Vertex’ experience with the development and approval of its oral solid hepatitis-C drug Incivek (telaprevir) testifies to the power of quality by design (QbD) to solve the problems posed by molecules that are difficult to develop, formulate and manufacture.
At a symposium sponsored by the “International Consortium for Innovation and Quality in Pharmaceutical Development” (IQ Consortium) in December in Cambridge, Massachusetts, Vertex Senior VP for Pharmaceutical Development Patricia Hurter commented on the close collaboration and cross-discipline efforts that were needed to address the QbD challenges and bring the development and commercialization process for Incivek to completion.
“Pharmaceutical development, which I am the head of, regulatory, technical operations and quality lived in each other’s pockets for months,” working together to solve the technical and communication problems, the Vertex official said. “I think being a small company helped us to be able to do that.”
In her presentation, Hurter discussed: ● Incivek development and characterization ● understanding chemical stability ● advancing the science of spray drying ● scaling down for new projects, and ● the firm’s QbD filing.
Hurter also spoke about Vertex’ focus on biopharmaceutics modeling and continuous manufacturing as potentially powerful tools for advancing its drug development and quality by design (QbD) program (IPQ “The News in Depth” June 22, 2011). [Editor’s Note: A third story in IPQ’s series on Vertex focuses on the communication pathways that had to be created with its contract manufacturing partners to achieve its QbD objectives (IPQ “The News in Depth” June 21, 2011).]
Incivek, approved in May 2011 under a six-month review clock, is Vertex’ first drug on the market. Approval of a second QbD-based application followed in January 2012 for Kalydeco, a drug 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).
Vertex currently has around 2,000 employees and uses contract partners to do all of its clinical and commercial manufacturing, from bulk production through final packaging.