D0165 - MODELLI PRECLINICI AVANZATI E APPLICAZIONI IN VIVO

Learning outcomes

The course is designed to balance biological theory, emerging engineering technologies, and ethical-regulatory aspects. Its aim is to provide students with the tools needed to select the most predictive model for a specific research question, while developing a critical understanding of the limitations of traditional models and the potential of new systems — such as organoids, organ-on-chip platforms, and humanized animal models — to reduce the translational gap.

Course contents

Module 1 — Fundamentals, Translational Gap, and Ethics in Preclinical Research
The challenge of preclinical predictivity; the 3Rs; NAMs; and robust experimental design.

Module 2 — 3D Cultures, Organoids, and Complex Tissue Models
From 2D to 3D cultures; spheroids and tumoroids as preclinical models; organoids derived from adult stem cells and iPSCs; advanced organoids and complex co-cultures.

Module 3 — Microfluidics, Organ-on-Chip, and Biofabrication
Microfluidics and organ-on-chip platforms; 3D bioprinting and tissue engineering.

Module 4 — Alternative In Vivo and Ex Vivo NAMs
Zebrafish as an alternative preclinical model; C. elegans, Drosophila, and non-mammalian models; CAM assay; explants, ex vivo tissues, and other NAMs.

Module 5 — Advanced Murine Models: Targeted Use and Integration with NAMs
When the murine model is still necessary.

Module 6 — Analysis Technologies, Validation, and Project Work
Advanced analysis of 3D models and NAMs.

Final Workshop
Designing a NAM-based preclinical pipeline.

Readings/Bibliography

Slides provided by the lecturer

Institutional documents and reference resources
Directive 2010/63/EU on the protection of animals used for scientific purposes. EURL ECVAM — European Union Reference Laboratory for alternatives to animal testing. ARRIVE Guidelines 2.0 for the reporting of in vivo studies.

Recommended readings
Recent review articles from journals such as Nature Reviews Drug Discovery, Nature Biomedical Engineering, Nature Biotechnology, Cell Stem Cell, Trends in Biotechnology, Lab on a Chip, Disease Models & Mechanisms, and Nature Methods. The final reading list will be updated annually to include recent articles and case studies aligned with developments in the field.

Teaching methods

Traditional teaching: lectures

Moreover, the course will adopt a comparative approach, presenting the different techniques through a comparison between traditional and innovative models, such as standard murine xenografts, organoids, and PDX models.

Students will be guided in selecting the most appropriate model according to the specific scientific question, understanding that there is no perfect experimental model: each system has its own advantages, limitations, and fields of application.

Whenever possible, the course will be enriched by seminars with external experts, aimed at exploring technical and applied aspects such as microfluidics, animal facility management, and the ethical implications of in vivo models.

Assessment methods

Written assignment — 60%
Students will prepare a short project, 2–3 pages, proposing a preclinical pipeline to address a biological or therapeutic question, with preference given to the use of 3D models, NAMs, and non-murine approaches. Any use of murine models must be critically justified and included as a targeted validation step.

Oral presentation — 40%
Project pitch followed by a critical discussion. Assessment will consider the student’s ability to select appropriate models, justify the use of NAMs, integrate validation technologies, and recognize the limitations of the proposed pipeline.

With regard to the assessment of learning outcomes, limited, declared, and non-substantial use of AI is permitted for support activities, such as summarization and reformulation. Substantial use of AI for completing parts of the assessment is not permitted.

Important notice
Students with specific learning disorders, or temporary or permanent disabilities, are strongly encouraged to contact the relevant University Office in good time: https://site.unibo.it/studenti-con-disabilita-e-dsa/it . The Office will propose any appropriate accommodations for the students concerned. These accommodations must in any case be submitted to the lecturer for approval at least 15 days in advance; the lecturer will assess their suitability also in relation to the learning objectives of the course.

Teaching tools

Slides to support the cultural and scientific background of the course (SLIDES ALONE ARE NOT SUFFICIENT FOR UNIVERSITY PREPARATION).

Office hours

See the website of Martina Rossi