Research scientists often confront the “valley of death”—the gaping hole that exists between laboratory discoveries and their transformation into new medical treatments and products. And the most lethal factor for most researchers is money. However, Purdue University is blazing an unusual trail to help make ends meet in translational research. Rather than rely on traditional sources, the university has formed a not-for-profit startup to take discoveries from the lab up to Phase 1 human clinical trials.
“We develop a lot of drugs [at Purdue]; there aren’t many academic institutions or cancer centers [in our position]—with 14 of their drugs that are synthesized at their own institution in human clinical trials,” says Purdue Center for Cancer Research Robert Wallace Miller Director Dr. Tim Ratliff. “It’s a real strength here, and we want to improve and speed the process.”
Translating basic research into life-changing treatments is one initiative of Purdue Moves, a program that involves 10 university initiatives designed to enhance research, education and the school’s global impact.
Purdue’s Center for Cancer Research is one of only seven basic science research centers in the country designated by the National Cancer Institute. While Ratliff describes the center as a very efficient entity that can “move things forward in a rapid manner,” the process is still slower than scientists like.
Researchers typically rely on external funding from government sources to help them uncover a discovery, but beyond that, the money often dries up.
“[Government sources] don’t fund drugs from the discovery through all these routine processes you have to go through to get that drug ready to go into clinical trials,” says Ratliff. “You have to take these drugs and develop them, so that we understand the toxicities associated with them, their distribution in the body and other fundamental things before we get into the clinic.”
This is when most scientists encounter the “valley of death,” but Purdue believes it can finance the very expensive process with its newly formed Boilermaker Health Innovations, a not-for-profit startup that represents a unique way to fund the gap. Boilermaker Health believes it will be much speedier than the traditional route of forming for-profit companies that aim to attract investments to reach human clinical trials.
Once Boilermaker Health has funded a scientist through early research, Ratliff says it will spin-off a for-profit company to develop the compound and take it through U.S. Food and Drug Administration approval or sell the drug to a large pharmaceutical company.
“As we develop these drugs from very early stages, we envision those drugs will gain value,” says Ratliff. “While we’re a not-for-profit company, that value will create a fund in Boilermaker Health that will allow us, over time, to become independent and support our cancer research and drug discovery very efficiently through the use of those funds.”
Ratliff acknowledges the unconventional model begs the question of how Boilermaker Health will get its first infusion of cash; he says it will rely on Purdue donors, federal funding agencies and private foundations. The Purdue Research Foundation is also matching each donation, up to a total of $1.3 million.
Additionally, Boilermaker Health is considering an alumni crowdfunding effort. The startup has already received a commitment of $175,000 and is “pushing hard” to collect more donations.
“Earning the match would give us $2.6 million, and that would be sufficient to move our first compound through pre-clinical analyses,” says Ratliff. “Once Boilermaker Health gets the drug through the proof of principle clinical trial, that will enable us to sell the product at a higher value, and that higher value will bring revenue back in. The money that we get back, we re-invest into drug discovery, amplifying our ability to move drugs through the valley of death.”
An external advisory committee is currently evaluating compounds in the Purdue pipeline to select the first for Boilermaker Health to “shepherd.” Leaders are hopeful the university’s unique strengths in drug discovery will also pave an unconventional path to patients.