Admission requirements
There are no formal entry requirements for this course. It is assumed that the knowledge has been covered during the entire BSc period that has been enjoyed up to that point. A relatively large part of this adequate knowledge concerns the general drug pathway (preclinical to 'Phase 1-3' research), statistics and basic knowledge of (patho)physiology.
Description
The course “Modern Drug Development” (abbreviated often in Dutch by 'OMG') covers the fundamental aspects of “drug development” to “commercialization” of a medicine. The entire drug process is completed through a kind of 'simulation'.
The course contains substantive lectures and lectures from various guest speakers from the pharmaceutical industry, research institutes, regulatory authorities, the patent center, etc. In addition, 'file work' is central as a large group assignment (a group assignment in which certain components are assessed at an individual level. that students (who are divided into groups of 6-7 people for the entire period) are assigned a drug file (with preclinical data from a real CHDR file), and students go through the clinical phases for this specific drug and put it on the market fictitiously. This part is supervised by staff members and external experts and should ultimately lead to a file containing the most important documents from 'drug development'.
An important part of this block is also pharmacovigilance (the 'phase IV' drug research if the drug is already on the market), with a major role for pharmacoepidemiology (FEP). This section also runs as a common thread throughout the block, and here the basic principles of epidemiological research into the use and effects of medicines are discussed. Components such as framing of the field, study designs, principles of bias & confounding, frequency and risk measures, meta-analyses are discussed here, which can also be used for the file, but to a lesser extent than the other components. That is why the FEP component is tested relatively extensively in the written exam (see testing).
Course objectives
The main objective of this course is to know, understand and apply the various aspects that are important during the drug development. In addition to the classic route, alternatives and trends are also discussed. This includes e.g. orphan drugs, biologics and personalized medicines. Finance, marketing, patents and business development of drug development are also discussed. Based on the main objective of the course, the following 12 concrete learning objectives can be formulated, in order from 'easy' learning level to 'complex' learning level:
The student…
- can explain which essential components are important for preclinical drug research.
- can explain how communication with relevant external parties involved in the medicine can contribute to its development.
- can indicate whether and when there is a form of intellectual property.
- can calculate in qualitative and quantitative form what the added value of a particular (drug) treatment is.
- can provide arguments for the choice of using specific biomarkers during clinical research.
- can draw up a risk analysis for a medicine and interpret this analysis.
- can assess whether a design for a drug study meets ethical conditions.
- can argue whether an investigation meets the requirements of quality assurance and complies with Dutch legislation and regulations.
- can put together a development process for (non-)regular medicines based on relevant questions for a medicine and differentiate between classical and modern approaches.
- can explain the follow-up process (pharmacovigilance and pharmacoepidemiology) for a registered medicine and compile documents that play a role in this process.
- can apply the concepts, foundations and technical terms to drug studies using knowledge of pharmacoepidemiology.
- can construct and present a development process for (non-)regular medicines on the basis of a case study.
Timetable
In MyTimetable (after login) you can find all subject and course schedules, with which you can put together most of your schedule (rooms and times). Educational activities for which you have registered via MyStudymap will automatically be shown in your timetable. In addition, you can easily link MyTimetable to a calendar app on your phone and schedule changes are automatically implemented in your calendar; In addition, if desired, you will receive an email notification of the change (set under 'Settings' after login).
Questions about MyTimetable? Watch the video, read the [instruction](https:// rooster.universiteitleidingen.nl/help?_ga=2.149825328.722230736.1609920490-320150080.1609920490 ) or contact the [ISSC helpdesk](https://www.werkers.universiteitleidingen.nl/ict/hulp-en-steun/helpdesks-en-contact Persons/helpdesk-issc )
NB:
We cannot currently display all schedule information in MyTimetable, so ALWAYS CHECK
the overview grid on the Brightspace module ‘Bachelor Bio-Farmaceutische Wetenschappen’ for a compact overview of the structure of each academic year, incl. . timing of resits and study-related activities such as information, symposia, etc. AND
the detailed schedule on the Brightspace module of each course (after registration), 2-3 weeks before a course starts. Your personal detailed schedule may differ, for example due to splitting into groups, interim deadlines, guest lecturers, etc. The detailed schedule of the course on Brightspace is leading.
Mode of instruction
The transfer of knowledge will mainly take place through self-study and (guest) speakers. Interactive lectures take place including several so-called 'flipping the classroom' elements. The entire block consists of a 'simulation' in which a file is built up for the fictitious launch of a new medicine. Various assessments about this project work are carried out in working groups and ultimately lead to a medicine file. With all the knowledge gained and implementation of the file, sufficient knowledge transfer for the exam has been achieved.
Assessment method
The students are tested in different ways. First of all, there is the written exam, which must be achieved by attending the lectures and emphatically also by completing the file work with the various assignments. In addition to participating in the interactive lectures with guest lecturers, a file must be drawn up during the entire period (as an indication: roughly on average between 120 (±40) pages)). Furthermore, the final presentation serves as an assessment instrument. The total grade is determined on the basis of various partial grades:
1. Exam (50%)
2. Final presentation (10%)
3. Final file with individual component (40%). This partial grade is determined on the basis of various components:
Overall file, including the average of the assessments between direct supervisor and coordinator (60%)
Assessment of the 'IB risk assessment' part (20%)
Assessment of the patent application by the 'NL Patent Center' (20%)
Assessment of the (individual) METC response 'bonus/deduction' (-1 to +1)
At least a 5.0 must be achieved for each of these 3 individual components for possible compensation with the other components. For the final grade, all components must be completed with at least a 'pass' or 6.0.
Reading list
General information (schedule, manual) and in-depth literature are offered via Brightspace; Articles can be consulted by the student via the internet for support.
Recommended books:
“Drug Discovery And Development, Technology in Transition”, H.P. Rank; ISBN: 978-0-7020-7804-0 (2nd edition remains usable = ISBN 978-0-7020-4299-7)
“Grondslagen der epidemiologie”, Vandenbroucke JP & Hofman A.; ISBN 978-9-0368-1984-8
Registration
To participate in this course, registration in uSis is required, use MyStudymap. The standard registration period of 5 calendar days before the first activity of the course applies to this course.
You can register for the (re)examination up to 10 calendar days before the (re)examination date.
NB Only register for the components that you will actually take, deregistration is also mandatory if you do not participate.
Detailed information about how MyStudymap works can be found here.
Contact
Dhr. Dr. Jeroen van Smeden
Dhr. Dr. Nienke van Rein
Remarks
Not applicable.