The Morula Health team are looking forward to attending ESMO Congress 2026 in Madrid, Spain and connecting with researchers, clinicians, biotechnology companies and industry leaders working to advance cancer care.
For us, ESMO is more than an opportunity to hear about the latest scientific developments. It is a chance to understand the challenges facing oncology developers and to explore how clear, scientifically rigorous medical writing can help sponsors progress innovative therapies from early research through to regulatory submission.
A rapidly evolving oncology landscape
Oncology remains one of the most active and complex areas of drug development. New approaches, including targeted therapies, antibody–drug conjugates, radiopharmaceuticals, cell and gene therapies, immunotherapies, precision medicine and AI-enabled drug development are creating new opportunities for patients while also increasing the complexity of clinical and regulatory programs. The need for innovation is clear. According to the latest estimates from the International Agency for Research on Cancer and the American Cancer Society, approximately 20.6 million people were diagnosed with cancer worldwide in 2024, while 9.8 million people died from the disease. Around one in five people is expected to develop cancer during their lifetime [1].
These figures underline the importance of advancing new therapies efficiently, while ensuring that the evidence supporting them is communicated accurately and effectively. At the same time, oncology programs are becoming increasingly specialised, data-rich and biomarker-driven. Sponsors must often bring together complex nonclinical, clinical, translational and regulatory information across multiple development milestones.
Key themes emerging in oncology
Looking Back at ESMO 2025
Several themes emerging at ESMO 2025 continue to shape oncology drug development and clinical research in 2026.
🧬 Precision Oncology
Continued growth in biomarker-led development and increasingly personalised treatment strategies.
🎯 Targeted Therapeutic Platforms
Increased investment in radiopharmaceuticals, antibody-drug conjugates (ADCs) and other targeted approaches.
⚡ Accelerated Development Pathways
Greater use of expedited clinical development and regulatory pathways to address high unmet medical need.
🤖 Artificial Intelligence
Expanding application of AI across target discovery, patient identification, trial design and data analysis.
📊 Increasing Program Complexity
Growing demands on sponsors to manage complex clinical programs while communicating data effectively to multiple stakeholders.
The scale and international nature of oncology innovation were also clear at ESMO 2025. As Morula Health’s Philip Burridge reflected:
“What was truly staggering was the amount of clinical data coming out of China.”
China’s growing influence in oncology innovation is explored further in our blog, “From China to Global Markets: Preparing Biotech Assets for FDA and EMA”.
AI is also becoming increasingly relevant across the oncology drug-development lifecycle, from target identification and compound screening to clinical trial optimisation and personalized treatment strategies. It makes clear scientific communication even more important.
For oncology sponsors, innovative science must be translated into coherent documentation that can be understood and assessed by regulators, investigators, clinical experts, investors and other stakeholders.
Supporting oncology development programs
These challenges are ones we see first-hand in our work with oncology-focused biotechnology companies. In fact in 2025, 53% of Morula Health’s projects have involved oncology research, reflecting our growing experience supporting sponsors across a range of oncology indications, therapeutic platforms and development stages.
Morula Health has supported oncology programs at several critical development milestones. This has included partnering with a UK neuro-oncology biotech preparing its first IND submission. Our team provided specialist support for nonclinical CTD modules, helping to transform complex datasets into a clear, structured and submission-ready package.
We have also worked with a European biotech developing a novel radiopharmaceutical therapy, providing strategic regulatory writing support for a US FDA Breakthrough Therapy Designation application. This project required the careful integration of complex clinical and regulatory information into a compelling, scientifically robust narrative.
Our experience also includes supporting oncology companies with:
– IND and regulatory submission packages.
– Nonclinical and clinical CTD modules.
– Breakthrough Therapy Designation applications.
– Investigator’s Brochures and other investigator-facing documents.
– Clinical development and regulatory strategy documentation.
– The interpretation and communication of complex oncology data.
These projects highlight a common reality across oncology development: as programs become more specialized, sponsors may need access to experienced scientific and regulatory writing expertise that can scale with their development plans. Effective medical writing is not simply about presenting information. It is about structuring evidence, clarifying the scientific rationale and ensuring that the overall development story remains consistent across documents and milestones. This allows internal teams to remain focused on scientific, clinical and operational priorities while maintaining the quality and momentum of their regulatory programs.
Connecting at ESMO 2026
As we prepare to attend ESMO Congress 2026, we are looking forward to learning how oncology developers are navigating the opportunities and challenges shaping the field.
The conversations taking place at ESMO often reflect the same challenges we help clients address every day: translating promising science into clear, accurate and compliant documentation that supports confident decision-making and successful regulatory interactions.
If you are attending ESMO 2026 and would like to discuss an oncology development program, regulatory writing requirements or additional support for upcoming milestones, we would be delighted to connect.
Morula Health is committed to supporting oncology-focused biotechnology companies as they communicate their science, navigate development challenges and work to bring innovative therapies to patients more efficiently and confidently.
Industry Insights
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UK biotech transitioning from a freelance medical writer to a scalable partner, delivering FDA‑aligned immuno‑oncology CSRs and safety narratives to support US expansion. As program demands grew, they needed a partner who could scale alongside their increasing volume of deliverables.
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Morula Health supported a UK biotech with the delivery and management of a large oncology IND submission. Our regulatory medical writing expertise ensured consistency across complex documentation and supported a successful regulatory outcome.
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