Journal Article

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

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

2021

Overview

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 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 therapeutic outcome; a need for a clear regulatory path addressing ASI modalities; and the limited acceptance to develop therapies intervening 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 and treat T1D.

• Publisher: Frontiers Media SA,Frontiers Media S.A
• Subject: Animals / Antigens / Antigens - immunology / Asymptomatic / Autoimmune diseases / Autoimmunity / Biomarkers / Biomarkers - metabolism / Clinical trials / Diabetes / Diabetes mellitus (insulin dependent) / Diabetes Mellitus, Type 1 - immunology / Diabetes Mellitus, Type 1 - metabolism / Diabetes Mellitus, Type 1 - therapy / Disease prevention / Drug development / Homeostasis / Humans / Immunology / Immunotherapy / Immunotherapy - adverse effects / Insulin / Medical research / Peptides / precision medicine / Regulatory approval / Success / T1D / tolerance / Translational Research, Biomedical