Monika Chabicovsky is the founder and managing director of MC Toxicology Consulting. She trained in experimental cancer research and toxicology at the Medical University of Vienna and the University of Innsbruck, and in regulatory affairs at the University of Cardiff. She is a EUROTOX registered toxicologist. In 2006, she founded MC Toxicology Consulting, with its initial core business focused on non-clinical drug development and regulatory affairs. Monika’s expertise comprises all aspects of regulatory and toxicology considerations in early-stage drug development, including a core expertise in regulatory toxicology of ATMPs.
Volker Blust is a senior consultant for non-clinical development of drugs and medical devices. He started his career at MC Toxicology Consulting in 2013. Since then Volker has worked on multiple projects including small molecules, herbals, biologics, vaccines and medical devices, including drug-device combinations. He was involved in the strategic planning of non-clinical development programs and has authored respective sections in various regulatory documents (CTDs, INDs, Briefing Documents, and IBs), biocompatibility reports, toxicological risk assessments and PDE calculations. Volker studied food chemistry at the Karlsruhe Institute of Technology in Germany and completed his doctoral studies in the field of toxicology at the University of Vienna, Austria. Since 2018 he is European Registered Toxicologist (ERT).
Verena Freistetter joined MC Toxicology Consulting in 2017. She is responsible for accounting and billing and also takes care of internal administrative workflow. Previously, she was head of office management for the Austrian, Swiss and German branches of BiC Graphic Europe S.A. Verena also completed a professional training in accounting and payroll accounting.
Roman Goetz, PmP®, joined MC Toxicology Consulting in 2015 as a senior project manager. Since then, he has augmented the team with project management capabilities and has assumed cross-functional tasks in non-clinical development of small molecules, biologics and Advanced Therapy Medicinal Products (ATMPs). He has more than 20 years of experience in the biopharmaceutical and biotech industries where he served in manufacturing/quality, project management and management positions. His past assignments included project management at Baxter Bioscience (now Takeda) and program management at PDC Biotech, where he later also served as managing director. Roman is a chemical engineer by training.
Alexandra Günzl works as a consultant at MC Toxicology Consulting. She joined the company in 2008. Since then she has contributed to the successful development of numerous drug candidates, with a focus on biologics and ATMPs. In addition, her experience includes environmental risk assessments and safety assessments for standard and borderline cosmetic products. In her current position, she is responsible for the coordination of diverse projects, also including preparation of briefing dossiers, IBs, non-clinical summaries and overviews for CTDs, INDs, and other documents required during drug development. Alexandra studied biotechnology at the University of Applied Sciences in Vienna and she trained in experimental cancer research during her PhD studies at the Medical University of Vienna. In 2016, she completed the EUCRAF postgraduate certificate program on “Regulatory Affairs of Biopharmaceuticals including ATMPs”.
Anne-Lise Perrier joined MC Toxicology Consulting in 2015 as a consultant and project manager. She has more than 15 years of experience in non-clinical R&D mostly gained in the CRO sector. Most recently, she has worked at Aurigon Life Science, a German full service non-clinical CRO, as a study director in pharmacology, safety pharmacology and regulatory toxicology. As a project manager for non-clinical programs, she has been involved in the development of numerous drug candidates (small molecules, biologics, biosimilars, ATMPs, herbals and vaccines), many of which have been successfully marketed in Europe, the USA and Canada. Prior to Aurigon Life Science, she was an associate scientist at IDEA AG (Munich, Germany). Anne-Lise is a biologist and graduated from the Pharmaceutical University in Paris (France) with a Master’s degree in Drug Metabolism and Pharmacokinetics. She is currently attending the postgraduate Project Management Professional (PMP®) certification program.
Currently on maternity leave
Marko Repic joined MC Toxicology Consulting in 2015 as a junior consultant. He supports the non-clinical development of small molecules and ATMPs with focus on cancer and gene therapies for rare genetic disorders. Marko contributes to preparation of various regulatory documents, such as Briefing Documents, non-clinical sections of IBs and INDs. He is a molecular biologist by training, with a core expertise in areas of cancer, mammalian neural development and stem cell biology. He studied molecular biology at the Comenius University in Bratislava and completed his doctoral and postdoctoral research at IMBA - Institute of Molecular Biotechnology in Vienna.
Anika Schröter joined the team of MC Toxicology Consulting in 2014. As a consultant, she supports the non-clinical development of small molecules, biologics and ATMPs. Her previous experience includes preparation of toxicological assessments, writing of regulatory documents (e.g. IBs, CTDs, Certification Dossiers), support for national scientific advice meetings as well as management and monitoring of non-clinical studies. Anika successfully attended the advanced training program as a certified Toxicologist of the German Society of Pharmacology and Toxicology (DGPT) and is European Registered Toxicologist (ERT). She is a biologist by training with focus on pharmacology and toxicology. During her doctoral studies at the University of Vienna she gained profound knowledge in the field of molecular cell biology, in vitro toxicology and human metabolism.
Swantje Winkler joined the team of MC Toxicology Consulting in February 2016 as a junior consultant. After her doctoral studies at the University of Vienna in the field of chemistry and toxicology she had a position as clinical research associate and project manager supporting clinical phase III and IV studies. Currently, she supports the team in non-clinical development of small molecules and medical devices. She also contributes to the preparation of regulatory documents (CTDs, INDs, IBs, Briefing Documents), biocompatibility reports, risk assessments and safety assessments for cosmetic products. Swantje is undertaking the advanced training program as a certified Toxicologist of the German Society of Pharmacology and Toxicology (DGPT).
Eva Zingler joined MC Toxicology Consulting in July 2014. She is responsible for contract management and supports the Managing Director as personal assistant. Before joining MC Toxicology Consulting Eva worked as a laboratory scientist at Savira pharmaceuticals, a biotech start up in the field of influenza research. She also spent many years at a law firm where she gained broad legal understanding. Eva graduated from the University of Applied Sciences in Vienna as a biotechnologist with a master’s degree in the field of immunology and cancer research.