Patient engagement in pharmaceutical development: Where are we? – Report from a 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 therefore important that all stakeholders - including patients – coordinate how patients can be effectively involved in the different stages and processes of a drug development program.

To shed light on the landscape of patient engagement in drug product development a symposium was organized by the Drug Research Academy of the University of Copenhagen (Denmark) to bring together representatives of regulatory authorities, pharmaceutical industry, academia and patients to share their views and experience of patient engagement.

Steffen Thirstrup, Chief Medical Officer at the European Medicines Agency (EMA) and Adjunct Professor at the University of Copenhagen provided details on EMAs history, actual and future directions in patient engagement (Regulatory perspective). Sven Stegemann, CEO of the Leibniz JointLab First in Translation and Professor at the Graz University of Technology focused on patient involvement activities in patient centric drug product development (Research on patient engagement in pharmaceutical technology development). Karsten Petterson, Director Explorative Formulation & Technologies at LEO Pharma gave insights into the journey of patients with dermatological diseases and how the industry engages with patient in drug product development (Industrial perspective). Anna Birna Almarsdóttir, Professor of Social and Clinical Pharmacy at the University of Copenhagen looked at patient engagement from an academic perspective highlighting definitions of concepts relating to the topic (The perspective on patient engagement from social and clinical pharmacy research). Anne Bülow-Olsen, Member of the Medical Council’s Expert Council for migraine and Merete Schmiegelow a patient advocate and Honorary Industrial Ambassador in Regulatory Science at the University of Copenhagen shared their experiences with patient engagement as patient representatives as well as their experience and journey of being a patient in the healthcare system (Patient perspective).

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