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Stakeholder collaboration key factor in orphan drug development

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A recent review of the literature related to orphan drug development incentives for pharmaceutical companies found regulatory factors in the USA, regulatory factors in the EU, clinical trials, and patient voice to be the main incentivizing factors.

Because there are several policies related to orphan drug research and development already in place in the United States in EU, the authors of the current review believe patient voice remains a key element in engagement orphan drug development.

One study argues patient organizations, such as European Organisation for Rare Diseases and National Organization for Rare Disorders, are crucial because they often keep patient registries and biobank specimen collections, “which could be vital in providing important data for drug developers that would be difficult to access otherwise.”

The study authors however state the patient advocates are usually included too late in the drug development process and that their involvement should happen alongside the clinical development process.

Reference
Abedi S, Chen J, Joshi S, et al. Incentives for Pharmaceutical Companies to Develop Treatments for Rare Diseases: A Review of the Literature. Int J Rare Dis.doi.org/10.23937/2643-4571/1710034

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