Drug Development: From Discovery to Market
Pharmaceutical sciences encompass a wide range of disciplines that are essential for the discovery, development, regulation, and commercialization of new drugs and therapies. These sciences can be broadly categorized into key areas, each including multiple specialized fields:
- Analysis and Pharmaceutical Quality Control
- Biotechnology
- Clinical Pharmacology and Translational Research
- Drug Discovery and Development Interface
- Formulation Design and Development
- Physical Pharmacy and Biopharmaceutics
- Pharmacokinetics, Pharmacodynamics, Drug Metabolism and Transport
- Regulatory Sciences and Pharmaceutical Marketing
Drug Development: From Discovery to Market is an intensive programme designed to provide participants with a comprehensive and integrated understanding of the entire drug development pathway, from the initial concept to market access and product commercialization. Drug development is a complex, multidisciplinary, and highly regulated process that requires coordinated expertise across scientific, regulatory, and business domains.
The programme offers advanced scientific training covering all key stages of the pipeline, including hit identification, lead optimization, formulation development, and clinical trial design. In addition, specific attention is given to regulatory strategies, approval processes, market access, and pharmaceutical marketing, highlighting the critical steps required to bring a drug successfully to patients.
The course builds on the strong multidisciplinary expertise of the Department of Drug and Health Sciences (DSFS), enriched by the contribution of internationally recognized experts from academia, industry, and regulatory agencies. This combination ensures that participants gain both solid theoretical foundations and real-world perspectives on modern drug development.
Participants will be exposed to a wide spectrum of disciplines, including medicinal chemistry, pharmaceutical technology, pharmacology, biochemistry, bioinformatics, genetics, preclinical and clinical research, as well as regulatory affairs and drug commercialization.
The multidisciplinary nature of the programme ensures an intellectually stimulating learning environment, where modules are delivered through intensive teaching formats by leading experts in their respective fields.
Overall, the programme provides a unique opportunity to understand, critically evaluate, and actively engage with the full lifecycle of drug development, including the scientific, regulatory, and market-driven components necessary for successful innovation.
The course functions as a “one-stop-shop” outlining the major scientific and strategic tools involved in drug discovery and development, illustrating how these contributions are phased over time and integrated to generate a drug suitable for clinical trials and eventual market entry. While the primary focus is on small-molecule drugs, comparisons with biotechnological products are also included.
Based on real-world experience, participants will follow the typical development pathway step by step:
Initiating Idea → Target Selection → Lead Identification → Clinical Candidate → Drug Delivery → Regulatory Approval → Market Access
Without this integrated, multidisciplinary approach—including regulatory and commercial considerations—it would not be possible for drugs to successfully reach the market.
Although the drug development process typically spans approximately 15 years, this programme condenses its key elements into an intensive 5-day experience. Participants will work in teams, simulating a drug discovery environment and stepping beyond their individual areas of expertise to gain a holistic understanding of the process.
A particular focus will be placed on formulation science. Drug substances are rarely administered alone but as part of dosage forms. Therefore, preformulation studies—aimed at characterizing the physicochemical and technological properties of active compounds—are essential. These studies enable a rational, science-based approach to formulation development and help identify potential challenges early in the process.
The programme will cover fundamental formulation principles, including preformulation, biopharmaceutical and bioavailability considerations, and the role of excipients in ensuring physical and chemical stability.
The course is delivered in a blended learning format, combining face-to-face teaching with digital components (8 hours). This flexible approach integrates the strengths of in-person and online learning, allowing for both synchronous and asynchronous activities tailored to diverse learning needs.
Blended teaching in pharmaceutical sciences represents an innovative educational strategy aimed at enhancing learning outcomes and student engagement while fostering the development of highly skilled pharmaceutical professionals.
The official language of the programme is English; therefore, proficiency in English is required.
The number of participants is limited to 20.
At least 20 places are reserved for international students supported by short-term mobility grants under the ERASMUS+ programme. In case of available places, students from the University of Catania may be admitted.
A minimum of 15 participants is required for activation.
Attendance of at least 75% of the blended course is mandatory. Assessment will be based on a laboratory report (25%) and a written exam covering the theoretical components (75%). Successful participants will receive a training certificate in accordance with the University of Catania regulations.
Participants wishing to present a poster are required to submit a Scientific Abstract (including title, authors, affiliation, abstract, references, and acknowledgements) at the time of application.
Registration is mandatory for all participants (ERASMUS+ and non-ERASMUS+) via the online form, including the indication of any specific dietary requirements:
https://webform.unict.it/en/drug-development-discovery-market
All participants are kindly requested to inform us of their arrival time and accommodation details by June 1, 2026 (please see contacts and CC: salvatore.guccione@unict.it).