Biotechnology and Pharmacotoxicology

A.Y. 2020/2021
10
Max ECTS
88
Overall hours
SSD
BIO/14
Language
English
Learning objectives
The main objectives of this module are:
1. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive adverse 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 current OECD guidelines with a direct involvement of students.
Expected learning outcomes
Students must learn the basic principles of genotoxicity, cancerogenicity, reproductive toxicity and immunotoxicity and their assessment. The tutorials also 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.
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
During the emergency teaching phase, the course program and the reference material will not change.
If classroom lessons will not be allowed, lessons will be implemented on line by synchronous lesson through the Microsoft Teams platform. The schedule and criteria for attending face-to-face lessons will be published in due time on the Ariel website along with any updates related to the Covid-19 emergency.
Course syllabus
Professor Corsini module
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. Integration of all this information is central to hazard identification and proper risk assessment. Among possible adverse effects, those affecting the immune and the reproductive system together with genotoxic effects and the development of cancer, are the ones that should arouse the greatest concern.
The main purposes of this module are:
1. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive adverse 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 current OECD guidelines with a direct involvement of students.

Professor Ceruti Module
Objectives
The aim of this module is to provide the basic knowledge for understanding the process of drug discovery that was applied to the development of the currently available biotechnological drugs and to give a prospective view on the next-generation drugs. Lectures will introduce students to the field with an historical perspective and will provide examples for each of the distinct categories (protein, nucleic acids etc). Finally, differences in development and toxicological analysis between biotech drugs and small molecules will be analyzed and discussed.

Detailed Program
- 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
Prerequisites for admission
The student must have basic knowledge of anatomy, biology, physiology, pathology, and pharmacology.
Teaching methods
Frontal lessons and tutorials. To facilitate the acquisition of the necessary skills and abilities to work effectively in teams and to achieve objectives (i.e. autonomy, ability to plan and organize and manage information) working groups will be organized.

For the module Biotechnology and Pharmacology: this module will consist of seminars (40 hours).
Teaching Resources
Suggested study materials for Prof Corsini module:
- Casarett and Doull's Toxicology: The Basic Science of Poisons 8th Edition (Curtis D. Klaassen, Ed). Mc Graw Hill Education.

For Prof Ceruti module:
· Slides provided by the teacher through the ARIEL website (and the Teams app if online teaching will be utilized)
· Scientific articles provided by the teacher through the ARIEL website (and the Teams app if online teaching will be utilized)
· Textbook: Biotechnology and Biopharmaceuticals. Ho RJY, Gibaldi M - Wiley-Liss (last edition)
2013
- Recent reviews and OECD guidelines on the subjects will be made available during class
Assessment methods and Criteria
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.
Two separate examinations will be organized for the two modules. The final mark will be the average of the two marks.
Biotechnology and Pharmacology
BIO/14 - PHARMACOLOGY - University credits: 5
Lectures: 40 hours
Genotoxicology, Cancerogenicity, Immunotoxicology, Reproductive and Developmental Toxicity
BIO/14 - PHARMACOLOGY - University credits: 5
Tutorials: 16 hours
Lectures: 32 hours
Professor: Corsini Emanuela