General provisions

The course is part of the Master's program in Drug Discovery and Development and can also be taken as an independent course choice.

Entry requirements

150 credits including 90 credits in pharmaceutical science, cell biology, biotechnology, physiology, biomedicine, chemistry and/or biology or the equivalent, and at least 7.5 credits in biologics. Proficiency in English equivalent to the general entry requirements for first-cycle (Bachelor's level) studies.

Learning outcomes

After taking the course, the student will be able to: 

• Plan, design, and execute experiments, as well as evaluate and justify experiments that can and should be used in order to evaluate the effect of new biological therapeutics.
• Use bioinformatic tools to analyse and interpret results from different types of measurements and analysis of biological therapeutics.
• Formulate a Target Product Profile (TPP) and a connected quality TPP (qTPP) for a biological therapeutic, focussing on meeting the global target for sustainable development devised by United Nations Development Programs (UNDP).
• Develop protocols based on TPP and qTPP that identify the analytical tools and pre-clinical testing (including ADME (Absorption, Distribution, Metabolism and Excretion) and CMC (Chemistry, Manufacturing and Control)) that should be used to comply to TPP and qTPP standards.
• Connect the need of diagnostic tools with the development of biological therapeutics and TPP, in order to evaluate how the biological therapeutic will be used with the correct patient group.
• Explain how the tumour's micro-environment is constructed.
• With the help of understanding how targets are identified in solid tumours, argue how combination therapies can be established in order to treat solid cancer forms.
• Explain how one constructs therapies in the field of autoimmunity and immunodeficient diseases, with the help of biological therapeutics.
• Motivate the use and development of biological therapeutics from a health economy, regulatory and ethical perspective.
• Show the ability to work in groups to identify, analyse and solve qualified biological therapeutic issues.
• Review scientific documentation, including searching, validating and critically evaluating relevant information in order to be able to analyse and solve problems related to the development of biological therapeutics.
• Write scientific-style reports to show and discuss their experimental findings related to biological therapeutics.

Content

The course will give the students an understanding of how one develops protein-based biological therapeutics. The students will have the opportunity to design experiments to determine whether the biological therapeutic has the desired effect, as well as showing with an in-depth understanding, the treatment strategy and diagnostic tools designed to identify the correct patient-group. The students will also develop a target product profile (TPP) for their intended therapeutic candidate, in order to develop a quality TPP (qTPP). With this as a basis, the students will develop an advanced understanding of analytical tools used during the process of biological therapeutic development and how the biological therapeutics can be measured in biological samples e.g. mass spectrometric analysis.

A case-study seminar, focussing on the tumours micro-environment and therapeutic targets, will be used to engage the students in developing ideas of different strategies for how one can use biological therapeutics to target solid tumours, as well as understanding how one can employ combination therapies to good therapeutic effect. One additional case-study will also be used to help the students gain an understanding of how biological therapeutics can be used to treat autoimmune and immunodeficiency diseases.

The course will be supplemented with lectures focussing on health economy, epidemiology, ethics and regulatory aspects related to biological therapeutics, as well as new types of biological therapeutics.

Instruction

Teaching moments will be in the forms of lectures, case-studies, theoretical labs, seminars, written and oral presentations, as well as literature review (student self-studies).

Obligatory teaching occasions: Written and oral presentations, case-studies and theoretical labs.

The course will be given entirely in English.

Assessment

Written exam in the end of course. In order to pass the course, one must pass the exam (3 hp), obtain a passing grade for theoretical lab  (3 hp) and case /seminar (1.5 hp).

In special circumstances, the examiner may make an exception from the specified examination method and allow a student to be examined in another way. For example, if the course coordinator is informed of the need for special pedagogical support from the university's coordinator.