Ateneo - UPO

The integrated course offers a comprehensive view of the drug lifecycle, guiding students through the translational pathway from the discovery and preclinical phases to commercialization. It addresses both pharmacological and clinical aspects—from target validation and in vitro/in vivo models to ADME-Tox studies, clinical trial phases, and the regulatory framework (EMA, FDA, GCP, GLP)—as well as practical medicinal chemistry and formulation development, focusing on developability criteria, process chemistry, GMP/non-GMP synthesis, ICH guidelines on impurities, advanced chemical modalities (such as PROTACs or ADCs), and the application of Quality by Design to balance efficacy, stability, and manufacturability. Completing this pathway, the course integrates principles of economics, patenting, and technology transfer—including methods for estimating the economic value of inventions, business plan development, and investor pitch design—while promoting the conscious and critical use of emerging technologies, such as generative AI and Machine Learning, across all modules for scientific data analysis and modeling.

• Caliceti P., Tecnologia Farmaceutica, CEA – Casa Editrice Ambrosiana, latest edition.
• Aulton M.E., Taylor K.M.G., Aulton's Pharmaceutics: The Design and Manufacture of Medicines, Elsevier, latest edition.
• Teaching material, web references, case studies and scientific papers provided during the course.

Knowledge and Understanding: Upon completion of this integrated course, students will understand: The scientific, strategic, and regulatory principles driving the industrial pharmaceutical R&D process; the medicinal chemistry criteria for candidate selection, process chemistry principles, impurity control, and non-GMP/GMP synthesis; formulation logic and Quality by Design principles required to turn an active molecule into an industrializable product; patent protection regulations, economic valuation of inventions, and funding channels for innovative projects.
Applying Knowledge and Understanding: Students will be able to critically evaluate the developability of a drug candidate by integrating physicochemical properties, ADME/PK profile, and synthetic manufacturability; apply Quality by Design tools to formulation design decisions; analyze the patentability of an invention, use analytical models to estimate its economic value, and draft funding plans; devise strategies to address unmet clinical needs while ensuring scientific, regulatory, and economic robustness.
Making Judgements: Ability to critically analyze technical documents, patents, EPARs , and scientific literature.
Learning Skills: Acquisition of a multidisciplinary, continuous problem-solving approach to understand and operate within industrial R&D.

Completion or attendance of Medicinal Chemistry 1, General and Cellular Pharmacology and Toxicology with Pharmacology Lab, alongside a foundational knowledge of Pharmaceutical Technology and Economics and Management of the Pharmaceutical Industry.

The course adopts a combination of traditional lectures and active learning activities:
- Real case studies and official documents, such as EMA EPARs, patents, and business plans.
-Interdisciplinary group work focused on the guided simulation of a start-up or drug discovery and development project, alongside practical sessions and exercises on Quality by Design (QbD) risk assessment, economic valuation of patents, and patent coverage analysis.
-Generative AI will be used under guided supervision as a supporting tool for literature research and hypothesis generation, with mandatory verification against primary sources.

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 written test will be common to the different modules of the course and will contribute 60% to the final grade. The final mark will be calculated as a weighted average of the scores obtained in each module.

The integrated course offers a multidisciplinary pathway designed to provide a comprehensive understanding of the various stages of drug research, development, and commercialization.
In Pharmacology and Clinical Development, the focus is placed on biological target identification and validation, in vitro and in vivo models, ADME-Tox studies, First-in-Human dose selection, clinical trial phases (Phases I, II, III), pharmacovigilance, and regulatory requirements including GCP, GLP, EPARs, and EMA/FDA/AIFA approvals.
Practical Medicinal Chemistry covers preclinical candidate selection and progression criteria, development synthesis, process chemistry (scalability, yield, safety, and sustainability), the transition between non-GMP and GMP synthesis, API characterization, and impurity control according to ICH guidelines Q3A, M7, Q7, and Q11. It also analyzes advanced chemical modalities such as PROTACs, molecular glues, antibody-drug conjugates (ADCs), peptidic and non-peptidic macrocycles, and deuterated drugs.
Formulation Development and Quality by Design (QbD) addresses the transformation of a preclinical candidate into an industrializable pharmaceutical product by integrating QbD concepts to design and document formulation choices, evaluating the trade-offs between stability, bioavailability, efficacy, quality, and manufacturability.
Economic-Patent Aspects and Technology Transfer covers intellectual property regulation and protection, patent databases, economic valuation of inventions using historical costs, market potential, and benchmarking, alongside assignments, licensing agreements, innovation financing models, and the drafting and critical evaluation of business plans and investor pitches.
Across all modules, the conscious and critical use of generative AI and machine learning is introduced and promoted as a supporting tool for information management, literature analysis, and scientific hypothesis development.

- Scientific and Regulatory Mastery: Acquire expertise in industrial pharmaceutical R&D principles, understanding pharmacological criteria (target validation, ADME-Tox studies, clinical trial phases) and the regulatory framework (GCP, GLP, EPAR, EMA/FDA/AIFA approvals).
- Developability Assessment: Critically evaluate the suitability of a drug candidate by integrating physicochemical properties, process chemistry, synthetic scalability, impurity control (ICH guidelines), and Quality by Design (QbD)-based formulation development strategies.
- Economic-Patent Expertise and Technology Transfer: Acquire an economic approach to analyzing and commercializing pharmaceutical inventions, with the ability to estimate R&D costs and market potential, analyze patentability, understand innovation financing mechanisms, and critically evaluate Business Plans.
- Multidisciplinary Integration and Problem Solving: Integrate knowledge across diverse disciplines (pharmacology, chemistry, pharmaceutical technology, and economics) to devise or evaluate innovative therapeutic strategies aimed at addressing unmet clinical needs.
- Critical Use of Sources and Artificial Intelligence: Ability to retrieve, select, and critically verify information from scientific and regulatory sources, demonstrating a conscious and transparent use of generative AI models to support project development.