6 research outputs found
Vaccines : A rapidly evolving technology - Are the hurdles being addressed?
AbstractVaccination usually works in infectious disease, why not in Cancer? Differences in the potency of microbial and cancer antigens, poor initiation of an immune response due to inadequate expression of tumour associated antigens, weak antigens or tolerance induction and local immune suppression were considered. There is a big difference between a therapeutic and a prophylactic vaccine.The opinion of the expert group was that an improved therapeutic efficacy can hardly be expected by further variation of types of vaccines, schedules, routes of administration and adjuvants alone. A major hurdle for developing therapeutic cancer vaccines is the need to effectively monitor the immune response and to be able to use this in an adaptive trial approach.End-points of assessment should be different from standard treatments as complete response or partial responses are usually low, unless combined with other therapies.In order to focus resources to overcome the hurdles of enhancing the therapeutic efficacy of cancer vaccines the Cancer Vaccine Clinical Trial Working Group, representing academia and the pharmaceutical and biotechnology industries has in a consensus process defined 'A clinical development paradigm for cancer vaccines and related biologics'
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective
Entwicklung einer Prototyp-Kathodenzerstaeubungsanlage Schlussbericht
With 26 figs.SIGLEDEGerman