Photography at the Politecnico di Milano

AI is already at the heart of the pharmaceutical industry, but budgets and expertise are needed

Artificial intelligence is a “priority” for 78 per cent of companies when it comes to improving the recruitment of healthcare professionals and for 48 per cent in supporting research, but limitations remain

Un medico in un concetto medico futuristico (Adobe Stock)

5' min read

Translated by AI
Versione italiana

5' min read

Translated by AI
Versione italiana

Almost 8 out of 10 pharmaceutical companies now regard artificial intelligence as a strategic priority for improving engagement with healthcare professionals, whilst in around half of them, AI is fully integrated into new drug discovery processes and clinical trials. And when it comes to generative AI, there is a rise in both the use of commercial platforms – such as ChatGPT, Copilot and Gemini – with corporate accounts, and in solutions developed specifically for individual companies, which have increased from 36 per cent to 76 per cent.

A bespoke budget is needed

The latest research from the Life Science Innovation Observatory at the Politecnico di Milano, which will be presented on 16 September in Milan during the conference ‘AI and Digital Technology in Life Sciences: Creating Value Beyond Experimentation’. However, the progress highlighted by the survey has yet to be consolidated, given a number of critical issues. First and foremost, the existence of a specific centralised budget is still limited to less than a third of companies (27 per cent), whilst in 50 per cent of cases no dedicated budget is allocated. This is a weakness: “Whilst it is true that digital technologies – and AI in particular – are increasingly integrated and regulated within the life sciences ecosystem, we must ensure that resources are allocated within a specific budget and not ‘buried’ amongst the various expenses available to a business function,” comments the Observatory’s director, Chiara Sgarbossa.

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Tailor-made training

Another area requiring attention is skills: whilst 83 per cent of companies have trained their staff on the opportunities offered by AI and the use of Generative AI, in most cases this ‘training’ only covers certain roles and is not particularly tailored. Furthermore, collaboration between pharmaceutical companies and the public sector in the development of digital solutions remains limited (24 per cent). These factors – with their mixed picture – have been incorporated by the Observatory into a ‘maturity’ matrix, developed in collaboration with the companies themselves and Farmindustria, which breaks down the relationship between the pharmaceutical industry and digital innovation into five areas: strategy, culture and skills; digital and AI governance; digital technology for clinical trials; digital innovation in the relationship between the pharmaceutical industry and doctors; and ‘beyond the pill’ services, ranging from Real World Evidence databases to new digital therapies.

A leap forward for ‘dedicated’ AI

As mentioned, AI is now an investment priority for pharmaceutical companies: 78 per cent consider it strategic for strengthening engagement with healthcare professionals, and 48 per cent for supporting the discovery of new drugs, as well as (56 per cent) the collection of real-world data. The ‘importance’ of other areas is more limited: summary data (37 per cent), ‘in silico’ trials (30 per cent), digital therapies (26 per cent) and health apps and sensors (11 per cent). Barriers to innovation include the reported difficulty in quantifying the benefits of investment (52 per cent), a lack of suitable skills (52 per cent) and complex regulations (48 per cent). However, the responsible use of AI is on the rise: almost half of companies (48 per cent) have introduced global policies for the ethical use of artificial intelligence, and a further 40 per cent have adapted these policies for global use. The surge to 76 per cent in the adoption of dedicated AI solutions is seen as one of the key indicators of maturity, particularly in terms of security and data management.

Research: AI ‘in progress’

As for digitalisation in clinical trials, 64 per cent of companies are still at ‘level 2’ (out of a total of four) of digital maturity, whilst the generation of synthetic data and the creation of synthetic control arms – adopted by 20 per cent of companies – remain at the cutting edge. However, the figure of 70% for the use of AI in the search for and analysis of scientific literature remains unchanged, whilst around half of the companies using AI design their trials.

Finally, the relationship with doctors, which is underpinned by digital innovation: 67 per cent of specialists are calling for less frequent but more targeted communications, and one in two doctors reports an overload of content, confirming that the company’s approach is still not sufficiently personalised.

Apps and digital therapies must be free and carry the “seal of approval”

From diabetes monitoring to mental health, apps – and even more so digital therapeutics (DTx) – represent the frontiers where digital technology and AI are being applied to the doctor-patient relationship. Whilst apps are already a reality in Italia, the future of DTx hinges on the fate of the consolidated bill unanimously approved by the Chamber of Deputies at the end of May and now awaiting consideration by the Senate.
Meanwhile, regarding apps: 55 per cent of patients use them to monitor physical activity, 36 per cent for clinical parameters, 26 per cent for nutrition and 20 per cent for treatment adherence. However – as the Politecnico Observatory warns – a safety issue remains, as as many as 52 per cent of users do not check whether the apps are certified as medical devices. This is why the role of doctors and pharmacists is crucial: whilst 36 per cent of specialists have already recommended at least one app – and 44 per cent have used data sent by patients – pharmacists have so far been consulted in only 13 per cent of cases, even though 28 per cent believe their role in providing guidance on the correct use of these tools will grow.
As for DTx, these are software solutions, certified as medical devices and subject to clinical validation, designed to alleviate or treat a disease, a health condition, an injury or a disability. They can be used on their own or in combination with traditional medicines and medical devices to improve clinical outcomes and patients’ quality of life by acting not on a person’s biology but on their thoughts and behaviours.
Globally, the market has taken off – with an estimated value of 70 billion dollars by 2034 – and, in fact, as of the end of May, there were 121 certified and clinically validated digital therapies in use worldwide, 40 per cent of which were in the field of mental health. According to the Politecnico, 43 per cent are used alongside pharmacological therapies, whilst 17 per cent incorporate technology and AI to support clinical decision-making and personalise treatments.
In Italia, legislation is expected to see these therapies included in the Essential Levels of Care (LEA) and thus made eligible for reimbursement: a development eagerly awaited by patients, with 75 per cent in favour of them being provided free of charge. However, it is precisely the current absence of legislation in Italia that contributes to a still limited understanding of these technologies, even amongst doctors: only 33 per cent of specialists can distinguish a DTx from a traditional health app, although 46 per cent would be willing to prescribe them. Sixty-three per cent of patients would use them if prescribed: a level of trust which, according to the Politecnico survey, is based on evidence of clinical efficacy (64 per cent), on the guarantee of personal data protection (63 per cent), support from healthcare professionals in understanding the benefits (62 per cent) and validation and approval by the authorities (60 per cent). For Chiara Sgarbossa, director of the Life Science Innovation Observatory, meanwhile, the draft bill approved by the Chamber of Deputies marks an important step: ‘It classifies DTx as medical devices, provides for their evaluation through Health Technology Assessment and – she emphasises – paves the way for their inclusion in the Essential Levels of Care (LEA), making them prescribable at the expense of the National Health Service. It will therefore be essential to establish appropriate reimbursement mechanisms to promote the accessibility and adoption of these therapies in Italia as well, offering patients new treatment options capable of improving their health’, concludes the expert.

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