Life Science R&D: an expensive race to market

In February of 2025, Iovance Biotherapeutics' stock plunged 32% – not because its newly approved melanoma treatment didn't work, but because investors were concerned about its cash burn and financial runway. With $397 million left and quarterly expenses of nearly $280 million, the company was under pressure to execute efficiently.

While high burn rates are not uncommon for late-stage biotech companies launching their first commercial product, Iovance’s financial position raised questions about whether it had enough runway to reach its next milestone.

This story is painfully familiar in biotech. We celebrate scientific breakthroughs but overlook a crucial truth: companies rarely fail because their science is marginally worse than their competitors'. They fail because they can't execute. The industry's graveyards are filled with companies that had promising drug candidates but ran out of runway. And although the pattern is clear, the lesson goes unlearned.

Biotech companies continue to treat operations, program management, and regulatory strategy as support functions – necessary bureaucracy rather than core capabilities. They assume that if their science is strong enough, everything else will fall into place: investors will fund it, regulators will approve it, and the market will embrace it.

Breaking this cycle requires a fundamental shift in how companies view and value operations. This guide is designed to help program managers and other operations leaders make this happen.

Emphasizing efficiency and operational roles alongside cutting-edge science

Biotech startups fail for a variety of operational reasons:

• They set their sights on scientifically exciting but commercially impractical targets.
• They burn through cash too quickly, assuming future fundraising will be straightforward.
• They underestimate the complexity of future challenges such as patient enrollment in clinical trials.
• They become entranced by platform technology without developing a clear asset strategy, leading to years of expensive exploration with no path to market.

The biotech ecosystem amplifies this problem by rewarding grand visions over operational excellence. But vision alone doesn't get drugs to patients. Investors increasingly need to believe not just in the science, but in a company's ability to execute with precision.

Defining milestones, mapping paths to market, and data-driven PM

Successful drug development programs institute operational rigor from day one:

• Clearly defining and communicating key milestones with precise requirements, metrics and stage gates.
• Planning for both the expected time and budget of each program and the potential risks that could derail them.
• Obsessively tracking operational metrics that makes sense in a high-risk, fast changing environment.
• Carefully tracking both the data that drives each milestone and the context behind it.
• Building detailed plans that map out different possible scenarios so they can pivot quickly when needed, while keeping development on track.
• Building long-term partnerships with manufacturers and vendors who can grow with them.

This kind of operational rigor, when implemented thoughtfully, becomes a competitive advantage in an industry where it’s the exception.

Project and program management as intentional drivers of biotech R&D success

Every biotech company races against time. Sometimes the science just doesn’t work out. But it’s a special kind of heartbreak when promising treatments die from preventable causes – a bank account run dry, a trial poorly planned, a manufacturing delay that comes too late to fix

This guide to data-driven biotech explores what program managers can do to instill operational rigor in their organizations and maximize their programs’ chances of success.

And it all starts with understanding How Drug Programs Go off the Rails.