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 28 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 150 publications in major scientific journals, published five books as author and editor and is named as inventor in more than 250 patents. After positions hold at Grünenthal GmbH (Aachen), Laboratorius Dr. Esteve S.A. (Barcelona) and SAVIRA Pharmaceuticals GmbH (Vienna) he is now Head of Chemistry, Pharmaceutical Development and Patents at AiCuris GmbH (Wuppertal). Since 2009 he works with Pharma Consulting Aachen. In 2014, he was awarded with the IUPAC-Richter Price for the discovery of the pain killer Tapentadol, which is marketed word-wide as Palexia® (Europe) and Nucynta® (US and Canada).
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. As a freelancer she has been part of Pharma Consulting Aachen since 2004. Currently, she works as Early Development Manager at Paion Deutschland GmbH but is still associated with Pharma Consulting Aachen. She is well grounded in text processing, and literature management as well as writing of pre-clinical admission documents and publications.
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. Thomas Christoph is a board certified pharmacologist (DGPT) and has a track record in the pharmacology of anti-inflammatory and analgesic drugs. He holds a PhD in Immunology and contributed to the pre-clinical development of classical and innovative analgesics such as lornoxicam (Xefo®), buprenorphine (Norspan®), tramadol (Tramal®), tapentadol (Palexia®), and cebranopadol. Numerous publications and patent applications document his scientific achievements. He has worked in industry for more than 25 years holding various positions at Hafslund Nycomed and Grünenthal. His current interest is in pre-clinical development from discovery to submission and life cycle management. He has a special focus on the translational value proposition of pre-clinical data. Since 2018 he works with Pharma Consulting Aachen.
Dr. Rolf Terlinden is a biochemist by training and during his 35 year career in the pharmaceutical industry he became an experienced pharmacokinetic expert. He successfully contributed to the preclinical and clinical development of a new analgesic until approval in Europe and the US. He helped to prepare and attended a number of regulatory meetings at the FDA and EMA. As an pharmacokinetic expert he provided input to IMPDs and INDs and worked in several assessments of in- and out-licensing opportunities and due diligence processes. Before joining Pharma Consulting Aachen, he served as Head of Pharmacokinetics and deputy head of the GLP facility at Grünenthal GmbH.
Dr. Tamara Pfaff is a German board-certified veterinary pathologist. In the course of her career in the pharmaceutical industry, she specialized in toxicology, gained a Master of Science in applied toxicology, and was recognized as a Eurotox-registered toxicologist. Since more than 15 years she has been responsible for the entire package of preclinical drug safety investigations during early research and development of pharmaceutical drug substances and drug products, including submissions to international regulatory authorities. As an toxicological expert she was involved in regulatory documents (IB, IMPDs, Briefing books for European agencies and FDA), agency meetings as well as in a number of due diligence processes. In 2018 Dr. Pfaff has joined Pharma Consulting Aachen.
Dr. Susanne Thun is a veterinarian and board-certified expert in pharmacology and toxicology and recognised as a Eurotox-registered toxicologist with a strong focus and long-lasting expertise in regulatory toxicology. She looks back to more than 30 years of working experience in toxicology and preclinical drug safety in small and medium sized pharmaceutical/biotech companies, non-clinical contract research organisations and in consultancy. As an expert in nonclinical drug development, she was involved in setting up of the strategies for non-clinical development programs from early research up to submissions to regulatory authorities around the world. She is familiar with the relevant international regulatory guidelines as well as preparation of regulatory documents (IB, IND, IMPD etc.) and took part in agency meetings and preparation of the respective documents.