Research lines

It is necessary to characterize the patients for subpopulations that differ in their susceptibility to a particular disease and in their evolution along the entire path of transition from health to pathology. The translational approach will be combined in this line with a “bed to bench” information management path also through the comparison with clinical data (real life scenarios).

The identification and characterization of “omics” and molecular mechanisms based on advanced technologies of genetic, cellular and molecular diagnostics can allow a coherent modeling of the process of transition from the state of health to that of disease on an individual basis through an ever deeper understanding of stratification criteria and predictive elements. This process, in addition to ensuring a better understanding of a basic physio-pathological nature, also makes it possible to better identify significant molecular targets for drug discovery and markers that will eventually be used in the future. Furthermore, understanding the role of environmental factors can help to prevent and to modify complex multifactor-based diseases. The same informations will also be enhanced from a predictive point of view.

Definition of new approaches and of new basic / preclinical research pathways on a mostly omic basis. They are aimed at understanding the molecular or omic mechanisms underlying complex diseases and at identifying new therapeutic targets.

New preclinical models of study of genetic, epigenetic and molecular mechanisms that regulate the pathogenesis of complex chronic diseases in order to develop, in another research line, procedures of personalized and preventive medicine.

The use of methodologies, that do not comply with the standard of care proper to personalized and predictive medicine in order to combat the specific pathogenetic mechanisms, must take in account the molecular and omic determinants of the high comorbid frequency – therefore the state of complexity – in sick individuals – and its impact on therapeutic outcome. Moreover, the clinical studies of this line will be based on the principle of technological innovation linked to the evolution of personalized medicine approaches. In a context of integrated, synergistic, diagnostic and therapeutic competences not yet registered or patented, the aim will be to carry out clinical studies to assess a “safe” access to personalized therapies and, potentially, to estimate the best possible benefit.

This line follows the translational phase of the research in Personalized Medicine of line 1. It focuses on the development of therapeutic techniques in pharmaceutical, interventional radiological or original radiotherapy matters. The techniques could be not yet registered, patented or commercially available. The association of innovative pharmacological treatments and advanced biotechnologies represents the basis for a substantial increase in the effectiveness of treatments.

The first aim of the line is the translation towards personalized and predictive medicine protocols, as described in the previous point, together with more targeted protocols for the different complex diseases, for multidisciplinary and innovative therapies and for biotechnological applications.

The development and the scientific progress related to new technologies and new approaches to personalized medicine, together with the current demographic trend and the life expectancy of citizens, can be hypothesized to have a revolutionary impact on the organization and on the management of the health service. However, the risk of widening the gap between available resources and health needs is present. To ensure the sustainability of the Personalized Medicine approaches it is necessary to carefully assess the value of the integration of the reactive approach (new treatments) with the preventive, predictive and participatory approach (4P Medicine) for those original iprocedures that have not yet been registered, patented or commercially available and which are not already assessed through other systems within the competence of the Regions.

Personalized medicine, in the broader definition of 4P Medicine (personalized, preventive, predictive and participatory) has been internationally identified as an area of potential “disruptive innovation”. The IC PerMed initiative (https://www.icpermed.eu/en/icpermed-medicine.php) carried out by the European Commission, to which this line is partially inspired, is centered not only on the sustainability paths of health systems in a context of application of the methods of personalized medicine, but also on research in the areas of development of Awareness and Empowerment, on integration of Big Data and digital solutions and on Technology Transfer.

Evaluation and validation of the new personalized medicine tools described in line 1.

Identification of multidimensional evidence based indicators suitable for representation and description of the introduction of techniques of personalized and predictive medicine in the health system not otherwise assessed through other systems within the competence of the Regions.

The aging of population is endangering the sustainability of traditional health systems, due to a growing demand for benefits and services that meet the needs of an elderly population with multi-morbidity. In this context, is important that the quality of elderly people’s lives is characterized by independence and preserved functionality.

The fragile elderly with multimorbidity hardly complies with any existing paradigm of clinical and health care management. In this context, the use of original and not yet registered, patented or commercially available innovative technologies and strategies can represent a valid tool for the development of personalized medicine approaches. The present research line proposes the adoption of new technological supports and new individualized clinical-health care models for the management of elderly patients. These strategies will be aimed at combating multiple aspects of fragility (such as functional impairment, cognitive decline, malnutrition, social isolation) and at acting on the development and the treatment of complex age-related chronic diseases.

• Validate new technological approaches in personalized clinical healthcare pathways for the fragile elderly with multimorbidity;
• Promote new paths of Personalized Medicine for the early diagnosis and management of chronic diseases of the elderly;
• Integrate new digital technologies (IoT, Artificial Intelligence) in the management of elderly patients.

• Definition of Personalized Medicine Pathways for the fragile elderly with multimorbidity;
• Determination and validation of new biomarkers useful for integrating specific measures not included in the standard of care or not already commercially available, in the clinical assessment of pathologies of the elderly, identification of new targets for targeted procedures and determination of new parameters to be used in clinical setting and in research;
• Development and validation of new technologies not commercially available (for example, wearable devices and devices for the detection of remote clinical parameters, IoT, Artificial Intelligence) for the early detection of events or pathologies;

Planning of innovative clinical studies aimed at validating approaches to personalized medicine in the elderly.

The diagnostic and therapeutic context in which the new health technologies are continuously tested, has undergone an acceleration in the uptake of these same new technologies, such as to make the implementation of structured and robust clinical validation paths indispensable. For example, in  minimally invasive surgery and in robotics, biotechnological innovation should ensure better efficiency and sustainability.

This line aims to create an “environment” in which quickly, effectively and sustainably verify the opportunity of a possible introduction in the biomedical market (diagnostic and therapeutic) of advanced technologies, developed through research paths and subsequently of HTA, aimed at verifying and measuring its applicability, safety, effectiveness, efficiency and sustainability. In a technological transfer perspective, this line will be structured so as to share structural elements to define the management of the knowledge’s context.

The line is proposed as a tool for the technological development of inventions and of the best innovations (in terms of procedures, products and clinical-therapeutic and healthcare processes) tested and adopted in research, diagnosis and treatment pathways.

• Participation in the design of health technology prototypes and medical-surgical devices with a high innovation component; specific TTO paths;
• Creation of a preclinical research environment (lab) and of a clinical research environment (real life scenario) for the development of validation pathways of new technological approaches (health technologies and medical-surgical devices) of personalized medicine and their regulatory consistency and strength.

It is known that the diagnostic and therapeutic approach focused on gender medicine is associated with a better response to therapies that must however take into account the peculiar characteristics of women and children. Thanks to the combination of the knowledge of genetic and molecular mechanisms that underlie the various pathologies and the conduct of national and international multicenter studies capable of producing high quality clinical data, it is now possible to target a personalized medicine, according to the criteria reported in the line 1, in which the laboratory’s acquisition translates into daily clinical practice at the level of the individual.

The optimization of a treatment based on personalized and predictive medicine requires a diagnostic / therapeutic path dedicated both for the woman and the child – especially during pregnancy – to obtain the maximum clinical result and to avoid exposing to related toxicities. Improving the care of these conditions requires a multidisciplinary approach, aimed at optimizing activities related to prevention, diagnosis, therapy and follow-up.

Definition of new clinical and preventive protocols with the use of innovative technological approaches centered on women and children.

Realization of clinical studies both in gynecology and pediatric, both mono and multicentered, using innovative approaches in personalized medicine.

Innovations in biotechnology and information technology play a central role in defining new diagnostic and therapeutic pathways. The intensive critical area represents a paradigm of great managerial impact in all health facilities. Being able to ensure the development of new biotechnological products capable of promptly responding to these needs, ensuring quality, accuracy and appropriateness of therapeutic pathways, represents an unavoidable need. These activities will be able to develop a process of optimization of the diagnostic and therapy pathways in acute cases with important assistance and economic repercussions on the entire healthcare facility.

The development of new biotechnologies represents a fundamental line of action aimed at developing new diagnostic, therapeutic, IT and management tools able to significantly affect health care pathways. Overall, these translational research activities can have a profound social impact in patients’ quality of life.

Processing of new biotechnological tools, including diagnostic, therapeutic, IT and management tools, in the development of personalization paths in diagnosis and treatment in the critical area.

• Design, implementation and testing (qualitative / appropriateness) of prototypes related to health biotechnologies not yet registered, patented or commercially available, which are not already considered standard of care, and which are not already assessed through other systems within the competence of the Regions or of agencies of the Ministry of Health;
• Definition of new guidelines and protocols for acute areas in the critical area. Creation of a specific Know-how, to be included in structured Technology Transfer paths.