The transformation of AZ’s MA central teams is based on a newly designed working model that aims to enhance the integration of MA functions throughout the product lifecycle. This model ensures effective positioning and differentiation in each therapeutic area (TA) from early phases, creating value for the healthcare ecosystem and stakeholders involved in the decision-making process. The working model was co-designed through a structured programme initiated by the transformation office, informed by the external–internal assessments previously published [11]. Cross-functional teams (including Medical Affairs, Evidence Generation, Regulatory, Value & Access, Business Insights, and Marketing) participated in iterative design sessions and pilot tests across TAs. Model components were refined and validated via the strategic-tactical planning forums and formal knowledge-transfer meetings, ensuring role clarity, governance, and traceability from early assets to post-launch execution.

The MA central team’s working model functions during all phases of product lifecycle: clinical development advice, early access, pre-launch, launch, and post-launch. Early in the lifecycle, the emphasis is placed on providing high-quality, detailed input to anticipate local needs, highlight unmet medical needs, and strategically position products to maximise their impact. During the pre-launch phase, the model supports rapid approval and reimbursement processes while striving to optimise access at regional and hospital levels. At this stage, the model aims to foster positive practice change and innovation within the healthcare ecosystem, improving care quality and adding value for patients, HCPs, and the entire system. Another key objective is to improve awareness, positioning and differentiation (APD), ensuring that the scientific and medical value of the product is accurately understood by HCPs and appropriately reflected in evidence-based clinical guidelines.

Implementing the MA central teams’ working model is aimed at five strategic goals (Fig. 1). First, anticipation, underscores the importance of working earlier in the process, identifying and engaging with key stakeholders well in advance during each phase of the product’s lifecycle. Second, coordination of efforts across different TAs and product teams is equally relevant, ensuring that the model is systematically implemented across all functions and roles involved in product development. Third, increasing the efficiency of internal processes is also paramount, as the new model aims to simplify existing systems and optimise operational workflows. Fourth, homogenisation ensures consistency in working methodologies, ensuring all teams follow the same approach focused on analysis, strategy definition and actionable planning. Finally, patient centricity is another key strategic area, emphasising both internal and external customer focus, with careful attention to strategy definition and deliverables.

Fig. 1

Objectives of the Medical Affairs (MA) central teams’ working model

To meet these goals, the MA central teams’ working model is designed to work through four main operational pillars: (1) Product Lifecycle Teams, (2) Work Methodology, (3) Coordination Model and (4) Information Management Process.

2.1 Product Lifecycle Teams

Product lifecycle teams are aligned with all stages of product development, ensuring that each phase has a dedicated expert team for oversighting. Medical affairs central teams play a pivotal role, working on two key areas: strategic-tactical planning and operational execution and monitoring. Strategic-tactical planning involves defining comprehensive plans for each team throughout the product’s lifecycle, following a pre-established work methodology. Operational execution & monitoring forums ensure that teams’ activities align with strategic goals and continuously track the progress to adapt to changing healthcare ecosystem conditions and stakeholder needs.

The ability of MA central teams to engage early in the product lifecycle and maintain a strategic focus is critical to achieving competitive positioning and optimising market access. Four leading teams are deployed during each product’s lifecycle: (1) the Early Asset Strategy Team, (2) the Launch Readiness Team, (3) the Core Value Team, and (4) the Brand Team. These teams work closely, ensuring that strategic and operational activities are aligned with the overall business goals and that the transition from product development to launch is effectively managed. As the product progresses towards the approval phase, a bidirectional feedback loop is established between in-field and central teams. The MA in-field roles, represented by the SSA [12], provide insights that inform MA central teams, while these relay the strategic product development information to the SSAs to optimise their interaction with all involved stakeholders (Fig. 2).

Fig. 2

Medical Affairs central teams’ involvement during the product’s lifecycle. MC3 marketing company consultation and collaboration

2.1.1 The Early Asset Strategy Team

The role of MA is pivotal in ensuring that new products are optimally positioned and differentiated from the earliest phases of development, even before Phase 3 clinical trial results are available. The Early Asset Strategy Team (EAST) plays a key role in this process by providing insights, strategic guidance and aligning cross-functional teams to maximise market access and clinical positioning opportunities.

The Early assets Medical Affairs Manager (EA-MM) role contributes to building critical medical insights and facilitates early alignment with real-world clinical practices. This role (part of the EAST) is responsible for continuously monitoring AZ’s portfolio and contributing to investment decisions for registration trials. Additionally, this role engages local clinical trial and MA teams to ensure the successful participation of Spain in global clinical trials. They identify key external experts, ensuring their timely involvement in trial design to generate differentiated evidence.

Another key responsibility is assessing opportunities for new products and designing specific medical plans to support these goals. The EA-MM identifies opportunities for clinical practice transformation linked to new products or indications, aligned with the CARABELA framework described in previous publications [2, 13]. This role facilitates cross-functional alignment by coordinating strategic discussions across regional, national, and global medical teams to ensure product development strategies are aligned between Phase 2 and Phase 3 trials in the MC3 process (marketing company consultation and collaboration) (Fig. 2)

In this role, the EA-MM defines and prioritises medical evidence generation and publication plans to support optimal product positioning and a successful pricing and reimbursement process with national health authorities, in collaboration with other functions in the EAST. The aim is that the products are well positioned from the earliest phases of development, facilitating smooth market access and maximising long-term strategic impact.

2.1.2 The Launch Readiness Team

Following the results of the Phase 3 clinical trial and leading up to European regulatory approval for a new indication, the Launch Readiness Team (LRT) becomes the key driver of strategic alignment and market preparation. This team incorporates MA central teams’ functions as medical managers and the MA lead, together with new functions beyond MA, such as Business Insights, Regulatory, Evidence Generation, Health Economics and Outcomes Research (HEOR), Value and Access (V&A), and Marketing, ensuring that all parties contribute with their expertise to comprehensive market preparation and alignment. This team works to refine the value strategy based on evolving market conditions and stakeholder feedback while preparing for the final stages of regulatory approval and market access negotiations.

2.1.3 The Brand Team

Once European approval has been secured and the product is ready for launch, the brand team assumes control of execution and post-launch strategy. The focus shifts toward driving the brand's market presence, ensuring effective market positioning, and executing the tactical plan to maximise market penetration and product differentiation. All functions previously mentioned in the LRT (MA central teams, Business Insights, Regulatory, Evidence Generation, HEOR, V&A, and Marketing) remain integral members of the brand team, continuing to participate in the brand strategy and ensuring alignment with the overall value strategy. The brand team ensures that post-launch initiatives are aligned with the overall value strategy and that the product’s performance is continuously monitored and optimised based on market feedback and real-world evidence.

2.1.4 The Core Value Team

The core value team is integrated within both the LRT and the brand team, focusing on the coordination of efforts between these teams to ensure seamless product lifecycle progression, defining the value proposition, and preparing the necessary evidence plans. The core value team is centred around three key functions: MA central teams, V&A, and marketing. It also integrates insights from HCPs, patients, and other stakeholders to build a robust launch and post-launch strategy. Furthermore, they oversee the execution and monitoring of these plans.

2.2 Work Methodology

The work methodology of the MA central teams’ working model aims to refine processes, ensuring that teams are working in the most effective way to meet all strategic goals. Teams adhere to a well-defined pathway that outlines their activities across the different stages of the product lifecycle, ensuring operational cohesion and precision in execution. This methodology guarantees consistency and quality in managing products, aligning with the overarching organisational goals [2]. The following activities and tasks are defined in the work methodology and must be executed promptly and co-ordinately.

2.2.1 Analysis of Healthcare Systems and Access Situation

This task entails analysing the healthcare ecosystem and market conditions for the TA and product in question, including identifying access opportunities, national and regional challenges, and evaluating the overall competitive landscape.

2.2.2 Disease Knowledge and Product Positioning

Teams must be well-versed in the disease’s epidemiology, impact, and available treatments. This knowledge is critical for positioning the new product in the market and understanding how it fits within the current healthcare environment. They continuously gather information from different sources, including clinical trials, expert opinions and existing literature.

2.2.3 Patient Journey and Patient Experience Mapping

A crucial part of the early development phase is understanding the patient journey: the emotional and clinical journey patients undergo from diagnosis through to treatment. This insight helps better understand patient needs and experiences, which can guide the product’s positioning and value proposition.

2.2.4 Stakeholder Mapping and Engagement

Identifying and mapping key stakeholders is another priority. These stakeholders include regulatory bodies, healthcare professionals, payers, patient advocacy groups, and others who play a role in the product’s success. Medical Affairs works to profile and segment these stakeholders to engage them effectively.

2.2.5 Competitive Landscape and Market Perception

Analyse the competitive landscape and assess how the new product will be perceived in the market compared to existing options. This helps to identify gaps, opportunities for differentiation, and potential challenges in positioning.

2.2.6 Target Product Profile and Gap Analysis

By identifying product requirements, the EAST starts developing a target profile document, which is regularly updated as new insights are gathered from stakeholders and early-stage studies. The gap analysis ensures that the product’s positioning aligns with unmet medical needs and strategic goals.

2.2.7 Evidence Generation Plans and Practice Change

A key part of the methodology is developing and implementing local and global evidence generation plans. Medical Affairs is vital in ensuring that the evidence generated supports the product’s positioning and differentiation in the market [8]. At the same time, the team works to identify opportunities for "practice change" to improve patient care and clinical practice. The methodology includes the execution of the CARABELA framework [2, 13], ensuring that healthcare practice transformations are integrated both at the national and local levels, with a strong focus on engaging stakeholders such as scientific societies and patient organisations.

2.2.8 Execution of Strategic-Tactical Plans and Monitoring

Another critical task is developing and executing strategic and tactical plans for each stage of the product’s lifecycle, ensuring that all activities are aligned with the broader strategic goals. Key performance indicators (KPIs) are regularly monitored to evaluate the effectiveness of their activities and make adjustments as needed, spanning five domains: (a) scientific engagement (APD index); (b) market access, time-to-reimbursement and regional access milestones; (c) evidence generation, closure of priority evidence gaps pre-launch; (d) transforming-care execution, adoption and outcomes of CARABELA projects captured through the Playbook/Account Clinical Pathway; and (e) scientific output, volume and quality of publications and congress communications. Quantitative signals already reported in our companion transformation framework (e.g., 2022–2024 increase in total and transforming-care publications, rise in average impact factor, and seven national CARABELA projects underway) complement the central teams’ working model described here and illustrate the trajectory of change [2].

2.3 Coordination Model

The coordination model ensures that all teams are in sync, improving collaboration across departments, including Evidence Generation, Regulatory Affairs, Market Access, and more. It focuses on two key elements: Strategic/Tactical Planning and Operational Execution/Monitoring. Strategic/Tactical Planning defines the pathway that will guide the teams throughout the product’s lifecycle, ensuring it is adjusted to healthcare trends and the competitive environment of each TA. Meanwhile, Operational Execution/Monitoring ensures that the strategies are effectively implemented throughout the process. The teams focus on executing their activities while monitoring progress to ensure alignment with the established plans. To streamline and simplify this process, the Strategic-Tactical Planning Forums were created, aiming to guarantee that the plans are effective and well founded, ensuring consistency across TAs.

These forums follow a structured approach (Fig. 3), which includes a thorough 360-degree analysis of all relevant information regarding the product and its environment. This comprehensive analysis helps identify potential opportunities and risks, providing teams with a clear understanding of the broader context in which the product will be launched. Following this, the strategic drivers and primary tactics are defined to guide the development and positioning of the product in the market. This step ensures preparation to adapt to any changing dynamics in the TA. Lastly, a detailed cross-functional initiatives and activities plan is developed to ensure alignment among all teams involved. This plan helps coordinate all efforts, guaranteeing that every function, from marketing to MA, contributes to achieving the product’s objectives.

Fig. 3

Structured approach of the strategic-tactical planning forums

2.4 Information Management Process

The Information Management Process aims to develop strategies to manage and share information effectively. This process seeks to break down silos and improve cross-functional collaboration, providing a single, updated information source accessible across all teams working throughout the product’s lifecycle. A standard repository system was designed to facilitate MA central teams’ Working Model implementation by warranting that all relevant product information is always available. Rather than relying on individual requests or specific team members, this system provides a unified, consistent source of data that can be accessed and transferred by all teams involved in the product development of a particular TA.

2.4.1 Knowledge Transfer Meetings

Knowledge transfer meetings have been designed as key communication elements to ensure that information flows correctly between Product Lifecycle Teams. These meetings ensure that insights relevant to the product, pathology, and environment flow seamlessly between the EAST, the LRT, and the Brand Team. The goal is to provide a clear and shared understanding of the product’s development, positioning and competitive environment in the TA. The dynamic of these meetings involves circulating an agenda and pre-read to the meeting participants, ensuring all parties are prepared for the discussion.

During the first part of the meeting, an executive summary is presented, including information on the pathology, product, and the plans already undertaken or in progress. Critical points informing the Launch Readiness Plan are also highlighted, such as evidence gaps, competitive analysis and potential regulatory impacts.

The second part of the meeting focuses on a detailed analysis of the information available, where gaps are identified in the Early Asset Factbook. This document is key to aligning teams and will guide the next steps for the team that will take over the product. The Factbook includes essential 360-degree data and insights, such as the product's disease knowledge, stakeholder landscape, pricing strategies, and market conditions. It serves as a dynamic document that is continuously updated and transferred across teams.

Knowledge transfer meetings help ensure that the information is accessible and actionable for all teams involved in the product's lifecycle. This structured approach allows for effective collaboration and alignment between teams as they move through each stage of the product development process.

2.4.2 Repository and Folder Structure

The information is organised in a repository by TA, with each area assigned a dedicated team folder. These folders are structured around product and indication-specific details and stages, such as EAST, LRT, and Brand Team. Each folder contains subfolders with categorised information, such as access plans, relevant bibliography, market analysis reports, strategic plans (for pre-launch and launch stages), and other essential data. The use of a single, centralised information repository enhances collaboration, optimises data management, and streamlines access to critical information across functions, ensuring that all teams are aligned and have the data they need at their fingertips to execute their tasks effectively.