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.
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