90822 - Pharmacotherapy of Biological Drugs

Learning outcomes

At the end of the course, the student: - has the skills to utilize pharmacological methods for the analysis of biological drugs or innovative drugs, having learned the mechanisms of action at the molecular and cellular level and the pharmacotherapeutic profile; - knows how to apply the analytical procedures for the evaluation of the individual response to drugs in relation to the individual genetic variants; - knows the pharmacotherapeutic profile of biological drugs; - knows and knows how to use cell models for the analysis of biotechnological drugs or innovative drugs.

Course contents

Unit 1 – Lectures (32 hours)

An integrative approach for the discovery of biological and innovative drug targets by pharmacological and gene-based strategies.

Hit-to-probe-to-lead optimization: high-throughput functional tests and cell-based assays.

Screening innovative drugs acting though G-Protein-Coupled receptors.

Screening of innovative drugs targeting protein kinase and phosphatase.

Screening of innovative and biological drugs acting at Nuclear hormone receptors.

Novel strategies to assay biological drugs.

cDNA penetration and expression in eukaryotic cells. Use of non-viral and viral vectors for gene therapy. Recombinant adeno-associated viruses developed for gene therapy.

Oligonucleotide therapy.

RNAi therapeutic and its innovative biotechnological evolution

Bret and Fret analysis for the study of interactions between proteins induced by drugs.

Biological drugs and post-translational modifications: glycosylation of recombinant proteins. The example of darbepoietin.

Pharmacotherapeutic profile of biological drugs.

Applications of pharmacogenetics and pharmacogenomics to personalized drug therapy.

Unit 2 – Practical Laboratory Course (30 hours) - Professor Andrea Bedini

Gene reporter assay on mu opioid receptor gene in a human neuroblastoma cell line. Evaluation of a neuronal differentiation marker (GAP-43) in a human neuroblastoma cell line exposed to PMA using an immunofluorescence technique. Analysis of a Si RNA in cell lines.

Readings/Bibliography

Students will be provided with teaching material, including reviews and scientific articles to download from the accessible IOL platform in the UNIBO website. Furthermore, students will receive protocols to carry out the practical laboratory course.

The educational supports, presented in class, will be provided as PDF files and will be available to download from the IOL platform.

The following textbooks can be consulted in the Department library (Via Belmeloro 6):

1. Handbook of drug screening Second Edition. Edited by Ramakrishna Seethaka and Litao Zhang - Drugs and the Pharmaceutical Sciences Volume 196. Informa Healthcare, New York, London.
2. Biotechnology. Second Edition. Edited by David P. Clark and Nanette J. Pazdernik. Elsevier and APCell.

Teaching methods

Unit 1. The teaching method is based on lectures during which the contents of the program are exposed with the help of slides and video and discussed with the class. Students should attend at least at 70% of the lessons.

Unit 2. During the practical laboratory course the students are supervised by the teacher and by an academic tutor in charge, with a constant dialogue and discussions aimed at clarifying the analytical approaches employed and the correct use of the scientific equipment. A workbench is assigned to each student to carry out individual experiments with the assigned equipment. Students are encouraged to communicate to the teacher and to the tutor any requirement. Attendance at the laboratory course is mandatory.

Assessment methods

Unit 1. An oral exam to assess student’s learning outcome will be carried out. The following topics of the lectures will be asked: a) discovery of biological and innovative drug targets by pharmacological and gene-based strategies; b) lead optimization: high-throughput functional tests and cell-based assays; c) innovative drugs acting though G-Protein-Coupled receptors; d) innovative drugs targeting protein kinase and phosphatase; e) innovative and biological drugs acting at nuclear hormone receptors; f) novel strategies to assay biological drugs; g) cDNA penetration and expression in eukaryotic cells; h) use of non-viral and viral vectors for gene therapy; i) recombinant adeno-associated viruses for gene therapy; j) oligonucleotide therapy. RNAi therapeutics; k) Bret and Fret analysis; l) glycosylation of biological drugs; m) pharmacotherapeutic profile of biological drugs; n) pharmacogenetics and pharmacogenomics for improving personalized drug therapy.

A written assessment with open-ended questions, to measure students' grasp of the course lessons and identify areas that need work, will be done on the topics treated in the first six lectures and is not mandatory. This students’ evaluation, with their consent, may also be used for summative assessment [https://en.wikipedia.org/wiki/Summative_assessment] to contribute to final grades of this course.

Teaching tools

Teaching tools include: scientific articles, video, websites, graphics and drawings. Scientific instruments and equipment used in the laboratory course.

Office hours

See the website of Santi Mario Spampinato

See the website of Andrea Bedini