FARMACI BIOLOGICI E BIOTECNOLOGICIModule MODULO 2 FARMACOLOGIA
Academic Year 2025/2026 - Teacher: Agata Graziella COPANIExpected Learning Outcomes
Acquire specific knowledge on the preclinical and clinical testing of biotechnological drugs and biosimilars. Gain updated knowledge on advanced therapies
Course Structure
Lectures
Required Prerequisites
Skills in Biochemistry and Pharmacology
Attendance of Lessons
Recommended
Detailed Course Content
Preclinical and Clinical Testing of Biotechnological Drugs.
Development of Biosimilars.
Overview of Advanced Therapies:
Gene therapies (viral vectors, genome editing)
Cell therapies (CAR-T)
Innovative vaccines (viral vector-based, nucleic acid-based, protein subunit vaccines)
Textbook Information
4) Goodman & Gilman's pharmacological basis of therapeutic. 14Th Edition only.
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Introduction to Biosimilars: Definition and Differences Compared to Originator Biotechnological Drugs and Generics. | 4 |
| 2 | Development and Approval of Biosimilars: A Comparative Study; Phase I and Phase III Clinical Trials; Indication Extrapolation; Interchangeability and Substitutability; Post-Marketing Monitoring. | 4 |
| 3 | Gene therapy: essential elements of genetic engineering. | 4 |
| 4 | The clinical applications of gene therapy. | 4 |
| 5 | CAR-T therapies: generations of CAR cells, clinical applications, side effects. | 4 |
| 6 | Innovative vaccines: biotechnological vaccines for infectious diseases and cancer vaccines. | 4 |
Learning Assessment
Learning Assessment Procedures
The correct understanding of the topics is verified during the oral exam. The ability to apply the knowledge acquired during the course through reasoning and synthesis is highly rated.