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
Dr. Gerald Hofer
GeCo Business Solutions, Austria
After 24 years in the pharmaceutical industry, Gerald founded his own consulting company to offer his knowledge and experience to the industry. In several leading positions in big, worldwide operating pharmaceutical companies he was able to gain a lot of experience in the development, manufacturing, analysis, GMP requirements and B2B sales of pharmaceutical products. Leading people on local level or over country borders, either as direct reports or in matrix organisations, was an enjoyable challenge throughout his career. After his Diploma Degree in Chemistry and PhD in Biochemistry from TU Graz, he joined Fresenius Kabi as a Group Leader Emulsion and Patents. Throughout his 23-years-long career at Fresenius Kabi, he gained extensive experience from different fields & positions in pharmaceutical production, project management and contract manufacturing. In 2019, he joined Tentamus Group as a Director of Sales & Business Development. In 2020, Gerald founded his own consulting company. Gerald‘s main expertise is in Biochemistry, Molecular Biology, Immunology, Biotechnology, Microbiology. He has vast experience in development of pharmaceutical products: sterile products, vaccines, emulsions and suspensions; analytical development, regulatory requirements, manufacturing, quality control, budgets, CAPEX, Project Controlling.
Dr. Karlheinz Landauer
Owner, Managing Director
QBDC GmbH, Switzerland
Karlheinz is a GMP person, working regularly with guidelines from EU, US, ICH but also WHO and guidelines from development countries. Understanding the needs of the customers as well as the regulators and understanding of the processes leads to efficiently working with the guidelines while keeping a close eye on implementing them efficiently and in a practical way. After his PhD in the field of animal cell culture medium development, he took his first job in a cancer-therapy company and was finally promoted to Head Manufacturing. Later he took the opportunity to take a job at Celltrion, South Korea followed by a CDMO in Basel. He was Head Manufacturing and COO. After 9 years of employment at CMOs , he decided to take the next step. In January 2016, he has founded QBDC, with the core focus on consulting biotech and pharma companies in CMC matters as process development, technology transfer and scale-up, facility layout and design as well as project management and quality management and assurance. Additionally to that we are developing Excel-based cGMP solutions with the goal to increase operational efficiency at our customers and to comply with the newest regulations in this field. Karlheinz has specialized on quality management, facility design and qualification, on up-stream process development, scale-up and tech transfer strategies as well as GMP operations. He was a project team member and a project manager to set-up and implement GMP Quality Management and Assurance Strategies including a new DP Facility in Saudi Arabia as Managing Director Quality Operations.