RDD 2024, which took place May 5-9 in Tucson, AZ, USA, brought together more than 530 delegates and 70 exhibitors for a meeting that highlighted a number of transitions taking place in the development of OINDPs. Compared to past meetings, the 2024 edition of Respiratory Drug Delivery featured a large proportion of the presentations, posters, and exhibitors focused on movements in the industry towards alternative approaches for establishing bioequivalence; transitioning to lower global warming potential delivery, including new LGWP propellants; and from inhalation products for asthma and COPD to other indications, including a trend toward delivery of large molecules.
The conference was also notable for increased participation by the FDA; the agency sent 18 delegates who presented 3 talks and 5 posters and who actively participated in question and answer sessions. FDA presenters specifically discussed both new product-specific guidances that allow for time- and cost-saving alternative BE approaches and its current thinking on the LGWP transition.
Recordings of the presentations and workshops are now available for delegates through June 30.
Regulatory issues for generic drug development
In the “Inhalation Innovation” knowledge space, the FDA presented two talks on alternative approaches to establishing bioequivalence that may allow sponsors to avoid the time and cost of comparative clinical endpoint and/or pharmacodynamic bioquivalence studies. In the first of those talks, Elizabeth Bielski and Susan Boc presented recommendations for in vivo and in vitro testing to establish BE, including specific discussion of recently published product specific guidances (PSGs) for suspension MDIs and for DPIs that include alternative approaches.
Bielski covered study design considerations for several methods including realistic APSD testing, noting that solution MDIs require method development for the specific product since the testing seems to be very product-dependent. She also covered study design considerations for dissolution testing of inhaled drugs, for which there is currently no standard method; in vivo charcoal block PK bioequivalence studies; and comparative characterization studies.
In her conclusions, Bielski emphasized FDA’s research, its efforts to get input from industry, and the agency’s will to expand the use of alternative approaches by providing more specific guidances in the future. “The main message I want to leave here today with you . . . is since 2018, FDA’s efforts have really been understanding that we don’t really want to be conducting these clinical endpoint BE studies any more for generics,” she stated.
