Please join the AAPS Bioanalytical Community on November 1st @ noon EDT for an Open Scientific Discussion Forum on
Bioanalytical perspectives and considerations in the assessment of Pharmacokinetics, biotransformation's, and Immunogenicity of ADCs
Antibody-drug conjugates (ADCs) represent a promising class of targeted cancer therapies, combining the specificity of monoclonal antibodies with the potent cytotoxic effects of small-molecule drugs. These conjugates, typically consisting of a cytotoxic drug covalently bound to an antibody via a synthetic linker, offer the potential for targeted delivery to tumors while minimizing damage to normal tissues. This open scientific discussion forum will delve into the bioanalytical challenges posed by the dynamic and heterogeneous nature of ADCs, which are complex mixtures of multiple species. The increasing interest in ADCs is underscored by a robust pipeline of candidates in discovery, pre-clinical and clinical development. However, the molecular complexity of ADCs necessitates the development of novel bioanalytical methods to ensure accurate assessment of pharmacokinetics, biotransformation, and immunogenicity.
One presentation will highlight the bioanalytical strategy employed for the BLA filing of POLIVY®, including the need for new analytical techniques to address its molecular complexity and the importance of understanding ADC biotransformation's in vivo. We will explore multiple quantitative assays for pharmacokinetics and discuss an integrated immunogenicity strategy. Additionally, a second presentation will provide an overview of the ADC landscape and a summary of the unique challenges for different types of conjugation/linkers as well as the critical considerations from a bioanalytical perspective to support ADC programs from discovery through development.
Presenters :
Ang Liu (JnJ Innovative Medicine)
Ola Saad (Genentech)
Moderator: Sanjeev Bhardwaj (Moderna Therapeutics)
Have an idea for an upcoming session?
Please contact the OSD Committee Co-Chairs, @Sanjeev Bhardwaj & @Laurelle Calliste
We start at noon EST sharp. To avoid interruptions, please dial in before noon and mute yourself until the Q&A starts.
(Please remain on mute and submit your questions via the Chat feature of GoToMeeting)
Please join from your computer, Tablet, or smartphone.
https://meet.goto.com/BA-OSD
You can also dial in using your phone.
Access Code: 871-534-861
United States: +1 (571) 317-3122
Join from a video-conferencing room or system.
Meeting ID: 871-534-861
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Or dial directly: [email protected] or 67.217.95.2##871534861
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https://www.linkedin.com/events/osdon-bioanalyticalconsideratio7252405403848708097/
#bioanalysis #Bioanalytical #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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