Ateneo - UPO

The course aims to provide an overview of the various stages of drug development, focusing on several aspects: 1) the different professional roles within the pharmaceutical industry; 2) in vitro and in vivo preclinical models used in the drug discovery process; 3) clinical trials; 4) examples of drug development approved by regulatory agencies in the current year, sourced from the www.ema.europa.eu website; 5) effective presentations (pitches); 6) selection of hit and lead candidates; 7) biotechnological drugs and advanced therapies; 8) the role of artificial intelligence in drug development. Teaching activities will include active learning sessions based on the discussion of EPARs of recently approved drugs, group work, flipped classrooms, and seminars with industry experts.

Lecture notes and handouts provided during classEPARs (European Public Assessment Reports) of drugs approved by the European Medicines AgencyScientific literature

Knowledge and UnderstandingUpon completion of the module, students will understand the scientific and strategic logic guiding research and development (R&D), the roles of various professional figures, and the impact of emerging technologies within the pharmaceutical industry.Applying Knowledge and UnderstandingThe course will foster the ability to critically analyze challenges associated with drug development and to propose new therapeutic strategies for unmet clinical needs. Students will be able to design an innovative drug or an improved therapeutic formulation using a strategy that is robust from both a scientific and regulatory perspective.Making JudgmentsStudents will be capable of critically reading documents related to marketed drugs, clinical studies, and scientific papers. In particular, they will have enhanced their critical thinking toward information generated by artificial intelligence.Communication SkillsStudents will have developed skills for effective communication tailored to the nature of the audience, and they will know how to deliver an effective pitch.Learning SkillsThe course will provide conceptual tools useful for understanding pharmaceutical development activities carried out in an industrial setting and for tackling advanced topics related to the design, optimization, and industrialization of medicinal products. Furthermore, the ability to use innovative tools responsibly and mindfully for acquiring and processing scientific information will be stimulated.

Attendance of the courses "General and Cellular Pharmacology" and "Toxicology and Pharmacology Laboratory" in the third year.

The course combines traditional lectures with active learning activities.Innovative teaching activities will include:Analysis and discussion of EPARs;Group work;Guided, simulated development of a start-up focused on the development of a new drug.As part of the group activities, students may use Generative Artificial Intelligence tools to support information gathering and organization, hypothesis formulation, and the preparation of the final case study. Particular attention will be dedicated to verifying the information obtained by consulting scientific literature and regulatory sources.These activities will be integrated with the objectives of the multidisciplinary course "Drug Discovery and Development" and aimed at preparing the case study that will be the subject of the final examination.

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.

Learning assessment will take place as part of the integrated final examination for the "Drug Discovery and Development" course.The exam will consist of two parts:Written ExamThe written exam will be common to the different modules of the course and will aim to verify the knowledge and understanding of the theoretical content covered during the classes.The evaluation of the written exam will contribute 60% to the final grade. The score for the written exam will be determined as a weighted average of the marks obtained in the individual course modules.Oral Presentation of a Case StudyStudents will develop and present a multidisciplinary case study related to the Drug Discovery and Development process. The presentation will take place on the final day of the course and aims to assess the ability to integrate the knowledge acquired across the different disciplinary areas of the teaching program. In preparing their work, students may utilize Generative Artificial Intelligence tools as a support for researching and processing information. During the presentation, they must be able to describe how these tools were used, which information was subsequently verified, and what contribution they provided to the development of the project. The oral presentation will contribute 40% to the final grade

Drug development, from target selection to marketing, involves several distinct stages. This module will address these various phases from a pharmacological perspective.1) Target Identification and Drug Discovery (Responding to Unmet Clinical Needs)Therapeutic Need Analysis: Definition of unmet clinical needs and priority criteria in pharmaceutical research.Target Identification & Validation: Pharmacological criteria for selecting and validating a biological target (receptors, enzymes, ion channels, nucleic acids).From Lead Compound to Drug Candidate: Screening strategies (high-throughput screening - HTS).2) Preclinical Development (In Vitro and In Vivo) and Translational ScienceIn Vitro and In Silico Experimental Models: Cell cultures (2D/3D), organoids, and predictive models for pharmacokinetics and toxicology (ADME-Tox).In Vivo Testing: Selection of animal models, regulatory toxicology studies (dose-response, acute and chronic toxicity, genotoxicity), calculation of the first-in-human dose, and IND (Investigational New Drug) submission.3) Clinical Development and Post-Marketing PhaseClinical Trial Phases (Phases I, II, III) and Pharmacovigilance: Objectives, study design (single/double-blind, randomization, cross-over), population selection (healthy volunteers vs. patients), and clinical endpoints.Throughout the course, emphasis will be placed on:The balance between scientific design and regulatory constraints (GCP - Good Clinical Practice, GLP - Good Laboratory Practice);The professional figures and competent authorities involved in the development and approval process (EMA, AIFA, FDA), including marketing authorization applications (CTD Dossier, MA - Marketing Authorization);The applications of Artificial Intelligence and Machine Learning in the drug design and development process.

1) ability to present ideas efficiently; 2) ability to develop a strategy for drug development; 3) ability to integrate in an industrial context; 4) ability to devise strategies for fund-raising in the pharmaceutical context.