Monday, February 7, 2011

Crossing Over the Valley of Death

by Angelo Bouselli, Senior Communications Manager

Stem cells. Genes linked to Alzheimer’s, autism, diabetes. Cancer drugs tailored to treat an individual tumor. Every day we see stories in the media about the latest medical “breakthroughs” that could lead to cures for dreaded diseases. And yet, over the years, many breakthroughs like these have yet to bear fruit for patients. Why? FasterCures’ new whitepaper Crossing Over the Valley of Death, examines one significant factor, a gap in funding and support for the critical stage of the research process known as translational research.

Many basic discoveries barely get to start the journey down the therapeutic development pipeline because structural, intellectual, technical, and funding barriers make it difficult to advance any further. They get stuck in an ever-widening gap, known as the "Valley of Death," between a promising scientific discovery and the point at which a company is willing to pick it up and move its development forward.

According to a recent Wall Street Journal article, “the Food and Drug Administration (FDA) approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.” Monthly drug-approval reports on the FDA's website show the number of new drugs approved in 2010 is down from 25 in 2009 and 24 in 2008, but slightly higher from a recent low of 18 in 2007.

The National Institutes of Health (NIH) states that 80 to 90 percent of research projects fail before they ever get tested in humans. By industry’s reckoning the number may be even higher— for every 5,000 compounds tested, only five make it to clinical trials, and only one is ever approved by the FDA. Half of all experimental drugs in Phase III trials never become approved medicines.

In Crossing Over the Valley of Death, FasterCures, in collaboration with the Parkinson’s Action Network, reviews the drug development pipeline from the most basic research conducted at academic research centers and supported by the NIH to the large-scale Phase III clinical trials conducted by pharmaceutical companies. It also features case studies from the sickle cell and neurodegenerative disease communities that illustrate the Valley of Death’s impact on cutting edge therapeutic development.

In the great film “Lawrence of Arabia,” T.E. Lawrence had a gift for making overcoming apparently insurmountable barriers seem merely a matter of taking them on. Confronted by a seemingly impassible desert, Sherif Ali says, “There is the railway. And that is the desert. From here until we reach the other side, no water but what we carry with us. For the camels, no water at all. If the camels die, we die. And in twenty days they will start to die.” Replies Lawrence, “There’s no time to waste then, is there?”

To learn more about the importance of translational research in the therapeutic development process, some promising approaches to trying to bridge the gap, and what more needs to be done, read: Crossing Over the Valley of Death.

1 comment:

Tim Shi said...

Crossing Over the Valley of Death
Indeed, we have to cross over the Valley of Death. However, before we start the “journey”, as mentioned in the article, the funding support was one of the significant and critical factors. In fact, the actual research subjects – human being or patients are the actually determining point to approve this or that drug would be useful and applied for.

This would bring up a logical question, where do we start to cross over the Valley? From the laboratory- “bench”? or should we reinvent a “frontline” at “bedside” firstly to dealing with patients? This core issue must be taken care of first and to be concerned first. We should have enough preliminary data or results from Phase III to help companies and investors to get off their headache- if not for all, how about sub-group or personalized solution? Yes, the funding would be available for your re-research there.