Two years of pandemic have given a decisive impetus to the transformation underway in the healthcare world and in the pharmaceutical industry by imposing “a radical and irreversible change”, as Giorgio Bruno, president of AFI, the pharmaceutical industry association defined it.

A change driven by a new consumer awareness and unstoppable scientific and technological progress. According to pharmaceutical industry leaders interviewed by Deloitte, crucial for the future of the sector will be technological advances (68% of the sample) and investments in Research and Development (58%).

At the height of the revolution

The emblem of innovation in the sector are undoubtedly biotechnologies which – as stated by Maria Luisa Nolli, CEO of NCNBio and moderator of the AFI 2022 symposium session dedicated to biotechs – have now reached “the apex of a revolution” that began thirty years ago with biological drugs – such as monoclonal antibodies and recombinant protein therapies – and continued until the development of advanced therapies that have completely transformed the research and production paradigm.

First of all, due to their revolutionary nature – cells rather than synthetic molecules – which requires the continuous presence of research throughout the development process, even after the marketing authorization, with post-marketing surveillance.

In fact, these are extremely complex drugs, until now dedicated only to rare diseases, therefore to niches of patients, if not even single individuals (as in the case of autologous therapies).

Maria Luisa Nolli explains:

Producing and developing a drug for rare diseases is completely different from making a drug for masses of the population.

All the more so when it comes to biological drugs: today dedicated plants are built, consisting of modular and disposable bioreactors suitable for growing cells in small quantities, very far from the vast plants for the production of large-scale crops necessary to make tons of drugs for large segments of the population.

The passage from the niche of rare diseases to the treatment of non-rare diseases will represent “one of the keys to the success of advanced therapies in the future”.

Real world evidence

The reduced number of patients, among other things, complicates the conduct of clinical studies, making it necessary to carry out a more intense phase of post-marketing data collection.

For this reason, evidence generation is also evolving, explains Lorenzo Cottini, country director of Evidenze Clinical Research Italy and moderator of the session of the AFI 2022 Symposium dedicated to clinical research:

At the moment we have an increasing number of tools available that allow us to collect a lot of data quickly and with a high level of quality. In fact, the data we obtain draw on a “real life” context, allowing us to develop drugs or devices that are closer to the patient’s needs.

In recent years, several promising tools have been developed that can support data collection, such as apps that convert smartphones into vital signs monitors, and so-called “wearables”, devices that can be worn by patients that automatically record data and send it on time real to software that can analyze them instantly.

In addition to facilitating the relationship with the patient, digital systems allow the creation of networks and data transfer systems between the different areas of a company and between the different organizations: producers, suppliers, research centers, public administrations, innovative start-ups, etc. .

The dark side of innovation

The Covid-19 period may have accelerated investment trends in digital pharma systems. More than 40% of pharma leaders believe that digital transformation will be strategic and priority over the next five years but the innovation process is far from immediate and has several critical aspects.

Excessive lightness in the governance of this transition can cost not only the failure of the entire process but also exposure to serious security risks to the point of compromising the company’s operations. The basic problem is that, by definition, a sector that deals with research and development requires the use of advanced technologies, which however tend to quickly become obsolete.

Explains Gian Paolo Baranzoni, member of the AFI Information Systems Study Group and moderator of the Symposium session dedicated to technological innovation:

The R&D sector has two intrinsic components. On the one hand a natural push towards innovation, on the other a trend of new solutions to premature aging.

The technological tools, in fact, are always designed on the basis of infrastructures of some time before and, given the speed of evolution of the components, they could now already be obsolescent. The critical point is represented by the technological infrastructure and not by the analytical systems, which instead could still constitute an updated and effective solution.

Over time, in fact, the number of devices for data collection will increase, increasing the general complexity of the system and weighing on an infrastructure that becomes more and more fragile. The most immediate risk is to generate errors during the data collection, compromising the integrity of the data and the functionality of the systems.

Also because often non-digital solutions are grafted into the existing structure, creating hybrid systems with a continuous cross-reference between electronic devices and paper documents: digital systems generate paper outputs which in turn feed software and so on. Each point of manual input, however, represents a potential node for generating errors and therefore a weakness of the system.

If the necessary technical skills are not introduced in the bodies dedicated to the governance of the risks of information systems, companies run the risk of generating a block of very important components, not to mention the possibility – far from remote – of a cyber- attack.

Furthermore, there are not only offensives against the front-end: attacks can also be launched – often with very significant results – against the industrial component, such as production machines or control systems.

If you do not have the right knowledge to fully understand all the implications and solutions are not identified in a coordinated way between all company departments, the risk of underestimating these dangers becomes very significant.