Launching a New Drug: Lessons Learned from the Front-Lines

Joseph Tcherkezian
Sep 19, 2025
7 min read

Updated: Sep 24, 2025

Summary

New product launches are among the most critical events in a pharmaceutical company’s lifecycle, yet more than half fail to meet sales targets at launch and beyond. Based on more than two decades of experience across several therapeutic areas, this white paper distills key success factors that consistently separate thriving launches from underperforming ones. Central to this framework is the understanding that success depends not only on the product itself but equally on the people, planning, and strategy that support it.

Introduction

Too often, life sciences organizations fall into the trap of believing that a strong clinical profile is all it takes to guarantee commercial success. The science is solid, the data are compelling, the unmet need is clear, and physician feedback is positive—so how could the product possibly fail? Yet history tells a different story. Time and again, promising therapies have stumbled at launch—not because the science wasn’t strong, but because the strategies and tactics were not tailored to the product’s unique internal and external realities.

Without foresight, cross-functional alignment, and disciplined execution, even breakthrough drugs struggle to gain traction. In fact, according to numerous reports, nearly two-thirds of new drugs miss their first-year sales targets (1-6). Once a launch falters, recovery is rare. These sobering numbers underscore a powerful truth: bringing innovation to patients requires more than great data. It requires early planning, seamless collaboration, and the courage to execute with precision from day one.

67 % Fail to meet launch expectations

70% Underperform post-launch

80% Future sales is determined by early action

This white paper outlines four critical pillars of launch success, shaped by lessons learned on the front lines of multiple product launches. We fully recognize that each launch is unique and that not all of these concepts will apply to every product; however, we hope the insights shared here will support stronger planning and execution.

Factor # 1: Time

Time is the single most valuable asset in any launch, serving as the foundation upon which all other success factors depend. The earlier you start, the more flexibility you have to anticipate challenges, align cross-functional teams, execute with precision, and ultimately reach targets. A long runway doesn’t always guarantee success, but a short one almost always forces compromise.

Do not delay pre-launch activities: Some tasks are simply too critical to delay—postponing them can put your entire launch at risk. Taking early action builds the foundation for alignment, preparedness, and a powerful market entry
Early stakeholder engagement: Early engagement of internal and external stakeholders helps uncover blind spots and ensures focus on what truly matters
The Pareto Principle: Focus the majority of your resources on the critical activities that will deliver the greatest impact and highest return for your launch. While this may sound intuitive, it is surprisingly easy for organizations to become distracted by secondary tasks and lose sight of what matters most.

How early is too early?

There is no such thing as starting too early when it comes to launch preparation. Strategic planning should begin the moment registrational clinical studies deliver positive results. The transition from clinical development to commercialization is a pivotal inflection point—companies that wait too long to plan often find themselves scrambling to catch up, leading to misalignment, missed opportunities, and costly delays.

While the current emphasis may be on pre-launch planning activities, it is equally important to maintain a clear view of the broader timeline extending through and beyond launch. This perspective underscores the critical value of early preparation, and demonstrates that initiating planning well in advance is essential to ensuring a successful outcome.

Factor # 2: Launch Team

The establishment of a formal product launch committee is a critical enabler of organizational alignment and execution excellence. By bringing together representatives from all core functions—medical, commercial, market access, regulatory, supply chain, and operations. the committee ensures that strategic priorities are consistently translated into coordinated actions.

Medical Affairs: Including MSL executives on the launch committee is essential, as their teams are the first in the field, shaping early HCP awareness and advocacy. Their scientific exchange not only educates but also generates insights that refine strategy, reveal data gaps, and support generation of real-world evidence. Bringing the voice of the field into the launch committee ensures launch plans are grounded in frontline realities, driving credibility and long-term success

Marketing: Marketing must work closely with global partners and all internal stakeholders—particularly Medical Affairs—to ensure that critical activities such as sales forecasting, competitive landscape analysis, sample programs, patient support initiatives, and messaging are firmly grounded in field insights. This collaboration not only strengthens the accuracy of forecasts and the relevance of messaging but also ensures that strategies reflect real-world clinical practice and patient needs.

Market Access: Market Access teams must take an active role in pre-launch planning. Early engagement with stakeholders—including KOLs, payers, and patient advocacy groups—can surface potential barriers to formulary access and reimbursement, such as unmet requirements for demonstrable economic or clinical value. Addressing these issues proactively ensures strategies are grounded in real-world expectations and allows organizations to anticipate and overcome obstacles.

Regulatory Affairs: Demonstrating the clinical value of a new therapy to health authorities requires cross-departmental input, with particular attention to ensuring that the proposed label is fully aligned with the registrational trial data. MSLs play a pivotal role in this process, providing critical KOL insights and supporting impactful presentations that strengthen the evidence package.

Supply Chain & Operations: Early discussions about product availability dates and quantities—including those allocated for sample programs—are essential to ensure timely delivery of medications and to prevent back orders. For this reason, Supply Chain and Operations colleagues must have a seat at the pre-launch table, contributing at diverse stages of planning and execution.

Compliance/legal: Every pre-launch strategy and tactic must be grounded in strict adherence to compliance and legal guidelines. Involving colleagues from Compliance and Legal teams early in the process helps ensure that activities are conducted responsibly and reduces the risk of costly missteps.

Factor # 3: Field Force

Beyond strategy and resources, the true differentiator is the team itself. A motivated, resilient, and purpose-driven field force can overcome unforeseen challenges. Passion, grit, and belief in the product often make the difference between success and failure. Continuous frontline feedback, especially about HCP and patient pain points is recognized as one of the most impactful contributors to a successful launch.

Establish clear expectations & KPIs: Measuring success is never an easy task but focusing heavily on reach and frequency will demotivate the teams and often lead to internal competition for HCP time. Hence, project-based assignments will empower your teams and give them a sense of purpose and accomplishment. Successful companies focus more on quality than quantity.
Crystal clear messaging: Your field force is the voice of your launch. If they can’t clearly communicate why your therapy matters—its differentiators and the unmet medical needs it addresses—you risk losing credibility. Invest heavily on consistent training and knowledge assessment.

Main Challenges

One of the most significant challenges in any product launch is determining the right field force allocation: should it be primarily MSL-led, sales-led, or a combination of both? There is no one-size-fits-all model—each launch is unique and requires a tailored approach. For example, products with complex mechanisms of action or challenging side-effect profiles require MSL engagement, whereas others may be better suited for a sales-driven strategy.

Typically, during the pre-launch phase, MSLs are the most active field representatives and focus on key activities such as HCP and center mapping-and engagements. Their early work supports generation of real-world evidence and fosters advocacy ahead of launch. Once the product is commercialized, sales teams play a critical role in enhancing the prescriber and patient experience.

Ultimately, these complementary roles—scientific engagement by MSLs and operational execution by sales—work together to ensure that products are used effectively and safely. The balance between them depends on multiple factors, including the product’s characteristics, its route and setting of administration, and the specific phase of the launch.

Factor # 4: KOL Connectivity

Strong, authentic relationships with KOLs are foundational. Ideally, these connections are established well before approval, usually by the MSL team. When your field team can build on existing trust, adoption accelerates. Conversely, launches often stumble when KOL engagement comes as an afterthought. Effectively identifying, engaging, and establishing credibility with the right KOLs can make the difference between success and failure.

MSL Scientific Exchanges: During the pre-launch phase, MSLs build trust with HCPs, assessing clinical value, identifying concerns or evidence gaps, engaging in scientific exchange, and generating actionable insights. Their early work supports real-world experience and fosters advocacy ahead of launch. Time and again, these MSL-HCP interactions have proven to be the key to a successful launch.

Consultative Meetings: Advisory boards and expert consultations are more than a box to tick—they’re a strategic advantage. The richest insights always come from physicians who have real-world experience, either through clinical trials or in markets where the drug is already approved. Their input shapes smarter strategy and avoids blind spots

Medical Education: Accredited and other educational activities give HCPs the opportunity to hear first-hand experiences with the drug and evaluate its role in therapy. These programs also help strengthen partnerships with national and international KOLs, fostering both scientific exchange and long-term success.

Clinical Trials: Whenever possible, create opportunities for HCPs to gain early experience with your therapy—whether through company-sponsored clinical trials, investigator-initiated research, or other programs. These initiatives not only generate valuable real-world insights but also enable the sharing of early experiences, helping to clarify the therapy’s place in clinical practice.

Preceptorships: A strong first experience is the single most powerful predictor of future product adoption.Preceptorships give HCPs the opportunity to learn directly from peers who are already familiar with the therapy and its place in treatment, greatly enhancing confidence and improving outcomes with their first patients

Administrative Support: Now more than ever, HCPs need support with reimbursement navigation and patient counseling. Robust logistics solutions and well-designed patient support programs not only ease these challenges but also foster stronger partnerships and a more positive overall experience.

Conclusion:

Successful drug launches are built on foresight, disciplined execution, and authentic relationships. While strategy and resources are essential, it is ultimately the commitment, resilience, and alignment of the people behind the launch that determine success. By prioritizing timing, assembling a focused launch team, developing a capable field force, and fostering strong KOL connectivity, organizations can greatly improve their chances of achieving launch excellence.

To learn more about launching smarter, book a meeting with one of our experts.