Dermal Open Flow Microperfusion (dOFM)
Revolutionizing dermatological drug development with dOFM
Dermal open flow microperfusion (dOFM) is an innovative, cutting-edge technology from Joanneum Research that allows the capture of unique cutaneous pharmacokinetic data, revolutionizing the way we approach dermatological drug development and dramatically enhancing clinical stage success for our Sponsors.
Increase early-stage success while reducing costs
Unlike traditional methods, dOFM provides time-resolved PK/PD data in preclinical and clinical studies, offering a deeper understanding of drug behavior in a clinical setting. dOFM clinical studies offer statically relevant human data using a small cohort (as little as 8-10 subjects) that may not be possible in standard end-point studies. Furthermore, because dOFM demonstrates intended therapeutic effects very early in drug development, our Sponsors save critical time and resources.
dOFM—An Innovative and Scientific Approach
At AXIS Clinicals, we delve deep into understanding the desired effects and potential side effects of your drug by directly applying a specially formulated drug through the intended route, whether it’s subcutaneous, oral, or topical. We employ dOFM in the dermis to continuously sample dermal interstitial fluid.
Our approach involves the strategic placement of multiple dOFM probes at each application site, enabling a streamlined study design that yields a wealth of reliable data, all while optimizing the use of a relatively small number of study subjects in pharmacokinetic/pharmacodynamic (PK/PD) studies.
AXIS is proud to be the exclusive provider of dOFM technology in clinical
research in North America.
A groundbreaking partnership
AXIS & Joanneum Research
Combining the scientific innovations from Joanneum Research and the comprehensive capability of AXIS Clinicals, we’re excited to establish dOFM as the premier method through which dermatological drug products can progress toward clinical success.
Joanneum Research is a highly successful research institution with a strong international presence. Since the 1960s, Joanneum has consistently delivered innovative research at the highest international standards, thanks to an extensive global network and dedication to excellence.
-
Precise Spatial and Temporal Pharmacokinetic Profiling in Dermal Tissues for up to 36 Hours
dOFM technology provides detailed spatial and temporal pharmacokinetic profiles, allowing you to gain comprehensive insights into how your drug behaves in dermal tissues over an extended period of up to 72 hours.
-
In-Vivo Dose-Response Evaluation Directly in Dermal Tissues
Instead of relying on surrogate parameters in blood, our approach enables direct invivo measurement of dose-response within dermal tissues, providing a more accurate assessment of your drug's impact.
-
Early Demonstration of Therapeutic Effects and Mechanisms of Action
At the very early stages of your drug development process, you can showcase the intended therapeutic effects and mechanisms of action within the dermis.
What the industry is saying about AXIS
Partnering with AXIS has been a transformative experience for us. Their team deeply understands the complexities of pharmacology cardiac safety TQT projects and has been exceptionally responsive and proactive at every stage. What could have been a challenging process was made significantly smoother, with seamless coordination between clinical and bioanalysis under one roof, keeping timelines on track and delivering high-quality data.
AXIS has been our long-time reliable partner for clinical research. Their team understands the challenges of developing 505(b)(2) products and has provided solid support throughout our clinical development program of studies. They’ve helped us stay on track and navigate a complex process with professionalism and quality data. I would recommend them to all of my industry contacts looking for a dependable CRO partner.
AXIS has consistently delivered outstanding support as a Phase 1 site partner. Their ability to recruit and enroll subjects quickly and efficiently has been a key factor in keeping our timelines on track. The team is professional, responsive, and well-organized, ensuring the smooth execution of even the most complex pharmacology studies. We value their expertise and look forward to continued collaboration.
We've worked with AXIS Clinicals USA on several Phase 1 studies, and their ability to quickly enroll subjects has been a huge advantage for us. They’re efficient, easy to work with, and always meet our timelines. Their team handles everything smoothly, which makes our job easier. We’re grateful for their support and look forward to working with them again.
Scroll to see more