Authors:
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Chris Hall – Spectrum Science
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Joe Balfour – Spectrum Science
A strategic synthesis prepared by Chris Hall and Joe Balfour of Spectrum Science. If you have questions or thoughts, please get in touch with [email protected].
Key Takeaways:
- Medical and Commercial should align early to address evidence gaps and launch needs.
- Strong insight systems help translate stakeholder feedback into decisions.
- Clear ownership and measurable impact strengthen Medical Affairs’ role in the launch.
This synthesis represents Spectrum Science’s perspective, based on verbatim contributions from participants who were present at the Medical Affairs Professional Society (MAPS) roundtable, reflecting their own views and not those of their employers. All participant contributions have been anonymised by organisation and role. The first draft of this report was written with the help of artificial intelligence (AI).
Introduction
Spectrum Science hosted a roundtable at the Medical Affairs Professional Society (MAPS) EMEA Annual Meeting on 19th May, 2026. The roundtable brought together nine senior global medical affairs leaders from small and mid-sized biotechnology companies and global organisations.
The roundtable sought to discuss strategies that have helped Medical and Commercial teams to stay aligned amid turbulent real-world constraints. This paper synthesises those insights and aligns them with our experience, focusing on specific implications for medical affairs leaders in small and mid-sized European organisations.
Executive Summary
By the time friction becomes visible between Medical and Commercial teams in a rare disease launch, the underlying causes are often already embedded in trial design, unclear ownership, poor insight systems, or leadership behaviours that have prioritised internal process over external understanding.
Alignment must be built as a strategic design choice upstream rather than as a coordination exercise downstream.
Those who succeed in rare disease launches will be those who:
- Shape globally relevant evidence plans early
- Create disciplined but flexible mechanisms for capturing market insight
- Define decision rights before launch pressure exposes a lack of preparation
Through this, Medical Affairs teams create direct value, not by being launch-adjacent, but by influencing the decisions that determine whether the launch succeeds.
Alignment is a cultural output, not a process input
The most consistently expressed view was that launch excellence frameworks do not produce genuine Medical-Commercial alignment; it must originate in leadership culture. When senior leadership, up to and including the C-Suite, is demonstrably patient-centred in resource allocation and decision-making, not just in how the aforementioned frameworks are worded, what strapline is on the website, or what arbitrary key performance indicators (KPIs) are tracked, alignment can follow with relative ease. When the leadership is fragmented or ambiguous, no cross-functional process can compensate.
In small- and mid-sized biotechnology companies, the focus is largely on one asset at a time, in limited or single therapy areas. This means leadership and resources, while less established than those of larger companies, are more focused and targeted. In larger companies, this focus can be diluted, meaning resources arrive late, limit the amount of work that can be achieved, and give rise to potential misalignment. Similarly, alignment is often constrained not by intent but by structural misalignment across global, regional, and local layers. Ensuring market insights are leveraged early can more effectively support alignment down the line.
In rare diseases, the impact of misalignment is amplified because patient communities are small or nonexistent, expert clinical teams are scarce, and every interaction carries significant reputational weight. A single inconsistency between the medical and commercial narrative can undermine months of scientific relationship building. This has become more evident as we have moved into a world of instant access to information. All our audiences can find information much more readily and quickly than ever before, which presents a significant risk of misinformation. Similarly, it is important to know what information our audiences are and will be digesting, so our field force teams can add value beyond that. All of this amplifies the need for us to be unified in our external voice.
Three potential strategic issues
Clinical development can be an upstream issue
A particular issue raised for expanding global biotechnology companies, especially in rare diseases, is not an alignment failure between Medical and Commercial teams, but between medical and clinical development. Specifically, trials designed with tunnel vision on US FDA endpoints often yield inadequate evidence for European health technology assessment. This leaves evidence gaps and Medical Affairs teams have to launch with data that do not answer the questions European payers may ask.
This argues for Global Medical Affairs to formally and scientifically co-author clinical development plans, rather than conduct post-hoc reviews. The window to influence endpoint selection and real-world evidence commitments closes well before Phase 3 enrolment begins. Attempting to backfill this issue only delays global patient access.
The insight loop fails before launch
The roundtable surfaced a central issue. Everyone agreed that insights, whether they come from MSLs, Medical Information teams, congresses, advisory boards, or patients, are critical both strategically and operationally. Yet systems for capturing, synthesising, and utilising such insights are often far from optimal.
The causes are mostly structural, including time pressure, inconsistent CRM adoption, and varying definitions of what constitutes an actual insight. Additionally, there is a ‘black box’ problem in which insights gleaned from face-to-face discussions disappear into the ether as they are never formally recorded. As AI-based synthesis tools are increasingly deployed, their accuracy is limited by the data inputted into them, making disciplined capture a critical issue if any downstream analytical value is to be gained from them.
A further complication applies to genuinely rare, unmapped diseases. Within these fields, it may be impossible to determine what quality insight looks like before any have been collected, because nothing has existed before. If we train ourselves to capture insights only in pre-defined categories, we risk filtering out the most strategically important signals that do not fit into pre-defined boxes. This really demonstrates the need to design rare disease insight capture in a phased fashion, open and broad pre-launch, then structured once the disease landscape becomes better understood.
Ambiguity concentrates in three domains
Participants identified three domains which, in their experience, had often been the source of recurring Medical-Commercial friction, specifically in terms of ownership and ‘swim lanes’:
- Data dissemination (publications, congress strategy, medical education, standalone educational meetings)
- External stakeholder engagement (external expert relationships, patient advocacy, payer interactions)
- Safety communications
In rare diseases, all of this is acutely sensitive because, as mentioned previously, stakeholder communities are small and overlapping. The same few expert clinicians may serve as external medical experts, speakers at commercial events, and advisory board members, and encounter both Medical and Commercial functions at the same congress.
It is essential to have confirmed authorisation of who initiates, consults, and holds the veto in each domain, before launch pressure arrives.
The internal–external conundrum
Multiple participants raised a similar concern: across businesses, teams are drowning in internal performance reporting, burdensome consultant-led launch-excellence frameworks, and cross-functional meeting cycles, at the very time when external understanding and engagement are of the utmost importance.
Medical Affairs’ unique contribution in rare diseases, which depends on strong scientific relationships with a small number of expert physicians, proximity to patient communities, and real-time field insights, depends entirely on time spent externally. Little of this value can be shortcut through AI, which can help to expedite some processes, but can never replace the foundational need for externally focused interaction. Internal reporting that yields no actionable decisions represents a significant opportunity cost that is rarely quantified or even discussed.
On demonstrating Medical Affairs value
The roundtable addressed the seemingly eternal ‘value’ debate with a sharp observation. If Commercial teams are asked to separate the demonstrable impact of Marketing teams from that of Sales, Marketing may also struggle to demonstrate explicit value. The demand for quantifiable attribution from Medical Affairs is often not applied symmetrically across the commercial organisation.
Organisations that genuinely understand rare disease do not ask the question in this way. Leadership has direct visibility of what the Medical team contributes to clinical development outcomes, HTA dossiers, label negotiations, and the quality of physician trust.
The strategic answer is not better activity metrics but greater involvement in decisions that matter. Identifying two or three decisions the organisation made differently, faster, or more effectively because of Medical Affairs input, and making those visible internally, is more persuasive than any KPI framework provided by an expensive consultancy a decade ago.
An interesting discussion was how Medical and Commercial teams could reframe their thoughts less around alignment and more around shared ownership of commercialisation. Commercialisation should not be seen as a dirty word for Medical to be part of; it should be seen as supporting the advancement of technologies for the betterment of patients, and this is how we judge true value.
Priorities
The strategic lesson is not that rare disease launches need more, be that more alignment meetings, more reporting, or more launch theatre. They need earlier medical input, clearer decision-making, and greater discipline in determining value. The medical priority cannot be to defend relevance through activity; rather, it must be to shape the scientific, evidentiary, and external movements that determine launch credibility across the community.
Based on the discussion in the room and our own perspective, the agenda for medical affairs leaders in small and mid-sized European organisations can be prioritised in three moves:
- Do now: Secure formal Medical Affairs input and influence over clinical development decisions, particularly in evidence generation, endpoint selection, and real-world evidence plans, to shape European access and launch credibility
- Do next: Build the pre-launch architecture for insight capture, synthesis, and cross-functional decision-making. Ensure to include clear definitions of insight, disciplined mechanisms for synthesis, and regulated decision rights
- Stop doing: Allowing internal reporting, legacy launch frameworks, and proxy KPIs to consume time that should be spent on building external understanding, scientific credibility, and decision quality in the field
Conclusion
Every company differs by culture, focus, goals, size, ambition, and more. However, there was significant alignment in thoughts and insights from experts during the roundtable discussion. There was much talk of having the right people in the right room at the right time, and of the importance of shared objectives and KPIs.
Our world is changing before our eyes like never before; it is, and will remain, turbulent and increasingly challenging. But fundamentally, success will be achieved more quickly and more often by those who focus outside their walls, endeavour to understand how healthcare is changing, how clinicians are consuming and synthesising data, and how technology will continue to change this (including and excluding AI). Clearly, no one has the answer to this, nor should they pretend to, but the most successful will likely be those who have tried to understand and add value to the external system, rather than just seeking to reduce internal costs and hit arbitrary launch KPIs.
The greatest danger in times of turbulence is not the turbulence; it is to act with yesterday’s logic
–Peter Drucker
INTERESTED IN HOSTING A ROUNDTABLE?
This article summarizes a Roundtable hosted by a MAPS Partner Circle member that brought together leading experts from across the industry. If you are a solution provider interested in hosting your own Roundtable – in-person or virtually – please check out our Media Planner or contact Luke with MAPS: [email protected].
