Chairperson First Day

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. 

 Chairperson Second Day

Dr. Mahwash Mukhtar is currently a Research fellow at the Institute of Pharmaceutical Technology and Regulatory Affairs at the University of Szeged (Hungary). She acquired her Ph.D. in Pharmaceutical Technology from the University of Szeged in 2022. She has previously been working as a principal scientist in different Hungarian, Hungarian-Croatian, and Hungarian-Pakistani bilateral projects, along with a visiting researcher in CiMUS, University of Santiago de Compostella (Spain).

Her areas of expertise include macrophage-targeted drug delivery in inflammatory disorders, pulmonary dry powder nanomedicines, anti-biofilm coating of 3D printed catheters, oral nano-mediated drug delivery, and in-vivo studies. Moreover, she is also working on the chemical derivatization of biocompatible polymers to improve therapeutic outcomes, especially in dealing with antibiotic and antimicrobial resistance.

Her educational and research achievements have been recognized by the Higher Education Commission, Pakistan. She has won many grants such as Stipendium Hungaricum, International travel fellowships, and an honorary Master’s degree in Science from the University of Lahore (Pakistan). Her research has been published in high-ranked journals; she is also an active member of the Aerosol Society (UK), Pakistan Pharmacists’ Association, and American Chemical Society and is serving as an editor in highly esteemed journals.

The Future for Microbial Fermentation Based Products

• 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

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.

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

• 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?

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.

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

• 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?

Iván Jákó has been a Senior Business Development Manager at Gedeon Richter since 2018, being responsible for licensing-out activities, the management of various aspects of the partnering process regarding biosimilar products for countries where Gedeon Richter would not commercialize these products via own subsidiaries. His tasks include the search for partners, coordination of business assessments and due diligence processes, negotiation of contracts and post-deal alliance management.

Furthermore, Iván also supports the CDMO services offered by Gedeon Richter in the field of biotechnology, by managing general business development activities, preparation and negotiation of proposals, contracting as well as client management.

Before joining Gedeon Richter he held several management positions such as Managing Director at DayMed, Marketing Manager Rx & OTC at Berlin-Chemie/A. Menarini Hungary, Marketing Manager Rx at Boehringer Ingelheim Hungary, and Leader of Generics Project at Biogal Rt. / TEVA Hungary.

In his leisure time, Iván enjoys flying, cycling, trekking, and active travelling to exotic places in the world.

Development of Biosimilars: From Streamlined Development to Increased Access to Affordable Biologicals

• Streamlining biosimilar development: do we really need biosimilar efficacy trials?
• Real-world evidence for biosimilars: impact on interchangeability
• Policy impact on sustainability of the biosimilar market
• Influence of biosimilar competition on access to affordable biologicals

Zsolt Holló MD, PhD, MBA, PMP

Zsolt Hollo is a medical doctor by training, holding various other degrees and qualifications. He is a biosimilar expert, active in this field for 14 years.

He is one of the founding scientists of Solvo Biotechnology (a Charles River Company), a pioneering biotechnology company in the drug transporter / ADME-Tox field. He was Medical Director and Chief Operations Officer at Solvo Biotechnology from 2004 to 2009.

He worked at EGIS Pharmaceuticals in 2010-2023. As the Head of the Center of Biotechnology Business Development and Technology, he was responsible for various biosimilar related projects (technology transfer, setting up an EU release testing laboratory, alliance management with a strategic biosimilar manufacturer, due diligence of biosimilar products) and various other R&D projects in chronic inflammatory diseases.

He joined Polpharma Biologics in Nov 2023 as alliance management head.

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

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

Paweł Dudzic brings more than 12 years of software engineering expertise, with a specialized focus on database development, to his current role at NaturalAntibody. With nearly three years dedicated to creating biological databases essential for drug discovery, he now focuses on developing databases and bioinformatics software specifically aimed at analyzing antibody sequences. His work at NaturalAntibody seamlessly merges technology with biology, pushing the boundaries of scientific research forward.

New Approach to Antibacterial Therapy: Development of bacteriophage-containing Formulations for Human Use

• In the European Union, 670,000 people are infected with antibiotic-resistant bacteria every year, 33,000 of whom die.
• This number is projected to increase tenfold by 2050. The WHO and EMA are working hard to tackle the problem, and one of the most promising tools is the use of phage therapy.
• FLUART Innovative Vaccines Ltd. started developing this technology a few years ago.
• The aim of our presentation is to describe the R&D and scale-up experiences and opportunities with this technology.

Balázs has 20 years of experience in the biopharmaceutical industry including Process technology, Regulatory and cGMP compliance for biotechnology. He has extent knowledge of novel technologies such as therapeutical proteins, vaccines, drug substance, drug product, which ensures him a complete understanding of all issues associated with red biotechnology.
Balázs has an impressive experience across all areas of the biopharmaceutical industry encompassing R&D and production processes and facilities for human biopharmaceuticals, vaccines, therapeutic proteins, plasma derivatives, radiopharmacons from drug substance to final drug product.

Implementation of eBatch record system - Lessons learnt

• Project summary

• Why to do it - Pro’s and Con’s

• GMP implications

• Do’s and Don’t

• Conclusions

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.

Understanding the Manufacturing Process – From Development to Ongoing Verification

• 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

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

• 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

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.

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

• 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

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.

AADvac1 lead active tau immunotherapy program for treatment and secondary prevention of Alzheimer’s Disease: Recent Phase 2 results

• AADvac1 is the first-in-man, first-in-kind active tau immunotherapy, stimulating the immune system to produce antibodies specific for all pathological forms of tau;
• The completed Phase II study has previously demonstrated an exceptional safety profile of the vaccine and an effect on several plasma and CSF biomarkers (Novak et al, Nature Aging 2021)
• The recent post-hoc analysis has revealed significant treatment effects in biomarker-confirmed AD patients on cognitive, functional and neurodegeneration-related biomarker endpoints. The response to treatment was directly related to the levels of AADvac1-induced anti-tau antibodies.

Branislav Kováčech, Ph.D., joined Axon Neuroscience in 2002 as a research scientist to identify therapeutic targets for Alzheimer's disease. He was part of the core team who developed immunotherapies for the disease, co-authoring several patents. As the head of Pharmacology, he supported the development of manufacturing processes and analytics for the lead vaccine. Branislav has actively participated in clinical development, the design of the clinical trial protocol, bioanalytical methods, and data interpretation, authoring several publications in high-impact journals as a result. Currently, he serves as a deputy CSO.

SITE VISIT TO THE GEDEON RICHTER Biotechnology plant in Debrecen

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 12:00 and will return after the visit at approximately 19:30.