Biotechnology and pharmacotoxicology

- Introduction:
a. the drug discovery process with an historical perspective
b. biotechnology in drug development and in the prediction of adverse reactions
- Biologics: biotechnology applied to the identification, generation and production of current available drugs.
a. Therapeutic proteins
b. Vaccines
c. Monoclonal antibodies
d. Epigenetic drugs
e. Gene therapy
f. Drugs targeting transcription factors
g. Nucleic acids as drugs
- Small molecules and biotechnological drugs:
a. differences in drug development - practical examples
b. differences in the toxicology analysis - practical examples
c. new tools for the drug pharmacotoxicological analysis - practical examples

Modern toxicology involves the study of structure and mechanism related to the toxic effects of chemical agents, and encompasses technology advances in research related to chemical aspects of toxicology. Toxicology is strongly multidisciplinary, spanning computational chemistry and synthetic chemistry, proteomics and metabolomics, drug discovery, drug metabolism and mechanisms of action, bioinformatics, bioanalytical chemistry, chemical biology, and molecular epidemiology.

The main purposes of this module are:
1. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive toxic effects of xenobiotics.
2. to characterize their molecular mechanisms of action.
3. 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 case studies with a direct involvement of students.

Learning will be assessed by 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.