For all tasks, students will work first individually and then in small groups. They will then compare the outputs of the different groups and propose a single response for the whole class. To be involved in all aspects of the assignment, all students will work on all tasks. The tasks will be carried out sequentially.
- Define a characteristics of an ideal yellow fever vaccine for travellers and for endemic countries (Target Product Profile or TPP), based on the current epidemiological situation. Compare the defined TPP with the characteristics of the existing vaccine and discuss the differences, if any.
- Reconstitute the manufacturing process flow-chart, including in-process and QC testing from publicly available information, define the critical quality attributes based on a risk assessment.
- Propose different improvements that could be made to the YF vaccine, including developing new vaccine(s). The proposals should be justified scientifically and based on medical need.
- Define a high level development plan for the proposed new vaccines. Include the preclinical studies, different clinical trials with clinical endpoints, and process development. The WHO guidelines should be taken into account.
- Assess and prioritize the different proposals in terms of (i) matching the requests of the TPP, (ii) time of development, (iii) technical risk, (iv) regulatory risks, (v) competencies needed, (vi) manufacturing cost drivers. For both the technical and regulatory risks, the risk will be considered higher if an untested technique is used or if no similar vaccine has been registered so far.
- Summarize and discuss the different options for a final recommendation.
Last update: Tuesday, July 21, 2015