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1 August 2014Generics

Productive partnerships: HemoShear's IP strategy

In the business of drug development, the biggest hurdle to clear is often the jump from pre-clinical testing, where the drug is screened for safety and efficacy in animals, to clinical testing, where it is first introduced into a human.

Many drugs fail at this point in their development but a serendipitous meeting of minds at the University of Virginia has presented a new hope for tackling an age-old problem.

Working models

HemoShear co-founders Brian Wamhoff, a molecular physiologist specialising in animal disease function, and Brett Blackman, a biomechanical engineer, brought together their respective expertise to create a working model of a human blood vessel and the microenvironment within it in the lab.

Over the next two years, they started generating data from their models, eventually finding that the information they were receiving was consistent with what would be seen in the blood vessel of a human being.

“It was pretty shocking to all of our colleagues,” says Wamhoff, vice president of research and development at HemoShear.

“It was absolutely amazing that we were getting this human response on the bench. Then in 2007 someone came to us and said: ‘Do you realise that this is a major problem in the pharmaceutical industry?’”

After investing years of research and millions of dollars in drug candidates, drug companies often find themselves back at square one when a new molecule fails in humans after animal testing. It’s a painfully common occurrence: Wamhoff puts the failure rate at up to 95 percent.

“We realised that we had something pretty special,” he says. “We could recreate human biology as well as recreate responses in the disease state and start to look at what drugs would do before they ever got into humans.”

Recognising the potential of what they had, they filed a patent to protect the technology, and in 2008 established HemoShear as a company in its own right.

Building protection

Wamhoff and Blackman’s novel move was to bring the two human cells that make up blood vessels together in a context in which they are used to finding each other. Traditionally, researchers would test the cells in isolation, Wamhoff explains. “Those two cell types ‘talk’ to each other. So if you’re not studying them in the same context, you’re not really doing good science.”

With some further engineering and assistance from their colleagues in radiology, the team could calculate the exact blood forces those vessels undergo in the human being, then transpose them to the cells in the lab.

HemoShear’s founding patent covers the vasculature in bringing human cells together. Wamhoff says that they filed broadly, and secured all the claims. Were they surprised to have been granted such wide protection from the off?

“In retrospect, no, but at first yes,” he says. Their broad patent could only indicate the novelty of their technology. “When you take two individuals who are very different in terms of scientific disciplines, and bring them together, beautiful things can happen.”

Wamhoff and Blackman later expanded their patent portfolio to include diseased organ systems.

Creating a knowledge base

Using its technology, the HemoShear team has tested 195 drugs that failed in clinical trials, were safe or unsafe on the market and built up a database of human response. Now it can screen a drug that has not yet been approved or undergone clinical testing to predict accurately what the drug will do.

HemoShear has collaborated with drug companies including Merck, Eli Lilly and Amgen. Each collaboration is an opportunity to add to the company’s body of knowledge, so HemoShear makes sure to negotiate specific agreements with all its partners.

“The companies own their assets,” says Wamhoff. Modifications and advances to the HemoShear platform are owned by HemoShear.

“With Merck, for example, we developed a thrombosis platform around our vascular core system that was presented at the American Heart Association annual meeting. We own these changes to our platform.

"Each collaboration is an opportunity to add to the company’s body of knowledge, so HemoShear makes sure to negotiate specific agreements with all its partners."

“It takes time, sometimes six months, in each of these deals to get them to agree to terms that HemoShear gets to keep any changes to the technology, regardless of who comes up with them,” Wamhoff says.

It’s an important approach to take, allowing HemoShear to use any new assays or technologies developed in its partnerships in its next collaboration. “It’s what has really allowed the company to grow and maintain our innovation,” says Wamhoff.

Steering the vessel

HemoShear works with pharmaceutical companies throughout the research and development process, from lead optimisation to Phase I and II clinical trials. The more collaborations it engages in, the stronger it is becoming, and the more it realises which therapeutic areas it could specialise in.

“We have targets that we’re identifying on our own that could be businesses within themselves,” says Wamhoff.

“We’re building a lucrative business with our current model, but in very specific therapeutics areas so we could make strategic moves to spin off drug companies and other assets.”

HemoShear has built and continues to grow  a network so it can access different kinds of human tissue for its research and development. It calls it a Bio Repository Network. “We’re building an infrastructure, some of it real, some of it virtual, that allows us to build any disease tissue we want, or to go into a hospital and get cells from any patient that our partner wants,” Wamhoff says.

“So if a company wants to develop a drug in a diabetic liver in a very specific type of individual, say 50 to 65 years of age, male, African American, with a background of hypertension and diabetes, we’re positioning ourselves to get cells from those people to recreate that liver and then start developing drugs.

“The only way you can do that today is if you make a rat, or pig, diabetic, and what good is that?”

Guiding HemoShear to its next port are its board of directors and industry advisers, which include John LaMattina, former president of research and development at Pfizer; Bob Ruffolo, former president of R&D at Wyeth Pharmaceuticals; Mehmood Khan, vice president and chief scientific officer at PepsiCo; and Frederick Brown who, Wamhoff says, transformed IBM’s genome supercomputer  services from a $500,000 business to a business line  with a $1 billion to $2 billion turnover.

In the next ten years, HemoShear plans to develop newtransitional tissue systems, for example, recreating human tumours in addition to the organs it creates, and leverage the technology to treat cancer.

Backed by the brainpower of its board of directors and industry advisers, $10 million of investment from the US National Institutes of Health, through the Small Business Innovation Research grant mechanism, and potentially slashing the drug development timeline, it looks as though HemoShear’s technology could deliver personalised therapies fast.

Wamhoff says: “Imagine that: taking primary tumours from patients, extracting their cells, recreating their tumour biology on the bench, understanding what it looks like and how it metathesises on the bench, or to the liver, and then developing drugs for that liver metathesis. It’s very exciting.”

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