KJM9490 – New Approach Methodologies for Biomedical Research and Drug Development

After you have completed this course you can:

• Identify key application areas for New Approach Methodologies (NAMs)
• Describe the limitations of conventional preclinical models and assess how NAMs can help address these challenges
• Design experimental strategies based on NAMs, including organoids and organ-on-chip technology
• Apply principles of qualification, validation, and benchmarking when evaluating NAM-based methods
• Interpret biological and chemical data generated from NAM-based studies
• Describe how results from NAMs are integrated into regulatory frameworks, including drug development and chemical risk assessment
• Relate practical laboratory observations from organoid and cell culture models to their application in biomedical/biochemical research and drug development
• Discuss the ethical and societal implications of replacing and reducing the use of animal experiments
• Prepare and deliver a presentation arguing for and against the use of NAMs for a specified area of ​​application

There are a total of 20 places available for the course, distributed between KJM5490 and KJM9490. Priority will be given to PhD students from the Department of Chemistry and participants in the NAM-TRANSFORM project at UiO.

PhD candidates from the University of Oslo should apply for classes and register for examinations through Studentweb.

If a course has limited intake capacity, priority will be given to PhD candidates who follow an individual education plan where this particular course is included. Some national researchers’ schools may have specific rules for ranking applicants for courses with limited intake capacity.

PhD candidates who have been admitted to another higher education institution must apply for a position as a visiting student within a given deadline.

The instruction covers:

• 24 hours of lectures covering scientific, technological, ethical, and regulatory aspects of New Approach Methodologies (NAMs)

• a case-based seminar where students analyze examples from drug development and safety assessment (4 hours)

• laboratory demonstrations and supervised practical exercises providing an introduction to organoid and cell culture models, as well as associated analytical methods (6 hours)

The following mandatory activities must be approved before the exam::

• at least 75% attendance/participation in seminars and group-based exercises

• participation in the practical laboratory module

• submission of a report related to the case-based teaching activities (the "case report"; is only valid for the current semester)

Detailed information regarding the mandatory course requirements will be provided at the start of the semester. Attendance at the first lecture is mandatory. One (1) laboratory day will be scheduled for students absent due to illness. Absence must be documented with a medical certificate.

As the teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.

Final oral exam which counts 100 % towards the final grade.

This course has mandatory exercises that must be approved before the final exam

Students who can document a valid reason for absence from the regular examination are offered a postponed examination at the beginning of the next semester.

Re-scheduled examinations are not offered to students who withdraw during, or did not pass, the original examination.