Preclinical development: From bench to first in human

PHOX Consulting e.U.,
Vienna, AUSTRIA

Volker Blust is the owner of PHOX Consulting e.U., an independent consultancy based in Vienna specialising in the non-clinical and biological evaluation of medical devices and medicinal products. He has extensive experience with a wide range of product types, including substance-based medical devices and implants. As a consultant, he works with companies to develop testing strategies for medical devices, acts as a study monitor for external trials, and prepares regulatory documents such as biological evaluation plans and reports (BEP/BER) as well as toxicological risk assessments.
Volker Blust studied food chemistry at the Karlsruhe Institute of Technology and completed his doctorate in toxicology at the University of Vienna. Following advanced training in the field of toxicology, he has been registered as a European Registered Toxicologist (ERT) in the European and Austrian toxicologist registers since 2018.

Merck KGaA,
Darmstadt, GERMANY

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.

Expert for Preclinical Research,
Bonn, GERMANY

Biotest AG,
Dreieich GERMANY

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
.

Toxicology Expert,
Bonn, GERMANY

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.