Biopharmaceuticals Drug Development

Course content

The commercial and scientific prominence of biopharmaceuticals is beyond dispute. This course provides an overview of the drug development process and highlights crucial aspects of specific importance for our ability to develop biologically active macromolecules into effective biopharmaceuticals.

At first sight, utilization of biologically active macromolecules for as drugs appears straightforward since the biology of endogenous compounds, such as peptides and proteins, are given (e.g. hormones, coagulation factors). Further, due to the tremendous recent advances in genetic understanding and knowledge of protein function in the biology of diseases, an explosion of novel opportunities for development of biopharmaceuticals has occurred. Advanced (bio)technological tools provide opportunities for tailoring macromolecules to improve drug-ability of these compounds, and new insight into formulation design and delivery approaches are continuously emerging. However, due to the structural complexity of these high molecular weight, labile compounds, drug development including efficacy and safety assessment in appropriate models still pose significant challenges in the overall development of novel biopharmaceuticals.

The course will address and highlight characteristics and procedures of relevance for the design and development of biopharmaceuticals. Experts from in relevant fields will lecture on and discuss both fundamental concepts and specific selected issues related to biopharmaceuticals drug development. Topics of special attention are picked from the discovery phase through development and assessment, and include protein engineering, pharmaceutical drug design, efficacy and safety assessment and regulatory aspects. Case studies will form the basis for interactive discussion sessions.

Education

The course is for professionals in the pharmaceutical industry; professionals, 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 and address potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing

 

Skills

  • Identify key challenges and suggest solutions for addressing critical issues in the development of biopharmaceuticals
  • 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 and address potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing

 

Skills

  • Identify key challenges and suggest solutions for addressing critical issues in the development of biopharmaceuticals
  • 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

Part time Master and Diploma courses

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