PROGRAMME & SPEAKERS

PHARM Connect Congress each year brings you an overview of the Central Eastern European trends and impacts on the pharmaceutical manufacturing & biotechnology world.

TOPICS & SPEAKERS 


POST EVENT INFORMATION
KEYNOTE PRESENTATION

 From Quality Metrics to Quality Management Maturity – Insights from the St.Gallen/US FDA Collaboration

 

Dr. Marten Ritz
Dr. Marten Ritz

Head of Global Projects | Operational Excellence, Production Networks, Smart Manufacturing at the Institute of Technology Management


Dr. Marten Ritz

From Quality Metrics to Quality Management Maturity – Insights from the St.Gallen/US FDA Collaboration


• How to operationalise Plant Performance and Maturity

• Linking OPEX Implementation to Performance

• Sustaining OPEX programmes over time

• An outlook on the future of regulatory surveillance


Dr. Marten Ritz is overseeing three research groups in the fields Operational Excellence, Global Production Networks and Smart Manufacturing at the Institute of Technology Management, University of St. Gallen, Switzerland. He joined the institute in 2018 and is responsible for the global industry projects across Asia, Europe and the US.

As the former head of the Operational Excellence research team, he brings extensive experience: Marten has supported numerous pharmaceutical companies in continuously improving operations in manufacturing areas and laboratories. Furthermore, he supported launching and maintaining Production Systems, KPI strategies as well as Quality Metrics programs in the pharmaceutical industry and beyond. His academic research focuses on Operational Excellence across manufacturing and quality control.

Marten holds a B.Sc. in Mechanical Engineering, a M.Sc. in Production Engineering with focus on Corporate Optimization from RWTH Aachen University (Germany) and a PhD in Management from the University of St.Gallen. Prior to joining the Institute of Technology Management, he researched at the Laboratory for Machine Tools and Production Engineering (WZL) and worked in process engineering as well as lean optimization with automotive companies.

KEYNOTE PRESENTATION

Strategies and Benefits to Deploy Digital Twins along the Product Life Cycle

Prof. Dr. Christoph Herwig
Prof. Dr. Christoph Herwig

Head of Research Group: Bioprocess Technology, Institute of Chemical Engineering


Prof. Dr. Christoph Herwig

Strategies and Benefits to Deploy Digital Twins along the Product Life Cycle


• Generic workflows to generate and adapt hybrid digital twins for biopharmaceutical processes

• Deployment of digital twins at different unit operations but also along the integrated process chain

• The benefits of this approach are: Robust control strategies for accelerated stage 1 and stage 3 process validation as well as prediction of process event to optimise productivity at consistent product quality


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. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle.

CASE STUDY PRESENTATION

Smart Target Selection to Enable a Personalized Medicine Approach and Optimize Clinical Development

Dr. Louis Boon
Dr. Louis Boon

CSO & Management Board Member, JJP Biologics & Principal Scientific Advisor, Polpharma Biologics


Dr. Louis Boon

Smart Target Selection to Enable a Personalized Medicine Approach and Optimize Clinical Development


• Personalized medicine and companion diagnostics

• Treatment of IgA-mediated autoimmune diseases

• Selection of antagonist anti-CD89

• IgA Rheumatoid Arthritis as new disease


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. 

CASE STUDY PRESENTATION

Factory-of-the-Future: How Digital Shapes the New Ways of Working at Takeda

Roland Straub
Roland Straub

Global Head of Digital Supply Chain


Roland Straub

Factory-of-the-Future: How Digital Shapes the New Ways of Working at Takeda


• Usage of automation, data and digital tools to reduce bottlenecks, increase capacity and improve the quality of our manufacturing network

• Impact of use of digital tools and robots on people capabilities and how they can shift their focus on value adding tasks


Experienced Senior IT & Supply Chain Manager with demonstrated history of working in Pharmaceutical and Fast Moving Consumer Goods industry (companies include e.g. Takeda, Coca-Cola Hellenic and Johnson & Johnson). Skilled in End-to-End Supply Chain Management, Strategy Development & Deployment as well as Business Digitization. Implemented various big change management initiatives in both digital and operational area and managed turn-around in business areas. At the moment he is thrilled to embark on a data & digital acceleration journey in a completely new business setting where he created a fully integrated Data, Digital & Technology function embedded in Takeda Global Manufacturing & Supply and Global Quality function.

KEYNOTE PRESENTATION

Bringing the Real Value from Digital Solutions for Industrial Operations & Quality in Polpharma

Łukasz Krause
Łukasz Krause

Group CIO


Łukasz Krause

Bringing the Real Value from Digital Solutions for Industrial Operations & Quality in Polpharma


  • Polpharma’s journey to embed digital solutions in business processes – from hype to rational
  • Usage of Internet of Things, Virtual & Augmented Reality to support business processes and bring real value to the organization

Łukasz acts as Chief Information Officer at Polpharma, the largest Polish manufacturer of pharmaceuticals and a leader of the Polish pharmaceutical market, which actively operate in the markets of Central and Eastern Europe, the Caucasus and Central Asia. He is focused on business-IT and data transformation as well as the implementation of innovative solutions to the organization's operations. Previously worked for the international and Polish energy sector, where he was responsible for IT transformation covering over 700-person team. Member of the CIONET Polska Program Council.

CASE STUDY PRESENTATION

The Road to Industry 4.0 in Novartis Technical Operations Poland

Przemyslaw Wierzbicki
Przemyslaw Wierzbicki

Project Engineer & Head of Continuous Improvement at Packaging Plant


Przemyslaw Wierzbicki

The Road to Industry 4.0 in Novartis Technical Operations Poland


• Novartis’s path towards Industry 4.0

• Cultural aspects: commitment, curiosity and process of continuous improvement

• Long-term strategy in different areas of our company

• Example of tools for automation and digitalization in our factory


Przemysław has over 7 years of experience in pharmaceutical industry. Currently, he is a Project Engineer and is responsible for continuous improvement in packaging plant. The experience includes particularly lean management tools implementation, implementation of IT systems supporting performance management, building and optimization of processes supporting production, problem solving trainings. Przemysław is passionate about inspiring colleagues to continuous improvement and to be curious.

CASE STUDY PRESENTATION

ICH M7 Assessment and Control of Mutagenic Impurities in Pharmaceuticals to Limit Risks

Dr. Piotr Lipiński
Dr. Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr. Piotr Lipiński

ICH M7 Assessment and Control of Mutagenic Impurities in Pharmaceuticals to Limit Risks


• ICH QM7 guideline content, purpose and applicability

• Impurities assessment, risk characterization with special focus on nitrosamines impurities

• Ways of mutagenic impurities control

• Lessons learned from ‘sartans case‘


Piotr has over 12 years of experience in pharmaceutical companies. Currently, he is a Global Quality Auditor in Novartis, 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.

CASE STUDY PRESENTATION

Smart PAT – Shifting Quality Control to the Shop-Floor

Giovanni Campologno
Giovanni Campologno

eMBA, Biopharma Segment Manager


Giovanni Campologno

Smart PAT – Shifting Quality Control to the Shop-Floor


  • New real-time measurement technologies that overcome the challenges of durability, specificity, and speed to measure PAT Critical Process Parameters and Key Performance Indicators during the process
  • Progressing digitalization to enable innovative process analytics (soft sensors), advanced process control (e.g. digital twin simulation), preventative maintenance, and asset management

Giovanni Campologno is a business development professional with experience in Biopharma, Chemical and Food Industry. Giovanni is working for the Business Unit Process Analytics by Hamilton Bonaduz AG as Segment Manager dedicated to the development of product and services portfolio for biopharma PAT applications: upstream and downstream. This includes active partnership with private industry as well as public organizations.

CASE STUDY PRESENTATION

Live Processes Around Electronic Batch Records (EBR)

Błażej Różański
Błażej Różański

Senior Production Systems Specialist, Department of Manufacturing Science & Technology


Błażej Różański

Live Processes Around Electronic Batch Records (EBR)


• Implementation of EBR and the surrounding processes in the production area

• Key conclusions from the implementation - expectations versus reality

• Quality assurance expectations and the production area perspective - stuck in the middle

• The batch release challenges caused by the implementation of EBR - laziness is the key to success


Błażej has over 5 years of experience in the pharmaceutical industry. Currently, he is a Process Engineer at Polpharma involved in the administration of MES and serialization systems.  He is responsible for the continuous improvement of employees in working with IT systems. The experience includes, in particular, the implementation of IT systems supporting performance management, the construction and optimization of processes supporting production and training staff in problem solving.

Błażej is a master's degree in the scope of Chemical Technology. He was participating as well in numerous courses related to GMP aspects in the pharmaceutical industry and is an active member of the PAS-X user forum.

AWARD PRESENTATIONs

 

- Winners' Project Presentations -

Apply for the 7th Central Eastern European Pharmaceutical Manufacturing Excellence Award!


BECOME A WINNER

 Winners' Project Presentations


The winners will have the unique chance to put their most outstanding products, services or best practices in the spotlight, by presenting their projects to the top pharmaceutical and biotechnology management professionals of the region aiming to raise their visibility on the professional horizon.

The organiser - TEG The Events Group - is supporting the winning projects with additional PR activities via more than 30 local and international media partners as well as associations highlighting the best innovations in each category.


For further information on the application process, please contact:

Katy Säurich
Head of Operations & Production
Email: katys[at]tegevents.eu

Tel: + 36 1 219-5725

CASE STUDY PRESENTATION

Product Life Cycle Management – Change Production Gx Mainset

Przemysław Młynarczyk
Przemysław Młynarczyk

Senior Process & OPEX Expert


Przemysław Młynarczyk

Risks Product Life Cycle Management – Change Production Gx Mainset


• New challenges ahead of the production of generic drugs 

• OPEX cost reduction – Opportunities

• Campaign production – Changing batch mindset

• Continuous process

• Industry 4.0


Przemysław has been associated with the pharmaceutical industry since 2002. He has experience in the area of production, manufacturing process technology, project implementation of new production devices, grow-up production volume, product transfer, and OPEX. He participated in many implementation projects and optimisation projects related to, for example, waste reduction, process efficiency improvement, improvement of materials and raw materials.

PANEL DISCUSSION

How to Increase the Flexibility & Reliability of the Supply Chain

• Lessons learned from COVID-19 and how to react in the future - Are we prepared for future outbreaks?

• Be ready for fast & flexible solutions - Manage disruptions – Ready for constant change

• Remote working – Ways of working in the future, esp. which pharma roles can be done remotely in the future and how?

• Chance for CEE pharma manufacturers to fill the existing vacuum / gap

• Impact on Supply Chains due to Russian war against Ukraine, following global sanction against Russia and Belarus, and voluntary exodus of many international companies from Russia

István Király
István Király

Managing Director


István Király
Ana Dzaleva
Ana Dzaleva

Sourcing manager


Ana Dzaleva
Roland Straub
Roland Straub

Global Head of Digital Supply


Roland Straub

PANEL DISCUSSION

Nitrosamines and Mutagenic Impurities – Challenges and Lessons learned from the Valsartan Case

.

Lenka Francišković
Lenka Francišković

Head of Processes and Products Quality and Lean Six Sigma Green Belt


Lenka Francišković
Dr Sergii Sur
Dr Sergii Sur

Regulatory Affairs Director


Dr Sergii Sur
Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor


Dr Piotr Lipiński

PLANT EXCURSION

Explore the enchanting world of factories as a PHARM Connect VIP visitor! Each year, participants of PHARM Connect are given a unique chance to visit and experience various pharmaceutical manufacturing sites of market-leading organisations.

16th MAY 2022

Plant Excursion to the Novartis Plant & Packaging Centre in Stryków

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 16th 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 16th May at 12:30 in the morning and will return after the visit at approximately 17:30.


Bulk – production:

Bulk unit in Styków (BCS) is 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 + 10 billion.

BCS plays significant role in Novartis Technical Operations network supplying over 8 billion tablets (from around 5000 batches) on yearly basis serving two packaging facilities in Poland as well as customers in Canada, Slovenia and Germany.

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 and torademide).

 

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:

PCS started operation in 2015 and it is one of the newest site in Novartis. We are operating on 13 highly automated packaging lines with potential to increase our capacity additionally up to 24 lines. Each year we are growing and our products are supplied to over 80 markets.

We have automated process:

  • flow of material (on production and on warehouse)
  • digital flow of production documentation
  • online monitoring production execution system which allow to us trace online results and problems on each line using laptop or even cell phone what ensures fast reaction
  • format parts washer that help us to reduce time of cleaning and drying.