Agility in medical affairs: responding to rapid market and regulatory shifts

By Maurice Leonard

Medical affairs plays a vital role in launch excellence by converting scientific and clinical data into clear, clinically useful information, anticipating regulator and payer questions, equipping the field to handle complex enquiries from day one, and adjusting the scientific narrative quickly when things change.

While commercial considerations such as the recent US drug tariffs are making a significant impact on market access and pricing strategies worldwide, these economic pressures must be kept distinct from the medical focus. Medical affairs teams are responsible for maintaining the integrity of scientific communication and patient-centric objectives, even as commercial teams navigate the indirect effects of such tariffs on business operations and strategy.

Uncertainty has become a consistent ‘stakeholder’ in today’s evolving market and the continuous shifting regulatory landscape. Agility enables successful delivery despite new challenges and, in rare diseases especially, guidance can change at short notice, creating a need to reframe the narrative promptly and accurately, without compromising scientific integrity.

With stop-go-start launches, reimbursement delays can leave ‘ready’ field teams in position for months before the work starts. If an organisation’s only approach is permanent hiring, this can result in significant financial impact during periods where teams are in a holding pattern.

Many sponsors now roll out specialised teams within medical affairs to engage healthcare professionals and other key stakeholders in advance of launching dedicated teams of key account managers (KAMs) for pricing and patient access. These teams typically include medical science liaisons (MSLs), field medical specialists and clinical educators who are responsible for scientific exchange, gathering medical insights and fostering relationships with thought leaders. By establishing these dependable in-region medical teams early, sponsors can ensure that scientific communication is prioritised, local clinical needs are understood and foundational trust is built with stakeholders before a broader commercial rollout. These teams may also support activities like evidence generation, advisory boards, educational initiatives and the coordination of early access programmes, all of which contribute to demonstrating product value and supporting market access objectives.

Agility is not improvisation – it’s a set of capabilities that can be confidently deployed, expanded or stood down. It enables companies to have the right resources at the right time. Utilising a partner with an established regional team, or one that can provide expert leads, creates opportunities to scale up as evidence, access and timelines evolve. This avoids ‘bench’ costs and reduces HR complications if plans change.

Pipelines rarely run in straight lines, and many companies have more than one asset, so if the focus needs to move from one therapeutic area or indication to another, a subject-matter lead can raise the quality of scientific exchange and upskill the team quickly.

In effect, it’s ‘try before you buy’ at an organisational level. It’s an opportunity to discover what you need to successfully deliver before you make it permanent.

In the US, Food and Drug Administration (FDA) timelines offer predictability. Many companies run a lean foundation team pre-approval and scale rapidly after the decision. It’s a model that delivers, but needs management to protect expert knowledge. Many US and European companies still start with FDA approval in the US but are occasionally surprised by the European regulatory requirements and payer expectations when seeking approval and reimbursement in Europe.

Europe remains a dynamic and interesting place to launch, but rigorous European Medicines Agency (EMA) processes, together with strong labour protections in Germany, Italy and France, raise the risk of over-hiring and reducing agility. A regional, flexible resourcing model, backed by medical, scientific and EMA and Medicines and Healthcare products Regulatory Agency (MHRA) expertise, delivers speed without long-term infrastructural investment.

In the United Arab Emirates (UAE), earlier launches to protect the price or establish a presence require credible and compliant capabilities. Small specialist medical and KAM teams provide a practical approach and can lead to longer-term arrangements in the country and in the Gulf Cooperation Council (GCC) region. FDA approval can also streamline the approvals process in many GCC countries in the Middle East such as Saudi Arabia and UAE.

Agile medical affairs can navigate perceived risks such as loss of institutional knowledge and maintaining quality. These can both be mitigated with clear, documented processes to capture expertise, and align onboarding standards and scientific style from the outset.

Markets and regulators will keep shifting, but an agile medical affairs function, built on flexible resourcing and disciplined knowledge capture, turns those shifts into manageable changes. That agility protects patients, gives clinicians consistency and clarity, and keeps launches on track.

For more information, visit www.Uniphar.com.

References are available on request.