At the MAPS Americas 2025 conference in New Orleans, one of the pivotal discussions centered around preparing for drug launches in the current pharmaceutical landscape. While many important topics were covered, a critical element that was notably missing from the discussion was the need for a strategic north star—a guiding philosophy that ensures all tactical efforts are aligned with the overarching goals of Medical Affairs.
Organizations are often tempted to rush into tactical execution without considering the strategic needs and communication of key messages to the medical community they are serving. Bringing all team leaders together to align on a high-level strategy cannot be overlooked, and it empowers leaders to make strategic decisions for their teams.
This strategic north star is essential for informing tactical decisions and ensuring cohesive execution across the team. Identifying this “north star” early allows for effective market conditioning and disease state awareness, building the need for the product well before its launch. Here, I will focus on the organizational best practices that ensure consistent strategic-tactical alignment, providing leadership with the structure to be nimble and adaptable in addressing risks. Below are some best practices discussed at the conference, combined with insights drawn from decades of experience across the industry, to help Medical Affairs teams set themselves up for a successful drug launch in the United States.
Aligning on the Medical Affairs launch strategy
A successful drug launch begins with a well-defined strategy that has buy-in from all the major leadership stakeholders. This strategy should be informed by insights collected early from key opinion leaders (KOLs), the broader medical community, patient advocacy groups, and especially field teams to understand the real-world market need. Additionally, too often, insights drawn from the field teams are deprioritized in favor of literature when the day-to-day routine of treating patients may reveal a different reality. Engaging and appropriately understanding these stakeholders early ensures that the strategy is robust and reflective of real-world needs and expectations.
Best practices:
- Stakeholder engagement: Regularly consult with KOLs and other key stakeholders to gather insights and validate the launch strategy.
- Cross-functional collaboration: Ensure that all medical teams, especially Field Medical, Medical Information, Clinical Development, Health Economics and Outcomes Research (HEOR), Regulatory, Patient Advisory/Advocacy, and others are aligned with the Medical Affairs strategy.
- Empowering team leads: Develop a strategy to empower team leaders, ensuring they can be confident that their strategic decisions will be supported and executed with the full support and resources of the organization.
Communication of strategy and feedback mechanisms
Effective communication is crucial for the successful execution of a drug launch strategy. This involves not only disseminating the strategy from leadership teams but also establishing mechanisms for feedback to flow upwards.
Best practices:
- Feedback loops: Implement regular team meetings to track progress and address any tactical misalignments promptly. Organizations that incorporate weekly meetings for operational alignment have achieved great success in streamlining the decision-making process.
- Addressing feedback: Prioritize collecting and addressing feedback during regular team meetings. Empower team leads to address internal tactical issues promptly and have a consistent avenue to escalate strategic imperatives as they arise.
- Transparent communication: Use clear and consistent messaging to communicate the strategy and project updates across all relevant levels of the organization.
Tracking launch progress against key milestones
Monitoring progress against predefined milestones helps ensure that the launch stays on track and any issues are addressed promptly.
Best practices:
- Milestone mapping: Define key milestones and track progress using project management tools. These milestones should be checked and addressed at all team meetings to ensure milestones are reasonable and teams have the resources to successfully execute the project.
- Regular reviews: Conduct regular reviews to assess progress and make necessary adjustments.
Identifying strategic gaps and harmonizing messages
Identifying and addressing strategic gaps early can prevent misalignments and ensure that the launch strategy is cohesive and aligned with the overall company strategy.
Best practices:
- Gap analysis: Regularly perform gap analyses to identify and address any strategic misalignments.
- Message harmonization: Ensure that all communications are consistent and aligned with the company’s overall strategy.
- Strategic meetings: Strategic meetings to create alignment must be small, including only those who are necessary to make the decision or should be consulted for their expertise or team role. This ensures efficiency and effective decision-making.
- Escalation of risks: In some cases, risks will require strategic alignment from leadership. The lead must be empowered to escalate issues as needed to ensure timely resolution.
Creating a single source of truth
A centralized system to track all priority launch workstreams is essential for maintaining clarity and accountability.
Best practices:
- Centralized tracking: Develop a single source of truth to track all workstreams, responsibilities, and interdependencies. This centralized management system should have a single individual or team responsible for coordinating the document.
- Operational dashboards: Use dashboards to provide real-time visibility into key performance indicators (KPIs).
Additional considerations:
- Regular project status updates: The coordinating team should be empowered to collect regular project status updates, highlight team needs, and address significant projects at risk based on interdependencies.
- Categorization of workstreams: Categorize workstreams as on track, at risk, or behind schedule. This helps in prioritizing efforts and addressing issues promptly.
- Presentation to the organization: The lead can then present to the rest of the Medical Affairs team and the organization about how the interdependent projects are tracking. This ensures transparency and keeps everyone informed.
- Access and informational sessions: All team members must have viewing access to the single source of truth document and the regular informational sessions. This promotes transparency and keeps everyone aligned.
Addressing timeline drift and misalignments
Proactively addressing issues of timeline drift and strategic/tactical misalignments can prevent delays and ensure a smooth launch.
Best practices:
- Early detection: Implement systems to detect and address timeline drifts early.
- Strategic adjustments: Be flexible and ready to adjust strategies as needed to stay on track.
- Quick status indicators and regular meetings: Use quick status indicators and hold regular meetings to help keep everyone informed and aligned.
- Status indicators: Use Red, Yellow, and Green indicators to quickly communicate the status of projects and workstreams.
- Biweekly meetings: Hold regular biweekly meetings to disseminate information and make strategic alignment decisions.
By integrating these best practices, Medical Affairs organizations can navigate the complexities of drug launches more effectively, ensuring that their efforts are coordinated, strategic, and ultimately successful. These insights from the MAPS conference, combined with practical experience, provide a comprehensive roadmap for achieving launch excellence in the pharmaceutical industry.
Nachum Serota
Medical Director