Biopharmaceuticals Drug Development

Course content

The commercial and scientific prominence of biopharmaceuticals is beyond dispute. This course provides an interdisciplinary introduction to the new advances in our ability to develop macromolecules into effective 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). However, given by tremendous recent advances in genetic understanding, biotechnology, and knowledge of protein function in the biology of diseases, an explosion of novel opportunities for development of biopharmaceuticals has occurred. Even though discovery of novel biopharmaceuticals may be void of typical small molecule pitfalls, the complexity of drug development, in particular pharmaceutical development and safety assessment, may still pose large challenges in the overall development of novel biopharmaceuticals.

The course will teach the specific characteristics and procedures within the development of biopharmaceuticals. Morning lectures held by experts touch upon basic concepts and specific issues related to biopharmaceuticals within their fields of expertise. Emphasis is put on issues and complexities related to development of biopharmaceuticals. There will be focus 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. Afternoon group sessions are allocated to cases addressing  potential issues during biopharmaceutical drug development and their solutions.

Education

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

The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme, the Master of Pharmaceutical Regulatory Affairs (MPRA), and the Master in Medicines Regulatory Affairs (MRA) programme and open for freelance students who meet the admission criteria.

Learning outcome

A student who has concluded the course will be able to:

Knowledge

  • Understand potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing

 

Skills

  • Identify and suggest solutions for issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
  • Design and develop novel interdisciplinary approaches within the field of expertise thereby improving current practice in the development of biopharmaceuticals 

 

Competencies

  • Communicate field specific issues and solutions regarding development of biopharmaceuticals to other specialists, and project stake-holders 
  • Cooperate within a multi-disciplinary development project team

The course is organized as an intensive 5-day course and comprises lectures, group discussions, presentations and discussions. In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.

The common course syllabus is approximately 300 pages: collections of review papers, textbook chapters, case stories and hand-outs from course presentations.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

ECTS
3 ECTS
Type of assessment
Written assignment
A written report based on a case story. 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.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

Knowledge

  • Understand potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing

 

Skills

  • Identify and suggest solutions for issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
  • Design and develop novel interdisciplinary approaches within the field of expertise thereby improving current practice in the development of biopharmaceuticals 

 

Competencies

  • Communicate a comprehensive and structured report on a selected case in his/hers own words, which is based on relevant literature. The report is based in a field specific issue and solution regarding development of biopharmaceuticals

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 22,5
  • Class Instruction
  • 40
  • Exam
  • 20
  • English
  • 82,5