Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies-Reference-Cited by-同舟云学术

Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies

Published:2022-07-22 Issue:3 Volume:66 Page:415-424
ISSN:0012-186X
Container-title:Diabetologia
language:en
Short-container-title:Diabetologia

Author:

Karpen Stephen R.^ORCID,Dunne Jessica L.,Frohnert Brigitte I.,Marinac Marjana,Richard Claudia,David Sarah E.,O’Doherty Inish M.,

Funder

Provention Bio

Leona M. and Harry B. Helmsley Charitable Trust

Janssen Research and Development

JDRF International

FDA

Novo Nordisk

Publisher

Springer Science and Business Media LLC

Subject

Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

https://link.springer.com/content/pdf/10.1007/s00125-022-05751-0.pdf

Reference36 articles.

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2. Insel RA, Dunne JL, Atkinson MA et al (2015) Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 38(10):1964–1974. https://doi.org/10.2337/dc15-1419

3. Herold KC, Bundy BN, Long SA et al (2019) An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med 381(7):603–613. https://doi.org/10.1056/NEJMoa1902226

4. Sims EK, Bundy BN, Stier K et al (2021) Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Sci Transl Med 13(583):eabc8980. https://doi.org/10.1126/scitranslmed.abc8980

5. Stephenson D, Sauer J-M (2014) The Predictive Safety Testing Consortium and the Coalition Against Major Diseases. Nat Rev Drug Discov 13(11):793–794. https://doi.org/10.1038/nrd4440

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