18 June 2026

7.00 – 8.00 CET

DELEGATE REGISTRATION AND NETWORKING BREAKFAST

8.00 – 8.10 CET

Chair's opening remarks

External Manufacturing

Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

Manda Pasarkar

Director, Global Regulatory Affairs, CMC
Sanofi

8.10 – 8.40 CET

Keynote

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

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

Luca Fardin

Director, EMEA Solutions Consulting
TraceLink

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

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

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 Manufacturing

Rolv Vereertbrugghen

Senior Manager, External Partners
GSK

Strengthening CDMO Governance in the Research and Development 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

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:

Golo Heckmann

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

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

Joana Gaspar

Associate Director, CMC Compliance Strategy, Integrations
Grünenthal

From Compliance to Product Excellence: Strategic Evolution of CMC

Marty Hughes

Executive Director, CMC
Immuneering

Building Adaptive Operations to Withstand Geopolitical Shifts and Regulatory Disruptions

Katherine Barton

Senior Director, CMC Global Regulatory Affairs
Fulcrum Therapeutics

Bridging CMC Innovation and Regulatory Compliance for Global Manufacturing Agility

Joseph Vu

Executive Director, Regulatory Affairs, Strategy and CMC
Taiho Oncology

Enhancing CMC Quality Assurance to Strengthen Global External Manufacturing Networks

Marina Palumbo

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

Strengthening External Supply Quality Operations to Protect Supply and Compliance Globally

Emma Newton

Head, Product Quality Assurance
Astellas Pharma Europe

Partnering for Quality: Aligning CMO Excellence with Pharma QA Expectations

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

  • Kristina Kölerud

    Senior Director, External Manufacturing
    LEO Pharma

  • Anna Löfgren

    SVP and Head, Quality Assurance
    Hansa Biopharma

  • Liesbeth Foesters

    VP and Head, External and Clinical Supply Quality
    UCB

  • Agnes Roque-Cera

    Director, Quality Control
    Gilead Sciences

  • Beverly Smith

    Senior Director, Technical Capabilities
    Bristol Myers Squibb

  • Monica Aragoneses Palomo

    Head, Quality Cluster Europe and Asia 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

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

  • Joseph Vu

    Executive Director, Regulatory Affairs, Strategy and CMC
    Taiho Oncology

  • Roeland Vandebrouck

    Senior Director and Head, External Supply Operations
    Grünenthal Group

  • Catherine Seigneur

    Senior Director, External Manufacturing Business Lead
    UCB

  • Salomon Engels

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

  • Carina Syring

    VP, External Manufacturing
    Bristol Myers Squibb

  • 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

Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

Manda Pasarkar

Director, Global Regulatory Affairs, CMC
Sanofi

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