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. Stane Srčič is 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).

Streamlining Biosimilar Development - The Next Step in the Evolution of the Biosimilar Regulatory Pathway

• Developing and manufacturing biosimilar medicines is a complex process, requiring significant expertise and investment over long period of times. There are many different factors impacting the feasibility of biosimilar development: scientific, technological, intellectual property, regulatory, market access, etc. 
• For many biologicals (70%) losing exclusivity over the next decade, do not have corresponding biosimilar medicines in development, resulting compromised opportunities for HC systems and patients across Europe. The ‘Void’ impacts BOTH blockbuster medicines and medicines intended for smaller population.  
• One of the ways of mitigating this ‘Void’, without compromising safety or efficacy, is the implementation of streamlined biosimilar development. Streamlining aims to eliminate comparable efficacy studies (or CES, so called ‘Phase III’) by relying on advanced analytical and clinical pharmacokinetic data. Under the current requirements, CES constitute an absolute barrier to biosimilar development. 
• Ensuring a brighter future for the biosimilar industry requires, but is not limited to: 

• evolving the biosimilar regulatory standard based on biologic regulatory-science progress,
• engaging stakeholders,
• promoting global regulatory convergence 

• to support a balanced and functioning biosimilar ecosystem. 

Mina Grguri is the Biosimilar Science and Policy Officer at Medicines for Europe, the trade association representing the generic, biosimilar, and value-added medicines industry. In her role, she is focusing on the Biosimilar regulatory and science Policy, advocating for a strong EU biosimilar industry and the evolution of the biosimilar regulatory framework in line with the scientific advances of today, with the goal of increasing patient access to innovative biologic therapies across Europe. Mina is active on the topic of streamlining Biosimilar development both at EU and International level, coordinating expert taskforces and engaging with external stakeholders.

A pharmacist by education, Mina has previously worked in the sphere of clinical trials at a global CRO company.

Topic to be confirmed

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.

Employee Retention in Pharma Industry by Offering New Ways of Self-Motivation

• Description of specific features of pharmaceutical continuous education
• Employees motivation approaches during career development
• List of motivation incentives for employees for self-improvements
• Development of educational concept based on the needs for different pharma companies

Petra works as a managing director in Cayman Pharma (Czech Republic), a company focused on API products based on prostaglandin skeleton. By training, she is an analytical chemist with high appreciation of chromatographic and mass spectral techniques. She is very passionate about her job while trying to combine different aspects of pharmaceutical world into one single concept: reliable production of pharmaceutical products in high quality and with significant added value. Petra strongly believes in focused team work and in workplace diversity. As such, she has a high appreciation of employees in Cayman Pharma as the most important moving force of the production process.

Drug Development and Project Management

• Project management is a key methodology to address the unique quality, regulatory and compliance requirements of the (bio)pharmaceutical industry. 
• This presentation will provide an overview about planning the needs, scope, resources to create a roadmap for a successful project planning and delivery.
• It will address the challenge how organizations can combine various project life cycles and embed innovation as a key capability in a structured project process.

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.

Audits and Inspections – Variety in Approach and Current Trends in Observations

• Variety in inspections approach (EU, US FDA, Rest of World)
• Current “hot topics” and observations trends
• Some “tips & tricks” for auditee

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.

Supplier Reliability & Product Supply (draft)

Nazima Hodžić is the Pharmaceutical Logistics Department Director with a demonstrated history of working for over 18-years in the pharmaceuticals industry. She is a strong expert professional with a Specialist Master of Pharmacy and a Master of Management certified in USA, with the focus on planning production, Supply chain, pharmaceutical technology, and science and economics business.

She has a proven track record of large-scale planning production and warehouse facilities with success. She is an expert in all aspects of managing planning production in order to maximize profit and minimize costs. She is bringing forth expertise in team building and leadership and quality control management. Nazima has the ability to coordinate stocks, production, and sales, build partnerships, and work collaboratively with all responsible persons and teams to ensure the timely and budget friendly completion of every project.

Risk-based Contamination Control Strategy in Sterile and Non-Sterile Manufacturing

• Risk Identification and Quantification
• Contamination and Cross-Contamination in Cleanrooms
• Case Study 1: Non-Sterile Manufacturing
• Case Study 2: Sterile Manufacturing
• Conclusion: key insights gained from both case studies and future advancements

Apostol Todorovski is the Quality Control Manager at Sinceritas EU, bringing years of expertise in ensuring rigorous quality standards in manufacturing. With a focus on managing QC processes, Apostol leads laboratory oversight, internal audits, and implements best practices to maintain product integrity and meet the highest industry standards. His proactive approach to quality management ensures consistency and reliability across all operations.

Successful Transfer of Finished Product from Contractual Partner - Technological & Quality Perspective

• Choosing the contractual partner and preparing the commercial agreement 
• Product transfer
• Changes from regulatory point of view
• QA activities after product transfer  

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.

Successful Transfer of Finished Product from Contractual Partner - Technological & Quality Perspective

• Choosing the contractual partner and preparing the commercial agreement 
• Product transfer
• Changes from regulatory point of view
• QA activities after product transfer  

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 Compliance Director 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.

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.