Predictive Toxicology becomes More Important as R&D Costs Rise



Pharma IQ
12/19/2011

It costs millions to get a drug from conception to development stages, as well as several years of research. However, a key challenge in the pharmaceutical industry is that scientists can put all this work and money into a compound, only to find it has unacceptable toxicology and they have to return to the drawing board. Indeed, the most recent figures suggest the cost of discovering and developing a drug is hundreds of millions of pounds.

Clearly this is an impossible situation, as no business wastes money lightly, especially in the current climate. With an increasing pressure to cut costs and streamline processes, pharmaceutical firms are doing all they can to avoid late stage drug attrition and all the connected expense.

This is where predictive toxicology becomes a valuable tool. It is one of the key processes in the battle against mounting costs, providing pharmaceutical firms with the ability to predict the toxicological effect of a drug or compound. This enables organisations to take steps at a far earlier stage to make change to improve the drug or identify the problem, rather than during clinical trials where it is more dangerous and far more expensive to identify problems.

The rising cost of R&D

A new report by Deloitte and Thomson Reuters found that among the largest drug developing companies in the world, the average cost of bringing a new drug to market has risen by around a quarter in just a year. In 2010, the cost came in at an average of $830m (£526m) while this year it is a staggering $1.04 billion.

However, unfortunately the value of drugs has remained the same, leaving pharmaceutical firms with an increasing reduction in profits that is adding pressure to make changes. Of course, predictive toxicology is a key tool in this, nevertheless Julian Remnant, head of Deloitte's European R&D advisory practice said that successful drugs carry the "burden of attrition". Simply put, this means that the cost of failed drugs has to be paid by those that eventually turn a profit.

"Every product that crosses a line carries all the legacy costs of those that didn't," he said.

"The very nature of drug development now is getting more costly because you have to demonstrate superior efficacy, superior value … There is a requirement on medicines developers to collect more data to present a more robust case, not just for regulatory approval, but for reimbursement."
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However, he said that while the research paints a worrying picture, it also doesn't show clearly how successful most firms are. Mr Remnant explained that Deloitte surveys the top global12 research-based pharmaceutical firms each year and has found that close to two-thirds realised more value from product commercialisation than they had lost through failures in drug development during the late-stages.

Dr. Fernando Muzzio, director of NSF Engineering Research Center at Rutgers University and Dr. Mauricio Futran, professor and chair of the Department of Chemical and Biochemical Engineering at Rutgers University suggested that predictive toxicology could be used to turn around the poor fortunes of pharmaceutical manufacturing in the United States.

The pair explained that in the past ten years "new molecular entities (NMEs) entering the market number less than half of those in the preceding decade". This has, of course, led to a decrease in revenues, causing reductions in workforces and increasing pressure on cost cutting and high-levels of productivity

To improve the pharmaceutical industry in the US, the government and organisations need to focus all of their resources on new technology and education – namely predictive toxicology as this will cut a significant amount from the cost of drug research and development.

"One of the few silver linings of the recent massive restructuring in US-based branded pharma is that there is a ready supply of available scientists eagerly awaiting the opportunity to upgrade their technical skills. It is hard to conceive a better use of educational resources than to devote them to this purpose," the pair wrote.

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