Launch preparation is critical for the success of any brand, impacting long-term performance and patient access to much-needed therapies. Medical affairs plays a central role, contributing expertise and strategic insights that ensure launch success.
Planning should start early to allow sufficient time for evidence generation and dissemination and to make effective use of resources. If carried out as early as proof of concept, Medical Affairs teams can contribute to pivotal trial design, ensuring endpoints are relevant for both clinicians and regulatory bodies, and setting the foundation for a successful launch. Below, I’ve outlined other areas in which medical affairs teams contribute to launch preparedness.
3. Pre-launch (2-4 years)
The pre-launch stage focuses on learning, planning and aligning internally. Medical affairs teams dive deep into understanding the competitive landscape, therapy area and patient treatment journey, engaging experts to explore care challenges and crafting a situational analysis, allowing crucial gaps to be identified. This early strategic work is critical. It helps launch teams avoid assumptions, gain new perspectives and allows ample time to gather data to address identified gaps. Furthermore, it allows time to develop a communication strategy that is pressure tested with experts and that educates clinicians progressively about the disease area.
2. Peri-launch (1-2 years)
During the peri-launch phase, execution of a comprehensive medical communications strategy is paramount. Consistency is essential to ensure audiences understand the brand’s scientific narrative in publications and presentations. It also means developing aligned internal training, so a unified narrative is articulated throughout the organisation.
1. Launch (0-1 year)
At launch, further refinements to the strategy based on emerging evidence is crucial. The medical affairs team should advance the scientific narrative and refine the communications platform, ensuring that it still resonates with clinicians. This is where early planning and insight gathering pay off because plans can be refined and executed in a considered way.
Launch planning is iterative, requiring regularly revisiting strategic objectives as market dynamics shift. However, it is preferable to tweak an existing well-considered and researched strategy than to scramble in a compressed time frame, potentially compromising the execution of market critical tactics important for launch success.
This thought leadership piece appeared in the May edition of PME. Read the full issue here.
