Just days ago the pharma industry consortium TransCelerate BioPharma flagged the completion of its "comparator network," a new initiative aimed at ensuring that developers out to go head-to-head with an approved drug in a clinical study will have a secure supply of the comparator drug as needed.
Over the past two years investigators have been bedeviled by irregular supplies of the drugs--particularly cancer drugs--they're going up against. A host of supply shortages was making it difficult and sometimes impossible to complete a study on schedule. And the new network obtained pledges from members, which includes heavyweights like Roche ($RHHBY), Johnson & Johnson ($JNJ) and Pfizer ($PFE), that they could make that problem go away.
This new industry agreement should also help resolve shortages that can result from a sudden demand for drugs needed for clinical trials--a situation likely to become more common as more specialized therapies make it to the market.
"When a buying company is looking to buy a comparator drug product for a clinical trial, it often ends up buying all of the product they need from a wholesaler, who in turn will buy the product in a smaller region or country of the world," says a spokesperson for TransCelerate. This can cause stock outs and drug shortages.
"With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial," said CEO Dalvir Gill in a statement.
(Editor's note: This story has been significantly changed after a spokesperson for TransCelerate contacted FierceBiotech to take issue with a Boston Business Journal story we referred to. The initial story was based on an interview with a TransCelerate official who described the shortages as intentional, created when drug companies heard of a head-to-head study in order to drive up the cost of the drug for the study sponsor. TransCelerate asserted that the BBJ reporter, Don Seiffert, misinterpreted what he was told, and on Thursday the BBJ changed the report to reflect the co-op's stance.)
- here's the Boston Business Journal report
- read the press release