Goals of the training
The problems of patients in dealing with their medications and the increase in medication-related problems are becoming increasingly apparent in pharmaceutical-clinical practice. This is due to the sharp increase in very old and multimorbid patients and the associated polypharmacy and complexity of the therapy to be carried out. In recent years, therefore, the consideration of the capabilities and needs of patients has increasingly become the focus of drug product development. Through regulatory reflection papers and guidelines, as well as research regarding patient-centered medicines, patients are now increasingly involved in all aspects of drug development and approval. Patients are taking on the role of data providers or advisors, thereby helping scientists develop a new product in a way that meets expectations for patient acceptance and usability of the drug product, and thus clinical endpoints and therapeutic benefit. Using case studies of patients as well as products, it will be shown why and how early patient involvement and patient-centered development makes a critical contribution to the therapeutic value of a drug.
The contents are available 12 months after your booking.
Target group
The course is designed for all scientists involved in the research, development and manufacture of therapeutic proteins and vaccines, working in Pharmaceutical and Biopharmaceutical Industry or at suppliers of analytical equipment or at service companies contributing, e.g. to analytical characterization of therapeutic protein drug products.
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Author
Sven Stegemann
Sven Stegemann is the Chief Executive Officer of the Leibniz JointLab “first in Translation” (fiT) in Aachen (Germany) and professor of patient centric drug design and manufacturing at the Graz University of Technology (Austria). He is pharmacist by education and worked for 30-years in the pharmaceutical industry, as an advisor to major pharmaceutical companies on ways to improve the formulation design, development and manufacture of pharmaceutical products including advanced drug delivery and manufacturing technologies and controls. Since 2022 he is the CEO of the Leibniz JointLab fiT a newly build clinical manufacturing facility embedded in the RWTH & University Hospital Aachen campus translating academic research into clinical evidence. In his academic role, he focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Beside many other initiatives he started the industrial-academic collaboration partnership Patient Centric Medicine (PaCeMe) to develop guidance for patient centric drug product design.