University of Michigan Comprehensive Cancer Center
It was 1986 when University of Michigan (U-M) regents designated a cancer center program. In May of 1997, a nine-story building was opened to house clinics and laboratories devoted to both cancer and geriatrics. Design of the facility was based on the then-radical premise that everyone involved in the fight against cancer should be working together under a single roof.
Today, as a National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, the U-M Comprehensive Cancer Center in Ann Arbor offers diagnostic, treatment, and support services while serving as a model for other branches of the U-M Health System and for academic peer organizations nationwide. Nearly 150 cancer physicians from eight departments collaborate in the center’s multidisciplinary clinics, streamlining care and maximizing communication by bringing together nurses, mid-level providers, and support staff grouped into teams, principally by tumor type.
Among the most noteworthy of the institution’s many programs designed to facilitate the translation of research findings into meaningful advancements in patient care are the Ravitz Foundation Phase I /Translational Research Center and the U-M Cancer Center’s stem cell research program.
Ravitz Foundation Phase I/Translational Research Center
Opened in 2008, the Ravitz Foundation Phase I/ Translational Research Center (TRC) is a specialty unit dedicated to phase I translational research and focused solely on targeted therapies. By harnessing U-M Cancer Center laboratory research, evaluating novel therapies at the earliest stage in the FDA’s regulatory process, and expediting their translation from bench to bedside, U-M scientists and clinicians are offering new hope to patients who would otherwise have no options.
Located within the university’s cancer center, the TRC is designed to enable specialized patient monitoring and, through its laboratory, to offer a wide range of services aimed at assessing the biologic impact of potential therapies used in the clinic.
David C. Smith, MD
With associate director of Translational Research Moshe Talpaz, MD, and TRC clinical director David C. Smith, MD, at the helm, the phase I program offers a comprehensive array of translational research resources not only to U-M faculty, but also to investigators at other institutions, and to pharmaceutical and biotechnology companies.
Among the most exciting benefits of the program is the potential for streamlined regulatory and contractual processes. When an investigator initiates a new study with the TRC, the protocol review process—much of which is managed electronically— is handled concurrently with study contract-services negotiations, enabling completion in approximately eight to 12 weeks.
A Pioneering Approach
U-M leaders are pleased with the way the TRC is developing.
“We initially expected to handle roughly 10 phase I trials per year, but we’ve actually exceeded those expectations, and currently have 13 trials in the pipeline,” said Smith, noting that more than 100 patients were enrolled in trials during the second full year of operation, and that additional patients are awaiting trial openings.
Smith was quick, however, to explain that the focus of the program is not to expand, but to build an infrastructure that will provide the highest-quality data. Central to the ability to generate such data, and to demonstrate the integrity and validity of study findings, he noted, are the TRC’s dedicated regulatory and data-management staff.
Another intriguing aspect of the program’s growth, Smith said, is its technique for matching patients to trials, which is about to become more complex.
“We’re looking beyond matching a patient to a given trial based solely on generic phase I eligibility,” he said. “Instead, the next step is to match patients to trials according to genetics—a concept we’re just about ready to launch with an ongoing program that will involve biopsying, and subsequent deep sequencing, of the tumors of patients enrolled in phase I trials. Ultimately, patients with several types of cancer may participate in a single phase I trial. Once researchers determine the best dosage of a given drug, they’ll use what they learn to help develop broader studies.”