Curriculum Vitae - Dr. med. Arne Erdmann Date of Birth: 30.04.1964 in Leverkusen Address: D – 82211 Herrsching am Ammersee Mobile: +49 / (0)151 / 2405 4605 E-Mail: Arne.Erdmann@Klinfor.de Employment history: 11.04.2022 - 31.07.2022 Fresenius-Kabi, Switzerland 01.04.2021 – 30.11.2021 Immunic, Gräfelfing Medical review and co-ordination of finalization of a CSR in COVID-19 Initiation of building up the pharmacovigilance department 01.04.2020 – 31.12.2020 Morphosys, Planegg Medical review of studies in diffuse large b-cell lymphoma 01.07.2019 – 31.12.2019 Novartis, Basel Medical Review for a Phase II study in transplantation 01.01.2019 – 31.08.2019 Abbott,Hannover ● Medical Safety Expert (part-time freelance position) Signal detection and Safety report writing for various drugs 01.08.2018 – 31.10.2021 Bayer, Berlin ● Medical Reviewer (part-time freelance position with variable FTE) Medical review of study data in ophthamology 10.07.2012 – 31.12.2018 Novartis, Basel Medical Reviewer (fulltime freelance position) Medical review of 5+ international studies in transplantation 15.06.2009 – 18.05.2012 Astellas Pharma GmbH, München Medical Advisor (in-house fulltime freelance position) Management of international studies for Germany, Austria and Switzerland, budget responsibility and line manager for the involved study team. Benign prostate hyperplasia, Phase III Prostate cancer, Phase III Invasive fungal infection prophylaxis in high risk patients receiving liver transplantation, Phase III Pre-emptive invasive fungal infection therapy in high risk patients with peritonitis after abdominal surgery, Phase II Clostridium difficile infection treatment in high risk immunocompromised patients, Phase III 01.10.2006 – 30.06.2009 Pharm-Olam International, München Project Manager 01.10.2006 – 30.09.2008 Project Management including budget responsibility and line management for national and international studies, phase I and III, attending and presenting at investigator and bid defence meetings. Lupus erythematosus, Phase III Cat allergy, Phase I Pneumonia, Phase III Medical Monitor 01.10.2008 – 30.06.2009 Responsible for Medical Monitoring and Drug Safety of international studies phase II – III NSCLC, Phase II Rheumatoid arthritis, Phase II Acromegaly, Phase III 01.07.2004 – 30.09.2006 UCB GmbH, Kerpen Medical Scientific Advisor Responsible for 12 investigator initiated studies conducted in Germany, regular contact to opinion leaders- indication was epilepsy, also giving scientific advice to investigators 03.02.2003 – 30.06.2004 MDS Pharma Services, Langenfeld Project Manager Project Management of international studies phase III Onychomycosis, Phase III Hand dermatitis, Phase III CRA Monitoring of national and international studies phase II and IV CABG, Phase IV Prostate cancer, Phase II Renal failure, Phase IV 01.04.2002 – 30.04.2002 Viscum AG, Bergisch Gladbach Medical Advisor Protocol development for a phase I study 01.07.1996 – 31.03.2002Omnicare Clinical Research, Cologne Medical Writer 01.07.1996 – 31.12.1996 Writing of 6 integrated study reports, 1 CRF and 1 Protocol CRA Monitoring of clinical studies phase II and IV, initiation and recruiting phase, maintenance of regulatory files, SAE reporting, attendance of investigator meetings Erythropoesis, Phase IV Hypertension, Phase II Ovarian cancer, Phase II NSCLC, Phase II Project Manager 01.01.1997 – 31.07.1999 Project Management of national and international studies phase III:Effectively manage of all aspects of assigned clinical trials according to the specificities of the sponsor’s contract; Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting; Regularly meet and liaise with sponsor to ensure study conduct and completion are progressing according to sponsor needs and established study timelines; Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer Atrial fibrillation, Phase III Artherosclerosis, Phase III Safety Officer 01.08.1999 – 31.03.2002 Responsible for the Drug Safety of 6 studies phase II – III Resident: 01/1996 – 06/1996 Rheinische Landes – und Hochschulklinik Düsseldorf (Psychiatry) 10/1994 – 09/1995 Private practice Dr. Storch, Düren (Nuclear medicine) 04/1984 – 02/1985 Mobile social service, „Arbeiterwohlfahrt“, Cologne 11/1983 – 03/1984 Home for the aged in Leverkusen Therapeutic Experience: Cardiovascular Gastroenterology Gynaecology Immunology Infectious diseases Musculoskeletal Nephrology Neurology Oncology Psychiatry Transplantation COVID 19 Dissertation: 1992 – 1998 University of Cologne, title: „Laserangioplasty of Peripheral Arteries“ (experimental work, “cum laude”) 1985 – 1992 Human medicine (MD) University of Cologne Graduation: License to practice medicine 1970 – 1974 Primary school in Leverkusen 1974 – 1983 Secondary school in Leverkusen Graduation: University-entrance diploma Languages: German – Mother tongue English – Business Fluent French – Good Knowledge Spanish – Good knowledge Memberships: Ärztekammer Bayern (Chamber of physicians) Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharMed) Study Details Form: (e.g. CRA, CPM etc.) Indication No. of patients No. of sites Countries involved Services involved (e.g. full service or just clinical) Stages of study involved (e.g. set up to end, just close-out etc.) Medical Writer Rejection prophylaxis 80 10 Germany Integrated clinical study report NA Medical Writer Burn 10 1 Germany Integrated clinical study report NA Medical Writer Helicobacter pylori infection 300 40 Germany CRF-Design NA Medical Writer Infertility 400 50 Germany Integrated clinical study report NA Medical writer Arthrosis 80 12 Germany Protocol development NA Medical writer Allergic rhinitis 70 8 Germany Integrated clinical study report NA Medical writer Allergic conjunctivitis 70 8 Germany Integrated clinical study report NA Medical writer Morbus Wegener 90 12 Germany Integrated clinical study report NA CPM/CRA Atrial fibrillation 1200 60 Germany, Czech republic Full service Set-up to recruiting CRA Erythropoesis 120 6 Germany Full service Set-up to recruiting CRA Hypertension 110 7 Germany Full service Set-up to recruiting CRA Ovarian cancer 100 5 Germany Full service Set-up to recruiting CRA NSCLC 100 8 Germany Full service Set-up to recruiting CPM Artherosclerosis 500 35 Germany Full service Set-up to recruiting Safety Officer Pneumonia 400 60 Germany Full service Set-up to end Safety Officer Schizophrenia 120 20 Germany Full service Set-up to end Safety Officer Torticollis 240 26 Germany Full service Set-up to recruiting Safety Officer Blepharopspasm 240 28 Germany Full service Set-up to recruiting Safety Officer COPD 220 23 Germany Full service Set-up to recruiting Safety Officer Small cell lung cancer 90 7 Germany Full service Set-up to end CRA CABG 110 8 Germany Full service Recruiting CRA Prostate cancer 85 7 Germany Full service Recruiting CRA Renal failure 240 12 Germany, Austria, Switzerland Full service Recruiting CPM Onychomycosis 220 11 Germany, France Full service Set-up to recruiting CPM Hand dermatitis 260 14 Germany, Switzerland Full service Set-up Medical scientific advisor Epilepsy 500 12 Germany Full service Set-up to end CPM Lupus erythematosus 260 20 Germany, Austria, Switzerland, USA, Georgia, Russia, Ukraine, Poland Full service Set-up CPM Cat allergy 88 1 Germany Full service Set-up to end Medical monitor NSCLC 120 50 Canada, Georgia, India, Poland, Romania, Russia, Serbia, New Zealand, Australia Full service Set-up to recruiting Medical monitor Rheumatoid arthritis 120 30 Canada, Georgia, India, Poland, Romania, Russia, Serbia Full service Set-up to recruiting Medical monitor Acromegaly 140 50 Germany, Czech Republic, Poland, Hungary, Russia, USA Full service Set-up to recruiting CPM / Lead CRA Pneumonia 610 80 Spain, France, Estonia, Serbia, Georgia, South Africa, Slovakia, Hungary Full service Recruiting to end Medical Advisor Benign prostate hyperplasia 1500 20 Germany Set-up Set-up Medical Advisor Prostate Cancer 250 6 Germany, Austria, Switzerland Set-up Set-up Medical Advisor Invasive fungal infection of liver transplant patients 300 (90 in Germany) 6 Germany, Austria, Switzerland Set-up to end Set-up to end Medical Advisor Pre-emptive antifungal treatment in patients with peritonitis after surgery 360 (60 in Germany) 5 Germany, Austria, Switzerland Set-up to end Set-up to end Medical advisor Clostridium difficile infection in high risk immunocompromised patients 650 (150 planned for Germany) 6 Germany Feasibility Medical reviewer Transplantation (5 studies) 1500 50 International Medical review |