DIA 2019 Global Annual Meeting

Pharmaceutical and biotechnology companies are piloting and adopting a variety of patient centric initiatives across their R&D functions – including development planning, protocol design, study conduct, benefit/risk assessment, regulatory submissions, medical writing and disclosure & transparency. Overall approach and level of adoption in functional areas varies widely within and between companies. DIA, Tufts CSDD, and 20 participating biopharmaceutical companies collaborated to develop a comprehensive process for assessing the adoption and integration of patient centric initiatives within participating company operating areas. Following development and validation of an assessment tool and process, an independent team led by DIA and the Tufts CSDD conducted assessments within participating companies. Data from recently completed assessments will be used to identify leadership areas, to recommend areas where patient centric practices can be strengthened; and to discuss areas where patient-focus in drug development can be expected to drive change in the future. Aggregate measures will be derived from the data and published as benchmarking data for the broader biopharmaceutical community. In this session, experiences and lessons learned with the collaborative development and use of the assessment tool will be discussed by members of the study team and collaborating companies.