Gretchen Chidester, PhD, MedThink SciCom; Alexandra Traut, PhD, AbbVie
When developing a scientific communication platform (SCP), are you considering whether it will be relevant to workstreams and stakeholders worldwide? The overarching story described within an SCP is not beholden to a specific label but is based in science and intended to be broadly applicable across the organization. However, to ensure uptake of an SCP into all relevant workstreams, the content of the SCP must be directly relevant to regional affiliates (eg, medical directors, market access personnel, publication leads, medical science liaisons), as well as global stakeholders. To ensure the broad relevance of the SCP, publication managers should evaluate regional needs, ensure regional considerations are represented in the final document, and involve regional stakeholders throughout the development process and during any subsequent updates.
Identifying Regional Insights
When initiating development of an SCP, publication managers should strive to understand regional needs as early in the process as possible. That is, rather than developing a global document and subsequently attempting to “shoehorn” in content relevant to specific regions, the needs of the regions should be considered from the beginning and integrated along the way into a cohesive document. Any insight generation activities undertaken to inform the development of the SCP (eg, gap analyses, literature reviews, scientific expert interviews) should be thoughtfully designed to obtain both global and regional insights. Further, region-specific product development plans and competitive landscapes should be evaluated, as these may inform unique communication needs within the regions. For example,
- Products not yet approved in each region may require an emphasis on communication related to understanding disease burden or differential diagnosis; in contrast, established products may require a greater emphasis on real-world clinical evidence or efficacy within specific patient subpopulations
- Differences between regions in availability of key competitor products may influence communication needs related to product differentiation
- Regional reimbursement landscape and competitive landscape may affect the patient journey, impacting communication needs related to the burden of disease
To ensure an accurate understanding of regional considerations, publication managers should involve stakeholders who can provide relevant insights at multiple stages of the SCP development process. While country medical directors are often asked to participate in the SCP development workstream and certainly provide valuable insights, such individuals may oversee multiple products and, as a result, lack detailed expertise for a given product or indication. Country medical directors may be able to connect the publication manager with additional regional stakeholders (eg, medical science liaisons, market access personnel, health economic and outcomes research stakeholders) who may be able to provide more detailed insight. These regional stakeholders may provide input at multiple stages of the SCP development process (see Figure 1 below). As publication managers may not have established relationships with these regional stakeholders, making these connections and soliciting insights may necessitate multiple communications; to ensure the SCP is developed in a timely manner, the publication manager should initiate these interactions as early in the development process as possible.
Figure 1. Possible roles of regional stakeholders
Ensuring Regional Considerations Are Represented
While at its core the SCP is a global document, regional elements should be incorporated into the SCP as appropriate. Primary and secondary statements generally describe scientific story elements at a global level; however, supporting statements provide the greatest level of detail and are often used to address specific regional considerations. Some SCP pillars, including those describing mechanisms of disease or action, are generally less likely to require the addition of region-specific supporting statements. Other pillars, such as those describing the burden of disease, are more likely to benefit from region-specific supporting statements—for example, statements describing regional prevalence data, regional economic burden considerations, and unique cultural considerations associated with disease burden. Value pillars are often the most challenging to develop in a way that adequately addresses regional needs, as economic- or payer-focused data are unlikely to have global applicability. However, there are several strategies that publication managers may utilize to address this challenge, including:
- Opting for a more comprehensive value pillar (ie, one that includes clinical value rather than purely economic statements, which may be addressed separately in global/regional value dossiers)
- Developing multiple region-specific secondary statements, each of which is supported by relevant and available region-specific economic data
It is also important that the lexicon included in an SCP is reviewed with regional and cultural considerations in mind. For example, it is important to understand whether specific words or terminology may have different—and potentially unintended—connotations in regions where downstream scientific and medical communications may be deployed. Additionally, the lexicon should be assessed to ensure there are no unintended access, reimbursement, or regulatory implications in certain regions (such as terminology related to dosing that may lead to reimbursement limitations).
Regional Rollout, Access, and Implementation
Once the global SCP is developed, individual regions are responsible for identifying how to incorporate it into their workstreams. For example, stakeholders worldwide may incorporate relevant scientific statements, associated references, and lexicon elements into regional publications or medical science liaison slide decks; refer to the lexicon when creating responses to physician queries; and leverage all components of the SCP during internal training of team members on the disease state, product, and overall strategy. Indeed, publication managers often find that regional affiliates report significant value in the SCP, as these stakeholders often support multiple products and therefore benefit from having a concise and scientifically supported resource to leverage as they develop regional communications. However, one of the biggest challenges that publication managers face is ensuring relevant regions or countries are aware of and have access to the SCP. Suggested strategies to address this challenge are described in Figure 2 below.
Figure 2. Strategies to optimize regional rollout and implementation
Updating the SCP
Best practices suggest that the SCP should be revisited and updated at regular intervals (eg, annually) or at prospectively identified times, the most common of which are following key data readouts, drug label changes, or expansion into new markets. As is recommended for the initial development process, it is important for the publication manager to ensure that regional needs are considered any time the SCP is updated; as previously noted, regional stakeholders should be engaged as early in the updating processes as possible to ensure the publication manager has sufficient time to gather relevant insights. For example, publication managers can survey regional stakeholders to understand what has worked well and what could be improved upon to optimize regional implementation. In preparation for making these updates, publication managers may want to ask questions, such as:
- Have any region-specific data (eg, efficacy within a specific population) been generated that should be incorporated?
- Have there been any changes to the approved indication(s) or the competitive landscape that should be addressed?
- Have there been any changes to regional guidelines that should be integrated?
As the SCP is a strategic document intended to provide a foundation for all medical and scientific communications, it is important to ensure that the SCP accurately and adequately represents the needs of a broad range of internal stakeholders, including regional affiliates. A summary of key steps for meeting regional communication needs in a global SCP are described in Figure 3 below.
Figure 3. Summary of key steps for addressing regional needs in a global SCP
Graphical assistance: Loftin Barnes, MedThink SciCom
Editorial assistance: Chris Lawrence, PhD, ELS, MedThink SciCom