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The Cost Crisis in Drug Development
The cost of drug development has risen considerably over the last two decades, and the rate of approval for new drugs has gone down. This occurred concurrently with a reduction in the pace of drug development, putting CROs in a precarious position.
Getting a new drug to market costs, on average, $2.9billion across the entire lifecycle of drug development and approval. These figures, from a report by the Tufts Center for the Study of Drug Development (CSDD) show a 145% increase on the amounts from 2003.
Some of this substantial resource drain comes from a lack of good data, resulting in part from the inability to properly assess central nervous system (CNS) symptoms or observe behaviour in rodents. These difficulties lead to high attrition and study repetition rates, using up resources and time that would be better allocated elsewhere.
Social isolation and relocation from the home cage can cause distress and anxiety; this is often mistaken for signs of CNS symptoms or vice versa. Mice and rats also provide unreliable temperature data, as they have to be removed from the home cage for individual measurement. ActualHCA is specifically designed to obtain higher quality data than traditional methods and provides access to data that is not currently accessible. It allows rodents to remain in the real home cage during testing, with temperature, identity, and location read using fingertip-sized RFID chips in their groins. The chips relay the individual rodent’s position within the cage to the unique antennae located in the system’s baseplate. The baseplate is read multiple times a second, ensuring the most accurate locomotive data possible.
Monitoring rodents 24/7 in their home cage allows for the refinement of disease models and early phenotypes can be identified and addressed sooner. Studies are therefore more accurate in the preclinical stages, leading to less failure when drugs are moved through the development pipeline.
Data quality is one issue; data volume is another. If there is insufficient information from each animal, more time and money is spent repeating and validating studies. 3Rs policies must also be considered with regard to waste, and statistical significance is paramount to running credible trials. ActualHCA offers 90% more data using 50% fewer animals than standard testing methods as identified by the University of Strathclyde.
Profiting from new drugs should in theory balance out the enormous cost, but the pace of drug development is now so slow that companies can wait for a considerable period of time before money is made on new compounds. The $2.9 billion end-to-end cost stated above includes $1.2 billion that investors see no return on while drugs are being developed over the course of a decade or more.
Drug project closures occur due to safety in 60% of cases, according to data from AstraZeneca, and a large proportion of these closures are due to CNS symptoms. Inadequate standard practice within preclinical trials is resulting in drugs failing further down the pipeline after considerable time and money has been spent. Acquiring the best possible data in the preclinical stage will eliminate numerous candidate drugs at an earlier stage, allowing only the most promising to be produced and developed.