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 E. Zoubek
Granzer Regulatory Consulting & Services, Germany
Bill Byrom has worked in the Pharmaceutical Industry for 30 years. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, Bill is a key strategic thinker helping to shape the direction and application of eClinical solutions. Bill is a thought leader in patient-facing technologies including electronic patient-reported outcome solutions, the use of wearables and connected devices, and new novel technology-derived endpoints. Bill is an active participant with the Critical Path Institute’s ePRO Consortium, and leads a research team within the DIA Study Endpoints Community on the use of wearables. He is a frequent conference speaker and has authored over 70 publications, including two industry textbooks on electronic patient-reported outcomes. His research has included work on bring your own device for eCOA, the use of wearables in clinical trials, and novel use of technology to develop new clinical endpoints to study health.