Back

Biography

Sven Stegemann is a pharmacist by training and holds a PhD in pharmacology. He started his career at Sanofi-Aventis working in different roles of the pharmaceutical product development and manufacturing cycle. Before joining Capsugel, he worked for AstaMedica where he was responsible for product licensing. Since 1997, he is Director for Pharmaceutical Business Development at Capsugel. Within this role he is leading common research projects with all major pharmaceutical as well as SME companies on a global base.Within the pharmaceutical community he is serving different organizations as president, chairman or committee member. Beside his professional tasks he is substantially engaged in Education & Training in academy and through high level conferences across the world and special engagement within the European Commission to support strengthening the life sciences in Europe.His scientific interest is in improving drug therapy in older adults through multidisciplinary and patient centered research. Recently he founded the Geriatric Medicines Society e.V., which is supported by industry, academia and regulatory authorities. Another area of scientific interest is the delivery of affordable medicines through simplified product design and manufacturing.

Abstract

Since decades pharmaceutical drug products are developed in traditional dosage form like capsules and tablets as well as injectables, transdermal and inhalation systems. However, significant advances have been made through drug delivery technologies that make nearly each product a unique therapeutic system with product specific requirements for use and administration. As majority of people are lay persons and the drug products still look alike each other medication errors and inappropriate alteration have been identified as a growing area of concerns for drug safety and efficacy. Patient information leaflets trying to make the patients fit the product have achieved only limited improvement as the heath literacy is often insufficient in the general patient population. Patient centric drug product design aims to increase drug product safety and effectiveness through a solid understanding and integration of patient needs and capabilities to design the pharmaceutical products that they are intuitively used as intended like smart phones and other products from the consumer industry.Factors that need to be considered in the design of patient centric products are based on the targeted patient population. The major areas that are taken into account are the cognitive, sensory, motoric and swallowing capabilities of the patient, but also the prediction of the context in which these drug therapies will be applied e.g. disease clusters and predicted co-morbidities. Based on this, the design features are determined for a specific product to make it most suited for the targeted patient increasing safety and effectiveness to the benefit of the patient and society.