about   CII home   shop   checkout
 
March 7, 2019
11 am to 12 pm ET
 
Clinical Flow Cytometry: Validation and Implementation in a Regulatory Setting  

Preview:

 

Webinar Description:

In this presentation, we will provide an overview of flow cytometry and describe its potential uses in the clinical setting. A case study will be presented to detail the unique aspects of conducting clinical flow cytometry in a regulated setting. The following phases of developing and validating a robust and reliable flow cytometry assay will be illustrated in the case study:

  1. The first critical step to any flow cytometry assay - panel design
  2. Descriptions of validation test scripts that should be conducted along with suitable acceptance criteria
  3. Proper instrument set-up and appropriate controls
  4. Gating strategy and identification of cell subsets
  5. Correct interpretation of flow cytometry data

Lastly, what to look for when choosing an outsourcing partner for flow cytometry will be discussed. These include some of the key decision points and factors to consider such as expertise, regulatory requirements, logistics, timelines, and price.

Learning Objectives:

  • Understanding flow cytometry in a clinical setting
  • Panel design strategies
  • Validation test scripts, acceptance criteria and interpretation of flow cytometry assays
  • Outsourcing Criteria and Options

Speaker:

Chelsea Riveley image

Chelsea Riveley, BA Biology, MBA
Director of Business Development
Flow Cytometry Services, Champions Oncology

Chelsea has over 13 years of experience in polychromatic flow cytometry and cell-based assays, as well as 7 years of experience selling both preclinical and clinical flow cytometry. Chelsea worked for 6 years at a large CRO as a bench scientist and project manager in the flow cytometry and cell culture department. During her time there, she developed and validated flow cytometry assays in a GxP setting and established harmonization processes across multiple sites. In 2011, Chelsea joined a start-up company focused on selling flow cytometry services. There, she developed and implemented a GxP compliance program, assisted in establishing a redundant site in Italy, and was responsible for managing client relations. In 2017, Chelsea joined a large CRO to develop and lead a newly formed commercial endeavor, global inside sales. In 2018, she joined Champions Oncology to lead the company’s clinical flow cytometry sales. Chelsea received her Bachelors in Biological Sciences from Rutgers University in New Brunswick, NJ and then earned her MBA at University of Scranton, in Scranton, PA.

Greg Bannish image

Greg Bannish, PhD
Head of Flow Cytometry
Champions Oncology

Greg Bannish received his Ph.D. in immunology studying MHC class II transcriptional regulation in patients with Bare Lymphocyte Syndrome at Weill Cornell university graduate school. He performed postdoctoral studies at UPENN studying B cell receptor signaling, developing a signaling protein used in adoptive transfer experiments to rescue B cell development in immunodeficient mice. He then worked at Centocor (present day Janssen) on antibody therapeutics to immunological targets, worked to increase antibody specific productivity, and candidate selection of optimal antibody drugs. He then went to Envigo for 11 years, first developing a flow cytometry, cell culture, and immunology laboratory operating under GLP regulations, developing novel immunological methods and validated flow cytometry assays predominantly in monkey, but also human, rodent, dog, and minipig. He later became Vice President, Biopharmaceutical research for 6 years, responsible for US biological drug efforts, writing proposals and leading a team of program managers, and serving as a member of the management team. Recently, Greg joined Champions Oncology as Head of Flow Cytometry, and is developing a regulatory flow cytometry capability to support clinical trial flow cytometry and expanding existing high-throughput preclinical flow cytometry with a focus on immune cell subset analysis to support immune oncology drug development in humanized tumor-challenged mice.