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From patent to patients

Summer 2014

Steven Frank is the doctor, inventor and entrepreneur who took the uncertainty out of a cancer treatment

By Will Fitzgerald

 

Photos: Wyatt McSpadden

When Steven Frank, M.D., had an idea to improve the effectiveness of a common prostate cancer treatment, he didn’t know his vision would result in the creation of an innovative device that would win Food and Drug Administration (FDA) approval and subsequently be spun off into a startup company.

It all began when Frank tackled a decadesold problem plaguing the field of prostate brachytherapy, a treatment in which tiny radioactive seeds are implanted in the body to destroy cancer cells. Because the seeds are difficult to view through imaging such as computed tomography (CT) scans, which are necessary to evaluate the success of treatment, uncertainties are created that can impact the therapy’s effectiveness.

Frank proposed that a highly visible marker of sorts, or implantable contrast agent, could be developed and placed between the seeds to guide treatment.

“The best analogy to describe this technology is looking at footage of machine gunners in World War I who would spray bullets everywhere and not have any idea where the bullets were going,” says Frank, associate professor in Radiation Oncology. “Finally, someone had an idea to insert a tracer every few rounds to increase accuracy. That’s essentially what we’ve created.”

In 2006, Frank collaborated with a biomolecular engineer at the University of Houston and together they began testing compounds believed to be visible under an MRI scan, the most accurate way to monitor brachytherapy seeds. The answer arrived in a compound called cobalt chloride, which to their surprise, lit up the scans during the investigation.

Steven Frank, M.D., invented the 
first FDA approved permanently 
implantable MRI marker for use 
in prostate brachytherapy.

After discovery, taking on the ‘beast’ 

Armed with this new finding, Frank’s next steps propelled him into unfamiliar — yet necessary — territory that he had to navigate if his idea was to become reality. He needed guidance to understand the very complex process required to commercialize this technology and bring it to patients.

For that he turned to Olivier Wenker, M.D., clinical professor in Anesthesiology and Perioperative Medicine, and Tom Lee, director of Technology Commercialization’s Active Venture Development, who are responsible for unearthing innovations within MD Anderson’s walls and determining commercial potential. The laborious process, which Frank describes as “a beast,” involves raising capital and obtaining financing, patents and regulatory approval.

“The ultimate goal is not just discovery, but taking that achievement from the laboratory to the patient, which is a very complicated process in medicine,” Frank says. “I was at a crossroads because I needed to license the technology out of 
MD Anderson, otherwise it would die.” 

With Wenker and Lee’s mentorship, and the help of outside counsel experienced in negotiating licensing agreements, Frank successfully transferred his discovery out of MD Anderson over the course of nine months. 

With an agreement in place, the institution would receive royalties and Frank would be free to incorporate a business of his own.

A maze of regulations 

In 2009, three years after making his initial discovery, Frank established C4 Imaging. He immediately began the first of two fundraising rounds that would generate more than $3 million in total startup capital.

But challenges remained. Before any new medical technology can be used clinically, it must be approved by the FDA. In anticipating the regulatory phase, Frank hired a CEO to lead the important next steps. Around that time, he also learned of an innovative program that would prove especially beneficial.

“The National Institutes of Health created a mechanism where experts with regulatory experience hand-select aspiring companies to help navigate their way through the FDA, and we were selected,” Frank says. “During this process we were also busy conducting trials and evaluating toxicity, so it was a critical time to make sure everything happened correctly.” 

Let us explain …

The Office of Technology Commercialization (OTC)

The OTC identifies technologies suitable for startup company formation. These companies help create institutional value for the intellectual property resulting from inventions made by MD Anderson researchers and clinicians. 

Since 1987, the OTC has been involved in the creation of 11 affiliated companies that have raised more than $300 million on the strength of MD Anderson-based discoveries. Four portfolio companies listed on NASDAQ have raised more than $230 million and funded $25 million in sponsored research at the institution.

After three years of discussions with the FDA, the world’s first permanently implantable MRI marker for use in prostate brachytherapy was approved.

Frank, who worked tirelessly on the development of his idea while his family — including four children less than 10 years old — slept, achieved an incredible feat without any formal business training, and in an industry known for high failure rates.

This past March, the first group of patients received the marker during their therapy. While Frank credits his success to a team of advisers and supporters, the end goal was
always focused on improving patient care.

“We can now limit uncertainty, provide optimal quality assurance and minimize side effects,” Franks says. “This technology could change the way brachytherapy is planned and evaluated for future patients.”

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© 2014 The University of Texas MD Anderson Cancer Center