Harmonization of qPCR - American Association of Pharmaceutical Scientists

Summary

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 many bioanalytical laboratories to implement 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 CROs that have implemented qPCR/ddPCR in a regulated environment. A critical aspect of the workshop will be open discussion – organizers plan to include as much discussion as presentation.

Learning Objectives

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

Programming Committee

Jim McNally, Ph.D., BioAgilytix Labs

Amanda Hays, Ph.D., PRA Health Sciences

Rafiq Islam, Ph.D., Smithers Avanza

Thank you to our workshop sponsors!

Registration

	All Sessions	Single Session
Member	$295	$150
NonMember	$395	$200
Student/Post Doc Member	$95	$50

All registrants will have access to the session slides and recordings post-event.

Group Registration

Bring four or more paid full conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g. speaker rate, complimentary sponsor passes, student rates, etc.). Please email [email protected] for your discount code. The deadline to redeem is June 11, 2021. If your group does not meet the minimum requirement, AAPS reserves the right to alter your registration fee.

Cancellation & Refund Policy

Cancellations must be submitted to AAPS in writing to [email protected] and will be honored as follows:

AAPS will issue a refund to any attendee who cancels at least two (2) business days in advance of the event:

If you cancel your registration on/before June 11, 2021 you will be refunded your registration fees minus an administrative fee of $50 for members/non-members or $25 for students.
In the case of a multi-day event, cancellation must be received no later than 2 business days before the first scheduled workshop date/start time.
Cancellations received less than 2 business days before the scheduled event date/start time will not be refunded.
In the rare event that AAPS must to cancel due to circumstances beyond our control, we will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another workshop or obtain a full refund.

No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the workshop. If a technical failure at your home or workplace prevents access to the live event, you are not eligible for a refund. If the technical problem is due to our error, we will issue a refund.

Press Passes

Media representatives with valid press credentials may request a complimentary press pass by completing this short online form. Questions? Contact AAPS Director of Publications and Communications Catherine Abbott.