After finishing successfully the student is able to:
- - Describe the various stages of drug development from preclinical to post-marketing and understand the roles of different stakeholders: patients, doctors, researchers and industry
- - Understand at a molecular and posttranslational level how humans differ and how disease differs from health and what the consequences are for innovative therapy of prevention
- - Explain what precision medicine means and what it will mean for the pharmaceutical industry and understand the method of diagnosis (including biomarkers) and companion diagnostics
- - Think of solutions for the barriers that currently face cell and gene therapy, as well as regenerative medicine
- - Assess the limits of “personalised” and of (bio)similarity
- - Discuss alternative funding models for the biotech industry.
This course is an elective for life sciences students in year two or three of the bachelor programme.|
The main trend is towards advanced therapy medicinal products (ATMP), which include biomolecules and cells, focusing on disease modification and on personal differences: personalised medicine. But a better understanding of a person’s characteristics can also be exploited by repurposing of old medicines.
In this course we will study personalised medicine at several levels. Molecular, cellular, organ, organism, and population.
The first topic is What makes a person a person? How do we differ at a molecular level. How can we diagnose disease?
The second topic is Which new therapies and vaccines make use of these personal differences?
The third topic is Can we regenerate degenerated cells, tissues and organs?
The fourth topic is Which similarities and dissimilarities really matter, both in patients and in medicines? And how can we control costs?
The course starts by looking openly and creatively at the far future in week 1. Which health care innovations do you anticipate in 2050? Small groups prepare and present a presentation. After this science fiction part, we look at the present day in week 2. Which new medicines have been registered in the last few years? Individual students select a drug and write a monograph about all phases of its discovery and development.
In week 3 and 4 we explore the questions of who we are and how we differ. Genomics and epigenetics, proteomics and glycomics. The focus is on a molecular level, and on the post translational dynamic reality. This part includes some experimental work: self typing. In workshops students learn how to read output from genotyping, from proteomics and from glycomic arrays.
In week 5 and 6, innovative therapies and vaccinations, not yet on the market, are studied. This part includes an interview at a biotech company. Small groups of students write a report on the combination of a diagnostic and a therapy.
In week 7 and 8 we will focus on cell and gene therapy, as well as on regenerative medicine. This part includes a tour at a cell preparation facility. Students discuss solutions to barriers in a final meeting.
In week 9 and 10 we discuss what is sufficiently similar to be useful. What do we expect from biosimilar medicines? And from cell therapy, or from organs, grown in animals? Which patients are similar enough to benefit from the same medicines or cells? We close this part with a debate about solutions for the problems associated with the current Pharma business model, in a time of ATMP’s.