Chairman First Day

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Louis is the CSO and Management Board Member of JJP Biologics, an innovative new Polish company backed by the Starak family. JJP Biologics develops the next generation of novel therapeutic biologics around personalized medicine and companion diagnostics. Louis obtained his Ph.D. in Biochemistry at the University of Amsterdam. He was the founder of various companies focused on the generation and development of therapeutic monoclonal antibodies, primarily in the field of cancer and inflammation.

In 2003, he was one of the founders of Bioceros BV, now Polpharma Biologics, where he currently holds the position of Principal Scientific Advisor. In addition, he held positions as CSO at MacroZyme BV, 4AZA Bioscience NV, FF Pharma, and VP preclinical for PanGenetics BV and Tanox. Louis is an author of over 340 publications in international scientific journals in the field of medical biotechnology and an inventor at more than 20 patent applications. 

 Chairman Second Day

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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).

The Future for Microbial Fermentation Based Products

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• What are the key differences between microbial and mammalian cell fermentation products?
• What are the key technology differences between these platforms
• What is the range of biopharmaceuticals that can be manufactured through microbial fermentation
• Opportunities and threats

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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, Hungar & 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.

Understanding the Manufacturing Process – From Development to Ongoing Verification

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• Manufacturing process development – establishing control strategies for CPPs
• Do the same control strategies apply for process validation and ongoing verification?
• Bringing ongoing process verification into life
• Two years later and after Regulatory inspection

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Ivana Kovač Lovrenčić, M.Pharm. has been in Belupo Inc. since 2006, primarily working in R&D on formulation and process development, technology transfer and CTD Module 3 preparation for small molecule solid, semi-solid and liquid dosage forms. Through the years she has gained broad experience working on different projects related to in-house development, contractual development, regulatory applications, process improvement and procurement and qualification of manufacturing equipment. She has also acquired advanced knowledge on GMP and ISO guideline implementation as a representative of small-scale solid dosage forms production. As a department head, she leads a small team of technicians and technologist dedicated to technological development of new generic products together with manufacture of small-scale commercial batches.

After work, Ivana enjoys doing DIY projects, travelling and spending active time in nature. She volunteers in a project for empowering young girls between 12 and 18 years of age.

Understanding the Manufacturing Process – From Development to Ongoing Verification

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• Manufacturing process development – establishing control strategies for CPPs
• Do the same control strategies apply for process validation and ongoing verification?
• Bringing ongoing process verification into life
• Two years later and after Regulatory inspection

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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.

Implementation of eBatch record system - Lessons learnt

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• What to look for in Real Time Monitoring Systems

• The Tive Solution including Proactive intervention in case of excursions

• Campaign production – Changing batch mindset

• Data Integration: The gain of partnering.

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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. In 2015 he was nominated to VP, 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 2016 he was promoted to VP, Site Director Siena & Rosia Operations, Italy at GSK Vaccines.

In 2018 István returned to Hungary, and joined HUMAN BioPlazma (part of Kedrion Group) as Site Director, were he was accountable for the entire operations of the Hungarian Subsidiary of Kedrion Biopharma.

Since 2022 István is the Site Director at Egis Pharmaceutical responsible for the Körmend site.

Cooperation between Quality and Production as a Road to Success in the Pharmaceutical World 

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• What Production and Quality can learn from each other?
• Necessary areas of cooperation
• The right way of thinking, openness, transparency and respect as the path to success

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Piotr has over 12 years of experience in pharmaceutical companies. Currently, he is a Global Quality Auditor in Sandoz, before he worked in pharmaceutical manufacturing sites as Quality Assurance Specialist, Qualified Person and Quality Systems Manager.

The experience includes particularly quality systems implementation, self-inspections, training and auditing of materials, products suppliers and service providers. Piotr has detailed knowledge in the scope of all GxP rules with a special focus on Good Manufacturing Practice and Good Distribution Practice.

Piotr is a PhD Eng. in the scope of Technology of Chemistry. Additionally, he completed post-graduate studies in the scope of Industrial Chemistry at the Medical University of Gdansk. He was participating as well in numerous courses related to GMP aspects in the pharmaceutical industry.

Benefits and Pitfalls in Implementation and Application of Machine Learning Methods in Biologics Discovery

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• Data curation
• Model development
• Orchestration of models
• Staying on top of science

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Konrad Krawczyk has more than a decade experience in developing databases and computational models for therapeutic antibody discovery, contributing to Oxford University resources such as SAbDab/SAbPred platform and the Observed Antibody Space, that are used widely by academia and industry. He is the founder of NaturalAntibody that focuses on building computational/machine learning tools to accelerate therapeutic antibody discovery.

Business Development: How to do it Right from a Small and Mid-sized Biotech Company Perspective

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• Main reasons for initiating business development and partnering activities
• Challenges in running business development activities efficiently
• Most frequent mistakes made
• How to do it right?

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Paweł is the COO and Management Board Member of JJP Biologics. Involved in the biopharmaceutical market since 2014 as Supervisory Board Member of Polpharma Biologics Warsaw. Paweł has built experience in the pharmaceutical industry since 2010. First in a pharma-specialized advisory and market research house and subsequently in various capacities in Polpharma, including Director of Corporate Project Office. Prior to that has worked for six years in investment banking and management consulting in Portugal and Poland. Paweł also serves as a Supervisory Board member of Herbapol Lublin. Paweł graduated from the Warsaw School of Economics (MSc) and holds a master’s degree in law from the Warsaw University.

topic to be confirmed 

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Michal Fresser first joined Axon in 2013 as a board member & general counsel to the firm. In 2019, he was appointed Chief Executive Officer of Axon, and also serves as Chairman of the Board of Directors of Axon’s two subsidiaries – Axon Neuroscience CRM Services SE and Axon Neuroscience R&D Services SE. Prior to his arrival at Axon, Michal had established a career in both legal advisory and consulting. There, he covered multiple sectors, gaining extensive knowledge on mergers and acquisitions, cross-border transactions, and both corporate and competition law.

SITE VISIT TO THE GEDEON RICHTER Biotechnology plant in Debrecen

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The congress also provides an opportunity to visit the Gedeon Richter Biotechnology plant in Debrecen limited for 40 delegates and available on a first come first serve complimentary basis at 15:00 on 4th March and will last for approximately 2 hours.

Gedeon Richter Plc. embarked on establishing biotechnology development and manufacturing capabilities over a decade ago. As a result, the company today has established sites and teams covering R&D and production activities to enable the creation of a biologics product pipeline in addition to offering CDMO activities in the biopharmaceuticals field.

The company has state-of-the-art manufacturing facilities covering microbial fermentation-based products at its Richter-Helm Biologics sites in the north of Germany, and mammalian cell fermentation-based manufacturing capacities, in addition to fill and finish capabilities at its plants on the Gedeon Richter site in Debrecen, Hungary.

The Debrecen GR site covers production, development, analytical testing and releasing activities on a greenfield site that has expanded continuously over past years, providing a workplace for over 400 highly skilled associates, benefiting from the growth momentum and strong higher education credentials of the city of Debrecen.

Your visit to the Gedeon Richter site will provide you with a good overview of the unique capabilities and assets of the facilities covering manufacturing, development and analytical areas. This will be followed by a site tour including the viewing corridor of the drug substance manufacturing upstream fermentation area and the visit of a laboratory. The tour will finish with a brief outdoor walk around of the site and a wrap-up meeting with refreshments. The 40 participants will be split into 2 groups for the site tour.

TRANSFER: The bus will leave from the front entrance of the Budapest Marriott Hotel on 4th March at 12:30 and will return after the visit at approximately 19:30.