PRA ‘toolkit’ pinpoints rare-disease clinical trial risks The free Patient-Centric Trial Development Toolkit is aimed toward helping sites and sponsors identify and minimize risks in rare-disease clinical studies.
PRA Health Sciences has launched its Patient-Centric Trial Development Toolkit, a resource designed to aid clinical trial teams in identifying risks that could stymie the effectiveness and efficiency of their research, and deal with those problems. Outsourcing-Pharma recently spoke with Scott Schleibner, senior vice president of the Center for Rare Diseases at PRA Health Sciences, about the toolkit, the unique challenges rare disease studies face, the importance of patient-centric trials, and more.
Affibody and Inmagene autoimmune partnership completes regulatory milestone Affibody and Inmagene Biopharmaceuticals report that the US FDA has cleared the interleukin-17 (IL-17) blocker, izokibep, to proceed to phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.
Uveitis is an orphan disease with significant unmet medical need. It is an inflammation of the uveal tract but can also include the inflammation of nearby tissues, such as the retina, the optic nerve, and the vitreous humor. It is one of the leading causes of blindness worldwide.
Sweden’s Affibody and Inmagene, which has wholly owned subsidiaries in San Diego, Shanghai, and Hangzhou, are jointly developing izokibep, a novel bispecific agent, targeting both subunits of IL-17A as well as albumin, to treat multiple autoimmune diseases.
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is not enough to all patients with this rare disease will find help in the system maybe some of the normal experts will know the disease but we have as are diseases in the range of twenty patients known worldwide to them so called an orphan disease so often disease is a disease when we don t even have the name for the disease but the red disease is a disease where we have a name and all those rare diseases have something in common next to that they re quite rare yeah indeed so calm. and problems into common topics are for us the diagnosis is always very late in this patients because no one knows the disease no one thinks about the disease and. years in the system the way to find diagnosis the second problem is not enough experts so if you mention different diseases you don t have to experts for all of a silent but every patient with the disease at least in the high developed health