OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Executive. All rights reserved.
Choosing the right team and implementing structure headline necessities for launch.
I’ve spent a career launching pharmaceutical drugs. Each product I worked on was a unicorn, a rare case of a drug that makes it all the way from initial idea to FDA approval. By the time my team and I join the process, there have been hundreds of thousands of hours and millions of dollars already invested in getting the drug to that point. Needless to say, the stakes are high, and so are the odds of failure!
While each launch is unique, there are five factors that guarantee success.
The first step in any successful product launch is building out a cross-functional team. It is critical that all of the key stakeholders are at the table for the entire life cycle of the product. You must ensure that everyone on the team is aligned on the strategy and path to launch. The functional areas should cover the following:
Regulatory: This team works closely with the FDA to finalize the product’s label, and the label is like the Bible when you are launching a product. If it isn’t on the label—your salesforce can’t talk about it.
Marketing: Every product needs a story to sell it. Your marketing team develops the messaging for your product. You aren’t just looking to commercialize your product; you are also trying to maximize your product’s value over its patent life. Ultimately, your sales representatives will share this story with customers—the final frontier.
Market Access: Over the past several years, market access has grown ever more important. As a manufacturer, it is critical that your product is covered under the payers’ formulary plans (the list of prescription drugs an insurance plan covers).
Commercial Operations: When launching a product, it is important to collect and synthesize data. Just like you use the rearview mirror when you drive to see what is coming, this data allows you to see what happened so far so you can push forward in the right direction toward launch with speed.
Clinical R&D: Often when launching a product, key stakeholders will share opinions on the product life cycle. It is critical that these things can be discussed early, at the right stage in the process when they can be effectively addressed.
Medical Affairs: Critical to any product’s success, this team works with key opinion leaders, healthcare professionals, congresses, and advocacy groups to ensure accurate product information is being communicated.
Legal: I cannot stress enough how important the legal team is. Given how much money goes into developing these products, it is critical that your intellectual property is protected.
Compliance: You need to have a team focused on whether your company and product are compliant with all the regulations and pharmaceutical codes.
Supply and Manufacturing: If you don’t have a product, you aren’t selling anything.
Anything that lacks structure tends to fall apart, and when you are working on a complicated project like a product launch, you might have anywhere from 12 to 20 teams involved. A governance structure can help ensure alignment between these various teams and control the flow of information.
Then, this central governance structure needs to develop and implement a launch strategy that takes market assessment into account, a cross-functional launch plan that outlines critical path activities and dependencies, launch support that is operational and includes executive decision making, and finally, launch execution and monitoring.
It is important to build communication and reporting channels to expedite important decisions through established governance bodies. Even one communication mistake can come at a major cost. You cannot afford not to communicate. You need to make sure that the people who need to know are in the know. You also need to establish an escalation path. Say a competitor launches a product six months earlier than you expected or you have delays that’ll impact your product launch date; how do you react? You need to have a plan and a process set up ahead of time so you can make quick decisions in such an event. This works best when you have a dedicated escalation team.
Not a single launch I have been involved in has gone perfectly according to plan. But that is the fun of it. The key is establishing processes and tools that align to the organizational model and help manage the launch effectively through regular touchpoints. When these are defined up front and are easily accessible, your team will have access to the single version of truth and they’ll be equipped to handle crisis when it hits—which it inevitably will.
Ahead of a product launch, it is important to identify readiness factors across six critical areas: approval readiness, marketplace readiness, customer and stakeholder readiness, organizational readiness, market access readiness, and supply chain readiness. Throughout the process, it is critical to monitor these touchpoints with your cross-functional team at regular intervals.
Divya Yerraguntla, Vice President, Asset Strategy, Syneos Health