Can someone please help explain the following in simple English?
WuXi: How do you think the 21st Century Cures Act will impact your company?
Daniel O’Connor: The Cures Act is important for Advaxis in a number of ways. First, the Cures Act expands FDA’s recognition of patient experience data in the drug development and approval process. For therapies under development in advanced- and late-stage diseases like Advaxis is studying, the patient experience is so critical to FDA’s understanding of the benefit and risk profiles of investigational products.
The Cures Act also requires FDA to formalize a process for qualification of drug development tools like biomarkers and surrogate endpoints and provides that such tools can be used to support licensure of a product. In the immunotherapy area in particular, there is a need for FDA’s recognition of new tools and endpoints that provide clinically meaningful data in the drug development process, particularly for the advanced cancers we study. Immunotherapies are on the front lines of working to qualify new endpoints, biomarkers, and surrogate or intermediate endpoints and we expect utilization of FDA’s formal qualification process will become an important drug development strategy for our company and the future products we develop.
WuXi: What other R&D projects are you working on?
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