OVERVIEW

The course provides 1 training credit corresponding to 8 hours of classroom teaching. It allows the student to learn the meaning of biotechnological drugs and their classification. It also allows to explore the pharmacokinetics and pharmacodynamics of certain biotechnological drugs, to understand the concept of gene therapy and its clinical applications, as well as the concept of epigenetics and epigenetic drugs. Furthermore, the course introduces students to the phases of clinical trials for biotechnological drugs and teaches the importance of selecting, conditioning, and premedicating patients who will receive such therapies.

AIMS AND CONTENT

LEARNING OUTCOMES

Define and classify biotechnological drugs. Describe the main post-translational modifications that can be applied to these drugs. Provide examples of oligonucleotides used as drugs and explain their mechanisms of action. Define the concept of gene therapy, the different approaches used in such therapy, and its clinical applications. Understand the concept of epigenetics and provide examples of epigenetic drugs. Understand the pharmacokinetics and pharmacodynamics of biotechnological drugs, including relevant examples. Describe the phases of clinical trials for biotechnological drugs. Recognize the importance of patient selection, conditioning, and premedication for those who will receive a biotechnological drug.

AIMS AND LEARNING OUTCOMES

The course aims to define the concept of biotechnological drugs, outline their classification, and highlight the differences from traditional drugs. It then examines the mechanism of action of biotechnological drugs, their pharmacokinetics and pharmacodynamics, and the possible post-translational modifications applicable to such molecules. It further explores the concepts of gene therapy, epigenetics and epigenetic drugs, and illustrates the idea of oligonucleotides used as biotechnological drugs.

By the end of the course, students will be able to distinguish a biotechnological drug from a traditional one, classify them, provide examples of modifications applicable to such biotechnological molecules, describe their mechanism of action, pharmacokinetics, and pharmacodynamics, and give examples of epigenetic drugs and oligonucleotides used in clinical practice. Additionally, students will be able to describe the phases of clinical trials for biotechnological drugs and explain the concepts of patient selection, conditioning, and premedication for those receiving such treatments.

PREREQUISITES

Knowledge of basic notions of biochemistry, organic chemistry, biology and immunology.

TEACHING METHODS

The course is organized in frontal lessons. The topics will be illustrated by the teacher through Powerpoint presentations that are shared on Aulaweb.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department (Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

Topics covered in the course:

1. Differences between traditional drugs and biotechnological drugs.
2. Classification of biotechnological drugs.
3. Post-translational modifications applicable to biotechnological drugs.
4. Mechanisms of action, pharmacokinetics, and pharmacodynamics of biotechnological drugs.
5. Clinical trial phases of a biotechnological drug.
6. Market authorization of a biosimilar biotechnological drug.
7. Use and mechanism of action of oligonucleotides as biotechnological drugs.
8. Gene therapy: examples of biotechnological drugs.
9. Epigenetics: examples of epigenetic drugs.
10. Biotechnological drugs for rare diseases.
11. Selection, conditioning, and premedication of patients receiving a biotechnological drug.

RECOMMENDED READING/BIBLIOGRAPHY

All materials used during the lectures will be made available on Aulaweb. For further study, the following texts are recommended:

• Farmaci biotecnologici, aspetti farmacologici e clinici, E. Vegeto, A. Maggi, P. Minghetti, Casa Editrice Ambrosiana, 2020.

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

The timetable for this course can be found at: EasyAcademy Portal.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam will consist of a written test with 3 open questions on the topics of all three 1 CFU modules (3 CFU total) lasting 1 hour and 30 minutes. To pass this test, the student must have obtained a passing grade in all three modules, otherwise he/she will have to repeat the entire written test. The written test can be taken only after having passed the 6 CFU immunology module.

ASSESSMENT METHODS

During the exam, the student will have to demonstrate the knowledge acquired during the lessons, also with connections to related disciplines.

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet.