The European Pharma Outsourcing Summit brought together senior pharmaceutical leaders for two days of strategic discussion, practical insight, and high-value networking in Düsseldorf, Germany. The event created a focused setting to explore the evolving challenges of outsourcing, external manufacturing, and global partner networks.
The program covered key priorities including CDMO partnerships, technology transfer, supplier performance, quality, regulatory compliance, digital transformation, and supply chain resilience. Sessions highlighted how pharma companies can strengthen collaboration, reduce risk, and build more agile and reliable manufacturing networks.
A special thank you to our emcees, speakers, sponsors, and attendees for making the summit such a success. Your expertise, perspectives, and participation helped drive meaningful conversations and valuable connections across the pharmaceutical outsourcing community.
Day One: A Powerful Dose of Pharma Outsourcing Insight
The summit opened with an engaging welcome from our emcees, Carina Syring, VP, External Manufacturing at Bristol Myers Squibb, and Manda Pasarkar, Director, Global Regulatory Affairs, CMC at Sanofi.
Timo Flessner, SVP, Manufacturing API and Lead, Medical Devices at Bayer, explored how smarter external partnerships can strengthen API supply resilience and scalability. In “Building Scalable and Resilient API Supply Networks Through Smart Partnerships,” he highlighted the importance of CDMO alignment, effective technology transfer, strong GMP oversight, and data-driven performance management to reduce risk, improve transparency, and support more agile global manufacturing networks.
Following the insightful keynote, we moved to a key plenary focused on how pharmaceutical companies can improve oversight and performance across global contract manufacturing networks. Mikkel Sandorff, Senior Director, Operations, Global Contract Manufacturing Drug Product at Novo Nordisk, shared a strategic framework for evaluating CMO performance through supplier segmentation, data-driven KPIs, benchmarking, and stronger collaboration. The session highlighted how these tools can drive greater accountability, operational consistency, and long-term supply resilience.
The conversation then turned to the growing role of intelligent orchestration in building more connected and responsive pharmaceutical supply chains. Luca Fardin, Director, EMEA Solutions Consulting at TraceLink, explored how end-to-end visibility, digitalized B2B collaboration, and agentic intelligence can help pharma leaders anticipate disruption, streamline partner coordination, and make faster, more informed decisions. His session highlighted the importance of creating secure, compliant digital networks that strengthen resilience while improving execution across complex global supply ecosystems.
The morning sessions set an engaging tone for the day, blending actionable takeaways with fresh perspectives on the future of pharmaceutical outsourcing. During the networking break and dedicated one-to-one meetings, attendees connected with industry peers, shared experiences, and expanded on the ideas raised throughout the morning.
Attendees then moved into two focused streams, External Manufacturing and External Quality, allowing for deeper conversations around the specific challenges, priorities, and opportunities shaping their organizations.
The External Manufacturing stream opened with Manuel Becker, Head, Digital Transformation, Core Model and Supply, Global External Manufacturing and Supply at Sanofi. He shared how AI, predictive analytics, and connected digital platforms can improve collaboration with external partners, strengthen supply visibility, identify risks earlier, and support consistent quality and compliance across global manufacturing networks.
Running alongside the External Manufacturing sessions, the External Quality stream featured Monica Aragoneses Palomo, Head, Quality Cluster Europe and Asia Operations, Global Quality, Global Operations at STADA Arzneimittel AG. Her discussion centered on protecting product integrity across external supply networks, with emphasis on stronger QA and QC alignment, risk-based testing, deviation management, batch release readiness, and more proactive supplier oversight.
The morning closed with two parallel workshops. Thomas Hauser, Director, Business Development at Tjoapack, explored how early packaging decisions, material selection, and CDMO expertise can support scalable commercialization. In parallel, Izak Lamprecht and Falk Lenk of Bluecrux examined how stronger supplier and CMO collaboration can improve visibility, reduce risk, and strengthen execution across external networks.
Lunch brought the exhibit hall to life with small-group Lunch & Learn Roundtables focused on practical outsourcing challenges. Radek Fialka of medac discussed aseptic fill & finish for high-potency and ADC products, while Siyu Sheng of Novartis Contract Manufacturing explored regional capacity strategies for more resilient supply chains. Amit Shrivastava and Rajesh Naik of R L Fine Chem examined how CDMO capabilities can accelerate scale-up, technology transfer, and commercial readiness, and Saloni Wagh and Shireesh Ambhaikar of Supriya Lifescience Ltd. focused on strengthening API supply through strategic manufacturing partnerships.
The afternoon streams continued with a closer look at regulatory readiness and quality oversight across external networks. In External Manufacturing, Joseph Vu, Executive Director, Regulatory Affairs, Strategy and CMC at Taiho Oncology, examined how stronger sponsor-CMO alignment, standardized CMC processes, and proactive risk management can support cGMP compliance, inspection readiness, and regulatory filings.
Running in parallel, Diana Aberion, Senior Director, Corporate Quality, Assurance Audit Program and Inspection Management at Gilead Sciences, focused on building stronger global compliance frameworks through risk management, regulatory intelligence, and unified inspection governance. She highlighted how mock inspections, cross-functional assessments, and AI-enabled insights can help organizations identify compliance risks earlier and maintain readiness across outsourced operations.
After the streams concluded, the program moved into two workshop sessions focused on strengthening CDMO partnerships across complex manufacturing and scale-up. Radek Fialka, VP, CDMO at medac, explored high-potency prefilled syringe manufacturing, highlighting containment strategies, dual-site planning, and early sponsor-CDMO alignment to safeguard quality, timelines, and supply reliability.
Continuing the focus on effective CDMO collaboration, Wouter Grymonpré, Ph.D., Global Scientific Lead, Continuous Manufacturing at Fette Compacting, examined how early engagement, advanced manufacturing technologies, and data-driven development can reduce risk and support a smoother transition from lab-scale development to commercial production.
Following Happy Hour, networking, and pre-arranged one-to-one meetings, attendees returned for a plenary led by Elisa Monari, VP, Global Quality Operations, and Piero D'Urso, Head, External Manufacturing Release Operations at Chiesi Group. Their discussion focused on maintaining consistent quality standards across multiple CMOs through stronger governance, risk-based oversight, standardized processes, and closer cross-functional collaboration. They also highlighted how audit insights and clearer accountability can strengthen supplier performance and long-term quality resilience.
Michael Kaeser, Senior Director, External API Manufacturing at Elanco, explored how stronger external manufacturing networks can accelerate technology transfer and support reliable API scale-up. He highlighted dual sourcing, closer integration between development and commercial manufacturing, supplier capacity planning, and cross-functional governance as key levers for reducing supply risk while maintaining consistent product quality.
Day one sessions finished on a high note with a dynamic panel on building stronger, more resilient supplier partnerships through quality-driven vendor oversight. Manda Pasarkar of Sanofi, Ivan Franco of Boehringer Ingelheim, Anna Löfgren of Hansa Biopharma, Emma Newton of Astellas Pharma Europe, and Shaun Crofts of Gilead Sciences shared practical perspectives on selecting the right partners, adapting oversight based on risk, strengthening supplier performance through KPIs, and creating clear escalation pathways when issues arise.
Day one came to a close with a lively Networking Drinks Reception, giving attendees the opportunity to reconnect, exchange takeaways, and build on the conversations sparked throughout the day. It was an energetic finish to a program shaped by quality, collaboration, risk management, and stronger external partnerships.
Day Two: Building the Next Generation of Pharma Operations
Day two opened with Maria Rigotti, Global Quality Officer at Chiesi Group, exploring how pharmaceutical operations can become more agile, efficient, and resilient. She highlighted the importance of simplifying operating models, strengthening cross-functional collaboration, improving data visibility, and building manufacturing networks that can respond faster to changing demand without compromising quality or compliance.
Building on the morning’s focus on resilient operations, Dominik Loitz, Ph.D., SVP and Head, External Manufacturing at Bayer, looked ahead to the next generation of contract manufacturing networks. He explored how stronger partnerships, greater data visibility, and smarter capacity planning can help pharma companies build more flexible, scalable, and resilient external manufacturing ecosystems.
The morning continued with two workshops, each tackling a distinct priority within pharmaceutical outsourcing. Luca Fardin and Pierre-Jacques Evrard of TraceLink explored how digital orchestration and AI agents can streamline workflows, detect exceptions, and enable more intelligent execution across connected business processes.
In Room 2, Dejan Lamešić, Ph.D., Director, Product Development at Catalent, focused on maximizing value from strategic CDMO partnerships, highlighting technology transfer, drug delivery, packaging, distribution, and resilient clinical-to-commercial supply.
The mid-morning break gave attendees another opportunity to connect with exhibitors, exchange perspectives, and build on conversations from the morning sessions. With plenty of fresh ideas in circulation, the room was re-energized and ready for the next stage of the program.
The External Manufacturing stream continued with two sessions examining how stronger supplier relationships and clearer governance can improve performance across outsourced networks. Linda Intoft Gauffin, Senior Director, Manufacturing Technical Operations at Calliditas Therapeutics, focused on building more collaborative supplier partnerships through transparency, accountability, and aligned business, quality, and supply objectives.
During the External Quality stream, Rolv Vereertbrugghen, Senior Manager, External Partners at GSK, focused on CDMO governance within R&D. He highlighted how clearly defined responsibilities, structured review processes, consistent communication, and transparent escalation pathways can strengthen oversight, accountability, and execution across external partnerships.
Taking a candid look at why outsourced manufacturing relationships can fail, Shaun Crofts, Executive Director, External Quality at Gilead Sciences, delivered “Failure is Predictable: Why Outsourced Manufacturing Breaks – and How to Prevent It.” He explored sponsor-CMO tensions, fit-for-purpose oversight, cost and compliance trade-offs, and the importance of building a strong quality culture that encourages learning, accountability, and long-term partnership success.
Building on the morning’s discussions, attendees came together for focused Lunch & Learn Roundtables covering key priorities across pharmaceutical outsourcing, CMC, quality, and external supply. Golo Heckmann of Boehringer Ingelheim, Joana Gaspar of Grünenthal, Marty Hughes of Immuneering, Katherine Barton of Fulcrum Therapeutics, Joseph Vu of Taiho Oncology, Marina Palumbo of Pfizer, Emma Newton of Astellas Pharma Europe, and Salomon Engels of Par Health led conversations on resilient API networks, regulatory agility, CMC strategy, external quality oversight, CMO alignment, and stronger vendor performance.
A Powerful Finish: Leadership and the Future of External Manufacturing
The program also featured an engaging Women in Leadership panel with Kristina Kölerud, Senior Director, External Manufacturing at LEO Pharma; Anna Löfgren, SVP and Head, Quality Assurance at Hansa Biopharma; Liesbeth Foesters, VP and Head, External and Clinical Supply Quality at UCB; Agnes Roque-Cera, Director, Quality Control at Gilead Sciences; Beverly Smith, Senior Director, Technical Capabilities at Bristol Myers Squibb; and Monica Aragoneses Palomo, Head, Quality Cluster Europe and Asia Operations, Global Quality, Global Operations at STADA Arzneimittel AG. The discussion explored career progression, visibility, confidence, leadership styles, and the practical steps organizations can take to build more diverse, future-ready leadership teams.
The summit’s final plenary was led by Tina Self, SVP and Global Head, Biologics Manufacturing at Bayer, who explored how niche CDMO offerings can help pharmaceutical companies make better use of available capabilities and capacity. She highlighted Bayer’s approach to addressing clinical and launch manufacturing gaps, supporting specialized customer needs, and using targeted insourcing opportunities to strengthen internal expertise and broader partnering strategies.
The summit concluded with a forward-looking panel on building stronger, more strategic CDMO partnerships. Joseph Vu, Executive Director, Regulatory Affairs, Strategy and CMC at Taiho Oncology; Roeland Vandebrouck, Senior Director and Head, External Supply Operations at Grünenthal; Catherine Seigneur, Senior Director, External Manufacturing Business Lead at UCB; Salomon Engels, Head, External Manufacturing at Par Health; Carina Syring, VP, External Manufacturing at Bristol Myers Squibb; and Golo Heckmann, Head, API and Chemical Process Development, Animal Health at Boehringer Ingelheim, shared perspectives on what sets truly strategic partnerships apart. The discussion explored governance, flexibility, supplier specialization, data transparency, and the trust needed to move sponsor-CDMO relationships beyond transactions and toward long-term collaboration, innovation, and shared success.
The Next Chapter of Pharma Outsourcing Starts Here
The European Pharma Outsourcing Summit brought senior pharma leaders together for two impactful days of practical insight, meaningful connections, and forward-looking discussions on the future of external manufacturing. From strengthening CDMO partnerships and building resilient supply networks to advancing quality, CMC, digital collaboration, and regulatory readiness, the summit highlighted the strategies helping pharma organizations navigate an increasingly complex outsourcing landscape.
With momentum already building for the next edition, we look forward to bringing the pharmaceutical outsourcing community together again to continue these important conversations.
Be part of what comes next. Learn more and secure your place at eposummit.com.
“Great conference with key Pharma Outsourcing leaders. The small group sessions and networking opportunities were valuable. The plenary presentations were insightful and very engaging. The right balance between industry knowledge sharing, networking and business discussions.”
Salomon Engels, Head of External Manufacturing @ Par Health
Great presentations and sharing experiences. Good connection time allowing to meet valuable professionals with the same business interests. Meeting with sponsors is well organized. Sponsors' readiness and relevance of selection for the event.”
Caroline Chardonnet, External Supply Quality Head @ UCB
“Great chance to connect with peers and boost networking. Get insights and share best practices with the only purpose to have better medicines for our patients.”
Ivan Franco, Head of Third Party Management @ Boehringer Ingelheim
“It is more personal and leaves room for interaction. ”
Wolfgang Schiek, Business Development Director, Agilent Advanced Therapeutics
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