AUTHOR=Thomas Ranjeny , Carballido José M. , Wesley Johnna D. , Ahmed Simi T. 

TITLE=Overcoming Obstacles in the Development of Antigen-Specific Immunotherapies for Type 1 Diabetes

JOURNAL=Frontiers in Immunology

VOLUME=Volume 12 - 2021

YEAR=2021

URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.730414

DOI=10.3389/fimmu.2021.730414

ISSN=1664-3224

ABSTRACT=Antigen-specific immunotherapy (ASI) holds great promise for type 1 diabetes (T1D). Preclinical success for this approach has been demonstrated in vivo, however, clinical translation is still pending. Reasons explaining the slow progress to approve ASI therapies are complex and span all stages of research and development, in both academic and industry environments. The basic four hurdles comprise a lack of translatability of pre-clinical research to human trials; an absence of robust prognostic and predictive biomarkers for disease outcome; a need for a clear regulatory path addressing this therapeutic modality; and the limited acceptance to intervene at the pre-symptomatic stages of disease. The core theme to address these challenges is collaboration—early, transparent, and engaged interactions between academic labs, pharmaceutical research and clinical development teams, advocacy groups, and regulatory agencies to drive a fundamental shift in how we think about and treat T1D.