ROAD TO THE CURE UPDATE OCTOBER 2015

SO WHAT DOES IT COST TO DEVELOP NEW PHARMACEUTICAL DRUG AND WHAT’S IMPORTANT?

The steep rise in costs comes despite an intense effort…. helps the public understand that this is a high-risk, expensive, and long-term endeavor…. We believe ICBI is much closer to CURING the disease than anyone else…

A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years (Rick Mullin and Chemical & Engineering News, November 24, 2014) The steep rise in costs to develop a new drug comes despite an intense effort in recent years to bring efficiency to pharmaceutical Research & Development. A new report published by the Tufts Center for the Study of Drug Development (CSDD) pegs the cost of developing a prescription drug that gains market approval at $2.6 billion, a 145% increase, correcting for inflation, over the estimate the center made in 2003. CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development.

The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007. The study concludes that another $312 million is spent on post approval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion. The steep rise in costs comes despite an intense effort in recent years to bring efficiency to pharmaceutical R&D. Offsetting any such savings, according to CSDD, are higher costs due to the increased complexity of clinical trials, a greater focus on chronic and degenerative diseases, and tests for insurers seeking comparative drug effectiveness data. Noting the high cost of failure in drug development, Joseph A. DiMasi, director of economic analysis at CSDD and principal investigator for the study, says the cost of unsuccessful projects is figured in the cost analysis. LaMattina says, “The value of the Tufts study is that it helps the public understand that this is a high-risk, expensive, and long-term endeavor.” The line graph below shows the rise of drug development cost from about $100M in 1970 to about $1.5 billion in 2010. Last year, this figure had risen to about $2.5 Billion.   The cost of developing a new drug has skyrocketed since the 1970s. Source: Tufts Center for the Study of Drug Development.

ICBI Perspective 

“Some of our investors naively think that ICBI can develop a new pharmaceutical drug with a few million dollars,” says ICBI founder, Dr. Ram Bhatt. “However, it may be possible to develop a new drug in 2016 at 1970’s prices by spending investors’ money very prudently as one would spend one’s own money. Eliminating waste, recruiting and retaining only the talented performers, improving efficiency and conducting clinical trials outside the US could help to lower the drug development cost without comprising quality to the level of 1970’s.”

Big Pharma Collaboration

ICBI is setting up collaboration with one of the US big pharmaceutical companies to validate ICBI technology at the headquarters of the pharma to explore business relations.

WHAT’S IMPORTANT?

Whether it is a scientist from Harvard, MIT, UCLA or someone from a relatively unknown small organization, all we care about is the rapid availability of a drug that can actually make a difference in patients’ lives by altering the course of the disease not just ONLY treating the symptoms. We believe ICBI is much closer to CURING the disease than anyone else.