In July, we participated in the Digital Innovation Observatories Congress with the title “Life Science: cavalcare l’onda dell’innovazione”. This Observatory for this event aims to collect and analyze valuable feedback from the Life Science industry and provide the audience with relevant findings that can lead to future innovation in the sector.
The Life Science sector is becoming fundamental for the development of the Italian economy and competitivity since it encompasses:
- 5500 companies;
- around 190.000 employees;
- an overall production value of 55 billion euros.
Another proof that Life Science is strategic for the country is the relevance that NRRP (National Recovery and Resilience Plan) gives to this sector in terms of funding and investments. The whole investment amount is higher than 2 billion euros. In particular:
- Mission 4 (Education and Research) will provide investments for the development of genic therapy and RNA medicines;
- Mission 6 (Health) focuses on biomedical research and modernization of IRCCS institutes with particular attention to chronic diseases.
Digital innovation is transforming the life science sector, including Pharma, Biotech, and MedTech companies. New technologies offer the possibility to develop new products and services in co-innovation and co-opetition by achieving important benefits for all stakeholders involved in the ecosystem. Below you will find a list of the main technologies that are gaining importance within the industry as both companies, patients, and doctors are starting to use them. We see now to what extent.
Digital Therapeutics (or DTx) are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. In other words, DTx are patient-facing software applications that have a proven clinical benefit and help patients treat, prevent, or manage diseases (source EDPS).
Working on changing the patient’s behavior is the basis on which DTx are based: inappropriate lifestyles affect our lives and can lead to problems such as addictions, insomnia, and eating disorders. By acting on behavior, digital therapy acts like a traditional drug. Compared to common apps dedicated to lifestyle and wellness, these are real medical interventions and are subject to strict controls to comply with safety and efficacy standards by fulfilling regulatory requirements requested by institutions.
While in countries such as the United States and Germany, DTx are rising consistently, Italy suffers from burdens that limitate the creation, adoption, and diffusion of DTx. These limitations are mainly related to the lack of reimbursement systems and clarity on the clinic validation processes.
Decentralized Clinical Trials
With the advent of cloud-native technologies and telemonitoring, as well as due to the Covid-19 pandemic, Decentralized Clinical Trials (DCT) gained great importance around the globe and among Pharma companies. DCT can be defined as a clinical investigation where some or all of the trial-related activities occur at a location separate from the investigator’s location (source FDA). Indeed, there are two cases involving DCT:
- Virtual trials (also known as direct-to-patient trials), when all the activities are run remotely;
- Hybrid trials, when some of the activities are run remotely.
Even though some experiments have been conducted in Italy, there are still obstacles to running the whole trial process by leveraging digital tools for many reasons, among which poor culture and training for healthcare professionals and lack of knowledge of digital solutions’ availability. However, in the enrollment phase of the trials, some tools such as e-consent and e-recruiting have been successfully implemented.
The advanced therapies, also known as Advanced Therapy Medicinal Products (ATMP), are a new frontier of medicine since, besides the traditional drugs’ active ingredients, they leverage:
- genes (DNA, RNA) to work on genetic sequences;
- cells or tissues to manipulate biological characteristics;
- one or more medical devices as an integral part of the medicinal product containing cells or tissues.
The opportunities to improve care quality are countless for patients, as well as, the economic impact on Pharma companies. However, these treatments are still little known to most healthcare professionals, who have not yet formed a judgment on how promising they may be for the future. Interestingly, 59% of the patients involved in the research said they are inclined to use this type of therapy if recommended by their doctor.
Sensors and Biosensors
The last technology that becomes strategically relevant for the Life Science sector is based on Sensors (devices able to detect a quantity and vary its property), and Biosensors (characterized by a biological system and a signal transducer). There are many classes of sensors, such as portable, wearable, attachable (i.e. ECG sensor), and swallowable devices (i.e. endoscopic capsule).
These systems are perfect for collecting valuable clinical data and real-world evidence to ingest a Health Data Platform used for different reasons, such as monitoring or predicting activities.
Both doctor specialists and patients understand the power of using sensors to monitor current health states and predict likely health issues, indeed the results showed by the Observatory are hopeful. The survey shows that patients are open to the possibility of sharing data collected by sensors for several purposes and personalized medicine. About one out of four patients declare they are ready to share their data, not only with the facilities that treat them but also with other actors, such as companies that produce drugs or medical devices.