Prof. Dr. Konrad Heintze is a specialist in pharmacology and toxicology. His career spans 12 years as professor at the medical faculty of the RWTH Aachen, 10 years in leading positions at the research departments of Byk Gulden (now Takeda) and Grünenthal. Later on he was head of the gastro-liver group at the German regulatory agency, BfArM, where he was responsible for centralised European applications and co-rapporteur in a number of cases. He has been working as an independent consultant since 1994.

 

Prof. Dr. med. Karl-Uwe Petersen is a physician specialized in pharmacology and toxicology. He has worked for 16 years at the medical faculty of the RWTH Aachen, where he is still teaching. After 7 years of consulting with pharmaceutical companies, he accepted a position with PAION Deutschland GMBH, Aachen, where he was active for 15 years until retiring in early 2016 as Vice President Preclinical Development. Major points of his expertise include all phases of drug development, toxicology, impurity qualification, and patent litigation. He is author/coauthor/editor of more than 170 scientific articles, book chapters and books and of more than 80 scientific abstracts.

 

Prof. Dr. Werner Winter is professor emeritus of organic chemistry at the University of Tübingen, Germany. He spent more than 12 years with Grünenthal and is a specialist for statistical data analyses and process control. He works as an expert for pharmaceutical quality for two German regulatory agencies (Federal Institute for Drugs and Medical devices, BfArM, and Federal Office of Consumer Protection and Food Safety, BVL) and has been involved in training courses for chemists and pharmacists on multivariate data analyses and design of experiments (DOE). His experience covers data mining, in-silico toxicity predictions and Environmental Risk Assessment of pharmaceuticals as well.

 

Dr. Helmut Buschmann gained over 17 years of international experience in drug discovery research and drug development with particular strengths in identifying, evaluating and integrating pre-clinical projects and transfer to clinical phase. He led or co-authored more than 90 publications in major scientific journals, published three books as author and editor and holds numerous patents. As a chemist he started his industrial career in 1992 at Grünenthal before joining Esteve (Barcelona) as Research Director in 2002, where he was responsible for chemistry, pharmacology, toxicology, pharmacokinetic and intellectual property departments. Since 2009 he works with Pharma Consulting Aachen.

 

Dr. Dr. Winfried Fuchs is a chemist and physician. After a short period in a hospital he worked in various positions at the research departments of Byk Gulden and Grünenthal. Thereafter he was head of clinical research at Takeda Pharma for more than 25 years. He has broad experience in all phases of drug development, especially in diabetes, hypertension, CHF, gastro-intestinal diseases, cancer, psychiatrics, and other indications. He also worked in the assessment of new drugs, new therapeutic principles and licences. Since 2013 he is working as an independent consultant.

 

Dr. Maren Kops, née Trost, is a biotechnologist and specialised in molecular biology and virology during doctoral thesis (University of Freiburg, Germany) and postdoctoral research at Harvard Medical School, USA. She is additionally experienced with text processing and literature management. Since 2004 she has been working with Pharma Consulting Aachen.

 

Dr. Theo Matthiesen is a veterinary pathologist and during his 30 year career in the pharmaceutical industry he specialised in experimental pathology and toxicology. During more than 15 years he was responsible for the entire package of preclinical-toxicological investigations during early research and development of pharmaceutical drug substances and drug products, including submissions to international regulatory authorities. In 2004 he joint Pharma Consulting Aachen.

 

Dr. Eve C. A. Morgenstern is a biologist experienced in research on various chemical entities, herbal extracts and other natural products for miscellaneous medicines, nutrition supplements and medical devices. As a professional pharmacologist (biologist in medicine) she worked successfully for more than 20 years in leading positions in several fields of pharmacological and toxicological research, quality assurance and regulatory affairs at the Institute for Pharmacological Research and the CRO Biopharm GmbH Berlin, later on at Nutri Pharma A/S, Copenhagen. Using her long international experience in interdisciplinary project management she is now providing advice and support in drug development and approval as an independent consultant.

 

Dr. Joachim Ossig is a chemist by training, originally specialized in gas chromatographic enantiomer separation during his doctoral thesis (University of Tübingen). After starting his career in the area of bioanalytics in a CRO, he worked for 23 years as pharmacokineticist in different positions at Grünenthal GmbH, Aachen. Since 2013 he is leading the pharmacokinetics and pharmacometrics department of AiCuris Anti-infective Cures GmbH in Wuppertal. In 2006 he started in parallel consulting activities in collaboration with his long-time mentor Dr. Wolfgang Lintz, who handed his role in Pharma Consulting Aachen over to him in 2013.