Japanese drug trial firm linchpin of new BioPark

THE BALTIMORE SUN

Sitting in his office, with a well-filled bookcase as a backdrop, David J. Ramsay, president of the University of Maryland, Baltimore, tells the story of an unlikely alliance. He hands over a business card as evidence.

On its face, the card is standard issue. There's the UMB seal, the requisite contact information, Ramsay's title. On the flip side is something unexpected: The card has been translated into Japanese.

Ramsay has spent the last decade cultivating a relationship between the school and the Japanese pharmaceutical industry - a sort of East meets West Baltimore collaboration that has led to a $20 million investment by a Tokyo businessman behind a new drug trial company.

"You never know where these things are going to lead," said Ramsay, who travels to Japan about three times a year, meeting with executives to try to persuade them to expand in Maryland.

With Ramsay's encouragement, a company called SNBL Clinical Pharmacology Center Inc. is setting up shop on the top two floors of a building at the university's new BioPark, the $350 million, 10-building biotechnology business complex rising just west of Martin Luther King Jr. Boulevard.

With construction complete on one of the buildings, the occupants and the university are throwing themselves a party today to celebrate the opening. Among the new tenants are the life sciences division of Baltimore law firm Miles & Stockbridge; Alba Therapeutics, a well-funded university startup working on treatments for celiac disease and diabetes; the School of Medicine Center for Vascular and Inflammatory Diseases, and Harbor Bank of Maryland.

At a ceremony this morning in a heated tent in the 800 block of W. Baltimore St., Ramsay will be joined by Gov. Robert L. Ehrlich Jr., Mayor Martin O'Malley, Baltimore City Council President Sheila Dixon and Ryoichi Nagata, president of Shin Nippon Biomedical Laboratories Ltd. Along with speeches will be a Japanese "sake barrel-breaking" ceremony called Kagami Biraki and a drum performance by percussionists dressed in traditional garb.

As biotechnology has emerged as a greater engine of business opportunity, government officials and investors have increasingly tried to grab a piece of it.

Maryland's secretary of business and economic development has promoted the state as a global hotspot for biotechnology and Baltimore's mayor recently suggested developing a vaccine manufacturing plant in the city in response to concern about avian flu.

The university's west-side BioPark is one of two such parks under development in Baltimore. Johns Hopkins is creating one adjacent to its sprawling medical campus on the east side of the city.

Combined, the two parks are expected to create more than 10,000 jobs and help small companies emerge from the universities. They will also help enhance the city and state's reputation as a life sciences hub, already bolstered by the Interstate 270 corridor in Montgomery County near the National Institutes of Health.

SNBL, which will test drugs for safety and tolerability on mostly healthy volunteers, will anchor the west-side BioPark. Landing the company, with its hefty cash outlay and long history in Japan, was considered something of a coup for the university and the project.

Researchers at the school will have direct and easy access to the clinical trial company, which is expected to draw high-profile clients such as Pfizer and Merck and Co.

Drug testing

The company's parent, Shin Nippon Biomedical Laboratories Ltd. of Tokyo, was founded in 1957 as Japan's first contract-research organization. It has offices in Boston and established a pre-clinical research facility outside Seattle in 1999.

The Baltimore location marks its first foray into the next stage of clinical work, testing the efficacy of various drugs in humans.

SNBL paid $10 million to buy the top two floors of the school's first BioPark building. It spent another $8 million developing and furnishing the 40,000 square feet, and plans to spend another couple of million recruiting talent.

"We commit ourselves," said Takeshi Yamakawa, SNBL's chief operating officer and president. A former diplomat and Japanese government official, Yamakawa decided to switch careers and work in the private sector a year ago. He hooked up with Shin Nippon Biomedical Laboratories, and was sent to Baltimore to set up shop as his first assignment.

"Dr. Nagata trusted me to start the business here by myself without experience," he said, looking simultaneously proud of and astonished by his admission.

After a year of interviews and construction oversight, Yamakawa is ready to open the company's doors. The first trials are set to begin in November.

Last week, Yamakawa stood at a window on the sixth floor of the new building. Before him, the Orioles' and Ravens' stadiums were visible, row homes stretched for miles and fall clouds hung low in the sky. Inside, tiles in soft blue formed swirl patterns on the floor, their colors chosen for their Japanese symbolism of life and the environment.

Yamakawa tested out a lounge loveseat. "It's comfortable enough for students" who make up the bulk of clinical trial participants, he said.

The Foosball tables and video games have yet to arrive - designed to keep boredom at bay for those in overnight trials lasting up to a month.

Soon, the company's doors will be locked, inhabitants carefully monitored and visitors kept out. The clinical trial industry is one of strict regulation and monitoring. At SNBL, studies will focus on early-stage trials, testing the safety and dosing levels of developing drugs on paid volunteers whose every movement will be tracked. along with what they eat.

"It's a strictly controlled environment," said Patrick R. Ayd, vice president of operations. "Something like a Rolaids or an M&M; could ruin a study."

100 employees

Eventually, the facility will employ about 100 people and have 96 beds for patients. For now, though, the sixth floor is the focus. Though the televisions have yet to be installed, beds have been set up in the large, light-filled rooms and green, glowing digital clocks affixed to the ceiling, ticking away the seconds.

"Everything is done by the second here," Ayd said.

It took years to establish the relationship that brought the company to America.

Ramsay, a native of England, laid the foundation for the partnership in the mid-1980s as vice chancellor of the University of California at San Francisco. The Japanese pharmaceutical industry was undergoing major changes at the time, deregulating its pricing practices and looking to expand.

"There was a big opportunity to form relationships," Ramsay said. He, a school librarian with home ties in Japan and a communications director set out to do just that. Using her family connections, the librarian set up meetings for Ramsay and acted as a translator and social guide, schooling him in Japan's cultural differences.

"There are very simple things you could do to commit huge mistakes," he said.

For one, Ramsay had to learn that a business card is more than a scrap of information in Japan. It's an important, personal document that must be given and received with great ceremony. He learned to accept the cards with both hands, study them carefully, thank the giver and hand over his own card - with the requisite Japanese translation on the back.

His efforts won the California university millions in Japanese research contracts. After he arrived in Maryland in the mid-1990s, he thought he should try to do the same, enlisting the help of his friends from California.

"Our little trio started making visits back to Japan," he said.

By then, Ramsay was known in Japanese circles. He soon netted research dollars for the school and an introduction with Nagata, chairman and chief executive officer of Shin Nippon. Over much green tea, Ramsay slowly won his trust and friendship.

Five years ago, over dinner at the Harbor Court Hotel, the two men struck their first deal. Ramsay and Nagata created a company based in Baltimore called University Medical International, or UMI, the Japanese word for "by the ocean," symbolizing Shin Nippon's location in Tokyo. UMI brought in contracts for the university from Japan and today acts as a marketing company to sell the school abroad.

That wasn't enough for Ramsay, who kept at Nagata over the years.

"I asked him to think about having a bigger presence in Baltimore, and then the BioPark came along," Ramsay said.

Ramsay is hoping SNBL will pave the way for others. He's still traveling to Japan and even offering training for foreign regulators in American drug development.

"Diseases do not stop at country borders," Ramsay said, pointing to avian flu and SARS, the severe acute respiratory syndrome that spread through Asia three years ago. "And neither, in fact, does the pharmaceutical industry anymore."

tricia.bishop@baltsun.com

SNBL Clinical Pharmacology Center Inc.

The business:

A subsidiary of Japan-based Shin Nippon Biomedical Laboratories Ltd. that will conduct early clinical trials on drugs testing their safety and tolerability.

Launch:

November 2005

Location:

The University of Maryland, Baltimore, BioPark, 800 W. Baltimore St.

Employees:

30 by the end of the year; 100 within three years.

Investment:

$20 million.

[Source: SNBL]

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