Knowledge of biotechnological drug production technologies. Knowledge of the aspects related to the development, production, therapeutic and clinical applications of the biological drugs currently on the market, as well as the new therapeutic frontiers, with particular reference to advanced therapies and precision medicine. Knowledge of pharmacodynamics (molecular mechanisms and pharmacological targets), pharmacokinetics, uses and adverse effects of the main categories of biological drugs [polypeptide hormones, cytokines, blood proteins, enzymes, vaccines, monoclonal antibodies, advanced therapies (Advanced Therapy Medicinal Products -ATMPs)]. Principles of gene therapy and pharmacogenomics.
Expected learning outcomes
Know the fundamental mechanisms that regulate cellular pharmacology, the main factors responsible for the variability in response to drugs, the modalities of action of biological drugs. Students will also have to study in depth the techniques used for the development of biotechnological products and their applications, including gene and cell therapy products, and the fundamental concepts of pharmacogenomics and personalized therapy.
Deep kowhow of pharmacological sciences and pharmacotherapy., the basic pharmacoddynamic and pharmacokinetic principles , the new developments in drug-target interactions, the role of gene-environment interactions in drug responses, pharmacogenetic and pharmacogenomic, the development of innovative drugs, repurposing of old drugs, pharmacolgy and COVID19.,the basic biochemical and molecular transduction mechanisms of the principal classes drugs, pharmacological strategies applied to major receptor systems especially regarding cell death/survival, differentiation, migration, immune and hormonal responses, cell therapies and gene therapies.
Lectures
1. History and revolution of bio (techno) logical drugs
2. Genetic engineering in the development of pharmaceutical biotechnology
3. Recombinant proteins: general aspects, production, pharmacokinetics and pharmacodynamics, adverse effects
4. Monoclonal antibodies: structure and classes, mechanisms of action, pharmacokinetics, interactions with other drugs, adverse effects
5. Antisense oligonucleotides
6. Gene therapy
7. Cell therapy
8. Therapeutic and clinical applications of biological drugs: hormones, hematopoietic growth factors, coagulation factors and recombinant thrombolytic agents, biological drugs and ATMPs used in cancer therapy, biological drugs and ATMPs used as immunostimulants and immunosuppressants, vaccines, other biological drugs and ATMPs ( drugs that act on bone structure and mineralization, drugs of the nervous system, drugs for obstructive syndromes of the respiratory tract, drugs for eye diseases)
9. Biosimilar drugs
10. Economic and regulatory aspects of biological and biosimilar drugs
General pinciples of pharmacology and frug origin, old and new drugsi,drug repurposing dei farmaci drugs in Covid-19 era.Pharmacokinetic concepts, varianility factors in drug response, gene-environment interactions, drug-drug interactions, collateral, adverse effect, allergy and idiosincrasy, pharmacovilgilance. Molecular pharmacogy, drug targets,receptors, ion channels, transporters, and enzymes.Drug-receptor interactions, agonism, anatagonism, dose-response and and therapeutic index.. Classes of receptors and transduction mechanisms, GPC and G proteins,(generali mechanisms, classification, effectors). Moaminergic receptors and neurotransmitters, acetilcolinergic, pre/post-sinaptic receptors.and pharmacological consquences of activation/antagonism in associated pathologies, channel-receptors, nicotinic, GABAa, AMPA/NMDA: classificaztion and pharmacological consquences of activation/antagonism in associated pathologies. GF receptors with TK activity, ’insulin, IGF, EGF,VEGF, BDNF, NGF, PDGF, cytokine reeptors,i TOLL-like receeptors and immune responsea, TNF-R , apoptosis, therapeutic targets in deveopment of anticancer drugs, immunomodulators, and drugs to combat neurodegneration, nintracellular receptorsi (i.ie., estrogen-R, glucocticoid-R ecc), genomic and non-genomic mechanisms , . Pharmacogenetic and pharmacogenomic, (targeted therapies).Tranlational pharmacology and drug discovery platforms, cellular therapies, gene therapies.
Clementi F, Fumagalli G, Farmacologia Generale e Molecolare, 5° edizione
Rossi F., Cuomo V., Riccardi, C, "Farmacologia. Principi di base e applicazioni terapeutiche", Minerva Medica
Goodman e Gilman: "Le basi Farmacologiche della terapia. il Manuale" ed italiana; McGraw-Hill.