Pharma Content, Review, and Approval Best Practices
Shifting drug launch timelines and content requirements can be challenging for emerging pharma companies. But by following launch best practices, from building and managing a commercial content launch plan to promoting alignment with key stakeholders, you can help ensure successful and timely content delivery. When you obtain final FDA approval, you can get your marketing collateral out to your sales teams and begin educating physicians quickly.
I started my career as an air traffic controller—an excellent foundation for marketing operations, which depends on keeping processes and traffic flowing.
Aligning teams and priorities
The marketing operations team plays an essential role in planning, preparing, and facilitating cross-team communication during launches. Depending on the size of your organization, you might have payer, direct-to-consumer, and healthcare professional (HCP) teams. These teams may communicate well, but they might have different priorities. Therefore, it can be helpful to bring the groups together well in advance of the expected launch with a list of all content materials to prioritize and agree upon.
I’m a proponent of adding content placeholders in Veeva Vault PromoMats with target medical, legal, and regulatory (MLR) dates so that you can start running reports and gaining visibility into when things are coming through. As soon as you decide you’re going to create a piece of content, even if it’s still in creative mode, add it in Vault PromoMats.
At the same time, it’s essential to manage expectations and make sure your content creators and agencies are involved in building the target dates, too. That way, you can ensure that what you’re promising is reality and that the agencies can keep up.
Content planning considerations
Recently, as with everything COVID-19-related, we had to be nimble as we went from emergency use authorization (EUA) to FDA approval. We didn’t have a single date when we expected a decision, so it wasn’t a traditional PDUFA date scenario. Instead, we prepared for several approval dates throughout the process; we had to be nimble and adapt to sliding timelines.
When it comes to marketing operations and content launch planning, don’t treat any particular date as the launch date. As you plan your launches, you might look at day one through a date you determine is the most appropriate for your organization. For example, you might plan as far as day one through 30 on a relaunch where you need to complete 200 to 300 different elements within 30 days. But, for a softer launch, you may decide to only plan for the first 10 to 15 days.
Communication is key
When planning a launch, it’s common to think about what will take place on day one, day zero, and so forth. In some instances, it’s helpful to track priority dates in Vault PromoMats and use the Veeva reporting capability or pull information into another tool to report on progress. For example, on day one, you could say precisely how many pieces of content went through, right up through the first 15 to 30 days of launch.
Especially during a launch, you might focus less on how long approvals take. For example, a content piece may require three rounds of review because of continuous updates with the draft label, which will skew your data. It’s more important to focus on how quickly you can execute from day one onward. Striking the right balance is critical. You don’t want to overwork your MLR review team, but you want to keep up with the label to avoid a significant lift at launch. The most important thing is to communicate with your teams regularly.
It’s helpful to show the throughput, share information with management, learn what’s working well, and identify gaps. Take those learnings into your next launch.
Launch timing considerations
There is sensitivity about who has a right to know, or needs to know, certain information during a launch and when you will share it because it can affect the market. For example, if you have an evening FDA approval, you may not launch it to the public until the following day when financial markets are fully open. Your legal department should provide guidance.
It’s essential that you can launch your website, documentation, and emails as quickly as possible.
Post-launch best practices
In addition to all of the elements considered for launch, it’s equally important to continue best practices after launch. Here are four post-launch recommendations:
- Establish the new normal: The biggest challenge for operations and brand teams is establishing a new volume for MLR review teams after a launch. You need to decide upon an acceptable capacity level and redefine your KPIs for a steady-state.
- Load balance: Leading up to launch, you spent a lot of time planning and forecasting. After launch, you can look at the future roadmap, a 60- or 90-day view into what’s coming down the pipe. This approach helps the review committee staff up or load balance, so people don’t become burned out.
- Keep up the momentum: You spend a lot of time creating good habits, which I refer to as the six Ps, “Proper prior planning prevents poor performance.” If you’ve set up proper prior planning, continue it. Don’t let it lapse because you’ve made it over the launch hurdle. The hurdles keep coming. It’s a marathon, not a sprint.
- Educate yourself about existing or new Vault PromoMats features: Attending industry forums, such as the Veeva Commercial Summit, is helpful to learn what’s coming.