Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.
Preparing a product for launch is much more than timing a commercial rollout: it requires early planning, cross-functional alignment and a clear understanding of the patient and prescriber journey. In this Q&A, Maria Natale, senior vice president at Intellia Therapeutics, shares her perspective on how to structure a launch-ready commercial organization, what companies often overlook and why starting early is essential in commercialization.
Background
Tell us a little bit about your background and experience in the commercial landscape
I’m Maria Natale and I’m senior vice president at Intellia Therapeutics. I’ve been with the company since the summer of 2024. I’ve worked in the pharmaceutical industry for 24 years. Before joining Intellia, I served as the franchise head of immunology and inflammation at Galderma. Previously, I was at Alexion, where I led the team responsible for new product strategy. I’ve spent significant time overseeing commercialization and leading teams that have successfully introduced new medicines to the market, with a heavy focus on the rare disease space.
Team structure and composition
When preparing a product launch, how do you think about structuring the commercial team — and how early does that process need to start?
The way some leaders structure commercial organizations depends on the type of medicine they plan to launch, as well as the challenges they anticipate in commercialization. Broadly speaking, most commercial organizations include market access, patient services, marketing, sales and commercial operations functions. The timing of each depends on the plan, but all of them are needed before launch. It’s important to work on preparing a product launch well before regulatory approval.
What are the core roles that absolutely must be in place before a product launch, and which can be built out over time?
Typically, medical affairs is established first as they need to be in place by the time Phase 2 results are available, and while the Phase 3 trial is ongoing to engage in scientific exchange and education. Commercial functions start with market access, then marketing, commercial operations and then finally the sales organization that will be calling on customers.
Cross-functional alignment
Drug launches require tight coordination across commercial, medical affairs, market access, regulatory and supply chain — how do you build that alignment organizationally?
It’s important to ensure that all the teams are coordinated. For example, Marketing works closely with development and regulatory teams to make sure the product strategy is shaped correctly, and the right clinical endpoints are considered from a commercial perspective. Market access teams usually include a global market access strategy group that develops the product’s value proposition and pricing strategy very early on. Closer to launch, the national accounts team is brought in and they begin payer engagement. That work is critical and should happen before approval. The sales organization usually comes later; shortly before approval.
How do you balance competing timelines during launch preparation?
A central project management function is crucial to coordinate the different teams and their launch readiness planning. A strong cadence and governance structure is equally important to review plans, raise risks and work together to mitigate those risks before they happen. Strong collaboration and communication are essential to keep planning and launch execution moving forward.
Planning and readiness
What does a launch-ready commercial team actually look like — how do you know when you’re ready?
There is a lot that needs to be done to get both the product and the organization ready for launch. It comes down to prioritization. There needs to be a clear vision of what must happen and when, versus what is simply nice to have. That is especially important for companies preparing to launch their first product, because they are not only preparing the product for launch, but also building the organizational capabilities needed to be launch-ready.
What’s on your launch preparedness organizational checklist that people often overlook?
A team with execution experience is essential. A plan must be established and then tracked to make sure milestones are met. Market access readiness must be in place so patients can attain access as quickly as possible at approval. Educating the community on the disease and supporting patient advocacy efforts is another consideration, and there are ways to measure that progress.
I think one of the most overlooked aspects is starting launch preparation too late. Budget can often be adjusted, but it’s very difficult to make up for lost time. Planning late is one of the main reasons some commercial organizations underperform. Another area is overestimating readiness. Plans, pressure tests and simulations are essential at every step to make sure what is planned can actually be executed. If problems come up, this ensures there is time before launch to fix them.
It’s also important to perform deep insight generation to understand the true potential of the drug, because that will help the company manage expectations externally. You don’t want to overestimate your commercial potential.
Field force and customer engagement
Is there anything unique to field force training when you’re working in complex or rare disease areas?
Training the field organization is critical, because they are the bridge between the company and customers. They need to be well-trained so they can represent the company and the product in a fair and balanced way. The training process should include multiple steps and checkpoints to ensure people are not just learning the material but can also explain it clearly and compellingly.
Leadership and culture
Based on your previous experience, how do you preserve team morale and keep momentum strong during prelaunch period?
To build a strong team, there must be a shared vision for the launch and clear goals. When people help shape that vision, they feel empowered and take ownership of the plan. Then, there must be strong collaboration. Launch preparation is a high-pressure period, so it is important that the team works well together. It also helps to celebrate progress along the way, even before the work is finished!
How do you maintain patient-centricity as an organizational value when there is significant commercial pressure around launch?
It is important to understand what patients go through and make sure employees have the chance to hear patient perspectives directly. Bringing patients into the organization is valuable. The company also needs to operate with strong core values and keep the person and the patient at the heart of every decision. When thinking about the patient first, those decisions usually support successful commercialization.
Lessons learned
If you could only give one piece of organizational advice to a company getting ready to launch, what would it be?
The number one piece of advice is to start early. Time is everything. It is never too early to start planning and hiring the right people. Onboarding can take a long time, especially when assembling new teams. 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.
