The aim of the course is to provide the student with concepts about the molecular basis, development, and function of biotechnological drugs.

Specifically, the aims of the course are the knowledge of:

- Molecular basis of Biotechnological drugs

- Different generations and related innovations of Biotechnological drugs

Difference between a biotech drug and a small molecule drug. Pharmacokinetics, Pharmacodynamics, and side effects of biotech drugs. Genetic engineering in Pharmacology.  Genetic Clonings and transfection methods of DNA in cell culture for the synthesis of recombinant proteins.   Transgenic mice for development and drug production. Proteins like drugs: biochemical properties to assess the efficacy and genetic engineering of proteins. Recombinant insulin (slow and fast-acting). Recombinant t-PA, recombinant Interferon, recombinant Human growth hormone, and antagonist of HGH receptor. Vaccine, new generation vaccine,  examples of Salk, Sabine, HBV, and HPV vaccines.

Oligonucleotides like drugs. Chemical modifications of oligonucleotides.  Gene therapy with ASO in Duchenne muscular dystrophy and SMA. Gene therapy, viruses as vectors for gene delivery. CRISPR/Cas9 and CAR-T. Gene therapy for ADA-SCID and Leber's congenital amaurosis. Monoclonal antibodies. Drugs acting on tyrosine kinase receptors. Human antibodies. Phage display and Xeno mouse technology to get human antibodies. TNF alpha inhibitors (infliximab, adalimumab, etanercept e certolizumab pegol). Inhibitor of VEGF signal and angiogenesis (sunitinib, sorafenib e bevacizumab, aflibercept, ranibizumab). Biotech drugs for breast cancers (Trastuzumab and Trastuzumab-DM1). Therapy with monoclonal antibodies, passive and active immunotherapy. Biotech drugs for chronic inflammatory diseases. Gene silencing for the treatment of dyslipidemia and hypertriglyceridemia. Drugs for multiple sclerosis. Pharmacogenomics and Pharmacogenetics.

Biochemistry

Pharmacology and Pharmacotherapy (optional)

At the end of the course, the student will have built a knowledge of the main classes of biotechnological drugs, their therapeutic uses, and the related toxic effects.

Knowledge and Understanding: The students will achieve the molecular basis, the pharmacology (i.e. pharmacokinetics and pharmacodynamics), and side effects of biotechnological drugs.

Ability to apply knowledge and understanding: The students will acquire a  proper pharmacological language and will be able to apply the acquired principles on biotech drugs for the study of intracellular signaling.

Judgment: The student will be able to critically evaluate the pro and cons of biotechnological drugs.

Communication skills: The student will be able to describe the pharmacology of Biotech drugs with proper scientific language.

Learning skills: The student will be able to build up his scientific knowledge in a critical way, using not only the study material provided by the professor but also dedicating himself to in-depth studies.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

The lectures include the use of multimedia tools (presentations in MS Power Point, etc,).

Teaching

 Lectures (presentations in MS Power Point, scientific papers etc,).

Innovative teaching methods

Scientific papers will be distributed to students to update them on some topics of the Course

Attendance

Knowledge of Pharmacology and Pharmacotherapy and Biochemistry.

Course books

Farmaci biotecnologici  Elisabetta Vegeto Cea casa Editrice Ambrosiana

Goodman and Gilman - Le basi farmacologiche della terapia (2019)

Assessment

During the course, there will be two in itinere written tests which replace the final exam. In this case, the final outcome will be the mean of the two marks achieved in each test, only if both are ≥ 18/30. Those who do not achieve a mark ≥ 18 in one of the two partial tests must take the full examination. 

The written test consists of a series of multiple-choice and open questions. The time available is of three hours.

Students who have passed both tests, but are not satisfied with the result, can refuse by communicating it within 5 days from the date of publication of the result. In that case, they have to register for the regular exam.

The exam consists of an oral test. The candidate will be asked questions on topics covered during the lessons in order to ascertain that the student has acquired the basic concepts on the development of biotechnological drugs. The final mark, expressed out of thirty, will result from the candidate's ability to answer the questions asked in an exhaustive and reasoned manner and with appropriate scientific language.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Teaching

Presentations in MS Power Point, scientific papers etc.

Attendance

Knowledge of Pharmacology and Pharmacotherapy and Biochemistry.

Course books

Farmaci biotecnologici  Elisabetta Vegeto Cea casa Editrice Ambrosiana

Goodman and Gilman - Le basi farmacologiche della terapia (2019)

Assessment

The exam consists of an oral test. The candidate will be asked questions on topics covered during the lessons in order to ascertain that the student has acquired the basic concepts on the development of biotechnological drugs. The final mark, expressed out of thirty, will result from the candidate's ability to answer the questions asked in an exhaustive and reasoned manner and with appropriate scientific language.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

It is suggested a previous study of Pharmacology and Pharmacotherapy