Module Details

Technology transfer and regulatory aspects

MS2148

Course
Technology transfer and regulatory aspects
Code
MS2148
Academic Year
2023/2024
Curriculum Year
2022/2023
Degree Programme
MEDICAL BIOTECHNOLOGY
Curriculum
A010 - CELL THERAPY, TISSUE ENGINEERING AND REGENERATIVE MEDICINE
Course coordinator
-
Lecturers
Credits
3
Lecture Hours
18
Scientific Disciplinary Sector (SSD)
SECS-P/07 - Business Administration
Course Type
Single-subject learning activity
Course Delivery
OBB - Obbligatoria
Year
2
Teaching period
Primo Semestre
Campus
NOVARA
Teaching language
English
Course Contents
The course is aimed at providing a comprehensive overview of the process steps and critical factors that lead to transform laboratory inventions into successful innovations available in the market. Therefore It deals with the nature and roles of the various actors involved in the process and the main methods and practices that can be exploited to create value on a socio-economic level. Special attention is paid to the technology transfer achieved through the creation of university spinoffs. From this perspective, the peculiar characteristics of science-based startups are analyzed with reference to both management issues and the main regulatory aspects.
Reference Texts
Slides in Power Point, scientific articles and other documents (reports, professional brochures) available on the UPO DIR website (https://www.dir.uniupo.it/course/view.php?id=18348 ) during the course.
Learning Outcomes
The course is designed to give students an essential understanding of the activities inherent in the technology commercialization processes, as well as of the related challenges and opportunities.
1. Knowledge and understanding. First of all, the Course aims at providing the key concepts, theoretical models and practices in the domains of technology transfer. It also aims to enable the students to understand the main issues (cultural, operational and regulatory) involved in technology transfer processes carried out within an entrepreneurial university ecosystem.
2. Applying knowledge and understanding. The course aims at developing the students’ ability:
- to actively contribute to the formulation of an action plan to transfer a scientific discovery from lab to market;
- to collaborate with their TTOs as knowledgeable partners in advancing the development of lab discoveries.
3. Making judgments. The course aims at developing the students’ ability:
- to assess the role of institutional and cultural factors affecting the technology transfer process, and
- to analyze critically and evaluate the key issues associated with the launch and the management of this process.
4. Communication skills. The students will acquire the ability to understand and use the technical terms used by professionals in the field of technology transfer.
5. Learning skills. The students will become familiar with the relevant information sources, including web sites.
Prerequisites
None
Teaching Methods
Frontal teaching will be accompanied by collective discussion, videos, the analysis of case studies and a presentation by a guest lecturer involved in the university spin-off process. Frontal teaching is based on the use of slides in Power Point available on the UPO DIR website (https://www.dir.uniupo.it/course/view.php?id=18348 ).
Additional Information
Further information can be found in the UPO DIR website at the following link: https://www.dir.uniupo.it/course/view.php?id=18348.
Assessment Methods
The exam will be in the context of the exam of the integrated course. The exam of "Technology Transfer and regulatory aspects" consists of a written test including 16 multiple choice questions.
Detailed Syllabus
 The technology transfer process and the role of universities and public research institutes (PRIs).
 Types of technology transfer processes between universities/PRIs and business firms.
 The university-based entrepreneurial ecosystem.
 The challenges inherent in adapting a context optimized for exploration to the task of exploitation.
 Technology transfer through university spin-offs.
 The peculiarities of entrepreneurial science-based firms.
 The variety of paths and the speed of early growth of entrepreneurial science-based firms.
 Critical factors for university spin-offs.
 Why startups fail.
 The spin-out process.
 Business model, Financial model and Business plan.
 The life of a science startup: a snapshot.
 The proof of concept (POC).
 A business model canvas.
 Building a financial model.
 Writing a business plan.
 Presenting to investors.
 Key forms of IP protection and types of legal structures for business ventures.
 Funding sources for the startup and expansion of business ventures.
 The financial needs across the life cycle.
 Corporate finance choices and valuation challenges across the life cycle.
 Equity vs. debt funding.
 Grants as funding sources.
 Business angels.
 Crowdfunding.
 Venture capital and Corporate venture capital.
 Regulatory aspects of health technology transfer. Health technology regulation and health technology assessment (HTA).
 EU regulation on Health Technology Assessment
 The legal framework governing medicinal products for human use in the EU.
 The legal framework governing medical devices and in vitro diagnostic medical devices (IVDs) in the EU.
Expected Learning Outcomes
At the end of the course students should show:
KNOWLEDGE of the different phases through which the technology transfer process develops, of the nature and roles of the subjects involved in it and of the managerial, technical, financial and regulatory issues related to the startup and growth of a science-based venture.
COMPETENCES consisting in the ability to analyze critically opportunities and constraints in the context of technology transfer and commercialization, as well as in the capacity to establish an appropriate line of action in problem-solving.
TRANSVERSAL SKILLS related to the effective framing and communication of both the critical factors involved the technology transfer activities and their alternative solutions.
Last update:09-09-2026 00:14:31