Please join this Open Scientific Discussion (OSD) hosted by the AAPS Biopharmaceutical Product Attributes and Biological Consequences (BPABC) Community on Monday, 20th May 2024, 12 PM – 1 PM US EDT on:
Incorporation of clinical observations into setting clinically relevant specifications for biologics
Speaker / Discussion Leader: Marisa Joubert, PhD (Amgen Inc.)
Abstract: Biological relevance tools are essential to gain knowledge about attribute impact which can be used to support clinically relevant specifications. A new data science method called the Clinical Impact of Attributes (CIA) approach will be shared that uses clinical trial information to justify clinically safe specifications. CIA analyzes clinical trial data to determine if any correlations exist between attribute levels exposed in patients and the development of adverse events. Several case studies of biologics that are commercial products will be shown.
We look forward to your participation in a lively discussion on this topic!
When: 20th May 2024, 12 PM – 1 PM US EDT
Where: Please join Teams meeting using link provided below from your computer, tablet or smartphone.
<https://teams.microsoft.com/l/meetup-join/19%3ameeting_OGRjZDYyMTgtMTA3Ni00YmVlLWFjNDAtODJjM2VkMjFiMGU4%40thread.v2/0?context=%7b%22Tid%22%3a%22d7811cde-ecef-496c-8f91-a1786241b99c%22%2c%22Oid%22%3a%22da6f9c8c-317b-4a76-90c1-87ab430ab9a3%22%7d>
Please feel free to share meeting information with your colleagues who may be interested in this discussion.
Thank you,
BPABC Leadership Team
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Michael Zaleski
PhD Candidate
University of Pennsylvania
Philadelphia PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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