The road to finding a cancer cure has added a major milepost: a Cornell-based production facility designed to make therapeutic cancer drugs for clinical tests.
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| From left, Frank Lee, manager of Cornell's new bioproduction facility, discusses the unit's systems with Andy Simpson of the Ludwig Institute for Cancer Research; David Wilson, Cornell professor of biochemistry; and Cornell President Hunter Rawlings at the facility's opening Nov. 13. It will begin producing tumor antigens for Phase I clinical trials in about six months. Charles Harrington/University Photography |
The lab facility, which celebrated its opening Nov. 13 on the third floor of Stocking Hall, is the first of its kind nationally on an academic campus. It is the result of a partnership formed three years ago between the Ludwig Institute for Cancer Research in New York City and Cornell.
Pharmaceutical companies cannot afford to take heavy risks as they wade through the vast number of drug possibilities. Thus it is up to institutions "such as Cornell and the Ludwig Institute ... to produce [cancer] reagents that can be administered to patients," said Lloyd Old, chief executive of the Ludwig Institute, at the Stocking Hall ribbon-cutting ceremony. The ceremony was organized by the facility's director, Carl Batt, Cornell's Liberty Hyde Bailey Professor of Food Science, and by Frank Lee, who is the unit's campus manager.
In his opening remarks, Old challenged the view that making therapeutic cancer products for human testing is not the job of academic institutions but of pharmaceutical and biotechnology companies. "This, of course, has been the traditional view of drug development, with distinct roles assigned to academia and to companies in the process of translating discoveries into applications," Old said.
Helping change that traditional view is the opening of the tentatively named Good Manufacturing Practices (GMP) Bioproduction Facility in Stocking Hall. Under the traditional model, company researchers have often complained that the further development of cancer drugs can be easily stifled when they don't hold promise in early clinical trials. The GMP facility at Cornell will help ensure that promising proteins are fully tested.
In addition to providing valuable therapeutic agents for clinical tests, the campus facility will be providing critical research material for the university's Weill Cornell Medical College in New York City. "This facility will serve as a link between the two ends of the university; and it is a link that is meaningful and useful," said Batt.
Initial discussions for the facility began between the university and the Ludwig Institute in 1998. By May 1999, the university had signed an agreement with the institute to create a bioprocess research laboratory and lay the foundation for the bioproduction facility.
The effort to bring the laboratory and production unit from idea to reality was led by Batt.
"Every project needs a champion, and on this project it has been Carl Batt. He is tenacious," said Cornell President Hunter Rawlings in remarks before the ribbon-cutting ceremony. "No matter what roadblocks are put in his way, he will either go around them or through them. Carl has had the will to cut through it all and accomplish this goal. And thanks to him, Cornell is living up to its part of the bargain."
Edward A. McDermott Jr., president of the Ludwig Institute, and Eric W. Hoffman, M.D., director of the institute's Office of Clinical Trials Management, also provided remarks at the ceremony. "We have had associations with the university for years through the medical school, but the presence in Ithaca adds a new and important dimension to the relationship," said McDermott.
Douglas Wilkins, a designer with Cornell's Office of Planning, Design and Construction, explained that the project has had many challenges due to the age of the nearly century-old Stocking Hall and the need to meet U.S. Food and Drug Administration GMP regulations for production of therapeutic agents. Electric service needed to be upgraded and all construction materials had to be documented in detail, even down to the brand name of the caulk. The new facility's clean-room production areas had to be sealed within the old structure of the building.
Production of proteins that hold promise as immunotherapeutic antigens is expected to begin within six months, after the clean rooms have been certified and the machines calibrated. A tumor antigen called NY ESO-1, part of a promising new class of cancer treatments, is expected to be among the first therapeutics made there for clinical trials. The trials will be headed by Dr. Nasser K. Altorki, professor of cardiothoracic surgery at Weill Cornell Medical College.
Rawlings praised the cooperative venture and the Ludwig Institute's vision for cancer research. "Lloyd Old wants to solve the ravages and tragedies of cancer and take full control of that discovery process at the early stages of clinical research. ... This fits well with Cornell's New Life Sciences Initiative and our tri-institutional partnership [with Memorial Sloan-Kettering Cancer Center and Rockefeller University]," Rawlings said.
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