Keynote Speakers
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Jörg Zimmermann
Vice President External Affairs at Vetter Pharma
- Started at Vetter in 1994 as an intern - Site Director for 10 years - Vice President Vetter Development Service for 10 years - Currently Vice President External Affairs (work in industry-and lobby organizations) - Past Chair of the International Board of Directors of ISPE
Introduction to Vetter Pharma and the Manufacturing of Sterile Dosage Forms
Day 1
Introduction to Vetter Pharma as the Host of FLD: Processes, Products, Business Model, Opportunities for Students and Emerging Leaders
Claudio Galbusera
VP HR Development & Systems at Vetter Pharma
- Master in Finance & Information Systems - With Vetter since 2019 - Started as a Controller - Last Position before VP promotion: Director Corporate Planning & Operations Controlling - Project lead in various HR-related projects (i.e. introduction of a new salary system for more than 7.000 Vetter employees)
Leading in the Age of AI: What Will Change, What Will Remain Human?
Day 1
Artificial Intelligence is transforming how work gets done and challenging traditional assumptions about leadership. This keynote explores a set of thought-provoking hypotheses on how AI may change leaders' roles, decision-making, and organizational structures, while highlighting the leadership capabilities that are likely to remain uniquely human. Participants will leave with a fresh perspective on the future of leadership and the skills that will matter most in an AI-driven world.
Dedric Day
Sr. Director-Strategic Talent Partnerships at Eli Lilly
Dedric Day has worked at Eli Lilly and Company for 23 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing modalities including API, Dry Products Packaging, and Device Manufacturing as well as being Lean Six Sigma Black Belt certified. In July of 2023, Dedric accepted the newly created role of Sr. Director- HR Strategic Talent Partnerships. In this role, he has responsibility for creating talent eco-systems leveraging partnerships with high schools, key higher education organizations, and government partners associated with Eli Lilly and Company’s new U.S. manufacturing sites announced as part of the more than $50 billion dollar expansion. Dedric has also been influential with Indiana’s Federally designated Biotech Hub (Heartland BioWorks HQ), the BioCrossroads Life Science Industry Talent Association, the Ascend Indiana Board Workforce Council Steering Committee, and is also a member of the Ascend Indiana Board of Directors. Dedric is an active ISPE member and has served on the organizing committee for the ISPE Facilities of the Future.
From Indiana to the Island: How Strategic Partnerships Answered Lilly’s Unprecedented Growth
Day 1
Artificial Intelligence is transforming how work gets done and challenging traditional assumptions about leadership. This keynote explores a set of thought-provoking hypotheses on how AI may change leaders' roles, decision-making, and organizational structures, while highlighting the leadership capabilities that are likely to remain uniquely human. Participants will leave with a fresh perspective on the future of leadership and the skills that will matter most in an AI-driven world.
Michelangelo Canzoneri
Global Head of Group Smart Manufacturing at Merck
Michelangelo Canzoneri is Global Head of Group Smart Manufacturing at Merck, where he leads the transformation of the company's manufacturing network into digital, automation and AI-enabled operations across Healthcare, Life Science and Electronics. He puts the people who run the processes at the center of that transformation. He joined Merck in 2020 as Global Head of Digital and Data for Healthcare, after twelve years at Sanofi, where he moved from upstream process development to leading technology and innovation for therapeutic proteins and then digital transformation. He is University Professor of Chemical and Bioprocess Engineering at Frankfurt University of Applied Sciences and holds academic appointments at MIT and Goethe Business School. He chairs the ISPE Biotechnology Community of Practice Steering Committee and is a member of the ISPE D/A/CH board. He holds a doctorate from the University of Bielefeld and patents on micro-bioreactors.
SMARTfacturing: Turning Digital Intelligence into Competitive Advantage
Day 1
Manufacturers are expected to improve cost, quality, speed, sustainability and service at the same time. In a volatile world, trading one against another is no longer an option. AI, automation and data technologies promise to help, yet they are available to every competitor. Advantage therefore comes from how well a company applies them and how reliably it repeats a success across its network. SMARTfacturing is the group-wide operating model for operations at Merck. It brings together data, digital technology and operational expertise across Healthcare, Life Science and Electronics. A shared foundation of IT/OT convergence and reliable operations data supports the core operations systems and advanced capabilities such as digital twins and predictive maintenance. This talk shows how Merck turns digital intelligence into dependable industrial performance at global scale. Three levers make the difference: solving the problems where better performance has a material effect, creating shared standards so that proven solutions move from one plant to the next and shortening the distance between learning and deployment. The talk closes with the people who run the processes. Workforce readiness sits at the center of the transformation, because a solution creates value only once it is part of daily operations.
Volker Storn
BPO E2E Standardized Facility Solutions at Roche
Volker Storn is an Engineer for Pharmaceutical Technology and Biomedical Engineering by training with 20+ years of experience and holds a PhD in Tumor Immunology. Since joining Roche he held various positions in Process Engineering, Project Management, Project Controls, Team Management, Technology Management and was involved in numerous large CAPEX projects globally and is currently working in Pharma Global Engineering, located in Basel, Switzerland. Since 2015 he is Board Member of the ISPE-DACH Affiliate, co-founder and Steering Committee Member of the ISPE DACH Community of Practice “Aseptic Processing”. Since 2025 he is Vice-Chair of the ISPE-DACH Affiliate.
Annex 1: A Driver For Collaboration And Innovation
Day 2
The publication of the revised Annex 1 in 2022 (which came into force in 2023) presented significant challenges for the pharmaceutical sector, requiring substantial capital expenditure and comprehensive operational adjustments. Existing technologies proved insufficient, necessitating extensive upgrades. Consequently, pharmaceutical organizations collaborated to share insights and regulatory experiences to establish industry best practices. Given that Europe accommodates both major pharmaceutical manufacturers and key process equipment vendors, the region serves as a primary center for technical innovation in aseptic processing, driven largely by strategic partnerships among manufacturers, suppliers, and engineering firms. Within this ecosystem, ISPE fulfills a key function by facilitating ongoing dialogue and structured collaboration.
Simona Riedel
Manager Manufacturing at VFA
- Manager Manufacturing at the German Association of Research-Based Pharmaceutical Companies (vfa) - Pharmacist with a doctorate in Biochemistry (Dr. rer. nat.) - Hands-on industry experience as GMP Coordinator in solid dosage packaging and experience in Quality Management in an ATMP start-up environment with previous experience at the Brandenburg Ministry of Health, providing a public-sector and regulatory perspective - Expertise across pharmaceutical manufacturing, GMP, quality, and regulatory frameworks - Works at the interface of industry, regulatory authorities, and policymakers - Particular focus on digitalization and AI in pharmaceutical manufacturing, including responsible and risk-based implementation in GMP-regulated environments - Passionate about equipping the next generation of pharmaceutical professionals with the skills to critically assess new technologies, make informed decisions, and take responsibility
AI in Pharma Manufacturing: Innovation, GMP and the Skills to Decide
Day 2
The presentation explores the role of artificial intelligence in shaping the future of pharmaceutical manufacturing in Europe. It will look at the opportunities offered by different AI technologies and discuss how innovation can be combined with the principles and requirements of GMP. Current regulatory developments, including the EU AI Act and the evolving EU GMP Annex 22, will provide a framework for discussing how AI can be implemented in a risk-based, reliable and responsible Future Leaders’ Days 2026 | Speaker Information Form Information requested Your information manner. Particular attention will be given to the human perspective: What skills and capabilities will future professionals need to critically assess AI, make informed decisions and take responsibility in an increasingly AI-enabled manufacturing environment?
Talks Session 1
Helen Sauter
Director Quality Assurance at Vetter Pharma
- Holds a degree in biology - 6 years of professional experience and a PhD in microbiological research - 12 years @Vetter in different positions, since 2019 Director QA Sterility Assurance/Lab Operations & Logistics/Pharmaceutical Training Systems - Extensive experiences in the field of Sterility Assurance (e.g. contamination control strategy, aseptic process validation) - Steering Committee Member ISPE D/A/CH CoP Aseptic Processing
Ensuring Sterility. Designing for Quality.
Technology & Innovation
Modern regulatory expectations require cleanroom and process designs that inherently minimize microbial and particulate contamination risks through engineering controls and optimized facility concepts. The presentation will explore how thoughtful design, appropriate technologies, and effective contamination control measures can help ensure sterility and shape quality from the outset. Particular attention will be given to how modern concepts can reduce contamination risks while supporting robust and reliable operations. The presentation aims to demonstrate how regulatory expectations, technological possibilities, and operational needs can be effectively balanced.
Ralf Huss
Managing Director at BioM Biotech Cluster Development
Ralf Huss, MD, PhD is managing director and CEO of the BioM Biotech Cluster Development GmbH in Martinsried near Munich and spokesperson of the Bavarian Biotechnology Cluster. Dr. Huss is a trained pathologist with many years of experience in leading positions in academia, pharma / diagnostic industry and biotechnology, also as a co-founder of early startups. Before assuming the position at BioM, Professor Huss was the founding director of the Institute of Digital Medicine (IDM) and Professor of Pathology and Molecular Diagnostics at the University Hospital in Augsburg, Germany.
The Munich & Bavaria Life Science Ecosystem – How Regional Innovation Creates Global Impact
Technology & Innovation
An insight into a regional biotech and start-up ecosystem in the context of European competition and a global world.
Fabian Stutz
CEO of Pharmabotix
- Role & Company: Founder & CEO of Pharmabotix AG – a Swiss specialist in advanced robotics and automation solutions for the Pharma, Biotech, and MedTech industries. - Background & Path: Trained plumber holding a Bachelor’s degree in Business Administration; combines hands-on technical grounding with strategic business leadership and over 12 years of experience in machine building. - Track Record: Built Pharmabotix from the ground up into a multi-award-winning partner for leading global pharma companies (multi-time ISPE RAYA winner). - Philosophy: Approaches leadership and entrepreneurship like a ""Formula 1 Team Principal"": driven by pragmatism, passion, team autonomy, and clear engineering standards.
Made a Baby Yet?–The Raw Truth Behind Delivering a Startup
Leadership & Career
Building a deep-tech startup in pharma robotics is like raising a child: exhilarating, exhausting, and unpredictable. This talk offers an unvarnished look at Pharmabotix’s journey—from shredded business plans and shifting team dynamics to becoming an award-winning automation specialist. Speaker Fabian Stutz shares why technical skills fall flat without passion and how standardizing customer-centric processes enables true scalability. Attendees will take away candid, battle-tested lessons on overcoming setbacks to deliver robust robotics solutions.
Hannah Marienberg
Principal Associate Scientist at Roche Diagnostics
- PAT Engineer in the late-stage development for large molecules at Roche, leading high new technology projects in a crossfunctional setting. - Holds a Master’s degree in Pharmaceutical Bioprocessing from the Technical University of Munich (TUM). - Spent three years at the spectroscopy startup Irubis, first as an Application Specialist and Product Manager, advancing the application and strategy of their MIR device. - Leverages entrepreneurial agility and communication skills at enterprise-scale operations, demonstrating how a non-conventional career path builds highly adaptable professionals.
The Power of the Pivot: Accelerating Your Pharma Career Through Unconventional Paths
Leadership & Career
For many emerging professionals, the pressure to follow a rigid, linear career path can overshadow the immense value of unexpected opportunities. By stepping away from a traditional academic trajectory to become the first biotechnology expert in a fast-paced startup, I was forced outside my technical comfort zone to develop essential cross-functional skills in communication, project management, and strategy. This unconventional pivot served as a powerful career accelerator, forging resilience, adapability, and networking skills necessary to successfully transition into late-stage development and technical leadership at a major biopharma enterprise. Through this talk, you will learn how to reframe deviations from your original plan not as setbacks, but as strategic advantages that build the comprehensive leadership toolkit required to thrive in today's industry.
Arne Skerra
Professor at TU Munich & Founder of XL-Protein
Dr. Arne Skerra is Full Professor at the Technical University of Munich, School of Life Sciences. He started his scientific career in the field of protein engineering, where he pioneered the biosynthesis of functional antibody fragments in E. coli. Apart from several other contributions to this area, including the development of Anticalin® proteins as an alternative to antibodies (commercialized by PIERIS Pharmaceuticals, Inc.) and the Strep-tag® technology for recombinant protein purification, he invented PASylation® technology to extend the in vivo half-life of therapeutic proteins and peptides. Dr. Skerra is co-founder and Chairman of XL-protein GmbH, a German biotech company that commercially exploits PASylation® technology and develops PASylated biological drug candidates, including antibodies and their fragments, for clinical application.
Founding a university spin-off company: XL-protein
Leadership & Career
PASylation® technology enables the design of biologics with extended half-life and enhanced in vivo activity. Discovered at the Technical University of Munich (TUM), this proprietary, now clinical-stage technology has been exclusively licensed to XL-protein GmbH for further development and commercial exploitation. PASylation® is a fully biological technology that can be applied both to approved biopharmaceuticals to yield second generation drugs (biobetters) and to innovative therapeutic proteins, peptides or small molecule drugs, thus allowing less frequent and lower dosing combined with better patient tolerability, either upon systemic application or in the eye. In addition, the recently developed XL-mAb® format opens a new dimension in antibody engineering.
Talks Session 2
Malthe Krüger
Process and Simulation Engineer at CRB
Malthe Krüger is a Simulation and Process Engineer at CRB Germany GmbH. He holds a Master's degree in Advanced Materials and Healthcare Engineering from the Technical University of Denmark. With a background in biomaterials engineering, his research focuses on how cells interact with materials.
The Silk Road to GMP: Manufacturing Next-Generation Biomaterials
Technology & Innovation
Naturally derived biomaterials are changing regenerative medicine, and silk fibroin is one of the most promising among them. It's strong, biocompatible and fully resorbable, which makes it suitable for applications from tissue repair to drug delivery. Moving it from the lab to commercial production, however, brings new challenges. This session gives an overview of where silk fibroin is used today, where its opportunities lie, and what it means for manufacturing processes and facility design. Participants will get a practical look at what it takes to bring this biomaterial to GMP-compliant production
Melissa Gleyen
Product Manager, Aseptic Transfer at Getinge
- Melissa Gleyen is Product Manager for Getinge’s Aseptic Transfer Solutions, including the original Rapid Transfer Port system – DPTE® – and single-use DPTE-BetaBag®. - Based in Vendôme, France, where these core products are designed and produced, Melissa has been with Getinge in the Life Science division for eight years. - Starting in communications and knowledge sharing for laboratory and pharmaceutical production equipment, she quickly developed a strong focus on aseptic transfer. - Today, her main responsibilities include market analysis and product management with a focus on developing solutions that help customers meet the latest regulatory requirements.
Annex 1: Rethinking Aseptic Transfer for Less Human Intervention
Technology & Innovation
- Overview of Annex 1’s impact on aseptic transfer processes - From internal to external operation: what’s driving the evolution of Rapid Transfer Ports - Gloveless transfer: where it can reduce interventions and simplify aseptic workflows - Designing single-use transfer bags for reliable, low-intervention operations - First Air considerations and technologies supporting aseptic transfer - Flexible approach to intervention: sterile glove-on-demand systems
Imme Kley
Partner at CMS Hasche Sigle
Imme has been a lawyer in the Hamburg office of the international law firm CMS for 13 years with a focus on lifesciences and healthcare. She advises on industry-specific contractual arrangements (including strategic cooperation projects, distribution) and regulatory issues (including litigation).
EU Pharma Package
Technology & Innovation
Brief overview of new EU Pharma Packages rules, in particular regulatory data protection, security of supply, advertising, implementation timelines.
Lena Mungenast
CEO of Partiris; Head of Programme at FHNW
Lena received her PhD from the University Freiburg, Germany in Tissue Engineering for her work on Biomaterials for spinal cord regeneration. Since 2024 she works as senior scientist at the University of Applied Sciences and Arts Northwestern Switzerland (FHNW) with focus on packaging, container-closure integrity, drug formulation and drug delivery systems. From 2026 on, she is Head of Programme of BSc Biotechnology and BSc Pharmaceutical Technology studies at FHNW. In 2025 she was one co-founder and CEO of Partiris, a start-up specialized in the field of innovative reference standards. Partiris develops and produces tailored particle standards for visual inspection of inherent particles in parenteral drugs.
Timing Is never perfect: taking opportunities and building the right network
Leadership & Career
We often wait for the right moment to take the next step in our careers, but the timing is rarely perfect. From scientific research and academic leadership to motherhood and co-founding a pharma-tech start-up, I have learned that progress often starts before we feel fully ready. In this talk, I will share personal lessons on embracing opportunities, navigating uncertainty, and building genuine relationships. Because the people we meet, learn from, and collaborate with can shape our careers in unexpected ways. My message to young professionals: take the opportunity, invest in your network, and figure things out as you go.
Talks Session 3
Lukas Rückauf
Partner at CMS Hasche Sigle
- Senior Consultant at Arup - 8+ years in pharmaceutical projects. - Experienced in project leadership, stakeholder management, and EPCMV delivery. - Delivered projects for Eli Lilly, Daiichi Sankyo, Baxter, and Boehringer Ingelheim.
From Made in China to Invented in China - How Chinese Pharma Innovation is Entering Europe
Technology & Innovation
China is rapidly emerging as a global pharmaceutical innovation hub, evolving from a manufacturing-driven industry into a major source of novel therapies and innovation. This talk examines the increasing influence of Chinese biopharma companies on the European pharmaceutical landscape. Through selected examples of partnerships, investments, acquisitions, and market entry strategies, it highlights key trends driving this shift, providing insights into how these trends may shape the future relationship between China and Europe in the pharmaceutical sector.
Marleen Grözinger
Consultant Drug Product at Arup
- State-Certified Pharmaceutical Technician - B.Sc. Pharmaceutical Engineering - M.Sc. Facility and Process Design - 5 years experience as Project Engineer and Consultant, focus on Fill&Finish/Drug Product
From Made in China to Invented in China - How Chinese Pharma Innovation is Entering Europe
Technology & Innovation
Brief overview of new EU Pharma Packages rules, in particular regulatory data protection, security of supply, advertising, implementation timelines.
Matthias Angelmaier
Senior SME Fill&Finish at PPE Intelligence
Matthias Angelmaier is a Senior SME for Fill-Finish at PPE Intelligence. He joined the company in 2026. His previous positions were at a multinational processing and packaging technology solutions provider where he started in 2009 as a project manager for handling complex customer projects. Since 2012 he was global responsible product manager for aseptic fill-finish, barrier and Isolator systems as well as process technology. Since 2022, he has been working as a senior fill-finish expert at an internationally renowned planning and consulting company specializing in pharma facility and equipment design. His expertise includes process engineering, sterilization, biodecontamination, aseptic and high-potent Isolator applications, GMP and HSE-related fill-finish applications as well as topics related to advanced aseptic processing. He has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He is a frequent speaker on international symposia and conferences including ISPE and PDA. Besides his professional career, he serves as a lecturer for Cleanroom Technology at Albstadt-Sigmaringen University.
„Back to the future” – 15 Years, One Industry, Many Lessons
Leadership & Career
- Revisiting which aseptic processing trends predicted 15 years ago have become reality. Exploring how robotics, AI, new products and sustainability are reshaping pharmaceutical manufacturing. - Reflecting on the lessons learned through 15 years of industry change and professional development.