Bavarian Biotech Report 2011/2012 (7MB) - Bio M

Apceth GmbH & Co. KGBIOTECH THERAPEUTICS & DIAGNOSTICSContact:Dr. med. Christine GüntherProf. Dr. Ralf HussMax-Lebsche-Platz 30D-81377 MünchenPhone: +49 (0) 89 7009608-0Fax: +49 (0) 89 7009608-79E-Mail: c.guenther@apceth.comE-Mail: r.huss@apceth.comInternet: www.apceth.comKeywords: Gene Transfer, Cell Therapy, Gene Therapy, CardiovascularDiseases, Oncology, Tissue Engineering / Cell CultureApceth is a biopharmaceutical company focused on the development andclinical application of pioneering cell and gene therapies for the treatmentof malignant and non-malignant diseases. Apceth combines the principlesof (stem) cell biology with ground-breaking technologies and the higheststandards for GMP manufacturing and quality control according to nationaland international regulations. These standards are applied in equal measureto apceth’s own as well as contract GMP-manufacturing of cell-based products.The company’s state-of-the-art GMP/BSL2 facilities comprise 600 m 2of cleanroom area (ISO8, ISO7, ISO5), quality control and R&D units, andpossess manufacturing license for somatic cell therapeutics (AMG §13, §20b).Apceth’s first clinical trial phase I/II is in progress.APEX GmbHCROContact:Dr. med. Gertraud Haug-PihaleLandsberger Str. 476D-81241 MünchenPhone: +49 (0) 89 896016-0Fax: +49 (0) 89 896016-33E-Mail: apexpkpd@aol.comInternet: www.apex-research.comKeywords: Pharmacology, Drug Development, Clinical Research,Pharmacokinetics, Diabetics, Hepatology, NephrologyOur Concept... APEX is a highly efficient combination of investigator andCRO. Our aim is to provide our clients with a service which combines theaccess to patients of an investigator with the expertise to perform acomplex, high quality research project of a CRO. We combine high levelphase 1 data quality with the typical phase 2/3 study population.Our Service... Is the clinical performance of pharmacokinetic and proof-ofconcept/ PKPD studies.Our Study Population... are patients with impaired renal or hepatic functionand patients with other chronic stabile diseases (diabetes, hypertension,asthma etc.). Since the patients come into our clinic, rather than us having togo to them via their GP‘s, the data we generate are more complete andaccurate, fewer patients are required and the project can be completed faster.Our Clients... are international pharmaceutical companies from mediumsized to members of the world‘s top ten.38