Alexandra Hill, Global Head of Quality Governance, Merck Healthcare KgaA

Throughout his career, he has built and scaled the global MES rollout in his role as Global MES Program Manager at Novartis. As Global Head of Biopharmaceutical Operations IT he led complex transformation programs, and digitalized biopharmaceutical manufacturing organizations and processes in highly regulated environments where execution is critical.

Thomas believes the next wave of performance in pharmaceutical manufacturing will come from fundamentally rethinking how production systems are structured, measured, and digitally enabled across the value chain. He works with leaders who aim to shape the future of pharma manufacturing rather than simply optimize the past.

Rajesh Thempadiyil is a pharmaceutical industry leader with over 25 years of cross-functional experience in Quality Management Systems, Regulatory Compliance, Validation & Qualification, and Computerized System Validation.
As Head of Digital Transformation for Manufacturing & Quality at Dr. Reddy’s Laboratories, he spearheads enterprise-wide digitalization of manufacturing and quality operations under the Digital & Process Excellence (DPEx) function. He was a core team member of the World Economic Forum’s Global Lighthouse Network program at Dr. Reddy’s — a prestigious recognition for leadership in adopting Fourth Industrial Revolution technologies.
A passionate advocate of industry standards and thought leadership, Rajesh serves as a core team member of the ISPE GAMP® Guide on “Data Integrity – Manufacturing Records” and has authored chapters on Aseptic Processing and Manufacturing Execution Systems (MES). He also served as Co-Chair of the GAMP India Community of Practice (CoP) within the International Society for Pharmaceutical Engineering (ISPE).

 
Abstract

 

• Inspection readiness must become a continuous, measurable capability.
• AI should augment experts, not replace GMP accountability.
• Connected evidence and governance are prerequisites for trustworthy AI.
• Readiness scoring should reveal the real drivers of inspection risk.
• Defensible AI requires traceability, human review, control, and explainability.

With over 19 years of experience in pharmaceutical manufacturing and digital transformation. In this role, I lead Grifols’ end-to-end digitalization strategy, defining technology roadmaps across all business units and factory typologies, and managing a portfolio of digitalization initiatives worth approximately €10M per year.
I bring a strong IT foundation combined with deep operational technology expertise gained through hands-on projects in serialization and packaging. I serve as the strategic interface between corporate digital vision and site-level execution, consolidating demand across business units and governing the full portfolio of digitalization programs.
My work is shaping how one of the world’s leading biopharma companies approaches manufacturing intelligence, connectivity, and operational excellence at scale.

Abstract

Digitizing manufacturing in a regulated biopharma environment is not a technology problem — it is about strategy, execution and shopfloor adoption.
In this session, Grifols shares the strategic framework it uses to approach manufacturing digitalization across a global biopharma network — covering plant typology decisions, data architecture principles, and the governance model that translates strategy into executable programs. The session then goes deep into a concrete case: the brownfield EBR rollout across four global sites, completed in under 12 months and covering more than 250 recipes

After graduating from a National School of Engineering in France, Luc started his career in the UK working for Rolls-Royce where he held several positions from Manufacturing
Engineering to Customer services in various locations around the world. He then supported the Singapore government to build a local ecosystem of Research and local enterprises
to boost Smart Manufacturing before moving back to Switzerland to drive Digital Manufacturing for Merck.

Abstract

Traditionally standards like the Digital Plant maturity model have been used to assess progress and readiness of sites for Digital Manufacturing. One key aspect was missed.
Adoption and end user effectiveness to use the deployed solutions. Why do we end up with highly connected sites that don’t yield the expected results from the Digital
architecture? It is paramount to fully understand the systems landscape, which system is the Master system for which data and map it for all sites. Once you have this,
you can superimpose critical business process and understand where Digital will bring value. Business process centric approach drives everything and enables sites and
networks to generate genuine impact through Digital.

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.

Paul is an Operational Excellence Leader with relevant experiences in the pharmaceutical sector and in e-commerce/retail industries. After his academic career as trained chemist, he started his journey in operational excellence as Six Sigma Expert with CellGenix – part of Sartorius. He was working in the integrated operational excellence setup with Pfizer Manufacturing GmbH, later as Lead for Process Excellence with Lounge by Zalando. Currently he is with Aristo Pharma GmbH, guiding the organizational transformation as Director of Operational Excellence.

Abstract

How can we transform a company rooted in tradition into a future-ready organization? In this presentation, we share the first steps of our journey at Aristo Pharma.

We focus on recognizing the value of our traditions while laying the foundation for sustainable change. Through Lean Leadership principles and practical tools like Coaching Kata, A3 Thinking, and the Hoshin Approach, we have initiated a cultural shift that drives engagement and ownership.

At the same time, we embrace innovative technologies, such as AI, to amplify human potential. By enhancing creativity, accelerating decision-making, and supporting long-term strategic alignment, AI becomes an enabler for driving transformation while staying true to our core values.

This session offers inspiration and practical insights for anyone looking to blend tradition, leadership, and technology into a cohesive path for organizational growth.

Amy Valentine (B.S., Biomedical Engineering) has over 15 years of experience in the biopharma industry in vaccine and large-scale biologics manufacturing execution systems. At Biogen Solothurn, Switzerland since 2018, she is currently accountable for automation core systems and digital strategy. She is driven by building operational maturity and resilience through forward-thinking automation and digital capabilities, and she is energized by knowledge sharing to support industry advancement.

Abstract

Biogen’s Solothurn manufacturing site is realizing its vision of Intelligent Operations by reimagining its workforce and implementing enabling tools and infrastructure. By integrating core platforms, the site is eliminating data silos, fostering seamless connectivity and tech transfer excellence.
This digital transformation has translated foundational capabilities into tangible outcomes: through targeted automation and data-driven initiatives, Solothurn has significantly reduced manual effort, enhanced right-first-time execution, and accelerated speed to market. The result is a scalable, mature ecosystem that provides a robust foundation for continued productivity gains and future analytics-driven biologics manufacturing.

 
 
Business:
• Anders has over 20 years of leadership experience within Pharma Production, Supply Chain & Digitalisation including leading several different factories responsible for producing some of AstraZeneca’s biggest brands.
• Management Consultant within Supply Chain (Purchasing, Production, Planning & Distribution) in 23 different companies covering: Production, Automotive, Wholesaler, Storage, Transport & Distribution and Banking.
 
Academic:
• Industrial and Societal board Digital Future, Stockholm Sweden
• Imperial Business Analytics, London Imperial Collage Business School, UK
• Enterprise Transformational Leadership, MIT, US
• Manufacturing Professionalism Program, Warwick University, UK
• Logistics Executives Program, Stockholm School of Economics
• Master of Science in Industrial Engineering and Management, LiTH, Sweden
• Wirtschaftsingenieurwesen at Fachhochschule München, Germany
 
AstraZeneca is a global biopharmaceutical business delivering medicines to patients through innovative science and excellence in development and commercialization. AstraZeneca has 90 000 employees globally and over 7 000 in Sweden. The medicines delivered from Sweden Operations represent more than a third of AstraZeneca’s sales.
 
Abstract
 
• WHY Digitalize? – For Patient, People, Planet and Investors
• WHAT to do? – Foundational systems, Digital Products, AI & LoCo NoCo (Successful use cases will be shown)
• HOW to do? – Think big, Start small, Scale fast. + Combining Lean and Digital + Culture change
• SO WHAT? – There is a Hugh Value to go for! (Learnings from successes and failures)
• NOW WHAT? – Your own reflections!

Three different professional lives:
– 15 years, 35 countries worldwide, deep application of lean, TPM, Six Sigma as Master Black Belt and Continuous improvement manager then Director, working with GE, Toyota & P&G Sensei’s in pharma, food and CDMO industries. Great results, hundreds of events and people engaged and coached all over the world.
– Almost 10 years, 3 countries, 4 roles as Managing Director and EU VP in Food, Pharma, CDMO. Great performance and transformation designed and executed, with people.
– Currently Empathetic Senior Advisor and mentor: inspiring and helping human beings and organizations to be themselves at their best, so that they can be full-filled and achieve extraordinary results, going above and beyond their own expectations.
Blending hard & soft skills, engaging organizations in creating a future together, then making it happen, starting from bringing stability and reliability.
Transforming through inspiring everyone and seeing it happen day by day.

Sven is an executive leader with 28 years’ experience in the pharma and biotech industry having led global manufacturing networks. He enjoys rallying the organization behind driving performance improvements as well as developing a vision and executable strategies. He is passionate about LEAN as well as servant leadership and creating a working environment in which employees can work in an empowered way.

A Chemist by training with an MBA, Sven spent his entire professional career within the Pharma industry at Roche, Leo Pharma and CordenPharma. After having worked in Germany, Switzerland, the USA, Ireland, and Denmark, he joined CordenPharma in Basel as Chief Operations Officer Drug Product last December.

Piet is a Pharmaceutical Operations Leader with experience in Supply Chain, Continuous Improvement, Manufacturing, Site & Multi-Site Leadership.

His mission is to help colleagues improve the value of their contribution in a supportive organization. He engages all value stream participants in standardizing and improving their production, management, and delivery processes.
Piet has led pharmaceutical operations in Italy, Spain, Switzerland, and Belgium. During his career of more than 30 years he has worked for Merck Serono, Kedrion Biopharma, Pfizer, and Zoetis.

Carolyn is a dynamic, results-driven business leader with deep expertise in manufacturing operations, Lean transformation, transactional process optimization, engineering, and commercial excellence. With more than 40 years of international leadership experience across multiple industries, Carolyn is renowned for designing and driving large-scale business transformations that deliver measurable operational and financial impact.

Throughout her career, she has consistently led enterprise-wide improvements by embedding Lean thinking, developing strategic roadmaps, and building organizational capability.

Marijo is a Digital Transformation leader with international experience, specialized in forward-looking business development and process digital transformation, ensuring that enterprise’s digital & AI strategy is optimal, given current and emerging digital realities, opportunities and threats.
Track-record of achievements in creating market advantage and value for process owners, customers and shareholders in Telecommunications, Life Sciences, Information Technology and Services, Fashion, Public sector and Financial industry

Lorenz Liesum began his pharmaceutical industry career at Novartis as an analytical scientist in pharmaceutical development. With over 15 years of experience in Process Analytical Technology, he has contributed to regulatory Quality by Design (QbD) filings. Currently, Lorenz works for the global quality control unit at Roche as the Head of Analytical Science. He is leading the Instant Release capability team to implement new technologies and control strategies across the internal manufacturing network, with the overall goal of increasing efficiency and reducing lead times in QC.

Abstract

There are rare cases for the application of PAT and RTRT in the field of aseptic manufacturing. In this talk, we present a use case where RTRT elements were incorporated into the release control system of a sterile Biotech drug product and implemented and filed at a commercial launch site. The main elements of this RTRT control strategy specifically included:
• Implementing an RTRT sampling point
• Using Raman spectroscopy as a multi-attribute method
• Leveraging the existing rapid microbiology toolbox.
In addition, the regulatory feedback and the lessons learned will be part of the presentation as well as the scale out strategy and potential for other launches.

With over a decade of experience as a chemical engineer, André has a record of success stories in employing process modelling for the design, monitoring, improvement, optimisation, and control of chemical processes. In recent years, André’s expertise and drive for innovation have been instrumental in developing model-based strategies for process intensification and real time release of intermediate drug products at J&J.

Abstract

Model-based characterization of processes stands at the forefront of innovation in pharmaceutical manufacturing, transforming how the industry develops and delivers high-quality products. As process models become increasingly integral, they are revolutionizing every stage—from development and optimization to scale-up, transfer, and now, as a cornerstone of advanced control strategies and real-time release testing. The vision of achieving real-time release in pharmaceutical production is becoming a reality, thanks to the power of process modeling. Andre exemplifies this breakthrough by combining data-driven modeling, machine learning, and mechanistic approaches to create resilient, predictive release strategies. These strategies enable precise forecasting of product quality attributes, significantly reducing lead times across the supply chain. Moreover, they foster a deeper, more timely understanding of process performance, unlocking substantial value through enhanced efficiency, flexibility, and confidence in product quality.

Dr. Shirazi is a seasoned AI , Digital and project management expert with Oxford University AI business Certified with PhD in Mechanical Engineering and specialization in digital strategy, transformation, business process technology, program/project management, project delivery, stakeholder engagement , portfolio support, ERP (SAP, Infor) system and IT Applications. He has earned master’s degree in quality technology & Management from Sweden with Six Sigma Black Belt certification. Dr. Shirazi has expertise in digital transformation, AI/ML: ML,LLM, MLOps/LLMOps, agentic systems and MCP. He has trained over four hundred people in professional career on IT Project Management related methodologies and techniques through workshops. He is an ambassador for digital transformation. He has successfully completed twenty-five digital/transformation business projects. He has hands on experience in Medical devices, pharmaceutical, healthcare, chemical, textile, education and public sector. With strong communicational, analytical, organization, planning skills, he is looking for challenging role.

 

Abstract

The pharmaceutical industry stands at the precipice of a revolutionary transformation, where the convergence of digital technologies is reshaping traditional manufacturing paradigms. The Factory of Future represents a paradigm shift from conventional production models to intelligent, interconnected ecosystems that leverage Industry 4.0 technologies to deliver unprecedented operational excellence.
At the heart of this transformation lie key technological enablers including Internet of Things (IoT) sensors for real-time monitoring, artificial intelligence and machine learning algorithms for predictive analytics, digital twins for virtual process optimization, and advanced automation systems. These technologies create a seamless integration between physical operations and digital intelligence, enabling pharmaceutical manufacturers to achieve new levels of precision, efficiency, and agility.
The value proposition extends far beyond operational improvements. Factory of Future initiatives deliver enhanced product quality through continuous monitoring and control, improved regulatory compliance through automated documentation and traceability, increased operational efficiency through predictive maintenance and optimized workflows, and strengthened sustainability through resource optimization and waste reduction. Most importantly, these advancements directly impact patient outcomes by ensuring consistent, high-quality medicine production and faster time-to-market for life-saving treatments.
Looking ahead, our roadmap envisions fully autonomous manufacturing ecosystems that continuously optimize themselves, delivering exceptional patient value while setting new industry standards for pharmaceutical excellence.

Arpan Suryawanshi is a LifeSciences Manufacturing IT Consultant with a 16+ year track record of driving operational excellence in Production/Manufacturing IT. He possesses a strategic mindset and a results-oriented approach, consistently delivering successful MES implementations across the globe.
 
His expertise lies in streamlining business processes, leading complex system deployments, and fostering strong stakeholder relationships. Possesses extensive experience with industry-leading manufacturing MES and Production IT applications. His portfolio includes significant contributions to global pharmaceutical projects, currently spearheading global initiatives in regards to Manuf. Data Analytics at Roche DIA based out of Germany.
 
Arpan is not only a technical expert but also a skilled leader and mentor. He builds high-performing teams, ensuring seamless collaboration between technical and business stakeholders. His commitment to exceeding client expectations has resulted in long-standing partnerships and the successful delivery of mission-critical manufacturing solutions.
 

Abstract

TAI is not just about fancy use cases, but environmentally sustainable with zero carbon emission and validated implementation to ensure global and scalable framework.
Simplified ways of ensuring Infrastructure in AI is environmental friendly.
Fail early and Fail fast is the go-to in AI experimentation world. 3-5 month MVP.

Praveer Mysore Mukunda (B.E., Electronics & Instrumentation Engineering) is a Platform Technical Lead at Biogen Solothurn, Switzerland, with over 15 years of experience in biopharma manufacturing IT and automation. He specializes in automation strategy, digital platform integration (DeltaV, Syncade, ERP), and leveraging new technologies to accelerate technology transfer and drive operational excellence through scalable digital solutions.

Abstract

Biogen’s Solothurn manufacturing site is realizing its vision of Intelligent Operations by reimagining its workforce and implementing enabling tools and infrastructure. By integrating core platforms, the site is eliminating data silos, fostering seamless connectivity and tech transfer excellence.
This digital transformation has translated foundational capabilities into tangible outcomes: through targeted automation and data-driven initiatives, Solothurn has significantly reduced manual effort, enhanced right-first-time execution, and accelerated speed to market. The result is a scalable, mature ecosystem that provides a robust foundation for continued productivity gains and future analytics-driven biologics manufacturing.

Davide Botta is a seasoned pharmaceutical operations site leader with over two decades of expertise spanning pharmaceutical manufacturing, environmental engineering, and utilities management.

As Site Lead at Recordati Ireland’s Cork facility, Davide oversees end-to-end plant operations — from production performance and regulatory compliance to sustainability strategy and continuous improvement. He brings a rare combination of technical depth and operational leadership, with a particular focus on energy efficiency and environmental stewardship in complex industrial environments.

Throughout his career, Davide has built a strong reputation for driving measurable improvements in production efficiency, leading cross-functional teams, and ensuring sites operate to the highest safety and quality standards. His tenure at Recordati Ireland , spanning roles from Production Manager to Plant Manager , reflects a progressive leadership journey defined by operational excellence and a commitment to long-term site performance.

Tim Albers started his journey at Honeywell in 2021 as a Senior Solutions Engineer. Since then, he has leveraged his extensive knowledge of the pharmaceutical and medical device industry to assist companies in transitioning to effective and powerful electronic Quality Management Systems.

Prior to joining Honeywell, Tim held a 20-year tenure in the life sciences industry with a prominent European-based manufacturer of disinfectants. His responsibilities in his role as an automation engineer encompassed the planning, commissioning, and life cycle management of automation systems, including DCS, along with the requisite computer system validation. This domain of work piqued his interest in GMP- and quality-related matters, leading to his transition to the quality assurance department. In this new role, he assumed primary responsibilities for Audits, Deviation Management, Change Control, Complaints, Supplier Qualification, and continued computer system validation.

Tim effectively integrates his expertise in automation processes and quality processes to guide customers toward achieving a comprehensive eQMS with all its integrations to other IT systems and its benefits to help customers make meaningful and data-driven decisions.

Global Program Manager at Grifols, where I lead the company’s manufacturing digitalization strategy across all sites worldwide. With over 12 years at Grifols, I built my foundation managing multiple concurrent projects on the shop floor — design and set up of production lines line , industrial automation upgrades, and system integrations across manufacturing environments. That hands-on project delivery experience now drives how I approach digitalization at scale.
A member of Grifols’ Global Talent Program — recognizing the top 100 employees globally — I bridge the gap between shop floor operations and enterprise digital systems. I am currently leading a multi-site EBR program with a €700M business impact across four biopharma manufacturing sites and managing the digital backbone of a greenfield factory of the future.

Adam Cross is the Industry Director for Pharmaceuticals & Life Sciences at Octave, bringing over 13 years of experience in delivering Full Asset Lifecycle solutions to Organisations across the EMIA region. Adam helps life Sciences Companies focus on driving improvement and efficiency in their Asset and Maintenance management activities whilst ensuring compliance and quality are not compromised

Antonio Buendia, Director of Automation, GSK, Global Supply Chain

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

Rethinking Industrial AI: From Cloud-First to Hybrid Intelligence

The industrial sector stands at a critical inflection point in its digital transformation journey. While the “Journey to Cloud” has dominated strategic thinking, promising to unlock unprecedented value from industrial data, organizations face mounting challenges with traditional cloud-first approaches. After investing 10-15 years building comprehensive local historians and data repositories, companies now confront the prohibitive costs and complexity of migrating massive datasets to cloud platforms.

This presentation challenges the conventional wisdom and proposes a paradigm shift: instead of moving data to the cloud, we should bring cloud capabilities to the data. By applying cloud-native tools and artificial intelligence directly to existing on-premise infrastructure, organizations can achieve the benefits of cloud computing while preserving their substantial investments in local systems.

The future of industrial intelligence lies not in choosing between cloud and edge, but in embracing a hybrid approach. This evolution encompasses a complete continuum—from sophisticated cloud-based analytics to autonomous embedded AI systems operating independently in devices, robots, and industrial controllers. This hybrid architecture delivers resilience, efficiency, and cost-effectiveness while positioning organizations for the next wave of industrial innovation.

Take-Home Message: The future of industrial AI is hybrid by design, not by compromise. Success lies in creating intelligent systems that seamlessly operate across the entire spectrum from cloud to edge, maximizing existing investments while unlocking new possibilities for autonomous, connected industrial operations.

Steven Driver, Ph.D. has over 35 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 and Northeastern University (1997) where he completed his graduate certificate in mechanical systems engineering. Steve is a board-certified energy manager (CEM) and auditor (CEA). At this time, he 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 carbon emissions and cost through the promotion of innovative technologies.

Abstract

In summary, the audience will learn about the rationale behind setting sustainability goals. How to gain knowledge around identifying sustainability opportunities including energy, waste, and water will be discussed. The importance of deploying a site energy maturity assessment to prepare for a project pipeline workshop will be reviewed. Different types of financing approaches to assist in the project execution process will be reviewed with deployment strategies (resources, budget, schedule). In conclusion, digital measurement and verification of the achieved results will be reviewed along with how to maintain the investment in sustainability over time.

Massimo Mura is a digital and transformation leader at Takeda’s Lessines manufacturing site in Belgium, where he leads Data, Digital & Technology initiatives supporting the site’s “Factory of the Future” vision.
He began his pharmaceutical career 25 years ago at Baxter International in Supply Chain before spending a decade in Procurement leadership roles, developing strong expertise in operations, industrial performance, and business transformation. 5 years ago, he transitioned into IT and digital transformation, combining deep operational understanding with technology, data, and innovation.
Today, Massimo is particularly passionate about Generative AI adoption, digital mindset transformation, and the evolution of modern ways of working powered by data and intelligent technologies. He focuses on helping manufacturing organizations become more agile, efficient, and future-ready through AI, automation, and data-driven decision-making.

Carolyn is a dynamic, results-driven business leader with deep expertise in manufacturing operations, Lean transformation, transactional process optimization, engineering, and commercial excellence. With more than 40 years of international leadership experience across multiple industries, Carolyn is renowned for designing and driving large-scale business transformations that deliver measurable operational and financial impact.

Throughout her career, she has consistently led enterprise-wide improvements by embedding Lean thinking, developing strategic roadmaps, and building organizational capability.