Nichols was scheduled to be followed by Sau (Larry) Lee of the US FDA via video conference; however, due to a blizzard in the Washington, DC area, the talk was instead presented by Bhawana Saluja with audio only. She delivered a “Rationale behind the recent Draft Guidance on Fluticasone Propionate/Salmeterol Xinafoate” that was interrupted by a short break due to technical difficulties.
Unlike a session a few weeks earlier, where the FDA draft guidance was defended by Lee and Saluja’s colleague Bing Li at the 2013 AAPS annual meeting, very little discussion followed the talk.
The afternoon podium session, titled “Formulation approaches for new inhaled therapies,” generated a bit more engagement with the audience. In the first talk, Jason McConville of the University of New Mexico described inhaled treatments for lung cancer and work in his lab to create a nebulized formulation of coenzyme Q10 as a proposed adjuvant treatment. After McConville’s talk, Jeff Weers of Novartis discussed the development of antibiotic DPIs, especially the Tobi Podhaler, that must deliver large doses of drug for patients with limited lung function.
In the final talk of the day, Eric Alton of Imperial College London presented a highly entertaining recap of work done so far on gene therapy for cystic fibrosis by himself and the other 80 members of the UK CF Gene Therapy Consortium. The narrative covered development of the Wave 1 liposome vector aerosol product currently in a Multi-Dose study with more than 120 patients and the Wave 2 modified lentiviral vector aerosol that appears to hold the promise of even more effective correction of the CF gene function.
During the evening awards reception, the DDL 24 organizers announced that, based on factors that included handling audience questions, sticking to the allotted time limit, and presenting the material for a general audience, not just an aerosol audience, the committee has awarded this year’s Pat Burnell New Investigator award to Daniel Zimarev of Cambridge. Chris Blatchford of 3M Drug Delivery Systems takes home the award for best industry poster, and Otmar Schmid of Helmholtz Zentrum München wins best academic poster.