PROFIL was founded in 1999 by a group of scientists from the Department for Nutrition/Metabolic Diseases at the Heinrich-Heine-University Düsseldorf headed by Prof. M. Berger. PROFIL has developed into a full service contract research institute and currently employs about 200 staff members (including 2 Masters of Drug Regulatory affairs) in its headquarter in Neuss, Germany. Expertise: PROFIL has performed more than 150 early-phase clinical studies investigating new anti-diabetic compounds or medical devices (e.g. glucose monitoring devices) with a variety of sophisticated methods including metabolic balance studies with complete standardisation of nutrients. PROFIL is one of the world's leading sites for glucose clamp studies doing approximately 3,000 glucose clamp experiments per year. PROFIL has established a huge patient database (>10,000 patients with diabetes) for recruiting appropriate candidates for their studies. PROFIL is certified according to ISO 9001:2000 and ISO 13485:2003. Facilities: PROFIL has a large research facility that hosts 12 beds for glucose clamp studies and additional 48 beds for inhouse experiments. The facility is equipped with an emergency power supply, continuous electronic temperature monitoring of freezers and refrigerators, a GMP-licenced pharmacy with clean room facilities and a metabolic kitchen. Within PCDIAB this partner will contribute as work package leader of WP 3 and conduct and coordinate the pilot trials and the larger multicentre trial. In addition PROFIL will participate in WP5 assessing the pharmacodynamic response of glucagon on blood glucose levels. Profil’s FP7 experience includes: AP @home; EU-Clamp
Dr. Tim Heise (CEO Finance & Administration). Clinical education at the Clinic of Metabolic Diseases and Nutrition in Düsseldorf. Involved in glucose clamp studies for the assessment of PK/PD properties of anti-diabetic compounds and of insulin sensitivity since 1988. Principal Investigator of numerous pharmacological studies on antidiabetic compounds. More than 120 publications in international peer-reviewed journals (majority on glucoseclamp studies). Reviewer and editorial board member of several international scientific journals.
Dr. Thomas Jax (Director of Cardiometabolic Research): Clinical training in Internal Medicine and Cardiology at the University of Düsseldorf, Germany, and Texas Heart Institute/ University of Texas, USA. Has been an active researcher in the cardiovascular field for the last 15 years. For the past 5 years scientific focus has been on development of new antidiabetic therapies and new devices for glucose measurements. He is experienced in the design and conduct of studies, having participated in >100 clinical studies. More than 50 publications in peer reviewed journals.