Biopharmaceuticals Drug Development – University of Copenhagen

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Biopharmaceuticals Drug Development

The complexity of drug development, in particular pharmaceutical development and safety assessment, still poses large challenges in the overall development of novel biopharmaceuticals. This course provides an interdisciplinary introduction to the newest advances in our ability to develop effective biopharmaceuticals.

Recent advances in genetics, biotechnology, and knowledge of protein function in the biology of diseases have provided an explosion of novel opportunities for development of biopharmaceuticals. At first sight, development of biopharmaceuticals appears straightforward since the biology of endogenous compounds, such as proteins or peptides, and clinical proof of concept and safety profile often are given beforehand (e.g. insulin, growth hormone, coagulation factors). But although discovery and development of novel biopharmaceuticals may be void of typical small molecule pitfalls, the delivery and formulation challenges are complex and call for a high degree of interdisciplinary approaches.

A short introduction to the course (opens in a new window)

Course content

The course uses a high degree of case-based learning with cases based on real-life examples. It is a major aim of the course to provide an overview of the field to facilitate the ability to work in or lead project teams related to biopharmaceutical drug development. The course will focus on characteristics and complexities specific to the development of biopharmaceuticals. The focus will be on project initiation, discovery phase, including pharmacology and protein engineering. Particular emphasis will be given to pharmaceutical development and safety assessment of biopharmaceuticals. Regulatory aspects will be taught as well.

The days are split into two sessions: In the mornings, there will be lectures held by experts (industry, academia and authorities), who will introduce basic concepts and specific issues related to  biopharmaceuticals within their fields of expertise. In the afternoons, you will work on specific cases in small groups.

Participants

The course is aimed for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for development of biopharmaceuticals.

Participants should:

  • Hold a relevant bachelor degree or equivalent
  • Have a minimum of 2 years of relevant job experience within drug development
  • Be proficient in English

Course fee

DKK 19,900. Fee includes teaching, course materials, all meals during the course and examination.

Course dates

  • 13-17 August 2018

Application deadline

  • 31 May 2018

Applications are processed upon receipt, and applicants are admitted on a "first come, first served" basis. Registration deadline will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks after submission of the application. Please note that the course is subject to cancellation or rescheduling if the number of participants fails to meet the required minimum.

Examination

To earn 3 ECTS credit points (Master’s level) a written report based on a case story needs to be submitted before the deadline. The report must be based on the common course syllabus and an individual selection of literature (scientific articles, regulatory documents, etc.) relevant for the selected case. Read more on the examination.

Deadline for submission in Digital Eksamen: 22 October 2018 at 2 p.m.

The course has been preapproved as an elective in the MIND, MRA and MPRA programmes at the University of Copenhagen.