Preparing for Launch: Building a Commercial Infrastructure in a Clinical Stage Company
First Critical Roles for an Emerging Company’s Commercial Build-Out
Let’s start at the beginning, when do you prefer to join a company who may be transitioning from clinical-stage to commercially ready?
In an ideal situation, the first commercial leader would be hired a minimum of two years prior to expected approval. This allows time to build the infrastructure required to support a launch, including the full commercial team, and execute against the launch plan.
When you join a clinical-stage company as one of the first commercial hires, what are your top priorities?
My immediate priorities fall into three areas – first, developing a comprehensive launch plan and identifying resource needs across departments. Second, engaging the entire company in the launch process to raise awareness and excitement, and also to identify my key cross-functional partners who will be helping execute against the launch plan. And third, beginning to build the commercial team that will ultimately drive launch success, focusing on critical hires first.
Who are some of the first critical hires once it’s been decided that a company will commercialize its first product?
There are certain strategic questions that must be answered early on to develop an initial assessment of market size, dynamics, and the key drivers and barriers a product will face, including pricing and reimbursement which are always hot topics for investors. So the earlier you can start building and refining your understanding of these areas, the better. While launch seems far away at this point, commercial launch activities will rapidly pick up speed, so I recommend staying ahead of the rush by hiring a team member dedicated to each area – marketing, market access, and market analytics.
Optimistically Cautious Hiring
As you actively plan for a first product launch, you’re also waiting for trial results or FDA feedback. How do you build your team and prepare your product for market when there is still great uncertainty? In what areas do you continue to invest resources in?
As a therapy completes the final stages of trials or FDA review, launch preparations can’t wait, and new projects need to be kicked off. This increase in activity requires a larger team to handle the workload, however hiring a complete commercial team of Full-Time Employees at this point can high risk, both for the company and for employees potentially leaving another secure job, should the trial fail or approval be delayed or rejected.
To mitigate those risks, finding options to flexibly supplement the team with experienced personnel is essential. In addition, finding people who are nimble and can work across multiple work streams is highly valuable. My past teams have been a mix of full-time hires and experienced commercial consultants who essentially act, and are treated, as a full-time member of our team. At all three of my most recent companies, we relied on Compass Consulting Group for this type of support.
Full Steam Ahead – What’s Next?
Assuming you have received your positive phase III data, and are now about 12-15 months from launch, what focus and activities do you plan to build out?
With everything looking positive and a foundational team in place, now is the time to consider converting any contractors with a full workload to full-time hires. It’s also time to finalize the design and build-out of your field force and support roles, such as training and sales operations. And finally, this is when I like to have a formal cross-functional launch team meeting on a regular basis to ensure all launch-related projects are moving forward seamlessly.
I think it’s important to note, even though it’s full-steam ahead at this point, there will always be new projects that are either finite in nature, or the workload may not justify a full-time hire. As our needs to support this extra project demand have grown, our partnerships with Compass helped us manage our headcount budget and risk at the same time.
I just want to thank you for the opportunity to share my experience building and leading commercial teams in clinical stage companies. I have a passion for building commercial infrastructure from scratch and Compass has been a great partner over the past six years.
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