by
Lauren Dubinsky, Senior Reporter | June 17, 2014
From the June 2014 issue of HealthCare Business News magazine
One example of what’s possible when researchers in an academic setting are able to experiment with the creation of PET radiopharmaceuticals is the story of Amyvid. In the early aughts, Dr. Daniel Skovronsky led a team of researchers from the University of Pennsylvania’s Center for Neurodegenerative Disease Research in developing Amyvid. The PET tracer was the first to be approved by the U.S. Food and Drug Administration to help physicians measure beta-amyloid plaque load in the brain, which is associated with Alzheimer’s disease. Skovronsky’s company, Avid Radiopharmaceuticals Inc., is now a subsidiary of Eli Lilly and Company.
Since December 2011, the FDA has put new good manufacturing practice guidelines in place. The agency declared they now require new drug or abbreviated new drug applications for any PET radiopharmaceutical that will be used in a clinical setting.
When the deadline for submission rolled around in June 2012, many of the facilities realized that putting together their own drug applications was a difficult task.
“There are a lot of regulatory burdens and paperwork and costs associated with these filings with the FDA,” says PETNET’s Alvarez. “The FDA does audit these sites quite frequently to ensure that they’re compliant with the cGMP regulation.”
Once the facilities filed with the FDA and understood the cost and additional regulatory constraints on manufacturing, many looked to outside suppliers to run their operations.
Besides the collaboration with the University of Washington, Cardinal Health also entered into a partnership with Ohio State University in 2009 to research and ultimately create short-lived radiopharmaceuticals. According to written material from Ohio State, the investment from the pharmaceutical industry can help not only with the research being done in the academic setting, but also in the commercialization of new radiopharmaceutical development projects.
Option three — buying a mini cyclotron
A mini cyclotron is a third option. ABT Molecular Imaging developed one of these units, called the Biomarker Generator. It’s commercially available in most countries, but still pending FDA approval in the U.S. for clinical use.
In the case of the Biomarker Generator, there is no need for a radiopharmaceutical laboratory or hot lab because the unit produces a single dose of FDG on demand. For now, the Biomarker Generator only produces FDG since it’s the primary PET agent in the world.
