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IQ Webinar: Perspectives on ADME of Therapeutic Proteins

IQ Webinar: Perspectives on ADME of Therapeutic Proteins

October 7, 2022

Webinar

Location: Virtual

Venue: GoToWebinar

Presented by IQ ADME of Therapeutic Proteins Working Group
Sponsored by Translational and ADME Sciences Leadership Group

Therapeutic proteins (TPs) have diverse structures and modalities and include antibody-based drugs, coagulation factors, recombinant cytokines, enzymes, growth factors, and hormones. TPs are subject to different ADME processes as a result of their distinct physicochemical characteristics. Limited regulatory guidance makes it challenging to determine the most relevant ADME data required for regulatory submissions. To address this challenge, the TP ADME working group, sponsored by the TALG within the Innovation and Quality (IQ) consortium and comprised of scientists from more than 20 IQ member companies, was formed with the objective to understand the current practices of ADME studies for TPs and regulatory strategies and interaction experiences across IQ member companies and to provide recommendations on best practices for conducting ADME studies for TPs. After more than 3 years of collaborative work, the ADME of TP working group published its work in three manuscripts in the June 2022 issue of Drug Metabolism and Disposition (https://dmd.aspetjournals.org/content/50/6). In this webinar, we will share cross-company survey results, case studies, decision trees, and methods and provide our perspectives and recommendations. A case-by-case and fit-for-purpose approach should be considered to examine ADME of TPs. Continued dialogue between regulatory agencies and the industry is important to ensure this approach is reviewed and evolved as needed.

Speakers

Moderator

This is a public webinar. IQ membership is not for registration.