Bringing a prescription drug to market now takes more than US$2.5bn and 10 years, according to a study published last year by the Tufts Center for the Study of Drug Development. The costs jumped by 145% compared with a similar study carried out by Tufts in 2003. That kind of staggering increase is not sustainable; drug development must change.
The Tufts study cited factors including increased clinical trial complexity, greater focus on targeting chronic and degenerative diseases, and changes in protocol design to include the gathering of health technology assessment information and testing on comparator drugs to accommodate payer demands for comparative effectiveness data.
However, the study overlooked three other significant factors: rising regulatory burdens; a batch manufacturing process that has not changed in more than a generation; and a changing R&D process that relies on developing trust more than ever before. These factors affect branded and generic drugs alike and understanding their impact can help when addressing them.
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