In the fast-moving world of drug development, there seems to be a common misconception that strategic medical communications and publication planning can wait until after pivotal clinical trials or even until asset launch. But, by that stage, you might find yourself playing catch-up – scrambling to address critical gaps, having missed opportunities to shape the narrative, build key relationships and establish your asset’s value early on.
Industry experts, including those at the Medical Affairs Professional Society (MAPS)1 and the International Society for Medical Publication Professionals (ISMPP),2 emphasize the importance of starting strategic medical and publications planning 3–5 years before asset launch. For biotech companies developing assets with novel mechanisms of action, first-in-class status or targeting areas with limited disease awareness, early communications are especially critical. They are equally crucial when gaps in the literature exist or when company relationships with key stakeholders are limited.
But why so early, you wonder? Because early communications lay the foundation for a smooth and impactful launch. Like a giraffe* surveying the landscape from above, early planning gives you a clearer view, allowing you to seize unforeseen opportunities and tackle key challenges before they become roadblocks. In turn, early execution helps you build a robust evidence base and strategically position your asset in a competitive landscape, all while avoiding silos and ensuring cross-functional alignment.
That’s why early communications planning and execution isn’t just a recommendation – it’s a strategic advantage, enabling you to:
- Identify and close evidence gaps
- Uncover and address gaps in the literature to strengthen the rationale for your asset, guide clinical trial design, support stakeholder engagement and avoid delays in regulatory and market acceptance.
- Engage key stakeholders
- Build trust and credibility through proactive engagement with investors, key experts, potential principal investigators and patient advocacy groups – all while gaining valuable insights that can help drive evidence generation and refine your overall strategy.
- Inform early-phase clinical trial design
- Use insights from literature reviews and stakeholder input to ensure that your clinical trials collect meaningful data and define endpoints in ways that resonate with key stakeholders, including patients, healthcare professionals and regulators.
- Develop a literature base
- Publish on unmet medical needs, the rationale for treatment, the competitive landscape and early-phase data to differentiate and establish your asset within the scientific community, generating momentum towards asset launch.
- Address knowledge gaps
- Identify areas where education is needed, both internally and externally, to ensure that stakeholders understand your asset’s value and to inform the development of targeted materials and activities.
Sounds great, but wondering how to make it happen? We get it. With so many immediate priorities and demands on your time, it’s not always easy to think years ahead. The good news? Medical communications don’t have to add complexity. A well-structured plan and the right support can help you focus your efforts – no matter where you are in your journey or the size of your team.
At SV, our scientific team is passionate about delivering the difference in early-phase medical communications. Through disease and treatment landscape reviews; needs assessments and gap analyses; along with stakeholder surveys, interviews and advisory boards, we uncover insights that shape your strategy. From publications to scientific communication platforms and lexicons, we craft and execute integrated communication plans that align teams, inspire stakeholders and position your asset for lasting success.
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References
- Farhood R, et al. Medical affairs launch excellence: Best practices for medical affairs. Available at: https://medicalaffairs.org/wp-content/uploads/2021/05/Launch-Excellence-Standards-Guidance.pdf. Accessed February 2025.
- Lea R, et al. Publication plan development: Variables affecting the timing and execution of a publication plan. Available at: https://www.ismpp.org/assets/docs/Education/AnnualMeeting/2ndAM/PosterPresentations/poster.presentation.5.pdf. Accessed February 2025.