Behind the scenes of the IRAKLIA study: advancing multiple myeloma research

At Banook, our teams are deeply engaged in advancing clinical research through reliable imaging and data solutions. In this interview, Chloë Danioux (Project Manager) and Pierre Tervé (Chief Scientific Officer) take us behind the scenes of the IRAKLIA study, a global clinical trial led by Sanofi to evaluate a more convenient form of treatment for patients with relapsed multiple myeloma.

They discuss the project’s goals, its challenges, and what this experience means for Banook’s future in complex oncology trials.

Introducing the Experts

Could you both introduce yourselves and tell us about your background?

CD: I’m Chloë Danioux, Project Manager at Banook for the past three years. I have a strong background in science. I studied genetics and completed a Master’s degree in Paris before earning my PhD at the Institut Pasteur.

After a postdoctoral position, I wanted to move closer to applied medical research. That’s how I joined Banook in Nantes. This transition allowed me to combine my love for science with a more tangible contribution to healthcare innovation.

PT: I’m Pierre Tervé, Chief Scientific Officer and co-founder of Keosys, which joined Banook in 2024. My background is in engineering, specializing in signal processing and electronics.

Originally, we focused on data transmission and computation. But working closely with physicians and nuclear medicine department opened our eyes to how these technologies could benefit nuclear medicine. We soon shifted toward medical imaging and clinical trial support. Over time, I’ve led research and scientific teams, focusing today on both medical writing and scientific coordination across projects.

Understanding the IRAKLIA study

Could you explain what the IRAKLIA study is and its objectives?

PT: IRAKLIA is a Phase III clinical study led by Sanofi, designed to assess a new subcutaneous form of isatuximab, a drug already available intravenously for treating multiple myeloma. This new form allows patients to receive treatment through a wearable auto-injector, significantly improving comfort and reducing the need for lengthy intravenous administrations .

It’s both a pharmaceutical and technological innovation — the same molecule, but with a new administration method that’s easier to use for patients and healthcare teams. This is the first time such a combination of the formulation and device has been tested on the market for this type of therapy, marking a significant milestone for patients and healthcare providers alike. For Banook, the challenge was to ensure the study followed a rigorous methodology consistent with previous trials to guarantee comparable and reliable results. We also had to adapt to the needs of the study by recruiting new experts to handle the workload in a very short period of time.

CD: Exactly. This was a large-scale global study involving over 530 patients across 150+ sites worldwide. Sanofi’s goal was to prove that the subcutaneous administration of isatuximab was as effective as intravenous infusion, while offering significant benefits in terms of patient comfort and hospital logistics.

For hematologists, this new delivery mode could simplify their workflow and improve capacity. From Banook’s side, we managed both the imaging (MRI, PET-CT, low-dose CT) and clinical data — including laboratory results from blood and urine analyses to provide blinded and independent determination of disease response and progression.

It was a demanding study, not only because of its size and complexity, but also because it represented a crucial milestone for Sanofi, paving the way for future submission after positive primary results.

Major Challenges Along the Way

What were the main challenges your teams faced?

CD: The biggest challenge came at the end of 2024 during the primary analysis with global filing intent. We had to process more than 16,000 time points — both clinical and imaging — within  eight months. This workload would normally take far longer to complete. That required expanding our reading teams to include 16 hematologists and 6 radiologists, and thanks to precise coordination, the commitment of our teams and experts, and significant platform upgrades, we met the deadline without compromising quality or accuracy.

Maintaining motivation and consistency across all readers was key, and we were fortunate to work with our highly committed experts who were genuinely invested in the success of this study.

PT: On the scientific side, one challenge was methodological consistency, ensuring the new study design matched earlier pivotal trials. We also collaborated closely with Sanofi’s data management teams on the Patient Profile, a standardized visual summary of biomarker evolution.

Another complexity was data synchronization. Imaging and biological assessments don’t always happen at the same time in multiple myeloma trials. We had to adapt our workflows to integrate these asynchronous datasets without compromising quality or accuracy.

Collaboration and Solutions

How did Banook and Sanofi work together to address these challenges?

PT: For Sanofi, this study represented the final stage of a long development program. Their expectations in terms of data quality and timelines were extremely high. We adjusted some of our image quality criteria to maintain momentum and avoid delays while keeping strict validation standards.

A key factor of success was our network of expert readers. We built an international team of hematologists — including several co-authors of the IMWG criteria — and coordinated their efforts and schedule to ensure consistent, high-quality readings. We recruited them very quickly to adapt to the pace of the study and prove that we were trustworthy partners.

CD: We also strengthened communication and transparency with the sponsor. Weekly meetings with Sanofi’s project managers, quarterly steering committees, and daily internal follow-ups allowed us to stay aligned and agile.

Our technical teams enhanced the reading platform to manage large data batches, improve workflow monitoring, and ensure full compliance with data management standards. This collaborative spirit, there was no “Banook” or “Sanofi,” just one team, made a huge difference.

At the end of the study, our teams received great feedback— a strong validation of the quality and commitment demonstrated throughout the project.

Lessons Learned

What did this study teach you and the Banook team?

PT: IRAKLIA broadened our expertise beyond imaging. We’ve developed strong capabilities in clinical and biological data analysis, while deepening collaboration with leading hematologists worldwide. It also confirmed our ability to deliver under pressure on complex, late-phase oncology studies.

CD: From a project management perspective, it strengthened our multidisciplinary coordination across radiology, hematology, data science, and IT. It also highlighted how important human factors are: teamwork, trust, and engagement. Those elements made it possible to meet such ambitious goals.

Looking Ahead

What’s next for Banook after this experience?

CD:  We’d love to run similar studies again. We now have a robust network of specialized readers and a solid workflow for integrating clinical and imaging data. Many of the experts involved have also expressed their eagerness to collaborate with us on future projects — a strong sign of the trust and engagement built throughout this study. This collective momentum opens new doors for advanced analytics and for supporting upcoming hematology and oncology trials.

PT: We’re eager to continue in this direction. With our strong methodology and expert network, we’re ready to support new sponsors and explore innovative imaging techniques like PET-FDG or diffusion MRI.

Our goal remains the same: to put our scientific expertise at the service of better, faster, and more patient-centric clinical research.

Conclusion

The IRAKLIA study was much more than a technical challenge — it was a human and scientific journey that united teams from Banook, Sanofi, and across the medical community.

This collaboration strengthened Banook’s position as a trusted partner for complex, high-impact clinical trials — where precision, innovation, and patient focus make all the difference.

👉 Contact our team today to discover how we can support your next study.