Immunological information: the new strategic infrastructure of personalised medicine

Major pharmaceutical companies are strengthening their commitment to immunology. In recent months, we have seen licensing agreements, research partnerships and multibillion-dollar acquisitions involving new antibodies, cell therapies, immunomodulators and platforms targeting inflammatory and autoimmune diseases.

The most immediate explanation lies in the expiry of patents and the need to renew product portfolios. Many companies must identify new sources of growth as some of their most profitable medicines lose market exclusivity.

However, reducing this movement to the so-called patent cliff would be to remain on the surface. The underlying reason is far more significant: immunology is changing the way we understand disease and, consequently, how we will develop diagnostics, treatments and models of care over the coming decades.

Behind these investments, however, lies a less visible but potentially more important issue: the need to understand more precisely what is happening within each patient’s immune system and how that information can be used to support better clinical decisions. Immunology is ceasing to be merely a therapeutic area and is becoming a genuine infrastructure of biological information on which much of personalised medicine will depend.

After decades in senior management, I have learnt that major transformations never depend on a single variable. A promising technology, a strong patent, an outstanding scientific team or an attractive market opportunity is not enough on its own. Value emerges when all these elements are brought together and converted into a real-world solution.

In healthcare, this integration is particularly demanding. Science, talent, clinical validation, regulation, intellectual property, funding, manufacturing and market access cannot operate in isolation. They must progress in a coordinated manner from the earliest stages.

Immunology is probably one of the clearest examples of how the generation and use of biological information can transform medical practice.

FROM THE ORGAN TO THE BIOLOGICAL MECHANISM

For decades, many diseases have been classified and treated according to the organ affected. A patient with Crohn’s disease would be referred to Gastroenterology; a patient with psoriasis to Dermatology; and someone with rheumatoid arthritis to Rheumatology.

Research is showing, however, that apparently different conditions can share immunological mechanisms. We also know that two patients with the same diagnosis may have different biological profiles and respond differently to the same treatment.

Medicine is therefore beginning to move away from treating broad diagnostic categories and towards understanding the mechanisms that predominate in each individual patient.

A recent article published in El Mundo explains how this transformation is beginning to reach some of Spain’s leading hospitals. Biomarkers, artificial intelligence, cell therapies and multidisciplinary units are enabling immune-mediated diseases to be addressed in a more integrated and cross-specialty manner.

The most significant aspect of this shift is that it requires new types of clinical information. Knowing the diagnosis or the organ affected is no longer enough. We need to understand which immunological mechanisms are dominant in each patient, which biological pathways are active and how they evolve over time.

The article is particularly relevant because it shows that this transformation is no longer confined to laboratories or to the investment strategies of pharmaceutical companies. It is beginning to reshape hospital organisation, the relationship between medical specialties and the connection between research and clinical practice.

The direction of travel appears clear: medicine will become increasingly less standardised and will depend more heavily on our ability to understand what is actually happening within each individual patient.

THE INDUSTRY IS NOT ONLY LOOKING FOR NEW MEDICINES

Transactions completed in recent years help us understand what the pharmaceutical industry is seeking in this field. AstraZeneca, Roche, AbbVie, Sanofi, Novartis, Biogen, Vertex and other companies have invested billions of dollars in advanced antibodies, cell therapies and new immunology platforms.

What matters is not only the financial scale of these transactions, but what they reveal about the direction of the sector. Major pharmaceutical companies are not simply acquiring molecules. They are acquiring options for the future: technology platforms, intellectual property, specialist talent and knowledge of immunological mechanisms with potential applications across multiple diseases.

These investments all have one element in common: the pursuit of increasingly precise biological knowledge. The more targeted treatments become, the greater the need to identify which patients are likely to benefit, when treatment should be administered and how the response should be measured.

Personalised medicine will not be able to scale through new treatments alone. It will require tools capable of identifying which patient needs which intervention, at what point and with what probability of response. In other words, it will require increasingly precise and actionable biological information.

Personalised medicine does not depend solely on having better therapies. It also depends on having better biological information systems.

Just as genomics became a knowledge platform for precision medicine, immunological information can become a decision-making platform for everyday clinical practice.

THE IMMUNE SYSTEM AS A SOURCE OF BIOLOGICAL INFORMATION

The paradigm shift involves moving beyond the view of the immune system solely as a defence mechanism that can fail or become dysregulated. It is increasingly understood as a platform that can be observed, modulated and, in some cases, reprogrammed.

CAR-T therapies are one of the most visible examples. They were originally developed to treat certain haematological cancers and are now also being studied in severe autoimmune diseases. But the movement is much broader and includes advanced antibodies, immunomodulators, cell therapies, RNA, gene editing and new diagnostic tools.

For years, much of biomedical development has focused on identifying molecules associated with a disease. The next step is to understand the functional state of the immune system. It is not simply a matter of knowing which biomarkers are present, but of understanding how different inflammatory pathways interact, which mechanisms predominate at any given time and how they evolve over the course of the disease.

This approach is particularly relevant in complex conditions such as sepsis, autoimmune diseases and certain chronic inflammatory processes, where similar clinical manifestations may correspond to completely different immunological states.

This does not mean that biology will replace chemistry, or that existing treatments have become obsolete. It means that we have a growing ability to intervene in more specific mechanisms and tailor decisions to the patient’s biological profile.

And the more targeted a treatment is, the greater the need to identify accurately who is likely to benefit from it.

THE REAL VALUE LIES IN ANTICIPATION

The immune system operates through networks and signalling cascades. What happens at the beginning of a response can determine subsequent processes involving inflammation, immunosuppression, tissue damage or recovery.

For years, we have mainly measured the downstream consequences of these processes. The major leap forward will be to move closer to the early signals — to the information generated upstream, before clinical deterioration becomes apparent.

The true value of immunology does not lie solely in intervening once disease is already visible. It lies in detecting early warning signals, identifying biological patterns before clinical deterioration occurs and dynamically monitoring the patient’s progress.

Biomarkers then cease to be simple diagnostic tools and become instruments for stratification, monitoring and clinical decision support.

This knowledge can help identify which patients will respond to a treatment, improve the selection of participants for clinical trials, establish whether a medicine is acting on its intended target, anticipate complications or modify an intervention before it is too late.

At Viva in Vitro Diagnostics, we are working precisely in this direction. Our work on biomarkers associated with the NLRP3 inflammasome reflects our conviction that the next generation of diagnostic tools must provide functional information about the patient’s immunological status. We believe that a functional understanding of the immune system will be one of the pillars of the next generation of personalised medicine.

At Viva in Vitro Diagnostics, we aim to make our own contribution to this transformation by working with leading research and clinical institutions, including Vall d’Hebron, Hospital Clínico Universitario de Valencia and Hospital Clínico Universitario Virgen de la Arrixaca. Through these collaborations, we are helping to advance a model in which immunological information becomes as important as the therapeutic intervention itself.

HEALTHCARE INNOVATION IS A TEAM DISCIPLINE

This reflection is particularly relevant for entrepreneurs and investors.

A healthcare start-up may have outstanding science and still fail to reach the market. It may address a clear clinical need but fail because it did not anticipate regulatory requirements. It may secure funding but lack the team required to execute its plan. It may even overcome every technical hurdle only to discover too late that its solution does not fit existing clinical pathways, hospital priorities or procurement mechanisms.

Biomedical innovation cannot be developed in silos.

It requires scientists who understand clinical application; clinicians involved from the development stage; regulatory specialists engaged from the earliest phases; business professionals capable of defining a viable model; market access experts who understand how the solution will be adopted; and investors who appreciate the real timelines of the sector. Family offices are playing an increasingly important role in this respect.

None of these disciplines can replace the others. The challenge is to ensure that they work towards the same direction, with shared priorities and a results-oriented culture.

In my experience, companies do not progress simply because they have a good strategy. They progress when that strategy is converted into decisions, clear ownership, deadlines and verifiable results.

A PUBLIC RESPONSIBILITY AS WELL

Public authorities must adopt the same long-term perspective.

Funding high-quality science is not enough. That science must be supported until it can become a validated, regulated and scalable technology that is adopted by the healthcare system.

This requires support for translational research, collaboration between hospitals and companies, responsible access to samples and data, innovation-oriented public procurement, manufacturing, intellectual property protection and access to specialist capital. The European Innovation Council, through programmes such as EIC Transition and the EIC Accelerator, provides a good example of this approach.

Europe, and Spain in particular, have scientific talent, leading hospitals and an increasingly robust biotechnology ecosystem. Nevertheless, there is still too great a gap between the generation of knowledge and its transformation into internationally competitive companies and solutions.

CONCLUSION

Immunology will take years, and possibly decades, to realise its full potential. We do not yet know all the applications that will emerge or which technologies will ultimately prevail.

We do know one thing: the countries, companies and institutions seeking to occupy a leading position must begin building the necessary capabilities today.

The true immunological revolution will not consist solely of developing new treatments. It will consist of understanding more clearly what is happening in each patient and transforming that knowledge into more precise clinical decisions.

The hospitals, companies and research centres that lead this transition will not necessarily be those with the greatest number of therapies, but those capable of generating, interpreting and applying immunological information effectively.

Immunology is becoming a strategic infrastructure for the medicine of the future. As with any critical infrastructure, its value will depend not only on the science underpinning it, but on our ability to translate that science into better decisions, better treatments and better outcomes for patients.