Dr. Erik Bogsch, Head of the Biotechnology R&D Division, Gedeon Richter
Dr. Erik Bogsch is the Head of the Biotechnology R&D Division at Gedeon Richter Plc. He is responsible for leading the R&D effort in the development of GR's biosimilar pipeline. Gedeon Richter Plc. is engaged in the development and manufacture of both bacterial cell fermentation based and mammalian cell fermentation based biosimilar products. GR has R&D, analytical & manufacturing capabilities in multiple locations in Hungary & Germany.
Dr. Bogsch, a Hungarian national, has a Natural Sciences degree from the University of Cambridge and a PhD in cell biology from the University of Warwick. Following a brief postdoctoral academic research career, he worked in the food industry for many years in R&D, Quality & Manufacturing roles in the UK, Hungary & Germany. He joined Gedeon Richter Plc. in 2012, as commissioning lead for GR's biotechnology factory in Debrecen, Hungary, before moving into his current role.
Marek Cichocki, Head of Operational R&D, Polpharma
Marek Cichocki has been working in pharmaceutical industry for 13 years. He is an R&D expert with special focus on solid oral dosage forms development and manufacturing. Marek’s professional specialization includes: formulation design, scale-up and technology transfer activities, process validation, and new manufacturing methods.
Marek started his career in 2005 in Pliva Kraków (Poland) where he was a Formulation Scientist. From the beginning of 2010 Marek spent almost 4 years at Synthon BV (The Netherlands) being responsible for the implementation of newly developed products at Contract Manufacturing Organisations. In February 2014 Marek joined Polpharma (Poland) and became Head of Formulation Development team. Currently he is holding a position of Head of Operational R&D and his main responsibilities are: post-approval product maintenance, technology transfers, R&D support for industrial operations and new technologies implementation.
Christopher Hunley, Site Director, GSK Biologicals Kft.
Chris is the Site Director at the GSK Biologicals Kft. Vaccine manufacturing facility in Gödöllő. He joined the site in 2015, after 5 years working in Italy and Germany with Novartis Vaccines. Before moving into the vaccines business, he spent several years working for Amgen in the United States on the manufacturing of various bulk biologics. Chris is a chemical engineer, who has spent his career working in manufacturing facilities with roles in Manufacturing, Validation, Project Management, and Manufacturing Sciences & Technology.
Dr. Piotr Lipiński, Quality Systems Manager/QP, Novartis Technical Operations-Platform Solids Europe, Lek / Novartis
Piotr has over 10 years of experience in pharmaceutical companies. Currently he is Quality Systems Manager and Qualified Person in Novartis Technical Operation in Poland.
The experience includes particularly scope quality systems implementation, self-inspections, trainings and auditing of materials, products suppliers and service providers. Piotr has detailed knowledge in scope of all GxP rules with special focus on Good Manufacturing Practice and Good Distribution Practice.
Piotr is a PhD. Eng. in scope of Technology of Chemistry. Additionally, he completed post-graduate studies in scope of Industrial Chemistry at Medical University of Gdansk. He was participating as well in numerous courses related to GMP aspects in pharmaceutical industry.
Dr. Tomáš Groh, Part of the Biotechnology R&D Division, Bioinova
Tomáš works at the Biotechnology R&D Division at Bioinova, Ltd., a company based in Prague, Czech Republic. He is responsible for early as well as late stages of new products development. Several key ideas arisen from his activities have already been patented. As for pharmaceutical industry, Tomáš has extensive experience in Quality Control (QC) Environment. He established new lab within Bioinova´s QC department, primarily performing flow cytometry and nucleic acid amplification techniques. Tomáš, a Czech national, has a Natural Sciences degree from Charles University in Prague. He obtained his PhD in Biochemistry during his work at the Department of Paediatric Haematology and Oncology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital.
Dr. Zsolt Holló, Head of the Center of Biological Business Development and Technology, EGIS
Dr. Holló is medical doctor by training, obtained his PhD in cellular physiology at Semmelweis University (Budapest) and MBA degree at the Budapest University of Technology and Economics. Dr. Holló has over 10 years experience in biotechnology. Currently he is Head of the Biological Business Development and Technology Center at EGIS Pharmaceuticals Plc. His major responsibilities include biosimilar product-candidate evaluations; the implementation of biosimilar product related manufacturing and analytical technologies, quality control, management of technology transfers; developing partnerships in these areas. Prior to this position he was Chief Operations Officer at Solvo Biotechnology. He has spent more than 5 years in molecular diagnostics, in various positions from laboratory head to CEO. He has worked in the Netherlands Cancer Institute as an EMBO postdoctoral fellowship holder. Dr. Hollo has several publications and patents in cellular signalling, multidrug resistance and molecular diagnostics.
Lenka Francišković, Head of Processes and Products Quality, Belupo Pharmaceuticals
Lenka is a Pharmaceutical Professional with a unique combination of pharmaceutical management experience and exceptional knowledge in the areas of the New Product Evaluation, Laboratory Operations, Pharmaceutical Analysis and Project Management. She has an extensive experience in pharmaceutical industry in Research and Development, Regulatory Affairs, Quality Assurance and Quality Control Environment as well as profound knowledge of TPB and FDA, EU and Croatian regulatory submission requirements. Strong knowledge of GMP, GLP, ICH guidelines and Pharmacopoeia is inevitable part of Lenkas‘ professional skills. Lenka is currently Head of Processes and Products Quality for Belupo Pharmaceuticals Croatia. Prior to this work, she worked in several positions at Apotex Inc. Toronto, Ontario and Genpharm Inc. (now Milan Pharmaceuticals) in Etobicoke, Ontario. Lenka has published several publications, is member of Pharmaceutical Sciences Group, Toronto and Croatian Association for Quality.
István Király, VP, Site Director Siena & Rosia Operations, Italy, GSK Vaccines S.r.l.
István Király graduated from the Technical University in Budapest as a mechanical engineer. During his professional career he has filled several technical- and production-related management positions in different industries at large international companies such as General Electric, DANONE, Alcoa and GlaxoSmithKline. These challenges allowed him to be involved in the implementation and operation of different management and quality systems such as ISO, HACCP, GMP, Toyota Production System, Six Sigma and Lean Sigma. In 2006 he joined GSK Vaccines and started his career in Gödöllő Manufacturing site. He held various senior management positions until he was appointed as Managing director of the site in 2011. Between September 2015 and June 2016 he was Head of Operations of the legacy Novartis Vaccines sites, overseeing the industrial operations of those sites and also managing the integration of those newly acquired manufacturing units into GSK Vaccines industrial network. In June 2016 István was promoted to his current position as VP, Site Director Siena & Rosia Operations, Italy at GSK Vaccines.
Dr. Sergii Sur, Regulatory Affairs Director, Arterium Corporation
Dr. Sur has over 25 years of work experience in the pharmaceutical market, including 14 years in management positions. He received his PhD degree in Pharmacy and published approximately 100 scientific publications. Between 1993 and 1998 he was the Head of State Laboratory for Quality Control of Medicines at the Institute of Pharmacology and Toxicology at the Ukrainian Academy of Medical Sciences in Kiev. Between 1998 and 2005 he worked for the Ukraine Ministry of Health, firstly as the Director of Central Laboratory for Quality Control of Medicines and since 2000 as the Deputy Chief Inspector for Quality Control of Medicines. Since 2005, Dr. Sur has been in his current position responsible for the development of a functional strategy in R&D; the development and introduction of R&D business processes and structure; and the organisation of research, development and registration of new products. Additionally, Dr. Sur is a member of the International Federation of Pharmacists (FIP) and since 1998 has been an adviser on International Pharmacopoeia and Pharmaceutical Preparations and since 2002 also on Traditional Medicines for the WHO which is headquartered in Geneva.
Prof. Dr. Stane Srčič, Head of Pharmaceutical Technology Department, Faculty of Pharmacy, University of Ljubljana
Dr. Stane Srčič is a Professor for Pharmaceutical Technology at the Faculty of Pharmacy, University of Ljubljana, Slovenia. His expertise is focused on solid oral dosage forms development and manufacturing and includes pre-formulation and formulation, new manufacturing methods and customized equipment. After PhD he spent as post doc at the University of Regensburg, and was/is acting as a visiting Professor at the University of Liverpool, Szeged and Sarajevo.
He served for more than 10 years as an expert from Slovenia on EMA (London) in the Committee for drugs in veterinary medicines and was responsible for quality parts of the dossiers.
He published more than 150 papers and is holder of numerous patents and patents applications in EU, US, Russian Federation and India. He is strongly connected with domestic and foreign pharmaceutical industry and was leading a lot of different academia-industry projects.
His international collaboration on the education and research areas has been recognized and awarded with the honorary doctorate from the University of Szeged (Hungary).
Dr. András Ballagi, CTO, Diagon
Dr. Ballagi moved to Sweden shortly after completing his degree in Bioengineering. There he worked in the field of the diagnosis and molecular evolution of veterinary viruses at the Swedish Veterinary Institute. He received his PhD for his research on application of PCR for virus detection and analysis of viral outbreaks. Later he moved on to fermentation technology of recombinant microorganisms at the University of Uppsala. After almost 20 years in Sweden he returned to Hungary in 2006 and joined Gedeon Richter Plc. to lead the technology development for biosimilar medicine production using bacteria (E.coli) as well as mammalian (CHO) cells.
In 2014 he formed the Biotechnology unit in the newly established Pharmatech Model Laboratory (PML) at the Budapest University of Technology and Economics, where he is also holding an Honorary Professorship. Since November 2016 he responsible for the recombinant protein development and production of human diagnostic at the Diagon Ltd, Budapest.