INTRODUCTION TO THE GENERAL PRINCIPLES OF R&D AND TRANSLATIONAL SKILLS

Armando Genazzani (6 h – 1 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: 3

Guest lecturers: 3

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: 6

Guest lecturers: 0

Laboratory: 0

The course wishes to give an introduction to the problems, hurdles and necessities to develop medicines and describes the entire process of R&D from ideation to approval. It will also show the market, patient and regulator perspectives as well as some historical cases that have modified R&D in the last 20 years.

 

Title Introduction to the general principles of R&D and translational skills (2 ECTS)
Program

The course is a short overview of the R&D process. Most concepts will then be more thoroughly covered during the course of the degree and the course is therefore seen as an introduction.

  • ideation and patenting;

  • big pharma, start-ups, consulting and the new concepts of R&D;

  • the different kinds of drugs (rare disease, community drugs, hospital drugs);

  • clinical research;

  • the importance of regulations and market access;

  • clinical need, clinical benefit and added value;

A focus is given to in vitro pharmacology in research and drug screening and cell-based models. Aspects of assay design ranging from cell type choice, readout selection, standardization, miniaturization, high content analysis, will be covered. Moreover, advantages of targeted versus phenotypic assays in drug screening will be discussed.

Textbooks Notes and handouts distributed during seminars; websites of the regulatory agencies or of the legislative bodies (e.g. www.ema.europa.eu; www.fda.gov; www.ich.gov)
Objectives

The aim of the short course is to give an overview of the R&D process.

Prerequisites None.
Teaching methods Lectures and seminars.
Expected Results

Students should be able to:

  • Correctly define the different phases of R&D;

  • Perform a patent search;

  • Design a strategy for a research idea; this will be implemented in the second semester and during the tutored activity;

  • Understand the main principles guiding rational design of cell-based assays and their application in drug screening.

Exam modality The exam mark will be composed of three parts: i) a group work associated to the evaluation of EMA approvals; ii) a project work in the form of a written assay that investigates the patenting of a particular drug class; iii) a group project work in the form of a ppt consisting in the proposal of a cell based-assay for drug discovery purposes.

The course wishes to give an introduction to the problems, hurdles and necessities to develop medicines and describes the entire process of R&D from ideation to approval. It will also show the market, patient and regulator perspectives as well as some historical cases that have modified R&D in the last 20 years.

TITLE

Introduction to the general principles of R&D and translational skills (2 ECTS)

PROGRAM

The course is a short overview of the R&D process. Most concepts will then be more thoroughly covered during the course of the degree and the course is therefore seen as an introduction.

  • ideation and patenting;

  • big pharma, start-ups, consulting and the new concepts of R&D;

  • the different kinds of drugs (rare disease, community drugs, hospital drugs);

  • clinical research;

  • the importance of regulations and market access;

  • clinical need, clinical benefit and added value;

A focus is given to in vitro pharmacology in research and drug screening and cell-based models. Aspects of assay design ranging from cell type choice, readout selection, standardization, miniaturization, high content analysis, will be covered. Moreover, advantages of targeted versus phenotypic assays in drug screening will be discussed.

TEXTBOOKS

Notes and handouts distributed during seminars; websites of the regulatory agencies or of the legislative bodies (e.g. www.ema.europa.eu; www.fda.gov; www.ich.gov)

OBJECTIVES

The aim of the short course is to give an overview of the R&D process.

PREREQUISITES

None

TEACHING METHODS

Lectures and seminars.

EXPECTED RESULTS

Students should be able to:

  • Correctly define the different phases of R&D;

  • Perform a patent search;

  • Design a strategy for a research idea; this will be implemented in the second semester and during the tutored activity;

  • Understand the main principles guiding rational design of cell-based assays and their application in drug screening.

EXAM MODALITY

The exam mark will be composed of three parts: i) a group work associated to the evaluation of EMA approvals; ii) a project work in the form of a written assay that investigates the patenting of a particular drug class; iii) a group project work in the form of a ppt consisting in the proposal of a cell based-assay for drug discovery purposes.

Last modified: September 17, 2020