Preparing a product for launch requires early planning, cross-functional alignment, and a clear understanding of the patient and prescriber journey, Maria Natale, senior vice president at Intellia Therapeutics, said in an interview published on June 15. Natale shared her perspective on structuring a launch-ready commercial organization and emphasized the importance of starting preparations well before regulatory approval.
Natale said she has worked in the pharmaceutical industry for 24 years, with experience overseeing commercialization efforts in rare disease spaces at companies such as Galderma and Alexion. She outlined that most commercial organizations include market access, patient services, marketing, sales, and commercial operations functions. "The timing of each depends on the plan," she said. "But all of them are needed before launch." She also noted that medical affairs is typically established first to engage in scientific exchange during clinical trials.
Cross-functional coordination is crucial during drug launches. Natale explained that marketing teams work closely with development and regulatory teams to ensure proper product strategy while market access groups develop value propositions early on. "Closer to launch, the national accounts team is brought in and they begin payer engagement," she said. A central project management function helps coordinate these teams' activities to keep planning moving forward.
When asked about what makes a team truly ready for launch, Natale said prioritization is key: "There needs to be a clear vision of what must happen and when." She cautioned against late preparation or overestimating readiness: "Planning late is one of the main reasons some commercial organizations underperform... Plans, pressure tests and simulations are essential at every step to make sure what is planned can actually be executed." Deep insight generation into drug potential also helps manage external expectations.
Regarding field force training for complex or rare diseases, Natale stressed its importance: "They need to be well-trained so they can represent the company and the product in a fair and balanced way." She also highlighted maintaining morale through shared vision building: "When people help shape that vision, they feel empowered... It also helps to celebrate progress along the way.”
Natale concluded by advising companies preparing for launch: “The number one piece of advice is to start early. Time is everything… You want to make sure the teams are cohesive, aligned and ready to identify challenges early enough to solve them before they become real commercialization problems.”
