Please join the AAPS Bioanalytical Community on Oct 16th@ noon EDT for an Open Scientific Discussion:
Sample Analysis Considerations for Regulated qPCR for Cell and Gene Therapies
This discussion will delve into the field of regulated bioanalysis highlighting bioanalytical strategies and considerations essential for clinical sample analysis used in qualified or validated fit-for-purpose PCR assays, specifically for evaluating the pharmacokinetics of cell and gene therapies. Case studies highlighting the unique workflows of qPCR readouts will be presented to stimulate discussion among industry experts on topics where consensus is lacking. Key areas of focus include the use of auto-thresholds, methods for testing PCR inhibition as well as data reporting. Attendees will engage in dialogue on standardization efforts, regulatory considerations, and share best practices through illustrative case studies. Additionally, recent advancements in bioanalytical techniques and quality control measures will be reviewed. The session will also address challenges in quantifying and detecting target nucleic acids within complex biological matrices, alongside exploring protocols for sample repeats or reporting failed samples. This collaborative platform aims to foster community-driven discussion on best practices, innovative approaches, and quality assurance measures to improve the reliability of clinical sample PCR bioanalysis.
Presenter(s)/Panel Members :
Niketa Jani (Novartis)
Jacqueline Murphy (J&J)
Kate Herr (J&J)
Amanda Hays (BioAgilytix)
Moderator: Sanjeev Bhardwaj (Moderna)
For more information, including calendar invites, and virtual meeting login info, please visit the EVENT PAGE .
Have an idea for an upcoming session?
Please contact the OSD Committee Co-Chairs, @Sanjeev Bhardwaj & @Laurelle Calliste
We start at noon EST sharp. Please dial in before noon to avoid interruptions and mute yourself until the Q&A starts.
You are encouraged to submit questions in the discussions section of the Bioanalytical Community Page prior to the event.
(Please remain muted and submit your questions via the Chat feature of MS Teams Meeting)
Please join from your computer, Tablet, or smartphone.
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Microsoft Teams
Join the meeting now
Meeting ID: 267 194 046 839 2
Passcode: Re6nw7ho
#bioanalysis #Bioanalytical # PCR # CellandGeneTherapy #OSD #OpenScientificDiscussions
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Sanjeev Bhardwaj
Moderna Therapeutics
Cambridge, MA.
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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