Ateneo - UPO

The course aims at providing a general knowledge on drug R&D process.

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.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The students, in an individual effort, will be required to search and retrieve data on a recently developed drug for skin disorders and critically evaluate either preclinical and/or clinical aspects of the R&D process as described in a peer reviewed publication of choice .

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 being a CEO of a start up company involved in R&D (3 h seminar by Dr. Beatrice Riva): 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.