FARMACI BIOLOGICI E BIOTECNOLOGICI

Module MODULO 2 FARMACOLOGIA

Acquire specific knowledge on the preclinical and clinical testing of biological, biotechnological drugs and biosimilars. Gain updated knowledge on advanced therapies.

In accordance with the Dublin Descriptors, the course aims to develop knowledge and understanding of the preclinical and clinical testing of biotechnological drugs, the development of biosimilars, and advanced therapies (gene therapies, CAR-T, innovative vaccines); the ability to critically apply experimental and clinical data; independent judgment on risk/benefit, immunogenicity, and comparability of biosimilars; specialist synthesis and communication skills; and the capacity for autonomous learning and continuous professional updating

Lectures according to the didactic calendar. The use of AI chatbots during lectures is permitted for real-time verification and deeper exploration of the content presented. Students are encouraged to share any questions or doubts arising from their interaction with the chatbot, turning the lecture into an opportunity for active dialogue. The professor remains the ultimate point of reference for the correct interpretation of the material.

If the course is delivered in blended or remote mode, appropriate adjustments may be made to the above, in order to ensure consistency with the syllabus.

Preclinical and Clinical Testing of Biological and 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)

The assessment of the correct understanding of the topics covered takes place exclusively during the oral examination. The ability to actively apply the knowledge acquired during the course (knowledge and application skills) is rated through reasoning (learning skills and independent judgment) and synthesis (communication skills).
A passing grade of 18/30 is achieved when the student demonstrates, for each question, at least the essential minimum knowledge required for the specific topic. The final grade, ranging from 18 to 30 with honors, is determined by the depth of the presentation, the ability to link different content areas, and the complexity of the items covered

Learning assessment may also be carried out on-line, should the conditions require it.

Information for students with disabilities and/or specific learning disorders (SLD).
To ensure equal opportunities and in accordance with applicable laws, interested students may request a personal meeting to plan any compensatory and/or exemptive measures, based on the learning objectives and individual needs. Please contact Prof. Santina Chiechio (santina.chiechio@unict.it), who also serves as the CInAP (Center for Active and Participated Inclusion – Services for Disabilities and/or SLD, https://www.cinap.unict.it/content/referenti) referent professor for the Department of Drug and Health Sciences."

Exam dates are published on the Degree Course website:https://www.dsf.unict.it/it/corsi/lm-13/calendario-esami

The exam will include questions similar to those discussed during the lessons, raised by students or suggested by the teacher, in order to assess the understanding of the topics covered in the course.