Legislation, management and technology transfer
A.A. 2025/2026
Obiettivi formativi
The course will deal with fundamental principles of management of biomedical laboratory, operations and processes, experimental models applied to laboratory medicine, occupational environmental exposure, and population-based studies. The ultimate goal is to aid the student in developing critical thinking and decision-making in relation to knowledge transfer problems and laboratory management.
In addition, the course is designed to familiarize the students with the Omic Research legislative obligations, the technological transfer process of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements.
In addition, the course is designed to familiarize the students with the Omic Research legislative obligations, the technological transfer process of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements.
Risultati apprendimento attesi
At the end of the course students are expected to have developed critical thinking and decision-making skills in relation to legislative obligations and strategies for the valorization of research results, in light of the variety of technologies available for research purposes.
Periodo: Secondo semestre
Modalità di valutazione: Esame
Giudizio di valutazione: voto verbalizzato in trentesimi
Corso singolo
Questo insegnamento può essere seguito come corso singolo.
Programma e organizzazione didattica
Edizione unica
Prerequisiti
No prior knowledge is required.
Modalità di verifica dell’apprendimento e criteri di valutazione
The exam consists in a single oral examination. There are no intermediate tests.
For the Laboratory Management module, the oral examination aims at evaluating the ability of the student to express him/herself with clarity and appropriate language on the topics of the course.
For the Legislation and Technology Transfer module, the oral examination aims at evaluating the ability of the student to express him/herself with clarity and appropriate language on the topics of the course, which deals with the variety of aspects concerning the process of professional technology transfer of scientific knowledge.
The outcome of the exam is expressed in thirtieths. The oral exam last, on the average, 20 minutes and consists of the discussion of 2-3 general topics, selected among the general issues, including exploitation strategies for commercial purposes (e.g. licensing or spin-off creation), identification of potential commercial partners (such as spin-offs or existing companies, public research organizations, investors, innovation support agencies), aspects related to the generation and protection of intellectual property. The outcome of the exam is expressed in thirtieths.
For the Laboratory Management module, the oral examination aims at evaluating the ability of the student to express him/herself with clarity and appropriate language on the topics of the course.
For the Legislation and Technology Transfer module, the oral examination aims at evaluating the ability of the student to express him/herself with clarity and appropriate language on the topics of the course, which deals with the variety of aspects concerning the process of professional technology transfer of scientific knowledge.
The outcome of the exam is expressed in thirtieths. The oral exam last, on the average, 20 minutes and consists of the discussion of 2-3 general topics, selected among the general issues, including exploitation strategies for commercial purposes (e.g. licensing or spin-off creation), identification of potential commercial partners (such as spin-offs or existing companies, public research organizations, investors, innovation support agencies), aspects related to the generation and protection of intellectual property. The outcome of the exam is expressed in thirtieths.
Legislation and technology transfer
Programma
Laboratory management
1) How to conduct an experiment, basic research, preclinical, and clinical/industrial settings. The concept of operations: standard operating procedures (SOPs) and reports, and organizational charts. Personnel management (team building and interdisciplinary communication).
2) Basic concepts of experimental models and patient-specific models. Introduction to patient specific modeling: two-dimensional cell cultures and three-dimensional models (organoids technologies), microfluidics systems and genetic humanized animal models. Applications to selected human pathologies and future directions in the clinical setting.
3) In vivo experimental models for tumor research: zebrafish; mouse models (transgenic mice), cell-derived xenografts and patient-derived xenografts (PDX).
4) Animal experimentation: Italian and European legislation governing the use of animals in biomedical experimentation; principles of the 3Rs.
5) Exposome: the concept of exposome; the three different domains of the exposome, internal, specific external and general external; measuring the exposome. Endocrine disruptors.
6) Laboratory safety and compliance with regulatory guidelines.
7) Use of patient modelling combined with -omics technologies to understand the molecular mechanisms of environmental exposures in multiple chronic pathologies (example of the association with cardiovascular, neurodegenerative and renal chronic diseases).
8) Example of population-based studies (air pollution, endocrine-disrupting elements and heavy metals). New molecular mechanisms of environmental exposures and human disease.
Legislation and Technology Transfer
1) Introduction on key issues of technology transfer: from research outputs to business opportunities
· What is technology transfer from public and private research centres
· What is the role of a Technology Transfer Office (TTO)?
2) The management of knowledge generated from research: phases and regulatory issues
· Research activities: the attribution of ownership and implementation measures
· Collaborative research: the need for prior agreements
· Sponsored research: the definition of roles
· Participation of researchers in the tech transfer results: the incentive policies
3) Protection of the technology
· The intellectual property and its value in the biomedicine sector
· The patent: conceptual and procedural aspects
· Patenting strategies and other forms of protection
4) Assessment and evaluation of technology
· Technology assessment: definition and understanding of the potential of the technology
· The process of patent evaluation
· De-risking strategies: definitions and implementation of actions to increase the technology value in a defined timeframe
5) Exploitation of research results
· Promotion of the technology to investors/industrial partners
· Types of agreements for transferring the rights to a third party (usage/exploitation licensing, full transfer or sale), other types of tech transfer agreements (material transfer, data sharing, non-disclosure), and aspects of negotiation
6) Creation of a company as a mechanism for technology transfer
· The creation of a spin-off
· Roles of researchers and research centre
· Rights and obligations of partners: the shareholders' agreement
7) The process for identifying technology with potential value
· The role of Technology Transfer Offices, tools of the European Commission, research institutes, technology brokers, social media, internet sites and databases, journals, brokerage events
1) How to conduct an experiment, basic research, preclinical, and clinical/industrial settings. The concept of operations: standard operating procedures (SOPs) and reports, and organizational charts. Personnel management (team building and interdisciplinary communication).
2) Basic concepts of experimental models and patient-specific models. Introduction to patient specific modeling: two-dimensional cell cultures and three-dimensional models (organoids technologies), microfluidics systems and genetic humanized animal models. Applications to selected human pathologies and future directions in the clinical setting.
3) In vivo experimental models for tumor research: zebrafish; mouse models (transgenic mice), cell-derived xenografts and patient-derived xenografts (PDX).
4) Animal experimentation: Italian and European legislation governing the use of animals in biomedical experimentation; principles of the 3Rs.
5) Exposome: the concept of exposome; the three different domains of the exposome, internal, specific external and general external; measuring the exposome. Endocrine disruptors.
6) Laboratory safety and compliance with regulatory guidelines.
7) Use of patient modelling combined with -omics technologies to understand the molecular mechanisms of environmental exposures in multiple chronic pathologies (example of the association with cardiovascular, neurodegenerative and renal chronic diseases).
8) Example of population-based studies (air pollution, endocrine-disrupting elements and heavy metals). New molecular mechanisms of environmental exposures and human disease.
Legislation and Technology Transfer
1) Introduction on key issues of technology transfer: from research outputs to business opportunities
· What is technology transfer from public and private research centres
· What is the role of a Technology Transfer Office (TTO)?
2) The management of knowledge generated from research: phases and regulatory issues
· Research activities: the attribution of ownership and implementation measures
· Collaborative research: the need for prior agreements
· Sponsored research: the definition of roles
· Participation of researchers in the tech transfer results: the incentive policies
3) Protection of the technology
· The intellectual property and its value in the biomedicine sector
· The patent: conceptual and procedural aspects
· Patenting strategies and other forms of protection
4) Assessment and evaluation of technology
· Technology assessment: definition and understanding of the potential of the technology
· The process of patent evaluation
· De-risking strategies: definitions and implementation of actions to increase the technology value in a defined timeframe
5) Exploitation of research results
· Promotion of the technology to investors/industrial partners
· Types of agreements for transferring the rights to a third party (usage/exploitation licensing, full transfer or sale), other types of tech transfer agreements (material transfer, data sharing, non-disclosure), and aspects of negotiation
6) Creation of a company as a mechanism for technology transfer
· The creation of a spin-off
· Roles of researchers and research centre
· Rights and obligations of partners: the shareholders' agreement
7) The process for identifying technology with potential value
· The role of Technology Transfer Offices, tools of the European Commission, research institutes, technology brokers, social media, internet sites and databases, journals, brokerage events
Metodi didattici
The course comprises 12 CFU. Frontal teaching will be accompanied by practicals, group work and time for reflection and collective discussion (5 CFU). Frontal teaching is based on the use of slides in Power Point. The slides are uploaded onto the Ariel website.
For the Laboratory Management module, these activities are designed to provide the students with critical understanding of laboratory operations and processes, principles of laboratory management, problem and decision making, building and managing an effective team, and strategic skills and competencies, contextualising these within the overall perspective of a laboratory based on -omics technologies.
For the Legislation and Technology Transfer modules, activities are designed to familiarize the students with the different issues throughout the process of technological transfer of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements, with the ultimate goal to aid the student developing critical-thinking and decision-making in relation to knowledge transfer problems.
For the Laboratory Management module, these activities are designed to provide the students with critical understanding of laboratory operations and processes, principles of laboratory management, problem and decision making, building and managing an effective team, and strategic skills and competencies, contextualising these within the overall perspective of a laboratory based on -omics technologies.
For the Legislation and Technology Transfer modules, activities are designed to familiarize the students with the different issues throughout the process of technological transfer of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements, with the ultimate goal to aid the student developing critical-thinking and decision-making in relation to knowledge transfer problems.
Materiale di riferimento
· Turgeon, Mary Louise. (2015). Clinical Laboratory Science, 7th ed. Maryland Heights, MO: Mosby. ISBN 9780323225458.
· Laboratory Management: Principles and Processes. Editor(s): Harmening DM. Publisher: Prentice Hall. ISBN: 0-13-019459-X.
· University Technology Transfer: What it is and How to do it. Author: Tom Hockaday. Publisher: Johns Hopkins University Press April 2020
· I contratti di licenza di trasferimento tecnologico in ambito accademico. Autore: Claudia Del Re. Edizione: il Mulino
· Gli accordi di trasferimento di tecnologia. Autore: Dario Mastrella. Edizione: Giappichelli
· Pubblicazioni scientifiche inerenti.
· Laboratory Management: Principles and Processes. Editor(s): Harmening DM. Publisher: Prentice Hall. ISBN: 0-13-019459-X.
· University Technology Transfer: What it is and How to do it. Author: Tom Hockaday. Publisher: Johns Hopkins University Press April 2020
· I contratti di licenza di trasferimento tecnologico in ambito accademico. Autore: Claudia Del Re. Edizione: il Mulino
· Gli accordi di trasferimento di tecnologia. Autore: Dario Mastrella. Edizione: Giappichelli
· Pubblicazioni scientifiche inerenti.
Laboratory management
Programma
1) Principles of Laboratory Management
- Managing operations and processes.
- Planning and control
- Objective setting
- Organization of work
2) Managing Teams in the Laboratory
- Organizational structure
- Job analysis and work description
3) Managing Quality in the Laboratory
- Laboratory Quality Assurance
- Analytical Process Control
- Continuous Improvement
- Risk Management
- Managing operations and processes.
- Planning and control
- Objective setting
- Organization of work
2) Managing Teams in the Laboratory
- Organizational structure
- Job analysis and work description
3) Managing Quality in the Laboratory
- Laboratory Quality Assurance
- Analytical Process Control
- Continuous Improvement
- Risk Management
Metodi didattici
The course comprises 12 CFU.
Frontal teaching will be accompanied by practicals, group work and time for reflection and collective discussion (5 CFU). Frontal teaching is based on the use of slides in Power Point. The slides are uploaded onto the Ariel website.
For the Laboratory Management module, these activities are designed to provide the students with critical understanding of laboratory operations and processes, principles of laboratory management, problem and decision making, building and managing an effective team, and strategic skills and competencies, contextualising these within the overall perspective of a laboratory based on -omics technologies. Fort the Legislation and Technology Transfer modules, activities are designed to familiarize the students with the different issues throughout the process of technological transfer of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements, with the ultimate goal to aid the student developing critical-thinking and decision-making in relation to knowledge transfer problems.
Frontal teaching will be accompanied by practicals, group work and time for reflection and collective discussion (5 CFU). Frontal teaching is based on the use of slides in Power Point. The slides are uploaded onto the Ariel website.
For the Laboratory Management module, these activities are designed to provide the students with critical understanding of laboratory operations and processes, principles of laboratory management, problem and decision making, building and managing an effective team, and strategic skills and competencies, contextualising these within the overall perspective of a laboratory based on -omics technologies. Fort the Legislation and Technology Transfer modules, activities are designed to familiarize the students with the different issues throughout the process of technological transfer of scientific knowledge, starting on the identification of the technology, following with the different alternatives for its protection, evaluation and assessment, to conclude with an overview of the exploitation strategies including the promotion activities and the different types of technology transfer agreements, with the ultimate goal to aid the student developing critical-thinking and decision-making in relation to knowledge transfer problems.
Materiale di riferimento
· Turgeon, Mary Louise. (2015). Clinical Laboratory Science, 7th ed. Maryland Heights, MO: Mosby. ISBN 9780323225458.
· Laboratory Management: Principles and Processes. Editor(s): Harmening DM. Publisher: Prentice Hall. ISBN: 0-13-019459-X.
· University Technology Transfer: What it is and How to do it. Author: Tom Hockaday. Publisher: Johns Hopkins University Press April 2020
· I contratti di licenza di trasferimento tecnologico in ambito accademico. Autore: Claudia Del Re. Edizione: il Mulino
· Gli accordi di trasferimento di tecnologia. Autore: Dario Mastrella. Edizione: Giappichelli
· Laboratory Management: Principles and Processes. Editor(s): Harmening DM. Publisher: Prentice Hall. ISBN: 0-13-019459-X.
· University Technology Transfer: What it is and How to do it. Author: Tom Hockaday. Publisher: Johns Hopkins University Press April 2020
· I contratti di licenza di trasferimento tecnologico in ambito accademico. Autore: Claudia Del Re. Edizione: il Mulino
· Gli accordi di trasferimento di tecnologia. Autore: Dario Mastrella. Edizione: Giappichelli
Moduli o unità didattiche
Laboratory management
MED/46 - SCIENZE TECNICHE DI MEDICINA DI LABORATORIO - CFU: 6
Esercitazioni: 80 ore
Lezioni: 8 ore
Lezioni: 8 ore
Legislation and technology transfer
MED/43 - MEDICINA LEGALE - CFU: 6
Lezioni: 48 ore
Docente/i
Ricevimento:
previo appuntamento da concordare via e-mail
Ricevimento:
previo appuntamento da concordare via e-mail