Dr. Markus Fido
Mfi Bio-Consulting, Austria
Founder, Managing Director Markus has more than 20 years of experience in pharmaceutical industry, with focus in vaccines, recombinant proteins and immune therapeutics. He has profound expertise in regulatory aspects such as third party audits, authority inspections and GMP guidelines. He has a management consulting education and holds a doctorate degree in immunology/biochemistry from the Technical University of Graz, Austria. Markus started his carrier at a Novartis “Spin off” in Vienna in 2006, he has acquired the oncology division and founded Velalabs & Meridian Biopharmaceutics. Besides serving as a CEO and formal Managing Director, Markus has also taken responsibilities as a Head of Regulatory Affairs within the Quality Operations team. Markus was previously Head Quality Control at Igeneon/Aphton Biopharma where he was responsible for all QC aspects of pre-clinical and clinical projects such as stability studies, specifications, method validation, and product release. Before that he was Group Leader of Immunology and Product Development at Biomin GmbH, Head Biochemical Control at Baxter AG and Head Quality Operations at Octapharma AG.
• 2 years Biomin AG Cell culture lab, development of immune enhancer drugs
• 6 years Baxter Inc Quality control of vaccines & coagulation factors
• 2 years Octapharma Head of Quality Operations & Quality Control (plasma products)
• 3 years Novartis AG Oncology, Cancer immune therapy, Quality + RA
• 15 years Management Buy-out (founder and CEO of 2 Biotech companies) VelaLabs & Meridian Biopharmaceuticals
Products: Biologics, Biopharmaceuticals, Biosimilars, ATMPs, Monoclonals, Antibodies
Focus: Analytics, Quality Control, Process & Clinical Development, Regulatory Affairs Member of advice team for ATMPs (ECA)
Dr. Florian Cymer
F. Hoffmann-La Roche Ltd., Switzerland
After his study of Biology with focus on Molecular Biology and Biophysics at the University of Ulm, Germany, Florian did his PhD and several PostDocs in the field of membrane protein folding & interaction in Freiburg, Mainz and Stockholm. Since 2014 he is working at Roche in Switzerland in the analytics department initially working on therapeutic protein/receptor interactions and later heading a QC group developing and using bioassays during clinical development stages.
His responsibilities are the functional characterization and QC release analytics of different large molecules, especially monoclonals in development and production for Roche Pharma Europe. The techniques used in his lab include cell-based potency assays, ELISAs, surface plasmon resonance and affinity chromatography for process development and product release.
His special focus is on antibody effector functions and how these are modulated by antibody glycans.
DI(FH) Rainer Fedra
After his study of medical and pharmaceutical Biotechnology at the University of applied Sciences in Krems, Austria, Rainer was engaged at Boehringer Ingelheim Austria in the Department of Quality Control. Since 2011 he is working at VelaLabs. At present he is Head of Portfolio Management at VelaLabs.
He is responsible for shaping the VelaLabs portfolio of services and technologies to keep up with international trends in biotech third party analytics. The techniques used at VelaLabs include: HPLC, SPR, ELISA/MSD, (q)PCR, pharmacopeial methods, microbiology, and bioassays.
Rainer has extensive experience with assay development, focus primarily on SPR, ELISA, bioassays, as well as statistical Design of Experiments.