Much has already been written about the subject of launch readiness, from critical success factors and launch excellence frameworks to tactical roadmaps and launch KPIs. The focus, however, typically tends to be skewed towards commercial activities, with medical launch preparations often not receiving the attention they deserve, considering today's strategic importance of the medical function. Here we discuss common pitfalls in medical launch readiness that pose significant risks to launch success and present experience-based best practices for overcoming them.
Rise of medical affairs
Traditionally, Medical Affairs has played a supporting role in the preparation for launch, largely focused on ensuring regulatory compliance; responding to healthcare professionals’ enquiries, especially those that fall outside a product’s label; and collaborating with investigators on post-launch clinical trials.
However, dramatic changes in the healthcare environment are redefining the role of Medical Affairs in the preparation for launch.
- Ever more stringent compliance requirements demand the strict separation of commercial and medical activities, including both content generation and its dissemination
- An increasingly complex healthcare landscape requires engagement with a broader set of stakeholders, beyond prescribers and KOLs, including regulators, payers, nurses and patients Furthermore, those stakeholders are seeking authenticity, in the form of unbiased information delivered via trust-based engagement, un-clouded by commercial objectives
- A rising burden of proof for demonstrating value to regulators, payers and HCPs across the product lifecycle requires the strategic planning and generation of critical, scientific evidence, including RCT data, RWE and patient-generated data (e.g., Patient Reported Outcomes)