How many drug development companies leave it up to the CMO to design or execute their formulation and 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 its 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).
Titanic Boat Deck PlanWhile all CMOs are not “sinkable,” it is true that drug development companies must oversee their work. In the last couple of years, Premier Consulting has been brought in to ‘re-float’ a CMC program after an injectable CMO went out of business. In another instance, we joined a program after a CMO suspended production.
Moreover, CMOs expect to have input from the sponsor. When the sponsor’s business model is outsourcing, it should use a service organization, such as Premier Consulting, to make sure its best interests are served. Yes, 64 life boats are expensive – it is cheaper to leave the CMO alone. Or is it? You choose – MAP Pharmaceuticals has an expensive and time consuming task ahead of it.