SMEA20077U Commercialisation of Biomedical Innovations

Volume 2020/2021
Content

The aim of the course is to provide a comprehensive and systematic overview of the most common aspects of commercialisation of Biomedical Innovations.

Concepts learned:

  • Innovation concepts & applications within Health Care & Biotechnology are presented. Examples of disruptive and incremental innovations are discussed. Different models of innovation are illustrated. Ten types of innovation and examples from health care are presented. The concepts of open and closed innovation are outlined. Innovation in networks and the innovation process including idea generation are discussed. Models of S curves are illustrated with monoclonal antibodies as examples.

  • Pharmaceutical drug development. The major steps in drug discovery, preclinical and clinical development are outlined. Success factors for drug development and reasons for drug development failures are discussed. Examples include small molecules from Lundbeck, insulin molecules from Novo Nordisk and monoclonal antibodies from biotech companies. Defining relevant product profiles to ensure a strong revenue model are discussed. Finally, differences between pharmaceutical drug development, diagnostics and device development are illustrated.                                               

  • Patents & know-how concepts are presented and the importance of patents for the commercialisation process is illustrated. Concepts such as novelty and inventive steps are discussed. Different types of patent claims are presented. Inventorship and ownership models of patents are discussed. Examples of patent claims for genes, proteins and chemical structures are provided. Examples of patent case stories for insulin and monoclonal antibodies are included. The drafting of patent applications and the patent life cycle are discussed. Patent strategies are illustrated with an example from Lundbeck. Finally, the field of patent infringement is discussed.

  • Publications and patent protection are discussed.

  • Tools for assessing business opportunities are discussed.

  • Commercialisation by Licensing is presented. Different types of commercialisation agreements are outlined.The licensing process with companies are outlined with examples of small molecule and protein cases provided. Basic financial term structures are discussed. University-Industry collaborations are discussed and a case story is provided.

  • Commercialisation by establishment of a new company is outlined. The Investment process is outlined. Group work on writing a business plan. Terms of investors and the concept of dilution of ownership are discussed and case stories of biotech companies are provided.

  • Negotiation of commercialisation deals are discussed. Exercise in negotiations

After completion of the course, the student is expected to be able to handle a commercialisation process overall including knowledge about when to seek professional advice for more specific commercialisation activities such as patenting and negotiation.

Learning Outcome

After participating in the course, the student must demonstrate the following abilities at a sufficient level:

As a medical expert, as a collaborator, as an academic, as a health promotor and as a professional master the learning outcomes, thus

Knowledge

  • Explain different commercialisation models by utilizing concrete examples from the Danish pharma & Biotech environment

  • Explain basic elements of innovation in different applications

  • Explain the steps in pharmaceutical drug development

  • Explain the steps in preparing a patent application and how to apply patent protection in the commercialisation process

  • Explain how to draft a business plan

  • Explain the basic steps in a licensing & in a investment process

  • Explain the basic steps in a negotiation process

Skills

  • Use acquired skills in planning a commercialisation process for new innovations

Competencies

  • Capable of applying different commercialisation models for different types of innovations
None
The course involves lectures by invited speakers, interactive seminars, simulation training, and group work.
An emphasis is placed on student participation, and several case studies, group work and group exercises are used in order to optimize learning and to prepare students for future opportunities of commercialisation of research.
  • Category
  • Hours
  • Class Instruction
  • 35
  • Preparation
  • 20
  • Exam Preparation
  • 2
  • Exam
  • 2
  • Total
  • 59
Continuous feedback during the course of the semester
Credit
5 ECTS
Type of assessment
Portfolio
Mandatory elements:
Course participation
Oral presentation of a commercialisation case. Duration: 1 hour
Marking scale
passed/not passed
Censorship form
No external censorship
One internal assessor
Criteria for exam assesment

In order to pass the course, the student must demonstrate the following abilities at a sufficient level:

As a medical expert, as a collaborator, as an academic, as a health promotor and as a professional master the learning outcomes, thus

Knowledge

  • Explain different commercialisation models by utilizing concrete examples from the Danish pharma & Biotech environment

  • Explain basic elements of innovation in different applications

  • Explain the steps in pharmaceutical drug development

  • Explain the steps in preparing a patent application and how to apply patent protection in the commercialisation process

  • Explain how to draft a business plan

  • Explain the basic steps in a licensing & in an investment process

  • Explain the basic steps in a negotiation process

Skills

  • Use acquired skills in planning a commercialisation process for new innovations

Competencies

  • Capable of applying different commercialisation models for different types of innovations