Betsy Kitchens, PhD, Ultragenyx Pharmaceutical, Inc.; Megan P. Hall, PhD, GRAIL, Inc.
Generating and deploying a robust publication plan at a smaller or earlier-stage company, where resources may be scarce, budgets low, and awareness of best practices limited, presents a unique set of challenges.
While the value of a strong publication plan to support pharmaceutical, device, and diagnostic products through the various stages of the product life cycle is clear, the resources available to generate, support, and implement a robust publication plan vary widely among companies. As such, there is no single, unified, standard approach.
Ideally, a Medical Communications team will have adequate support to leverage internal and external resources: sufficient full-time staff, budget to onboard a medical communications agency, and buy-in from senior leadership to enable adherence to policy, procedures, and best practices. This is often the case at larger companies with teams in place; at smaller (either in budget or size) or earlier-stage companies (including start-ups), however, such resources and support may not be available. Further, publication management may rest on the shoulders of a single employee, who is often tasked with other responsibilities in addition to publication management.
To share insights and aid in these situations, this article offers the top five learnings for success for publication planning at smaller companies.
- Establish value for the Publications role
At a smaller company, building trust and relationships with colleagues is critical; it will also be important to establish the value of the publication management role, as some may not have previously worked with a publication professional. One recommendation is to meet individually with key internal stakeholders to understand their prior publication experience. This should enable advocating for and educating on the publications role accordingly. Additionally, gaining buy-in from senior leadership early can help with “top-down” support. The following practices are suggested as a publication management function is established:
- Plan an internal “road show” with key stakeholder teams to socialize the publication function and how it is expected to integrate into and work with the various teams, as well as to educate on industry best practices (ICMJE Recommendations, GPP3, etc)
- Remember: this is a marathon and not a sprint. Take “baby steps” and don’t try to enact full processes from the beginning. Add processes one by one. For example, start by introducing a cross-functional publication team, then move to socializing the importance of author agreements, forming a medical/legal/regulatory approval committee, and educating on the appropriate timelines for generating publications based on a full series of reviews and approvals.
- Gain buy-in from senior management. This can be accomplished by, for example, demonstrating the value of establishing compliant processes and the potential for increased reach with appropriate resources. Start early!
- Establish and build relationships with key authors. Having strong relationships with authors and understanding what motivates them will help you achieve publication timelines.
- Develop a publication process
Begin to develop and implement publication processes and a publication plan. Helping the teams be proactive in the publication planning and data release strategy discussions will show your value and help the company. Publication policies that are aligned with industry standards and establish documentation processes may have less immediate visibility but tend to prove their value over time by ensuring the company has compliant publication practices from its earliest stages, thus avoiding concerns later. As there may be challenges to establishing processes, it is important to concurrently advocate for why instituting processes would be beneficial for the company. The following points may be helpful in the quest to establish and adhere to specific processes:
- Initiate publication planning. Begin gathering target congresses and data-cut timelines. Discuss with key team members the strategy for data release and help them map out publication plans. As you create the plan, help your stakeholders create timelines for execution of the publication plan.
- Work with product teams to determine data gaps. Can they be filled with publications? Additionally, help the teams with long-term planning for manuscript release. Create timeline visuals that show submission and projected estimate of publication. Overlay this with the congress timelines. Use the work done for congresses to feed into manuscript preparation and writing to ensure key results are published after congress presentation.
- Track process for publications. Multiple commercial tracking platforms are available, including Datavision, PubStrat, and PMSolution. Or, given resource constraints or a small publication volume, an Excel file will work. Start tracking early for documentation purposes, as well as for gathering metrics.
- Establish a publication review and approval process. If there are publication processes in place, determine whether they need updating. If not already in place, create publication processes to follow best practices and that also align with the company policies and culture considerations. It is important to not make the process overly burdensome, as it will be hard to get adoption, but do ensure the necessary stakeholders have seen and/or approved the publication before submission or presentation.
- Create a company publication policy. Obtain input from your compliance colleagues and make certain the policy covers key publication practices (eg, GPP3, ICMJE Recommendations). If a policy is already in place, ensure it is current; if not, update the policy accordingly.
- Establish a publication team. The team could minimally include representatives from Medical Communications (leading the publication team), Medical Affairs, Clinical Development, Medical Science Liaisons, Biostatistics or Data Science, and Research and Development; the team could also include ad hoc attendance from Health Economics and Outcomes Research, Regulatory, and Compliance. Publication teams sometimes include representatives from Commercial; guidance from Compliance can determine whether Commercial representatives should be included at your company and their extent of involvement (eg, publication strategy discussions only). It will be important to get team buy-in on the publication processes. It will also be beneficial to shift publication strategy discussions from other forums into the publication team meeting.
- Determine resourcing available
- Resourcing may include internal medical writers, an agency, or contract medical writers. Additionally, internal team members may be leveraged to draft publications (or sections of publications) or to participate in creating congress presentations.
- Determine whether there is existing funding for publication planning and writing support. If not, ask if any funding can be available. Be prepared to show some examples of what support the funding can provide when making the request (eg, a contract graphic artist to develop figures or generate poster layouts, a contract project manager to submit the manuscripts).
- With limited resourcing, determine how you can provide the most value. This may mean contracting with a graphic designer for figures and poster layout. Or, it might involve a contract writer to help the team put together that challenging first draft. This will depend on your publication plan and the amount of funding available to you. The value of resourcing will become apparent as content is generated and should help with securing additional funds.
- Expand your influence
- As internal teams begin to see the value of the publication management role, they will likely request support. This, along with the publication metrics you have been tracking, will be helpful in requesting additional resources, such as more full-time employees or increased funding for agency or contract support.
- Offer publications development support to colleagues in other departments, such as Research and Development. Leverage any available vendor support to help generate content: a graphic designer to standardize conference posters, or contract writers to support more technical manuscripts, for example.
- Attend meetings in which data is being shared and ensure the teams are aware of the support for publication efforts.
- Host a yearly or bi-yearly publication strategy meeting that includes cross-functional colleagues.
- Leverage your and other’s publication knowledge
You might be the only publication professional at your company, but you are not alone! Leverage publication knowledge from other resources. Some helpful resources include:
- ISMPP (https://www.ismpp.org/)
- The organization’s website includes resources, such as GPP3 and position statements, a platform to reach out to ISMPP members for advice, and information about the ISMPP Certified Medical Publication ProfessionalTM (ISMPP CMPPTM) certification process.
- A monthly call hosted by ISMPP member Donna Simcoe, for publication managers at smaller companies to review and discuss the unique issues and challenges faced by those working at smaller companies (firstname.lastname@example.org).
- TIPPA (The International Publication Planning Association) Annual Meeting (https://www.risehealth.org/tippa)
- The Publication Plan (https://thepublicationplan.com/)
- Includes a resource page: https://thepublicationplan.com/publication-planning-resources/
- MAPS (Medical Affairs Professional Society: https://www.medicalaffairs.org/)
- The organization’s resources could help with other medical affairs responsibilities outside of publications.
- AMWA (American Medical Writers Association; https://www.amwa.org)
- The organization’s website includes resources focused on writing, as well as a Jobs Board where contract medical writers may be found.
In embarking on the journey to establish publications support, start early, take small steps, and be creative. Be prepared for the publication plan to quickly evolve. Most importantly, enjoy the unique opportunity to create a unique path to publication management as a Medical Communications leader at a smaller company.