Launching a drug website the same day you receive FDA approval for a new therapy (or new indication) can feel daunting. This is especially true for brand teams whose digital launch roadmaps follow planning models that don’t allow for the flexibility required—and enabled—by our current digital landscape.
Enter the phased launch plan: A new way to prepare for FDA approval day that removes constraints and accelerates your workflow. With a phased launch plan, you can go live with HCP and patient sites within hours of FDA approval. Many pharma marketers are surprised that this is possible, but it can be done. I know, because my team has worked with pharma brands to make it happen hundreds of times.
Given the size and scope of the investment required to get past Phase 3, a fast and successful launch is non-negotiable. A delay in market launch equates to an average of $21 million per day in opportunity cost for the 15 top-selling drugs in the United States in 2018.
With so many variables, traditional launch plans just don’t work anymore. The good news is that a phased plan can accelerate your speed to market, eliminate wasteful spending, and bring more clarity to the process. Three critical steps to get started:
Step 1: Scope a Minimum Viable Product (MVP)
A common mistake in new therapy and new indication site launches is to over-scope requirements. Because final label approval is the last step before launching your site, only so much can happen pre-approval.
If too much information is submitted to compliance teams without clear prioritization, launch-critical items risk getting buried or overlooked. Do your digital sales aids and point of care content need to be released on the day of approval, or can they be reviewed post-launch? Do you want your regulatory teams prioritizing print materials that will not have the immediate impact that digital will on launch day?
On FDA approval day, HCPs and patients are looking for specific, and limited, information. Providers want clear efficacy and safety information. Patients are looking for key questions to ask their doctors. All stakeholders will seek “now approved” messaging. Incorporating too much information, too many interactive website features, MOA video tutorials, and other resource-intensive elements could cost you a launch deadline.
As a marketer, align with your team on what a minimum-viable product should include. Consider adding information about cost, potential financial assistance, and multimedia features such as videos, graphics, or FAQs, in future iterations (accounting for any current and future legal requirements, of course). Common “release” milestones, when you incorporate additional features, include seven days and 30 days post-approval. Clarity is key: Be upfront about what content needs approval first.
Step 2: Scenario Mapping
Countless internal and external variables can affect your website launch, and marketing teams are expected to handle any scenario that arises. Scenario planning involves developing hypothetical action plans that map to all possible outcomes so you can quickly and effectively accommodate the unexpected.
If your stakeholders are aware of all possible timelines and key delivery dates—and have action plans in hand to accommodate each one—they can effectively allocate resources to review materials so that your tactics launch quickly. Suppose your plan includes a branded email announcing FDA approval that drives to the website for more information. Regulatory should know what dates and times the email may be sent, and how much notice they will receive in each scenario.
To further expedite the process, request a “soft approval” from your regulatory team for the MVP you defined in Step 1 above. That way, the only step for regulatory on approval day is to approve final label updates.
Scenario mapping alone is not enough; your site launch success depends on continuous communication. Tactics, status, issues, risks, progress, and approval status updates must be communicated immediately among leaders, stakeholders, and the individuals responsible for executing the work. Having all stakeholders aligned at all times ensures quick and efficient action.
Step 3: Branch Your Code
Code branching is a technique where developers work from a master code base, processing multiple “branches” of code based on your scenario maps. These branches can be merged and published immediately depending on various possible outcomes. Because it is not always known what will be approved by regulatory, code branches can be created for each scenario. This enables your team to launch an approved site instead of waiting for a single piece of functionality to be completed or content derived from another source to be approved.
The three primary methods of code branching are:
- Linear branching: Each site release is completed and launched in succession.
- Simultaneous start: Each site release is created as a separate line of development, and merged together for launch.
- Staggered branching: Release B starts at some point in Release A’s project lifecycle (the most common scenario, and can include numerous releases).
Additionally, code branching allows for flexibility in multi-indication planning. If a second indication for an existing therapy with a live site is pending FDA approval, you can work on both indications in parallel from the master code. If the first indication site needs changes, you can incorporate them without interfering with the potential changes that are in process for the second indication. This removes repetitive back-end development from the equation, saving you time, resources, and cost.
Ready for Launch?
A phase launched plan can bring more speed, efficiency, and cost savings to a process that is fraught with uncertainty. Done correctly, it can give you more flexibility to adapt quickly to internal, regulatory, or market changes and align everyone involved. Congratulations on reaching this stage in the drug development process! Now take it the rest of the way to launch the websites you need to help the market benefit from your brand’s innovation.