Month: August 2026

I’m a biomedical scientist by training, and during my studies I became particularly interested in neuroscience, psychiatry and neurology. That interest led me into pharmaceutical research, where I spent many years working in clinical development for large pharma companies.

Throughout my career I gradually moved from scientific research into clinical operations and programme management, leading the design and delivery of clinical development programmes across different therapeutic areas.

Today, I’m a Senior Consultant for Clinical Operations Management at 3D-PharmXchange, a consultancy specialising in drug development, regulatory affairs, translational medicine and clinical research. And within REPO4EU, I lead Work Package 8, which focuses on clinical trials and how they can be designed as efficiently and effectively as possible for drug repurposing.

To be honest, it wasn’t something I had worked on directly.

Of course I knew examples of medicines that had successfully been repurposed, but I hadn’t been involved in developing them myself. So joining REPO4EU introduced me to an entirely new area of research.

It’s been an interesting learning journey because drug repurposing presents many of the same scientific challenges as traditional drug development, but also brings its own unique opportunities.

Every medicine ultimately needs clinical evidence demonstrating that it is safe and effective for the patients it is intended to treat.

Traditionally, drug development progresses through Phase I studies that establish safety and dosage, Phase II studies that provide proof of concept, and Phase III trials that confirm efficacy and safety in larger patient populations.

With repurposed medicines, some of this existing evidence is already available because the drug has previously been approved. That can sometimes reduce the amount of clinical research required, but it doesn’t automatically mean that clinical trials can be skipped.

If you’re testing the medicine in a completely different disease, using a new dose or treating a different patient population, new clinical evidence may still be needed. Every development programme has to be carefully evaluated on its own merits.

Clinical trials remain one of the largest investments in drug development, which makes careful planning absolutely essential.

One of the biggest challenges is balancing investment with uncertainty.

Clinical trials are expensive, and before researchers begin a development programme they need confidence that the investment is worthwhile. This becomes particularly challenging for medicines that are already off-patent, because they can often be prescribed off-label without requiring a formal development programme.

That makes it even more important to reduce development costs while also lowering the risk of failure; one way to achieve this is through smarter clinical trial design.

Rather than recruiting very broad patient populations, REPO4EU promotes selecting patients based on the biological mechanisms underlying their disease. By focusing on biomarkers, genetic variants or specific disease subtypes, researchers can increase the likelihood of detecting meaningful treatment effects while reducing unnecessary costs and patient burden.

Ultimately, it’s about learning as much as possible from every patient included in a study.

The REO4EU Platform is designed as a free online resource that helps academic researchers and small companies navigate every stage of the drug repurposing journey.

Within the clinical trials section, our goal has been to translate complex regulatory and operational knowledge into practical guidance that is easy to understand and apply.

Through Work Package 8, which I lead, we have contributed by developing a wide range of resources, including clinical trial guidance, decision-support tools, templates and practical services. One example is the matchmaking database, which helps researchers identify clinical sites with experience running early-phase studies.

We also provide direct access to the latest regulatory guidance from organisations such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), helping researchers stay aligned with current requirements.

The Platform brings together a wide range of practical resources designed to support researchers throughout the clinical development process.

One of the key features is the clinical trial design tool, built as an interactive decision tree that guides users towards suitable trial strategies based on their specific project. Alongside this, researchers can access protocol templates, budgeting tools, checklists, responsibility matrices and guidance on obtaining scientific advice from regulators, all aimed at simplifying the planning and management of complex clinical studies.

The Platform also includes case studies showcasing real-world drug repurposing projects, allowing users to explore different trial designs, endpoints and development approaches, including REPO4EU’s own pilot clinical studies.

Personally, I am particularly proud of the Clinical Trial Handbook – or Compendium, as we also call it internally –, which is a comprehensive guide covering every stage of a clinical trial, from study design and protocol development to study start-up, execution and completion; it also explains the regulatory requirements that help ensure patient safety and data integrity.

All these resources inside the REPO4EU Platform provide both experienced and first-time investigators with practical support for designing and delivering efficient clinical trials.