Avoiding Drug Development’s Death Valley

The months after launch are when promising brands either accelerate or fade into clinical irrelevance. Here's why follow-up data matters more than you think.

I've watched too many promising pharmaceutical launches follow the same predictable trajectory: strong Phase III results, enthusiastic launch campaigns, solid initial uptake—and then a slow fade into background noise as physicians move on to newer options.

The problem isn't the quality of the science or even the commercial execution. It's what I call the data “Death Valley”: that critical period between your launch package and your next meaningful clinical insight, when your brand has nothing new to say while the market continues evolving around you.

Why Follow-Up Data Has Become Make-or-Break

The pharmaceutical landscape has fundamentally changed in ways that make post-launch evidence generation more critical than ever. Your competitors aren't waiting years to generate their next data point—they're running parallel studies, exploring combinations, and expanding into adjacent indications while you're still celebrating your launch.

The physician attention span has also shortened considerably. With treatment landscapes evolving rapidly, doctors form opinions quickly and move on. That initial enthusiasm for your launch data has a shelf life of maybe 12-18 months before it becomes just another option in their mental toolkit.

Market access pressures have intensified too. Payers increasingly want real-world evidence, combination data, and broader population studies before they'll maintain premium pricing or favorable coverage.

The Jardiance Model: Speed to Cardiovascular Evidence

Boehringer Ingelheim's approach with Jardiance (empagliflozin) provides the textbook example of how to accelerate through Death Valley. While competitors were still focused on glucose control, Jardiance rapidly generated cardiovascular outcomes data that transformed the entire diabetes treatment landscape.

The EMPA-REG OUTCOME trial results, presented in September 2015, caught the medical community completely by surprise. While there had been speculation that SGLT2 therapy had some cardiovascular benefit, they went beyond showing cardiovascular safety in their diabetes population, but proved dramatic reductions in cardiovascular death—a 38% reduction that exceeded even the most optimistic predictions.

The timing advantage was enormous. While Jardiance was generating headlines about cardiovascular protection in 2015, its main competitor Farxiga (dapagliflozin) didn't deliver comparable cardiovascular outcomes data until the DECLARE-TIMI 58 trial reported in late 2018—more than three years later. During those crucial years, Jardiance dominated cardiovascular conversations and built relationships with cardiologists who were suddenly interested in prescribing diabetes medications.

This speed-to-evidence strategy paid off: Jardiance maintains a substantial 31.2% market share in the SGLT2 inhibitor market, largely stemming from its proven clinical benefits and strategic positioning that emphasizes cardiovascular protection. The brand could have been a me-too, but instead it shaped the entire category's value proposition around cardiovascular benefits.

The Darzalex Approach: Continuous Evidence Generation

Johnson & Johnson's approach with Darzalex provides another excellent example of navigating this challenge successfully. Rather than resting on their multiple myeloma approvals, they executed what I'd call a "data drumbeat" strategy.

The key was their systematic approach to follow-up studies. By 2020, they had compelling data on adding daratumumab to standard treatments. By 2023, the PERSEUS trial provided confirmatory evidence for newly diagnosed patients. By 2024, AQUILA showed promise in high-risk smoldering disease.

Each study gave their commercial team fresh reasons to re-engage physicians, new conversation starters, and expanding patient populations. As one Stanford hematologist put it after the latest data: "For people who were waiting, this changes their practice."

What made their approach work was the strategic sequencing. Instead of conducting one study at a time, they ran parallel pathways across different patient populations. They studied combinations with various backbone therapies, creating multiple shots at practice-changing insights. And they moved upstream in the treatment paradigm quickly, rather than just exploring later-line opportunities.

When Brands Get Stuck

I've seen the opposite scenario too many times: brands that generate strong launch data and then go quiet for years while they pursue their "next big study." Even worse are the brands who hope that their longitudinal data will be enough to keep customers engaged. Meanwhile, competitive dynamics shift, physician preferences evolve, and market access becomes more challenging.

The pattern is predictable. Initial enthusiasm gives way to clinical inertia. If your initial data wasn’t enough to completely overturn the status quo, physicians fall back on their existing treatment habits and your brand fades in importance. Over time, those patterns become entrenched, and by the time you have new data to share, they’ve already niched your drug.

What's particularly frustrating is hearing from KOLs that they believe a brand is innovative and has untapped potential, but it loses momentum regardless because it couldn't maintain clinical relevance during the crucial post-launch period.

Building Your Follow-Up Strategy

If you're facing this challenge, there are practical steps you can take:

Start evidence planning during development, not after launch. Every study should generate insights your commercial team can immediately deploy. Don’t design a study, especially a follow-on study, without analyzing what’s going to drive customer behavior change in light of the future environment. If a data generation plan is too conservative, it might not do anything to gain attention or influence clinical practice.

Embrace adaptive approaches. Advanced analytics (and, increasingly, AI tools) can accelerate insight generation, with estimates suggesting 15-30% improvements in operating performance over five years. The brands succeeding today leverage these tools to compress traditional development timelines.

Think like a marketer. Design your clinical program to deliver a steady stream of practice-relevant insights over time, just like you'd plan touchpoint sequences.

Consider combinations early. Darzalex's success came partly from studying their drug with various backbone therapies, multiplying opportunities for meaningful data while expanding the addressable market. When I interview physicians, their biggest desire is often to get better data on whether and how to combine or sequence drugs.

The Bottom Line

Your launch data got you to market, but it's your follow-up data strategy that determines whether you thrive or fade away. In a landscape where physician attention spans are short and competitive pressures are intense, the brands that maintain clinical momentum are the ones that survive and prosper.

The companies getting this right aren't just avoiding clinical irrelevance—they're building sustainable competitive advantages that persist long after their initial launch excitement fades.