Day2 Diabetes Track Session I eapmmilan2018
27th November – 08:30 – 09:45 – Session I
T1D prevention and personalization strategies in Europe
In the US, JDRF provided the FDA with information to help review and approve drugs and technologies for safe and swift delivery to people with Type 1 diabetes (T1D). Establishing these clear and reasonable pathways for scientific research and regulatory approval promotes continued innovation in:
Artificial pancreas systems: JDRF worked closely with the FDA to establish guidance for AP systems in 2012.
Prevention therapies: We play a leading role in a consortium seeking FDA qualification of certain T1D biomarkers, or measurable indicators of the disease. Qualification facilitates the agency’s regulatory decision-making and may accelerate research and development of promising prevention therapies to stop or slow the progression of T1D.
Beta cell replacement: JDRF educates FDA staff on beta cell encapsulation technologies—which wrap insulin-producing islet cells in a protective barrier before implanting them into the body. These therapies may give people with T1D freedom from insulin injections for up to two years.
Can these issues be addressed at the EU Level?
Senior Director, European Research JDRF
Causes of T1D and prevention
Assistant Professor in Endocrinology, Pediatric Clinical Research Center Romeo ed Enrica Invernizzi, University of Milan, Milan Italy
Public-Private Partnership: In Pursuit of Personalized Medicine
Director, Business Operations – Applied Systems Biology Core University of Michigan Health System
EU level prevention efforts – strategies from DG connect
Head of Unit eHealth, Wellbeing & Ageing – European Commission