The Patient is Waiting … The Economics of BioPharma R&D FAILURE

What chronic condition do you have? Do you know someone who is suffering from cancer?

With all of the great minds and scientific advances we have at our fingertips, it is unforgiveable that some of these problems have not been solved! You will ‘soon’ be driving a driverless car … but you and your family will still have to suffer with debilitating diseases.

How can we fix this!? How can we improve the success rate for the pharmaceutical industry?

Pharmaceutical productivity is measured by the average Research and Development (R&D) cost per new approved drug, which includes the amount spent on failures. The DECLINE in productivity is staggering. For every one billion US dollars spent on R&D, the number of new drugs approved has been cut in half approximately every 9 years since 1950.

The pharmaceutical industry has raised eyebrows due to the staggering costs of innovation and shrinking positive results — drug development is suffering. A substantial gap has been created between the expenditure on R&D and the return on investment for the pharmaceutical industry.

Innovation has a cost. A benchmark report by the Tufts Centre for the Study of Drug Development estimates that the cost of bringing a drug to the market has more than doubled over the last decade.

If a breakthrough drug is developed, then the returns to both investors and patients will be enormous. However, the quest to develop new drugs has experienced escalating costs. In fact, a recent MIT study revealed that companies lost about $26 million on each new drug they developed between the years 2005 and 2009.

Over the past six decades, scientific and technological advances have expanded and should have aided in the development of new therapeutic options. However, innovation has been fleeting and grown more challenging over the same period of time. While it is impossible to completely rule out all failures in drug development, the 40% failure rate in Phase 3 clinical trials has been cataclysmic for the pharmaceutical industry. Many companies have cut down on the number of projects they are working on, instead of trimming the cost per project. This, in turn, has created an adverse effect on innovation.

In my opinion, it is the industry’s lack of focus on safety that is costing the industry millions and millions of dollars. SAFETY issues are the items which stop most drugs from proceeding forward. To any outsider, it is OBVIOUS something is wrong here and requires a concerted, industry-wide focus in order to be able to fix it and garner more success.

We need the Presidents in the biopharma industry to start to fund the future safety and toxicology tools, assays and in silico modeling solutions that could bring ALL of us more success … and bring cures to market FASTER!

Let’s look at the facts:

“The in vitro and in vivo preclinical models don’t predict what will happen in humans … 36% of the time,” from ‘Nature Biotechnology’ as quoted in Forbes by John LaMattina, Previous President of Pfizer Global Research and Development.

And, based on a study published in 2015, a whopping 51% of compounds from four major pharmaceutical companies listed the primary cause of failure for terminated compounds as non-clinical toxicology or clinical safety.

SAFETY must become JOB #1 for the industry! Period.