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Profil Institute for Clinical Research, Inc. and Rosa Announce Strategic Partnership Offering Newest Simulation Technology to Enhance Diabetes and Obesity Clinical Trials


6/8/2011 7:08:16 AM

SAN DIEGO and SAN CARLOS, Calif., June 8, 2011 /PRNewswire/ -- 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."

About Rosa & Co. LLC.

Rosa informs our customer's most critical decisions from preclinical through clinical development with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/pharmacodynamic (PK/PD) models and Rosa's innovative PhysioPD models. With these approaches, Rosa's clients collaborate in model creation and testing, retain the final model, and acquire the ability to use it and understand its implications for their drug development programs. Rosa's staff have close to two decades of unparalleled professional experience in using drug-disease modeling and simulation (M&S) to accelerate drug development; they have covered hundreds of applications with dozens of clients. The Rosa team is unique in their breadth and depth of disease area experience, which includes metabolic and cardiovascular diseases, oncology, gastro-intestinal disease, inflammatory diseases, immune dysfunction (including rheumatoid arthritis), pain, skin conditions, respiratory disorders, and antibacterials/antivirals. For more information, visit www.rosaandco.com. Rosa and the Rosa logo are registered trademarks of Rosa & Co. LLC.

About Profil Institute for Clinical Research, Inc.

Profil Institute is world-renowned as a Center of Excellence for diabetes and obesity early phase clinical research. The company's advances in early phase drug research and its specific focus on diabetes, obesity and cardio-metabolic diseases as it relates to the diabetic patient population have led Profil Institute to be the most highly regarded clinical research institute for early phase diabetes drug trials.

To date, Profil Institute has been involved with almost every clinically promising drug category and device development in diabetes and in more than 140 clinical studies since the company's inception in 2004. Contributing to Profil Institute's success is that the company is recognized as the leader in automated glucose clamps, considered the "Gold Standard" for the evaluation of anti-diabetic drugs and devices. The company's key scientists hail from academic centers including the WHO Collaborating Center of Diabetes at the Heinrich-Heine University of Düsseldorf, Columbia University, University of Michigan and Harvard University. For more information visit www.profilinstitute.com.

SOURCE Profil Institute for Clinical Research, Inc.


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