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Press Clipping / Sep 12, 2017

Live from PDA/FDA: Culture of Quality

Healthcare Packaging, September 12, 2017

Empowering employees with a strong sense of ownership can lead to improved outcomes and increased cost efficiency.

Guy Villax, CEO of Hovione agrees. As a CEO, he says, it has to be established that everyone in an organization shares responsibility for the quality of their products and that everyone must be quality-minded. Villax encourages his employees to be open and transparent and notes he’s often the first to call FDA or order investigation/root cause analysis if something goes wrong, so his teams can learn from issues and fix them. Villax says it’s important to keep patients in mind… the medicine they’re creating literally saves lives.

 

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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