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December 21, 2017 | The Philadelphia Citizen
When Benjamin Lewis was in veterinary school at the University of Pennsylvania, he worked both in vets’ offices caring for sick animals, and in research labs where healthy animals were injected with diseases for drug testing. In the same day, Lewis might see a dog suffering naturally from the same disease that he had seen injected into a healthy animal in the name of medical research a few hours before.
“It never quite made sense to me that the two markets had never connected,” he says. “We have 100 million sick animals per year, and at the same time we’re taking 100 million healthy animals and giving them the diseases that the sick animals already had.”
In 2016, Lewis and his co-founder and wife Christina Lopes launched The One Health Company, originally known as Ethical Animal Research, to connect these markets. One Health is a contract research company with a network of 110 specialty veterinary hospitals in the United States that connects already sick pets with pharmaceutical clinical trials that meet their needs, in much the same way that human drug trials work. One Health currently has access to five million sick pets in its research network.
In the traditional animal research model, researchers inject the animal with the disease, test the drug on it, and then kill it. The One Health Company’s model skips the first and last steps and focuses on the in-between: the treatment. According to Lewis, this is “far more predictive, far cheaper, and far more humane” than the traditional model.
The payout of this model for humans is huge: Only eight percent of cancer drugs tested on animals with artificial diseases actually work on humans; data on drugs tested on naturally sick animals is proving to be much more accurate when advanced to the human stage.
That’s in part because lab-created diseases cannot perfectly mirror real diseases. In order to give cancer to a mouse, for example, you have to first destroy its immune system. A drug’s effect on an animal without an immune system is going to be hugely different from its effect on a human with an immune system. You could create a fake immune system for the mouse, but the conditions still will not be exactly the same.
According to David Roth, a Penn pathologist who spent most of his career building mouse models for drug research, the innate differences between human and rodents contributes to this failure rate as well, and can expose participants in human trials to unexpected and unpleasant side effects. “Mice don’t get nausea and vomiting,” says Roth, the Chair of Pathology and Laboratory Medicine at Penn’s Perelman School of Medicine and the Director of the Penn Center for Precision Medicine. “You can’t even observe that set of side effects.”
Those effects do show up in dogs, though, which makes them a more accurate representation of human experience. One Health’s canine patients have real diseases and real immune systems that react to those diseases—as close to human experience as you can get. “This saves millions of dollars, years of work, and hundreds of patients from being unnecessarily treated,” says Jenna Burton, a medical oncologist and the Associate Director of the Veterinary Center for Clinical Trials at at UC Davis School of Veterinary Medicine.
Burton and Lopes both offered the example of the lymphoma drug Imbruvica as an example of an incredibly successful drug that included pet dogs naturally sick with lymphoma in its development process. A study released in 2015 followed humans with chronic lymphocytic leukemia over the course of two years, and found that while 85 percent of patients participating in chemotherapy survived, 98 percent of patients taking Imbruvica survived.
When Lewis first pitched the idea for The One Health Company while he was in veterinary school, he says his colleagues “laughed him out of the room.” He needed credibility and financial means to make it happen, but he was just a student.
He found both of these things in an unlikely place: on a spring break trip to Brazil during his first year in business school. The trip was supposed to last two weeks, but Lewis never used his return plane ticket, instead staying to run a new business he founded while there: 4Vets, a multi-brand animal health supply distributor that is still in operation. His two week trip turned into a four-year hiatus from school and stint as the company’s CEO.
4Vets gave Lewis the entrepreneurial experience and funds to get the venture others had told him would never happen years before off the ground. By the time the company officially launched in 2016, Lewis and Lopes had impressive combined experience: she the former Managing Director at Cerberus Capital Management, a former Advisory Board Director for Planned Parenthood, and a World Economic Forum Young Global Leader in 2010; he a graduate of the University of Pennsylvania’s Wharton School of Business six months away from his veterinary degree (and the captain of the US kayaking team in the 2004 Athens Olympics).
In addition to his and Lopes’ personal funds, investors including BioAdvance, Ben Franklin Technology Partners of Southeastern Pennsylvania, and Rittenhouse Ventures, plus some “wonderful local angels” keep the organization running. The company is not yet profitable, but the founders anticipate becoming so via their research and development clients in 2018.
One Health is not alone in facilitating veterinary clinical trials; this is happening throughout the country at places like Penn Vet’s Veterinary Clinical Investigations Center. However, most of these entities are conducting tests with the goal of improving veterinary outcomes. To Lewis’ knowledge, no other companies have created a network like One Health’s, nor have an eye to improving human trials in the way the company does.
Lewis was inspired to start One Health out of a desire to protect animals from harm. It also benefits already sick animals by giving them access to incredibly expensive treatment—sometimes over $100,000— that their owners likely wouldn’t have been able to afford, all at the expense of the pharmaceutical company testing the drug.
One Health won’t test just anything on its patients, though. “We don’t want to put anything in someone’s pet dog that is going to hurt them,” Lewis says. “We’re not jut testing random molecules. We answer very specific questions for pharmaceutical companies.” Lewis gave the hypothetical example of a drug the FDA has already approved in two cancers, and now the company that produces it wants to see if it’s effective against a third type of cancer. Similarly, two different drugs may be known to be effective against a certain disease, but the FDA needs compelling data from clinical trials that show that when combined, the drugs work even more efficiently.
“We weren’t sure how we would be viewed by animal rights organizations, and instead they’re our biggest advocates,” laughs Lewis, who says he and his partners had initially seen backlash from these groups as a huge possible roadblock to success. “My dog has been in a clinical trial, and I have participated in a clinical trial, so it’s certainly a process that I’m a firm believer in,” Lewis says.