Press Room

Guy Villax speaker at the 2014 PDA Pharmaceutical Quality Metrics Conference

Start
Tuesday, December 02, 2014 - 09:00
End
Tuesday, December 02, 2014 - 09:30
Location: Omni Shoreham Hotel, Washington, DC

 

Guy Villax

Speaker at the 2014 PDA Pharmaceutical Quality Metrics Conference. Exploring Quality Culture and Quality Systems Maturity.

      9:00 a.m. - 9:30 a.m.
      Why Dr. Hamburg Needs Her Dean's List
      Guy Villax, CEO, Hovione

Pharmaceutical leaders will share their experience and challenges for improving corporate quality culture and quality management systems.

FDA will share their thoughts and proposed actions for gathering quality metrics from the pharmaceutical industry as well as their interest in aligning quality metrics with inspectional outcomes.

This year’s conference will also have breakout sessions to allow detailed discussion and feedback on quality culture and on FDA’s new quantitative measures program.

To read the articles behind this talk click on the following links:

  • Read the extended version with links to references, examples and case studies here
  • Read the article in Pharmaceutical Technology  here

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net    

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