June 10, 2011 — At the Society of Nuclear Medicine’s 58th Annual Meeting in San Antonio, June 4-8, Cardinal Health previewed The Center for the Advancement of Molecular Imaging, its new, first-of-its-kind innovation laboratory, which it plans to open in July 2011.
The campus, located in Phoenix, will be a “one-stop” destination where pharmaceutical companies and academic institutions can access Cardinal Health’s industry-leading scientists, engineers and manufacturing experts. The center’s state-of the-art technology, infrastructure and capabilities will accelerate the development, testing and commercialization of new radiopharmaceuticals and positron emission tomography (PET) biomarkers that diagnose and treat complex diseases like cancer, heart disease and neurological disorders.
“Our goal is for pharmaceutical companies and academic institutions to come to the center with a concept for a new imaging agent – and have access to everything they need to simplify and expedite the product development lifecycle,” said John Rademacher, president of Cardinal Health’s nuclear pharmacy services business. “The center will support the product innovation pipeline and drive industry growth by meeting two key industry needs. First, it will help forge collaborative partnerships that push the science of molecular imaging in new directions. Second, it will help expedite the market introduction of new biomarkers.”
At the center, Cardinal Health will leverage its considerable expertise in lean six sigma methodology – capabilities that simplify processes and eliminate process waste – to improve the quality, reliability and scalability of PET manufacturing. These steps are critical, says Rademacher, to help the industry develop large-scale commercial production capabilities that can more easily ramp up to meet growing market demand for new radiopharmaceuticals.
The campus will house large-scale PET production capabilities and stand-alone laboratory space to allow the company’s partners to conduct confidential experiments. It will also provide access to the quality and regulatory expertise that is critical to earning U.S. Food and Drug Administration (FDA) approval of new imaging agents, and will house a global training facility for Cardinal Health’s nuclear pharmacy services business.
Once new PET drugs are FDA-approved, pharmaceutical companies and research institutions will also have access to Cardinal Health’s industry-leading network of manufacturing facilities and its nationwide network of more than 155 nuclear pharmacies. More than 100 of these nuclear pharmacies are “PET-enabled” to manufacture and dispense high-energy PET imaging agents in unit dose form to more than 90 percent of the U.S. patient population.
Key features of The Center for the Advancement of Molecular Imaging include:
Collaboration laboratory: The center will house “collaborative laboratories” where Cardinal Health will bring industry innovators together with its experts in the fields of scientific research, technology, quality and regulatory affairs and manufacturing. These cross-functional teams will increase the speed of innovation by finding new ways to decrease the time it takes to secure FDA approval of new imaging agents and by sharing best practices for commercialization.
State-of-the-art PET manufacturing facility: The center will house the latest technology in PET manufacturing, including dual cyclotrons, which can be used to produce large quantities of radioisotopes. It will also contain production facilities that allow for the simultaneous radio-synthesis of multiple imaging agents, for both commercial and research purposes.
Fully functional, confidential, private guest laboratories: The center will have dedicated, fully equipped laboratories where guest researchers can conduct experiments that will produce, test and develop radioactive products, which will facilitate more rapid deployment into large-scale, multisite clinical trials.
Global PET Production Control Center: The center will also make it easier for pharmaceutical companies and academic institutions to monitor the production of their drugs at any of Cardinal Health’s PET manufacturing sites during multi-site clinical trials. The center’s PET production control center will provide video access to each of Cardinal Health’s PET manufacturing sites, effectively serving as a “mission control,” where partners can trouble shoot, offer technical assistance and more efficiently deploy resources against manufacturing challenges.
“The launch of The Center for the Advancement of Molecular Imaging is a strategic investment in the future of the molecular imaging and pharmaceutical industries,” said Rademacher. “By helping the pharmaceutical and academic research communities accelerate innovation and reduce the time it takes to get new imaging agents to market, we can achieve our ultimate goals: to enable the earlier and more accurate diagnoses of disease, drive more effective treatment and produce better outcomes for patients.”
For more information: www.cardinalhealth.com