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INTEGRATED COURSE OF BIOTECHNOLOGY DRUGS

Academic year and teacher
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Versione italiana
Academic year
2022/2023
Teacher
LUCA FERRARO
Credits
12
Curriculum
BIOTECNOLOGIE FARMACEUTICHE
Didactic period
Secondo Semestre

Training objectives

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Modulo: 56761 - BIOTECNOLOGIE FARMACOLOGICHE NELLA RICERCA PRECLINICA
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Pharmacological Biotechnology in Preclinical Research
The module reviews the main experimental approaches, based on the use of biotechnology, concerning drug research and preclinical development. The course is carried out through an integrated approach to general pharmacology aspects, their application in drug research and preclinical development, the "biotechnology revolution" of drug research and drug preclinical development and the application of biotechnologies in drug research and preclinical development. Together with the "Cellular and Molecular Therapies" module, the course aims to provide theoretical and methodological basis to adequately address a modern preclinical development of new drugs.
The main acquired knowledge will be:
1) general concepts of pharmacokinetics and pharmacodynamics;
2) basic knowledge of preclinical and clinical research strategies;
3) basic knowledge of traditional methods used in preclinical research, and their general aspects;
4) knowledge of biotechnological methods used in preclinical research;

On completion of the course a student should be able to:
1) design a preclinical study using biotechnology;
2) analytically understand scientific publications related to drug pre-clinical research.

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Modulo: 72198 - TECNOLOGIE GENOMICHE E FARMACOGENETICA
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Genomic Technologies and Pharmacogenetics module
The module reviews the main experimental approaches, based on the use of biotechnology, concerning the main genomic technologies and how these methodologies can be used in Pharmacogenetics, a discipline that aims to identify genes and gene variants that determine inter-individual variability in drug response. The course aims to provide the theoretical and methodological foundations that will enable students to learn how pharmacogenetic/genomic investigation can improve drug selection/dosing (examples diseases/drugs), reduce the number of adverse reactions, and facilitate new drug discovery.

The main acquired knowledge will be:
1) The basis of individual variability in responses to drug therapy (efficacy and tolerability). Allelic variants in the human population. Polymorphisms of enzymes responsible for drug metabolism or genes coding for the therapeutic target of the drug.
2) Nucleic acid sequencing technologies. Sanger and next-generation sequencing. Human genome sequencing and strategies for whole genome/exome sequencing.
3) Polygenic complexity and modulators of drug action. Genes influencing drug response: genes coding for proteins involved in drug bioavailability (pharmacokinetics); genes coding for the therapeutic target of the drug (pharmacodynamics).
4) Study methods in pharmacogenetics and pharmacogenomics (pharmacogenetic measures, candidate genes, GWA studies) to identify biological targets with diagnostic, prognostic, and therapeutic value to arrive at predictive medicine and personalized therapy.
5) Gender pharmacology.

On completion of the course a student should be able to:
1) understand the factors underlying personalized therapy (genetics, gene-environment interaction, age, nutritional status, etc.).
2) understand how pharmacogenetics and pharmacogenomics direct the clinical use of drugs (disease/drug examples) and new drug/target discovery
3) understand and analytically interpret scientific publications related to pharmacogenetic research.

Prerequisites

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Modulo: 56761 - BIOTECNOLOGIE FARMACOLOGICHE NELLA RICERCA PRECLINICA
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The following knowledges, acquired in previous courses, are required:
1) basic notions of Physiology and Pathology;
2) basic notions of Biochemistry and Molecular Biology;
3) basic notions of Biochemical and Recombinant Technologies.

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Modulo: 72198 - TECNOLOGIE GENOMICHE E FARMACOGENETICA
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Module in Genomic Technologies and Pharmacogenetics:
The following knowledges, acquired in previous courses, are required:
1) basic notions of General Biology;
2) basic notions of Genetics;
3) basic notions of Biochemistry and Molecular Biology;

Course programme

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Modulo: 56761 - BIOTECNOLOGIE FARMACOLOGICHE NELLA RICERCA PRECLINICA
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Pharmacological Biotechnology in Preclinical Research
1) General concepts of Pharmacokinetics and Pharmacodynamics (10 hours):
physicochemical characteristics of traditional and biological medicines; routes of administration; absorption; distribution; drug metabolism and elimination pathways; molecular targets of drugs; Drug-receptor interaction; agonism, antagonism and synergism; dose-effect relationship.
2) Traditional methods in preclinical research (18 hours):
in vitro and in vivo experimental approaches; receptor binding; dose- and concentration-response curves; isolated organs; methods for the study of the release of calcium and for the evaluation of drug effects on transduction mechanisms; study of neurotransmitter release; study of animal behavior; behavioral methods for the evaluation of analgesic, anxiolytic, antidepressant and neuroprotective drug’s effects.
3) Biotechnology in preclinical research (20 hours):
analysis of the "biotechnology revolution" of the traditional methods of preclinical research (relating to all the above methods); stem cells in preclinical research; recombinant cell models; transfected cells and preclinical research; transgenic animals and preclinical research; use of monoclonal antibodies and sequences of nucleic acids in preclinical research; genomics, transcriptomics, proteomics and secretomics in preclinical research.

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Modulo: 72198 - TECNOLOGIE GENOMICHE E FARMACOGENETICA
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Module in Genomic Technologies and Pharmacogenetics:
Genomic technologies:
- Genetic variability characterization methodologies: from Sanger to SNP-chips to next generation sequencing; historical perspective and published case studies
- Principles of NGS methodologies: advantages and disadvantages, perspectives. Whole exome sequencing; Whole genome sequencing.
- Bioinformatics of NGS data analysis. Genomic data format. Paired-end vs single-end. SAM/BAM format. Quality assessment of reads.
- SNV Panels, NGS short reads, NGS long reads: principles of methodologies, advantages and disadvantages, perspectives. Major genomic databases and applications.
General concepts of pharmacogenomics and pharmacogenetics
- The basis of individual variability: polymorphisms/mutations, phenotypic variability (genetic, environmental) and genetic variability in the human population.
Individual variability in responses to drug therapy:
- monogenic, polygenic and complex traits
- Pharmacokinetic and pharmacodynamic phenotypes
Pharmacogenomics target genes:
- Polymorphisms/mutations of genes coding for proteins involved in drug bioavailability (pharmacokinetics)
- Polymorphisms/mutations of genes coding for the therapeutic target of the drug (pharmacodynamics)
Study methods in pharmacogenetics and pharmacogenomics:
- candidate gene; GWA, WES, WGS studies
- Pharmacogenetics-genomics in clinical trials: examples of diseases for which pharmacogenomics approaches are used
- Hints of gender medicine/pharmacology

Didactic methods

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Modulo: 56761 - BIOTECNOLOGIE FARMACOLOGICHE NELLA RICERCA PRECLINICA
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Formal teaching consists of lectures and workshop-based integrated problem-solving exercises.

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Modulo: 72198 - TECNOLOGIE GENOMICHE E FARMACOGENETICA
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Module in Genomic Technologies and Pharmacogenetics:

The module consists of 48 hours of face-to-face lectures during which the program topics will be discussed with the help of slides, scientific publications and guidelines that will refer to the most up-to-date and accredited scientific literature..

Learning assessment procedures

The level of achievement of previously indicated learning objectives and skills is assessed through two written exams. In particular, the exams aim to evaluate the study of the matter and the understanding of the main topics of the two modules.
Pharmacological Biotechnology in Preclinical Research
The written exam includes 31 questions with multiple choice (with 4 answers only one of which is correct) and will be carried out OMR modules. The exam will last up to 60 minutes.
For DSA students, the test procedure will be evaluated individually.
To pass the exam (vote 18/30) it will be necessary to correctly answer at least 18 questions. The vote of 30/30 and honors will be achieved by answering correctly to 31 questions. No penalty points will be counted for wrong answers or unspecified answers.


Reference texts

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Modulo: 56761 - BIOTECNOLOGIE FARMACOLOGICHE NELLA RICERCA PRECLINICA
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Lecture’ slides.
Farmacologia Generale e Molecolare – Autori: F. Clementi, G. Fumagalli – Utet Ed.

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Modulo: 72198 - TECNOLOGIE GENOMICHE E FARMACOGENETICA
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Module in Genomic Technologies and Pharmacogenetics:
Lecture’ slides (must be a study guide and cannot replace textbooks);
Farmacologia Generale e Molecolare – Autori: F. Clementi, G. Fumagalli – Utet Ed.
Farmaci biotecnologici – E. Vegeto, A. Maggi, P. Minghetti – Ambrosiana Ed.
Fondamenti di bioinformatica – M. H. Citterich, F.Ferrè, G.Pavesi, G. Pesole, C. Romualdi – Zanichelli Ed.