Yale PET Center Opens with President Levin and Pfizer CEO

A ribbon-cutting ceremony for the state-of-the-art Yale Positron Emission Tomography (PET) Research Center for molecular imaging takes place today at the Anlyan Center Auditorium, 300 Cedar St.

Speakers at the ceremony and reception include Yale President Richard C. Levin; Yale School of Medicine Dean Robert J. Alpern, M.D.; Pfizer, Inc. Chairman and Chief Executive Officer Jeffrey B. Kindler; and Pfizer, Inc. Vice President of Worldwide Clinical Research Operations Diane K. Jorkasky, M.D.

The event includes a keynote address by George Mills, M.D., director of the Division of Medical Imaging and Radiopharmaceutical Drug Products of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. The topic is “PET Imaging: The Essential Foundation for the Imaging Critical Path.” Mills oversees the FDA division responsible for approving new contrast media and diagnostic imaging drugs that help enhance the visualization of an X-ray, CT, MRI or PET scan. The division also approves new biologic drugs for non-cancerous, blood-related conditions.

PET is a non-invasive diagnostic scanning technique that provides researchers and clinicians with visual images of organ function. PET scans can detect biochemical changes in body tissues before structural damage occurs from disease. These indications of early disease allow clinicians to more quickly identify and treat disease.

Pfizer, Inc., has invested in the Yale-Pfizer Bioimaging Alliance and contributed to the establishment of the Yale PET Center, which was created to advance the interests of Yale clinicians, scientists and students in molecular imaging research. Yale University broke ground for the 22,000 square foot facility in 2004. Located at 801 Howard Avenue, the Center is in close proximity to other Yale School of Medicine departments and the Pfizer Clinical Research Unit in New Haven.

“The PET Center exemplifies Yale’s commitment to cutting-edge research and strong partnership with industry,” said Yale President Richard C. Levin.

Understanding the molecular basis of the diseases of the central nervous system, cancer and cardiovascular disease will help researchers develop targeted treatments. The high-resolution imaging and quantitative analysis that Yale’s PET Center offers will give researchers a more rapid and accurate way to determine whether a drug is reaching its target in the brain and other tissues. This advantage will enable earlier decisions on whether to embark on a large clinical trial or abandon a drug candidate before investing large amounts of money.

“Clinical trials to determine a drug’s effectiveness often fail because a drug doesn’t reach its target or there isn’t a sufficient amount of the drug to treat the disease,” said PET Center Director J. James Frost, M.D., professor of diagnostic radiology and psychiatry and chief of nuclear medicine at Yale-New Haven Hospital. “PET can now be used to determine this very early on. This knowledge will help cut down on large, costly clinical trials, and research can be focused on alternative drugs.”

Targeting where and how well medicines work in the body is now possible, but a second, future use for PET, Frost said, will be to identify patients with specific molecular abnormalities, and to select the right drug to treat an identified pathological change, such as an increase or decrease in a brain chemical or receptor.

“Schizophrenia in one patient might not be the same type of schizophrenia in another patient,” said Frost. “The brain scan may in the future not only identify whether it is schizophrenia, but also identify the sub-type of schizophrenia. That is where individualized medicine comes into play. We would then be able to subcategorize patients within an otherwise homogenous category for their specific illness and then individualize their treatment.”

Another potential use for PET is the identification of specific biochemical changes in the target organs that correlate with the therapeutic responses demonstrated by large clinical trials. This use of PET scanning would permit the early identification of a positive clinical response, such as increased survival, based on a biochemical endpoint. In the future, PET could be used in this way as a substitute or surrogate for the usual clinical measures and thus speed the development and approval phases of a new drug.

“Because diseases like Alzheimer’s, cancer and heart conditions represent highly complex scientific puzzles and enormous challenges to our health care system, it is imperative that we bring together great scientists to work in partnership,” said Pfizer CEO Kindler. “This venture illustrates how great things can happen when a science-based company like Pfizer and a leading academic medical center like Yale combine resources. Speaking on behalf of the more than 6,000 Pfizer colleagues at our three R&D sites in Connecticut, I am confident that this collaboration will yield important research insights and, ultimately, new treatments for patients.”

The Yale PET Center is part of the Department of Diagnostic Radiology and collaborates with School of Medicine departments and sections including Psychiatry and Cardiovascular Medicine. The staff will also collaborate heavily with the Yale Cancer Center. Collaborations with Pfizer and other industry partners are advancing the use of molecular imaging in new medication discovery and the development of new diagnostic PET radiopharmaceuticals.

Clinicians at the nearby Pfizer Clinical Research Unit will collaborate with the Yale PET Center on new drug development projects. Pfizer recruits volunteers who are given potential new medicines under close supervision by physicians and other Pfizer staff. Some of these volunteers will be referred to the Yale PET Center, where PET scans will be done to confirm the safety and effectiveness of these potential new treatments. Several collaborative studies have already taken place, with more planned for the future.

Frost said the Yale PET Center is one of the few PET laboratories in the United States that is cGMP (current good manufacturing practice) compliant. It meets the highest safety standards for human subjects and quality control and has been certified by Pfizer as such through a rigorous review process. The Center also boasts one of the few PET scanners in the world dedicated to imaging the human brain that achieves a resolution of 2.5 millimeters.

The lead staff at the PET Center has a combined total experience of about nine decades in the field. In addition to Frost, they include Co-Directors Richard E. Carson, professor of diagnostic radiology and biomedical engineering and chief physicist; Yu-Shin Ding, professor of diagnostic radiology and chief radiochemist; and Henry Huang, a radiochemist and associate professor of diagnostic radiology. Other faculty staff members include James Ropchan, lead production radiochemist and associate research scientist in diagnostic radiology; David Labaree, associate research scientist in diagnostic radiology; and Nabeel Nabulsi, associate research scientist in diagnostic radiology.