Watchdog And Innovator: Modernizing The FDA-Industry Relationship
As each medical advance introduces a new regulatory challenge, FDA’s need for reinvention is as constant as industry’s need for innovation. If the agency is going to help sponsors bring breakthrough medicines to market, it must rethink its role as both watchdog and regulatory innovator.
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In our second annual Life Science VC Survey, biopharma investors continue to look to oncology and rare disease, while their cold shoulder toward metabolic disease seems to be warming. Even though most agree the traditional biotech funding model is broken, our participants are far from convinced that new models such as asset-based financing are the answer.
The biopharma industry must think differently about funding high-risk/reward development of drug candidates against novel targets. Multiplexing Phase II proof-of-concept trials can light a path toward lower-risk pivotal studies and provide a model for building biotechs to deliver what patients, providers, payors, and investors all want: solutions.
The UK-headquartered life sciences investment firm has comfortably exceeded its target of $350m for a fund dedicated to taking on late-stage products, incurring all the clinical and regulatory risk and receiving a pre-negotiated return once the drug is approved.