Pharma III – Pharmaceutical and Biotech Regulation

Course 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, 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.

Education

BRIDGE - Translational Excellence Programme

 

Learning outcome

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

Site visits, lectures and discussions.

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.

Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme

Oral
Continuous feedback during the course of the semester
ECTS
0 ECTS
Type of assessment
Continuous assessment
Course participation
Attendance and active participation
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

Active contribution and course participation according to the BRIDGE Guidelines.

Part time Master and Diploma courses

  • Category
  • Hours
  • Lectures
  • 2
  • Preparation
  • 4
  • Excursions
  • 15
  • English
  • 21