>The National Institute for Pharmaceutical Technology and Education (NIPTE) will play a critical role in tackling one of the major issues affecting the pharmaceutical industry - pressure on drug prices.
The NIPTE - a collaboration of 11 major US universities - says it will focus on improving pharmaceutical development and manufacturing, by learning more about the precise science involved in making pharmaceuticals and then exploring ways to reduce costs.
"We believe we can save $250-400 million (€210-340 million) for every drug that goes to market," Dr Prabir Basu, executive director, NIPTE, told In-PharmaTechnologist.com.
"A recent study at Purdue University estimates that the overall cost of bringing a new drug to market in 2004-2005 can be as high as between $2 billion-$2.5 billion and appears to be increasing at a rate of nearly 50 per cent every 5 to 7 years," said Dr Basu.
Pharmaceutical development and manufacturing processes have become so complex that it is becoming increasingly more difficult to provide safe and effective drugs at a low cost to patients unless fundamental research is conducted to change how pharmaceutical products are developed and manufactured after a new molecule is discovered.
Between 1997-2003, the number of new drugs submitted for Food and Drug Administration (FDA) approval declined by nearly 50 per cent, according to published reports by the Tufts Center for the Study of Drug Development.
This can be partly attributed to the fact that it is harder to discover new molecules and most pharmaceutical companies are now only looking to market blockbusters due to the high costs of R&D and manufacturing.
The success rate of a new molecule being developed into a marketable compound is as low as 5-10 per cent.
A major problem is that companies currently have to undertake a trial and error based product development process on new molecules and as a result the cost of developing new drugs to the market is high and manufacturing processes are not robust.
Another reason for high drug costs is that the product development and manufacturing processes for the new generation of drugs are becoming more complicated and time consuming due to the increased complexity of the diseases and drug delivery mechanisms that are requiring new drug therapies.
Furthermore, once a compound has been successfully developed, the manufacturing process can be extremely variable, leading to a huge amount of product wastage, at an estimated cost to manufacturers in the US of $20-50 billion.
"If you have proper manufacturing processes in place you can avoid this but currently the science is not available for manufacturers to reliably and consistently produce drugs with low quality variability," said Dr Basu.
"We believe we can reduce the cost of drug manufacturing by 20-30 per cent and save between $15-20 billion a year by improving the quality of manufacturing process and reducing resources and product wastage," he said.
Improved product development processes also mean clinical trials could be as much as halved in cost and time and drugs could be available on the market earlier.
Clinical trials are often rate limiting on the cost and availability of clinical supplies and are often delayed due to manufacturing processes for clinical supplies that aren't robust enough, Basu said.
In order to combat these problems, NIPTE will carry out fundamental research and provide education that will enhance and expand manufacturing science, improve the scientific basis for understanding the behavior of pharmaceutical materials and the ability to develop robust processes early in the development process, develop strategies to allow rapid design and scale-up of manufacturing processes, improve quality and allow pharmaceutical technologies to anticipate problems by "learning before doing."
The group will perform a mixture of experimentation and physics, maths-and computer-based modeling and aim to develop and understanding of the physical and functional properties of materials and mixtures for predictability of "the science behind the compound."
"Our goal is to develop the tools to make the all aspects of bringing a drug product to market cheaper, faster and more robust," said Dr Basu.
The 11 universities involved in the collaboration are Duquesne University, the Illinois Institute of Technology, Purdue University, Rutgers University, the University of Maryland's School of Pharmacy and the universities of Connecticut, Puerto Rico, Iowa, Kansas, Kentucky, and Minnesota and the group are working in conjunction with the FDA.
The collaboration is hoping to have the results of their research in the public domain in the next 5-10 years, and is currently seeking government funding of $25 million a year.
"This is a small investment compared to the potential savings in drug prices," said Dr Basu.