Discovery & Development of JJP-1212, the first Polish developed biological with Orphan Drug Designation

---

• Smart target selection

• Personalized medicine

• Preclinical package

• First-Human strategy

---

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. 

Holistic Data Management & Digital Twins for Accelerated Product Life Cycle

---

• The product life cycle aims for efficient experimental design to obtain process knowledge and to make sure that process knowledge is transferable to manufacturing via smooth process validation.

• Digital Twins are a key enabler to capture and deploy process knowledge. We show cases and scientific approaches to develop and deploy digital twins for multiple applications in biopharmaceutical processes.

• Prerequisite for the shown approach is the holistic management of data of different frequencies and dimensionalities to obtain a contextualized data source.

---

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology.

The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. 

Belupo's Experience of Introducing a New Dosage Form into the Portfolio – How to become a Medicated Foams Manufacturer & Lessons Learned

---

Preview of requirements a pharma company needs to take in mind when planning to become a manufacturer of a specific type of aerosol product, medicated foams:

• design of production area and liquid petroleum gas storage,

• procuration of specific manufacturing and process control equipment,

• setting up of critical safety measures, and

• establishing processes in line with GMP and Aerosol Directive requirements.

---

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.

Unlocking the Therapeutic Potential of Synthetic Lethality in Cancer Precision Medicine

---

• Overview of synthetic lethality and its relevance to cancer precision medicine

• Case studies of successful applications of synthetic lethality in preclinical and clinical settings, highlighting therapeutic benefits and potential limitations

• Presentation of projects from Ryvu pipeline in the area of synthetic lethality

• Future directions for synthetic lethality research, including the identification of novel discovery models, new biomarkers and therapeutic targets using 2D Prime platform 

---

Dr. Brzozka is a highly accomplished Chief Scientific Officer at Ryvu Therapeutics, having joined the company in 2007. With his interdisciplinary expertise, he has played a pivotal role in building a robust pipeline of small molecule oncology therapeutics and a high throughput discovery engine platform. Dr. Brzozka is responsible for managing the early pipeline candidates, covering their full development until clinical phase, and he has brought two Ryvu first-in-class oncology programs into the clinic: dual PIM/FLT3 inhibitor SEL24/MEN1703 and SEL120, CDK8 inhibitor. He also sits on the board of Ardigen, a bioinformatics and precision medicine company, and played a key role in the founding of NodThera, a biotechnology company focused on therapeutics related to inflammasome biology.

Dr. Brzozka earned his Ph.D. degree from Ludwig Maximilian University and his MBA from the Stockholm University School of Business and the Krakow University of Economics Business School. He has contributed to over 70 scientific publications and presentations in areas of oncology, immunology, intracellular signaling, and medicinal chemistry. His publications have been cited nearly 3500 times and published in respected journals such as Science, Blood, Molecular Cell, and Oncotarget. Dr. Brzozka's extensive experience and contributions have helped to advance the field of oncology and bring innovative therapies to patients.

Increase Analytical Throughput with Laboratory Workflow Automation

---

• Challenge of multi-platform analytical laboratories

• How to generate high throughput analytics by improving processes and combining assets

• Impact of process changes and improved analytical hardware

• Challenges of multi-attribute analysis on large sample sizes

• Difficulties of cell based bioanalytical method automation

• Accelerated small scale technology optimization

---

László is a manager at Gedeon Richter pharmaceutical company with 11 years of biotechnology experience and a degree in chemistry and food engineering. He worked in various positions in the area of quality assurance, quality control, production and R&D. Currently, he works as the manager of small-scale biotechnology development and is responsible for managing a team of Experts, process and cell line performance optimization, development and validation of analytical and bioanalytical methods.

In his free time, László is interested in cultures and history, efficient management methods, reading scientific articles and books.

Molecure, a pioneering clinical-stage biotech company striving to become a global leader in the discovery and development of groundbreaking small molecule drugs targeting unexplored protein and novel mRNA targets, with a focus on OATD-01 as a case study

---

• Molecure, DNA, pipeline and key events
• Value generating programs
• OATD-01 history
• OATD-01 future

---

Marcin is a serial life science entrepreneur and investor, who has over 20 years of experience in technology transfer, R&D project management and investments. He has been involved in preparation and management of more than 40 R&D and investment projects with a combined budget of over EUR 250 m. His previous company, Medicalgorithmics SA, was the first Polish ICT company to introduce an FDA-approved cardiac telemetry solution to the US and global market. He was also responsible for business development and oversaw the first products cleared for marketing in Europe and USA. Marcin co-founded and has been the lead investor in an early stage seed fund with a portfolio of 11 innovative life science companies and 2 successful exits. He has been a member of the GLG Institute and assisted the European Commission on independent expert panels performing the impact assessment and interim evaluations of the Innovative Medicines Initiative the world’s largest public-private partnership in pharmaceutical research.

Me better and Me smart in IO Drug Development

---

• 'me-better' approach as a risk mitigation of project attrition

• 'smart clinical trial design' to create value infliction point in early clinical development

---

Dr Pieter Spee graduated as medical biologist/biochemist and later specialized in immunology and oncology during his Ph.D. in Amsterdam. He worked at Novo Nordisk, where he went from a scientist dealing with cancer biology, angiogenesis, and immunology, through positions of principal investigator, project manager, up to Director of the NK cell biology department and then taking the position of Director and Scientific Director of the Department of Translational Immunology. At Novo Nordisk he took part in the development of Lirilumab and Monalizumab antibodies that are now in late-stage clinical development. He has served, among others, as CTO of FibroTX in Estonia (skin diagnostics), and CSO of Tikomed in Sweden (preclinical and clinical development of IBSOLVMIR for the improvement of pancreatic islet transplantation). He is a co-inventor of 7 patents in the field of antibodies and has authored almost 30 scientific publications.

Continues Processes in the Pharmaceutical Industry

---

• What is Continuous Manufacturing?

• Parallel granulation

• Continuous coater

• Multilotting

• Benefits of continuous processes

---

Sylwia is a Manager, with 17 years of experience in working for the largest international pharmaceutical companies SANDOZ, ALCON in the area of quality, production, registration, logistics and distribution of medicinal products and medical device. Sylwia is a Certificate Coach ACTP IC, Certified internal and external auditor /GMP, ISO 9001, and ISO 13485.

Currently, she works on the position of Process Support Unit Lead in Bulk Production and is responsible for managing a team of Experts, optimization production process according to LEAN and long horizons planning of investments and initiatives to increase the production capacity of our bulk production.

After work, Sylwia is interested in psychology, modern management methods and personal development.

Continues Processes in the Pharmaceutical Industry

---

• What is Continuous Manufacturing?

• Parallel granulation

• Continuous coater

• Multilotting

• Benefits of continuous processes

---

Łukasz Lipiński is a graduate of the Lodz University of Technology, Faculty of Organization and Management, majoring in Management and Production Engineering, specializing in Logistics in 2007.

He started his professional career while he was in college, working in the FMCG market at Coca-Cola HBC Polska Sp. z o.o company. He has gained professional experience in many positions for 6 years. He was mainly responsible for: calculation of logistics indicators, inventory control and cooperation with distribution companies

Then Łukasz started working in the company Leroy Merlin Polska Sp. z o.o., in which he was mainly responsible for optimizing the efficiency of warehouse processes and for cost and efficiency control of the Logistics Operator.

Currently he is gaining experience in the pharmaceutical market in the company Lek S.A. / Sandoz (Novartis group), where he has been working since 2014. Łukasz started working in the SCM department, then Continuous Improvement. He was responsible for administration and creation of logistics databases, lead optimization projects and spreading a design culture based on the methodology Lean Six Sigma.

Currently he is working as an OpEx and technology specialist on the production manufacture of tablets, where he acted as the Production Coordinator. He implements optimization projects and is responsible for the standardization of technological processes.

Evolution of Real Time Monitoring

---

• 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.

---

Alex Guillen is an established executive with a proven record in global business and market development, with well-rounded experience in multicultural sales management and brand building. Alex has extensive experience and expertise in cold chain; as Director of Sales, Life Science and Pharma at Tive, Alex leads sales and business development within the company's rapid-growth Life Science division. Previously, Guillen served as a Board Member and leader of Corporate Strategy at SWITRACE S.A, a developer of temperature and humidity data loggers compliant to the Pharma and Biotech industries. Alex's extensive experience also includes serving as Global Cold Chain Director of Fisher Clinical Services, CEO of Escort Cold Chain Solutions SA, and Director for Commercial Operations for Novartis Vaccines.

Drug Manufacturing during One Year of War – Impact on HR, Logistics, QA & RA

---

• Influence on Ukrainian pharmaceutical market: customer decrease & changing needs, reduced healthcare infrastructure, decrease in orders for local products due humanitarian aid, partial blackouts, stoppage of work during air alarms - consequences for manufacturers, distributors, pharmacies and customers

• Staff is a main value for company's sustainability during the war: corporative program for staff support

• Interaction & cooperation with DRA during the war

• Main results of 2022 and prospects for 2023 and beyond

---

Dr Sur has over 30 years of work experience in the pharmaceutical sector, including 20 years in management positions. He received his PhD degree in Pharmacy and published over 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 Kyiv.

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 State Chief Inspector for Quality Control of Medicines.

Since 2005, Dr Sur has been responsible for the development of a functional strategy in R&D and RA of ARTERIUM Corp.; the development and implementation of R&D and RA business processes and structure; and the organisation of research, development and marketing authorization of new products on all markets. Since 2018, Dr Sur is the Director of ARTERIUM LTD and a Member of Company Directors Board.

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.

What makes a good Strategy for Outsourcing?

---

• How to shape outsourcing strategies and manage the transition using the example of a larger outsourcing project

• Resource-based view (RBV): Creating competitive advantage, risk management, efficiency gains, and change management strategies

• Importance of defining processes which avoid problems during the transfer of activities

---

Moritz is an organic chemist and MBA by education. He received his PhD in chemistry from the University of Mainz for his work on strained, axial chiral allenyl lactams and he is a graduate of the Open University Business School.  Moritz is a member of the EDQM working groups for excipients. At LGC Moritz has been leading the pharma services business for reference standards and served as strategic marketing manager. He gained significant experience in handling larger outsourcing projects which effect the organisation of departments.

Targeting Apoptosis for Anticancer Therapy: Updates from Adamed's Pipeline

---

• Apoptosis as a target for anticancer therapy

• Novel apoptosis inducing  molecules in Adamed pipeline

• Proapoptotic fusion protein at a Pre-IND stage 

• IND-ready MDM2 small molecule inhibitor program

---

Katarzyna is a Scientific Program Manager and Principal Investigator in Adamed's Innovative Department, where she is responsible for the development program of innovative anti-cancer biomolecules from lead optimization to IND/CTA. She is a preclinical development expert specializing in toxicology studies and supports other programs of new and generic drugs in the area of non-clinical studies.Katarzyna's educational background is in medical biotechnology, and her interests focus on cancer biology and cancer therapy. She graduated from Karol Marcinkiewicz Medical University of Poznan. She conducted her PhD research on recombinant silk protein carriers for anticancer drug delivery at the Greater Poland Cancer Centre in Poznan and Tufts University in Boston.

Plant Excursion to the Novartis Plant & Packaging Centre in Stryków

---

The congress also provides an opportunity to visit the Novartis Plant & Packaging Centre in Stryków, limited for 40 delegates and available on a first come first serve complimentary basis at 14:00 in the afternoon on 22nd May. This will last for approximately 2 hours and delegates will be split into two groups, 20 people joining a section focusing on production and quality and a further 20 comprising a group focusing on warehousing and packaging.

TRANSFER: The bus will leave from the front entrance of the Warsaw Marriott Hotel on 22nd May at 12:30 in the morning and will return after the visit at approximately 17:30.

---

Bulk – production:

Bulk unit in Strykow (BCS) is a modern, big scale facility production Centre focused on manufacturing of generic solid dosages drugs.

Facility opened in 2004 and originally planned for around 1billion tablets. Today, in the same foot print has an impressive capacity of over 10 billion.

BCS plays significant role in Novartis Technical Operations and supply two packaging facilities in Poland as well as customers in Canada, Slovenia, Germany and Asia market.

Innovative approach to mature generic products and fit to purpose and standardized equipment allows efficient manufacturing processes and as consequence very competitive costing for our customers and eventually for patients around the world.

Current product portfolio concentrates around alimentary tract and metabolism (mostly metformin) and cardiovascular (bisoprolol, ramipril, torasemide, atorvastatin, rosuvastatin) and in the near future Combo Products sitagliptin+metformin.

Growing product portfolio and market demand for our products urges us to optimize current processes and target the continuous processes. 

 

Quality:

Quality Unit consists of Quality Assurance and Quality Control. Quality Assurance teams are located according to main responsibilities – close to Production Unit for Operational QA and in the main office building for Quality Systems and Compliance.

Quality Control has QC laboratories in two locations. All our laboratories (chemical, microbiological and packaging material lab) are well equipped with modern techniques fulfilling data integrity requirements. In QC labs we test raw materials, API, finished products and packaging materials as well as environment. Central Testing Laboratory provides analytical testing services for other manufacturers in the scope of EU re-testing, stability testing and stability management. QC Lab is certified for Lean Lab management, supported with planning tools and continuous improvement. Next to QC team we have well-developed Analytical Science & Technology team responsible for analytical methods development, transfer, validation and equipment service. The design of the laboratories is compliant with GMP and HSE requirements.

 

Warehouse Management:

In Stryków we operate two automated warehouses dedicated to: bulk and packaging operations. The first one with a capacity of 8,2 k pallets supports bulk operations and is used for handling and storage of APIs, excipients and bulk manufactured locally prior it is shipped to Packaging Centres. The second one, with 50% bigger capacity (13,5 k pallets), started its operations only in 2015, is dedicated to packaging and used as a distribution warehouse for all products packed in Polish sites. Majority of its capacity is utilized by FDFs, the rest is consumed by primary and secondary packaging materials and bulk (both locally manufactured and imported from other suppliers). The warehouse and packaging operations are equipped with AGVs which ensure fully automated material between both operations. AGVs are also used on the production floor. 

Key numbers (2021):

1. Total pallets shipped to customers (Finished Dosage Form) ~ 72 k, over 1300 trucks
2. Total pallets received ~ 27 k
3. Total number of pallet on stock ~19 k

 

Packaging Center Stryków:

Packaging Center in Strykow has been operating since 2015.

We are one of the largest Pharmaceutical packaging site in Poland.

At our plant, we put operations safety first and the highest products quality.

We operate on 15 highly automated packaging lines with potential to increase our capacity additionally up to 24 lines. We are growing 25% volumes every year. Our current production capacity is more than 9 billion tablets per year.

We have innovative solutions in areas:

• robotization
• automatic material flow
• paperless production
• integrated support systems: MES, ERP, WMS, SCADA
• automatic washing and storage for format parts

 

We invite you to visit our plant!