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Hadley Myers serves as the JMP System Engineer Manager for the North-West EMEA subregion, supporting a team of JMP System Engineers to help clients maximize the value gained from JMP and increase the analytic maturity of their respective organizations. Prior to his current role, Hadley served as a JMP System Engineer in the Benelux and UK territories. He joined JMP in 2017 after having worked in the manufacturing and machine industries. Hadley is originally from Canada and holds a master’s degree and a PhD in electrical engineering from McGill University in Montréal.

Rolf Hemminga is an entrepreneur, team motivator and customer focused professional with over 30 years’ experience in the automation industry. In his current role, Rolf is leading the global life sciences sales and marketing organisation for Emerson Automation Solutions with particular focus on process control systems and level 3 manufacturing operations management.

Rolf is a process control and information technology professional with demonstrated skills in sales and negotiation, business leadership, account management building and leading business development teams. Rolf has also a strategic understanding and experience in operations and business finance.

Rolf has a motivated personality with emphasise on sustainable, profitable business growth and ethical values and sees himself as a team player helping to motivate teams and peers focused on obtaining results.

Rolf holds a Bachelor of Science degree in Computer Science, Telematics and Electronics.

Frederic is Global Head of Healthcare Quality Governance at Merck. He is a Doctor in Pharmacy from the University of Paris, France, with more than 35 years of experience in the pharmaceutical and life science industry - in Manufacturing, Logistics, Human Resources, Regulatory Affairs, Drug safety and of course in various Quality Management positions, in both GxP/ICH and ISO worlds.

Stefano Caruso is a global director of Procter & Gamble’s “Product Supply Manufacturing, Innovation & Capability center of excellence”.
Stefano is from Italy. His 20+ years of professional experience in P&G spans multiple supply chains, manufacturing sites and corporate functions.
He has worked in many areas of product supply: at country-, regional- and global level, from initiative planner to manufacturing execution roles, from site responsible to manufacturing excellence within and outside P&G.
He is recognized as a very pragmatic expert in applying and coaching the IWS methodology.

Abstract

P&G is widely regarded for its operational excellence capability. That capability has helped the company to transform the employee engagement and digitalization. Results are year-on-year program of cost saving, inventory reduction, service improvement, productivity gains, and employee satisfaction. In this presentation, you will learn about some critical leadership actions needed to accelerate and maintain the capabilities to achieve this level of performance.

I am Head of Operational Excellence for CSL Seqirus at the Liverpool manufacturing site in North West England, the only end-to-end flu vaccine facility in the UK.
I have over 25 years’ experience in use of Operational Excellence in fast moving consumer goods, agriculture, financial services and pharmaceutical manufacturing,
The first company I worked for after university was part of the Lean development pilot written about by Womack and Jones in “Lean Thinking”. I had direct involvement in many aspects of this on my graduate program, first as a production line supervisor, then as a forecasting manager and finally as a factory planning manager. I then worked directly as a shift leader, successfully applying many of the principles on the front line. My career has built on these foundations over the last 20 years. I have worked in the pharmaceutical, food, agricultural and financial services sectors, always taking greatest enjoyment and satisfaction in the development of people and the improvement of processes. I have learnt and grown in every role and hugely appreciate the support and guidance I have received from many talented and committed colleagues. Currently I am part of the CSL family, working in the influenza vaccination part of the business (Seqirus).
I have a Master’s Degree in Engineering and Business Management.

- M.Sc. in Mechanical & Process Engineering from Technical University Darmstadt
- Project Manager of MES rollouts in different locations around the globe
- Head of the global MES Competence Team

Abstract

Implementing a Manufacturing Execution System (MES) can be complex, and organizations may encounter various challenges along the way. Here are 10 common mistakes that can occur during MES implementation:

1. Insufficient planning: Failing to adequately plan and define project goals, scope, and requirements can lead to unexpected complications and delays.

2. Lack of executive support: Without strong support from top management, MES implementation may face resistance, lack of resources, or insufficient prioritization, which can hinder progress.

3. Inadequate user involvement: Neglecting to involve end-users and operators in the system design and implementation process can result in a mismatch between the MES and their needs, leading to low adoption and productivity issues.

4. Poor data integration: Integrating the MES with existing enterprise systems, such as ERP or other software applications, is crucial. Failure to establish proper data integration can result in data inconsistencies, duplication, or inaccurate reporting.

5. Overly complex customization: Excessive customization of the MES can lead to higher costs, longer implementation timelines, and increased maintenance efforts. Striking a balance between customization and standardization is essential.

6. Insufficient training and change management: Inadequate training and change management efforts can impede user adoption and result in resistance or confusion. Users should receive proper training to understand and effectively use the MES.

7. Neglecting scalability and future requirements: Failing to consider future growth and scalability needs can result in an MES that becomes obsolete quickly, requiring costly upgrades or replacements sooner than expected.

8. Incomplete testing and validation: Inadequate testing of the MES before going live can lead to system errors, data inconsistencies, or unexpected issues in production. Comprehensive testing and validation are necessary to ensure a smooth transition.

9. Lack of continuous improvement and optimization: Treating MES implementation as a one-time project instead of an ongoing process can hinder the organization from leveraging the system's full potential for continuous improvement and optimization.

10. Ignoring organizational culture and resistance: Resistance to change and cultural barriers can hinder MES implementation. Addressing organizational culture, communicating the benefits, and involving key stakeholders are crucial to overcoming resistance.

Avoiding these common mistakes and adopting a well-planned, phased approach with proper stakeholder involvement, effective change management, and thorough testing can greatly increase the chances of successful MES implementation.

Tomas is currently leading the Sweden Lean Academy based in Södertälje Sweden and is responsible for delivering and developing Lean Academy programs to customers across Global Operations. Tomas has got 30 years’ experience from the Pharma industry and has held a range of different leadership positions across AstraZeneca, both in R&D and Operations leading Lean implementation and cultural change. Tomas has got a MSc. in Chemical Engineering and a Ph. Lic. in Biophysical Technology from Lund University Sweden.

I have a PhD in Neurosciences and 23 years of experience in the pharma industry in different GxP environments (from clinical to industrial). Through my career, I held different positions at local level (auditor, shopfloor quality) and managed different quality systems at corporate level (audit, documentation, training, quality risk management, quality third party). I contributed to the implementation of the harmonized quality framework used today at Sanofi. I’m currently supporting our Business Process Owners in defining simplified, harmonized and compliant quality processes supporting the performance of the quality organization and contributing to the ambition of Sanofi.

I am an Analytical Chemist by study with 20 years of End-to-End supply chain experience from R&D Quality and New Product introduction to Internal and External Manufacturing up to Commercial Quality. Throughout my career journey, I have continuously helped shape the physical and data flow of products and turned to become passioned in digital. Today, I am leading a diverse team with a global footprint, reporting to the Q&C organization and dotted line to the Supply Chain Technology Group and I am responsible for the digital transformation of the global quality organization, fully integrated and aligned with our corporate "Digital First" vision.

With more than 10 years experience in the development of solid dosage forms, Mr. Kiehm joined Rottendorf Pharma in 2014 as Director Product Development.

Prior to joining Rottendorf, he served in various positions including section head of formulation development at Merz Pharmaceuticals GmbH and head of pharmaceutical and analytical development at B.Braun group. Mr.Kiehm is a registered pharmacist and holds a PhD in pharmaceutical technology.

Currently Kevin serves Rottendorf as the Director of Bulk Manufacturing.

Petter Mörée is leading Seeq life sciences market globally, this market has been assigned by Seeq BOD as the first key market for Seeq. Before, Petter was the managing director of EMEA and industry principal for life sciences and pharmaceuticals at Seeq Corporation, Petter formerly served as the industry principal for life sciences and pharmaceuticals at OSIsoft, now part of AVEVA, for seven years, where he was responsible for growing its life sciences customer base globally. Prior to that, Petter spent 17 years at MKS Umetrics, now Sartorius, where he led product management and the sales organization for the U.S., Europe, and Asia as the Global Sales Director. He holds an M.S. in chemical engineering and chemometrics from Sweden’s Umeå University. His specialties in data analytics started when studying for Professor Svante Wold, the inventor of chemometrics and multivariate analytics.

Born in Latina (Italy) in 1976, Graduated Master Degree in Telecommunication Engineering at “La Sapienza” University in Rome.
In 2003 I Joined Janssen in the Commission & Qualification Dept. In 2012 I moved in the Operations as responsible for the Formulation Area, including Continuous Mfg and Technology Center. In 2020 I took the responsibility of the Digital & Strategy team and in 2022 I extended my responsibility also to Bex.

In her current function, Catherine is leading the digital transformation in Industry within Michelin; it represents more than 70 sites in 17 countries on the 3 continents; she is focusing on the digital transformation for the 50 000 frontline workers; she put in place a BOTTOM-UP method to support her vision and associated strategies. She had experiences in different domains Research & Development, Marketing&Sales, Distribution and now Industry mainly in strategy & transformation in order to put in place new products on the market, new way of working & new mindset for people.
Her extra professional activities are very close to protection of environment: manage 20ha of forests, herbalist, beekeeper.
Catherine grew up in France and holds a diploma of engineer from EFREI school at Paris.

Abstract

Digital transformation is a long journey process to accompany our People in plants (Frontline workers & Business unit leaders); it requires methodology through a vision, strategies, a roadmap and also an opened mindset, a glimpse of creativity and an out of the box thinking; a continuous accompaniment along the years also stays key.
Don’t be afraid to put in place new method/new way of working: it’s part of the success to sustain our people in the digital world. After 3 years where I onboarded our people in plants, we started to harvest the fruits with digital: empowerment, attractivity, agility and at ease with digital tools.

Christian is a food chemist by education with a PhD from the Technical University of Munich, Germany. He joined Merck in 2007 and has held managerial and project management positions with increasing responsibility in development, launch management and analytical life cycle management. Since 2021 he is heading the Global Quality Control unit within Merck’s Healthcare Quality organization. In this position he drives the digital transformation, the implementation of new technologies, standardization of processes and the collaboration across the global network of Quality Control units

Abstract

Quality 4.0 is a great opportunity to maximize quality process performance to assure we deliver the right Healthcare product to the right patient at the right time. It is key to have the digital foundations in place to realize the value of data and to move to Quality 4.0. Our Quality 4.0 digital journey includes the #Futurelab program, which builds the foundational systems in quality control labs (Global Laboratory Information Management System, Global Chromatography Data Systems, Scientific Data Management System, Lab Scheduling Tool) to digitalize and automate lab operations, moving away from isolated, siloed applications towards global and connected solutions.
Moreover, a proactive approach is being embedded in our Quality organization by digitalizing substantial quality processes such as Supplier Quality Management.
With data from multiple systems, being available in a centralized platform, we are looking forward to move towards predictive quality, anticipating quality events by having an end-to-end product risk profile.

Valeria Palvi is a Pharmacist by Education with 15 years of international experience in local and global quality leadership roles, with a broad expertise in Quality management processes, Compliance, Computerized System Validation, Project Management and Digital Quality. She is currently the Head of Global Quality Systems, Digital and Data Governance at Merck Healthcare Quality, responsible to define and implement the strategy and governance for the Quality Management Systems, Digital & Data roadmap definition & prioritization as well leading Computerised Systems Validation & Data Integrity global teams. She is currently based in Darmstadt, Germany.

Grew up in Pisa, Italy, she has always been attracted by the healthcare sector, because she wanted to help people who suffer to improve their quality of life.
For this reason, soon after she graduated in Pharmaceutical Chemistry at the University of Pisa with maximum grades, she started working in pharmaceutical industry, covering different quality and production roles in manufacturing companies of life savers products, as Novartis and Eli Lilly.

Those experiences gave her the chance to be very close to sterile production processes and to obtain the QP certification.
She joined Takeda in 2018 leading the Visual inspection department at Pisa site and today she is one of the leads of the Takeda global initiative “Factories of the Future” for the Plasma Operational Unit with the responsibility of defining the vision and deploying the standard of new technologies in visual inspection and packaging processes for all the production sites.

Abstract

We no longer live in an incremental world: exponential waves of innovation that create disruptions and paradigm shifts are the new normal.

Pushed by its strong purpose, “Better Health for People, Brighter Future for the World”, Takeda decided to be both the surfer and the creator of a new disruption wave in pharmaceutical industry and launched the global initiative “Factories of the Future” in Plasma Operational Unit in 2020.

In this presentation, I like to walk you through this exciting and complex journey I’ve been involved since the beginning and that it is still ongoing nowadays. The goal is to share a direct experience on how Takeda is transforming Plasma sites in Factories of the Future, including best practices, common pitfalls and lessons learned until now.

Mike is currently leading the UK Lean Academy team, based out of the Macclesfield facility and is responsible for delivering and developing the Lean Academy programmes to customers in all functions within Global Operations.
Prior to joining AZ, Mike held several improvement and operational leadership roles within the Aerospace industry for Airbus, building upon his MEng in Aerospace Engineering.

Tomas is currently leading the Sweden Lean Academy based in Södertälje Sweden and is responsible for delivering and developing Lean Academy programs to customers across Global Operations. Tomas has got 30 years’ experience from the Pharma industry and has held a range of different leadership positions across AstraZeneca, both in R&D and Operations leading Lean implementation and cultural change. Tomas has got a MSc. in Chemical Engineering and a Ph. Lic. in Biophysical Technology from Lund University Sweden.

Daniel studied industrial engineering in Karlsruhe and began his career as an Industrial Performance Specialist at Nestlé in Frankfurt. His first years mainly involved Lean Six Sigma projects and Total Performance Management. After being certified as a Master blackbelt, he established the continuous improvement structure as Market Pillar leader for all Nestlé factories in the German and Austrian market. In 2012, he then worked as production manager at Nestlé Purina before taking on the position of factory manager at Coca-Cola European Partners in 2015. In 2018, he moved from the FMCG industry to the pharmaceutical industry as Site Director at Grunenthal in Aachen. Since April 2022, Daniel has been Head of Operational Excellence at Lonza in Visp/Switzerland, focusing on lean leadership, improvement tools and cultural transformation.

Ole joined Novo Nordisk in 2011 as Corporate Vice President of Manufacturing Development for Devices and Finished Products with responsibility for all marketed devices and all Finished Product equipment and processes.

In 2020, he was announced head of Technology and Digital transformation for Novo Nordisk Product Supply.
Ole has a background as Mechanical Engineer from The Danish Technical University and has held several management positions in Nokia Denmark from 1989 to 2011.

Additionally, he is a member of the board of EYE-GO A/S in Denmark. EYE-GO is a Danish-based MedTech start-up developing disruptive eye care technologies.

Abstract

How do you go from lighthouse to scale and maximise the impact on your business?
In Novo Nordisk Product Supply, massive investments are being made to ensure a strong foundational target architecture and harmonising IT/OT. While we strongly encourage and rely on local innovation in Line of Business addressing ideas to optimise processes, increase efficiency, and work smarter, the centralisation of foundational solutions enables the scaling of these solutions across the organisation – thereby, strengthening the impact.
Examples of concrete use cases from the Product Supply business and journey of scale will be presented to exemplify what it takes to go successfully from lighthouse to scale in a Novo Nordisk manufacturing context.

Over 25 years of experience in the industry, first 10 years with Dupont, the last 15 Years in Lonza
Head of Training, Biologics Operations Visp 2018 – today)
Head Lonza Error Prevention System (2014 – 2017)
Head Operational Excellence Lonza Chemical Manufacturing (2010 – 2013)
Lean Six Sigma Master Black Belt DuPont Performance Coatings (2006 – 2009)
Six Sigma Specialist & Process Safety Manager DuPont Herberts Automotive Systems (1999 – 2005)
Study & PhD. Thesis at University of Hanover 1997

Abstract

Adding proven digital technology such as virtual reality training for muscle memory and augmented reality for real time guidance to supplement classical training methods, has proven to increase training effectiveness for surgeon students, helicopter and airline pilots as well as astronauts.

Virtual Reality and Mixed Reality (VR/MR) training at Lonza decrease “door-to-floor time” by around 60%, reduce training costs, eliminate the trainer-time bottleneck, increase the productivity of new hires, and enable on-demand retraining of employees without additional expense. All these benefits add up to ensure higher-level operator performance, required for higher-quality processes and products with fewer costly errors at the same time.

Andreas currently is site IT Lead, business partner, and member of Senior leadership responsible for driving and continuous improving infrastructure and service portfolio supporting manufacturing operations for a cancer drug, valued at $1+ Billion annually.

Until 2014, Andreas served as the Medtronic’s site lead of IT and member of the leadership team in Arizona. He also had global responsibilities for critical applications used in Manufacturing across 10 Medtronic facilities located in Europe, Asia, Puerto Rico and the US supporting revenue of $7 Billion annually and a user base of 4,500+. Prior, Andreas spent more than 10 years in the Semiconductor Industry, Financial Industry, and IT Industry. He started his career with Sun Microsystems, Germany as a consultant and inside sales representative, and after two years moved to a start-up in the financial risk management sector. Over the next 6 years he rose from a System Integrator and SW consultant to IT/Engineering Manager at a start-up company in the Semiconductor sector.

Andreas holds a Joint Masters of Business Administration and Industrial Engineering degree from University of Applied Sciences Munich, Germany.

In her current function, Isabelle is leading the Digital & Technology team of a critical manufacturing site within the Johnson & Johnson network located in Schaffhausen, Switzerland. She is part of the Site Leadership Team. In her role she drives the digital & technology roadmap to support the site in achieving it’s defined key strategic goals. She is leading a pillar in the WLI (Women Leadership Initiative) of the internal Employee Resource Group, sharing her lessons learned and supporting other women to overcome struggles and finding their way in business.
Isabelle has many years of experience in the IT sector. She led big projects in the areas of batch traceability, analytics and financial reporting in the pharmaceutical and banking sector.
Isabelle grew up in Switzerland and holds a master’s in Business Information Technology from the Hochschule Luzern and certificates on Digital Business Transformation from MIT and IMD.

Global Lead for AstraZeneca Lean Program and owner of the AstraZeneca Supply System (AZSS).
Multiple years’ experience delivering business value through embedding of Lean/Operational Excellence capabilities across the end to end supply chain, including the external supply base.
Fellow of the Institute of Engineering Technology and Chartered Electrical Engineer with 20+years’ experience of Technical/Engineering Leadership within Petrochemical and Pharmaceutical sectors.

After studying electrical engineering Martin Fuseks career started as a project engineer and later as a project manager and quality manager for MES at Propack Data GmbH. In 2005, he moved from the vendor to customer site and hold various IT management positions within Merckle Biotech and later in the Novartis group. In 2019 he took the role of Global Program Manager Manufacturing at Merck KGaA, before he joined Roche in 2021 as Head of Manufacturing IT.

Dirk Schrader is CEO and co-founder of Goodly Innovations. A Pharmacist with PhD in pharmaceutical technology, he has been responsible for more than 40 pharmaceutical manufacturing sites and technical operations organisations at Bayer Pharma, Bristol-Myers Squibb, AstraZeneca, Vifor Pharma and Insud Pharma, often including supply chain, project management, product development, purchasing and quality management.
He was Country General Manager and Regional Commercial Head for Bayer and led AstraZeneca's global Lean Operations programme. Dirk is currently also a member of the Advisory Board at AMW, a medium-sized German pharmaceutical company.

Mathieu des Robert is Global Quality OPEX Manager at Novartis. A Master Black Belt Lean Six Sigma, Mathieu has supported several companies during their Opex journey; from gaining efficiency to digitalization. Mathieu specialties include Margin Analysis, Kaizen, Datamining, MRP, Innovation, VSM, Change Management, Business Excellence and Empowerment

Marie-Helene has 33 years Engineer career and has been 100% dedicated to industrial operations from Rhone Poulenc to Sanofi and has experienced most operational functions covering in heavy chemicals Chemistry to Pharma industry. Marie-Helene conducted massive Sites and industrial regional hubs masterplans, defining strategy and tactics to implement and participated to a fantastic 10 years journey

Jerome is pharmacist by education. After joining Solvay Pharmaceuticals, now Abbott, as a production head, he spent 8 years working in different roles in France, including the construction of a green field site back 2002, with a full MES. After running a lean transformation program, he joined Ferring in Switzerland where, over 11 years, he occupied several positions in production, manufacturing excellence and Lean Six Sigma and also headquarters, becoming lately head of Operational Excellence & digital, reporting to COO. Just 2 years ago, Jerome joined Sanofi HQ Industrial Affairs, in Paris, as head of MES program (called MARS for MES Accelerated Roadmap at Sanofi)

Dr. Tim Noetzel is currently Manager of Lab Data Solutions within Roche Pharma IT at Biotech Production in Penzberg, Germany. In this role, he leads a team responsible operating the Sm@rt Line Data Cockpit (SDC), the Laboratory Management and Information System (LIMS) as well as several equipment entities. Prior to his role in Lab IT Tim was responsible for operating a large eukaryotic cell culture fermentation line as well as seed train cultivation, fermentation process analytics and served as responsible production process owner.
Tim partners with Operational Excellence, Quality Compliance, Pharma Research and Roche Applied Science to improve efficiency, productivity and product quality. Tim holds a PhD in molecular cell biology from the Technical University of Dresden and has worked as a research scientist for the Max Planck Institute of Molecular Cell Biology and Genetics in Dresden.

Fabio is a computer engineer and EMBA with expertise in program management within the IT 4.0 sector. With a strong background in pharma manufacturing, he has held various global positions at Baxter, Takeda, and Merck. Since 2023, Fabio has been serving as the Global Manufacturing Platforms Director at Kenvue. In this capacity, he leads a global team of senior managers, overseeing the IT/OT transformation and the implementation of various manufacturing systems such as MES, CMMS, Serialization, and performance management.

Abstract

IT/OT convergence offers significant advantages and opportunities for organizations. By integrating IT and OT systems, businesses can streamline operations, improve efficiency, and enhance decision-making processes. However, managing global platforms and adopting a technology-oriented perspective require careful planning and consideration of various factors. Establishing effective operating models is crucial to ensure successful IT/OT convergence and maximize its benefits.

Born in Barcelona. More than 20 years of experience in the chemical and pharmaceutical industry in functions related to production. In recent years I have been based in Germany, next to Hamburg. Working for the company Almirall Hermal GmbH, a subsidiary of the Spanish company Almirall S.A..

In recent years I have combined the responsibilities in the daily business of the factory with the leadership and implementation of different solutions in the field of production. Manufacturing Execution System, (paperless and with "review by exception"), Scheduling system, Master data management and Track and trace. Currently I am working in the deployment of MES in our factories in Spain and the implementation of a connectivity layer as part of the digitalization road map.

Change Agent with 14 years of experience in a multinational context, my professional career began about one year before graduation in Management Engineering obtained in 2009. For more than 13 years I am working on Continuous Improvement & Operational Excellence projects related to the implementation of Lean Production methodologies in industrial area, deepening my experience within several different sectors (white goods, mechanical and most recently Pharma) and obtaining important certification like APICS CPIM.

Some of my strengths are a strong propensity for mediation and negotiation and the ability to communicate effectively to others; these qualities, combined with a healthy dose of pragmatism and tenacity, have often driven me towards achieving objectives.

Abstract

In my presentation I will tell about a success story for the eOEE digital tool launch in the Sanofi Scoppito site in Italy, specialized in mfg & packaging of oral solid pharma forms (tablet and soft gel capsules). Specifically, I will cover all the most important aspects of this successful implementation: effective PM for the launch, performance governance upgrade basing on the new tool/data available and engagement system to embark the department team in the improvement journey.

As Performance/Operational Excellence director of Ipsen Pharma Biotech* in the south of France, Frank Meinderink is a veteran of many improvement projects (great and small), a mentor to numerous continuous improvement practitioners and driver of business transformations in several large pharma companies.

His current mission is to sustain and refine the systems and processes that earned Ipsen Pharma Biotech the Shingo Prize in Feb 2020.

Frank’s own journey to excellence has been fueled with an unrelenting passion for empowering people and achieving sustainable results as part of various global organisations over the last 20 years.

Frank has a Master’s degree in Chemical Engineering from the University of Groningen (the Netherlands) and has been black belt certified since 2008. He has a special interest in change management and dabbles in NLP (Neuro Linguistic Programming) on the side.

*Ipsen is a global specialty-driven biopharmaceutical company focusing on oncology, rare diseases and neurosciences.

Martin combines engineering skills and entrepreneurship: while working as an assistant scientist in process engineering at the RWTH Aachen (Aachen University of Technology) from 1996 - 2002, he founded aixprocess company for technical consulting and simulation services in 2001. In the following years, he established aixprocess as one of the leading simulation providers in Germany, building up a team of > 20 highly qualified experts for modeling and simulation. Comprehensive engineering with a focus on cyclone, fluidized bed and high temperature process technology complement the portfolio as a process optimisation company with international customers throughout the process industry.

In 2015, Martin initiated the development of aixProM software platform for real-time Big Data Analytics and online process digitalisation – joining well-established engineering models with Big Data statistics and AI

Ib Alstrup is a Medicines Inspector, GxP IT, with the Danish Medicines Agency. As an electronic engineer, he has many years of experience in software design, test and quality assurance from within and outside the pharmaceutical industry. He joined the agency in 2017 and leads their work of inspecting industry’s use of IT systems across all GxP areas, focusing on the integrity and trustworthiness of systems and data including the validation and safe operation of systems; and lately, the use of AI/ML in critical applications, for which he has proposed a set of questions. He is a member of a long list of drafting groups writing guidelines for industry within the different GxP areas at a national, EMA and PIC/S level, e.g. the PIC/S DI Guideline, the draft EMA Guideline on Computerised Systems in GCP and the revision of the EU and PIC/S GMP Annex 11, which he is chairing.

Antonio Buendia, Director of Automation, Global Industrial Operations, GSK vaccines

Antonio Buendia joined GSK Vaccines as Director of Automation, Global Industrial Operations, in August 2019. He is a member of the Global Engineering Lead Team

At GSK, he is responsible for establishing and executing the Automation Strategy, aiming to secure OT assets, setup the right foundations, simplify, and enable the next wave of productivity gains.

Antonio joined GSK from Novartis where he was Global Head of Automation of Novartis Pharma. Before that, Antonio had roles of increasing responsibility at the Madrid Factory of Eli Lilly where he contributed to transform a local market supply site to OUS launch site.

Antonio has more than 25 years of experience in the areas of Industrial Automation, Operational technology, Project management, Facilities master planning, solid dosage, liquid dosage, R&D laboratories, and qualification of facilities, utilities and equipment.

Antonio holds a Master of Industrial Engineering from the University of Comillas in Madrid.
Antonio is a founding member of the ISPE Spain, which chaired from 2007-2009 and as well as a member of the international board of Directors of the ISPE, Tampa from 2009-2011

Abstract

GSK is paving the way towards the factory of the future.
Together with traditional programs such as MES, we are digitalizing our operations.
There are four key programs that are providing clear business benefits
• Tertiary packaging optimization
• Real time process monitoring
• PAT
• Digital Twins
There are two main pitfalls
• Pilot Purgatory
• Island approach
To avoid those pitfalls, and to be able to deploy at SCALE, we are following a disciplined approach that focus on setting up the right foundations.
We have set up a Technology roadmap to define priorities and what are the foundational element to enable the “advanced” digitalization initiatives

Dirk has 25 years of experience in the pharmaceutical industry, in technical as well as commercial roles, in global headquarters as well as in emerging markets, particularly 13 years in the Asian region.
Between 1992 and 2005 Dirk worked at Bayer Pharma as Head Technical Operations in Beijing/China, Senior Vice President International Technical Operations with accountability for Bayer’s sites in LatAm, Europe and AsiaPac/Japan, General Manager for the Healthcare Businesses in Taiwan and as Head of a regional European Diagnostics/Diabetes Care business based in Switzerland.
Then he moved to Singapore as VP Operations & Supply Asia Pacific/Japan for Bristol-Myers Squibb and in 2007 changed to AstraZeneca, first as VP Supply Asia Pacific/Japan in Singapore and from 2010 as Global VP Lean Operations in the UK.
In 2012 Dirk joined Vifor Pharma in Switzerland where he is EVP Global Head of Technical Operations.

Vincent Fender is holding a Master’s Degree in Information System and Management at Grenoble Ecole de Management. He is working at Lilly as IT Director for Supply-Chain, MES and Serialization solutions, in charge of a Global IT organization. He has 30 years of IT and business experience, in industrial environment and pharmaceutical operations, and is actively engaged in Industry 4.0 and Digital Transformation programs.

Chris Morse has more than 30 years experience in the process automation industry, including project execution in the Pharmaceutical and Specialty Chemicals markets specializing in batch processes. He is qualified as a Chartered Engineer and based in the UK. Currently Chris is responsible for the development and roll out of batch products within Honeywell Process Solutions. Based on his long-time experience Chris knows perfectly well the complexity of issues in the definition, implementation and lifecycle management of an automation system in the Pharmaceutical industry and their impact on end user business results. He understands the need for automation solutions which provide production flexibility with an acceptable level of effort to maintain them in a GMP environment.

Silke Huster joined Rottendorf in 2007. After serving Rottendorf in different leading positions, since June 1st, 2018 she holds the position as Rottendorf’s Executive Officer for Commercial Operations. Prior to joining Rottendorf,

Silke Huster held leading IT positions mainly in the IT industry. Throughout her career, she gained extensive international work experience.Silke Huster holds a degree in chemistry and a PhD in chemistry from the University of Bielefeld (Germany).

After Dirk Hendrik Kneusels completed his studies of applied physics in Wiesbaden, Germany, he entered the business of packaging security. As a developer, he invented products like optical control devices for primary and secondary packaging materials as well as initial tools and systems for packaging optimisation.
Based on his sound knowledge and due to his ability to describe complex solutions in an easily comprehensible way, he first moved into project management and ultimately into sales. His efforts and initiatives were followed by a successful expansion of his know-how within the fields of packaging security and pharma-specific requirements.
After several years of being the Managing Director of Laetus GmbH with the responsibility for implementing a new organizational structure and efficiency increases for the international Laetus Group, he joined Antares Vision in 2014 , building up the branch for the German speaking area . Thanks to his sound experience in the pharma-related T&T business, he is well known and accepted in the industry when it comes to clear structured answers in regard to technical but also strategic and business-related questions

Co-founder of the company in 2006. With his endless imagination, he sets the direction for the development of systems and solutions. With his approach to production, he repeatedly proved that the unique combination of automation and IT brings great results for business. To this day involved in over 500 implementations in factories of various industries on 5 continents. Passionate about sailing.

Bachelor's degree Industrial Engineering
In total +30 years IT/OT project experience both on customer and vendor site. For more than 20 years focussing on Life Sciences (R&D, Clinical Supply and Production).
Specialties: Smart Manufacturing, IT/OT Convergence, Network/Cyber Security, Data Integrity, Analytics, MES, Data Historians, Plug & Produce with CMOs or OEMs, Enterprise Agreements.
Together with my local Account team members consistently deepening global client relationships. Understanding our client’s industry, growth strategy, operational goals to identify how Rockwell Automation solutions can make value contributions to their business. This includes the potential possibilities and implications of emerging trends, regulations and product collaboration.

Frédéric Zwahlen holds an MSc in Biochemistry from the University of Geneva (Switzerland). Since 1989 Frédéric has worked in various managerial positions in the areas of Quality Control and Manufacturing at Roche Diagnostics in Switzerland. In 1998 Frédéric moved to CSL Behring as Head of Quality Control. Frédéric joined Vifor Pharma in October 2001 as Head of Manufacturing and Supply Chain. He then went on to be appointed as the Vice President and Head of Supply Chain and Contract Manufacturing. In January 2011 Frédéric became Site Manager of Vifor Pharma in Fribourg and Basel. In 2014 Frédéric moved to Geneva to become Site Manager of OM Pharma in Geneva and Lisbon. In 2016, he moved back to Fribourg to become Head of Pharmaceutical Manufacturing for sites Basel, Fribourg, Geneva and Lisbon and in addition was appointed Site Head Glattbrugg Headquarters and Senior Vice President in 2018.

Dr. Inka Bosse started her career in the pharmaceutical industry as manufacturing manager at Hoechst AG. Afterwards she was working as Lab leader in QC. Later in Quality Assurance she took part at implementation of Quality Assurance Systems in Hoechst Marion Roussel. From 1999 until 2011 she was responsible as Regulatory Liaison CMC for all drug products manufactured at Sanofi-Aventis GmbH, Frankfurt. She was Quality Head and Qualified Person for two manufacturing units at Sanofi before she joined MSD International GmbH, Global Biologics Sterile Quality, Life Cycle Management in October 2017.

Manager with more than 18 years’ experience in managing interdisciplinary / global projects, global / local improvement programs and develop site strategies
Large expertise in lean six sigma, site strategy development, engineering, technology and product development, risk and quality management as well as development of new suppliers structures
Driving cultural change and organizational transformation. Numerous successes in building new / transfer company locations and product
Combines technical and business knowledge with distinctive hands-on mentality
Manager with over 18 years of cross-cultural international experience, strong ability to adapt to diverse work settings and teams, solid academic background and leadership skills. Comprehensive experience in all stages of project management.

Broad experience with starting- and ramping up various pharmaceutical productions in Denmark, China and US. Both in a technical, compliance and inspection readiness context.
Past job experience Director and Senior Manager in Bavarian Nordic, Novo Nordisk and Xellia Pharmaceutical in various production setups.

In more than fifteen years of experience in the pharmaceutical business, I have been covering roles with increasing responsibility in different functions, from Commercial to Industrial Operations and Quality. I am specialized in strategic, cross functional programs, managing staff and providing Senior leaders expertise and support in driving improvements within the organization, through well-structured and well-monitored initiatives. I possess a strong background in cross-functional leadership, change management and stake-holders management, and more pharma specific projects (like Facility start-ups and technical transfers).

Philip Gammell has 26 year’s experience in the Bio/Pharma industry ranging from large scale Biopharma (vaccine) manufacture to Oral Solid dosage, Sterile fill finish and complex packaging. Philip is experienced in Validation, Manufacturing, Engineering & Project management, Technology transfer and process development. Philip is currently a member of Astellas’ Global Engineering function, responsible for globalisation of the Engineering function in Astellas. Key focus areas include establishing Global Engineering standards, leading innovation and technology developments and implementing Engineering best practices across Astellas’ Global Sites.

Head of Global Operational Excellence and member of Strategy & Business Operation (SBO) leadership team created late 2017 with the mission to accelerate transformation of Global Healthcare Operation into a competitive advantage for Merck. Working in strong collaboration within SBO (e.g. Strategy, Digital & Organizational Excellence ) and with the various functions & sites to generate business results through strategy execution and deployment of Operational Excellence mindset & behaviors.

Over 20 years’ experience in the Global Healthcare division of Merck in Quality and Operational Excellence. In depth experience in Biotechnology quality operations for clinical & commercial productions, working in small CMOs as well as larger sites and global function. Management experience with operational teams as well as virtual team management in cross functional environment. Pharmacist with a Master in Quality and certified as Master Black Belt Lean Six Sigma. Passionate by improvement & transformation programs requiring advanced analytical skills and change management leadership. I am French and have 3 children

Robert Mühlhaus studied Chemical Engineering and received his PhD at the university of Essen (Germany). He started his professional career in process development for Degussa (today Evonik). After joining Merck he worked for several years as development engineer and project manager for the specialty chemistry division often with a strong focus on data-analysis, modelling and Six Sixma methodology (he is a certified Six Sigma Black-Belt), and increasingly with a global dimension. In his current position in Merck Healthcare he is leading the global program for scientific data management for Pharma Manufacturing and acts as lead expert for data management, data analysis and statistics.

Elliott has extensive experience in helping organizations develop action oriented corporate strategies that offer a clear ROI for stakeholders. His experiences span Pharmaceuticals, Oil & Gas, Media, Telecommunications, Capital Markets, Transportation, Banking, and Asset & Wealth Management. Prior to joining Element AI, Elliott was a Senior Consultant with Monitor Deloitte focused on designing strategies closely tied to shareholder value analyses and tactical operating models. He holds a Bachelor of Commerce from McGill University and is a Chartered Financial Analyst (CFA).

Bernard Cubizolles is the global product marketing manager for the GE Digital industrial software products. He has been with General Electric for over 15 years and holds a PhD in applied physics. In his 30-plus-year career, Bernard has become a recognized expert in the process industry. His expertise in industrial automation helps companies achieve real value from the Industrial Internet. By using software and mobile solutions, Bernard believes infrastructure and manufacturing executives can transform big data into actionable information and knowledge.

After being bioinformatic project leader for biotechnology laboratories I joined Sanofi Pasteur. In my previous job, I developed several software to quantify proteins analysed by mass spectrometry. For Sanofi Pasteur, I work for the Manufacturing Technologies department whose purpose is to optimize the manufacturing processes of vaccines. To that end, my role is to develop and support the digital 4.0 strategy in order to perform data analysis and anticipate results using advance analytics methods such as machine learning approaches.

Ben Dionne is the Director of the Drug Substance Technology and Engineering team in Cambridge, MA. Ben leads a team of engineers responsible for interfacing with Early and Late stage Process Development partners to design and transfer processes to manufacturing sites across the Amgen network as well as for transfers and commercial support for biologics drug substance GMP manufacturing at CMOs globally. He has over 20 years of experience, working with bench scale and large scale biologics in fermentation and mammalian cell culture. Ben holds a Ph.D. from the University of Manitoba with a thesis focused on cell culture parameters and their impact on glycosylation of recombinant proteins.

Steven Driver, Ph.D. has over 30 years of experience in engineering, project management, mechanical system design, commissioning, and energy auditing. Steve is an alumnus of Northcentral University where he earned his Ph.D. in Engineering and Technology (2010) with a concentration in building commissioning. Steve is also an alumnus of Norwich University (2004) where he earned his MBA specializing in Engineering Administration. Steve is a board certified energy manager (CEM) and auditor (CEA). At this time, Steve has acquired three copyrights, two publications, and a U.S. patent associated with sustainable building commissioning technology. Having completed numerous energy audits Internationally, Steve continues his mission to reduce industry emissions and cost through the promotion of innovative technologies.

Christophe Dohr is Site Quality Head at Acino Pharma, Switzerland, with 10+ years’ experience in the pharma industry and in the operational excellence field. Acino is a Swiss pharmaceutical company headquartered in Zurich, which provides high-quality medicines to emerging markets with a strategic focus on the Middle East, Africa, Ukraine/CIS including Russia, and Latin America. In his previous positions, he was Head of Manufacturing Science & Technology (MS&T) (from February 2017 to October 2017) and Production Head of the Liesberg Site (from February 2014 to February 2017). Christophe was responsible for the manufacturing of pharmaceutical solid forms (1.8 Bio Units/year) at the production site Liesberg and ambassador for a continuous improvement culture which enabled the site Liesberg to raise its output by 140% in the last 3 years, while addressing costs containment targets and increasing Quality & HSE requirements. The site Liesberg is specialized in the production of complex galenic formulations with delayed API release (e.g. Multiple Unit Pellet Systems / M.U.P.S.). Acino’s portfolio at the Liesberg site comprises oral drugs for treating cardiovascular disorders and Parkinson’s disease as well as various narcotic substances. Before joining Acino Pharma in February 2014, Christophe worked 7 years at Novartis in various fields of the Production, Regulatory-CMC as well as in the Pharmaceutical Production Global Strategy Team.

Richard has a unique profile that combines over 20 years of experience in industry with software development expertise. After studying Mechanical Engineering at the University of Sheffield, he started working for Pirelli, holding various leadership roles in England, Germany and Italy. Most recently he was responsible for the Smart Manufacturing and Digital Innovation programmes where the focus was as much working practice and culture change as it was technology.

Alongside industry, he has a passion for all things data and software related. He runs courses teaching a vast range of skills covering areas such as web and mobile application development, data analysis, game development, web scraping, social media, desktop applications, and much more.

During his time with Pirelli, Richard developed a programme of education and training to stimulate and ‘kick-start’ the digital transformation process, with great success. Using this as a foundation, he now works independently helping other organizations with their digital transformation.

In his spare time, Richard enjoys running, cycling, coding, playing guitar & piano in a band and spending time with his family. He is also fluent in English, German and Italian.

Christian is responsible for Manufacturing Intelligence for the global finished product network, covering a multitude of different assembly and packaging lines for all of Novo Nordisk’s products. Manufacturing Intelligence covers a variety of tools, aggregating production data from sensors, environment etc. for actionable insights. Predictive tools based on ML models, increasing our productivity and stability.

He is leading a core team to inspire and build competencies throughout our production. Working closely together with production and IT to devise the best solutions for the colleagues working at the machines. Using agile methodologies to design and develop solutions. Collaborating globally and with externals to innovate and accelerate our transformation.

Dr. Christoph Schaub holds a Ph.D. in bioorganic chemistry from the University of Konstanz, Germany. His carrer at Bayer AG began in 1998 in the central research department in the field of intellectual property management and information brokering. In the following years Christoph held different positions within Bayer AG in information management, especially in the field of patent information. Since 2003, he is responsible for the product management of the product "Library & Information Services" of the Bayer Business Services GmbH, the service company for IT-based services within the Bayer group. Christoph is an active member and main delegate for Bayer in the Patent Documentation Group (PDG).

John M Walker leads the Global Asset and Investment organization for Mondelez International based at the company’s European Headquarters in Zurich. Prior to his current role, Walker spend a decade managing procurement, infrastructure and manufacturing organizations for ABB, SBB and Buhler in German-speaking Europe. In addition he held a variety of procurement and supply chain leadership roles in the automotive industry in North America and Asia with Ford Motor Company and Faurecia respectively (following the latter company’s spin off from Peugeot).

Walker holds undergraduate and graduate degrees from Carnegie Mellon University and the Wharton School. In 2014 he co-developed and launched a non-profit organization which provides companies with on-skills diagnostic tools to assess their organizational supply chain skills. Walker holds Irish and Swiss citizenships, is a passionate historian, a mediocre skier and a horrendous golfer.

Kevin loves to help organizations overcome insurmountable obstacles. He has nearly 20 years of experience in biopharmaceutical technical operations in Europe and the United States. He currently works for Roche Pharmaceuticals in Mannheim Germany as the Director of Manufacturing Science and Technology, where he leads their digital transformation and is a relentless sponsor of developing their lean culture. Kevin earned his bachelors of science in Electrical Engineering from the State University of New York at Buffalo.

Supply Chain IT Senior Professional with a 17-year track record of international experience in the design and implementation of Manufacturing Execution, Quality Management, Product Lifecycle Management and Supply Chain Systems in Pharmaceutical and Chemical industries.
Graduated from the University Carlos III de Madrid as Industrial Engineer in Automation/Robotics, Electricity and Industrial Electronics, counts with several collaborations with the University and other technical schools.

Director of Digital Quality that was established in 2019 to drive Digital transformation and Innovation across Novo Nordisk Quality and our quality processes. Working in strong collaboration with our Global IT organisation and other digital functions across Novo Nordisk to deliver business value. Close to 20 years’ experience working with leadership and projects across Product Supply and Quality in Novo Nordisk, from API production over Filling and finished products to Business support. Has a background as a Chemical Engineer and is Lean Six Sigma Black Belt certified.

Gertjan Reichman is a Pharmacist by education and studied at Groningen University in the Netherlands. He worked in several international healthcare companies, always in global leadership functions in the manufacturing, quality and regulatory area. Currently he works for Merck Healthcare in Darmstadt and is head of the Global Pharma Technology department in Global Healthcare Operations. He recently led a project assessing the feasibility of implementing PAT applications in the manufacturing of a mature products portfolio.

Dr. Danish Rafique is currently working as a Head of Digitalization and Data Analytics at Bayer. He has 10+ years of corporate experience in several countries, where he has led, built and deployed digital products and services across industries, including telecom, automotive and healthcare sectors. Danish focuses on strategic evolution of AI production infrastructure and is a well-recognized international speaker on AI. He has authored 100+ publications, together with several patent applications on digital technologies.

Scott works as an OE expert for a team serving the Drug Substance Manufacturing Unit at Roche/Genentech with client sites in the US, EU, and Singapore. Certified as a Lean Six Sigma Black Belt and Agile Scrum Master, Scott has been with the company for 15 years. In that time, he has provided project coordination and performance measurement first with MSAT, then with Manufacturing before moving to Operational Excellence in local operations. Since his transition to the global team, Scott has focused on human factors in defect reduction and Quality processes optimization. He has led global improvement initiatives in discrepancy management, investigation reduction, and the application of standard work in quality-controlled procedures. He is the project lead for SHERPA deployment at Roche.

Dr Thielmann has a PhD in Physical Chemistry/ Material Science from the University of Duesseldorf, Germany. Frank joined Novartis Pharmaceutical Development (Basel, Switzerland) in July 2007 as Formulation Lab Head. From 2009 until 2011 he managed the pharmaceutical development group in the UK. Upon his return to Switzerland he joined Novartis Technical Operations where he was managing the setup of a new solid dosage form manufacturing facility and the transfer of the corresponding portfolio before moving to the Biotechnology department as global Leader for PMO & Operational Excellence in November 2016, In this role Frank had an additional responsibility as Operational Excellence Head of the new Novartis manufacturing facility for Cell & Gene Therapeutics in Switzerland. In November 2019, Dr Thielmann moved to a new responsibility at Takeda Manufacturing & Supply as Operational Excellence Director, where he is responsible for the implementation of process improvement in the manufacturing of a wide portfolio ranging from small molecules to ATMPs with special focus on digitalization & automation. Dr Thielmann is member of the Steering Committee of the Material Science and Biotherapeutics Focus Group in the British Academy of Pharmaceutical Sciences.

With a Background in BioTech for 25 years, worked 15 years in USP, DSP and Analytical labs focused on wet work and integrating Lab IT solution. Resulting in proficiency in both Laboratory and IT language.

Past 10 years specialized in lab IT and currently leading a small IT group within our MS&T department. This department consist of an USP, DSP and Analytic group which is moving into a digital transformation towards pharma 4.0 readiness. This IT group is creating the right environment to fully make use of all the digitized and contextualized data using PAT technology in combination with MVDA

I’m highly interested in the upcoming digital world and the (digital) possibilities which it creates, making use of the collected data in large- and small-scale production. In all these environments we can make use of MVDA, PAT & feedback control, and in the (near) future digital twins to test in silico.

Experienced Information Technology Director with an extensive knowledge across all the main business processes in the Fast-Moving Consumer Goods industry and most recently in the Pharma industry. Skilled in Business Process, ITIL, Business Process Improvement, Cross-functional Team Leadership, and IT Service Management. Focused on enabling IT value to Manufacturing through a sustainable portfolio of solutions driven by Six Sigma/Lean metrics and systematic approach. Hands-on leadership style with excellent interpersonal, training and communicational capabilities. Proven management skills and global mindset.

Jelena holds a Master’s degree in Molecular Biology and has been in the pharma industry since 2013. Her career began within the Quality Control at Teva in Zagreb, Croatia, where she carried out method validation and technology transfer before establishing a biological laboratory within Quality Control in 2015. With increased focus in data integrity, she led gap site assessment of computerized systems within Quality Control and Manufacturing and designed site remediation plan for Teva´s sites.

In 2017, Jelena relocated to The Netherlands, working for Lonza in the field of cell and gene therapy, where her work evolved towards Quality Assurance, and where she leads the CSV team and site remediation to ensure data integrity. In April 2021, she became Head of Compliance, additionally overseeing the Quality Management System, ensuring overall site compliance and working in global data integrity community across multiple Lonza sites.