Please see the highlight of our condensational growth technology at the recent Gates Goalkeepers Conference - time point 4:00:22 for a discussion of lung surfactant therapy and our excipient enhanced growth (EEG) video shown at 4:01:25
As highlighted at the recent RDD 2024 conference, use of CFD modeling as an Alternative Bioequivalence Approach is now included in US FDA guidance to industry for multiple inhalation products. Projects from the AIM Lab in collaboration with the Hindle Research Group over a 15 year time span have significantly contributed to this milestone - a sample US FDA guidance document attached above.
Also highlighted at the recent RDD 2024 conference, use of In vitro airway models (such as the VCU mouth-throat series) as an Alternative Bioequivalence Approach is now included in US FDA guidance to industry for many inhalation products. Projects from the AIM Lab in collaboration with the Hindle Research Group and VCU Pharmaceutics Aerosol Research Group (ARG) over a 15 year time span have significantly contributed to this milestone - a sample US FDA guidance document attached above.
Great session on aerosol surfactant therapy hosted by RDD 2024. Rob DiBlasi (pictured) provided an overview presentation followed by Aerogen Pharma (Jim Fink and Andy Clark) presented progress with a liquid-based approach; VCU (Worth Longest and Michael Hindle) then presented progress with a dry powder approach. The combined AIM Lab and Hindle Research Group made seven presentations on various topics at the meeting.
Part I: We describe the development and testing that were required to create a new dry powder aerosol synthetic lung surfactant product (strategy, formulation and device) with the potential for a high-efficacy response in subsequent preclinical model testing (Part II)
Part II: We report the efficacy of the new aerosol surfactant product in a preclinical model of neonatal RDS including improved efficacy at 1/10 the dose compared with the current clinical standard of liquid bolus instillation.
Thanks to advances in 3D printing technology, stainless steel versions of the VCU mouth-throat models (in small, medium and large) are now available for testing the lung delivery efficiency of pharmaceutical aerosol products. These models are in addition to the 3D printed polymer versions that have been available for several years through our commercial partner, RDD Online. Use of these models is now recommended in draft guidance to industry by the US FDA as a way to minimize human subject and animal model testing in the approval of pharmaceutical aerosol products.
Based on recent success with our low-resource dry powder aerosol lung surfactant therapy, we are currently screening manufacturers with the ability to scale-up and produce cGMP compliant versions of the device and formulation. First-in-human testing is within sight!
Thanks to AIM Lab PhD student Laura Vargas for helping to showcase some components of the AIM Lab for a VCU College of Engineering highlight video.
I'm very pleased to share our latest progress on developing a neonatal dry powder aerosol synthetic lung surfactant (SLS) therapy for infants with respiratory distress syndrome (RDS). Results in the preclinical model demonstrated that compared with the current clinical standard of liquid bolus instillation, the surfactant aerosol was significantly more effective, provided an almost instantaneous response and could be delivered at 1/10 the dose of the liquid, using a much simpler process. These results highlight the importance of targeted dose delivery within the lungs, and what can be accomplished when aerosol therapies are efficiently delivered to the intended targets within the airways. This work was a true team effort among the Hindle Research Group, DiBlasi Lab and AIM Lab. Congratulations to all co-authors!
VCU News recently published this article on our dry powder aerosol synthetic lung surfactant (SLS) therapy for treating neonatal RDS. The article highlights the collaborative work of the Longest and Hindle Labs, over 15 years, to develop a next-generation inhalation product consisting of an aerosol targeting strategy, formulation and delivery system. I greatly value our collaboration and very much look forward to seeing this product progress to human subjects and saving lives!
Mike Hindle recently presented the keynote address a the RDD Europe 2025 conference, titled: "It's All About Delivery: Pre-clinical Development of a Surfactant Powder Aerosol Product". This was an additional honor given that it was the 20th anniversary of the conference series. Dr. Hindle gave a fantastic presentation that highlighted the challenges of delivering therapeutic aerosols to infants and the high-efficacy response that can be achieved when targeted dose delivery is done well. As Dr. Hindle highlighted in his title: It's all about delivery!
We were thrilled to see our dry powder aerosol SLS product featured in this video from our sponsors, the Gates Foundation. This is a very proud moment for all of the Longest (AIM) Lab, Hindle Lab, and DiBlasi Lab Team members who have worked tirelessly to make this technology a reality.
Gates Notes recently published an article highlighting the critical need for improved treatment options to address neonatal respiratory distress syndrome. Exogeneous surfactant therapy, which currently requires intubation and liquid bolus instillation, simply is not available in many low and middle income countries, which contributes to high infant mortality rates. The article then features our dry power aerosol surfactant product as a solution, including a demonstration video by Bill Gates! This is a very proud moment for all of the Longest (AIM), Hindle, and DiBlasi Lab members who have worked tirelessly to make this technology a reality.
Congratulations to the AIM Lab's own Casey Grey on receiving a VCU Commercialization Award and his progress with novel treatments for neurological diseases and disorders! Keep bubbling with brainpower Casey!
The Aerosols in Medicine (AIM) Lab had an excellent showing at the 2025 International Society for Aerosols in Medicine (ISAM) conference last week. We presented on topics including aerosol device technology, new spray dryer designs, a new intranasal aerosol targeting platform and complete-airway CFD modeling. Overall, the AIM Lab contributed 5 posters and 3 platform presentations and we were affiliated with a total 10 posters and 6 platform presentations. Thanks to all of the hard work from team members and collaborators that made this possible. It was an excellent conference!
Prof. Longest presented a talk titled "Computational Fluid Dynamic Modeling and Intranasal Delivery of Aerosolized Vaccines" during the Intranasal Delivery of Aerosolized Vaccines session at the ISAM 2025 conference. In the first part of the talk he discussed lessons learned from 20 years of experience with intranasal aerosol delivery. He then described how the AIM Lab has translated this knowledge to a new platform for the delivery of dry powder intranasal vaccines and other nasally targeted aerosol therapies. A summary video of the new multiple cycle oscillating jet (MC-OJ) dry powder device is shown above. Thanks to Arun Varghese Kolanjiyil and Rabijit Dutta for the supporting CFD and Dale Farkas, Ghali Aladwani, Mohammad Momin and Michael Hindle for the device, formulation and translational work.