Ateneo - UPO

The course aims at providing a general knowledge on drug R&D process, its steps, the complex regulatory aspects, the bottlenecks and hurdles.

The course topics, for their nature, are usually not appropriately covered by booktexts; for these reasons selected bibliographic references and drug documentation for discussions/group work will be provided
to students.

People involved in the development of drugs have really diverse educational backgrounds and
cooperate with their complementary knowledge and skills to the final goal of R&D. The course aims at
conveying a general knowledge on the drug discovery and development process so that students from
different backgrounds may be able to appreciate the meaning and importance of the different phases of
R&D, become familiar with key terminology, understand complexity and identify critical factors and
bottlenecks that impact the discovery of medicines. Finally students may also be able to critically
understand the process that allowed a new medicine to be approved and, if given the opportunity,
communicate/cooperate across the different fields of the R&D process.

No required background knowledge

Teaching is given in the form of: i) classroom lectures; ii) practicals including literature and data
searches; iii) discussions of case studies. Additionally, the course is enriched by 3 h seminars by the
CEO of the start up company ChemiCare (Dr. Beatrice Riva) who will provide additional and personal
insights into R&D process and drug development with particular reference to GXP compliance and ICH
(international Council for Harmonization of Technical Requirements for Pharmaceuticals for Human
Use) guidelines.

Gli studenti con disabilità fisiche, difficoltà di apprendimento o bisogni educativi speciali possono richiedere
servizi e strumenti specifici tramite l’Ufficio Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e
agli Studenti, consultando la pagina web dell’Università: https://www.uniupo.it/en/services/services-students-
disabilità-fisiche-o-difficoltà-di-apprendimento
Gli studenti con disabilità, difficoltà di apprendimento o bisogni educativi speciali, una volta contattato il
personale dell’Università, possono rivolgersi al tutor responsabile del corso per definire le modalità d’esame,
per quanto riguarda gli aspetti accademici.

The different phases of R&D and the different professional profiles involved in R&D; early and key
decisions in R&D; preclinical in vitro and in vivo models in drug discovery; general principles of drug
screening and assay development for drug screening; clinical trials; critical discussion of R&D process
of drugs for skin disorders recently licensed; insights from start up company involved
in R&D: mindset, challenges, personal skills, business and market opportunity.

Upon course completion, the student should be able to: i) understand the significance and relevance of
the different and distinct phases of the R&D process; ii) recognize key decision points in R&D; iii)
carry out searches aimed at retrieving information relevant to the development of a drug; iv) review and
critically evaluate preclinical and clinical studies with a general understanding of their aim based on
medical needs, of chosen procedures, of results, conclusions and relevance.