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• W2140296089 abstract "Fewer prospective drugs and biologics that enter Phase 1 trials eventually win FDA approval, according to Food and Drug Administration commissioner Lester M. Crawford. In a July 7th speech to a group of institutional investment analysts, Crawford said the “critical path” of drug development is “underperforming.”“In recent years, the vast majority of the tested compounds have never made it all the way from the sponsor's lab to the patient's bedside. Historically, 14% of the tested products eventually cleared the hurdle of FDA's approval and entered the marketplace. Today, the chance of success of a candidate drugs entering the Phase 1 trial is estimated at 8%.”Crawford said this extremely high attrition rate has had 2 inescapable consequences, “We've been getting fewer drug and biological submissions and the development costs of these products have reached unprecedented proportions.” He told the Banc of American Securities Healthcare Institutional Conference that filings of standard new molecular entities have gone down from 34 in 1995 to 12 last year. Original biological license applications have declined from 33 in 1997 to 14 last year. “At the same time, in some estimates the cost of a single drug development has soared from $1.1 billion in 1995 to $1.7 billion in 2002.”According to Crawford, part of the problem is the increasing complexity and toxicity of new therapies, which increases the difficulty of proving their safety and effectiveness. “But at least equally serious is the sponsor's inability to foresee these hurdles along the product's critical path. This leads to mistakes that frequently derail the development process when it is in an advanced stage, and has cost millions of dollars.” Moreover, these unexpected obstacles are becoming increasingly common, Crawford said. “In the past, we used to see a 20% product failure in the late stages of the Phase 3 trials. Currently, the failure ratio at this stage is 50%. The reason for this unpredictability, in our analysis, is the growing disconnect between the dramatically advancing basic sciences that accelerate the drug discovery process, and the lagging applied sciences that guide the drug development along the critical path.”The FDA commissioner said he believed that “not enough advanced applied scientific work has been done to create new tools to provide early, less costly, and more dependable answers about the tested products' potential for demonstrating safety and effectiveness. A measure of the economic consequences of this lack of foresight is our estimate that a mere 10% improvement in predicting products' failures in clinical trials could save $100 million in development costs per drug.”For more details, go to http://www.fda.gov/oc/speeches/2004/bascrty0707.html Fewer prospective drugs and biologics that enter Phase 1 trials eventually win FDA approval, according to Food and Drug Administration commissioner Lester M. Crawford. In a July 7th speech to a group of institutional investment analysts, Crawford said the “critical path” of drug development is “underperforming.” “In recent years, the vast majority of the tested compounds have never made it all the way from the sponsor's lab to the patient's bedside. Historically, 14% of the tested products eventually cleared the hurdle of FDA's approval and entered the marketplace. Today, the chance of success of a candidate drugs entering the Phase 1 trial is estimated at 8%.” Crawford said this extremely high attrition rate has had 2 inescapable consequences, “We've been getting fewer drug and biological submissions and the development costs of these products have reached unprecedented proportions.” He told the Banc of American Securities Healthcare Institutional Conference that filings of standard new molecular entities have gone down from 34 in 1995 to 12 last year. Original biological license applications have declined from 33 in 1997 to 14 last year. “At the same time, in some estimates the cost of a single drug development has soared from $1.1 billion in 1995 to $1.7 billion in 2002.” According to Crawford, part of the problem is the increasing complexity and toxicity of new therapies, which increases the difficulty of proving their safety and effectiveness. “But at least equally serious is the sponsor's inability to foresee these hurdles along the product's critical path. This leads to mistakes that frequently derail the development process when it is in an advanced stage, and has cost millions of dollars.” Moreover, these unexpected obstacles are becoming increasingly common, Crawford said. “In the past, we used to see a 20% product failure in the late stages of the Phase 3 trials. Currently, the failure ratio at this stage is 50%. The reason for this unpredictability, in our analysis, is the growing disconnect between the dramatically advancing basic sciences that accelerate the drug discovery process, and the lagging applied sciences that guide the drug development along the critical path.” The FDA commissioner said he believed that “not enough advanced applied scientific work has been done to create new tools to provide early, less costly, and more dependable answers about the tested products' potential for demonstrating safety and effectiveness. A measure of the economic consequences of this lack of foresight is our estimate that a mere 10% improvement in predicting products' failures in clinical trials could save $100 million in development costs per drug.” For more details, go to http://www.fda.gov/oc/speeches/2004/bascrty0707.html" @default.
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• W2140296089 date "2004-10-01" @default.
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• W2140296089 title "High clinical trials attrition rate is boosting drug development costs" @default.
• W2140296089 doi "https://doi.org/10.1053/j.gastro.2004.08.066" @default.
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