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As Vice President of Translational Medicine, Dr. Cooreman is responsiblefor leading the Company's Translational Medicine Department. TranslationalMedicine seeks to define as early as possible the indications for which a newcompound will most likely show therapeutic benefit, based on the knowninteraction of the compound in disease pathways, in addition to confirmationof safety and efficacy of that compound in animal studies. Once likelyindications are determined, a clinical proof-of-concept study is initiatedwith the goal of demonstrating clinical safety, pharmacokinetic properties andtherapeutic efficacy study in a particular disease. The results are used tomake a data-based decision on whether or not to initiate a Phase 3 trial.
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Dr. Rosskamp commented, "In this recently created position, Michael willhelp us translate pre-clinical research findings into meaningful, earlyclinical trials. Translational Medicine is often defined as 'bench-to-bedside'research and represents a paradigm shift of developing new drugs and devices.Rather than progressing a new drug or device from preclinical research throughtraditional Phase 1 to 3 development, we will now focus on a much earlierpatient-oriented research. This will help Ikaria to accelerate ourdecision-making process on promising compounds and indications, which webelieve will increase our success rate once we enter the costly late stagedevelopment phase."
Daniel Tasse, President & CEO of Ikaria, remarked, "Translational Medicineincorporates the use of tools such as biomarkers to better understand acompound's likely safety and efficacy to promote faster drug development. Inaddition, because it estimates a compound's likelihood to succeed in latestage clinical development, it facilitates earlier, more reliable decisions onwhether or not to proceed with development, thus freeing up R&D resources topursue more promising pathways. We believe that the establishment of aTranslational Medicine department is a significant step towards expanding ourcapabilities in the development of therapies for critically ill patients andlook forward to seeing Michael's work in this important and growing area ofclinical trial design."
Dr. Cooreman most recently served as a Senior Translational MedicineExpert, Autoimmune Diseases and Transplantation, Exploratory ClinicalDevelopment at Novartis. Prior to joining Novartis in 2003, Michael spentalmost ten years in academic medicine, with appointments including AssociateProfessor of Medicine and Staff Gastroenterologist at the University ofAmsterdam in The Netherlands and as Visiting Scientist at Mt. Sinai School ofMedicine, Department of Liver Diseases, in New York City. Earlier in hiscareer, he spent two years as Head of Clinical Research and Development,Gastroenterology and Oncology at Janssen Pharmaceuticals in Germany. Michaelreceived certification in Germany in Internal Medicine, Gastroenterology andHepatology, earned an M.D. at the University of Leuven Medical School,Belgium, and a doctorate at the University of Dusseldorf, Germany.
About Ikaria Holdings, Inc.
Ikaria Holdings, Inc. is a fully integrated biotherapeutics companyfocused on the development and commercialization of innovative pharmaceuticaland biological products and drug/device combinations for the critically ill inthe hospital and ICU setting. The company's product, INOmax(R) (nitric oxide)for inhalation, is an FDA-approved drug for the treatment of hypoxicrespiratory failure in term and near-term newborns. The drug also is approvedby regulatory authorities and used in Canada, Europe,
