Biobank, Advanced Biotechnology and Biomarker Discovery.

Responsabile:
Guadagni Fiorella

 Staff:
 Spila Antonella, Ferroni Patrizia, Valente Maria Giovanna, Narducci Luigi, Ibrahim Danilo Sayed, Miele Chiara, Ramadan Dania

Disabling chronic diseases represent one of the most visible public health problems because of their high prevalence and incidence in the population and the considerable complexity of their clinical management. For these reasons, there is a growing need to introduce into clinical practice new predictive medicine tools that allow the adoption of personalized diagnostic-therapeutic-rehabilitation protocols, in order to improve the quality and appropriateness of the clinical management of the disease and its complications.In this complex and articulated context, the research projects pertaining to the Area of BiomarkerDiscovery and Advanced Biotechnology, aimed at the discovery and characterization of new biomarkers to be usedfor the implementation of clinical decision-making systems, are located. The presence of a Biological Resource Center (BioBIM) equipped with its own Data Lake on which to apply advanced data science techniques is further assurancefor the development of new precision medicine approaches in therapeutics and/or rehabilitation.

Gli obiettivi

Consistent with National and Community programs, the research activities of the BioDAT Laboratorydedicate a strong focus on the digitization of the health and biomedical research sectors through the conversion of new knowledge/technologies into innovative processes and services, which provide opportunities for health professionals for better clinical management planning and, at the same time, contribute to the improvement of citizens’ lives.

The general objectives of the research program of the BioDAT Laboratorycan be summarized as:

  • Performing BiomarkerDiscovery studies aimed at identifying new biomarkers that can aid the promotion of individualized medicine programs in patients with chronic-degenerative diseases
  • Implementation of innovative approaches to enable data analysis processes for the purpose of a:
    1. Characterization of the current situation described by a statistical exploration of the data;
    2. prediction of the current situation, such as trends in clinical parameters of interest;
    3. prevention, i.e., changing an undesirable prediction (e.g., increased risk) as a function of some corrective action (e.g., a change in therapy).
  • Creating a network of knowledge useful for the diagnosis, prognosis, and treatment of diseases of interest and associated comorbidities in order to develop integrated solutions for medical decision making.

The ultimate goal is to provide new decision-making tools to support healthcare professionals in planning the clinical management of patients with chronic-degenerative diseases.

Gli interessi dell’Area

BioBIM Project: Multidisciplinary Interinstitutional Biobank (BioBIM)

The application of personalized medicine protocols cannot be separated from the use of integrated multidisciplinary techniques that allow, on the one hand, the design and implementation of IT platforms for proper data management and, on the other hand, the implementation of innovative clinical decision support systems. Business intelligence, artificial intelligence, and machine learning are just a few of the methodological principles that Data Science deploys to interpret and extract knowledge from the growing volumes of digitized biomedical data-whether derived from the real world (e.g., electronic health records), or from new technologies (omics sciences, nanotechnology, biosensing, telemedicine, etc.)-in order to create models that are potentially transferable to clinical practice (IT infrastructure, prediction software, management APPs, etc.). However, the application of these principles is only possible through the creation of platforms capable of handling the ever-increasing volume of digitized data.

The presence within the BioDAT Laboratory of the Multidisciplinary BiobankInterinstitutional (BioBIM®)-an advanced Biological Resource Center (CRB) equipped with its own Data Lake for data matching, data mining and integration-has made it possible to combine, on the one hand, the need for increasing numbers of biological samples for use in high-throughput analysis and, on the other, the growing demand for digitized biomedical data on which to apply innovative artificial intelligence techniques. BioBIM is, in fact, capable of preserving different types of samples collected during biomedical research projects, diagnostic flows and epidemiological investigations, to be subjected to traditional and innovative analytical processes even many years after collection. Each biological sample is associated with the donor’s data: clinical and family history, any pathology, and other data deemed relevant for specific studies. All data obtained are processed in a manner that complies with current regulations, both in terms of security and protection of personal data (EU Regulation 2016/679, Legislative Decree 196/2003 and subsequent recommendations of the Guarantor), and in terms of technical requirements regarding storage methods (International Guidelines).

For these reasons, BioBIM is currently configured as a transversal research infrastructure across the areas and themes developed in IRCCS San Raffaele Roma, whose multidisciplinary organization allows pluripotency, flexibility and involvement of multiple areas of expertise, among which ICT represents the core management of most of the activities, enabling the tracking of the entire lifecycle of the associated samples/data and ensuring their quality. BioBIM is ISO certified, accredited by the Italian Ministry of Health and part of the BBMRI node.

IRCCS San Raffaele Pisana’s BioBIM represents an interinstitutional reference center, as it allows peripheral facilities that lack the dedicated infrastructure to participate in the implementation of the BioBank. The structural, organizational and management characteristics of a BioInterinstitutional Bank are the same as those of a BioBank with a single collection location. Decentralized storage within Satellite Health Facilities and/or the sending to the central BioBank of biological samples from peripheral collection facilities represents a moment of growth for the Institutions participating in the project and for the BioBank itself, as it allows for the development of its potential in a much faster time frame. In addition, the affiliation of facilities with diversified health competencies with respect to the Institution where the BioBank is located, determines its multidisciplinary collection and the possibility of creating/developing a network of multicenter and multidisciplinary afferents from the Institutions (Public/Private of reference and excellence for different pathologies) and their peripheral offices involved (Partners).

With this in mind and in order to develop a network of inter-institutional/multisciplinary collaborations, special agreements have been entered into in which the methods and criteria for:

  • Collect, identify and manage samples by delivering them to BioBIM IRCCS San Raffaele Pisana or store them at the collection site if the facility is suitable for the function;
  • Transfer the data inherent to the samples and all information associated with them to the BioBanca IRCCS San Raffaele Pisana in compliance with the protection of personal data (Legislative Decree 196/2003 and subsequent recommendations of the Guarantor);
  • Ensure compliance with procedures (especially administration of informed consent approved by the Ethics Committee of IRCCS San Raffaele Pisana and the Ethics Committee of the partner institution).

Thanks to this inter-institutional network, IRCCS San Raffaele Pisana’s BioBIM includes, in addition to a control population consisting of apparently healthy subjects, samples of the most prominent diseases/disciplines in healthcare (cardiovascular and respiratory, neurodegenerative, oncological, motor and cognitive developmental, and rare diseases), in order to study ethio-pathogenetic processes in their complexity and dynamism.

 

The institutional network of collaborations with other Research Institutes and Biobanks strengthens the possibilities of BioBIM® to promote cultural exchange at the national and international level, and has fostered its inclusion within a number of working tables activated as part of specific pathways (including the Biobanks Table Of the IRCCSs in the Cardiology Network and the Biological Material Catalog Table. of IRCCSs), promoted by the Directorate General of Research and Innovation in Health Care in order to consolidate the expertise of IRCCSs through the shared adoption of homogeneous procedures and common language and tools as a testament to the relevance and prestige that IRCCS biological material represents for the National Health System.

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