First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
Course unit
MEO2045675, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2018/19

Information on the course unit
Degree course Second cycle degree in
ME1934, Degree course structure A.Y. 2012/13, A.Y. 2019/20
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Degree course track MOLECULAR MEDICINE [001PD]
Number of ECTS credits allocated 14.0
Type of assessment Mark
Department of reference Department of Molecular Medicine
Mandatory attendance
Language of instruction English
Single Course unit The Course unit CANNOT be attended under the option Single Course unit attendance
Optional Course unit The Course unit is available ONLY for students enrolled in MEDICAL BIOTECHNOLOGIES

Other lecturers ANDREA CIGNARELLA BIO/14

Course unit code Course unit name Teacher in charge Degree course code

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Educational activities in elective or integrative disciplines BIO/14 Pharmacology 4.0
Educational activities in elective or integrative disciplines MED/07 Microbiology and Clinical Microbiology 1.0
Core courses BIO/19 General Microbiology 4.0
Core courses MED/07 Microbiology and Clinical Microbiology 2.0
Core courses MED/07 Microbiology and Clinical Microbiology 3.0

Course unit organization
Period First semester
Year 2nd Year
Teaching method frontal

Type of hours Credits Teaching
Hours of
Individual study
Lecture 14.0 112 238.0 No turn

Start of activities 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2012 course timetable

Prerequisites: Background knowledge in biomedical disciplines such as biochemistry, physiology, pathology, molecular biology, cell biology, microbiology.
Target skills and knowledge: Pharmacology: This course focuses on drug design & development. The main learning outcome is how to manage approaches to drug discovery, and establish safety and efficacy.
Molecular Therapies: This course will provide a broad and in-depth knowledge of basic concepts and innovative tools in the rapidly developing field of innovative molecular therapeutic approaches.
Examination methods: Pharmacology: Written test including open and multiple choice questions. Time: 1 hour. Extra books not allowed. Group work before test will be awarded extra marks according to content, focus, organization, style.
Molecular Therapies: Written test with open questions. Time: 45 min per question. Group discussion on selected topics will be taken into consideration for additional score
Assessment criteria: Knowledge of topic; ability to argue and justify the decision-making process when required; structure of argument; scientific language and terminology skills.
Course unit contents: PHARMACOLOGY:
Origin of new drugs – Small molecules versus biopharmaceuticals; the drug discovery phase; preclinical development; clinical development.
Pharmacokinetics – Physical processes underlying drug disposition; drug absorption and routes of administration; distribution of drugs in the body; drug metabolism; drug and metabolite excretion; clinical pharmacokinetics: temporal characteristics of drug effects and relationship to the therapeutic window; first-order kinetics; effect of repeated dosing.
Pharmacogenetics and Pharmacogenomics – Individual variation in drug response: genetic factors; biomarkers as predictors of efficacy and safety; clinical validity and clinical utility of genomic biomarkers; moving from bench to bedside.
Biopharmaceuticals – Examples of therapeutic proteins; biosimilars; problems in manufacture; evolution of monoclonal antibodies; safety issues; pharmacokinetics and pharmacodynamics.
Introduction to advanced molecular therapies: definition, advantages and main current limitations, ethical issues; concepts and tools of gene and cell therapy; delivery systems and therapeutic strategies for cell and gene therapy.
Gene therapy: development and application of virus-based vectors: retroviruses, lentiviruses, adenoviruses, adeno-associated viruses, herpes simplex virus, alphaviruses; oncolytic viruses for treatment of cancer; applications of gene therapy to non-neoplastic disorders; gene therapy approaches for HIV-1 infection. Gene editing strategies: delivery technologies and platforms for genome editing: zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and CRISPR–Cas9 system engineered nucleases to correct genetic defects and to cure chronic viral infections: design, mechanism of action, limitations and examples.
Regenerative Medicine: advances in the use of adult stem cells and induced pluripotent stem cells as “medicinal products” for therapies. The identification of natural or the development of artificial scaffolds capable to mimic the niche: a major area of enquiry to optimize the outcome from stem cell transplantation and tissue engineering. Stem cell aging: mechanisms, regulators and therapeutic opportunities. The development of new biotechnologies and their application to Precision Medicine in cancer treatment.
Process of developing products starting from lab-based research, from the crucial step of protecting intellectual property, marketing strategies, basic knowledge on how a company works, and the status of the biotechnology sector in Italy. Rare and neglected diseases, orphan drugs; challenges and potential of developing new peptide-based therapeutics; nucleic acids as therapeutic agents/therapeutic targets; nanoparticles as delivery systems.
Planned learning activities and teaching methods: Classes, group work, Kahoot.
Additional notes about suggested reading: Students will receive lecture slides and review articles on selected topics.
A review of a general text of pharmacology/therapeutics and gene and cell therapy would be appropriate. No one single text is absolutely recommended. Suitable texts are indicated.
Textbooks (and optional supplementary readings)
  • Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor, Basic and Clinical Pharmacology. New York: 13 ed. McGraw-Hill Education, 2015. Cerca nel catalogo
  • Nancy Smyth Templeton, Gene and Cell Therapy: Therapeutic Mechanisms and Strategies. --: Fourth Edition, CRC Press Taylor & Francis Group, 2015. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Interactive lecturing
  • Working in group
  • Questioning
  • Auto correcting quizzes or tests for periodic feedback or exams

Innovative teaching methods: Software or applications used
  • Moodle (files, quizzes, workshops, ...)

Sustainable Development Goals (SDGs)
Good Health and Well-Being