Profil™ Institute for Clinical Research, Inc., a company leading the industry in early phase clinical trials for diabetes and obesity, and Rosa & Co. LLC, a drug development advisory firm with expertise in drug-disease modeling and simulation, jointly announced today a strategic alliance to offer Profil Institute customers use of Rosa's modeling technology to simulate disease physiology, drug action, patient variability, and trial outcomes for their early phase clinical development programs.
With this partnership, Profil Institute will use Rosa's pharmacokinetic/pharmacodynamic (PK/PD) and physiologically-based PK/PD (PhysioPD™) modeling and simulation technology as a component of its clinical study designs and data interpretations. Profil Institute, focused on the disease areas of diabetes and obesity, uses specialized clinical research methods, including first-in-patient studies, automated glucose clamp studies, and methods to assess body composition and turnover rates of certain metabolites. Rosa brings extensive experience in modeling diabetes and obesity in support of early-phase preclinical and clinical programs. Rosa's models will be used to simulate drug effects and trial outcomes to further optimize study designs and to derive scientific and clinical insight from the clinical trial data.
"Combining our proven disease-specific expertise with Rosa's highly advanced simulation technology gives our customers immeasurable value through the most meaningful study design, successful study execution and verifiable data interpretation," said Dr. Marcus Hompesch, Profil Institute CEO. "With the addition of Rosa's modeling and simulation technology, we further enhance our scientific leadership and research capabilities, generating unprecedented standards and added value for early phase clinical research programs in diabetes and obesity."
"This partnership combines deep disease area expertise, powerful simulation technology, and unique study capabilities to address the central issue faced by all drug developers – how to separate successful and unsuccessful drugs as early as possible in the development process," said Ron Beaver, Ph.D., CEO and Founder of Rosa. "Together, we can deliver greater scientific insight to Profil Institute's customers regarding the viability of their diabetes or obesity drug candidates."
Obesity crisis in the U.S. expected to worsen by 2050