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an online version of the magazine Fall 2004
Features
The Research Brass Ring Picture of brass ring
 
  To get discoveries out of the lab and into the market, the School of Medicine has called in a group of high-powered businessmen.
BY PATRICK A. GILBERT
 
 
 
 

Jonathan Schneck had a lot riding on the next 10 minutes. The pediatrician-turned-immunologist-pathologist had been summoned to the School of Medicine boardroom on a gray Saturday last March to tell a high-powered group of businessmen about an invention he hoped to bring to market.

If he sold these pharmaceutical leaders, venture-capitalists and medical-device innovators on the potential of his discovery, they’d help him commercialize it. If he failed, he’d be on his own.

Schneck told the entrepreneurs that he and his colleagues had spent five years developing a process by which artificial disease-fighting cells, called beads, can be infused into immunosuppressed patients who suffer from dangerous viruses, like HIV, or certain kinds of cancer, such as melanoma. When the patients received the artificial antigen-presenting cells, the T-cells in their own bodies would be stimulated to target and destroy the cancerous cells or those carrying infectious viruses.

But the therapy would have even broader value, Schneck said. The artificial cells would be enormously beneficial, for instance, for patients undergoing chemotherapy, whose immune systems become compromised as the chemo destroys their own antigen-presenting cells at the same time it destroys the cancer. Additionally, the treatment could be used to boost the immune systems of transplant recipients, who are highly susceptible to infections.

Schneck described how the process would work. “We can build the beads,” he said, “attach the protein antigens and then use another invention made in our lab, along with some minor manipulations of the proteins, to target a variety of situations in patients’ bodies. These off-the-shelf artificial cells are cheaper and more efficient than current therapies. And we feel our platform is broad enough to attract interest.”

His concise presentation ended, Schneck got ready for the grilling he knew would follow. This wasn’t his first brush with technology development (he already has a licensing agreement with Becton-Dickinson for one of the molecular compounds attached to the artificial antigen-presenting cells), so he knew these businessmen would have plenty to ask about the details of his project. And like heat-seeking missiles, the questions commenced from all sides of the table.

“Individualized therapies are a tough sell,” pointed out Thomas Caskey, president/CEO of Cogene BioTech Ventures and a former vice president for research at Merck. “Investors like the one-pill-fits-all method. Can your invention have more mass application?”

“Have you calculated your production costs? Do you have a business plan?” queried one of the financial experts.

“And have you considered whether a tumor might avoid the destructive signals of your cells?” a second pharmaceutical specialist wanted to know.

Welcome to the Johns Hopkins Medicine Alliance for Science and Technology Development, a group of seven industrialists brought together by the School of Medicine to help kick-start its sputtering technology-transfer program. Administrators are counting on the businessmen to become the linchpin in an all-out drive to turn more Hopkins research discoveries into treatments for patients and cash cows for the institution. They’ll be working in synch with a new School of Medicine online patent and licensing application system and a faculty oversight group that can head off snafus before they become impediments.

“But the bottom line,” says Chi Dang, vice dean for research, “is to get honest advice from people who have a proven track record in this business, network the faculty to the outside world and make things happen.”

 

*****

 

Before 1980, the idea that a university might license new technology developed by faculty would have seemed farfetched. Then, with the stroke of a pen, Congress passed the Bayh-Dole Act. And suddenly, it became possible for nonprofit research institutions to patent discoveries by faculty supported by federal grants and to strike exclusive licensing agreements with commercial companies interested in bringing these discoveries to the marketplace.

Still, it took awhile for academic institutions to harness the opportunities offered by the legislation. As recently as 1995, according to the Association of University Technology Managers, American universities earned a total of just $495 million through licensing income. Six years later, however, in 2002 (the last year for which figures are available), that figure had skyrocketed to nearly $1 billion. Universities, it seemed, had opened their eyes to their potential new bonanza.

For certain institutions, it had actually taken but a single major research hit to fatten their annual income by millions of dollars. Today, Columbia University, which leads major research institutions in yearly licensing revenue with more than $157 million, realizes most of that revenue from one key genetic engineering technique developed there. At Emory University, 90 percent of the annual $29 million in licensing revenue comes from sales of a single patented anti-AIDS drug, Emtriva.

Johns Hopkins, meanwhile, has added more than $52.7 million to its coffers since 1997 from the commercialization of faculty discoveries and holds 661 licenses. But those numbers are not all they appear to be. In 2002, the University brought in just $8 million from technology licensing, good for only 24th place in the national university rankings.

Hopkins splits its technology revenue five ways: For licensed discoveries providing annual net revenue of up to $300,000, 35 percent goes to the principal investigator, 15 percent to the investigator’s laboratory; 15 percent to the home department, 30 percent to the school and 5 percent to the University. For discoveries that produce income above $300,000, the University’s share increases to 10 percent and the school’s to 25 percent.

Chi Dang
> “The bottom line is to get honest advice from people who have a proven track record in this business, network the faculty to the outside world and make things happen.”

Chi Dang, Vice Dean for Research

Hopkins doesn’t provide a breakdown of revenue produced by individual discoveries or even individual schools. But according to Deborah Barbara, senior director of technology management, about 90 percent of the University’s 660 licensed inventions came from the School of Medicine. Leading the pack of “inventors” here is the oncology research team of Bert Vogelstein and Ken Kinzler with a total of 162 licensed inventions between them. Internationally renowned for their advances concerning the inheritable aspects of cancer, Vogelstein and Kinzler have little trouble catching the interest of companies interested in licensing biomedical discoveries.

Many scientists, however, simply don’t have their know-how, but rely instead on experts in the School of Medicine’s licensing and technology development office to guide them through the often-complicated process of positioning their inventions for the marketplace. It is this institutional function that researchers have found cumbersome and full of problems.

An internal survey in the summer of 2003 made clear just how frustrated the faculty felt with internal obstacles they said prevented them from negotiating technology-transfer agreements or even obtaining information about how to proceed. They criticized the protracted legal negotiations required in connection with every discovery to make certain Hopkins’ own intellectual property rights would be protected. They said they didn’t get timely feedback from the research development office about the status of their applications for patents or licensing agreements, and they didn’t have any influence over what happened to the application once the paperwork got into the pipeline.

“What the faculty voiced in the survey,” says Dang, the research dean, “was what they’d been grumbling about for quite awhile—that taking their discoveries through the Hopkins technology development process was like waiting in line at the Motor Vehicle Administration. They’d finally reach the open window only to hear that they had to get into another line.”

 

*****

 

In the summer of 2003, at just about the same time Chi Dang was realizing the magnitude of the changes that would be necessary to shore up the School of Medicine’s technology transfer program, onto the medical campus walked David Hochenbrocht. The hard-charging president and CEO of Sparton Corporation, a medical device-manufacturing firm, had come at the invitation of Richard Johns, former chairman of the Department of Biomedical Engineering and a special adviser to Dean/CEO Edward Miller.

Johns, who sits on Sparton’s board of directors, wanted Hochenbrocht to evaluate the School of Medicine’s research-development program. And in the end, it was Hochenbrocht’s insight that gave the dean what he hopes will become the reincarnated program’s most compelling feature.

Hochenbrocht spent hours making the rounds of campus laboratories and talking to researchers about their projects. Then, Johns took him to see Miller, who recalls the meeting this way: “David told me how impressed he was with the wealth of research here, but he seemed puzzled that so few of these discoveries were finding their way to market. I asked him what he would do in my shoes. He said, Form a committee of industry heads who could be the pipeline to move faculty research to its ultimate destination—the patients. I told him, Do it.”

Starting with names suggested by Hochenbrocht, Miller asked more than 40 industry chief executives if they’d be willing to serve as consultants to Hopkins’ technology transfer effort. From the 20 who showed interest, seven were selected to make up a volunteer advisory committee: Hochenbrocht, who was named chair; C. Thomas Caskey, president/CEO of Cogene BioTech Ventures; Craig Smith , president/CEO of Guilford Pharmaceuticals; Paul Citron, retired vice president for science and technology at Medtronics Inc.; Richard Newman, director of research and development at Welch Allyn Medical Products; Phillip Goelet, director of Red Abbey Venture Partners; and Irving Sherman, an entrepreneurial retired neurosurgeon.

Last March, the committee convened a two-day meeting to lay out its ground rules and decide on the modus operandi. Members at first considered labeling each faculty research project they reviewed as either a winner or a loser and then putting their weight behind those they deemed sure-fire commercial successes. But in the end they decided on a softer approach.

“If we focused only on inventions that were instantly marketable,” Goelet says, “we’d leave behind 90 percent of the research value here. We needed two categories for the projects we’d support: those that are marketable right away, and those we consider worthy but which need more time to develop.”

The committee decided it would assign each “worthy” research project a champion, one member who would take on the responsibility of either getting the product to market or advising the investigator on how to make it commercial-ready.

Hochenbrocht set a firm objective: to bring at least three inventions to market this year. He knew the committee had to establish credibility with the faculty quickly, so the stakes were high. “There’s no doubt that we’re authoring something of great value,” he says. “Now, we have to produce. We’ll either take the products to our own companies or act as the pipeline to connect faculty with other industry firms that will be interested in their discoveries.”

 

*****

 

Chi Dang is a determined man who puts great value on outcomes. Five years ago, when he took over as the School of Medicine’s vice dean for research after Elias Zerhouni, his predecessor, was named head of the National Institutes of Health, one of the tasks Dang inherited was orchestrating Hopkins’ role in the 2-million-square-foot life sciences and technology park now taking shape in the blighted area just north of the medical campus.

Plans for the park are huge—Hopkins is even planning a new campus basic science research building in conjunction with it—and officials here are banking on the University’s number one ranking in NIH grants and 18 start-up companies to draw in biotech and pharmaceutical firms from around the country. But no one knows better than Dang the degree to which the success or failure of this potential biomedical bonanza will depend on the intellectual property of faculty investigators and their relationships with industry.

“We have a lot of faculty interested in identifying key projects that would be of interest to pharmaceutical companies,” Dang says. “To the extent that we can get our discoveries out into the market and then back into the biotech park for development, that would be a plus. Then, if a faculty member wanted to build a start-up company around that technology, we could work with enterprise development to locate the company in the biotech park."

David Hockenbrocht
> “Now, we have to produce. We’ll either take the products to our own companies or act as the pipeline to connect faculty with other industry firms.”

David Hochenbrocht, President and CEO of Sparton Corporation.

But Dang also knows that for all these steps to fall into place, researchers will need a user- friendly technology development program that ties easily into work going on at the park. And so, once he and Miller had jumped on Hochenbrocht’s offer of help from industry experts, he immediately turned his attention to the technical arm of moving discoveries to market, the School of Medicine’s licensing and technology development process. He had to make it easier for researchers to file applications and for staff to process and track them. And he had to do it quickly.

Dang’s first step was to turn the OTD office into a profit center. Henceforth, it would be in the staff’s best interest to respond quickly to faculty, because they would know “it’s the faculty’s intellectual property that’s paying their freight.” Dang then set out to replace every paper form with a Web-based system, eliminating any chance that documents could fall between the cracks. Researchers will enter their application information for patents and licensing and technology transfer agreements, save the data, and then go back and make adjustments before sending in the final submission. Once the dated and timed application is in the hands of OTD staff to process, both the office and the researcher will be able to track its progress. The system also will serve as a secure database that allows alliance committee members to keep up on faculty discoveries between their quarterly meetings on campus.

But Dang sees an even broader advantage. “Sometimes a single discovery may not be marketable, but when it’s bunched with others, the collection becomes more attractive. We’ve never had a good handle on all the faculty inventions out there. With this electronic repository, we could gather together all the cardiovascular discoveries, for example, and e-mail them through a listserv to interested companies.”

The research dean also put together a group of seasoned faculty investigators and dubbed it the Technology Opportunities Program. The group will serve as the liaison with the scientific community here, with the Alliance committee and the dean’s office, and will also act as an adviser in the construction of the OTD Web site. Meanwhile, the University’s Office of Enterprise Development, headed by assistant provost Nora Zietz, will continue helping faculty write business plans for marketing their inventions and maintain relationships with the pharmaceutical and biotech industries.

“The faculty has to have ownership of institutional activities affecting their research,” Dang states categorically. “What it all comes down to is that we’ve got to show them we’ve heard their complaints, and we’re coming through for them.”

 

*****

 

At their first meeting, the businessmen who make up the Johns Hopkins Alliance for Science and Technology Development listened to 17 Johns Hopkins Medicine faculty members present their research and exhort its commercial value. Jonathan Schneck was one of the first. “I was a little surprised by the questions concerning the commercial versatility of our creation,” Schneck admitted afterward. Like other inventors, he says Hopkins hasn’t been aggressive enough in informing industry of what’s going on here and getting products out to companies. But he views the alliance as a positive step.

“I think it’s a great undertaking from the University’s perspective,” Schneck says cautiously, “but the whole program is going to need a lot more resources to improve its track record.” And despite the tough grilling the group gave him, the businessmen came to the conclusion that his project had real potential. Hochenbrocht assigned it to Craig Smith, head of Guilford Pharmaceuticals. The Alliance for Science and Technology Development evaluated 17 projects that day, and agreed to champion inventions from 13 investigators.

Much will be riding on the success of the revamped technology transfer process—the amount of income that flows into the School of Medicine’s coffers from commercialized products, for one. And perhaps even the success of the biotechnology park. But Dang isn’t worried; this is the kind of project that strikes at the core of his determination. “I am,” he says, “a very endpoint-oriented person.”

 
 
 
 
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