PRECLINICAL AND CLINICAL PHARMACOLOGY

Armando Genazzani (12 h, 2 ECTS)

Armando Genazzani obtained his degree in Medicine and Surgery in 1992. He then moved to Oxford, to the Eidgenössische Technische Hochschule (ETH, Zurich; where he held an EMBO long-term fellowship) and to Cambridge, where he was appointed to a lectureship up to retirement age and was also named an Official Fellow and graduate tutor of Clare Hall.He returned to Italy in 2003 and is now a Full Professor of Pharmacology.

He has authored over 150 papers in international journals and is a named inventor on four patents in the field that have been licenced or have been the object of research contracts with pharmaceutical companies. He has also received the David Phillips Fellowship for research in marine biology and the Marine Biology station of Plymouth in 1997 and the Galeno Prize for Young Scientists in 2008.

At present he organizes a Masters degree in Regulatory Affairs and Market Access, is the Vice-Rector of the University for International Relations and is on the expert panel of the World Health Organization for international non-proprietary names. He has sat on the Scientific-Technical Committee of the Italian Medicine’s Agency (AIFA) from 2015 to 2018 and at present sits on the Institutional Review Boards for Clinical Research.

Academic lecturers: 12

Guest lecturers: 0

Laboratory: 0

Mariagrazia Grilli (6 h, 1 ECTS)

After an MD and a PhD in Experimental Medicine, University of Brescia, Italy, she spent more than four years as Visiting Scientist at the NIH, Bethesda, MD, USA. In 1997 she became Principal Scientist and then in 2000 Section Head, Cellular and Molecular Biology, at the Schering Plough Research Institute, San Raffaele Biomedical Science Park, in Milan, Italy. Currently, she is Associate Professor of Pharmacology at the Department of Pharmaceutical Sciences (UPO). Her main current research interests include: i) the role of adult neurogenesis and the cross-communication between neural stem cells and non-neuronal cells in the adult neurogenic niche in the physiopathology of neuropsychiatric disorders; ii) hippocampal and hypothalamic adult neural stem cells as targets of psychoactive drugs; iii) the contribution of neural stem cell abnormalities to cognitive impairment associated with Down Syndrome; iv) the role of NF-kB mediated signalling in the modulation of adult neurogenesis and neuroplasticity

Academic lecturers: 8

Guest lecturers: 0

Laboratory: 0

Fausto Chiazza (6 h, 1 ECTS)

Fausto Chiazza is a Researcher at the Department of Pharmaceutical Sciences of the University of Piemonte Orientale in Novara. He received a master degree in Pharmaceutical Chemistry and Technology at the University of Turin and a PhD in ‘Pharmaceutical and Biomolecular Sciences’ at the School of ‘Science of nature and innovative technologies’ of the University of Turin with a project entitled: ”Development of original experimental models of “diabesity” to identify innovative therapeutic targets”. Fausto Chiazza spent part of his PhD as a visiting PhD student in the laboratories of “Diabetology and Endocrinology” of Children Hospital of Zurich. After obtaining his PhD, Fausto Chiazza continued its research at the University of Turin, at the Department of Clinical Science and Education Karolinska Institutet in Stockholm and, eventually, at University of Piemonte Orientale. This Activity led to the publication of 43 scientific papers in international peer reviewed journals. His research regards:
the characterization of the molecular basis of metabolic diseases, mainly focusing on the investigation of inflammatory pathways and identification of mediators of inter-organ communication in these settings;
the study of the cellular mechanisms at the basis of the neurological complications of diabetes;
the pharmacological modulation of these pathways aimed at the prevention/management of the health consequences of metabolic related inflammation (“metaflammation”), as one of the key drivers of metabolic disorders and related neurological/cardiovascular co-morbidities.

Academic lecturers: 6

Guest lecturers: 0

Laboratory: 0

Pre-clinical and Clinical Pharmacology. The course will illustrate the drug discovery process from a pharmacological perspective and will highlight, with discussion of successful and unsuccessful case studies, the current challenges and limitations of the use of animal models in pharmacological research. Particular attention will be dedicated to aspects which may be relevant for improving the translational value of such models in drug discovery.

Furthermore, the course will provide students with the ability to read and critically analyze pre-clinical and clinical data. Importantly, lectures and exercises will deal with the genral principles of pharmacology, and will include PK and binding exercises.

Title Preclinical and clinical pharmacology
Program

 

Advanced principles of general pharmacology including robustness of data, risk/benefit profile and unmet therapeutic need.

  • Principles of occupancy theory;
  • Nomenclature of drugs;
  • Benefit/risk;
  • Pharmacokinetics;
  • Binding calculations;
  • Pharmacokinetic calculations.

Animal models in drug discovery:

  • The European legislation on the use of animals in research
  • Conventional and less conventional animal models
  • The concepts of “validity” for animal models
  • The use of genetically modified animals as relevant tools in drug discovery
  • Discussion of selected animal models for relevant human disorders
  • Animal models of skin diseases
Textbooks Lecture notes;

Scientific articles from the literature;

Goodman and Gilman, The Pharmacological basis of therapeutics.

Objectives The course aims to allow students to understand the general principles of drug action.

Furthermore, it also to allow students to understand current standards and unmet therapeutic needs and to participate in preclinical and clinical drug developments.

Single drugs and drug classes used in dermatology will be dealt with during the assignment.

Pre-requisites Basic knowledge of pharmacology, including pharmacokinetics and pharmacodynamics.

 

Teaching methods Traditional lectures, discussion of case studies, work groups.
Expected Results At the end of the course, the student is expected to throughly know the principles governing drug action for both small chemical entities and biological drugs. He/she will also be expected to know the molecular mechanisms, the side effects and the potential and limits of the assigned drug as a platform to be able to disclose any other drug.

Students are expected to critically analyse the translational value of animal models as well as to understand challenges and limitations of recapitulating human disorders in animal species for pharmacological studies.

Exam modality The exam mark is composed of 3 parts:

  • A written part with 4 questions taken from the program. It would be expected that students are able to summarize the information given at lectures and to implement it from data from the literature. For the part on animal models, students will be required to give a power point presentation describing an animal model of their choice and critically dissect its advantages and limitations for drug discovery.
  • A written exam in which students are expected to undertake binding and pharmacokinetic calculations in problems similar to those posted on the common repository;
  • An assignment of a drug in which students should describe mechanism of action, pharmacokinetics, therapeutic need, competitors, and place in therapy.

Pre-clinical and Clinical Pharmacology. The course will illustrate the drug discovery process from a pharmacological perspective and will highlight, with discussion of successful and unsuccessful case studies, the current challenges and limitations of the use of animal models in pharmacological research. Particular attention will be dedicated to aspects which may be relevant for improving the translational value of such models in drug discovery.

Furthermore, the course will provide students with the ability to read and critically analyze pre-clinical and clinical data. Importantly, lectures and exercises will deal with the genral principles of pharmacology, and will include PK and binding exercises.

TITLE

Preclinical and clinical pharmacology

PROGRAM

Advanced principles of general pharmacology including robustness of data, risk/benefit profile and unmet therapeutic need.

  • Principles of occupancy theory;
  • Nomenclature of drugs;
  • Benefit/risk;
  • Pharmacokinetics;
  • Binding calculations;
  • Pharmacokinetic calculations.

Animal models in drug discovery:

  • The European legislation on the use of animals in research
  • Conventional and less conventional animal models
  • The concepts of “validity” for animal models
  • The use of genetically modified animals as relevant tools in drug discovery
  • Discussion of selected animal models for relevant human disorders
  • Animal models of skin diseases

TEXTBOOKS

Lecture notes;

Scientific articles from the literature;

Goodman and Gilman, The Pharmacological basis of therapeutics.

OBJECTIVES

The course aims to allow students to understand the general principles of drug action.

Furthermore, it also to allow students to understand current standards and unmet therapeutic needs and to participate in preclinical and clinical drug developments.

Single drugs and drug classes used in dermatology will be dealt with during the assignment.

PREREQUISITES

Basic knowledge of pharmacology, including pharmacokinetics and pharmacodynamics.

TEACHING METHODS

Traditional lectures, discussion of case studies, work groups.

EXPECTED RESULTS

At the end of the course, the student is expected to throughly know the principles governing drug action for both small chemical entities and biological drugs. He/she will also be expected to know the molecular mechanisms, the side effects and the potential and limits of the assigned drug as a platform to be able to disclose any other drug.

Students are expected to critically analyse the translational value of animal models as well as to understand challenges and limitations of recapitulating human disorders in animal species for pharmacological studies.

EXAM MODALITY

The exam mark is composed of 3 parts:

  • A written part with 4 questions taken from the program. It would be expected that students are able to summarize the information given at lectures and to implement it from data from the literature. For the part on animal models, students will be required to give a power point presentation describing an animal model of their choice and critically dissect its advantages and limitations for drug discovery.
  • A written exam in which students are expected to undertake binding and pharmacokinetic calculations in problems similar to those posted on the common repository;
  • An assignment of a drug in which students should describe mechanism of action, pharmacokinetics, therapeutic need, competitors, and place in therapy.

Last modified: June 03, 2021