Today’s path to launch is increasingly complex. It’s a delicate balance to make timely, strategic investment decisions while also anticipating regulatory uncertainty and fast-changing market dynamics. For commercial, data, and IT leaders at emerging biopharma brands, you often face the added challenge of limited resources.
How can you make confident decisions about the strategic timing of activities and investments ahead of launch?
With limited resources compared to legacy, established pharmaceutical companies, emerging biopharma companies face greater challenges leading up to a launch. Specifically, your company must make difficult decisions about how much to invest in commercial data and technology—and when.
For some, the initial instinct is to go all in and invest heavily in data, software, and new hires. But this approach carries significant risk. If your drug ends up failing, you’ve expended a substantial amount of effort, money, and resources—with nothing to show for it.
The alternative route isn’t any better. If you play it safe, delay commitments, and invest conservatively in data and technology, then you risk being under-resourced and underprepared come launch time.
To ensure a successful launch, commercial teams must toe a fine line.
The challenge lies in striking the right balance between protection and preparation. At the same time, you need to be on the lookout for time slippage, where tasks take longer than originally expected, pushing back timelines, creating stress, and ultimately impacting launch success.
How can you balance cash flow and regulatory uncertainty so your brand is both prepared for launch and protected from unexpected surprises?
You need to be able to identify which activities require investment ahead of launch and which are better prioritized post-launch. For example, it makes more sense to hire FTEs and build in-house data and analytics teams when your workload is stable and more predictable.
Ultimately, what’s most important is understanding which activities you should prioritize and conduct “at risk,” i.e., before launch as you balance limited resources and regulatory uncertainty.
Beghou has worked with dozens of emerging biopharma companies, so we know what works to prepare for a successful launch—and what doesn’t. Most importantly, your team should prioritize four key “at risk” activities to strategically prepare for launch while protecting against unexpected outcomes.
Although it is common to purchase HCP-level data early to help build the CRM and with targeting efforts, adding patient-level data is an investment that enables patient-centric decision-making. In addition, it avoids potentially having to purchase duplicative data sets later because you can choose a more complete data set from the outset.
The core data should include patients on therapy or who are candidates for therapy to help build a deeper understanding of the market in your disease area and allow you to judge how to best access patients and providers alike.
Finally, this data can help with forecasting and assessing how providers, patients, and payers are likely to react to your product.
A well-implemented CRM allows you to engage with key stakeholders early on, which is essential for developing brand awareness; forming strong, collaborative relationships; and establishing long-term trust. You can prioritize the KOLs and HCPs for early engagement based on influence, specialty, and geographic reach, allowing you to use your resources more efficiently. To set the stage for scalable success, the sooner your brand begins nurturing these connections, the better.
Plus, by investing early in a CRM, you create a centralized space for cross-team communication and data management. Ensuring strong alignment from the get-go positions all teams for success and ensures a unified approach at launch and beyond.
Finally, investing in a quality CRM system helps minimize your team’s reliance on more rudimentary, less secure data management methods like Excel files, which aren’t as well suited for future integrations.
For a successful launch and sustained growth, your company should also focus on investing in an initial customer master, which will ensure an organized, unified view of all HCPs and KOLs. You should prioritize this information well ahead of launch, as it will play a key role in guiding your messaging, marketing, and engagement efforts.
Start with a relevant HCP list. If your brand is in Phase III commercialization and pending drug approval, you’ve likely already determined target specialists and physicians. At this point, you’ll need to fill in data like missing addresses, phone numbers, and emails.
As you establish the initial customer master, keep it flexible; you’ll need to add to your database over time as new information becomes available via public or paid sources, such as claims data and specific HCP affiliations. This approach also allows teams to evolve the customer master organically based on their real-world use.
Lastly, as you prepare for launch, take care to allocate enough resources to establish a CDW and MDM process. It’s important to have these systems in place prior to launch, as they’ll provide the critical information needed to drive data-driven decision-making.
As always, you should approach this “at risk” activity with a combination of preparation and protection. By prioritizing a simple, lightweight initial setup focused on HCP and payer data, you’ll create a solid foundation that can later evolve to handle more complex datasets more complex data sets that will support future analytics use cases, such as forecasting, segmentation, call planning, and launch tracking.
Tackling CDW and MDM setup ahead of launch will position your company for scalable infrastructure growth as your data needs expand.
Interested in learning more about “at-risk” activities and other key decisions like “buy vs. build”, ensuring scalability, and prioritizing data sources and tech?
View our recent webinar and slides, where my colleague Melissa McDevitt and I share real-life scenarios and practical guidance on topics like this, buy vs. build, assessing data and vendors, future proofing your tech stack and more: Emerging Biopharma Data and Analytics Roadmap: Overcoming 4 Key Challenges for Launch Success
Todd Foster is an associate partner at Beghou Consulting.
