Indústria Farmacêutica – Produção, Tendências e Oportunidades

Objectives

The main objective of this course is to provide students with an in-depth understanding of the internal functioning of the pharmaceutical industry, with a focus on the development, production, and commercialization of medicines. The course seeks to integrate scientific and engineering foundations with strategic, regulatory, and financing dimensions, preparing engineers to contribute effectively in the complex contexts of the biopharmaceutical industry. Aimed at engineering students at a decisive stage of their academic path, the course addresses key questions: What is the pharmaceutical industry really like, and how does it fit within health systems? How do pharmaceutical and biotechnology companies operate? What career paths are available, and how can students position themselves? What major strategic trends are transforming the sector? How is cutting-edge science translated into real products that save lives? And how is innovation financed within health systems?

Syllabus

The course is structured around three thematic pillars that integrate pharmaceutical bioprocesses with strategic perspectives and their broader context within health systems. Pillar 1 – Biopharmaceutical Innovation & Development (DBE): cell and gene therapies, radioligands, biologics and biosimilars; challenges of scale-up, quality assurance and GMP compliance; business models and intellectual property. Pillar 2 – Technological Trends (DBE): artificial intelligence, digital data and automation applied to bioprocess optimization; continuous manufacturing, process intensification and single-use technologies; personalized therapies and precision medicine. Pillar 3 – Regulation, Market Access & Financing (DER): European and international regulatory frameworks; strategies for the introduction of medicines and competition in biosimilars; pricing and reimbursement policies; health technology assessment (HTA) and innovative financing models (value-based healthcare and real-world evidence).

Prerequisites

No pre-requisites.

Cross Competence Component

The course allows the development of transversal competences in the following areas: i) Critical and Innovative Thinking: working on real business strategy cases challenges students to apply critical thinking, develop strategic reasoning, propose creative solutions, and make decisions in complex scenarios. ii) Interpersonal Skills: group work, oral presentations, and interaction with industry professionals foster collaboration, effective communication (both written and oral), and argumentation skills in professional settings. iii) Intrapersonal Skills: students develop time management, individual responsibility, and adaptability in demanding contexts, particularly during the planning and execution of the business case phases. The share of the overall assessment associated with these competences is approximately 30%

Laboratorial Component

No laboratorial component.

Programming And Computing Component

No programming nad computing component.

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.