Biotechnology and pharmacotoxicology

The main objectives are:
1. to compare the characteristics of small molecule drugs, biotechnological agents, biosimilars and bioequivalent drugs
2. to characterize their molecular mechanisms of action, and to identify the mechanisms at the basis of the toxicity of small molecule drugs and biotechnological agents
3. to gain knowledge on the processes leading to the development and manufacturing of recombinant proteins for therapeutic use and on the possible related quality and safety issues
4. to learn about cell and gene therapy and their possible applications
5. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive adverse effects of xenobiotics.
6. to provide notions on preclinical toxicology for product development and the EU legislations concerning the following endpoints: genotoxicity, cancerogenicity, immunotoxicity, reproductive and developmental toxicity.

Lectures will be dedicated to the introduction of the different topics and their toxicological evaluation, while the tutorials will be dedicated to the discussion of current OECD guidelines and case studies with a direct involvement of students.

Students will be able to identify the possible critical steps which could pose safety issues during the whole life of a pharmacologically active entity, from its synthesis and development up to its distribution and therapeutic use. They will also gain basic knowledge on the consequences of drug-drug interactions in multidrug therapy and on the critical issues about gene and cell therapy. Students will learn the basic principles of genotoxicity, cancerogenicity, reproductive toxicity and immunotoxicity and their assessment.
The tutorials aim to stimulate the student toward critical thinking and problem solving, promoting his/her attitude to growth and constant improvement (lifelong learning). At the end, to assess the actual learning of the student, an oral examination of approximately 30 minutes on the topics and issues related to the evaluation of these critical toxicity endpoints as discussed during lectures will be done. In addition, students will perform a literature search on a topic of their interest and will discuss it in light of subjects presented during lectures. This will promote their critical thinking and will set the bases for their future ability to successfully face different problems and to identify unforeseen critical safety issues in the field of pharmacology and biotechnology.