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New challenges in developing advanced therapies
01WNXXC, 01WNXMV
A.A. 2026/27
Course Language
Inglese
Degree programme(s)
Master of science-level of the Bologna process in Ingegneria Biomedica - Torino
Course structure
| Teaching | Hours |
|---|---|
| Lezioni | 42 |
| Esercitazioni in aula | 18 |
Lecturers
| Teacher | Status | SSD | h.Les | h.Ex | h.Lab | h.Tut | Years teaching |
|---|---|---|---|---|---|---|---|
| Boffito Monica | Professore Associato | IBIO-01/A | 21 | 1,5 | 0 | 0 | 1 |
Co-lectures
Context
| SSD | CFU | Activities | Area context | ING-IND/34 | 6 | D - A scelta dello studente | A scelta dello studente |
|---|
2026/27
cccccc
Over the last decades, progress in biomedical technologies has brought significant benefits to all sectors aimed at protecting and improving human health. The potential of these technologies is limitless, and their impact on the development of medicine and our society is of great significance.
To date, the number of advanced therapies available on the market in Europe is relatively low, but the field is continuously growing and rapidly evolving. The challenges to address towards the development of advanced therapies deal with their economic sustainability for healthcare systems, the fulfillment of bioethical and regulatory aspects, and the thorough evaluation of their clinical value, with particular attention to safety, efficacy, risks, and intended use.
In this context, the course “New challenges in developing advanced therapies” aims to provide students with knowledge of the development process of advanced therapies, with particular reference to: (i) regulatory aspects, (ii) validation procedures, (iii) access procedures, (iv) manufacturing and marketing authorization procedures, and (v) the role of artificial intelligence in the development process of a new advanced therapy.
The course will be complemented by an overview of recent developments in the field, with particular attention to therapeutic approaches that have recently completed the approval process and are currently used in clinical practice.
By the end of the course, the student will acquire:
1. Knowledge of recent developments in the emerging field of advanced therapies, with particular reference to therapeutic approaches that have recently completed the approval process and are currently used in clinical practice;
2. Knowledge on the pathway a new advanced therapy must follow to progress from the bench to the bedside, with particular focus on regulatory aspects, validation and access procedures, manufacturing processes (e.g., scale-up, sterilization, storage procedures for advanced therapies), and market authorization;
3. Knowledge of the contribution of artificial intelligence methods to the development of new advanced therapies;
4. Ability to apply the knowledge and methods acquired during the course to address emerging and frontier challenges related to human health;
5. Ability to conduct literature and market surveys and to effectively communicate data and results.
By the end of the course, the student will acquire:
1. Knowledge of recent developments in the emerging field of advanced therapies, with particular reference to therapeutic approaches that have recently completed the approval process and are currently used in clinical practice;
2. Knowledge on the pathway a new advanced therapy must follow to progress from the bench to the bedside, with particular focus on regulatory aspects, validation and access procedures, manufacturing processes (e.g., scale-up, sterilization, storage procedures for advanced therapies), and market authorization;
3. Knowledge of the contribution of artificial intelligence methods to the development of new advanced therapies;
4. Ability to apply the knowledge and methods acquired during the course to address emerging and frontier challenges related to human health;
5. Ability to conduct literature and market surveys and to effectively communicate data and results.
Knowledge of artificial intelligence applications in medicine
Knowledge of personalized medicine approaches
Knowledge of bionanotechnologies
Basic knowledge of material science
Basic knowledge of tissue engineering and regenerative medicine principles
Knowledge of artificial intelligence applications in medicine
Knowledge of personalized medicine approaches
Knowledge of bionanotechnologies
Basic knowledge of material science
Basic knowledge of tissue engineering and regenerative medicine principles
- Introduction to advanced biomedical technologies: advanced therapies
- The pathway enabling new advanced therapies to move from the bench to the bedside (regulatory aspects, validation and access procedures, manufacturing processes, and market authorization)
- Advanced therapies (e.g., gene therapy products with particular focus on in vivo therapies, tissue engineering products, combined advanced therapies): classification, definitions, examples of already approved therapies and therapies currently at the development stage
- Multi omics approaches as drivers for advanced therapies development
- Artificial intelligence in the development of advanced therapies: definitions, methodologies, examples, contribution to personalized medicine
During the in-class exercises, students will work in groups to conduct an in-depth analysis of case studies, with particular focus on the pathway driving a new therapy from the scientific idea to the approved and commercially available product (through literature review, market research, and analysis of clinical trial results). Furthermore, students will evaluate the potential contribution of artificial intelligence across the different stages of development, including target identification, patient stratification, clinical trial design, manufacturing optimization, and post-marketing monitoring.
- Introduction to advanced biomedical technologies: advanced therapies
- The pathway enabling new advanced therapies to move from the bench to the bedside (regulatory aspects, validation and access procedures, manufacturing processes, and market authorization)
- Advanced therapies (e.g., gene therapy products with particular focus on in vivo therapies, tissue engineering products, combined advanced therapies): classification, definitions, examples of already approved therapies and therapies currently at the development stage
- Multi omics approaches as drivers for advanced therapies development
- Artificial intelligence in the development of advanced therapies: definitions, methodologies, examples, contribution to personalized medicine
During the in-class exercises, students will work in groups to conduct an in-depth analysis of case studies, with particular focus on the pathway driving a new therapy from the scientific idea to the approved and commercially available product (through literature review, market research, and analysis of clinical trial results). Furthermore, students will evaluate the potential contribution of artificial intelligence across the different stages of development, including target identification, patient stratification, clinical trial design, manufacturing optimization, and post-marketing monitoring.
The course is composed by lectures (42 h) and in-class exercises (18 h). The lectures will be delivered in the classroom (or in the virtual classroom if necessary). For in-class exercises the students will be divided into groups of 4-5 components each.
The course is composed by lectures (42 h) and in-class exercises (18 h). The lectures will be delivered in the classroom (or in the virtual classroom if necessary). For in-class exercises the students will be divided into groups of 4-5 components each.
Reviews and research papers
Reviews and research papers
Slides;
Lecture slides;
Modalita di esame: Prova orale obbligatoria;
Exam: Compulsory oral exam;
...
The final exam will consist of two parts. In the first part the students divided into groups will present an advanced therapy focusing on the pathway that has led the therapy from the scientific idea to the approved and commercially available product. The presentation will be followed by a discussion on the course topics.
Gli studenti e le studentesse con disabilita o con Disturbi Specifici di Apprendimento (DSA), oltre alla segnalazione tramite procedura informatizzata, sono invitati a comunicare anche direttamente al/la docente titolare dell'insegnamento, con un preavviso non inferiore ad una settimana dall'avvio della sessione d'esame, gli strumenti compensativi concordati con l'Unita Special Needs, al fine di permettere al/la docente la declinazione piu idonea in riferimento alla specifica tipologia di esame.
Exam: Compulsory oral exam;
The final exam will consist of two parts. In the first part the students divided into groups will present an advanced therapy focusing on the pathway that has led the therapy from the scientific idea to the approved and commercially available product. The presentation will be followed by a discussion on the course topics.
In addition to the message sent by the online system, students with disabilities or Specific Learning Disorders (SLD) are invited to directly inform the professor in charge of the course about the special arrangements for the exam that have been agreed with the Special Needs Unit. The professor has to be informed at least one week before the beginning of the examination session in order to provide students with the most suitable arrangements for each specific type of exam.