Author:

Abstract:

Cancer is a disease that still affects many people's lives, despite the significant progress that scientists have made in understanding the disease mechanisms. Drug repurposing, which is finding new uses for existing medicines, holds the promise of providing safe, affordable and effective new treatments for cancer patients. For the purpose of this PhD project, we primarily focused on the repurposing of authorised medicines that are out of basic patent and regulatory protection (also referred to as "off-patent drug repurposing") as this specific category may offer opportunities in oncology but is also faced with a distinct set of scientific, regulatory, legal and financial challenges. Addressing these challenges is essential to enable efficient research in this field and to bridge the current gap between clinical research and practice.The overall aim of this PhD project is to investigate the challenges that hinder the clinical research and implementation of drug repurposing and to explore possible solutions for unlocking the full potential of this strategy. This aim was translated in the following three objectives: 1) To investigate data sharing initiatives, partnerships and new funding mechanisms that could facilitate the research and development of repurposed medicines; 2) To portray the regulatory framework relevant for making repurposed medicines available to patients in Europe and to explore solutions that have been proposed to overcome regulatory and financial barriers for clinical adoption of repurposed medicines; 3) To propose policy recommendations for addressing the current challenges in the clinical research and implementation of drug repurposing, while considering different stakeholder perspectives (i.e., academia and non-profit sector, industry, regulators, health technology assessment (HTA) bodies and payers, healthcare professionals and patients).