Explore the whitepaper on Engaging With Regulators on Novel Statistical Approaches to Clinical Development written by Scendea and Exploristics



The Pharmaceutical Industry is undergoing significant change as it faces extreme pressure to deliver new treatments to market at a time of increased spending in R&D. Multiple economic pressures are being exer ted on the industry, ranging from an impending patent cliff, a decrease in income due to greater competition from generics and biosimilars, to demands on drug pricing by governments. Each approved new drug costs around $3 billion to develop whilst healthcare providers seek to reduce the price paid for treatments making development costs unsustainable in the medium term. The current high at trition rate of treatments in development contributes to these high R&D costs, with 90% of treatments undergoing clinical trials failing to reach the market.

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