Competencies Consulting Services Drug Development
Developing drugs and finding effective treatments for patients with rare diseases present one of the most scientifically complicated challenges for the medical world. Millions of people suffer from a rare disease but only a few percentage of the known, over 6 000 such diseases have any approved treatment. For us at Accelsiors, this huge medical need is something that we fully embrace as a part of paving the way for future research.
We provide a comprehensive solution to properly handle your orphan drug development program from professional guidance on orphan designation application preparations to successful clinical study conduct at any stage of clinical research.
Please contact us and we will schedule a full hour complimentary drug development consultancy.Contact Our Experts!
However, the designation application procedure consists of a network of complex and interconnected pathways and processes Sponsors of designated orphan medicines authorized by EMA and/or FDA can benefit from numerous incentives both in the EU and the US both, such as
One of the primary objectives for the authorities is to support the development of new treatments for rare diseases and conditions with no available treatment. Both EMA and FDA are able to grant Orphan-Drug Designation (ODD) to a medicine or biological compound to prevent, diagnose or treat unmet diseases. When receiving ODD, you are eligible for protocol assistance at a reduced charge, market exclusivity after approval, fee reductions, tax credits for qualified clinical trials, and so on.
Here at Accelsiors, we can support you during the whole process of preparing and submitting your ODD application.
Accelsiors’ experienced orphan drug development team will help you find the shortest and most efficient way and advise you how to prepare and conduct successfully the application process. Our experts have significant experience in dealing with all the challenges of orphan designation applications.
Accelsiors is an expert in planning and conducting clinical trials in orphan medicines for a wide range of therapeutic areas and indications, such as Acromegaly, Cushing Syndrome, Genetic Diseases, Cystic Fibrosis and Growth Hormone Disorders, etc. both in pediatric and adult population. We have an excellent understanding of study endpoints, scientific and medical aspects, deep experience in assay validation and additionally, a close relationship with a network of Key Opinion Leaders in these fields to help reduce costs of your study.