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.
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“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 |
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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."
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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