SBRI19013U Pharma III – Pharmaceutical and Biotech Regulation

Volume 2020/2021

BRIDGE - Translational Excellence Programme



Lectures, Site visits and discussions with key industry players from both speciality pharma companies (Novo Nordisk, Lundbeck, LEO) and biotech companies (Genmab, Symphogen, Orphazyme).

Learning Outcome

On completion of the course, the participants should be able to:


  • 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



  • Describe how a pharmaceutical company is organized to secure optimal decision processes between research and development (R&D) and commercial units
  • Describe the processes behind construction of a portfolio review board
  • Describe the interdependency between scientific, financial and commercial criteria for building a profitable drug portfolio



  • 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 companies
  • Discuss and understand potential political factors influencing decisions in pharmaceutical companies

To be decided and confirmed together with management in companies.

Suggestion is:

Drug Design, Development and Therapy 2014:8 2009–2016, Review. Antti Jekunen, Decision-making in product portfolios of pharmaceutical research and development – managing streams of innovation in highly regulated markets.

M. Ding et al. (eds.), Innovation and Marketing in the Pharmaceutical Industry, 83-118.

International Series in Quantitative Marketing 20, DOI 10.1007/​978-1-4614-7801-0_3,

© Springer Science+Business Media New York 2014. Chapter 3, Min Ding, Songting Dong, Jehoshua Eliashberg, and Arun Gopalakrishnan: Portfolio Management in New Drug Development.

Z. Antonijevic (ed.), 2015. © Springer International Publishing Switzerland. Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy, Chapter 2 p19-33: Clinical Aspects of Pharmaceutical Portfolio Management Frederic (Rick) Sax , Raymond A. Huml , and Judith Ng-Cashin

Schuhmacher et al. J Transl Med (2016) 14:105. Changing R&D models in research-based pharmaceutical companies.

Alzheimer’s & Dementia: Translational Research & Clinical Interventions 3 (2017) 651-657. Richard C. Mohs, Nigel H. Greig: Perspective: Drug discovery and development: Role of basic biological research

Schuhmacher et al. J Transl Med (2018) 16:119, Open innovation and external sources of innovation. An opportunity to fuel the R&D pipeline and enhance decision making?

Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme
Site visits, lectures and group works.
  • Category
  • Hours
  • Lectures
  • 2
  • Preparation
  • 4
  • Excursions
  • 15
  • Total
  • 21
Continuous feedback during the course of the semester
Type of assessment
Continuous assessment
Course participation
Attendance and active participation
Exam registration requirements

Participants are automatically registered for the Examination upon course registration.

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

Attendance and active participation