COURSE #1
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

COURSE #2
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

COURSE #3
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

COURSE #4
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

COURSE #5
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

Parallel Sessions

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

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

Parallel Sessions

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

Track 6: Colloquium Session
Biomarkers

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

Social Hour & Sponsored Workshops

WORKSHOP

Sponsored by Sound Analytics

WORKSHOP
Microsampling and Patient Centric Blood Sampling and Analysis: Practical Aspects of Implementation

Sponsored by Spooner Bioanalytical Solutions

WORKSHOP

Sponsored by Agilent Technologiess

Sponsor Hospitality & Evening Workshops

Microsampling Summit:
Connecting Workflows from The Patient to Outcomes

Hosted by New Objective and Spooner Bioanalytical Solutions

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

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

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

Social Hour & Sponsored Workshops

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

Sponsored by New Objective

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

WORKSHOP
Maven User Meeting

Sponsored by Elucidata

Workshop Leader: Abhishek Jha

Parallel Sessions

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

TRACK 7
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

TRACK 8
Steven A. Hofstadler Graduate Student Session
Inspiring Career Paths for Young Scientists

Sponsored by New Objective

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

Mentors:
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
Josh Mann, SOPHiA GENETICS
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

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.

Parallel Sessions

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

CLOSING REMARKS & ADJOURN

Alla Kloss, Sanofi
Mike Lee, Milestone Development Services