How many drug development companies leave it up to the CRO or CMO to design or execute their studies or formulation/manufacturing without oversight? Like those who boarded the Titantic 100 years ago, they seem to trust the mantra that their contractor’s work is unsinkable. MAP Pharmaceuticals seemed to do just that – the approval of their 505(b)(2) dihydroergotamine inhalation aerosol was blocked by deficiencies at the contract manufacturer.
When the Titanic was being designed the engineers were confident that the ship couldn’t sink. Normally a ship like this would require 64 lifeboats to accommodate all of the passengers. Yet, the ship’s owner declared that having 64 life boats would cause passengers to believe the ship could sink. Thus, he ordered the minimum number of lifeboats – 16 (as shown below, #16 was on the aft port deck).
I certainly don’t believe that all CRO’s and CMO’s are “sinkable”. But I do believe that drug development companies must oversee their work. In the last couple of years, Camargo has been brought in to ‘re-float’ CMC and clinical studies. An injectable CMO went out of business, another has suspended production. A CRO has declared bankruptcy and another had a couple of investigator sites shade data.
Moreover, CRO’s and CMO’s expect to have input from the sponsor. When the sponsor’s business model is outsourcing, they should use a service organization, such as Camargo, to make sure their best interests are served. Yes, 64 life boats are expensive – it is cheaper to leave the CRO or CMO alone. Or is it? You choose – MAP Pharmaceuticals has an expensive and time consuming task ahead of them.