18 June 2026

7.00 – 8.00 CET

DELEGATE REGISTRATION AND NETWORKING BREAKFAST

8.00 – 8.10 CET

Chair's opening remarks

External Manufacturing

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Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

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Manda Pasarkar

Director, Global Regulatory Affairs, CMC
Sanofi

8.10 – 8.40 CET

Keynote

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Maria Rigotti

Global Quality Officer
Chiesi

Transforming Pharmaceutical Operations to Drive Efficiency, Agility, and Long-Term Supply Resilience

  • Modernizing operational models to reduce complexity and improve end-to-end execution across internal and external networks
  • Building agile manufacturing and supply structures that respond faster to demand shifts and capacity constraints
  • Embedding operational excellence principles to drive sustainable efficiency without compromising quality or compliance
  • Strengthening cross-functional collaboration between supply, quality, technical operations, and external partners
  • Improving decision-making speed through better governance, data visibility, and escalation pathways
8.40 – 9.10 CET

PLENARY

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Dominik Loitz, Ph.D.

SVP and Head, External Manufacturing
Bayer

Building the Next Generation of Contract Manufacturing Networks in Healthcare

  • Strengthening strategic partnerships across global contract manufacturing networks
  • Balancing capacity, flexibility, and risk in evolving healthcare supply chains
  • Enhancing collaboration between sponsors, CMOs, and critical supply partners
  • Leveraging digitalization and data visibility to improve network performance
  • Building more resilient and scalable manufacturing ecosystems for future demand
9.15 - 9.45 CET

Workshops

Room 1

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Brian Daleiden

VP, Corporate Marketing and Demand Generation
TraceLink

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Pierre-Jacques Evrard

Senior Solution Consultant
TraceLink

Agentic Orchestration in Action: From Digitalization to Intelligent Execution

  • Driving cross-enterprise digitalization of business transactions to improve efficiency and reduce manual complexity
  • Enabling no-code orchestration across commercial, manufacturing, quality, and logistics processes
  • Leveraging AI agents to interpret real-time data, automate workflows, detect exceptions, and support decision-making
  • Mapping the agentic value journey - from digitalization to orchestration to intelligent, autonomous execution

Room 2

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Dejan Lamešić, Ph.D

Director, Product Development
Catalent

Maximizing Value Through Strategic CDMO Partnership

  • Highlighting Catalent’s approach to seamless collaboration from early development through commercial supply execution
  • Leveraging integrated drug delivery technologies to overcome formulation and bioavailability challenges
  • Streamlining technology transfers to support predictable scale-up across dosage forms
  • Driving resilient clinical and commercial supply through optimized packaging and distribution
  • Enhancing operational oversight across a global CDMO network to mitigate supply risk and protect timelines
9.50 – 11.10 CET

Refreshments, Networking and Pre-Arranged 1-2-1 Meetings

11.15 – 11.45 CET

STREAMS

EXTERNAL MANUFACTURING

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Linda Intoft Gauffin

Senior Director, Manufacturing Technical Operations
Calliditas Therapeutics

Maximizing Supplier Relationship Performance: Strengthening Collaboration and Long-Term Value

  • Strengthening supplier relationship management to improve performance and operational alignment
  • Building collaborative partnerships that drive long-term value across external manufacturing networks
  • Identifying and addressing performance gaps through structured governance and communication
  • Aligning quality, supply, and business objectives to improve responsiveness and reliability
  • Maximizing the return on supplier relationships through transparency, accountability, and continuous improvement

EXTERNAL QUALITY

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Alba Fernández Font

Director, cGMP, External Partners
GSK

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Rolv Vereertbrugghen

Senior Manager, External Partners
GSK

Strengthening CDMO Governance in the R&D Space to Improve Oversight, Execution, and Accountability

  • Defining governance frameworks to manage cross-functional CDMO relationships
  • Aligning internal roles and responsibilities for vendor oversight
  • Tracking project progress through structured review boards
  • Balancing central and regional control in decision-making.
  • Driving accountability with transparent escalation mechanisms
  • Standardizing communication and documentation protocols across teams
11.50 - 12.20 CET

Plenary

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Shaun Crofts

Executive Director, External Quality
Gilead Sciences

Failure is Predictable: Why Outsourced Manufacturing Breaks – and How to Prevent It

  • Understanding how natural sponsor-CMO tensions can influence decision-making
  • Defining fit-for-purpose oversight and when sponsors should step back
  • Balancing efficiency and cost discipline without compromising compliance
  • Building learning systems that prioritize insight over reassurance
  • Strengthening quality culture as a key predictor of outsourcing success
12.25 - 13.25 CET

Lunch & Learn Roundtable Discussions

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance is limited. Choose from:

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Golo Heckmann

Head, API and Chemical Process Development, Animal Health
Boehringer Ingelheim

From External Development to Commercial Supply – Building Resilient GMP‑Compliant API Networks

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Joana Gaspar

Associate Director, CMC Compliance Strategy, Integrations
Grünenthal

From Compliance to Product Excellence: Strategic Evolution of CMC

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Marty Hughes

Executive Director, CMC
Immuneering

Building Adaptive Operations to Withstand Geopolitical Shifts and Regulatory Disruptions

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Katherine Barton

Senior Director, CMC Global Regulatory Affairs
Fulcrum Therapeutics

Bridging CMC Innovation and Regulatory Compliance for Global Manufacturing Agility

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Joseph Vu

Executive Director, Regulatory Affairs, Strategy and CMC
Taiho Oncology

Enhancing CMC Quality Assurance to Strengthen Global External Manufacturing Networks

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Marina Palumbo

Senior Director, Cluster Head, External Supply Operations, Quality
Pfizer

Strengthening External Supply Quality Operations to Protect Supply and Compliance Globally

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Emma Newton

Head, Product QA
Astellas Pharma Europe

Partnering for Quality: Aligning CMO Excellence with Pharma QA Expectations

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Salomon Engels

Head, External Manufacturing
Par Health (formerly Mallinckrodt-Endo)

Defining the KPIs That Improve Vendor Performance and Operational Reliability

13.30 - 14.15 CET

Panel Discussion

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    Kristina Kölerud

    Senior Director, External Manufacturing
    LEO Pharma

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    Anna Löfgren

    SVP and Head, Quality Assurance
    Hansa Biopharma

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    Liesbeth Foesters

    VP and Head, External and Clinical Supply Quality
    UCB

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    Agnes Roque-Cera

    Director, Quality Control
    Gilead Sciences

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    Beverly Smith

    Senior Director, Technical Capabilities
    Bristol Myers Squibb

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    Monica Aragoneses Palomo

    Head, Quality Cluster E&A Operations, Global Quality, Global Operations
    Stada Arzneimittel AG

Women In Leadership

  • What changes have you seen genuinely help women progress into senior leadership roles?
  • What key experiences or leadership lessons have shaped your own career journey?
  • How can organizations better support women in areas such as visibility, confidence, communication styles, and access to networks?
  • How do cultural backgrounds and workplace expectations influence leadership styles and career progression?
  • Women are often highly collaborative and supportive leaders - how can leaders balance supporting others while also advocating for themselves?
  • What practical actions can organizations take to build more diverse and future-ready leadership teams?
14.20 - 14.50 CET

Plenary

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Tina Self

SVP and Global Head, Biologics Manufacturing
Bayer

Maximizing Capabilities and Capacities Through Niche CDMO Offerings

  •  Managing timing and capacity challenges across pipeline development and transitions into clinical and launch manufacturing
  • Exploring Bayer’s approach to filling gaps in clinical and launch manufacturing schedules to maximize resources
  • Designing BioPartnering Solutions offerings to support niche customer and manufacturing needs
  • Leveraging targeted “insourcing” opportunities to strengthen internal capabilities and support broader partnering engagements
14.55 - 15.40 CET

Panel Discussion

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    Joseph Vu

    Executive Director, Regulatory Affairs, Strategy and CMC
    Taiho Oncology

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    Roeland Vandebrouck

    Senior Director and Head, External Supply Operations
    Grünenthal Group

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    Catherine Seigneur

    Senior Director, External Manufacturing Business Lead
    UCB

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    Salomon Engels

    Head, External Manufacturing
    Par Health (formerly Mallinckrodt-Endo)

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    Carina Syring

    VP, External Manufacturing
    Bristol Myers Squibb

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    Golo Heckmann

    Head, API and Chemical Process Development, Animal Health
    Boehringer Ingelheim

Optimizing CDMO Partnerships for Long-Term Success and Strategic Alignment

  • Defining what differentiates a truly strategic CDMO partnership from a transactional relationship
  • Balancing flexibility, speed, and control across commercial supply partnerships
  • Evaluating the benefits of “one-stop shop” CDMOs versus specialized technical providers
  • Governance models and communication structures for long-term CDMO collaborations
  • Improving transparency, data exchange, and digital connectivity between sponsors and CDMOs
  • Building long-term trust, innovation, and co-creation between sponsors and CDMOs
15.40 - 15.50 CET

Chair's Closing Remarks

External Manufacturing

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Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

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Manda Pasarkar

Director, Global Regulatory Affairs, CMC
Sanofi

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