Medical Affairs Transformation in Specialty Pharma: Next-Level Collaboration at the Core

People: Careers, Training, and Knowledge Transfer

A new medical career path tool allows staff across diverse functions to explore how their expertise can be applied and developed in well-trodden or unique directions. Roles have been mapped within a competency framework, allowing lateral and vertical moves to be plotted, boosting progression opportunities and illustrating the interconnectedness of functions and flow of skills within the organization. New recruitment and fast-track promotion programs have been instigated to encourage attraction and retention of the best talent. Medical-Science Liaison and patient centricity teams have been expanded. Training has been updated to create the Medical Excellence Academy, to systematically train medical staff on core and role-specific capabilities. Integral to this plan has been the hiring of new Knowledge Transfer Leads per TA, to ensure a deep understanding of products, TA, and other critical medical information for all relevant staff. These roles proved challenging to fill, as few corollaries exist, but are rapidly making an impact. As new core training modules come online, the team is working with colleagues in TAs, publications, communications, and medical information to pilot effective ways of providing real-time updates, such as priority data at congresses, new manuscripts, and collective insights. Periodic assessment will measure skill development against defined pillars, and delivery of content in terms of scientific excellence, clarity, and objectivity. This structure will be important to equip staff, and also to ensure staff feel equipped, to provide value in their interactions. Expansion of the medical affairs remit has prompted some industry voices to call for the creation of “super-medics” [16]. Others caution against creating a sense that people must be superhuman to manage emerging technologies and new approaches [17]. Using data-driven approaches to foster both individual development and collaborative expertise will help embed the new organizational culture while protecting and leveraging a bedrock of high-functioning talent.

Stakeholder Engagement

The upskilling of medical staff, and provision of tailored training materials, are key to effective engagement, enabling the proactive exchange of knowledge, data, and solutions. Another aspect is identifying who to engage with, when, and how to do so most effectively. A key milestone in the medical transformation was achieved in August 2021, with the rollout of the Thought Leader Identification and Mapping tool, a data-driven application to help find, validate, and select thought leaders based on evidence. The tool increases the ease, visibility, and transparency of profile building, and supports planning for local and global activities with HCPs.

Medical Insights

How to gather, analyze, and effectively use high-quality insights is fundamental to the discussions around usefulness of medical, digital, and pharma [1,2,3,4, 9, 13, 18]. Traditional sources such as advisory boards, MSL interactions with HCPs, publications, and congresses are themselves becoming more technologically varied, and are supplemented by new sources created by novel technologies. Making use of these myriad opportunities will require medical staff trained to recognize actionable insights, and systems that can recognize patterns. In June 2021, a new medical insight system went live. Users can input insights as free text or in response to approved surveys, record the source, associate them with predefined tags or with medical objectives, and submit them for review. Reviewers check for plausibility, quality, potential safety events, and compliance of information. A dashboard offers instant analytics and custom reports. Assessing input and addressing feedback from users are integral to the active ongoing development of the system.

Data, Insights, and Strategy

A major new capability established during the medical transformation is the Data, Insights & Strategy function, incorporating the existing Biometry group alongside Epidemiology (with a new head to be recruited) and Data Strategy and RWE. This function will oversee access to advanced data sources, analytics, and machine learning and ensure a strategic approach to data and insights generation. As a first step, integrated evidence plans are being created for priority products by the end of 2021, bringing together data-generation planning across medical, health-economic outcomes research, market access, development, safety, regulatory, and commercial at a global and local level. Externally, RWE is already being used to support label expansions and approvals [19], while pharmaceutical companies and regulators are rapidly adapting to the place of RWE in drug development pathways [20, 21]. Guidelines for reporting randomized controlled trials using routinely collected data including from registries, electronic health records, and administrative databases were published in 2021.22 While these technology-based solutions are alluring, a full appreciation of the nature of the data sources, their accuracy, completeness, and relevance are needed to allow insights and RWE to be reliably and transparently used to help bring therapeutic solutions to patients.

Country Medical

Worldwide, country medical health checks have been completed, resulting in profound changes in resource allocation. Investment has shifted substantially from marketing to medical, with a refocused operating model and correctly sized country medical organizations. High-value studies and programs—those most likely to make an impact for patients—have been prioritized, with support provided to rationally end underperforming studies. This step change in ambition, ensuring that all data generation activities are aligned with cross-functional plans and patient needs, aims to provide genuine and differentiated data to support better care. Involving a change in the culture of ongoing support, oversight, and performance management in relation to all forms of data generation, it has been necessary at times to shift from an activity-driven to an outcome-driven mindset, with a focus on tracking and execution across all aspects of medical and clinical operations. Ongoing efforts aim to establish a deep quality mindset and structure, develop a detailed understanding of patient flow and journey, positively influence healthcare systems to improve the standard of care, and improve knowledge transfer from headquarters to countries. Countries also offer the opportunity to pilot new approaches. For example, an innovative virtual launch event platform, hosting regional advisory boards, post-launch events, and a homepage for medical professionals was deployed in Germany.

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