Monday, October 18

8:30 am – 4:30 pm

Short Courses – Bucks County Sheraton Hotel
(2nd Floor Boardroom Lobby Level)

Method Development for LC/MS: Traditional Approaches and Emerging Trends
Roger N. Hayes, Schering-Plough
Shane R. Needham, Alturas Analytics

High Throughput Drug Discovery Support: LC/MS Strategies for Method Development, Profiling and Workflow Solutions
Mark J. Hayward, Lundbeck Research USA
Ken Lewis, OpAns

Is Poor Bioavailability in Early drug Discovery a Problem and If So, How Can We Solve It?
Ayman El-Kattan, Pfizer

Analysis of Peptides and Proteins: Sample Preparation to Identification to Quantitation
Nalini Sadagopan, Agilent Technologies
Gary A. Valaskovic, New Objective
Chuck Witkowski, Protein Discovery

Fundamentals of Structural Characterization by NMR
Paul A. Keifer, Agilent Technologies

5:30 pm – 7:30 pm

Pre-Event Reception and Sponsors Dinner - Sheraton Bucks County Hotel (University I and II Ballroom)
Hosted by AB Sciex

The New AB Sciex
Andrew Boorn, Chief Operating Officer, AB Sciex

Emerging Technologies for Application to Surface and Dried Blood Spot Analysis
Thomas Covey, AB Sciex

Dried Blood and Matrix Spot Analysis: Another Tool for Bioanalytical Sample Analysis
Shane Needham, Alturas Analytics

Tuesday, October 19

7:30 am – 8:30 am

Registration and Continental Breakfast (University Ballroom Foyer)

8:30 am – 8:35 am

Welcome (University II Ballroom)
Mike S. Lee, Milestone Development Services

8:35 am – 9:00 am

Objectives, Format & Opening Remarks (University II Ballroom)
Petia Shipkova, Bristol-Myers Squibb

9:00 am – 9:45 am

Plenary Lecture (University II Ballroom)
Using Quantitative Mass Spectrometry to Enable Clinical Translation Through Analysis of Biochemical Markers
Bradley L. Ackermann, Eli Lilly and Company

9:45 am – 10:00 am

Break/Roundtables

10:00 am – 12:00 pm

Parallel Sessions

Parallel Session 1
Symposia Session
Biomarker/Toxicity Marker Discovery
Discussion Leader: Mike Reily,Bristol-Myers Squibb
University II Ballroom

10:00 am

Metabolomic Biomarker Discovery
Chris Beecher, University of Michigan Center for Translational Pathology

10:20 am

Endogenous Metabolites as Biomarkers of Toxicity: Discovery Through NMR-Based Biochemical Profiling
Nelly Aranibar, Bristol-Myers Squibb

10:40 am

3-Indoxyl Sulfate as a Potential Marker of Renal and CNS Toxicities During Acute Renal Failure in Mice
Joanna Pols, Merck Research Laboratories

11:00 am

Roundtable Discussion

Parallel Session 2
Colloquium Session
A Practical Guide to Regulated Bioanalysis
Discussion Leader: Roger Hayes, Merck Research Laboratories
Princeton I and II Ballroom

10:00 am

What Regulations?
Patrick Bennett, Thermo Fisher Scientific

10:20 am

When and How to Validate a Method
Min Meng, Tandem Labs

10:40 am

How to Implement a Validated Method
Ron Shoup, AIT Laboratories

10:55 am

Help, I’m Being Audited! – Conduct During a Regulatory Inspection
Tina Baxter, OpAns

11:10 am

How to Avoid 483’s
Chad Briscoe, PRA International

11:25 am

Incurred Sample Re-Analysis
Yuan Shek Chen, QPS

11:35 am

Anomalous Data– Investigations and Case Studies
Shane Needham, Alturas Analytics, Inc

12:00 pm – 1:15 pm

Complimentary Lunch/Roundtables – High-Resolution Technologies and Applications
(University II Ballroom)
Discussion Leader: Ken Imatani, Agilent Technologies

High Resolution Advancements in Hybrid QTOF Mass Spectrometry
Discussion Leader: George Stafford, Agilent Technologies

Emerging Applications for High Resolution Mass Spectrometry in Drug Discovery Discussion Leader: Tim Olah, Bristol-Myers Squibb

1:15 pm – 3:00 pm

Poster Session/Roundtables (University I Ballroom)

Session Chairs: James L. Stephenson, RTI International
Matthew E. Szapacs, GlaxoSmithKline
Tracie Williams, Centers for Disease Control & Prevention
Donglu Zhang, Bristol-Myers Squibb

2:00 pm – 3:00 pm

Workshop – Affinity Selection: A Means to Increase LC/MS Dimensionality Sponsored by Shimadzu (Princeton I – 2nd Floor Boardroom Lobby Level)

• Faith Hays, Shimadzu
• Kevin Meyer, Perfinity Biosciences
• Nick Herold, Perfinity Biosciences
• Fred Regnier, Perfinity Biosciences

• Guodong Chen, Bristol-Myers Squibb
• Ronald Hendrickson, Merck Research Laboratories
• Richard Ludwig, Bristol-Myers Squibb
• Chuck Witkowski, Protein Discovery

• Bradley L. Ackermann, Eli Lilly and Company
• Carmen Fernandez-Metzler, PharmaCadence
• Christopher Gibson, Merck Research Laboratories

Symposia Session (3:00 pm – 4:30 pm)
DMPK with Accurate Mass Measurements
Discussion Leader: Jonathan Josephs, Bristol-Myers Squibb
University II Ballroom

3:00 pm – 3:20 pm

High Resolution Mass Spectrometry is the Future of DMPK
Kevin Bateman, Merck Research Laboratories

3:20 pm – 3:40 pm

High Resolution TOF for Combined Qualitative and Quantitative Drug Metabolism Studies
Tom Covey and Yves LeBlanc, AB/Sciex

3:40 pm – 4:00 pm

Panel Discussion
Discussion Leader: Jonathan Josephs, Bristol-Myers Squibb

Symposia Session (4:30 pm – 6:00 pm)
Can Dried Blood Spots Revolutionize Our Industry? Case-studies and Practical Considerations
Discussion Leader: Christopher A. Evans, GlaxoSmithKline
University II Ballroom - Held in conjunction with the North Jersey ACS Chromatography and NMR Discussion Groups and Chromatography Forum of the Delaware Valley

4:30 pm – 4:50 pm

Substantial Increases in Detection Limits for DBS Analysis Using a Novel Instrument Platform

Jonathan Kehler, GlaxoSmithKline

4:50 pm – 5:10 pm

Extension of DBS Technology to Support Other, Non-Blood Matrices in Pharmaceutical Development
Shane Needham, Alturas Analytics

5:10 pm – 5:30 pm

Dried Blood Spot Sampling in a Clinical Phase I Environment: Pharmacokinetics, Phenotyping, Genotyping and Trace Essential Elemental Analysis
Jaap Wieling, Xendo Drug Development

5:30 pm – 6:00 pm

Roundtable Discussion

6:00 pm – 8:00 pm

Sponsor Hospitality – Evening Workshops
Held in conjunction with the North Jersey ACS Chromatography and NMR Discussion Groups and Groups and Chromatography Forum of the Delaware Valley

• Hospitality Seminar Sponsored by Eksigent Technologies (University II Ballroom)
• The Use of 1 mm ID Columns as a Practical and Economical Alternative to Existing UPLC-MS
  Richard C. King, PharmaCadence
• Dried Blood Spot Summit – Sponsored by Alliance Pharma, Inc. and McKinley Scientific (Princeton I & II)
• Workshop Leaders: Lucinda H. Cohen, Merck Research Laboratories, Christopher A. Evans, GlaxoSmithKline, and Henry Song, Alliance Pharma
• Opening Remarks
  Lucinda H. Cohen, Merck Research Laboratories
• Considerations Associated with Clinical Implementation of Dry Blood Spot Technology
  Yang Xu, Merck Research Laboratories
• LC/MS-Based Lipid Profiling using Dried Blood Spots
  Wensheng, Lang, Johnson & Johnson
• The Glories and Pitfalls of Dried Blood Spots (DBS) Sampling in the Quantitative LC-MS/MS Analysis of Small Molecules
  Tapan Majumdar, Novartis
• Working Towards Practical DBS Bioanalytical Applications in Drug Development
  Qin Ji, Bristol-Myers Squibb
• Application of Dried Blood Spot Technique Combined with ELISA in the Determination of Large Molecule Drug-Exenatide
  Henry Song, Alliance Pharma
• Current Components of DBS Validation Criteria for NCEs
  Chester Bowen, GlaxoSmithKline

Wednesday, October 20

7:30 am – 8:30 am

Registration and Continental Breakfast (University Ballroom Foyer)

Symposia Session (8:30 am – 10:30 am)
Biologics as Pharmaceutical Agents
Discussion Leaders: Yan-Hui Liu, Merck Research Laboratories
Ragu Ramanathan, Bristol-Myers Squibb University II Ballroom

8:30 am – 8:50 am

The Advances of Analytical Technology Challenge the Definitions of Biological Comparability
Kate Zhang, Genzyme

8:50 am – 9:10 am

Quantitation of Intact Proteins
Ronald Hendrickson, Merck Research Laboratories

9:10 am – 9:30 am

Protein Analytical Approaches for In-vivo/Ex-vivo Biologics
Ashok Dongre, Bristol-Myers Squibb

9:30 am – 10:30 am

Roundtable Discussion

10:30 am – 12:00 pm

Parallel Sessions

Parallel Session 1

Symposia Session
Imaging and Tissue Analysis
Discussion Leader: Dieter Drexler, Bristol-Myers Squibb
University II Ballroom

10:30 am

Imaging Mass Spectrometry: Progress and Prospects
Richard A. Yost, Timothy J. Garrett, University of Florida; Dieter Drexler, Bristol-Myers Squibb

10:50 am

Imaging Mass Spectrometry Influence in Pharmaceutical R&D from Therapeutic Research to Environmental Safety
Stacey R. Oppenheimer, Pfizer

11:10 am

Imaging Mass Spectrometry for in situ Analysis of Peptides and Oligonucleotides Therapeutics
Rita Casadonte, Vanderbilt University

11:30 am

Roundtable Discussion

Parallel Session 2
Colloquium Session
International Harmonization of Bioanalytical Guidance
Discussion Leader: Mark Arnold, Bristol-Myers Squibb Princeton I and II Ballroom

10:30 am

Status of Activities Towards Harmonization
Mark Arnold, Bristol-Myers Squibb

10:50 am

Open/Panel Discussion
Eric Woolf, Merck Research Laboratories

11:00 am

Open/Panel Discussion
Doug Fast, Covance

11:10 am

Open/Panel Discussion
Steve Lowes, Advion

11:20 am

Open/Panel Discussion
Surendra Bansal, Hoffmann-La Roche

11:30 am

Open/Panel Discussion
Mark Arnold, Bristol-Myers Squibb

12:00 pm – 2:15 pm

Exhibition Opens (University I Ballroom and Ballroom Foyer)

Lunch & Learn Sessions and Poster Session (Villanova Amphitheater – 2nd Floor Boardroom Lobby Level)

High Performance Nanospray: Protein and Peptide Quantitation – Sponsored by New Objective (Princeton I – 2nd Floor Boardroom Lobby Level)

• Christopher A. Evans, GlaxoSmithKline
• Nathan A. Yates, Merck Research Laboratories
• Gary Valaskovic, New Objective

• Mark Arnold, Bristol-Myers Squibb
• Steve Dueker, Vitalea Science
• John Vogei, Vitalea Science
• Xiaomin Wang, Celgene
• Graeme Young, GlaxoSmithKline

• Mark J. Hayward, Lundbeck Research USA
• Richard C. King, PharmaCadence
• Dragan Vuckovic, IONICS Mass Spectrometry Group

Symposia Session (2:15 pm – 3:30 pm)
Recent Trends in ADME
Discussion Leader: Dan Morgan, Bristol-Myers Squibb
University II Ballroom – Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and Delaware Valley Drug Metabolism

2:15 pm – 2:35 pm

Absolute Quantification of Human UGTs
Richard C. King, Pharmacadence

2:35 pm – 2:55 pm

Mass Spectrometry Tools for Discovery ADME Applications
Walter Korfmacher, Merck Research Laboratories

2:55 pm – 3:15 pm

Using Ion Mobility Mass Spectrometry for Small Molecule Applications
Michael Donegan, Bristol-Myers Squibb

3:15 pm – 3:45 pm

Roundtable Discussion

3:45 pm – 5:30 pm

Vendor Session (Princeton I and II – 2nd Floor Boardroom Lobby Level)
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group
Discussion Leaders: Mark J. Hayward, Lundbeck Research USA
Ragu Ramanathan, Bristol-Myers Squibb

5:30 pm – 6:30 pm

Exhibition & Social Hour (University I Ballroom and University Ballroom Foyer)
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group

6:30 pm – 7:30 pm

Dinner (University I Ballroom and University Ballroom Foyer)
Held in conjunction with the North Jersey ACS Mass Spectrometry Discussion Group and the Delaware Valley Drug Metabolism Discussion Group

7:30 pm – 7:45 pm

Announcements

CPSA – Distinguished Analytical Scientist Award Presentation

7:45 pm – 9:00 pm

Keynote Lectures (University II Ballroom)

Accuracy for the Masses: Resolution of the Quan/Qual Debate
Jonathan Josephs, Bristol-Myers Squibb

Resolution for the Masses: The Debate is Over – Now What?
Mark Sanders, Thermo Fisher Scientific

Thursday, October 21

8:00 am – 9:00 am

Registration and Continental Breakfast (2nd Floor Boardroom Lobby Level)

8:00 am – 4:30 pm

Short Courses – Bucks County Sheraton Hotel
(2nd Floor Boardroom Lobby Level)

• Understanding Autoradiography in Drug Discovery and Development
  Eric Solon, QPS, LLC
• HPLC Method Development for LC
  Jerry Wang, Agela Technologies

Symposia Session (9:00 am – 10:30 am)
Protein/Peptide Biomarkers
Discussion Leader: Susan Abbatiello, Broad Institute Princeton I & II – 2nd Floor Boardroom Lobby Level)

9:00 am – 9:20 am

Top Down Differential Mass Spectrometry (dMS) of Intact Apolipoproteins in Human HDL
Helene Cardasis, Merck Research Laboratories

8:20 am – 9:40 am

Increasing the Sensitivity and Throughput of MRM-based Protein Assays Coupling SISCAPA and Automation
Eric Kuhn, Broad Institute

9:40 am – 10:00 am

Mass Spectrometric Measurement of Biomarker Proteins in Plasma
N. Leigh Anderson, Plasma Proteome Institute

10:00 am – 10:30 am

Break/Roundtables

Symposia Session (10:30 am – 12:15 pm)
Bioinformatics
Discussion Leader: James Stephenson, RTI International Princeton I & II Ballroom

10:30 am – 12:15 pm

Bioinformatics (Princeton I & II – 2nd Floor Boardroom Lobby Level)
Discussion Leader: James Stephenson, RTI International

10:30 am – 10:50 am

"omics" Data Analysis Not as Easy as you Think
James Stephenson, RTI International

10:50 am – 11:10 am

Analyzing Multiple Data Streams: Challenges and Outcomes
Peter Schad, RTI International

11:10 am – 11:30 am

Artificial Intelligence for Real Results: Visualizing Multiple Data Streams in
n-Dimensional Space
Karen A. Stark, Digital Infuzion

11:30 am – 12:00 pm

Roundtable Discussion

12:00 pm – 2:00 pm

Lunch/Roundtables – Where Do We Go From Here? (Princeton I & II – 2nd Floor Boardroom Lobby Level)
Discussion Leaders: Kevin Bateman, Merck Research Laboratories
Richard C. King, Pharmacadence

2:00 pm – 2:15 pm

Wrap Up & Adjourn
Petia Shipkova, Bristol-Myers Squibb