D1 Knowledge and understanding
At the end of the course the student must know the principles for the identification, research and registration of new drugs; moreover, it will have to know the genomic bases of inter-individual variability in the response to drugs and the pharmacogenomic effects on the main classes of drugs and their molecular targets.

D2 Applying knowledge and understanding
At the end of the course the student must know how to choose and apply, considering both technical and ethical aspects, a genetic essay to characterize a pharmacogenomic characteristic and be able to draw an experimental study for the development of a drug or adapt the treatment with the main classes of drugs on the basis of pharmacogenomic characteristics.

D3 Making judgments
At the end of the course the student must be able to work independently using the knowledge regarding the development of drugs and the personalization of therapies through a pharmacogenomic approach, both in design of an experimental study and in clinical implementation.

D4 Communication skills
At the end of the course the student must be able to clearly explain the concepts acquired in point 1.

D5 Learning skills
At the end of the course the student must be able to study independently the topics covered in the course, also through the consultation of specific bibliography texts.

Basic notions of pharmacology are required to follow the course profitably.

Drug development
Evidence Based Medicine and Real World Data
Frictions in drug development and new research frontiers
Identification and characterization of the active substance
Pre-clinical experimentation
Pre-registration and post-registration clinical experimentation
ICH and regulatory guidelines
Registration dossier and marketing authorization
Manufacturing practices and quality control (GXP)
Principles of pharmacovigilance

Pharmacogenomics
General aspects
Genotyping techniques
Principles of pharmacokinetics
Pharmacogenomics of phase I and phase II enzymes of drug biotransformation
Pharmacogenomics and drug transporters
Principles of pharmacodynamics: pharmacogenomic aspects
Databases and ethical considerations
Patient-specific models in personalized medicine
Pharmacogenomics of drugs used in different therapeutic areas.
The content of the teaching corresponds to the educational objectives stated in Article 2 of the Teaching Regulations of the Course of Studies

F Rossi, V Cuomo, C Riccardi, Pharmacology: basic principles and applications, Ed. Minerva Medica

RB Altman, D Flockhart, DB Goldstein eds: Principles of pharmacogenetics and pharmacogenomics, Cambridge University Press, 2012.

Drug development
Evidence-based medicine and real-world data.
Frictions and critical factors in drug development; new frontiers of research: the concept of "innovation" in pharmaceuticals, "first-in-class" drugs and "followers," AIFA criteria for attributing innovativeness.
Research and development process for new drugs: target identification, target validation, lead identification, lead optimization.
Preclinical development: screening of active compounds, in vitro and in vivo efficacy studies, toxicological studies.
Pre-approval clinical trials: phase I, phase II, phase III studies, main features and objectives; post-approval clinical trials: PAES, PASS, phase IV studies.
Ethical aspects of drug testing in humans.
ICH and regulatory guidelines.
Registration and marketing authorization dossier: legal basis, application types and national and supranational approval.
Manufacturing and quality control procedures from laboratory to clinic (GXP).
Principles of pharmacovigilance: the national, European and global pharmacovigilance network; methods for pharmacovigilance studies.

Pharmacogenomics
General aspects: genetic basis of pharmacogenomics
Genotyping techniques
Principles of pharmacokinetics: absorption, distribution, biotransformation, excretion
Pharmacogenomics of phase I and phase II enzymes of drug biotransformation
Pharmacogenomics and drug transporters
Principles of pharmacodynamics: pharmacogenomic aspects
Pharmacological and pharmacogenetic databases
Ethical considerations
Patient-specific models in personalized medicine

Therapeutic areas:
Pharmacogenomics of oncological drugs: the paradigm of thiopurine drugs
Pharmacogenomics of antidepressants and antipsychotics
Pain therapy and pharmacogenomics
Pharmacogenomics of carbamazepine and other antiepileptics
Pharmacogenomics of cardiovascular drugs: warfarin, clopidogrel, statins
Pharmacoepigenomics of glucocorticoids

Frontal lectures with the help and support of images and short explanatory texts regarding the essential aspects of the topics covered.

Any changes to the methods described here that may be necessary to ensure the application of safety protocols in the context of possible emergency situations will be announced on the Department website, the Course of Study and on the Moodle page for teaching.

Lecture’s slides and any other additional material are available on Moodle2.units.it and are accessible via a password provided by the course teacher.
For any other information contact the course teachers at the email address: abergamo@units.it and/or mlucafo@units.it

Any changes to the methods described here that may be necessary to ensure the application of safety protocols in the context of possible emergency situations will be announced on the Department website, the Course of Study and on the Moodle page for teaching.

The learning assessment includes an oral exam designed to assess the level of knowledge of the topics covered in the program, the level of mastery and precision of the specialized language, and the ability to develop an argument by applying the knowledge acquired in teaching course and integrating it with the other disciplines already covered in the study course. The exam lasts between 20 and 40 minutes and covers all topics in the program. The result of the exam will be evaluated with a score of thirty points based on the following criteria:
-Excellent (30-30 cum laude): excellent knowledge of the topics, excellent language skills, excellent analytical skills; the student is able to brilliantly apply theoretical knowledge to concrete cases.
-Very good (27-29): good knowledge of the topics, remarkable language skills, good analytical skills; the student is able to correctly apply theoretical knowledge to concrete cases.
-Good (24-26): good knowledge of the main topics, good language skills; the student shows adequate ability to apply theoretical knowledge to concrete cases.
- Satisfactory (21-23): The student does not fully master the main topics of teaching, but has the basic knowledge; however, he/she demonstrates satisfactory language skills and an adequate ability to apply theoretical knowledge to concrete cases.
-Sufficient (18-20): minimal knowledge of the main topics of teaching and technical language, limited ability to adequately apply theoretical knowledge to concrete cases.
- Insufficient (<18): The student does not have acceptable knowledge of the content of the various topics of the teaching course.

Any changes to the methods described here that may be necessary to ensure the application of safety protocols in the context of possible emergency situations will be announced on the Department website, the Course of Study and on the Moodle page for teaching.

This course addresses issues closely related to one or more of the United Nations 2030 Agenda for Sustainable Development goals.