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 –Prof. Andrea Bedini

Lectures (16 hours)

Antisense oligonucleotides-based innovative therapies.

Monoclonal antibodies and molecular engineering of therapeutic antibodies.

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.

An integrative approach for the discovery of biological and innovative drug targets. 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.

Immunogenicity of biotech drugs.

Practical Laboratory Course (15 hours)

Set up of neuronal cellular models to investigate opioid receptors transcriptional regulation through reporter gene assays. Set up of tumoral cell models to test and validate gene silencing strategies. Set up of neuronal cell models to characterize differentiating agents.

Unit 2 - Prof. Monica Baiula 

Lectures (16 hours)

Recombinant therapeutic proteins.

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

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

Pharmacotherapeutic profile of biological drugs.

Gene therapy

RNAi therapeutic and its innovative biotechnological evolution

Applications of pharmacogenetics and pharmacogenomics to personalized drug therapy.

Practical Laboratory Course (15 hours)

Analysing gene silencing efficacy and the subsequent modulation of cellular effectors in tumoral cell models via Western Blot. Analysing neuronal in vitro differentiation via immunocitochemistry and fluorescence microscopy  

Readings/Bibliography

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

The educational supports, showcased in class, will be provided as Power-point or PDF files and will be available for download from the Virtuale platform.

The following textbooks can be consulted at Biblioteca del Navile (https://navile.sba.unibo.it/):

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

Lectures. The teaching method is based on lectures during which program contents are presented  using slides and video and discussed with the class. Students should attend at least to 70% of the lessons.

Practical laboratory course. During the practical laboratory course the students are supervised by Professors 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 with Professors and academic tutor in case of any doubts or need for further information. Attendance to the laboratory course is mandatory.

Assessment methods

Lectures (Unit 1 + Unit 2). 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 to be studied and elaborated further, will be done on the topics treated in the first six lectures and is not mandatory. This students’ evaluation may also be included to contribute to final grades of this course, should the students agree upon.

Practical laboratory course (Unit 1 + Unit 2). Students are required to submit a written report on the experimental activities carried out during the practical laboratory course and the obtained results. Report should be submitted at least 10 days prior to mark registration.

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 Andrea Bedini

See the website of Monica Baiula