Skin Tissue

The power of dOFM lies in its membrane-free, open-structure probe design, which provides direct access to the dermal interstitial fluid without any filtering and clogging issues that limit membrane-based sampling approaches. dOFM hence enables unrestricted sampling regardless of substance size, lipophilicity, or protein-binding properties. This means researchers can capture complete biochemical information of molecules and biological matters of all sizes, from small molecules, large therapeutic to whole immune competence cells.

dOFM technology supports comprehensive drug development across all stages, from early candidate screening to clinical studies. The same study setup can be applied both ex-vivo and in-vivo, ensuring that preclinical data maintains direct relevance for subsequent clinical development phases. Clinical trials conducted using dOFM follow ICH-GCP standards and can monitor local pharmacokinetic (PK) and pharmacodynamic (PD) effects directly in the dermis in repeated sessions up to 72 hours each, hence providing unprecedented temporal resolution of drug behavior in living tissue.

The modular setup of dOFM offers substantial practical advantages through its efficient study design. Multiple probes can be used on various locations on the body (e.g., thighs, arms), generating large volumes of reliable data while requiring only a small number of study participants. This efficiency translates directly into reduced costs and quicker development cycles. Furthermore, dOFM enables investigation of both intended therapeutic effects and potential side effects directly at the tissue level, with resulting data minimally affected by other metabolic processes in the body—a significant advantage over standard blood sampling approaches and biopsies.

The minimally invasive nature of dOFM has allowed direct assessment of therapeutic effects for first- or best-in-class therapeutic antibodies such as secukinumab and dupilumab, by measuring inflammatory biomarkers in both healthy and diseased skins of psoriasis and atopic dermatitis patients. This capability represents a paradigm shift in translational research for dermatological conditions and their therapeutic options.

Last but not least, dOFM offers a particularly valuable solution for complex generic drug development. In collaboration with the U.S. Food and Drug Administration, we are in the process of establishing dOFM as a pharmacokinetics-based bioequivalence approach for topical drug products, providing an alternative to expensive and uncertain clinical endpoint studies.