A clear communication pathway with contract partners for escalating issues during and after development has been key to Vertex’ success in building state-of-the-art, quality-by-design (QbD) applications as a virtual company.
Eda Montgomery, who as CMC/QbD quality director helped Vertex develop and gain clearance for two seminal QbD applications over the past year, emphasized the importance of these communication pathways in presentations on the firm’s experience in CMO management at IFPAC’s annual conference in Baltimore in January and again at an ISPE supply chain conference held there in June. Montgomery is now working with Shire to help advance its QbD program.
The two prominent Vertex approvals were for Incivek (telaprevir) in May 2011 – the first drug approved for curing hepatitis C – and Kalydeco – approved in January for treating cystic fibrosis. In a speech delivered in February, FDA Commissioner Hamburg touted Kalydeco as the first drug to “treat the underlying mechanism of the disease rather than the symptoms” (IPQ “The News in Depth” February 26, 2012).
The first step in developing a QbD-oriented contract relationship is to put a joint sponsor/CMO project team in place, Montgomery explained. Vertex’ experience indicates that it is then “crucial to have a process for and an agreement on an open line of communication regarding how to escalate issues, how to manage the relationship, how to talk about what is working well and what needs to be improved.”
The escalation pathway established during the QbD development process, in turn, she pointed out, provides “a nice stepping stone to activities around communication of out-of-specification [OOS] and out-of-trend [OOT] results, conducting investigations, discussions around oversight and how closely managed certain activities are going to be, and finally evaluation metrics and frequency.”
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