Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.

ABSTRACT: Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously untreatable and high-burden diseases. Expectations are high and active company pipelines are observed, yet only 10 market authorizations were approved in Europe. Our aim was to identify challenges experienced in European ATMP clinical development by companies. A survey-based cohort study was conducted among commercial ATMP developers. Respondents shared challenges experienced during various development phases, as well as developer and product characteristics. Descriptions of challenges were grouped in domains (clinical, financial, human resource management, regulatory, scientific, technical, other) and further categorized using thematic content analysis. A descriptive analysis was performed. We invited 27

SUBMITTER: Ten Ham RMT 

PROVIDER: S-EPMC6234262 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature