Pharmahungary Group

Innovative preclinical & clinical pharmacology contract research: from in vitro to in vivo efficacy and proof-of-concept studies in cardiovascular and metabolic diseases.

Mission of Pharmahungary

• providing wide range of innovative and cost-effective preclinical pharmacology R&D services focusing on cardiovascular (infarction, heart failure, stroke, sepsis, arrhythmias, etc) and metabolic diseases (diabetes, dyslipidemia, atherosclerosis, obesity, uremia, etc) with strong scientific support
• clinical R&D services focusing on special clinical studies including medical device that need sensitive patient population and thereby strong regulatory & scientific support
• to manage internal R&D projects to develop new technologies for outlicensing in the fileds of diagnosis and therapy of cardiovascular and metabolic diseases

Technology platform for preclinical R&D is under continuous development

Cardiovascular Platform:

• Custom designed, combined disease models: e.g. myocardial infarction and stroke with risk factors and co-morbidities such as hyperlipidemia and diabetes
• Cardiac myocyte assays, including stem-cell based assays
• Ex vivo isolated heart perfusion systems for myocardial infarction, ischemia/reperfusion, arrhythmias, heat-shock
• In vivo animal model systems for infarction, heart failure, arrhythmias, and cardioprotection, large animal models available for proof-of-concept studies
• In vivo models for systemic inflammatory response syndrome (e.g. septic shock)
• In vivo cardiac gene and stem cell therapy for proof-of-concept studies and target validation
• All models are provided by a wide range of biochemical, bio-analytical, and genomic assays, e.g. assessment of oxidative and nitrosative stress, cell signaling, gene and miRNA expression)

Metabolic (diabetes, hyperlipidemia/atherosclerosis, obesity)

Platform:

• In vivo diabetes models (toxin-induced, neonatal STZ, Goto-Kakizaki rats)
• In vivo metabolic disease models (diet and genetic models, e.g. Zucker Fatty, ZDF, db/db mice)
• In vivo hyperlipidemia/atherosclerosis models (hyperlipidemic diet, genetic models)
• In vivo diet-induced and genetic obesity models
• All models include glucose, glucose-clamp, on-line OGT-test, insulin and related hormone assays, pancreatic insulin, serum and tissue lipid analysis, atherosclerotic plaque, inflammatory markers and risk factor assays
  
  

Why Pharmahungary?

• Full service: creative, cost-effective, flexible, high quality
• Internationally trained management & staff (MDs, PhDs, clinical pharmacologists, PharmDs, chemists, biologists, medical engineers, MBA quality managers)
• Complex platforms of cardiovascular and metabolic disease models,
• Custom design models with co-morbidities, including large animals
• Strong biochemical and molecular biological background for complex proof-of-concept studies
• Scientific support based on international scientific excellence

(publications over 100, impact factors over 400, citations over 3000)

• Strict confidentiality, IP rights under regulations of the European Union

Major in-house R&D projects

• Biglycan^TM project (www.biglycan.com): development of biglycan therapy for atherosclerosis and ischemic heart disease (IP protected, primary filing Jan 2007; J Proteome Res, 6:854-861, 2007; J Mol Cell Cardiol 48:649-652, 2010)
• MMPharma^TM project (www.mmpharma.com): development of selective inhibitors of matrix metalloproteinases, small molecules (IP protected, primary filing Nov 2010; J Pharm Exp Ther, 316:154-161, 2006; Drugs 70:949-964, 2010)
• Nitroscience™ project (www.nitroscience.com): development of peroxynitrite inactivators for acute ischemic heart disease (Br J Pharmacol, 148:1-3, 2006)
• Infarct size limitation and cardioprotection in the presence of risk factors (Pharmacol Rev, 59:418-458, 2007; Cardiovasc Res, 87:406-423, 2010)
• miRNAtarget™ project (www.mirnatarget.com): identification of cytoprotective miRNA-s (IP protected, primary filing Apr, 2011)
• Cardistem™ project (www.cardistem.com): development of stem-cell derived cardiomyocyte assays for drug screening

Clinical R&D, regulatory and marketing solutions

• focusing on special clinical studies that need sensitive patient population and strong regulatory & scientific support.
• Qualified and experienced investigators and centers

Consulting and managing clinical trials (drugs, medical device, drug-device combination, phases I, II, III, IV), in Hungary and CEE):

• Preparation of Investigator’s Brochures, Study Protocols, CRFs, Patient Information Sheets and Informed Consent Forms
• Regulatory, ethics committee submission
• Full service including feasibility studies, monitoring and project management from start-up to closure
• Investigational site training for audits

Regulatory and marketing (medicinal products, medical devices):

• Preparation of preclinical and clinical dossiers for product registration
• Preparation of PIL and SmPC, readability testing
• Marketing via medical representatives: focusing on niche products that need scientific support and exclusive marketing

Pharmahungary Group

Prof. Péter Ferdinandy, MD, PhD, MBA

CEO, Professor of biochemistry & clinical pharmacology

Postal address: Hajnoczy u. 6.,Szeged H-6722, Hungary, European Union

e-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

www.pharmahungary.com