SBRI19013U Pharma III – Pharmaceutical and Biotech Regulation and Innovation

Volume 2024/2025
Education

BRIDGE - Translational Excellence Programme

Content

The course will give the participants knowledge on how to move research towards a commercial setting by connecting and learning from industry players, biotech, start-ups, and venture capital from the Danish innovation ecosystem. The course will provide insights on how to secure IP, legals, and financing in the early phases. The course will also provide insights on critical issues for translating research into either products (medtech and drugs primarily) or start-ups, and on decision processes for progressing research either in industry or start-ups.

 

The course will include lectures, site-visits and discussions with key industry players from both speciality pharma companies (for instance Novo Nordisk and Lundbeck), biotech companies (for instance Galecto and IO-Biotech), and start-ups primarily from BioInnovation Institute and COBIS.

Learning Outcome

Upon completing the course, participants should be able to:

 

Knowledge

  • Understand how the organizational set-up supports how projects are prioritized in pharmaceutical and biotech companies.
  • Understand the rationale behind key business processes in the pharmaceutical and biotech industry - and how to move research from academia into start-ups or existing companies.
  • Gain an insight into the Danish innovation ecosystem and its possibilities.
  • Basic knowledge on legal concepts that needs to be addressed while setting up a start-up company.
     

Skills

  • Describe the process of evaluating research results and securing IP rights, how to secure financing in the early phases, and key research and business concepts in building a start-up based on translational research or in the collaboration with biotech or pharma.
     

Competences

  • Explain the rationale behind a project management portfolio, including how companies decide from a pool of competing projects to create a profitable portfolio that achieve the company’s strategic goals.
  • Discuss and understand commercial decision structures in pharmaceutical and biotech companies and start-ups.
  • Discuss and understand potential factors influencing the IP, legal and financing processes from research lab to start-up company or license agreement with an established company.
Literature

Course literature will be published on Absalon.

Participants must meet the admission criteria of the BRIDGE - Translational Excellence Programme.
Site visits, lectures and discussions.

The course will end with an evaluation where participants must reflect on course learning outcomes and give feedback for course development.
  • Category
  • Hours
  • Lectures
  • 2
  • Preparation
  • 4
  • Excursions
  • 15
  • Total
  • 21
Oral
Continuous feedback during the course of the semester
Credit
0 ECTS
Type of assessment
Continuous assessment
Requirement to attend classes
Type of assessment details
Attendance and active participation.
Exam registration requirements

Participants are automatically registered for the examination upon admission to the BRIDGE - Translational Excellence Programme.

Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

Active contribution and course participation according to the BRIDGE Guidelines and Practicalities.