Preclinical development:
From bench to frist in human

Volker Blust is the founder of PHOX Consulting. He started his career in 2013 by joining MC Toxicology Consulting, a company specialized in nonclinical development and toxicology. At MC Toxicology Consulting, Volker has worked on multiple drug candidates including small molecules, herbals, biologics, and vaccines. In addition, he has contributed to the successful development of substance based medical devices and implants. In 2021 Volker founded PHOX Consulting. During his work as a senior consultant for nonclinical development and toxicology of drugs and medical devices Volker 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. In 2018 he received his certificate as a European Registered Toxicologist.

Meike Harms holds a doctorate in pharmacy and has been working in the Healthcare division at Merck KGaA in Darmstadt since 2011. Throughout this time, she has mainly been involved in the preclinical formulation development of new drugs. In the field of formulations, she has gained experience in various areas such as special application routes (e.g. intra-articular or transdermal), bioavailability improvement via amorphous formulations, nanosuspensions and lipid-based formulations as well as drug targeting to reduce toxic effects.

Vice President Preclinical Research Matthias Germer has been Head of Preclinical Research at Biotest AG since 1999 and is responsible for the non-clinical parts of study submissions and product approvals for biotherapeutic and biological drugs in the EU, the USA and other countries. Since then he has been an expert in analytics under GMP and GCLP, pharmacology, toxicology and pharmacokinetics. As head of the testing facility, he is responsible for the organization and functioning according to GLP principles. He shares his know-how in numerous congresses, lectures and seminars .

Specialist in Genetic and Reproductive Toxicology He works at the Genetic and Reproductive Toxicology, Bundesinstitut für Arzneimittel und Medizinprodukte and does research in Diabetology, Pharmacy and Toxicology.