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 (3 h – 0,5 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: 3

Guest lecturers: 0

Laboratory: 0

Giovanni Appendino (3 h - 0.5 ECTS)

He obtained his degree in Chemistry and Pharmaceutical Sciences at the University of Turin. Currently, he is Full Professor of Organic Chemistry at UPO. He has been awarded the Rhone Poulenc-Rorer Prize and Brucker Prize of the Phytochemical Society of Europe and the Quilico Medal of the Italian Chemical Society, and has acted as local coordinator of 5 EU grants centering on natural products. He is at present the Editor-in-chief of the international journal Fitoterapia. He is chief scientific advisor of Indena, a world’s leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries.

Academic lecturers: 3

Guest lecturers: 0

Laboratory: 0

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. It describes the entire process of R&D from ideation to approval. It describes the main professional figures involved, the transversal skills required. 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;

–        chemistry in R&D;

–        hits, leads and drugs;

–        in vitro pharmacology in research;

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

–        in vivo pharmacology models;

–        clinical research;

–        the importance of regulations and market access;

–        clinical need, clinical benefit and added value.

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;

·       Be able to design a strategy for a research idea; This will be implemented in the second semester

Exam modality The exam is composed of two parts, each worth 50% of the final mark:

(a) A 30-question multiple-choice questionnaire that will cover lectures, seminars and reading material. Each correct answer will award 1 point, whereas wrong or blank answers will be evaluated 0 points (maximum score will be 30 points). The exam will be either on paper or computer-based;

(b) A group project based on EPARs of new molecules approved by the EMA in the period 2014-2018. Briefly, students will be asked to extract data from the EMA website to describe the number of approved medicines in a given year, the number of generics, biosimilars, chemical, biotechnological or ATMP entities. The number of oncological, orphan, or drugs that have no alternative may also be classified. Students will then be asked to attempt to find the origin of the original patents of the new chemical entities (not generics) as well as classify and provide statistics on the quality of pivotal trials performed. This quality can be declined differently by the different groups and may include, for example, the number of Phase III trials, appropriate comparator, length of time, therapeutic area, appropriate length of time according to use, appropriate primary endpoint (hard, soft, surrogate, etc). A report that will include, when appropriate, graphs, tables and descriptive or analytical statistics, will be the resultant of this work. The report will be evaluated for completeness of information, depth of analysis, quality of the report, and whether the conclusions that the group has drawn are backed up by the data obtained. Each group will receive drugs that have been authorized in 1 year and the project will be explained in a dedicated lecture. Each group will have the chance to consult the lecturer once after the design of the extraction database and once after data has been extracted.

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. It describes the entire process of R&D from ideation to approval. It describes the main professional figures involved, the transversal skills required. 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;
  • chemistry in R&D;
  • hits, leads and drugs;
  • in vitro pharmacology in research;
  • the different kinds of drugs (rare disease, community drugs, hospital drugs);
  • in vivo pharmacology models;
  • clinical research;
  • the importance of regulations and market access;

clinical need, clinical benefit and added value.

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;

Be able to design a strategy for a research idea; This will be implemented in the second semester

EXAM MODALITY

The exam is composed of two parts, each worth 50% of the final mark:

(a) A 30-question multiple-choice questionnaire that will cover lectures, seminars and reading material. Each correct answer will award 1 point, whereas wrong or blank answers will be evaluated 0 points (maximum score will be 30 points). The exam will be either on paper or computer-based;

(b) A group project based on EPARs of new molecules approved by the EMA in the period 2014-2018. Briefly, students will be asked to extract data from the EMA website to describe the number of approved medicines in a given year, the number of generics, biosimilars, chemical, biotechnological or ATMP entities. The number of oncological, orphan, or drugs that have no alternative may also be classified. Students will then be asked to attempt to find the origin of the original patents of the new chemical entities (not generics) as well as classify and provide statistics on the quality of pivotal trials performed. This quality can be declined differently by the different groups and may include, for example, the number of Phase III trials, appropriate comparator, length of time, therapeutic area, appropriate length of time according to use, appropriate primary endpoint (hard, soft, surrogate, etc). A report that will include, when appropriate, graphs, tables and descriptive or analytical statistics, will be the resultant of this work. The report will be evaluated for completeness of information, depth of analysis, quality of the report, and whether the conclusions that the group has drawn are backed up by the data obtained. Each group will receive drugs that have been authorized in 1 year and the project will be explained in a dedicated lecture. Each group will have the chance to consult the lecturer once after the design of the extraction database and once after data has been extracted.

Last modified: November 12, 2019