PCM 2027 | Speaker Interview with Anna-Kaisa Lehtivarjo

Chapter headingChapter subheadingAnna-Kaisa Lehtivarjo, VP Quality Assurance at Resolution Therapeutics, shares her perspective on what separates high-performing outsourcing relationships from those that struggle with misalignment, poor visibility and delayed technology transfers.Contents

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9-11 March 2027 | Berlin, Germany

Anna-Kaisa Lehtivarjo

VP Quality Assurance

Resolution Therapeutics

Beyond the Template: How to Build Pharma-CDMO Partnerships Around the Needs of the Project

INTRODUCTION

As outsourced manufacturing relationships become more complex, pharma companies are under increasing pressure to balance quality, speed, visibility and risk.

For Anna-Kaisa Lehtivarjo, VP Quality Assurance at Resolution Therapeutics, successful partnerships are built on more than contracts and standard processes.

In this interview, she explores how pharma companies and CDMOs can improve communication, create more effective quality agreements and reduce technology transfer risk through better planning and collaboration.

The pharma–CDMO relationship is increasingly moving beyond a transactional supplier arrangement. In your experience, what separates a truly strategic partnership from one that is simply meeting the terms of a contract?

A truly strategic partnership is possible when the relationship between the teams is collaborative, and both parties have the right development mindset.

When both parties understand what the main goals for the project are, they can work together to achieve them in the best possible way.

However, the contracts and agreements also need to allow this and not penalise either party for, for example, doing activities more efficiently or faster.

Price, quality, and speed are often treated as competing priorities. How should pharma companies and CDMOs benchmark expectations across these three metrics – and where do you most often see misalignment?

None of the three – price, quality or speed – can be overlooked, and rather than seeing the three as competing, pharma companies should evaluate cross-functionally what the minimum acceptable level is for each parameter in the specific outsourcing project they are working on.

I don’t think you can set a universal benchmark for these; the expectations are very different for an early-phase project compared to a commercial partnership.

I might have been lucky, but I haven’t seen that much misalignment personally. When everyone in the team understands the risks and opportunities comprehensively, it’s easy to evaluate what the best approach is for the specific project.

Poor communication can quickly turn into inconsistent performance or commercial tension. What does effective communication between pharma and CDMO partners look like in practice, and how can both sides create greater accountability?

Communication is definitely key to the successful completion of any project, especially when there are multiple players and stakeholders, as in any project involving outsourced manufacturing.

I think it is important to build good relationships between the counterparts

in both companies, design a clear meeting structure, and agree on the project plans and deliverables on a detailed level.

It’s also good to remember not to underestimate the knowledge or level of expertise of the other party and treat everyone with respect even when there are disagreements. This goes both ways!

Quality agreements are intended to create clarity and accountability, but disputes around KPIs, standards and responsibilities still occur. What should organisations be doing differently when defining and managing quality expectations with their CDMO partners?

It’s important to approach this with a project-specific lens.

I know that when you are busy with your day-to-day quality activities, trying to make your standard quality agreement fit all new supplier projects might seem like the easiest way forward.

But, you can’t expect the same of the quality system of a custom-made raw material supplier as you would of a commercial drug product manufacturer.

Involving the cross-functional outsourcing team in the review process will help you to define the most critical aspects of the quality agreement in question.

Where are you seeing digital tools and AI deliver the most tangible improvements in operational efficiency, performance visibility, or decision-making?

Digital tools make data visible, enable fast data analysis and help with truly data-driven decision-making. These tools will also help to detect emerging issues before they become reality, and AI tools can help you to identify new KPIs that would be beneficial to follow.

Both digital tools and AI have a lot of potential, but I have also seen communication between two companies turn into a conversation between their AI agents, and this kind of use of AI doesn’t bring any value to anyone.

Even though AI can speed up complicated tasks, you need to put effort into teaching and designing the tools; you can’t just hope they magically do something for you because you are struggling with resources.

Manual reporting and fragmented data can make it difficult to understand what is really happening across a CMO/CDMO network. What does good end-to-end visibility look like, and what should pharma companies prioritise when closing these visibility gaps?

You shouldn’t underestimate the importance of data transfer practices and planning them early in the project. Well-thought-out data transfer processes also differentiate excellent CDMOs from the average ones.

It doesn’t matter how detailed your quality agreement is in terms of what data needs to be provided and when, or how advanced your data transfer tools are, if the actual transfer depends on individual employees remembering to do it.

That said, manual reporting can also work well if it is embedded in the procedures of the CDMO.

Tech transfer is often a critical point of friction between pharma and CDMO partners. How can better processes, data, and technology accelerate technology transfer while reducing the risk of delays, quality issues, and miscommunication?

Knowledge is the key to a successful tech transfer, and not just the knowledge about the manufacturing process or the analytical methods being transferred, but also knowledge of what information the CDMO requires to prepare for and execute the tech transfer.

In my experience, the actual process or method is not what ends up delaying the project; it’s something that felt so insignificant or easy that no one really thought of it, for example, the availability of a specific raw material in the country where the CDMO operates.

Based on my experience, risk management is extremely important

Anna-Kaisa Lehtivarjo

VP Quality Assurance

Resolution Therapeutics

from the start. All risk assessments should have a real purpose; they shouldn’t be thought of as just another tick-box exercise QA is asking for, but a tool to help the tech transfer team to focus on the right areas.

PCM 2027 brings together some of the most pressing challenges and opportunities in pharma contract manufacturing.

With so many demands on your time, what made you decide this was a conversation worth prioritising, and what do you hope to share that attendees won’t get anywhere else?

I have participated in PCM once before and really liked the conversations with other participants. As I have worked both at a CDMO and now on the other side at a company outsourcing manufacturing to CDMOs, I thought I might have useful perspectives and practical experiences to share.

9-11 March 2027 | Berlin, Germany

As manufacturing networks grow more complex, organisations must find better ways to align quality expectations, improve communication, strengthen visibility and reduce technology transfer risk.

These are no longer operational considerations alone. They have become critical factors in partnership performance and supply resilience.

At Pharma Contract Manufacturing 2027, 9-11 March 2027, Berlin, Germany, senior leaders from pharma, biotech, CMOs and CDMOs will come together to share practical experiences, benchmark approaches and explore how stronger partnerships can drive better outcomes across the manufacturing lifecycle.

Attendees will gain actionable strategies for improving outsourcing relationships, enhancing operational efficiency and building more resilient manufacturing networks.

To learn more about the event, explore the agenda, and discover how your peers are tackling the industry's most pressing contract manufacturing challenges, visit the PCM 2027 website today.

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