PCM 2027 | Eight Challenges. Eight Agenda Sessions: Your Guide to Pharma Contract Manufacturing 2027

Chapter headingChapter subheadingThis infographic explores the eight key challenges facing pharma contract manufacturing and match each one with a PCM 2027 agenda session designed to help address it.Contents

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9-11 March 2027 | Berlin, Germany

EIGHT CHALLENGES.

EIGHT AGENDA SESSIONS

Your Guide to Pharma Contract Manufacturing 2027

Pharma contract manufacturing is under pressure. Supply chain disruption, geopolitical uncertainty, rising costs and increasingly complex outsourcing relationships are creating new challenges for pharmaceutical companies and their manufacturing partners.

But identifying the challenge is only the first step. The next question is where to find the conversations, insights and practical approaches that can help address it.

This infographic brings together eight challenges facing pharma contract manufacturing and maps each one to a relevant session on the PCM 2027 agenda. From strengthening communication and navigating cost pressures to improving supply chain resilience, benchmarking AI adoption, accelerating technology transfer and finding the right manufacturing partner, use this guide to identify the sessions most relevant to the pressures facing your organisation.

Discover the challenge, why it matters, and where it is being tackled at PCM 2027, helping you turn the agenda into a practical roadmap for the conversations you need to have.

01 | COMMUNICATION GAPS

THE PERFECT PARTNERSHIP: WHAT DO ORIGINATORS, GENERICS AND CDMOS REALLY WANT FROM EACH OTHER?

In this candid panel discussion, leaders from pharmaceutical companies and CDMOs will share their perspectives on what drives long-term collaboration. From reliability, communication and quality to commercial negotiations, innovation, and sustainability, we will explore how expectations are evolving and what both organisations can do to build stronger, more resilient partnerships.

Speakers:

Ulrich Rumenapp, Senior Biotech Program Lead, Bayer

Jaffer Shahab, Senior Procurement Manager, External Manufacturing, Roche

Stephanie Wohl Bruhn, External Manufacturing Expert, Former Sandoz

Patrick Wallquist, External Manufacturing API Manager, Elanco

When information is late, fragmented or inconsistent, small issues can escalate into missed expectations, slower decisions and tension over accountability.

Pharma–CDMO partnerships rely on frequent, honest and efficient communication. Yet different teams, systems, priorities, cultures and time zones can leave critical context trapped in meetings, email chains or functional silos.

The result is often duplicated work, delayed escalation and disagreement over who owns the next action. Stronger partnerships create clear governance, decision rights, escalation routes and communication rhythms, while ensuring both sides remain transparent, responsive and proactive.

FROM RISK TO RESILIENCE: STRESS-TESTING YOUR SUPPLY CHAIN IN TIMES OF UNCERTAINTY

This interactive workshop will explore how pharmaceutical companies and CMOs can move from a reactive approach to supply chain disruption toward a proactive resilience strategy.

Through practical group exercises and industry discussion, delegates will stress-test their supply chains, identify critical vulnerabilities, and explore strategies to strengthen long-term supply security.

API shortages, supplier failure, transport delays and regulatory non-compliance can quickly threaten production continuity and patient access.

Lean, globally distributed supply models face pressure from raw-material shortages, disrupted logistics, cyber threats, cost inflation and tightening regulatory expectations. A single point of failure can delay production or interrupt supply.

Resilience therefore requires more than emergency response: organisations need visibility of critical dependencies, practical stress-testing, flexible manufacturing and inventory strategies, and joint contingency planning between sponsors and manufacturing partners.

AGENDA SESSION

02 | SUPPLY CHAIN DISRUPTIONS

03 | GEOPOLITICAL TURBULENCE

AGENDA SESSION

Tariffs, trade restrictions and shifting regulation are forcing manufacturers to reassess where they source, produce and launch medicines.

Geopolitical change now reaches deeply into external manufacturing strategy. New tariffs, trade restrictions and pricing proposals can alter landed cost, supplier viability, manufacturing footprints and market-access assumptions.

European organisations must also consider how U.S. policy changes may affect medicine availability, investment decisions and product launches. Building resilience means monitoring policy, testing scenarios and aligning sourcing, production and commercial choices before disruption occurs.

HOW U.S. POLICY IS CHANGING THE SUPPLY CHAIN RULES: PREPARING FOR TARIFFS, TRADE RESTRICTIONS AND REGULATORY DISRUPTION

This session will provide the latest update on evolving U.S. policy, examining how changes in trade and regulations are influencing pharmaceutical manufacturing, supply chains and global market dynamics. The discussion will explore the implications for Europe, including the potential impact on medicine availability, investment decisions and product launches.

Speaker: Gil Roth, President, Pharma and Biopharma Outsourcing Association

04 | PRICE NEGOTIATIONS & COST PRESSURES

AGENDA SESSION

Rising labour, energy, material, logistics and quality costs are intensifying repricing conversations across long-term agreements.

Repricing is rarely a simple question of accepting or rejecting a higher unit cost. Product complexity, volume, capacity, service scope, logistics, quality activity and investment requirements can all shape a fair outcome.

Pharma companies still need predictability, competitiveness and continuity, while CDMOs need sustainable economics. Productive negotiation depends on a transparent, evidence-based case, agreed review mechanisms and consideration of alternatives such as volume commitments, operational improvements, scope changes or risk sharing.

BEYOND THE ORIGINAL AGREEMENT: A PRACTICAL FRAMEWORK FOR CDMO REPRICING

In this interactive workshop, participants will examine repricing from both the pharmaceutical company and CDMO perspectives. Practical scenarios and structured frameworks will be used to explore how companies can build and evaluate a robust repricing case, distinguish justified cost changes from commercial repositioning, and identify alternatives to a straightforward unit-price increase.

The workshop will be facilitated by Fuliginous Management Consulting, drawing on its team’s extensive, hands-on experience in CDMO costing, pricing, profitability measurement, industry best practices, and pharma–CDMO negotiations.

Speakers:

George Ntortas, Partner, Fuliginous Management Consulting

Kyriakos Kansos, Partner, Fuliginous Management Consulting

05 | MISALIGNED EXPECTATIONS

AGENDA SESSION

Speed, cost and quality are interdependent – but sponsors and partners may weight them differently or leave important criteria unstated.

Misalignment often begins before a contract is signed. One party may optimise for speed to market while the other focuses on cost, capacity utilisation or technical risk. Quality and compliance cannot be treated as negotiable variables, yet timelines and budgets still matter.

Better decisions make trade-offs explicit, define measurable expectations and look beyond the traditional ‘golden triangle’ to technical expertise, regulatory track record, communication, flexibility, innovation and cultural fit.

THE DECISION MATRIX: SPEED VS COST VS QUALITY

Join senior leaders from three pharmaceutical companies as they share how to weigh these priorities and select CDMO partners. Through practical examples, the panel will explore the decision-making frameworks they use, the trade-offs they are willing to make, and the qualities they value most in a long-term manufacturing partner.

Speakers:

Olaf Birkenmeier, Senior Advisory, CMC Strategy, Polpharma Biologics

Anna-Kaisa Lehtivarjo, VP Quality Assurance, Resolution Therapeutics

Carlo Capobianco, Global Head ESO MS&T, Business Development and Launch, Sandoz

06 | AI INTEGRATION

AGENDA SESSION

AI promises better insight and efficiency, but adoption is uneven and depends on trusted data, interoperable systems and clear governance.

The challenge is not simply acquiring an AI tool. Organisations need to understand their current maturity, identify high-value use cases and address the fragmented data, manual reporting and legacy systems that limit visibility across external manufacturing networks.

Sensitive commercial and quality data also demand appropriate governance. Progress starts with honest benchmarking: where is AI already supporting analysis or decisions, and where must data quality, integration and operating practices improve first?

POLL YOUR PEERS: WHERE ARE YOU ON THE AI ADOPTION CURVE?

Attend this interactive live poll to discover where you and your peers are on the AI adoption journey. Compare your organisation’s progress against fellow delegates, uncover real-time insights into AI maturity across the room, and see how your experience stacks up against the wider industry. The results will provide a valuable benchmark and set the stage for the discussions ahead.

Speaker: Philip Coetzee, Director, CMO Management, Daiichi Sankyo

07 | TECHNOLOGY TRANSFER

AGENDA SESSION

A document handover is not a knowledge transfer; fragmented records and missing context can create quality, compliance and scale-up risk.

Successful technology transfer requires the receiving team to understand not only what to do, but why the process works and where its risks sit. Paper-on-glass practices, disconnected files and late quality alignment weaken traceability and obscure critical know-how.

Stronger transfers establish a single source of truth, identify the necessary process knowledge and data, define responsibilities early, and use structured risk assessments to address vulnerabilities before engineering and validation runs.

PRACTICAL STRATEGIES FOR MASTERING TECHNOLOGY TRANSFER TO ACCELERATE TIME TO MARKET

Successful technology transfer requires far more than the handover of documentation. It demands that the receiving team has the knowledge, context, and operational understanding needed to execute the transfer efficiently.

Yet many organisations continue to rely on fragmented paper and electronic documentation (known as paper on glass), creating inefficiencies, increasing risk, and limiting visibility throughout the transfer lifecycle. Join this expert panel as industry leaders share practical strategies for overcoming common technology transfer challenges.

Speaker: Christian Simon, Head of Technical Transfer External Manufacturing, Sanofi

08 | FINDING YOUR MANUFACTURING PARTNER

AGENDA SESSION

The right CDMO must fit the product, process and partnership – not simply offer a broadly relevant technology or an available slot.

Partner identification is increasingly complex because technical fit depends on dosage form, process requirements, containment, batch size, approvals, geography, capacity and strategic alignment. Public capability statements may not reveal product–site fit or the practical realities of working together.

A disciplined search combines detailed manufacturing intelligence with market expertise, then applies quality, regulatory, commercial and cultural due diligence to narrow the field to partners capable of supporting the product over time.

FINDING THE RIGHT CDMO: A DATA-DRIVEN APPROACH TO PARTNER IDENTIFICATION

During this 30-minute presentation, Fuliginous Management Consulting will demonstrate how its proprietary web-based intelligence platform can transform the initial CDMO search from a process lasting weeks – or even months – into one completed within minutes.

Covering more than 780 CDMOs, 1,480 manufacturing sites of finished dosage forms and 35 manufacturing technologies, the platform systematically screens the market and narrows an extensive universe of manufacturers to the most relevant candidates for a specific product.

Speakers:

George Ntortas, Partner, Fuliginous Management Consulting

Kyriakos Kansos, Partner, Fuliginous Management Consulting

9-11 March 2027 | Berlin, Germany

There may be no single solution to the pressures facing pharma contract manufacturing. But there are many opportunities to benchmark different approaches, learn from industry peers and tackle these challenges alongside the people facing them every day.

The wider PCM 2027 agenda is designed to bring pharma and CMO leaders together to address external manufacturing challenges collectively, while strengthening relationships and sharing practical insights.

At Pharma Contract Manufacturing, 9-11 March 2027, Berlin, Germany, the challenges explored in this infographic move from the page into the conference room. The agenda creates opportunities to stress-test supply chains, explore approaches to repricing, benchmark AI adoption, improve technology transfer and examine how organisations can identify the right manufacturing partners.

Join us at Pharma Contract Manufacturing 2027 and turn the challenges putting contract manufacturing under pressure into the conversations that can help move your strategy forward.

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