After a review of the past year’s activities by incoming chair Jeff Breit of Bend Research, final voting for new executive committee members got underway, and Jayne Hastedt of JDP Pharma Consulting presented a talk on “Formulation of Proteins for Dry Powder Inhalation Drug Delivery” while ballots were being counted.
With the 40 votes cast during the meeting added to 72 votes cast earlier online, Bill Schachtner was elected Vice Chair, Jayne Hastedt Secretary, Gonçalo Andrade and Prabo Wijetunge as general executive committee members, and Brijeshkumar Patel as the student representative.
Bill Schachtner and Magdalena Mejillano of PPD and Brent Donovan of Merck enjoy cowboy cocktail hour at the Bend Research booth
The other event of interest to OINDP specialists, a symposium titled “Global Clinical Regulatory Requirements for Inhalation Products,” took place on the final morning of the meeting. The symposium drew approximately 60 attendees to hear presentations by Guenther Hochhaus of the University of Florida, Anders Fuglsang of Fuglsang Pharma, and Bing Li of the US FDA.
Despite the broad topic suggested by the title of the symposium, the majority of the discussion centered around the differing US and EU approaches to approval of generic inhalers, especially in light of the FDA’s recent draft guidance on bioequivalence for generic Advair, which Bing Li called “one of the most rigorous regulatory standards we have ever had.”
Fuglsang, a former EU regulator, noting that the new guidance, based on a “weight of evidence” approach, calls for a total of 50 tests, of which 36 are in vitro, 12 PK, and 2 PD, suggested that the process is “completely unrealistic.” Several attendees also questioned the usefulness of required therapeutic equivalence studies, especially for fluticasone, suggesting that such studies are non-discriminative and a waste of money. Bing Li defended the weight of evidence approach, saying essentially that the cost is a matter of concern for industry but not a decisive factor for regulators.
Fuglsgang noted that the 2009 EU guideline, based on a “stepwise approach” that allows for approval on in vitro testing alone, has failed to produce a significant number of generic inhaler approvals and that EU regulators are currently reevaluating the guidelines. His advice for companies looking to develop a generic inhaler: “Kids, don’t try this at home.”
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