The first steps towards the transformation required a careful analysis of our working scenario, which led to a detailed outside assessment and a deep study of our internal structures, methodologies, and resources. For this purpose, a cross-functional team was appointed to a transformation office that developed a research strategy to fully understand our reality and provide the foundations that would lead to orchestrating a short-, medium-, and long-term pathway for this transformational journey. The internal evaluation and external assessment of the Spanish healthcare ecosystem was systematic and has been reported in a previous publication [10]. In short, this program identified all current trends of the healthcare stakeholders in Spain—within patients, healthcare professionals (HCPs), and institutions—providing an information map and a summary of key insights about their needs and motivations. These data, together with our internal assessment and the analysis of macrotrends that impact the pharmaceutical industry (Fig. 1), led to the identification of opportunities for improvement and formed the basis for a strategic revision of the MA model in our organization (Fig. 2).

Fig. 1

Macrotrends that impact the pharmaceutical industry

Fig. 2

Opportunities for improvement identified in medical affairs

On the basis of our analysis, we defined a new mindset and structure for the MA function that was aligned with our vision and company values. We aim to put the patient at the center of everything we do, to provide innovative and value-added solutions to healthcare stakeholders through science and innovation, to foster a lifelong learning culture, to collaborate internally and externally with trust and transparency, and to be accountable for our results and impact. We structured our mindset and pillars in work streams that cover the five priorities delineated by Algazy et al. [9] for MA transformation (Table 1): (1) boost medical affairs leadership to achieve next-level patient impact, (2) integrate end-to-end data and analytics, (3) refocus resources according to data-backed strategies, (4) align evidence-generation with stakeholder needs, and (5) orchestrate medical engagement across different channels.

2.1 Boost Medical Affairs Leadership to Achieve Next-Level Patient Impact

This priority of the MA 2030 vision entails elevating the role of MA to a strategic leadership position within the company, ensuring it drives decision-making and innovation that directly impacts patient outcomes [8, 9]. The boost of our MA department leadership to meet real-world patient trends is required by involving MA central teams and in-field medical staff in earlier preparatory activities for clinical development and product launches. In-field medical engagement is a core activity of the MA department that demands an upgrade from the traditional roles of the medical science liaison (MSL) [7, 11,12,13]. Therefore, we developed a new profile in our company: the strategic scientific advisor (SSA).

While the role of MA central teams will be detailed in an upcoming publication, the responsibilities of the SSAs were described in a recent article [14]. The SSA transcends the traditional MSL definition to become a trusted partner and advisor for all external stakeholders, who can provide strategic insights, tailored solutions, and value-added services that address their needs and expectations. The SSA is also a key source of medical intelligence and feedback for the internal teams, who can inform and influence medical strategy and tactics.

To achieve next-level patient impact, we developed the CARABELA initiative, which is a structured approach aimed at driving optimization of the clinical pathways through the patient’s journey. By focusing on real-world healthcare challenges in each therapeutic area (TA), CARABELA enables the development of sustainable, impactful solutions that improve healthcare efficiency and patient outcomes. SSAs and MA central teams are key in leading these initiatives within their TAs.

2.1.1 Key Points of the Strategy to Boost MA Leadership

A profound understanding of the healthcare ecosystem is crucial for MA to evolve and drive patient-centered outcomes. By engaging directly with HCPs and other stakeholders, MA departments can identify their needs and align their activities to improve clinical outcomes and transform healthcare. This strategic leadership extends beyond traditional medical functions, involving collaboration with both internal and external innovation teams to deliver solutions that address the dynamic needs of the healthcare ecosystem. The strategy unfolds in four key stages: early access, pre-launch, launch, and post-launch [14]. Throughout these stages, MA teams collaborate with external experts, policymakers, and patient associations to: (1) gain a comprehensive understanding of the healthcare landscape, map stakeholders, and identify their specific needs; (2) foster strong, collaborative partnerships across the ecosystem, from payers to healthcare providers; and (3) develop and implement innovative solutions that add value and go beyond traditional therapies. To implement this strategy, SSAs are equipped with essential skills, such as healthcare knowledge, communication techniques, medical leadership, scientific expertise, and digital technology mastery, enabling them to drive transformation in their TA [14].

In AZ Spain, this new concept of leadership was born from the implementation of a new operational model across the entire company, emphasizing a shift in mindset and leadership within each functional area. The approach combines horizontal or multidisciplinary coordination, where cross-functional teams work collaboratively and continuously, organized by work levels (national, regional, autonomous community, and hospital accounts). These teams are tasked with developing, implementing, and monitoring medical plans for each specific area. Simultaneously, the model includes vertical or functional coordination, where functional teams (e.g., access, MA, and commercial) contribute their specialized expertise to ensure strategic alignment and coherence across all levels of the operational model.

MA plays a pivotal role in these teams by identifying needs and co-creating solutions that deliver direct benefits to patients. Achieving this requires a comprehensive, 360-degree understanding of the healthcare ecosystem at all levels. To this end, the 360-degree vision was defined using six descriptors, collaboratively developed by the cross-functional teams of each health area: (1) regional archetyping and access, (2) general characterization of the health area/account, (3) research, development and innovation (I + D + I, for its Spanish acronym) evaluation, (4) clinical care model analysis, and (5) mapping and characterization of stakeholders.

2.1.2 Region Archetyping

This task characterizes each region on the basis of five key qualitative and quantitative variables (Table 2): access complexity, decision-making centralization, innovation profile, protocolization level, and HCP’s prescribing freedom. Access complexity refers to the challenges in navigating the approval process, including the steps, interlocutors, and timelines required. Decision-making centralization assesses whether decisions are made at the account/hospital or centralized regional health council level. The innovation profile considers the degree to which new treatments and innovations are adopted to improve patient care, while protocolization assesses how regulated HCP prescribing practices are. Understanding these factors allows for strategic differentiation of approaches based on each region’s unique needs and characteristics.

Table 2 Variables of region archetyping

By systematically evaluating these factors, region archetyping provides a data-driven foundation for differentiating engagement strategies across diverse healthcare landscapes. This structured approach can be customized to reflect the nuances of different national and regional healthcare systems. While some countries may exhibit highly centralized decision-making structures with strict protocolized care pathways, others may have more decentralized frameworks where prescribing autonomy and regional variability play a larger role. Similarly, market access complexity and the level of digital transformation may differ significantly between countries, requiring a flexible approach to archetyping. By applying a standardized yet adaptable framework, MA teams can generate insights that inform tailored strategies, ensuring that evidence generation, stakeholder engagement, and innovation adoption align with the realities of each specific healthcare ecosystem.

2.1.3 General Characterization of the Health Area/Account

Once the regional archetype has been established, it is essential to proceed with a structured characterization of the healthcare area or hospital (account). This characterization involves a 360-degree evaluation, covering the hospital environment, resources, patient demographics, and competitive intelligence. It examines the hospital’s infrastructure, including the availability of specialized units and their coordination. It also assesses the HCPs involved in each hospital specialty and primary care, as well as the presence of residents and nursing staff. An analysis of the available infrastructure includes the number of consultations carried out in specific units, the presence of specialized nursing consultations, day hospitals dedicated to particular areas, and the number of affiliated primary care centers and specialized centers linked to the hospital.

Data on the patient population attended are examined in detail, including annual admissions, recurrence rates, mortality, and how patients are distributed across different care settings, including primary care, emergency services, and specialties. In addition to these medical resources, the characterization provides insights into HCP’s ability to digitalize patient data, integrate health records, and adopt innovative clinical solutions.

The characterization also includes an analysis of the competitive landscape, detailing collaborations and initiatives led by other organizations. For instance, partnerships between research groups and pharmaceutical companies are evaluated to understand their impact on local healthcare dynamics. This thorough account characterization helps ensure that strategic action plans are tailored to each healthcare environment’s specific resources, needs, and challenges, enabling better decision-making and collaboration with key stakeholders.

2.1.4 Research, Development, and Innovation Evaluation

The research, development, and innovation (I + D + I, for its Spanish acronym) area evaluates the healthcare account’s capabilities in fostering I + D + I, which is crucial for advancing medical science and improving clinical outcomes. This assessment focuses on quantitative and qualitative aspects related to evidence generation and innovation activities within the institution. Together, these criteria provide a comprehensive overview of the hospital’s contribution to medical innovation, its research capabilities, and its engagement in advancing healthcare through scientific evidence and process innovation.

Key criteria include whether the hospital has an associated research center and dedicated research units. Its capacity for conducting independent clinical studies, coupled with the involvement in external partnerships with research organizations, are other critical factors. Furthermore, the number of clinicians with relevant publications and involvement in clinical trials are crucial markers of the hospital’s research activity.

Qualitatively, the I + D + I profile considers the hospital’s involvement in innovative care models and technologies. These include experience in integrated value solutions programs, big data, and artificial intelligence (AI). The adoption of telemedicine and other process innovations is also examined. Lastly, participation in specific innovative projects, particularly those designed to enhance healthcare processes, reflects the institution’s commitment to continuous improvement and its readiness to adopt new methodologies and technologies in patient care.

2.1.5 Healthcare Model Analysis

Understanding the clinical processes that patients undergo (from diagnosis to treatment and follow-up) is essential for identifying inefficiencies and areas for improvement in healthcare delivery. For each stage of the patient’s journey, the relevant HCPs and departments involved are mapped, characterized and analyzed. This process plays a pivotal role in aligning medical interventions with patient needs, ensuring that all stakeholders involved in patient management contribute efficiently.

Healthcare model analysis is rooted in the CARABELA methodology, which has been extensively described in our previous publications [10, 14, 15]. In short, it follows a structured four-phase approach in each disease area. The first phase analyzes and characterizes existing management models for a targeted disease, with a scientific committee selecting pilot centers to study healthcare processes, clinical practices, and patient experiences. The second phase validates improvement areas and proposed solutions through national workshops, where key indicators identified in the first phase are refined. The third phase involves regional meetings across Spain, engaging multidisciplinary teams to co-create and optimize the proposed solutions. In some cases, an additional quantitative consensus step ensures further validation of key indicators. The final phase focuses on implementation, integrating validated models into real-world practice, forming a comprehensive framework for sustainable healthcare transformation.

To implement the final phase of the CARABELA methodology, the CARABELA Playbook was developed as a digital platform to enable healthcare centers across Spain to collect, evaluate, and monitor key clinical management indicators. Participating centers define and receive summaries of findings and expected improvements, allowing them to prioritize and implement tailored solutions, whether technological or process-based, according to their local context.

The data generated using Playbook is fed into the Account Clinical Pathway (ACP), which is the main analysis tool of the healthcare model analysis. As such, Playbook and the ACP are key methodologies for identifying inefficiencies and optimizing patient care at the hospital or healthcare area level. By analyzing several ACP variables, MA teams work with the stakeholders to co-create strategies addressing the needs of each healthcare account, ensuring that scientific collaborations and medical initiatives align with local priorities. In addition, the ACP incorporates real-world data that helps identify key opportunities for evidence generation, as has been recommended [16, 17].

Collaborative engagement through the Playbook and ACP fosters the co-creation of strategic solutions and action plans for each TA, ensuring medical interventions are scientifically robust, aligned with healthcare priorities, and optimized for clinical and economic efficiency. In addition, the platform enables impact measurement, reinforcing AZ Spain’s commitment to catalyze healthcare ecosystem improvement.

2.1.6 Stakeholder Mapping and Characterization

A fundamental task of MA is the mapping of stakeholders, ensuring that the most relevant and influential healthcare professionals, decision-makers, and key external experts (KEEs) within each account are strategically engaged. Each healthcare institution presents a unique network of stakeholders whose roles, influence, and decision-making processes vary significantly. To optimize engagement and evidence generation, it is essential to identify and prioritize these stakeholders on the basis of a structured set of segmentation criteria (Table 3).

Table 3 Segmentation variables for stakeholder mapping

Institutional relevance defines a stakeholder’s significance within the scientific and healthcare community, categorizing them as international, national, regional, or local. Clinical practice influence assesses their role in shaping treatment decisions and guidelines within their TA. The research profile considers the stakeholder’s involvement in scientific research, publications, and clinical trials, further categorized by their geographical impact. Digital influence evaluates their presence and engagement on social media, quantified through metrics such as the number of followers and activity levels.

The stakeholder mapping process provides a systematic framework of KEE categorization. However, beyond this classification, it is critical to assess how their knowledge, perception, and engagement with a product evolve over time. The Awareness, Positioning, and Differentiation index (APDi) serves as a quantitative tool for tracking this evolution, enabling a dynamic understanding of how HCPs engage with scientific advancements and the role of a product in clinical practice. The APDi is calculated using a structured questionnaire that assesses three key dimensions: awareness, positioning, and differentiation. Each dimension is evaluated through a set of questions related to disease knowledge, therapeutic practices, and the perception of treatment attributes.

Awareness quantifies the extent of a KEE’s understanding of the disease and the scientific rationale behind a given therapy. Positioning assesses how the product is integrated into the stakeholder’s treatment paradigm, while differentiation measures how the product is perceived relative to available alternatives. As a product progresses through its life cycle, the APDi facilitates longitudinal monitoring of these perceptions, ensuring that engagement strategies remain evidence-based and tailored to evolving stakeholder insights. By integrating stakeholder mapping with APDi-based assessments, MA teams can optimize scientific communication and engagement strategies, thereby reinforcing the translation of evidence into clinical practice.

2.2 Integration of End-to-End Data and Analytics in Cross-Functional Plans

Establishing end-to-end data and analytics capabilities is a top priority for MA leaders, ensuring that insights derived across the product lifecycle are effectively leveraged to guide decision-making and stakeholder engagement. The comprehensive data gathered from the CARABELA Playbook, ACP, and APDi serve as the foundation for designing account-specific action plans, ensuring full alignment with each healthcare account’s evolving needs. This process is dynamic and cross-functional, continuously adapting to environmental changes and stakeholder feedback. Using the CARABELA Playbook and ACP, we structure patient journeys and assess healthcare process inefficiencies, while APDi provides insights into stakeholder perceptions, awareness, and scientific alignment over time. The integration of these tools ensures that action plans are not only tailored but also strategically co-created with key stakeholders, maximizing scientific impact and healthcare outcomes.

This structured approach feeds into our transforming care methodology, an initiative fully embedded in our strategic scientific plan at the account, regional, and national levels. Within this model, data-driven strategic objectives are translated into scientific engagement strategies and action plans that optimize clinical decision-making and enhance healthcare efficiency. The SSA plays a key role in this process, orchestrating these activities in collaboration with cross-functional teams, as detailed in our previous publication [14].

The impact that these strategies are having on patient outcomes and the overall healthcare ecosystem can be inferred by the significant increase in scientific output associated with the transformation of the AZ Spain MA department (Fig. 3). From 2022 to 2024, the total number of scientific articles and congress communications has steadily risen (Fig. 3A), with a notable increase in publications related to transforming care projects led by SSAs (Fig. 3B). The average impact factor of our publications has also improved, from 5.0 in 2022 and 2023 to 5.6 in 2024, reflecting the growing influence of our work on the healthcare community. Particularly, the CARABELA initiative has already led to seven ongoing national projects, addressing conditions such as severe asthma, chronic obstructive pulmonary disease, heart failure, chronic kidney disease, amyloidosis, and immunosuppression [15, 18,19,20,21,22]. CARABELA has improved chronic disease management by establishing quality indicators, enhancing clinical outcomes, and enabling continuous analysis and implementation of solutions that improve healthcare system efficiency across diverse settings via locally led workshops.

Fig. 3

Evolution in the amount of scientific articles and congress communications from 2022 to 2024: A total number of publications; B publications related to the transforming care methodology

2.3 Differentiation of Medical Engagement According to Data-Backed Strategies

According to the MA 2030 vision, strategic planning should be more ambitious, focusing on measurable progress and optimizing resource allocation to areas with the highest potential for improving patient care [8, 9]. Planning should be backed on advanced analytics and digital tools to ensure that every engagement is tailored to individual needs and leads to meaningful improvements in patient care [9]. MA should lead efforts to produce real-world evidence (RWE) aligned with the needs of various stakeholders, such as HCPs, payers, and regulators. Beyond informing regulatory and reimbursement decisions, RWE plays a crucial role in identifying gaps in clinical practice and optimizing patient care pathways, serving as the foundation for strategic interventions that drive system-wide transformation. Innovative approaches should ensure the timely delivery of relevant and impactful evidence for each disease area.

The CARABELA framework serves as a catalyst for the self-assessment and transformation of healthcare teams at both local and regional levels, ultimately driving impact at a national scale. Building upon insights derived from RWE, CARABELA translates real-world findings into actionable strategies, ensuring that clinical management improvements are evidence-based and aligned with evolving healthcare priorities. Upon request, structured workshops are conducted with the CARABELA Playbooks, facilitated by the corresponding SSA and involving key stakeholders engaged in the management of the targeted pathology. These workshops provide a systematic approach for healthcare teams to analyze their organizational models, clinical pathways, and unmet needs. By leveraging insights from the CARABELA Playbooks, teams collaboratively identify challenges and develop tailored, practical solutions aligned with their specific operational contexts. This process fosters a structured framework for public–private collaboration, enabling the co-creation of both traditional and innovative interventions aimed at enhancing healthcare efficiency and improving patient outcomes.

The practical solutions implemented through CARABELA are designed to address key challenges in healthcare delivery by focusing on four strategic areas. First, proactive screening and early diagnosis initiatives facilitate early disease identification through systematic patient screening and simple diagnostic tools in community settings. Second, guideline adoption at the practice level ensures that evidence-based recommendations are seamlessly integrated into clinical workflows, supported by top-down quality improvement initiatives and clinical decision-support tools. Third, advanced specialist pathways and personalized care optimize transitions between care settings, promote precision diagnosis and treatment, and incorporate remote monitoring strategies for high-risk patients. Finally, world-class policy leadership initiatives work to expand public health and social science research (PHSSR), drive disease policy advancements, and support health system modeling to guide resource allocation and long-term planning. By addressing these areas, CARABELA ensures that medical engagement is aligned with real-world healthcare needs, fostering sustainable improvements in patient care and health system efficiency.

2.4 Alignment of Evidence Generation with Stakeholders’ Needs

In today’s evolving therapeutic landscape, expanding RWE is fundamental to generating meaningful insights that drive healthcare decision-making. A comprehensive and scalable approach is required to integrate diverse data sources, including claims databases, electronic medical records, clinical trials, and disease registries, into a unified evidence-generation framework. To ensure impactful outcomes, close collaboration across key areas of RWE, health economics, and outcomes research is essential. This integration ensures that the resulting evidence is not only robust but also directly applicable to real-world clinical and payer environments.

By refining evidence generation strategies, our MA department transitioned from traditional descriptive analyses to predictive modeling, enabling a more proactive approach to healthcare management to achieve optimal pricing and reimbursement and therapeutic positioning. Our new evidence generation plans focus on capturing in-depth data on disease burden, healthcare resource utilization, and treatment patterns to build a compelling value story. This approach addresses knowledge gaps by collecting comprehensive data on patient population characteristics, disease progression, healthcare resource utilization, and costs associated with the target disease.

This model enhances decision-making by providing early insights that support clinical and payer strategies. In addition, our efforts extend beyond data collection, emphasizing the importance of making RWE both accessible and actionable. By tailoring data visualization tools and interactive evidence platforms, we ensure that key stakeholders, including patients, regulators, HCPs, and payers, can efficiently interpret and apply scientific findings to their respective domains.

By embedding evidence generation into a dynamic, stakeholder-centered approach, we reinforce our commitment to delivering data-driven solutions that align with healthcare priorities. The impact of these initiatives, along with further advancements in our evidence strategies, will be explored in upcoming publications.

2.5 Orchestration of Medical Engagement Across Channels

Enhancing data visualization across various channels will enable quicker understanding of the evidence and its implications for clinical practice, facilitating data-driven decision-making [9]. Our new medical omnichannel strategy focuses on creating seamless and integrated customer experiences using personalized real-time insights. At its core, this strategy is designed to meet the needs of HCPs throughout the product lifecycle (from early access to post-launch). A key aspect of the strategy is leveraging data and insight analytics, allowing the integration of medical activities into the entire company. This enables a unified and enriched view of performance metrics, ensuring that medical and commercial teams are aligned.

Personalization is another essential pillar, as it allows us to adapt medical and scientific content to the specific needs of each stakeholder. Our omnichannel strategy is built on orchestration, ensuring that all interactions are coordinated across both physical and digital channels. The methodology includes detailed situational analysis, profiling of stakeholders, and a customized omnichannel engagement plan for each person involved. We continuously review and adapt our plans on the basis of KPIs, feedback, and outcomes, ensuring continuous improvement in engagement and the delivery of value. Our medical omnichannel strategy will be described in detail in an upcoming publication.