Second ICPerMed Training “Personalised Medicine: Ethical and Legal Aspects of Biobanking and Data Management”

28 October 2022 – The second ICPerMed Training entitled “Personalised Medicine Research: Ethical and Legal Aspects of Biobanking and Data Management” took place virtually on 10 October, 2022 with 130 international participants. The training was organised in collaboration with Dr Luca Sangiorgi (Director of the Department of Rare skeletal disorders at Istituto Ortopedico Rizzoli, IT).

The rationale behind the training organisation was to provide an extensive and all-embracing knowledge of the biobanking management.

The course aimed at educating health care professionals and personnel dedicated to biomedical, technological and scientific research. It was held during one entire working day and dealt with the main issues concerning the establishment and management of a biobank of biological samples, the data associated with them, and the creation and launch of a Pathology Register, giving ample space for practical, organisational and scientific aspects. 

The event was carried out through 7 lectures with the participation of external teachers, who are leading experts in the sector:

1- Barbara Parodi (Biological Resources Center, Ospedale San Martino and Project Manager BBMRI, IT): Samples & BioBanks the Infrastructure.

Biobanks, which hold hundreds of millions of biological samples – including those from humans, animals, plants, and microbes – help the global scientific community in various aspects from crop production to personalised medicine. Biobanks vary widely in terms of the kinds of biological material they hold, the activities they undertake, the services they provide, and their geographical location, size, and structure. This talk provided an overview on the state of the art.

2- Maria Grazia Daidone (IRCCS Istituto Nazionale dei Tumori, IT):” Biobanking: training and definition of competencies for the next generation Biobankers” 

Biomarker-driven precision medicine (personalised medicine) is fundamentally changing life sciences research. Central to biomarker research is the access to quality biospecimens in biobanks that have been extensively annotated with clinical, molecular, and patient data. Biobanks are no longer measured by how many samples they keep, but by the utilisation of these samples to drive investigational research. This shift poses challenges for traditional, first-generation biobanks. Next Generation Biobanking not only supports operational activities, but also functions as the knowledge hub for an integrated translational and clinical research ecosystem. 

3- George Dagher (Inserm, FR): “Biobanks and quality Management” 

The ISO 20387 requires biobanks to implement the quality management, and was published to help organisations get the most out of the standard. The requirements of ISO 20387 are complex and require to improve the quality of biological material and data collections that are stored and shared, enhance the outcomes of collaboration, strengthen trust between partners, and advance research and development.

4- Lorena Casareto (Fondazione Telethon, IT): “Example of Biobank network in the Rare Disease environment”

This talk provided concrete examples on how a biobank works in practice and how a network of biobanks can stimulate and favour up to date research in the personalised medicine field.

5- Marina Mordenti (IRCCS Istituto Ortopedico Rizzoli, IT): “Data interoperability and FAIR principles”

The FAIR principles describe how research outputs should be organised so they can be more easily accessed, understood, exchanged and reused. Major funding bodies, including the European Commission, promote FAIR data to maximise the integrity and impact of their research investment.

6- Monica Mazzucato (RD Coordinating Center, RD Registry Veneto Region, IT) : “Data and Registries: Ontologies”

Personalised medicine is critically dependent on three sources of information: a medical knowledge base, the patient’s medical record and knowledge of available resources, including, where appropriate, clinical protocols. Patient data is often scattered in a variety of databases and may, in a distributed model, be held across several disparate repositories. Consequently addressing the needs of a personalised medicine community presents issues of biomedical data integration, clinical interpretation and knowledge management. Ontologies respond to the need of standardising information favouring (bio-) medical data integration, from the level of cellular data, through disease to that of patient and population.

7- Jaime Fons Martinez (FISABIO, ES): “The informed consent process and the importance of interaction with donors. Perspective of the i-CONSENT project”

Dynamic informed consent is a tool that is based on a personalised communication platform that aims to facilitate the consent process. It is oriented to support continuous two-way communication between researchers and participants. This talk presented the requirements of informed consent in the context of personalised medicine, reviewed various current implementations of dynamic consent, assessed whether they fulfil the requirement of informed consent, and, in turn, enabled participants to make autonomous and informed choices on whether or not to participate in research projects.

This online training was one of several activities of ICPerMed in order to support research and implementation of PM in Europe and beyond