Startups

This startup is using tech to make animal testing in clinical trials more ethical

“We collect data on side effects, which are very, very valuable for pharmaceutical companies,” says co-founder and CEO Christina Lopes.

IMG_6476Dog as man’s best friend is a trope that stretches across sitcoms, cartoons, and even reporters’ news articles. Now a small startup in Philadelphia is making the saying applicable to the pharmaceutical and drug development world.

Drugs that are developed by pharmaceutical companies are tested on laboratory animals, such as mice and monkeys. As the Food and Drug Administration outlines, usually drugs to be used in human clinical trials are tested first in animals to evaluate their safety and how they interact with living tissue. But the typical testing method is to take a healthy animal, give them a certain disease, test the drug, therapy, or medical device, and then kill them.

The One Health Company is trying something new by finding dogs (and cats) with naturally occurring diseases that are also present in humans, like bone cancer, and testing new drugs or therapies on them. The goal is two-fold: Provide pro-bono care for pet owners to heal their own pets, while facilitating bringing new drugs to market by collecting data for pharmaceutical companies.

“Nobody talks about animal testing because it’s so taboo. We work the same way as a human clinical trial, except we recruit sick pets instead of sick people,” says Benjamin Lewis, co-founder and chief operating officer of The One Health Company.

The One Health Company itself is a contract research organization conducting research on behalf of those companies. Although Lewis declined to name specific institutions, he said the company already has partnerships with more than 35 trial sites in the U.S. and abroad, including France, Belgium, and Brazil. These trial sites are top veterinary hospitals and animal cancer centers, which care for the sorts of pets who could benefit the most from the clinical trials and research The One Health Company helps facilitate.

Given that recruitment is the most challenging part of clinical trials for humans, how does it work with sick pets? The company uses its software to scrape data from the databases of the trial sites to determine what pets have naturally occurring diseases, and therefore which pets might be good to recruit for trials. They can do this because pet health data is not bound by HIPAA laws, since pets legally are property. According to Lewis, the startup has its own database of 450,000 potential pets to recruit for trials.

The startup’s approach, however, is notably different. Pets remain with their families, diseases are never induced, and putting a pet down is never considered an option in any of their clinical trials. Families caring for their sick pets as they undergo these trials collect data, via smartphone, on their pets’ behavior and habits using proprietary clinical trial management software.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

“We collect data on side effects, which are very, very valuable for pharmaceutical companies,” says co-founder and CEO Christina Lopes.

The data also goes back to the veterinary care centers from which pets are recruited. And pets, at no time, are trying out therapies that have not been through extensive testing in other animals.

So why test on dogs, then, if the therapies being tested have already been tried on other animals? In 2005, the canine genome was mapped, and a dog mimics a human much more so than a lab mouse. For example, Lewis says that bone cancer in kids is almost identical to naturally occurring bone cancer in a dog. It’s in this way that clinical trials run by the startup are more cost-effective and potentially more revelatory for pharmaceutical companies, since the data collected is more predictive in human outcomes.

According to Lopes, the startup can have the most impact for both pets and humans in combination therapy—cocktails of drugs, where the order and dosage of drugs taken must be considered and tested—and immunotherapy, where drugs that harness the body’s immune system are used to defeat cancer or other diseases. It’s the latter that really demonstrates the potential impact of the company Lopes and Lewis have built. After all, to induce cancer in a lab mouse, you have to first knock out its immune system. How, then, do you test an immunotherapy drug?

In just seven months since it was founded, The One Health Company has moved fast. It has raised more than $750,000 to date from investors such as Ben Franklin Technology Partners of Southeastern Pennsylvania. It has also received $50,000 through its participation in the second cohort of the University City Science Center Digital Health Accelerator.

The One Health Company has also has set up contracts with a top gene therapy lab, one of the five largest pharmaceutical companies, and a top-five medical device company. The startup is also currently running two live trials on two different diseases. Lewis and Lopes said they are unable to share specifics right now.

But the potential seems huge. Lewis’ own dog, Euro, participated in an animal clinical trial for a new cancer immunotherapy drug several years ago. A doberman pinscher, Euro had osteosarcoma, an aggressive bone cancer. His prognosis was three months, but three years later, Euro is still alive and barking.

Photo: Boa, Michael Colvin