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DDL 24 — Day 1

On day 1 of DDL 24, attendees gathered in the Pentland Auditorium of the Edinburgh International Conference Centre, where they were welcomed by conference chair Gary Pitcairn. In his opening remarks, Pitcairn noted that attendance had broken the 500 mark for the first time in the meeting’s history.

Following Pitcairn’s remarks, OINDP consultant and Affiliate Professor at the University of Hawaii Jolyon Mitchell presented the 2013 DDL Lecture, titled “Taking the Evaluation of Orally Inhaled Products in the Laboratory to the Next Level: Introducing the Patient Experience into the Picture.” Speaking on a topic whose importance he emphasized in a Q&A with OINDPnews earlier this year, Mitchell reiterated the need to take user experience into consideration during product development.

Jolyon Mitchell shows off gifts presented by EPAG after his DDL lecture

Jolyon Mitchell shows off gifts presented by EPAG after his DDL lecture

“Nobody deliberately starts out trying to misuse an inhaler,” he noted while reviewing the difficulties inherent in using the devices and asserting the responsibility of developers and manufacturers for insuring that devices are patient friendly. He emphasized the need for development of methods to allow for collection of clinically relevant data instead of relying entirely on data more suited for quality control purposes such as fine particle fraction.

Mitchell pointed out that for clinically relevant assessments, the entire product — including the drug, device and any add-ons such as spacers, valved holding chambers, or face masks — must be evaluated as a single entity. In the case of face masks, he added, developers will need to use age-appropriate face models with soft tissue modeling capabilities in order to have an accurate understanding of the patient’s interaction with the device.

He also advocated the development of analyses capable of taking age-appropriate breathing patterns and coordination of the actuator with inhalation into account. These techniques, Mitchell said, should eventually become compendial methods.

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published on December 12, 2013

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