Entrepreneur Opens Clinical Cancer Facility

Bioscientist Royston turns his attention to creating a center in San Diego's crowded research community Ivor Royston, who at the age of 33 founded Hybritech Inc., the first company in the United States to exploit monoclonal antibodies commercially, and who became a millionaire in the process, is taking his vision for enterprise to a new nonprofit venture. Among the palm trees, a handful of research institutes, and the 90 biotechnology companies that make San Diego an idyllic place for scientists to work, Royston is opening a clinical research cancer center. The entrepreneur hopes his small cancer center, with its initial focus on immunotherapy and gene therapy research and clinical care, will flower into a full-fledged research and cancer care facility and be a resource for cancer researchers and oncologists of the 21st century. Since 1971, when Congress passed the National Cancer Act, legislators and scientists have attempted to address the need for more research and public education in the areas of cancer prevention and control. The National Cancer Institute funds 15 basic research cancer centers, 14 clinical research centers, 25 comprehensive centers, and one mixed comprehensive and consortium center. NCI-designated comprehensive cancer centers were established to be leaders in the country in laboratory, clinical, and cancer control research. To be designated a comprehensive care center, an institution must first secure a peer-reviewed cancer center support grant from the NCI. Next the Cancer Center Support Review Committee, composed of nonfederal scientific experts, determines if the institution meets criteria established for comprehensiveness. Under guidelines revised in 1989, an NCI-designated comprehensive cancer center must have a strong core of basic laboratory research in several fields, such as biology, chemistry, immunology, and molecular genetics; find ways to transfer research findings into clinical practice; conduct clinical studies, especially those of importance to the community served by the center; participate in high-priority clinical trials; conduct research in cancer prevention and control; provide research training and continuing education for health care professionals; offer cancer information services for patients, health professionals, and the community; and provide community service and outreach activities related to cancer prevention and control. --R.E. Last month, Royston moved his tumor immunology laboratory of 16 people from the University of California, San Diego, campus to an 8,200-square-foot facility at La Jolla Spectrum, where his new San Diego Regional Cancer Center (SDRCC) is located. La Jolla Spectrum, a new research park about 15 miles from the UC-San Diego campus, is within walking distance of the Salk Institute and La Jolla Cancer Research Foundation. With $1.5 million from his academic grants and contributions from his new board of trustees, Royston expects his fledgling center will someday resemble the more than two dozen National Cancer Institute-designated comprehensive cancer centers across the U.S. that do basic and clinical research and provide state-of-the-art treatment and diagnosis. An NCI designation means funding and prestige (see story on page 5). Although there are other cancer research and treatment facilities in the area, Royston plans to carve a new niche for his high-tech center by initially pursuing specialized research in immunotherapy and gene therapy. The Salk Institute for Biological Studies, La Jolla Cancer Research Foundation, and Scripps Clinic and Research Foundation, all in the immediate San Diego area, do basic research; Royston expects SDRCC to do basic and clinical investigations. Royston and his board also anticipate collaborations with hospitals, other research institutes, and biotechnology companies to bring in fresh ideas and revenue to SDRCC. And, they say, an independent cancer center that takes benchtop research to the bedside will fulfill a vital need in the community. "The first phase is establishing the laboratory," says Royston. "But we have the opportunity to expand. Our growth will depend on the ability to raise funds and bring in other principal investigators who come with their grants." While colleagues warn that it may be risky to begin such an enterprise today, given the shrinking federal cancer dollar and the threat of economic recession, they say that if anyone can make a new cancer center succeed, it is Royston. Royston says it took courage to leave the academic womb at UCSD, where he had been a practicing oncologist and researcher for 13 years, to start the new venture. But he has taken risks before. He was a young, nontenured assistant professor when he started Hybritech in 1978, a move that could have jeopardized his academic career, he admits. Eight years later, he sold his part of the firm to Eli Lilly & Co. of Indianapolis. Today Royston, 45, reflects on his newest gamble: "I have always wanted to be on my own and have more say in the kinds of programs I would like to be involved in. There is a feeling in San Diego from the people that I talk to that an independent cancer center can really focus on cutting-edge treatment and take technology from the laboratory to the clinic. A cancer center should have an academic affiliation, but I believe it should be independent and have one priority--cancer. Other organizations, like universities, have many other priorities besides cancer." Royston, members of his board, and colleagues believe that the project embraces many of the ingredients that could blossom into a comprehensive cancer center for San Diego similar to the Fred Hutchinson Cancer Research Center in Seattle, which employs about 250 scientists plus 1,250 support personnel and leads the nation in bone marrow transplantation therapy. Plans for the facility crystallized for Royston this past year when he was on sabbatical from UCSD. Over the year he met informally with others interested in such a project who eventually became his board of trustees: Thomas Shiftan, SDRCC chairman and cancer specialist; Sidney Green, who helped found and administered the La Jolla Cancer Research Center in 1976; Christine White, a medical oncologist at Scripps Memorial Hospitals in Encinitas and La Jolla; Robert Barone, a surgical oncologist in San Diego; and Allan Goodman, a thoracic surgeon. "We all felt that San Diego, the sixth largest city in the U.S., needed a more comprehensive center which could provide more sophisticated treatment," says Goodman. "The closest facility for such treatment was 150 miles away at Los Angeles [the Jonsson Comprehensive Cancer Center]." So they drew up the business plan and all contributed an undisclosed amount of money to supplement Royston's NCI and National Aging Institute grants that he transferred from the university to the SDRCC. Royston currently serves as the center's scientific director and is establishing a scientific advisory board to help guide future research. The other board members are starting a fund-raising drive. The efforts of Royston and his board are praised by peers in the cancer center community. For example, Erkki Ruoslahti, director of the La Jolla Cancer Research Center in San Diego, says, "Small is beautiful. Having been an institution that took a similar route, we know it can be done. Royston has started a number of things, and there is no reason to think [that he can't succeed at this] as well." Edwin Mirand, associate institute director of the Roswell Park Memorial Institute in Buffalo, N.Y., and secretary-treasurer of the American Association for Cancer Centers in Washington, D.C., says Royston "knows it isn't easy, but that's the gamble he obviously is willing to take. He needs to develop an endowment or maybe get state aid like we have. But his immunotherapy and gene therapy approaches are probably where cancer therapy will go in the next decade. And he has the background, the personality, contacts, and good people on his board to make it work." Others in the field, however, question whether San Diego needs another independent cancer facility. SDRCC will be in direct competition for shrinking federal funds with the UCSD Cancer Center. The UCSD facility is an NCI-designated clinical cancer center, one of 14 in the country. And according to the program director for the NCI cancer centers, Allan Schrier, "we have been reducing the number of centers we fund. In 1985 we funded 65; today we only fund 55." Gerard Burrow, UCSD Cancer Center acting director, says he doesn't think San Diego needs a new independent cancer center. "We have active plans to double the size of our center in terms of numbers of oncologists and space we occupy," he says. In response to critics, Royston says that one role of the SDRCC will be to coordinate efforts with already existing facilities. Starting a new clinical research facility in a competitive market and being criticized is nothing new to SDRCC board member Sidney Green. Colleagues thought Green was crazy in 1976, he says, when he started the La Jolla Cancer Research Foundation in San Diego with only $250,000, amid the goliaths--Salk, Scripps, and UCSD. Green, who was a Tufts University Cancer Center administrator, founded La Jolla with Robert Fishman, the former director of the Tufts center in Boston. Now La Jolla is an NCI-designated basic cancer research center. In 1989 Green left La Jolla to start his own consulting business for nonprofit research institutions. Green cites three reasons why SDRCC will succeed as a first-class cancer-treatment center: "One, it will hopefully be a peer-reviewed center of excellence"; second, it will attract good researchers; and third, because the center will be doing cut-ting-edge research that doesn't duplicate other efforts, it will draw oncologists and their patients from the community. "Ivor's program of monoclonal antibody therapy is unique," he adds. Since the La Jolla Spectrum space is not currently set up for patient care, Royston envisions that therapy would be offered in the area's hospitals through affiliations with board and local oncologists. Being in biotechnology country is also a plus for the center, according to Green. "These companies may be interested in the technology transfer of these therapies or research that may emanate from the center," he says. "If there is anything of interest, there would be a licensing agreement where any profits accrued would go to the cancer center and not to individuals." The center is planning to first offer immunotherapy and eventually gene therapy. One immunotherapy method uses antibodies to hone in on and destroy a patient's lymphoma cells. "We now have a panel of some 100 antibodies that have been custom-made to different patients," says SDRCC chairman and oncologist Shiftan. "We have found that cells from a new lymphoma patient have a 50 percent chance of cross-reacting with the panel of antibodies that we have. So any new patient won't have to wait so long before treatment in order to have the antibodies manufactured." Ongoing research in Royston's lab focuses on human monoclonal antibody development for this kind of therapy as well as working out efficient mechanisms to arm antibodies with poisons to kill the lymphoma cells. Another immunotherapy protocol would involve genetically transforming a patient's cells to produce lymphokines to stimulate the pa-tient's immune system. Board member Allan Goodman says he realized that San Diego needed another high-tech cancer center when he had to take his late 20-year-old son, who had leukemia, to Hutchinson in Seattle for treatment. "I realized what a deficiency San Diego had," he says. "Before my son passed away, I made a commitment to him that I would get involved in starting a major cancer center in San Diego." Goodman predicts that there will be tremendous achievements in cancer treatment in the next 20 years and says he believes that the SDRCC will be able to evolve along with all the new developments: "Come visit us in five years and see how we are getting along." Ivor Royston speaks softly and carefully as he describes the origins of the San Diego Regional Cancer Center (SDRCC). He says he prefers to talk of his work rather than himself. Colleagues say that's because Royston has always been humble. "Most people who get started in something like this have large amounts of money," he says "We are small and we want to make something of it. That is the challenge.," As he speaks, his evenly modulated never rises. For him, challenge is a statement of fact which requires no exclamation. Such a manner may reflect Royston's training and experience as a physician. Royston graduated with his medical degree from Johns Hopkins Medical School in 1970. While there, in his last year, he also did graduate studies in the department of microbiology. He did an internship and residency in internal medicine at Stanford University Hospital from 1970 to 1972. Then he worked for the U.S. Public Health Service from 1972 through 1974. In that capacity, he worked as a staff associate from 1973 to 1973 at the division of virology in the bureau of biologics. He became chief of the viral oncology section in 1973 in the division of oncology and stayed until 1975. In 1975 Royston returned to Stanford as a postdoctoral fellow in the division of oncology in the medical school's department of medicine. He left Stanford in 1977 to become assistant professor of medicine at the University of San Diego School of Medicine. He also had an appointment as staff physician at San Diego Veterans Administration Medical Center in 1977. Between 1978 and 1981 he was a clinical investigator at the VA hospital. He received his board certification in internal medicine in 1977 and in 1979 he became certified in medical oncology. It was in October 1978 that he started Hybritech, Inc., which introduced the world to monoclonal antibodies as diagnostics and made him a millionaire. In the eighties, Royston became the director of the Cell Surface Marker Laboratory at the University of California at San Diego Cancer Center, associate professor of medicine at UCSD School of Medicine in hematology and oncology, and chief of oncology at the San Diego VA Medical Center. In 1984 he also became director of the Clinical Immunology Program at UCSD's cancer center. In 1985, he started his second biotechnology company, the San Diego-based IDEC Pharmaceuticals Corp., which manufactures a special type of monoclonal antibody and now employs about 50 people. In 1986 he sold his portion of Hybritech to Eli Lilly of Indianapolis. Reflecting on his latest venture at SDRCC, where he is scientific director and board member, Royston's self-effacing manner emerges: "You can't make it alone. You need enough people to get together to make it happen."

Entrepreneur Opens Clinical Cancer Facility

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