Remember Tim Russert? He was a journalist and political analyst, NBC News Washington bureau chief, and moderator of the television show, “Meet the Press.” His death in 2008 at the age of 58, said David Mueller, “is why Clear Vascular is in business.”
Mueller, CEO of Clear Vascular, a three-person virtual company, said, “Russert died on the set and had no symptoms. He died from ruptured plaque.” Clear Vascular is a medical/pharmaceutical firm that’s developed an injectable radiopharmaceutical product for imaging heart disease.
“We do all of our production under contract,” said Mueller during his presentation “Case Study: Implementing Reusable Containers For Global Shipment Of Radioactive Clinical Trial Material” Sept. 28 at the 9th Annual Cold Chain Temperature Management Global Forum in Philadelphia.
The company’s size and virtual status have “allowed us to push boundaries,” said Mueller. “We’ve taken product for clinical trials in humans at about one-third the cost of most. With this product, a protein is attached to a radioisotope and injected into the body. The protein is temperature-sensitive, and the radioactivity adds to the challenge in that some companies won’t even ship it.”
“Any excursion in temperature beyond the 2- to 8-degree C range beyond one hour means the product must be destroyed,” said Mueller. “One vial in a box is worth $65,000, so four in a container is a financial loss our company can’t afford. It could shut our company down.”
So far, Clear Vascular has made more than 90 shipments using the EcoTherm containers, “and we’ve not experienced any failures,” said Mueller. “It’s met all of our requirements for clinical temperature-sensitive shipping and we will continue to use it for worldwide shipments once the product is approved.”