Six in ten chronic patients are likely to use advanced therapies (like the now famous Car-T), if recommended by your doctor. On the other hand, three out of four would be interested in participating in one clinical trial using digital technologies such as i portable devices and the televisit
. Not only. One in two Italians indicate that they want to use wearable, implantable or recordable sensors for collecting data on clinical parameters to monitor a pathologyalways on the advice of the attending physician.
As for recordable sensors, the tendency is even higher reaching 62% in chronic patients or patients with severe problems. These are some of the research results of the Life Science Innovation Observatory of the School of Management of the Politecnico di Milano, presented at the conference “Life Science: riding the innovation wave” which involved various patient associations (Aisc, Alliance for Rare Diseases, Apmarr, Fand, Federasma, Onconauti and Ropi).
“These innovations could enable the collection of large amounts of patient data,” he says Alberto Redaelli, scientific director of the Life Science Innovation Observatory. “Patients are open to the opportunity to share the data collected by the sensors
, and other digital tools, for purposes such as diagnostics, clinical research, personalized medicine. About one in four say they are willing to share their data, not only with the structures that handle them, but also with other actors, such as companies that produce drugs or medical devices, “he adds. Perhaps because of this surprising tendency of our compatriots, there is also the hand of Covid, who has shown how it is possible to “practice digital medicine”. “However, to date the
i level use is still limited as such innovations are not yet widespreadespecially in Italy, and when they are present, they are hardly known by the patients themselves », he emphasizes Chiara Sgarbossadirector of the Life Science Innovation Observatory.
Strategies and Barriers
The sector of the life sciences (ie the pharmaceutical, biotech and medical device industries) is in full swing. Some innovations have already entered corporate strategies: 25% of pharmaceutical companies in Italy say they already have advanced therapies in their offer, while 46% have developed other innovative medicines.
Some innovations have yet to be identified
in our country, such as digital therapies, ie medical devices based on apps and/or video games prescribed by the doctor in combination with a drug or “autonomously”. They are now establishing themselves internationally, especially in the United States and Germany, while in Italy some barriers, even regulatory ones, do not yet allow full development, although 36% of companies in the sector consider them to be one of the priorities for the future. They stand out l
the non-reimbursement of these therapiesreported as relevant by 60% of the companies involved in the study – conducted in collaboration with Confindustria Medical Devices and Farmindustria -, and the lack of clarity of the necessary clinical validation process (61%). This last barrier is r
also recognized by 41% of medical specialistswho also struggle to see the differences between these solutions and other health apps (67%).
In order to realize this new innovation area in concrete terms, it will be essential to resolve the uncertainties related to the regulatory issue and to make the opportunities offered to industry players in the Italian context more uniform with those of other countries.
The health emergency has forced many research centers to conduct some phases remotely, towards: Decentralized Clinical Trial, (clinical trial in which some or all of the activities take place in a location other than the investigator’s). As the Observatory’s research shows in collaboration with several scientific associations (Ame, Anmco, Fadoi, Pke and Simfer), 25% of medical specialists have already participated in clinical trials with at least one decentralized phase and 50% of those who have not yet done so would be interested in doing so in the future to do.
The potential benefits
They are relevant, the report explains: «For doctors, the opportunity to» collect more data during the trial (marked by 61% of specialists) and the ability to differentiate more between the types of patients involved (56%). The same benefits are also recognized by: Data manager (75% and 54%, respectively) involved in the survey, conducted in collaboration with the Italian Data Manager Group (GIDM) ».
“The digital solutions most commonly used in clinical trials today are those for digitizing and managing data related to patients participating in the study, such as theelectronic case report form (used by 58% of medical specialists) and even to collect patient data remotely, such as wearable devices (used by 44%). One of the less common solutionsbut those of greater importance to physicians emerge those who support the patient during treatment;“.
“In Italy, despite the numerous benefits that decentralized clinical trials could bring to clinical research, different barriers they still restrict its adoption – underlines Chiara Sgarbossa -. The main ones relate to the culture and digital skills of the actors involvedi, from the professionals to the patients themselves, the uncertainty related to the regulatory framework and some complexities related to the management of patient data privacy and security. It is therefore a priority to develop a cultural, organizational and regulatory context that makes it possible to break through these barriers”.
Life Science ecosystem companies seek answers to hitherto unsolved problems and healthcare needs through the rethinking traditional therapies. Innovative therapies, such as advanced therapies, are emerging to treat pathologies for which treatments are not yet available or to respond more effectively to specific needs. “They are biologics classified into four categories – explains Gabriele Dubini, scientific director of the Life Science Innovation Observatory –: gene therapy drugs (e.g. CAR-T), somatic cell therapy drugs, tissue engineering drugs, even available now by 3D bioprinting of substances, and finally combination advanced therapy drugscontaining one or more medical devices as an integral part of the cell or tissue-based medicinal product. However, the options offered are still little known to most healthcare professionals, who have not yet reached an opinion on how promising they can be for the future ». Interesting to see that 59% of patients involved in the study are likely to use this type of therapy if recommended by your doctor.
According to the Politecnico survey at the global level, life science startups have raised an average of €36.4 million in funding. 62% are involved in the making innovative productssuch as medical devices or drugs, while the rest focuses on development of solutions to improve the clinical research process. When analyzing this second category, 44% suggestinnovations to the post-market pilot phase31% at the stage of discovery and preclinical research25% treats innovate the clinical trial phase. The startups that have received the most funding are related to solutions that can collect and exploit real-world data ($77 million in average funding) and digital therapies (67 million), a sign of the great confidence investors have in these companies. propose digital solutions, paying particular attention to the data they can collect.
Ride the wave of innovation
What can you do to avoid being overwhelmed by this wave of innovation? «All players of this ecosystem are called to understand how to ride it, so as not to be overwhelmed – concludes Emanuele Lettieri, scientific director of the Life Science Innovation Observatory -. To do this, you need accelerate the cultural transformation of this ecosystemcreating more awareness and new skills, developing laws and regulations both at European and national level e encourage sharing of knowledge, tools and best practices at least on a European scale”.