Open AccessImmunogenicity in Clinical Practice and Drug Development: When is it Significant?
Author(s) -
Shakhnovich Valentina,
Meibohm Bernd,
Rosenberg Amy,
Kierzek Andrzej M.,
Hasenkamp Rachel,
Funk Ryan S.,
Thalhauser Craig J.,
Graaf Piet H.,
Wang YowMing C.,
Hamuro Lora
Publication year - 2020
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12717
Subject(s) - immunogenicity , medicine , intensive care medicine , clinical trial , tolerability , immunology , pharmacology , immune system , adverse effect
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.