KineMed, Inc. and Roche have entered a collaboration to jointly validate KineMed's translational KineMarker technology, which measures the on-mechanism activity of compounds in animals and humans. This technology helps to accelerate the translation of promising therapeutic agents into advanced clinical studies. The two companies will clinically validate its proprietary KineMarker of collagen synthesis, a therapeutic target underlying tissue fibrosis, in an undisclosed disease area.
David Fineman, president and chief executive officer of KineMed, commented, "Fibrosis is a critical process underlying important diseases affecting major organ systems, including the lungs, kidneys and liver. The research collaboration with Roche will help to establish our approach as a possible surrogate for an important indication and as a means for monitoring on-mechanism activity of drug candidates in ensuing clinical studies."
"As part of our commitment to develop innovative therapies for inflammatory and autoimmune disorders, we are intensifying our focus on developing novel biomarker modalities to better monitor disease processes and the effect of our therapies on pathways driving these outcomes," commented Anthony Manning, Ph.D., vice president and global head of inflammation, autoimmunity and transplantation research at Roche Palo Alto LLC in CA.
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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