SAN DIEGO, June 17, 2010 – Profil™ Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced today the appointment of Prof. Dr. Lutz Heinemann as Director of Scientific Services and Robert J. Schott, MD, MPH, FACC as Director of Cardiometabolic Research. Prof. Dr. Heinemann will oversee the scientific aspects of Profil’s integrated approach from clinical trial protocol design to the publication of study results. Dr. Schott will oversee the design and execution of cardiometabolic and cardiac safety studies for the company’s biopharmaceutical clients.
“We couldn’t be more pleased to have Drs. Heinemann and Schott join the Profil scientific management team where they will have a direct impact on finding better treatments for diabetes and obesity,” said Dr. Marcus Hompesch, Profil President and CEO.
“In performing diabetes research, there are few others that can compare to the expertise and experience of Dr. Heinemann,” continued Dr. Hompesch. “Dr. Heinemann has been involved with many key diabetes drug developments and pioneered development of the automated glucose clamp technique, a method that has changed the way we do clinical research.”
“We are equally delighted to have Dr. Schott join Profil’s scientific team,” continued Dr. Hompesch. “He is an expert in the field of cardiology and a perfect fit for our expanding cardiometabolic studies as it relates to anti-diabetic and anti-obesity drug safety and efficacy. Dr. Schott will play a critical role in Profil’s growth as a leader in diabetes and obesity clinical research.“
The inclusion of cardiometabolic capabilities is becoming increasingly important for diabetes and obesity drug studies. The FDA recently provided guidance that an anti-diabetic clinical trial to treat type 2 diabetes should include evidence that the drug candidate will not increase the risk of cardiovascular disease.
Before joining Profil, Dr. Schott was Chairman of the Cardiology Department at Deborah Heart and Lung Center in Browns Mills, NJ. Prior to that, he was Chief of the Cardiovascular Disease Section at Sutter Medical Center in Sacramento, CA, and before that was Associate Medical Director of the Lipid Institute Medical Clinic, associated with Berkeley Heart Labs. Dr. Schott has also participated in the Speaker’s Bureau for Pfizer, Merck, Abbot and GlaxoSmithKline. A graduate of the University of Michigan Medical School, he was subsequently a Burgher fellow in cardiology at Harvard Medical School and conducted post-doctoral research in cardiac molecular biology at Children’s Hospital in Boston. Prof. Dr. Heinemann has acted as scientific advisor for Profil in San Diego since the company’s inception in 2004. He is also co-founder of Profil Institute for Metabolic Research in Neuss, Germany and led the company as CEO for 10 years until 2009. Prior to that, Prof. Dr. Heinemann spent 17 years performing diabetes-related clinical and experimental research at the Department of Metabolic Diseases and Nutrition, a World Health Organization Collaborating Center of Diabetes, at Heinrich-Heine University of Düsseldorf in Germany. Prof. Dr. Heinemann has published more than 180 scientific papers and is author of the book “Time-Action Profiles of Insulin Preparations.” He is the recipient of the award “Leadership in Diabetes Technology” from the Diabetes Technology Society in 2007 and is a member of the editorial board of a number of diabetes-related publications. Prof. Dr. Heinemann’s position at Profil will allow sufficient time for him to also continue his role in coordinating an EU-supported consortium aiming to create AP@home, an artificial pancreas (AP) that would allow automated glucose control under daily life conditions for people with insulin treated diabetes.
About Profil™ Institute for Clinical Research, Inc.
Profil is a privately held institute providing high quality early phase clinical research services in diabetes and obesity. Profil uses its expertise to guide the developmental planning, design and actual performance of early phase clinical studies that help in the determination of whether a new compound should be carried forward into the later phases of clinical development. In order to make reliable and solid development decisions based on the most accurate data, Profil utilizes specific research methods, including the automated glucose clamp procedure, which is accepted as the gold standard for pharmacodynamic data. 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.profil-research.com
