The development of patient centric or clinically relevant specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and life-cycle of a biologic. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of clinical/marketing application, significant benefits can be gained for patients.
This presentation will cover the application of patient centric specifications for a range of critical quality attributes. It will highlight the challenges the industry is faced with by adopting and managing discordant product specifications, across both a clinical and commercial space, and the benefits from adopting patient centric specifications will be discussed. The hope is that wider adoption of these principles could form the cornerstone to achieving global regulatory harmonization, reducing the complexity of managing a product through its life-cycle, improving supply chain robustness and minimizing drug shortage and disruption of supply of medicines to patients.
This presentation builds on the principles discussed in the white paper prepared by ISPE patient centric specification working group: Bercu, J., Berlam, S.C., Berridge, J. et al. J Pharm Innov (2019) 14: 76.