October 10, 2011

Patents, R&D Push Science At MUSC

Matt Tomsic  /  SC BIZ

Professor Rob Gourdie and his students were studying the structure of cell communication in a Medical University of South Carolina lab in 2004 when they discovered a peptide gel that helped wounds heal faster and reduced scar tissue.

"We knew we were onto something important for quite a while," said Gourdie, a professor of regenerative medicine at the Children's Research Institute.

The scientists realized the gel could be used by surgeons to heal scars from cesarean sections and plastic surgery, among other applications.

With help from MUSC and its Foundation for Research Development, Gourdie's lab filed patents for the gel and spun off a company, FirstString Research, to develop and commercialize the product, taking the first step to move it from an MUSC lab to a patient's bedside.

Chip Hood, executive director for the foundation, said Gourdie's gel is an example of many discoveries made by MUSC scientists and taken from the university to hospitals and doctors' offices with the help of the foundation, which was created in the 1990s.

The foundation works with MUSC scientists and private industries to develop inventions, patent them and license them to private companies or spin off an independent company for continued development and manufacture, Hood said.

The company could then take the patented invention to market, improving care for patients and generating royalties to the patent holder, which is MUSC. Some health care businesses, including pharmaceutical companies, are moving away from basic research, opening up opportunities for medical universities like MUSC to perform the early discoveries and then license them to a private company, said Charles Smith, professor of pharmaceutical sciences at MUSC.

"For the company, it's good because it reduces the risk of the project because they're not involved in the very early discovery component of it," Smith said. "It takes substantial investment to prove that it's something worth developing."

Gourdie said the patent process for the gel took about six years. The U.S. Patent and Trademark Office asked the university to file one patent for the gel and a second patent for its uses.

"It's a long, slow, expensive process," Gourdie said, adding that FirstString now runs without his help.While the patents pended, FirstString evolved, creating a board of directors, performing clinical trials and obtaining Series-A financing.

The company attracted experts and investment, while the research reinforced the gel's use by doctors and surgeons to heal wounds quickly.

In 2008, Dr. Paul Ehrlich, director of the Wound Healing Research Laboratory at Penn State University's Division of Plastic Surgery, joined FirstString's Advisory Board. A year later, Dr. Carl Ehmann, a former executive vice president for Johnson & Johnson Consumer Products, also joined the board. In November 2009, FirstString received $200,000 at the Small Business Innovation Summit & Expo in North Charleston.

In March, FirstString received its two patents. Patents are crucial to the medical industry because of the cost of developing, testing and manufacturing new drugs and medical technology. Patents provide protection for medical companies and were designed to encourage innovation and invention.

A new drug could cost a company $500 million to get it to market. "No one is going to invest that kind of money unless they have protection –- exclusivity," Hood said.

Patents provide that exclusivity, protecting the patent holder's product from competitors for 20 years after the filing and ensuring companies have an opportunity to recoup the money spent on advancing medical technologies and products.

Hood said the foundation has about 50 issued patents. They include a portable radiographic machine and an invention that provides an adjustable ligament anchor used for attaching a ligament to a bone, among more complex inventions.

Hood said the university files patents for between 10 and 15 new discoveries each year. "I want to double that amount," he said. But choosing the inventions to patent is challenging.The university has to be selective, weighing the cost of filing the patent with its potential benefits. That process isn't always clear.

Smith, the pharmaceutical sciences professor, said most patents the university files aren't developed into commercial products. He said filing patents is like gambling in Las Vegas. If a gambler knew what number to bet on, he'd win every time.

"But you don't; you've got to lay a lot of bets," Smith said, adding that patents involve similar risk. "It's a tough job making the decisions on which ones to maintain and which ones you have to let go."

The process has been made easier by the industry representatives on the foundation's board, Hood said.

"The majority of our board are industry people, so they help us choose what technologies to file on," he said. "Life gets easier for me because I've got some really high-end folks that other places don't have access to. That helps us be successful with less."

Hood said filing a basic patent costs between $10,000 and $15,000. To protect a patent in "major industrial countries," he said, a patent holder could spend hundreds of thousands of dollars or more. But for a patent holder with a commercial hit, the revenue generated could easily outweigh the patent's costs.

Hood cited Clemson University's patent for an artificial hip replacement coating and Florida State University's patent for a breast cancer drug as examples of university discoveries that generated substantial revenue. Smith also cited the University of Florida's formula for Gatorade.

Those high-earning breakthroughs are rare, they said, making the revenue stream minor for most university research foundations.

At MUSC, the foundation generates between $200,000 and $1 million each year through its patent licensing, Hood said. "We want to get to maybe $3 million, then have a hit," Hood said.

The foundation also counts research grants and awards, which help lead to discoveries, as a revenue stream for the university.

During fiscal year 2011, MUSC received more than $238 million in research funding. The awards passed $200 million for the fourth consecutive year and increased by $4.4 million compared with fiscal year 2010. About $117 million came from the National Institutes of Health.

Hood said patents and research and development involve long-term projects that might not earn money until years later.

'A better place'
Hood said that in 2000, when Dr. Ray Greenberg became MUSC's president, the university was doing about $60 million worth of research. Hood said Greenberg pushed the university to become a larger academic research center, and the research budget grew to about $230 million.

Smith said he sees research and development continuing to grow at MUSC, which supports the research foundation's entrepreneurial and technological goals.

One aspect of the university's five-year plan is entrepreneurship, with a goal of taking inventions from MUSC labs into the commercial world. Smith cited the new drug discovery building and new biotechnology center as investments that support the institution's research goals.

"The buildings I think are a real tangible and important component of MUSC's process," he said. "It is recognized as important within the administration of MUSC."

Gourdie agrees, saying the university's goal should be to increase the number and improve the quality of patents issued to MUSC.

Now, Gourdie is working in a cardiac lab, focusing on heart attack-caused heart scarring, which can create heart arrhythmia. But that scarring –- and the heart arrhythmia –- could be mitigated by a peptide gel similar to the MUSC lab's 2004 discovery.

Gourdie said the gel could also have applications for scarring issues beyond plastic surgery and heart arrhythmia. Similar gels could be applied to spinal cord injuries that could be complicated by scar tissue.

And Gourdie said MUSC's patent practices and push for research and development also have applications for the state's economy, in addition to the care hospitals like MUSC provide.

"An investment in science and the creative individuals who do science is important for the economic development of the state," he said. "There's no get-
rich-quick solution to things."

And to develop the biosciences industry in the Lowcountry, MUSC needs to continue emphasizing patents and research and development while supporting the scientists who discover medical inventions that improve patients' lives in the Lowcountry and beyond.

"The real reason we do it, we want to change the world," Hood said. "We want to make the world a better place."