Impel NeuroPharma, a Seattle-based clinical stage biotechnology company developing first-in-class intranasal drug treatmentsm, has  entered into service agreements with Camargo Pharmaceutical Services, LLC. Camargo will be providing end-to-end regulatory consulting and strategic development services for Impel’s pipeline of drug-device combination products built upon its Precision Olfactory Delivery (POD) nasal delivery platform. The first programmes will concentrate on treatments for migraines and Alzheimer’s, including pre-Investigational New Drug (pre-IND) meeting planning and preparations through to New Drug Applications (NDA) submissions.

Camargo is the most experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1100 FDA meetings and more than 200 FDA NDA and ANDA approvals.

“Camargo has a deep experience in 505(b)(2) strategy and combination product development which perfectly complements Impel’s capabilities. Partnering with Camargo will allow Impel to take full advantage of our POD nasal drug delivery platform and efficiently develop multiple meaningful drug products,” says John Hoekman, chief executive officer and co-founder of Impel NeuroPharma.

“By bringing together Camargo’s expertise with 505(b)(2) drug development and Impel Neuropharma’s revolutionary POD technology, we are able to help enable effective new therapies for patients worldwide,” says Ken Phelps, chief executive officer of Camargo Pharmaceutical Services. “By utilizing the 505(b)(2) pathway and employing best strategies, Impel’s products will move through approval and reach the market in the most cost- and time-effective manner.”

Impel NeuroPharma’s POD nasal drug delivery platform is designed to deliver drugs to the upper nasal cavity for improved biodistribution. By delivering therapeutics to the upper nasal cavity, the POD nasal delivery platform takes advantage of the vascular rich olfactory region for improved bioavailability and has the potential to target the brain via the olfactory and trigeminal nerves.