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Challenges and Opportunities for Patient Centric Drug Product Design: Industry Perspectives
Matthew D Burke1, Melissa Keeney2, Rochelle Kleinberg3
1GlaxoSmithKline, 1250 South Collegeville Rd, Collegeville, PA, 19426, USA. matthew.d.burke@gsk.com.
Abstract:
For an industry dedicated to preventing and treating disease, the concept of patient centric drug product design is remarkably new, yet it is beginning to transform medicinal development. The paternalistic paradigm of delivering efficacious and safe medicinal products, with inconsistent emphasis on patient centric considerations, is no longer sufficient. Patient expectations have evolved, and treatment use must complement patients' daily lives. While designing medicines to facilitate patients' use is now expected, the patient diversity across sub-populations and markets as well as industrial factors such as physicochemical properties, supply chain and shelf life aspects may preclude the development of a single, universal patient centric solution that meets all the needs of those with a particular disease. The objective of this publication is to highlight the complexities of implementing patient centric drug product design through a hypothetical HIV case study using the existing development and business processes to raise awareness and to suggest opportunities for collaboration.
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