Employees

Lydia is a senior regulated bioanalysis expert with over 10 years of experience in the clinical development of biotherapeutics and gene therapies.

Her 25-year career has spanned molecular biology, genetics and immunology, making her an expert in all the bioanalytical tools needed to support the Advanced Therapy Medicinal Products.

Lydia has outstanding CRO oversight expertise developed over 10 years in PK-PD and immunogenicity bioanalysis outsourcing at Novartis. She brings a significant experience in CRO selection, audit and monitoring, as well as her impressive track record of technology transfer.

Lydia supported the successful regulatory submissions of multiple biotherapeutics to various health agencies worldwide.

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.