Driving Over the Drug Development Valley of Death

It’s a long, hard road that begins with the identification of a promising drug candidate and ends with its introduction to the marketplace. A drug must pass through a series of dangerous spots on the route, and the vast majority don’t make it. Researchers must validate the target, optimize the structure of the drug, and produce it in large amounts. All this before the drug faces the ordeals of preclinical drug development and clinical trials. The “valley of death” represents the challenging part of drug development where most drugs go to die.

On top of that, many potential drugs born in academic institutions never have the chance to prove their mettle. For various reasons, including costs, regulatory hurdles, and looming patent expirations, pharmaceutical firms tend to say “no, thanks” to the prospect of sponsoring drug development. Start-up companies, often founded by academic researchers, intend to take a drug through the next stages, but many run out of funding.

The situation is all the more unfortunate in light of the fact that most academic medical-related research is funded in the billions by taxpayers through the National Institutes of Health and others. Despite the investment and the hundreds of thousands of papers annually published each year, the number of new drugs approved by the Food and Drug Administration was just 27 in 2013.¹

Dennis Liotta, a professor of chemistry at Emory University, had this to say about the current state of affairs: “The traditional model of drug development is no longer sustainable.”² In response, he and others at Emory have founded Drug Innovation Ventures at Emory, or DRIVE. DRIVE is aimed at managing the drug development process where academic, NIH-funded research leaves off. It is wholly owned by Emory, but it has the independence to enjoy the “best of both worlds” from academia and industry. It can license technology from other universities, for example, yet it has access to Emory’s research infrastructure. It is capable of spinning off for-profit companies; at the same time, its own not-for-profit status allows for donations from philanthropic foundations.

DRIVE focuses on viruses that use RNA as its genetic material. These include the virus that causes dengue fever, a disease whose incidence has increased 30-fold in the last 50 years and has eluded a cure or vaccine, despite much research attention. There are 19 vendors that offer pharmacological models for dengue virus through Scientist. Another virus in the cross-hairs is equine encephalitis, against which the Emory Institute for Drug Development (EIDD) has received a federal grant for drug development. EIDD has also established collaborations with other universities. The hope is that, through DRIVE, drug candidates for these projects can be shuttled efficiently along the drug development path.

Medical research is hard, and the reasons that the valley of death exist are as complex and intricate as the research itself. Time will tell whether an approach such as DRIVE is a bridge that can help drugs make the entire journey, all the way to the patient.