Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

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Issue Date
2019-11-25
Author
Shakhnovich, Valentina
Meibohm, Bernd
Rosenberg, Amy
Kierzek, Andrzej M.
Hasenkamp, Rachel
Funk, Ryan S.
Thalhauser, Craig J.
van der Graaf, Piet H.
Wang, Yow-Ming C.
Hamuro, Lora
Publisher
Wiley Open Access
Type
Article
Article Version
Scholarly/refereed, publisher version
Rights
© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.
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Abstract
Managing immunogenicity in clinical practice and during drug development was a recent topic at the ASCPT 2019 annual meeting. This commentary expands on the discussion to facilitate a broader engagement across the community. The intent is to provide a rationale for ongoing research into the current gaps in assessing and interpreting immunogenicity in drug development and managing clinical immunogenicity for an approved drug. The following are highlighted: (i) Immunogenicity Considerations in Clinical Practice, (ii) Immunogenicity Testing and Current Limitations, (iii) Immunogenicity Risk Assessment and Mitigation, and (iv) Quantitative Systems Pharmacology (QSP) models of Immunogenicity.
URI
http://hdl.handle.net/1808/33440
DOI
https://doi.org/10.1111/cts.12717
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Citation
Shakhnovich, V., Meibohm, B., Rosenberg, A., Kierzek, A.M., Hasenkamp, R., Funk, R.S., Thalhauser, C.J., van der Graaf, P.H., Wang, Y.-M.C. and Hamuro, L. (2020), Immunogenicity in Clinical Practice and Drug Development: When is it Significant?. Clin Transl Sci, 13: 219-223. https://doi.org/10.1111/cts.12717

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© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.
Except where otherwise noted, this item's license is described as: © 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.