Associates

Jörg is a Board-Certified Toxicologist in the EU (ERT) and the US (DABT) with over 20 years of experience in the Biopharmaceutical Industry. Jörg holds a degree in Chemistry and received his PhD from the Institute of Toxicology at the University of Würzburg.

Jörg worked for a range of biotech companies as an expert in the field of non-clinical development and safety evaluation and thereby collected a proven track record of moving discovery projects of various molecular scaffolds (polypeptides, fusion proteins, monoclonal antibodies, DARPins, cancer vaccines) into clinical development and towards market authorization.

Jörg has considerable experience in planning and execution of non-clinical safety and efficacy assessments and elaboration of program budgets and timing of such nonclinical packages in support of clinical programs in a broad range of indications and throughout all development stages. He profits from his profound knowledge on GLP requirements, regulatory guidelines on nonclinical development and his excellent contacts to numerous CROs. He has supervised a multitude of pivotal GLP toxicity and safety pharmacology studies and has authored several Investigator’s Brochures and other regulatory documents. He is experienced in European and US procedures concerning meetings with regulatory authorities.

Jörg is appointed as a full member to the Advisory Committee for pharmacologically active substances and veterinary drugs of the Federal Institute for Risk Assessment of Germany.

Paul specializes in developmental, reproductive and pediatric safety testing. He is a former President of the European Teratology Society and was a member of the ICH S5(R3) expert working group.

Paul’s previous experience includes:

Global Head of Reproductive and Juvenile Toxicology at Roche in Basel for 9 years. Sole point of contact for all nonclinical aspects of reproductive and pediatric safety testing. Responsible for devising and implementing the reproductive and pediatric testing strategy of all pharmaceutical projects, including: small molecules, monoclonal antibodies, antibody conjugates, nucleic acid therapeutics and gene therapy. Interactions with health authorities worldwide and contributing nonclinical sections to regulatory submission documents (IND, NDA, BLA, CTAs, PIP/PSP, etc.). Founder member and co-chair of the Subject Expert Group in Reproductive Toxicology for the Roche group of companies (Roche, Genentech and Chugai), advising clinical teams on reproductive risk assessment, pregnancy prevention precautions and drug labelling.

Director of Toxicology for 15 years at a CRO in France (now Charles River Lyon).

Head of Reproductive Toxicology Department at a CRO in Italy (now RTC).

Lab technician, then toxicologist at Beecham Pharmaceuticals, UK.

Elisabeth is a Board-Certified Toxicologist in the EU (ERT) with over 25 years of experience in the Biopharmaceutical Industry. Elisabeth holds a degree in Chemistry and received her PhD from the Institute of Toxicology at the University of Würzburg.

Elisabeth worked for a CRO (study director and head of rodent toxicology at RCC), a bench of biotech companies (Head of Toxicology at Speedel, Galderma and Galapagos) and big-pharma company (sr. project toxicologist at Novartis) as an expert in the field of drug safety and drug development from target selection to market authorization. She has a proven track record in the development of small molecules, but also in biologics (monoclonal antibodies and ADC’s).

Elisabeth has considerable experience in all aspects of planning, execution, and evaluation of non-clinical safety assessments at all stages of drug development. This includes risk–benefit evaluations and all relevant heath authority interactions in Europe, US, Japan, and China. She has a broad experience in a range of indications with an in-depth knowledge in immunology, immuno-oncology, infectious diseases, and dermatology.

Elisabeth was appointed as a full member to the Advisory Committee for pharmacologically active substances and veterinary drugs of the Federal Institute for Risk Assessment of Germany in 2008/10.
She was the secretary of the Swiss Society of Toxicology from 2013-2019
She is author of the chapter ‘toxicology in drug development – understanding a drugs toxicity and managing safety and risks’ in ‘ Principles of Biomedical Sciences and Industry’ by Hinder et al, Wiley-VCH., 2022.