CPSA USA 2019

Clinical and Pharmaceutical Analysts United:
Human Wellbeing is Our Responsibility

Short Courses

Monday, October 28, 2019
Sheraton Bucks County Hotel
Langhorne, Pennsylvania

The CPSA Short Courses focus on specialized training. These workshop-style events provide a unique opportunity to learn about current industry practices, emerging applications, and innovative analytical technologies. CPSA Short Course Instructors create a truly dynamic learning environment as key fundamentals are reviewed and first-hand experiences and practical case studies are openly discussed.


Weixyn Wang
Weixun Wang

  
Harris Bell-Temin
Harris Bell-Temin

  
Nalini Sadagopan
Nalini Sadagopan

  
Gary Valaskovic
Gary Valaskovic

  
Nathan Yates
Nathan Yates
 

Short Course 1
Protein Identification, Quantification, and Biomarker Analysis

Mass spectrometry, as enabled by modern ionization methods such as MALDI and ESI, has dramatically transformed the science of protein identification and quantification. There is a rapidly growing demand for the quantitative analysis of proteins and peptides by LC-MS/MS in the bio-analytical and clinical laboratories. This short course will help attendees deeply appreciate specific challenges associated with successful outcomes in LC-MS based protein analysis. An in-depth view of the practical aspects involved in protein/peptide analysis by LC-MS/MS will be covered and will include case studies from the literature and from the instructor's personal experiences.

The use of nanospray enabled LC-MS has developed from a qualitative tool for (global) proteomics to a quantitative method suitable for activities such as peptide/protein biomarker validation. Key to success has been the combination of highly specific sample preparation methods, high sensitivity nanospray ionization, and high performance tandem mass spectrometry. Critical parameters involved in robust sample preparation, nanobore LC and nanospray, sensitive & selective MS detection along and their analytical benefits will be emphasized. The transition of the qualitative nLC-MS/MS technology to methods suitable for absolute quantification will be discussed. New tools for cloud based data sharing and the underlying principles for biomarker identification and validation by differential mass spectrometry will be presented. Real world examples will be presented. The course will also feature an additional hands-on "connections workshop" to hone your expertise is making high quality LC-MS fluid connections.

The target audience includes analysts that have been engaged in qualitative proteomics wishing to transition to quantitative methods, analysts that have specialized in small molecule quantification, and those involved in the development of methods for clinical outcomes.

Instructors:
Weixun Wang, Bristol-Myers Squibb
Harris Bell-Temin, Bristol-Myers Squibb
Nalini Sadagopan, Agilent Technologies
Gary Valaskovic, New Objective
Nathan Yates, University of Pittsburgh


Suzanne Cordovad
Suzanne Cordovado

  
Barry Jones
Barry Jones

Linlin Luo
Linlin Luo

Jim Shen
Jim Shen

 

 

Short Course 2
Bioanalysis of Mix Modalities via Hybrid and Orthogonal Approaches

Over the past 10 years, the development of mixed modalities such as therapeutic protein, millia molecule, ADCs, and DNAs have resulted in new bioanalytical and subsequent diagnostic challenges. A number of hybrid or orthogonal approaches have been developed to quantify the different types of biomolecules. This course will give an overview of the methods, practices, technologies and instrumentation used to perform LBA, protein LC-MS, and genomic analysis in a modern bioanalytical laboratory. The course will introduce students to the fundamentals of ligand binding assay, immunogenicity, genomic analysis and orthogonal approaches to improve sensitivity and selectivity of quantification of protein and DNA biomarkers. The courses begins with an introduction to ligand binding assay and the principles of developing a pharmacokinetic (PK) or immunogenicity (IMG) assay, including generation and selection of critical reagents, application of emerging technologies to meet clinical needs. The LC-MS based quantitation techniques such as “bottom-up” digestion, pellet digestion, Immunoaffinity Purification will be discussed next with examples covering their usages. The genomic analysis will focus on the impact of next-generation sequencing and its utility in detecting newborn disorders. This course will feature a dynamic format where the latest technologies will be presented and the advantages of hybrid approaches will be highlighted.

Instructors:
Suzanne Cordovado, CDC
Barry Jones, Q2 Solutions
Linlin Luo, Bristol-Myers Squibb
Jim Shen, Bristol-Myers Squibb


Neil Spooner
Neil Spooner

  
Joe Siple
Joe Siple

Kevin Bateman
Kevin Bateman

Tim Olah
Tim Olah

Enaksha Wickremsinhe
Enaksha Wickremsinhe

 

Short Course 3
Microsampling and Patient Centric Sampling:
A journey through what it is and how you can incorporate it into your workflows

There is growing interest in the collection and analysis of smaller volume matrix samples (≤100 µL compared to typical traditional volumes ≥200 µL) for the accurate quantitative determination of circulating drug, metabolite and biomarker concentrations in humans and animals. This has been brought about by the increasing sensitivity of analytical systems (particularly LC-MS) and the numerous advantages of implementing these workflows and their associated technologies. These advantages include the ability to collect clinical samples from previously intractable subjects and study locations, i.e. pediatric, critically ill, remote locations, near patient sampling (pharmacists, etc) and at home sampling. Further, microsampling facilitates the collection of samples via alternative approaches (viz. finger prick sampling) delivering patient convenience and enables cost savings through ambient temperature sample shipments. For animal studies, microsampling enables serial sampling from animals, the elimination of the requirement for additional toxicokinetic satellite animals and the sampling of juvenile animals, delivering higher quality data from fewer animals (particularly for rodent studies). Microsampling also facilitates refinement in sampling procedures. The reduced blood sample volume also enables blood samples to be taken for other purposes, e.g. biomarkers.

In addition to gaining an understanding of what the drivers for the implementation of microsampling are, attendees of this interactive short course will learn and discuss what techniques are available and will explore the pathways and challenges to the implementation of the approach for their discovery, regulatory toxicology, clinical and bioanalytical workflows. This will include addressing the practical, data quality and regulatory issues likely to be encountered and will understand the benefits and challenges of implementation not only for themselves, but also for other functions and workflows involved in the generation of high quality data for robust decision making and regulatory submission.

Attendance of this short course is encouraged for delegates from a wide variety of backgrounds, including (but not limited to) animal technicians, discovery scientists, regulated toxicologists, clinical trials experts, regulators and bioanalysts from pharma, biotechs and academia. Delegates will be encouraged to interact with colleagues and will be led by instructors with world leading expertise in the field.

Instructors:
Neil Spooner, Spooner Bioanalytical Solutions
Joe Siple, New Objective
Kevin Bateman, Merck
Tim Olah, Bristol-Myers Squibb
Enaksha Wickremsinhe, Eli Lilly & Co.