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Harmonization of qPCR



qPCR has been increasingly used in many bioanalytical laboratories to support pharmacokinetic evaluation of nucleic acid-based therapies and to support quantitation of biomarkers. Bioanalytical laboratories ten years ago were primarily LC/MS/MS and Immunoassay-focused. Drug development has grown more challenging with higher complexity therapies.

The emergence of RNA biomarker assays and the evolution of cell and gene therapy has led to many bioanalytical laboratories implementing qPCR and/or ddPCR. While there are existing papers and recommendations available on how to approach the development and validation of qPCR/ddPCR assays, there has not been any consensus paper that is based on a dialogue amongst bioanalytical scientists. This workshop includes a series of presentations with case studies from CRO’s who have implemented qPCR/ddPCR in a regulated environment. A critical aspect of the workshop will be open discussion that comprises as much discussion as presentation. 

Learning Objectives

  1. Upon completion, participants will understand the various ways the PCT is being used in regulated environments to support clinical trials.
  2. Upon completion, participants will understand the key aspects of the development of qPCR/ddPCR assays to enable successful implementation validation.
  3. Upon completion, participants will understand the applications of PCR in measurement of nucleic acid biomarkers and the application of context of use principles in those assay validations.
  4. Upon completion, participants will understand the applications of PCR in gene therapy trials and how the various assays types are validated.

Tuesday, June 15
Part 1: Method Development
: 10:30 am - 12:00 pm ET

  • Extraction of DNA/RNA
  • Method Development Considerations

Wednesday, June 16
Part 2: Method Validation
: 10:30 am - 12:00 pm ET
  • Validation of PCR Methods
  • Considerations for ddPCR Method Development and Validation
   

You may purchase the entire workshop series or just an individual session(s). To purchase a single session, please click on the links below and add that item to your shopping cart. All registrants will have access to the session slides and recordings post-event.
 
Event Pricing





All Sessions Single Session
Member Event Registration $295 $150
Non-Member Event Registration $395 $200
Student Member Registration $95 $50