Patient engagement in pharmaceutical development
DRA symposium
Pharmaceutical companies are tasked with developing life-changing products that meet the needs of patients while adhering to regulatory standards, managing health technology and payer scrutiny. Developing a drug treatment that can truly help to improve the lives of patients should be rooted in a deep understanding of the challenges, patients face in their daily lives, their needs, and the trade-offs they are willing to make to gain relief.
The traditionally established drug-centered paradigm within drug development has been criticized because important patient-focused aspects related to the real-world use of drugs are unaddressed. This has led to the emergence of a research gap between the pre-approval development of drugs and their post-approval use in real-world conditions. This gap could potentially be bridged by transitioning towards a patient-focused framework that places strong emphasis on treatment optimization, which strives to optimize the way health treatments are applied in clinical practice.
Hence, during the past decade, attitudes towards patient engagement in drug development have changed significantly. Until recently, regulators, industry, and academic researchers think of patients mostly as clinical trial participants with their contribution limited to data provision. However, it may be time for a shift to a more patient-centered paradigm. The role of patients is being reconsidered. It is now becoming evident that patients' contributions based on knowledge of living a life with their disease and treatment is of great importance to drug developers.
It is our impression that the overall landscape of patient engagement during the recent decade is less studied. At this symposium we want to shed light on what is actually being done and what are the challenges.
Programme
| 14:00 | Welcome Cluster leader, Associate Professor Charlotte Vermehren |
| 14:05 | Patient engagement in a regulatory perspective CMO at EMA, Adjunct Professor Steffen Thirstrup |
| 14:45 | Efficacy is science, Effectiveness is reality: How to make science a reality! CEO Leibniz JointLab First in Translation, Professor Sven Stegemann |
| 15:25 | Break |
| 15:50 | Developing products for- and with the users Director at LEO, Karsten Petterson |
| 16:10 | Patient engagement in drug development Professor Anna Birna Almarsdóttir |
| 16:25 |
Patient’s perspective |
| 16:40 | Patient Engagement in medicines R&D Merete Schmiegelow, Patient Advocate |
| 16:55-17:00 | Rounding off the day Cluster leader, Associate Professor Charlotte Vermehren |
The symposium is organized on behalf of the graduate programme in pharmaceutical sciences, Drug Research Academy, by Associate Professor Charlotte Vermehren, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen.
The symposium is free of charge and open for attendance by all interested parties. It is not necessary to pre-register.