Nanopharm pioneered the development of the alternative bioequivalence regulatory pathway for US FDA approval of generic OIDPs for asthma and chronic obstructive pulmonary disease (COPD) using its proprietary service platform in vitro and in silico, SmartTrack. Fluidda’s proprietary in silico FRI (Functional Respiratory Imaging) platform provides quantitative predictions of regional drug deposition in diseased lungs using computational fluid dynamics (CFD). The FRI platform provides critical information to help understand drug availability and activity at the site of action in the lungs, when complemented by the Local Pulmonary Physiological Pharmacokinetic (PBPK) Models Platform from Nanopharm and its in vitro data.
This new approach aims to allow pharmaceutical companies to file abbreviated new drug application (ANDA) dossiers without having to perform time-consuming, expensive and often unpredictable clinical studies. Likewise, it can support 505(b)(2) filings, reducing risk and abbreviating clinical studies.
“We are excited to solidify our relationship with Fluidda and its industry-leading FRI technology,” said Jag Shur, vice president, science and technology at Nanopharm. “A company would have to spend several years to reach the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway. »
Having already worked closely together for several years, Nanopharm and Fluidda have gained a better understanding of complex and evolving regulatory requirements. This collaboration deepens the relationship between Fluidda and Nanopharm, benefiting both patients and customers with an uncompromising and holistic approach in developing the scientific rationale to demonstrate bioequivalence using only in vitro and in silico methodologies. The first potential approval of an OIDP using the alternative bioequivalence approach is pending and, once approved, will further validate Nanopharm’s SmartTrack as a go-to solution for alternative bioequivalence studies and should accelerate demand for utility services companies.
With the momentum of the transition to new low Global Warming Potential (GWP) propellants for pMDIs, SmartTrack will also help companies understand and modulate the impact of these new propellants on drug deposition and dissolution in the lungs, giving confidence in the performance of the reformulated product before embarking on the necessary clinical studies.
Dr. Jan de Backer, CEO of Fluidda, said, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data to accurately assess and deliver inhaled drug products. Nanopharm’s unique SmartTrack platform gives us clinically relevant input data without having to go to the clinic, which really adds another level of confidence to the models and provides an integrated perspective.
Guillaume Brouet, Vice President of Analytical, Regulatory and Scientific Affairs at Aptar Pharma, said: “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help our customers reduce risk and accelerate their drug development programs.