CPSA USA 2017

Enabling Personalized Medicine:
Connecting People, Disciplines and Technology

Preliminary Program     Monday | Tuesday | Wednesday | Thursday

Updated September 13, 2017

Monday OCTOBER 23

7:30 am - 8:30 am
Princeton Foyer

Registration Open


Short Courses

All short courses are held at the Sheraton Bucks County Hotel

8:30 AM - 4:00 PM Princeton I

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

8:30 AM - 4:00 PM Princeton II

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
Lehigh

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 LaSalle

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
University Grille

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

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

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

10:00 am - 3:00 pm
Makefield Highlands Golf Club, Yardley, PA

CPSA Open Charity Golf Event

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

12:00 pm - 4:00 pm
Villanova Amphitheater

Advanced Training in MassMetaSite / WebMetabase / MassChemSite Structure Elucidation Tools

Discussion Leaders: Ismael Zamora, Molecular Discovery

12:00 pm - 4:00 pm
To Be Announced

Joint ACS Meeting

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

Executive Roundtable
Where Technology and Solutions Meet Business

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

6:00 pm - 9:00 pm
University I/II

Reception & Sponsor's Dinner

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

Tuesday OCTOBER 24

7:30 am - 8:30 am
University Foyer

Registration & Continental Breakfast

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

Welcome & Opening Remarks

Opening Remarks – Disease is the Enemy!

Mike Lee

Welcome
Mike S. Lee
Milestone Development Services

Suzanne Cordovado

Format, Objectives, Opening Remarks
Suzanne Cordovado
Centers for Disease Control and Prevention

Emily Ehrenfeld


Emily Ehrenfeld
New Objective

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

Plenary Lecture

Kyriakie Sarafoglou

Screening, Diagnosis and Treatment of Newborns with Congenital Adrenal Hyperplasia:
Opportunities for Improvements
Kyriakie Sarafoglou
University of Minnesota

10:00 am - 11:45 am

Parallel Sessions

Princeton I

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

TBA
Stephan Kang, Intero Life Sciences

TBA
University of Florida

Princeton II

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

Biomarker Strategy in Non-Clinical Drug Development
TBA, Bristol-Myers Squibb

Villanova

TRACK III: Colloquium Session

Session Title to Be Announced
Discussion Leader: To Be Announced

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

Sponsored Lunch & Roundtables

1:00 pm - 3:00 pm
University Foyer

Poster Session & Roundtables

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

3:15 pm - 4:45 pm

Parallel Sessions

University I

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

University II

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

Villanova

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

Lehigh

TRACK V-c - Colloquium Session

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

4:45 pm - 5:15 pm
2nd Floor Lobby

Let Them Eat Cake!
Donald Chace, Medolac Laboratories

5:00 pm - 6:00 pm
 

Social Hour & Sponsored Workshops

Princeton I

WORKSHOP

Princeton II

WORKSHOP
So You Want to Start a Business?

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

Villanova

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

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.?

Lehigh

WORKSHOP

6:30 pm - 9:00 pm

Sponsor Hospitality & Evening Workshops

University I

Microsampling Summit

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

University II

Workshop

Wednesday OCTOBER 25

7:30 am - 8:30 am
University Foyer

Registration & Continental Breakfast

7:30 am - 8:30 am
University I/II
8:30 am - 10:00 am

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

10:15 am - 11:45 am

Parallel Sessions

Villanova Amphitheater

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

Princeton I/II

TRACK VII-a:Colloquium Session

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

Lehigh

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

TBD
Christopher Kochansky, Merck

TBD
TBD

LaSalle

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.

12:00 pm - 1:00 pm
 

Sponsored Lunch & Roundtable

1:15 pm - 2:15 pm
 

Social Hour & Sponsored Workshops

Princeton I

WORKSHOP

Princeton II

WORKSHOP

Villanova

WORKSHOP

Lehigh

WORKSHOP

Elucidata User Group Meeting

Introduction of Flux
Richard Kibbey, Yale University

Application of Flux in Drug Discovery
Thomas Roddy, Agios Pharmaceuticals

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

Panel Discussion
Moderated by John Janiszewski, Pfizer

2:30 pm - 3:30 pm

Parallel Sessions

University II

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

Villanova Ampitheatre

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

Session Leader: Petia Shipkova, Bristol-Myers Squibb

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
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:
Sue Abbatiello, Thermo Fisher Scientific
Brad Ackermann, Eli Lilly and Company
Don Chace, Medolac Laboratories
Paul Corcoran, McKinley Scientific
Emily Ehrenfeld, New Objective
Lucinda Hittle, Merck
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
Anthony Yeung, Fox Chase Cancer Center

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

CPSA Announcements & Award Presentations

Local ACS Discussion Groups

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

CPSA Metabolomics
Timothy Garrett, University of Florida

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

4:15 pm - 5:45 pm

Keynote Dinner Lectures

Keynote Lecture

Carla Cuthbert

Bringing Precision Medicine to Public Health: The role of Newborn Screening
Carla Cuthbert
Center for Disease Control and Prevention


Distinguished Analytical Scientist Award

Binodh DeSilva

Don’t Gamble with Bioanalysis in Enabling Precision Medicine: Bioanalysis – Empowered by Innovation Shaped by Regulation
Biondh DeSilva
Bristol-Myers Squibb

5:45 pm - 6:45 pm
University I & Lobby

Exhibition & Social Hour

6:45 pm - 9:00 pm
University II

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

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

Thursday OCTOBER 26

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

Registration & Continental Breakfast

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

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

10:15 am - 11:45 am

Parallel Sessions

Villanova

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 Picolli, Neoteric Consulting

Lehigh

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

12:00 pm - 1:15 pm

Sponsored Lunch & Roundtables

TBD
Naidong Weng, Janssen Research & Development

1:30 pm - 3:00 pm
Princeton I/II

Symposium Session & Roundtables

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

Michelle Robinson, Merck
Timothy Sikorski, GlaxoSmithKline
Kristen Randall, Sanofi

1:30 pm - 3:00 pm
Villanova

Symposium Session & Roundtables

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

3:00 pm

Adjourn