From R&D to Launching Your First Drug: How to Navigate the Drug Launch Process and Stay on Schedule

In the past decade, the share of new molecular entities (NMEs) introduced by first-time launchers has surged. According to data from McKinsey, between 2017 and 2021, 42% of NMEs came from first-time launchers, a three-fold increase from 2002 to 2006. This upward trend is expected to continue, particularly for blockbuster products with forecasted annual peak sales exceeding $1 billion, like capivasertib (AZD5363) in the breast cancer market and lecanemab (LEQEMBI) and donanemab (LY3002813) in the Alzheimer’s market. By 2026, first-time launches are projected to outnumber launches by established companies almost two to one.

While these trends are indicative of the growing prominence of emerging biotech firms bringing innovative new therapies to market, it also means that a growing number of newcomers are undergoing a major shift in priorities as they transition from research and drug development to commercialization. This transition requires strategic and serious considerations around investments, scalability, workforce planning, and culture.

It’s crucial that biotech leaders navigate the drug launch process with foresight and agility, ensuring a successful transition that propels their groundbreaking therapies from the laboratory to the healthcare marketplace. From discovery to launch, we explore each critical aspect of the drug launch process; we also review how Compass’s life sciences workforce solutions can help your firm stay on track and on schedule with our deep expertise in life sciences and a robust network of embedded consultants.

Launching Your First Drug: How to Navigate the Transition

Building a commercial-ready organization while transitioning from R&D and managing your product launch may seem like an impossible task, but it’s a critical part of ensuring your drug launch is a success. Your new drug therapy may be a revolutionary product, but if your organization isn’t firmly established in the pre-launch phase, your company is likely to struggle with low performance. During this transition phase, it’s important to focus on name recognition, market relationships, and ensuring sufficient resources – three key predictors of success that first-time launchers often lack.

Luckily, small biopharma startups have a big advantage over other more established companies: a clean slate. New pharma companies bringing a product to market can design their commercial-ready organization without being constrained by legacy systems or prior organizational structures that don’t serve their go-to-market needs. That said, it’s important that first-time launchers begin planning and executing this transition months in advance of any expected product approval date. One of the biggest challenges faced by first-time launchers is maximizing drug adoption and meeting pre-launch forecasts. As a result, your launch teams need sufficient time and resources to prepare for product introduction, building market relationships and name recognition while clinical trials are ongoing.

Ultimately, navigating and executing a successful first-time drug launch requires a product launch plan template and strategy that enables your medical and commercial teams to align and collaborate. Next, we’ll explore the four key factors to navigating this transition, establishing an organizational foundation that allows you to effectively bring your new drug to market.

1. Define Your North Star

The first step in transitioning from R&D to drug launch planning and preparation is setting a vision for how your company seeks to change the treatment landscape. What does your product offer that makes it unique from current drug therapies on the market? Defining your north star or guiding principles is a critical step to ensure that every component of your plan is strategically aligned. It also helps provide a foundation for how your organization will respond and adapt to any changes and challenges in the healthcare ecosystem that may impact your commercial phase.

Along with defining your core values and organizational purpose, it’s important to identify the critical functions and teams you’ll need to support your overarching vision and goals. How does each team support the organization’s vision? Deciding on these key functions at the start of the process and months before any actual transition begins is critical to ensuring your organization is built for success and can withstand potential go-to-market challenges or launch delays.

2. Invest in Commercial Capability

After years of investing in research and development to create your new drug, it might be tempting to assume that you won’t need the same level of resources to bring your product to market. Unfortunately, this mindset often causes first-time launchers to spread their resources too thin, depriving their launch of the funding necessary to meet their commercial goals. Instead of building a launch plan around your budget, which could be limited by the size of your startup, first-time pharma companies navigating the drug launch process should tailor their go-to-market strategy to their product and invest accordingly.

A critical first step to developing an effective pharmaceutical product launch template is understanding the potential of your drug in the marketplace. By investing early and building relationships with key opinion leaders, you’ll be able to develop a deeper understanding of your position in the current market. It’s also important to draw on a wide range of data sources to assess how providers, payers, and patients are likely to react to your product. With this crucial market knowledge, you can build a launch strategy that fits your product then determine what funds are necessary to support the launch process. By investing effectively from the start, your company will be more successful during the drug launch and more likely to meet sales targets as a result.

3. Build a Patient-Centric Culture

Along with defining your organizational values and investing resources in your launch, you’ll need to re-evaluate the culture of your organization. During the R&D phase, your company was focused on the technical side of the work and likely had an output-focused culture as a result. Now, as you move into the commercial phase, you’ll need to adjust and become more patient-centric. Based on your “north star” vision, your R&D and commercial teams should collaborate to ensure they are aligned with the company’s commercial priorities. Ultimately you’ll want to facilitate a unified culture shared across teams.

Next, consider how you might take a patient-centric view in each area of your business. It’s not enough to rely on product efficacy or safety to make sales. As customer experience becomes more and more important, companies need to understand the journeys of both patients and prescribers and work to create a better experience for each group. One way to accomplish this is to embrace digital technology and analytics to engage healthcare professionals and patients. The more you understand your consumers, the more patient-centric and effective your business will be.

4. Attract and Hire Top Talent

Navigating the drug launch process to bring a new product to market requires time, resources, and, most importantly, the right people. Often, first-time launchers wait too long to hire the people they need, resulting in delays as new hires try to catch up with the launch process. Instead, get a jump on hiring by identifying the top roles you’ll need to fill for a successful launch. These usually include external-facing medical and market-access roles. Hiring for these positions first ensures you’ll have the talent you need to begin engaging with key stakeholders early on, creating excitement for your product and gaining access to valuable market insights at the same time.

Moreover, the importance of having embedded consultants who are experts in their respective fields cannot be overstated. These professionals can be swiftly integrated into your team, bringing with them a wealth of knowledge and experience that is invaluable during critical launch phases. Their expertise bridges gaps in your team’s skill set, provides fresh perspectives, and ensures best practices are followed, all of which are crucial for a successful launch.

Next, revisit those critical functions your organization identified when you created your vision. Which do you need to prioritize as you move from launch planning and strategy to execution? Staffing up your organization while completing drug trials and planning for your product launch can be challenging for smaller biopharmaceutical companies. This is where Compass can help. Instead of trying to manage the recruitment and hiring process on your own, Compass can help you find the talent you need.

With our exclusive focus on the biotech, pharmaceutical, and device industries, we provide access to the largest network of life science experts. Our expert recruiters can help you build your commercial team prior to launch and hire new talent as your drug launch plan proceeds, consulting on best practices and ensuring you always have the people you need to make your market entry a success.

Challenges and Opportunities for First-Time Launches

Navigating the drug launch process to bring a new pharmaceutical product to market can be a long and grueling process, especially for first-time launchers. Completing drug trials and gaining final approval while creating a launch template and strategy is just the start. Staying on schedule, meeting pre-launch forecasts, and maximizing drug adoption all require significant resources, workforce planning, and cultural capital.

While these challenges are considerable, in the end, the opportunities available to companies and biotech leaders who successfully navigate the drug launch process make up for the risk of bringing their own product to market. The addition of expert embedded consultants can significantly enhance the likelihood of a successful market entry, turning potential challenges into improved patient outcomes.

Are you preparing to launch your first pharmaceutical product? Compass has a proven track record of guiding companies like yours through the complexities of bringing new products to market. Read our case study to learn more.