SBRI19013U Pharma III – Pharmaceutical and Biotech Regulation
BRIDGE - Translational Excellence Programme
A two-year postdoctoral fellowship in translational medicine
The course will give the participants knowledge on how to move research towards a commercial setting by connecting and learning from industry players, biotech, and start-ups from the Danish innovation ecosytem. The course will also provide insights on how to secure IP, legals and financing in the early phases. The course will provide insights on critical issues for translating research into either products 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, Lundbeck),biotech companies (for instance Genmab, Symphogen, Orphazyme) and start-ups primarily from BioInnovation Institute and COBIS.
On completion of the course, the 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.
Skills
- Describe how a pharmaceutical company is organized to secure optimal decision processes between research and development (R&D) and commercial units
- Describe the IP, legal and financial processes behind building a start-up based on translational research.
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 is published on Absalon.
Course literature includes:
A practical guide to drug development in academia. The SPARK approach. Daria Mochly-rosen and Kevin Grimes (editors). Springer briefs in pharmaceutical science and drug development, 2014.
- Category
- Hours
- Lectures
- 2
- Preparation
- 4
- Excursions
- 15
- Total
- 21
Automatic registration upon appointment in the Translational Excellence Programme
- Credit
- 0 ECTS
- Type of assessment
- Continuous assessmentCourse participationAttendance and active participation
- Exam registration requirements
Participants are automatically registered for the Examination upon course registration.
- 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.
Course information
- Language
- English
- Course code
- SBRI19013U
- Credit
- 0 ECTS
- Level
- Part Time Master
- Duration
- Placement
- Spring
- Schedule
- See course dates and course programme in Absalon
*This course is offered in spring 2023 for BRIDGE 2021-2023. - Course capacity
- 15 participants
- Course is also available as continuing and professional education
- 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 (6-77756c7a6c714376787167316e7831676e)