01677 - Business Management

Learning outcomes

By the end of the module the students will develop: (a)  the basics of the  management, knowledge of the firms' financial analysis, and basics of strategic analysis; (b) the management literacy and the communication abilities consistent with the management discipline. 

Course contents

The course covers: the study context: the firm; the role of management; strategic management—methods for analyzing the internal and external environment to define strategy; sustainability strategies and business model; strategy implementation; organizational designs and the finance function; investments in research and development, with examples from the pharmaceutical value chain (preclinical/clinical R&D, GMP manufacturing, quality), regulatory affairs (EMA/AIFA), intellectual property and market access (pricing and reimbursement), pharmacovigilance and risk management, data integrity, digital transformation (AI and digital health), and sustainability in chemistry/pharmaceuticals.

The topics are addressed synergistically and progressively across the following modules:

Module 1: The study context—firm as a “sustainable” system and competitive environment
With case studies from pharmaceutical/biotech companies, the drug value chain (discovery–development–manufacturing–distribution), competitive dynamics, and the role of regulatory agencies (European Medicines Agency—EMA; Italian Medicines Agency—AIFA).

Module 2: Strategy and distinctiveness—tangible and intangible resources and the role of capabilities
Emphasis on sector-specific intangible assets (patents, regulatory dossiers, GMP know-how, clinical data), laboratory and pharmaceutical development capabilities, academia–industry partnerships, and open innovation in biotech.

Module 3: Strategic management, business models, and growth strategies
Examples of pharma/biotech business models (pipeline-based, technology platforms, CDMO/CMO), co-development, lifecycle management of APIs and formulations, and market access.

Module 4: Strategy implementation, financial function, and organizational design
In regulated settings: GMP and quality systems, Quality by Design (QbD), lab-to-plant technology transfer, process validation, data integrity, and the organization of QA/QC and manufacturing departments.

Module 5: Efficiency Analysis and Strategic Management of Investments in Research and Development Elements of pharmacoeconomics, Health Technology Assessment (from the perspective of the National Health Service), risk management, and post-marketing pharmacovigilance.

Module 6: New venture creation—start-ups in health and biotech (with guest practitioners)
From discovery to proof-of-concept, early-stage regulatory pathways, IP strategies, fundraising (grants/VC), biotech accelerators, ethics and sustainability in pharmaceutical chemistry, and digital health/AI for drug discovery.

Readings/Bibliography

Students can consult:
F. Fontana, M. Caroli (2017): Economia e Gestione delle Imprese. McGraw Hill, 5th edition.

Specifically, the course program consists of a summary of the topics covered in Chapters 1, 2, 3, 4, 5, 6, 8, 10, and 13.

Learning materials are provided weekly. 

Teaching methods

On campus interactive lectures;

Case studies analysis;

Exercises.

 

The attendance requirement is considered fulfilled with participation in no less than 60% of the face-to-face lessons. Attendance is recorded through the student attendance tracking application.

Assessment methods

Students will be assessed based on a written assessment organised as follows:

-20 closed answer tests;

-2 open answer questions and/or brief exercise.

Teaching tools

Websites of pharmaceutical companies and a seminar by one or more experts will contribute to the students’ learning experience.

Office hours

See the website of Edoardo Trincanato