Ateneo - UPO

The course aims to provide a detailed understanding of the INN naming process for biological active substances, including proteins, monoclonal antibodies, and advanced therapies. Students will gain insights into the scientific principles, nomenclature rules, and the importance of INN usage in the healthcare and pharmaceutical sectors.

The reference materials for the course are available on the official website of the World Health Organization (WHO). Participants can access documents related to the INN Programme, nomenclature guidelines, and other relevant resources. All materials are freely accessible and serve as the primary source for exploring the topics covered in the course. Link to WHO website: https://www.who.int/teams/health-product-and-policy-standards/inn

The course aims to provide an in-depth understanding of the naming process for biologically active substances under the WHO’s International Nonproprietary Name (INN) Programme. Participants will learn about general policies, naming schemes, and rules applied to complex biological medicines, proteins, monoclonal antibodies, and advanced therapies. The course also explores specific naming policies for vaccines and innovative technologies, including gene and cell therapies.

Suggestion: FA0721 - Introduction to Drug Nomenclature and INN

The course is conducted entirely online via the Moodle platform. It consists of a series of video lectures covering the various thematic modules of the program. Supporting materials, including slides and additional resources, are provided to deepen the topics covered and enhance learning.

For further information, please refer to the course page on D.I.R. at: https://www.dir.uniupo.it/course/view.php?id=22355 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.

Assessment will be conducted through practical exercises and self-assessment quizzes embedded within the course modules. Each quiz is designed to test the understanding of key concepts and the application of rules and principles of INN nomenclature. No final exam is required. Eligibility is determined by successfully completing the self-assessment quizzes for each module.

The course is divided into seven modules: 1. Introduction to Biologically Active Substances and the INN Programme: o Definition of biological medicines. o Examples of biological medicines. o Challenges and specific descriptions for biologicals within the INN framework. 2. Proteins and Other Complex Biological Substances: o General policies for non-glycosylated substances. o Glycosylated substances, fusion proteins, and transgenic substances. o Naming policies for conjugated and PEGylated proteins. 3. Monoclonal Antibodies – Traditional Naming Scheme: o Policies and challenges related to monoclonal antibodies. o Evolution of the naming scheme. 4. Monoclonal Antibodies – New Naming Scheme: o Definition and application of new suffixes (-tug, -bart, -ment, -mig). 5. Advanced Therapies: o Nomenclature for gene and cell therapies. o Naming rules for gene, vector, and virus-based components. o New rules for autologous cell-based therapies and virus-based therapies. 6. Vaccines: o Naming policies for recombinant therapeutic proteins and vaccines. o Innovative technologies, including mRNA therapies.

By the end of the course, students will be able to: • Understand the scientific principles and rules for naming INN for biological substances. • Analyze specific cases of proteins, monoclonal antibodies, and advanced therapies. • Apply naming rules to new contexts in the pharmaceutical field.