Course ObjectiveWhether scientific discoveries get translated into novel therapeutics or
diagnostics, is dependent on many issues. These include such down-to-
earth factors as whether a drug can indeed be manufactured at large
scale, and careful indication selection and clinical study planning. The
goal of the course is to provide insight in the factors that dictate
success in present-day development of therapeutics and diagnostics.
Questions that will be addressed are:
- What are the many factors involved in getting from a laboratory
discovery to a novel approved medicine, from clinical and regulatory
to economic issues;
- How does the pharma and biotech industry access innovation through
strategic partnerships with universities and small companies;
- How do entrepreneurial universities contribute to innovation, and turn
science into novel medicines and diagnostics?
After the course the students will have thorough knowledge and in-depth
- The scientific, clinical, regulatory and economic issues involved in
present-day drug development;
- Which party plays which role at all stages from research to
development to commercialisation;
- The keys to success in translating innovative technologies and
therapeutic principles to new drugs and diagnostics.
Course ContentThe subjects of the course will include the following:
• General aspects of how several miracle drugs have been developed
(Gleevec,Herceptin, Rituxan, Avastin, anti-TNF), form early laboratory
research stage to development and clinical proof-of-principle, and the
economic and regulatory issues involved;
• General aspects of how certain novel diagnostic tools for staging
cancers and for determining drug sensitivity have been developed (for
instance for breast cancer, the mamma chip developed by Agendia);
• Impact of careful indication selection and clinical study planning in
• Regulatory issues regarding drug development, including impact of the
European Clinical Trial Directive for Advanced medicinal Therapy
• Examples of a number of VUmc spin-off companies and their activities
in drug development and diagnostics;
• Legal and patent issues in technology transfer and partnerships
between universities and pharma, biotech and devices companies.
Teaching MethodsThere will be 24 contact hours in the form of lectures by the course
coordinator and a number of invited lecturers. These will include
external experts on molecular diagnostics and regulatory affairs, VUmc
colleagues with presentation on their own spin-off companies, and TTO
colleagues on legal and patent issues. In addition, the course consists
of independent learning on the basis of exploring literature and
business reports on selected topics, with the intent of preparing a
final presentation and report at the end of the course by small groups.
Method of AssessmentThe course will be concluded by group presentations on studies of
scientific literature and business reports on development of certain
drugs and diagnostics. These will be assigned by the course coordinator,
and the literature and business studies will also be summarized in
short written reports, to be delivered at the end of the course.
LiteratureThere is no mandatory literature for this course. The assignments
involve reading of dedicated papers and viewing of web-based lectures.
Target AudienceThis course is optional for students of the Masters Oncology and
Cardiovascular Research, who have completed at least three out of the
four compulsory courses of their programme. If enough places are
available, students from other MSc in Life Sciences may apply.
Additional InformationIf you have any questions or need extra information, please contact
Maartje Klaassen (firstname.lastname@example.org).
Custom Course RegistrationStudents can register for this course and examinations via vunet.vu.nl (under My study, register for courses and exams). The general VU registration rules apply. Information on registration deadlines can be found in VUnet. Please note that the general VU rules are strict, both for booking of the classes and (resit-)exams.
Explanation CanvasA CANVAS course is available for this module. Students will be
enrolled automatically when they register for the module via VUnet. The
lecturers will post information such as presentations slides and
literature links in the course.
|Language of Tuition||English|
|Faculty||VUmc School of Medical Sciences|
|Course Coordinator||prof. dr. A.W. Griffioen|
|Examiner||prof. dr. A.W. Griffioen|
You cannot register for this course yourself; your faculty's education office carries out registration
|Teaching Methods||Lecture, Study Group|
This course is also available as: