To support generic drug companies in obtaining a market license for their orally inhaled drug products (OIDPs), Nanopharm and FLUIDDA entered into an exclusive collaboration to combine Nanopharm’s SmartTrack™ with FLUIDDA’s Functional Respiratory Imaging technology to create a unique in-vitro in-silico platform. This allows pharma companies to shorten their clinical pathways – and potentially avoid comparative clinical endpoint studies by demonstrating a holistic understanding of both the product and patient-specific variables associated with the performance of their drug product, without having to go into the clinic.
In this interview at the ERS convention in Barcelona, Gemma Budd, Director Business Development of Nanopharm, an Aptar Company, and Dr Jan De Backer, CEO of Fluidda, explains the context behind the industry and regulatory need and what the technologies offer in response.
Click here to see the short video on LinkedIn
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Nanopharm Announces Exclusive Collaboration With Fluidda To Accelerate Regulatory Pathway For OINDP Using SmartTrack
Crystal Lake, Illinois, September 22, 2022 – Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.