Admission requirements
See Brightspace for the admission requirements.
International Students should have an adequate background in Medicine. Admission will be considered based on CV and motivation letter.
For more information, please contact internationalisering@lumc.nl.
Description
In the minor Academic Pharma students will learn about the complex process of drug development. The minor will highlight the role of academic researchers and clinicians in drug development.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, followed by clinical trials in healthy volunteers and patients (Phase I–III trials). This process can take up to 10 years of time, and hopefully ends with obtaining regulatory approval with a new drug application to market the drug.
Traditionally drug development is in the hands of pharmaceutical industry. They have the expertise and the resources needed for this lengthy and costly process. Academic researchers have little experience or expertise in the complex regulatory issues related to drug development. This is a pity, as there are several diseases or compounds for which pharma has no interest. Especially in the area of rare diseases there is an unmet need to develop new drugs, for an affordable price.
Within the new Research Theme Academic Pharma, in LUMC now several drug development projects have been initiated. It is the ambition of Academic Pharma to drive the translation of innovative basic research to develop drugs that fulfil an unmet clinical need and will benefit patients. With the support of consultants and pharma companies the expertise is now “in the heads of” our team and it is important to disseminate the expertise. This is an important motivation to start this minor program. The projects we have worked on can be integrated as use-cases in the teaching modules, to ensure “real life” situations. Modules will be focused on parts of the drug development process (such as clinical development or market approval) and we will teach students in the discovery and development of medical interventions. There is a perfect match between the necessity to safeguard the collected expertise and the creation of human capital with the right knowledge and skills to work in drug discovery and development, either in academia (LUMC) or in pharmaceutical industry (biotech, big pharma).
Drug discovery and development is a multi-step process involving multiple disciplines. The Leiden BioScience Park (LBSP) is host to about 150 biomedical life science companies which, in collaboration with the LUMC and University Leiden, are involved in development of innovative drugs, vaccines, diagnostics, and platform technologies. Both LUMC and University Leiden have recognized that the local ecosystem is excellent for the discovery of novel drug targets, molecules, and concepts for drug discovery, allowing more effective and safer treatments to be developed. Collaborations with internal and external partners are stimulated, thereby showcasing how novel collaborative approaches can benefit patients
Course objectives
Describe the different stages of the drug discovery and development process.
Understands terms like good clinical practice, primary and secondary outcomes, pharmacovigilance, health economics, intellectual property, drug rediscovery, orphan drugs.
Analyze the role of different stakeholders in the drug discovery and development process.
Discern the challenges in traditional and academic drug development.
Teach and educate fellow students on the issues encountered in the development of a promising candidate drug.
Collaborate with fellow students in the development of a promising candidate drug.
Participate and provide advice and feedback in simulated meetings of the medical ethics committee and the medicines evaluation board.
Present the clinical trajectory of a promising candidate drug at a drug development board.
Develop a research protocol.
Timetable
All course and group schedules are published on MyTimeTable.
The exam dates have been determined by the Education Board and are published in MyTimeTable.
It will be announced in MyTimeTable and/or Brightspace when and how the post-exam feedback will be organized.
Mode of instruction
Technology enhanced learning, with blend of face-2-face and online sessions. Innovative working groups will use case-based learning representing the drug development projects currently executed under the guidance of Academic Pharma (real life cases). Students will also be involved in simulated discussions of both the medical ethics committee (for research proposals) and of the medicines evaluation board (for registration of drugs). Students will work in groups of students on a candidate drug, and with this drug they will make the different steps of the drug development process. A guided tour to a company involved in drug development will also be organized.
Assessment method
At the end of the course students make syntheses of the discussed theme-subjects and do an exam. This time is also available to work on writing and preparations of the end assignment, which consists of a written project proposal and a presentation.
25% General subject assessment: Exam with MC questions and short open answer questions.
25% Presentation during the simulated meetings
50% Written research protocol
Reading list
Papers will be provided per day-to-day schedule via Brightspace
Registration
Information about the registration process can be found on the Brightspace course Half Minors.
Contact
Prof. Dr. T. van Gelder, internist – clinical pharmacologist, LUMC t.van_gelder1@lumc.nl
W.R. Bakker, MD, PharmD, LUMC w.r.bakker@lumc.nl