Maria Haughton, AstraZeneca; Tom Grant, UCB Pharma; Anisha Mehra, Ferring Pharmaceuticals; Michael Sheldon, GSK; Farah Dunlop, Eisai Europe Ltd; Beryl Gonzalez, Meridian HealthComms (part of the Bioscript Group)
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Pharma-sponsored publications add to the evidence base and play a crucial role in various activities, including medical education, medical information, marketing, pricing and market access, and regulatory affairs. They also ensure timeliness of transparent data disclosure. At the local level, publications primarily serve specific needs, such as reimbursement activities, filling evidence gaps, or guiding local clinical practice. However, local stakeholders often have limited knowledge of publication processes and best practices. This article aims to address the perspectives and barriers involved in achieving seamless integration between global, regional, and local publication planning.
This article aims to address the perspectives and barriers involved in achieving seamless integration between global, regional, and local publication planning.
Strategic Publications Planning
Global team endorsement of publication plans is critical for strategic oversight, avoiding redundancy, and ensuring compliance with best practices. While global publication plans are designed and validated at the global level, they may not fully cater to local needs. Thus, local publication plans become essential to bridge this gap. As these publications serve local needs, local teams are likely to need support from Global Publication Leads to demonstrate the value of these local publication plans to global and regional stakeholders. A non-exhaustive checklist of information needed for global endorsement of local publication plans is included below.
Global Publication Leads must recognize that local stakeholders often have hybrid roles and therefore must juggle multiple priorities, including leading local publications. Often, discovering the correct contacts within each local/functional team is more challenging than you would expect.
It is critical that wider publication team stakeholders are continuously kept up to speed with publications best practice and regional/global strategic objectives, considering the inevitability of staff turnover. Ideally, new hires, and anyone who may be involved in publications, should undergo regular training on publications process and best practices.
The Regional Publications Lead: Bridging the Gap
A robust interface between global and local teams is crucial for incorporating local communication needs into the Global Strategic Publication Plan. Regional Publication Leads, dedicated to specific regions, can play a pivotal role in achieving this integration. They act as the primary contact for regions/countries regarding publications, support local strategic publication planning, and facilitate collaboration between the global team and regions. This role doesn’t exist in all companies, but where it can be resourced, it is found to be beneficial.
Regional Publication Leads support local strategic publication planning and facilitate collaboration between the global team and regions.
Communication works in both directions, so it is important that global teams also promptly share publication plan updates with the regions and local markets. Coordination between global and local publication planning can be achieved in various ways. Key local stakeholders should be included and able to input into annual or bi-annual global publication planning workshops, invited to regular (monthly or bi-monthly) global publications forums, and can be informed of publication updates (including manuscript acceptances and congress submissions) via newsletters or email blasts. Local publication concepts can be vetted at regular Regional Medical Affairs meetings (or equivalent), before being taken to Global Medical Affairs or global publications forums for endorsement by the global team.
Small Companies’ Considerations
Small companies often have decentralized structures and limited resources for developing strategic publication plans and sharing best practices. Additionally, there may be a lack of awareness regarding the role of medical publication professionals. Engaging with internal stakeholders is essential to raise the profile of the publications function, establish relationships, and comprehend stakeholder roles, responsibilities, and priorities. Leveraging existing regional and local structures/meetings can help develop a global approach to strategic publication planning.
Small companies often have decentralized structures and limited resources for developing strategic publication plans and sharing best practices. Engaging with internal stakeholders is essential to raise the profile of the publications function.
Addressing Evidence Generation and Data Gaps
Pharmaceutical companies have increasingly introduced ‘evidence generation leads’ who collaborate with publication and medical leads in joint ‘evidence generation and publication teams.’ Coordinating evidence gaps identified by local markets and regions into a global evidence generation plan is vital. This plan should prioritize needs and inform data availability to support the strategic publication plan.
Publications Delivery
Mitigating risk in locally led publications, especially when local teams may not fully understand the risks involved, is essential. As for global publications, key global pharma stakeholders, including intellectual property, drug safety, and global subject matter experts, should provide final approval for local and regional publications, consistent with the approach for global publications. Unless experienced with the process, local stakeholders are unlikely to be aware of timescales for final approval of publications, and this should form a key part of training materials to avoid frustration at both local and global levels.
Local language publications are a useful tool to facilitate understanding of the evidence base internationally. They are encouraged by GPP but can present challenges especially in the review process. Making an English language version visible to gain agreement of the concept and be able to conduct review at the global level can aid with communication.
Conclusions
Effective communication and robust processes between global and regional/local publication leads are crucial to create a genuinely global strategic publications plan that incorporates regional/local market needs. Small companies and small local franchises of larger global companies face substantial challenges. This makes it essential to understand existing stakeholder structures and roles and then build upon them to develop publication processes that are strategic, compliant, and effective.
Effective communication and robust processes between global and regional/local publication leads are crucial to create a genuinely global strategic publications plan that incorporates regional/local market needs.
Contributorship
Outline: all authors
First draft: Tom Grant
Second draft: first draft edited to improve the flow and readability, remove redundancy by Chat GPT 3.5 https://chat.openai.com and then sense check amendments by Tom Grant
Third draft: Tom Grant, Maria Haughton, Anisha Mehra, Michael Sheldon, Farah Dunlop, Beryl Gonzalez
Disclaimer:
Views discussed in this article reflect personal knowledge and are not on behalf of the affiliated companies.
References:
Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 update. DeTora et al. Annals of Internal Medicine; 175: 1298-1304, 2022. Doi:10.7326/M22-1460
Parallel Session presentation at the EU meeting of ISMPP 25 January 2023 – Publications Without Borders; Faculty: Maria Haughton – AstraZeneca, Tom Grant – UCB Pharma, Anisha Mehra – Ferring Pharmaceuticals, Michael Sheldon – GSK.