SBRI19013U Pharma III – Pharmaceutical and Biotech Regulation and Innovation
BRIDGE - Translational Excellence Programme
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.
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.
Course literature will be published on Absalon.
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
The BRIDGE – Translational Excellence Programme offers a few selected graduated PhDs a two-year postdoctoral fellowship in translational medicine. This course is only available to the fellows enrolled in the programme. Fellows are automatically enrolled in this course upon admission to the programme.
For further information about the programme, please go to the website: www.bridge.ku.dk
- Credit
- 0 ECTS
- Type of assessment
- Continuous assessmentRequirement 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.
Course information
- Language
- English
- Course code
- SBRI19013U
- Credit
- 0 ECTS
- Level
- Part Time MasterPh.D.
- Placement
- Spring
- Schedule
- See course dates and course programme in Absalon.
*This course is offered in spring 2025 for the BRIDGE 2023-2025 Academic Curriculum.
** This course is offered in spring 2026 for the BRIDGE 2024-2026 Academic Curriculum. - Course capacity
- 15 participants
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Biomedical Sciences
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Trine Winterø (triwin@sund.ku.dk)