In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.
Digital Lead PS Operations, Bayer AG
With over 15 years of dedicated service at Bayer, Bianca Brenner currently holds the esteemed position of Global Director of MES Projects, overseeing the successful implementation of Manufacturing Execution Systems on a global scale. Prior to assuming this pivotal role, Bianca Brenner served as the Digital Lead for Product Supply within the Pharma sector and as a Transition and Transformation Program Manager, demonstrating exceptional leadership and strategic acumen. Before joining Bayer, Bianca Brenner contributed over four years at Convestro, cultivating invaluable expertise in project management and process optimization. Bianca's proficiency lies in MES implementation and SAP configuration, ensuring the seamless integration of technologies to drive efficiency and innovation within manufacturing operations.
Advanced MES Analyst, Novo Nordisk A/S
1999-2004 Novo Nordisk, QC-lab Laboratory technician, Chemical and biological analysis
2004-2007 Novo Nordisk, Supporter Formulation of insulin products
2007-2010 Novo Nordisk, Special technician, Formulation of insulin products
2011-2012 Novo Nordisk, Special technician, Project coordinator, work package owner for formulation of insulin products
2012-2018 Novo Nordisk, Professional (formulation) Project manager, work package owner for formulation of hGH and hemophilia products.
2018- Novo Nordisk, Advanced MES analyst (PAS-X) in Global Novo Nordisk MES agile program.
Currently part of the Fill & Finish expansions project with focus on standardized and harmonized GMBRs for multiple site deployment.
Advanced MES Analyst MIT-MES; Cand. Med. Vet, Novo Nordisk
Marianne Hansen worked for Novo Nordisk for 7 years initially as Filling Process supporter and Local PAS-X super user and designer. From 2021 as Advanced MES analyst in Global Novo Nordisk MES agile program. currently part of the central PAS-X CORE 3.3. project with focus on migration and deployment.
Production Applications Systems Senior Expert, Boehringer Ingelheim
Timoleon Hatzikyriazis has been an MES Expert and (G)MBR Designer at Boehringer Ingelheim for more than 10 years, currently responsible for the Werum PAS-X system.
Site Head IT/OT, F. Hoffmann-La Roche AG
After studying electrical engineering Martin Fusek's 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.
LES/MES Advocate, Apprentice.io
With 24 years of experience in the Life Science industry, Keith is well respected for his knowledge and experience with MES product development, solution design, system integration, implementations, and support services for both large and small MES projects.
He has worked with many of the Top 10 Pharma, Biotech and Medical Device companies, on both automation and MES solutions.
Today, he is an MES/LES Advocate at Apprentice.io and works primarily with new customer engagement, interfacing between sales, product, and marketing.
Senior Manager OT, Elevatebio
Isabelle Sumera is 4+ years with ElevateBio where she holds the position as Senior Manager Operational Technology. In her work she supports the MES and LIMS teams, the greater OT team and the IT organization to maintain and enhance the systems. In her field of work she is dealing with MES- ERP interface, MES master recipes and LIMS support.
Global Program Manager and Solutions Architect, MES, Merck KGaA
Philip Hamm is Global Program Manager and Solutions Architect MES at Merck for 3+ years. There he is responsible for the digital transformation of Merck and his focus is the ensuring of compliance to relevant GxP and quality guidelines together with establishing a Centre of Expertise for efficiency and support of MES. Prior to his position with Merck he was 19+ years with Nestle working in the position as Operations Service Delivery and Integration Manager.
Associate Director Manufacturing Systems, Merck SA
David is Manufacturing Systems Global Lead in the Life Science Business Unit of Merck. He has more than 20 years experience in all facets of program and project management, enterprise-wide software deployment and professional services covering the entire deployment cycle, from business process re-design and project implementation, through validation and roll-out. His enterprise software specialties are Manufacturing Execution Systems (MES) and Product Lifecycle management (PLM).
His software and chemical engineering background coupled with economics gives him a unique perspective to accomplishing goals while managing the bottom line. He strives to build successful teams and set up sites for success.
David has over 15 years experience working with companies in FDA regulated industries. Companies he has helped range from medical device manufacturers to food and consumer packaged goods companies to chemical and now pharmaceuticals and biotech.
Sam, originally from Belgium and currently residing in Marburg, Germany, graduated as an Engineer with an additional Master's degree in General Management from Vlerick Business School.
Throughout his career, he has been involved in the Life Science industry, focusing on large-scale digital transformation projects. These projects included significant mergers and acquisitions.
Following his consulting work, Sam joined a pharmaceutical company to lead the technical implementation of a paperless Laboratory Information Management System (LIMS). The goal of this project was to eliminate paper usage in all quality control laboratories, using cutting-edge technology within a heavily regulated environment.
In 2021, he joined NNIT In Frankfurt where he is now working as the Global Lead for Data & Digital Solutions. He drives key projects that use Mixed Reality or AI from ideation to real implementations across the entire value-chain with NNITs Life Science customers.
Head of Customer Services, Tulip Interfaces, Inc.
Dr. Gilad Langer is an accomplished business leader with 28+ years of experience in digital transformation, manufacturing IT, engineering services delivery, and technical operations. He has deep domain expertise in Digital Technologies and Manufacturing Business Systems (IIoT, Big Data, AI, MES, MI, PLM, QMS, DCS, & SCADA). He has an accomplished track record of Digital Transformation to drive high levels of operational performance in manufacturing industries with a specific focus in the regulated Life Sciences industries (pharma, biotech, & med device). He has also served as trusted adviser and business consultant in the areas of technology directions, industry strategy, and software implementations. His focus and passion is next generation (Pharma 4.0) digital technologies and IIoT for manufacturing. Dr. Langer started his career in academia, researching concepts and architectures for agile manufacturing systems using novel concepts that were the archetype for Industry 4.0 and Industrial IoT. He takes a systematic and strategic approach that he has honed throughout his career in different roles including consulting, sales, marketing, product strategy, project management, software development and implementation, and research.
Industrial Solution Architect I Lead Industry X Austria, Accenture
Andreas Stamminger is responsible for strategic consulting for enterprise and IT architectures in digital manufacturing. This encompasses mainly the solution design for MES/MOM and IIoT.
Global Digital Manufacturing and Operations Lead, Accenture
There’s a technological shift within the industry motivated by the need to increase competitiveness and combat climate change. Both are seen as essential to an organization’s profitability, maybe even survival. My role is to help clients plan for this shift and execute it successfully.
I joined Accenture to help insert technology deeper into manufacturing and operations. This is the new frontier for innovation. The opportunities we have with Cloud and Edge computing, AI, and Digital Twins are what’s going to make the difference to how our companies—and our planet—thrive. Digital manufacturing contributes to a reduction in the waste of raw materials, energy and time, and results in fewer product errors. By providing workers with the right information at the right time, they can make better decisions.
My entire career has been in and around manufacturing. From leading strategy in IT, technology in OT, and in running a product line, I know it well. Currently, I’m most excited about the Digital Twin, and how it intersects with three key aspects of manufacturing: operations, technology and the business operating model. This is key as manufacturing is becoming ever more complex, and companies are finding it hard to keep up on all three fronts. My job is to bring these three aspects together and make them work for client organizations. That’s also my strength. I like to think of myself as the ultimate generalist.
Head of Services, Körber AG
Head of Department for Körber's Service unit in America. Managing the Consulting, Training and Service Desk departments. Responsible for all areas of the business unit with direct reports to the Senior VP of Operations. Global alignment with Körber's other Service units around the globe.
Bayer is a global company with core competencies in the life science fields of health and nutrition. We develop our products and services for the benefit of people and the planet, helping to address the global challenges of an ever-growing and aging world population. At Bayer, we are committed to promoting sustainable development and making a positive contribution through our business. With bold ideas and insights, we are paving the way for new possibilities that improve life for all of us. This means rethinking the way we care for ourselves and each other. We do this by strengthening personal health, improving patient care and finding better ways to feed everyone, everywhere in the world.
We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 55,000 people in 80 offices around the world, and market our products in 170 countries.
We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 55,000 people in 80 offices around the world, and market our products in 170 countries.
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit http://www.roche.com.
Apprentice helps life science manufacturers get treatments to patients faster by providing one platform to turn molecules into medicine. Our Tempo Manufacturing Cloud lets you scale up and out with unprecedented speed and accuracy. From preclinical benchtop to large-scale commercial manufacturing, Tempo keeps your global teams connected, empowered, and in sync. With $140M in funding, a 12x growth rate, and 512% net customer retention, Apprentice is a trusted partner to modernize your operations and change the way drugs are made in your facility. Learn how leading companies like Catalent, Synthego, and Bristol Myers Squibb are using Tempo to scale from drug discovery to patient delivery faster at www.apprentice.io.
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
Our passion for science and technology is what drives our more than 64,000 employees across 66 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live. We are here for people at every step, helping create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services, and digital platform make research simpler, more exact, and help to deliver breakthroughs more quickly. We provide progressive treatment solutions that help improve access to health thanks to the accuracy of our tests and the reliability of our medicine. As a company, we are at the forefront of digital living. Our science sits inside technologies that change the way we access, store, process, and display information. Our innovative technology drives human progress and opens new possibilities to transform life on Earth as we know it. Thanks to the constant curiosity of our employees, we are making discoveries that can change the landscape of entire industries. For more than 350 years, we’ve been pushing the boundaries of what’s possible, and we’ll continue to do so in the years to come.
Our passion for science and technology is what drives our more than 64,000 employees across 66 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live. We are here for people at every step, helping create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services, and digital platform make research simpler, more exact, and help to deliver breakthroughs more quickly. We provide progressive treatment solutions that help improve access to health thanks to the accuracy of our tests and the reliability of our medicine. As a company, we are at the forefront of digital living. Our science sits inside technologies that change the way we access, store, process, and display information. Our innovative technology drives human progress and opens new possibilities to transform life on Earth as we know it. Thanks to the constant curiosity of our employees, we are making discoveries that can change the landscape of entire industries. For more than 350 years, we’ve been pushing the boundaries of what’s possible, and we’ll continue to do so in the years to come.
Whether it is the incremental improvements or the radical re-thinking of IT technology required to achieve advantage, innovation matters. In the German speaking countries, NNIT is based in Frankfurt (Germany) and Basel (Switzerland), thus in the center of a flourishing Life Sciences industry. We are well-known for our ability to bring inspiration and vision to life and to work with both IT and business groups to help them connect and transform data into valuable information. We are not just service providers and advisors; we are project managers, scientists, engineers, digital and data experts. We work in lab environments, clinical operations, regulatory affairs, manufacturing and supply chain and on system validation across the value chain. It is in this diverse mix, where we bring people and technology together, ideas are created, nurtured and delivered and the future of our Life Sciences clients is refined.
Tulip, the leader in frontline operations, is empowering the world’s leading companies to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. Companies use Tulip to digitally transform their operations and gain real-time visibility into the people, machines and processes involved in production—all in a matter of days. Companies of all sizes, across industries including consumer electronics, pharmaceuticals, aerospace and defense, contract manufacturing, automotive, apparel, medical devices and more, have implemented Tulip’s intuitive software and hardware platform to solve some of the most pressing challenges in frontline operations. Companies use Tulip to error-proof processes with guided workflows, integrate industrial IoT (IIoT) technologies with legacy machines, and capture and analyze real-time operations data.
Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 743,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. We are uniquely able to deliver tangible outcomes because of our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song. These capabilities, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities. Visit us at www.accenture.com
We are Körber – an international technology group with more than 12,000 employees at over 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, and Technologies, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group. At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions. With our software solutions we help drug manufacturers to digitalize their pharmaceutical, biotech and cell & gene therapy production. The Werum PAS-X MES Suite is recognized as the world’s leading Manufacturing Execution System for pharma, biotech and cell & gene. Our Werum PAS-X Savvy Suite accelerates product commercialization with data analytics and AI solutions and uncovers hidden business value. www.koerber-pharma.com