization

Discussion Leaders: James Small, Merck

Traditional Drug Metabolite Generation Schemes
Kerry Fillgrove, Merck

Non-Traditional Drug Metabolite Generation Schemes
Yong Liu, Merck

Role of Drug Metabolite Identification in Drug Discovery and Development
Tom Rushmore, University of the Sciences

12:00 pm - 1:15 pm
Princeton I/II

Sponsored Lunch & Roundtables

Discussion Leaders: Tim Garrett, University of Florida and Petia Shipkova, Bristol-Myers Squibb

LC-MS and Prenatal Metabolism from Population to Bench
Nathaniel Snyder, Drexel University

Improving Metabolomics Separations with Ion Mobility Mass Spectrometry
Chris Chouinard, University of Florida

1:30 pm - 3:00 pm
Villanova Amphitheater

Symposia & Roundtables

New Alternative Instrumentation

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

3:00 pm