Cancer vaccines in the past have failed clinically but may have succeeded biologically, according to Roche R&D exec Hy Levitsky. The immunosuppressive tumor microenvironment must be circumvented if the vaccine response is to be effective – and Roche thinks its immuno-oncology pipeline could do the trick.
Development of new oncologics targeting the immunosuppressive tumor microenvironment could rejuvenate the prospects for therapeutic cancer vaccines, a field that has long been heavy on promise but light on actual commercial or clinical success.
“Ultimately, unless you do something about this suppressive tumor microenvironment, you’re going to have a very hard time,” Roche...
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
