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Evolution of Flow Cytometry Guidelines for Drug Development and Clinical Testing

WEBINAR DETAILS

Date: April 8, 2015 (60 minutes)

Featured Speakers:

Flow cytometry is the leading technology for cellular analysis because it allows for the simultaneous detection of numerous characteristics on individual cells.

As the biopharmaceutical industry focuses on cancer immunotherapy, autoimmunity and chronic viral diseases, the importance of flow cytometry in the drug development process is increasing. Its high-dimensional approach allows for more specific drug screening processes and the ability to more thoroughly characterize the effects of new drug entities.

While the technology is advancing at a rapid rate, users are hampered by the lack of official regulatory guidance documents regarding the validation of flow cytometric instruments and methods.

This webinar, presented by three Covance scientists in flow cytometry, will address the following topics:

  • Flow cytometry practice guidelines and timeline of events
  • Regulatory considerations
  • Recommendations for instrument validation
  • Recommendation for method development and validation
  • Assay development / optimization

In addition, the Covance panel will tackle the following questions:

  • Who’s setting the standards?
  • How is the practice guideline evolving, and why?
  • Which regulations would apply for my project?
  • What are practical steps drug developers can take during this period of flux?

Please join the presenters for an insightful discussion on this clinically relevant and rapidly evolving topic.

Keywords: Flow Cytometry, Validation Guidelines, Standardization

ABOUT OUR SPEAKERS

Virginia M. Litwin

Virginia M. Litwin, PhD, Principal Scientist in Hematology/Flow Cytometry, Covance

Virginia M. Litwin, PhD, is a Principal Scientist in Hematology/Flow Cytometry at Covance Central Laboratory Services in Indianapolis, Indiana. As the global flow cytometry lead for Covance, she directs flow cytometry method development, validation and deployment for all Covance labs worldwide. She also leads new initiatives and consults clients on translational medicine, biomarker selection and assay design. In 2014, Dr. Litwin was the recipient of the prestigious Covance Science and Technology Award. She earned her PhD in Microbiology from the University of Iowa and has more than 20 years of experience in the pharmaceutical and biotechnology industry. Dr. Litwin joined Covance in 2010.

Dr. Litwin founded the AAPS Flow Cytometry Action Program Committee and is an active contributor to the International Clinical Cytometry Society and the International Society for Analytical Cytology. She is the editor of the book, Flow Cytometry in Drug Discovery and Development (John Wiley & Sons), and the Special Issue of the Journal of Immunological Methods on Flow Cytometry Biomarkers and Translational Medicine. She has co-authored nearly two dozen peer-reviewed publications and is an editor for Clinical and Vaccine Immunology. She also is on the editorial board of Cytometry Part B, Clinical Cytometry.

Lisa Green

Lisa Green, MS, Manager of Flow Cytometry, Covance

Lisa Green, MS, manager of Flow Cytometry in Covance Translational Biomarkers Services (TBS) has nearly 30 years combined experience in clinical and pharmaceutical research laboratories. She has specialized in development of novel flow cytometry-based biomarkers to support drug development in. Lisa’s work has focused on assays of leukocyte cellular function, including immune response and activation and cell signaling cascades to provide valuable pharmacodynamic data in preclinical and clinical studies.

Linsen Du

Linsen Du, PhD, Lead Scientist, Flow Cytometry/Hematology, Covance

Linsen Du, PhD, Lead Scientist, Flow Cytometry/Hematology, Covance Central Laboratory Services Singapore. Dr. Du received her PhD in Biological Sciences from National University of Singapore and specialized in using flow cytometry technology for supporting biomedical research and clinical trials. She has extensive experience in cytometry platform management and assay development. She joined Covance in 2012 as a Scientist to work with pharmaceutical companies to design and implement custom flow assays in drug development.

THIS PROGRAM IS INTENDED FOR

  • Pharmaceutical R&D scientists
  • Translational and clinical scientists
OUR XTALKS PARTNER FOR THIS EVENT

Covance is one of the world's largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries.

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