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Matthias Renner

Head of Section Non-viral Gene Transfer Medicinal Products, Senior Scientific Assessor for quality and non-clinical aspects of ATMPs

Paul-Ehrlich-Institut (PEI), Germany

Matthias Renner is Acting Head of Section “Nonviral Gene Transfer Medicinal Products” and Senior Scientific Assessor for quality and non-clinical aspects of ATMPs at the Paul-Ehrlich-Institut (PEI), the German Federal Institute for the regulation of Vaccines and Biomedicines. In his work Matthias is involved in the evaluation of clinical trial applications and national scientific advice procedures for ATMPs and serves as scientific consultant in GMP-inspections of Gene Therapy Medicinal Products. Since 2009 he is expert to the European Medicines Agency (EMA) for the assessment of marketing authorisation applications, for scientific advices and other EMA procedures. He was member of the EMA CAT Gene Therapy Working Party since 2010, and its vice chair since 2011. He is Member of the Cell and Gene Therapy Committee of the International Alliance for Biological Standardization and since 2016, German Alternate to the CHMP Biologics Working Party. Prior to joining PEI in 2009, he served as Head of Vector Development and Preclinical Models at Austrianova AG, Vienna, where he was responsible for the development of the Company´s gene therapy products. From 1997 to 2016 he was also affiliated to the University of Veterinary Medicine Vienna, serving as group leader at the Institute of Virology till 2008 and as senior lecturer in Virology till 2017. Matthias did his Ph.D. and PostDoc in Hepatitis B virus research at the Max-Planck Institute of Biochemistry, Martinsried, Germany.

Robert Zoubek rounded

Robert E. Zoubek

Senior Consultant

Granzer Regulatory Consulting & Services, Germany

Dr. Robert E. Zoubek is passionate biochemist with large experience protein degradation and protein analytics - an experience which he combines with his profound knowledge about the regulatory requirements in the US and EU for the different development stages. At Granzer Regulatory Consulting & Services Robert supports clients in all questions concerning drug development, manufacturing and quality control for biologics, biosimilars and ATMPs. Before Granzer, he owned several positions at Formycon, Germany, and GlycoForm. UK. As Director Scientific Affairs he led Formycon's drug product development, formulation and analytical services and provided solutions for difficult-to-formulate proteins. Prior to that, he was Head of Protein Characterisation & Preformulation and Head Quality Control. Robert has seen many Peptides and Proteins exhibiting different propensities in degradation. Over the years he gained a profound understanding about parameters causing degradation, ways to mitigate degradation, how to design studies effectively and the real challenges in physico-chemical and biological analytics.