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

P.SS.T Pharma Scientific Services TeamCROKeywords: Pharmacovigiliance, Regulatory Affairs, Drug Development,Devices, Nutraceuticals, AntibioticsP.SS.T is a small international consultancy and service provider for pharmaceuticaland related industries. We accompany your drug / medical devicedevelopment projects with advise and services in:regulatory affairs (from Clinical trials to Marketing authorisation filings,strategies+services including e.g. eCTD, User testing for PILs) drug dev.project management organisation+services, quality management clinicaldev. (incl. scientific writing, protocol development, EUDRACT filings, IMPD etc.)general services and consultancy training and information provisionP.SS.T’s range includes scientific services for all sections of pharmaceutical,medical and healthcare industry. For support in other countries we establishedpartnerships with local CROs and consultant.Contact:Dr. Axel F. WenzelKreillerstr. 65D-81673 MünchenPhone: +49 (0) 89 922003-0Fax: +49 (0) 89 922003-90E-Mail: office@p-ss-t.deInternet: www.p-ss-t.dePAKTIS Antibody Service GmbHBIOTECH DNA/PROTEIN ANALYTICSKeywords: Transgenic Animals, Xenotransplantation, Antibody ProductionService, Drug Development, AgrobiotechnologyPaktis is a biotechnological company located in the north of Munich thatproduces and tests bispecific antibodies for the treatment of tumors. Paktisis using a unique production technology based on transgenic cattle to rapidlyprogress its first generation product into early stage clinical trials. In thisrespect Paktis is the only company in Europe with a GMP qualified transgeniclivestock production unit. The company's lead product is a bi-specificantibody directed against tumour specific antigens that will locally and specificallyactivate the immune system of the treated patient. After demonstrationof safety and efficacy in an initial clinical trial, Paktis plans to manufacturesecond generation product using conventional bioreactors and conductphase I/II clinical trials in a number of indications including melanoma andglioblastoma multiforme. Line extension with other tumor based specificantibodies and the same t-cell efficacy will also allow the treatment of otherindications including some advanced metastatic breast cancers and prostatecancers. The company operates with a lean and efficient managementstructure where a core development team in the company manages sourcedout operations and processes.Contact:Prof. Dr. Gottfried BremLarezhausen 3D-86567 HilgertshausenPhone: +49 (0) 8250 92790 10Fax: +49 (0) 8250 92790 19E-Mail: info@paktis.deInternet: www.paktis.de97