Presenter: Mike Rice, MS, MBA, Principal, Defined Health
The recent, unprecedented FDA approvals of three advanced therapeutics, in the form of gene and cell therapies based on viral DNA transfer platforms, signify that a therapeutic paradigm change is upon us.
All three of these programs demonstrated dramatic efficacy in previously hopeless clinical situations. Such breakthroughs are based on decades of research and are likely to become a mainstay in treating, if not, curing, many devastating and intractable illnesses. Paving the way, FDA Commissioner Scott Gottlieb recently indicated that the agency is establishing a policy framework for the evaluation and review of a busy queue of advanced therapeutics expecting to seek review over the next year.
In Defined Health’s upcoming presentation, Mike Rice of Defined Health will discuss:
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