Failed biotech partnerships: defining and proving milestones

What causes biopharma partnerships to fail? Can these failures be mitigated? One such example: a failure to clearly align on technical milestones and the data needed to prove them. Read on to find out more and, if anything here resonates, please reach out!

In biotech, we’re fixated on risk. We dissect our science, pressure-test our manufacturing, and meticulously validate our clinical trials. But there’s one overlooked risk that can derail even the most promising partnerships: the inability to prove we’ve done what we said we would.

Just last week, we touched on this on LinkedIn, pointing to the flurry of new partnerships that were recently announced – Roche and Flare Therapeutics, GSK and Vesalius Therapeutics, Novartis and Schrödinger. These partnerships are indicators of an ecosystem that’s thriving (a great signal for all of biotech!). But they also raise an important question: how do we keep these deals alive after the ink dries? 

The issue hit home during a recent dinner we had with a BD executive from a top-five pharma company. What started as a discussion about development KPIs turned into an interesting conversation about why bio partnerships fail. His take was candid: the science might be solid, the strategy sound, but deals crumble when success metrics aren't clearly defined upfront, or when companies can't definitively prove they've hit those marks. And, as always with proof, it’s primarily a documentation issue. 

The conversation was reminiscent of an interesting parallel: the FDA Good Manufacturing Practices (GMP). Back in the late 20th century, as drug manufacturing scaled up, the FDA faced a new challenge - not in production itself, but in proving every step had been followed precisely and consistently. The stakes were high: a single error could lead to ineffective or harmful products. GMP guidelines emerged as the gold standard for documentation, creating an ‘audit trail’ to verify each step in the process. Today, for any batch of medicine, there’s a documented history that traces back to specific conditions, quality checks, and safety tests.

This shift didn’t just improve safety; it turned documentation into an integral part of trust in healthcare. GMP compliance is now a blueprint for reliability and verification. Biotech partnerships face a similar challenge: in the rush toward milestones, companies often overlook the value of daily documentation – evidence that could be the difference between a partnership that goes the distance and one that falls apart.

Take Alexion’s acquisition of Syntimmune. This deal hinged on meeting specific development milestones, the first being the completion of a Phase I Clinical Trial. On paper, it seemed straightforward, yet it quickly spiraled into a legal battle. The court not only found that Alexion, preoccupied with post-merger demands, hadn’t met its 'commercially reasonable efforts' obligation, but that the parties fundamentally disagreed on what data was required to prove the trial’s PK/PD profile requirements had been met. Millions and millions of dollars, years of research, and a promising therapeutic were all on the line — because they couldn’t definitively prove that their work met contract standards, right down to the specific data needed to validate key technical criteria.

Or look at J&J and Auris Health. When J&J acquired Auris Health, a disputed milestone centered on regulatory achievements for Auris’s iPlatform device. J&J prioritized their Verb project over iPlatform, delaying its progress. The court ruled that J&J’s choices actively breached milestone commitments, with documentation - or the lack of it - at the core. There are likely countless more examples of companies that settled their dispute in private. 

All this to say, saying “trust me, I did it” isn’t enough; you need tight alignment on each milestone, and proof that each step was done as promised. Many companies respond with increasingly complex legal definitions - 'commercially reasonable efforts', 'best efforts' - but no language can substitute for a consistent, verifiable record of actions.

Imagine a typical biotech’s weekly data reviews. Critical decisions on resource allocation, shifting priorities, and development strategies are often buried in PowerPoint slides and email threads. When disputes arise months or even years later, reconstructing these decisions becomes nearly impossible. The evidence exists, but it’s fragmented across emails, presentations, and memories of team members who may no longer be with the company.

A proactive documentation approach could be transformative. At Kaleidoscope, we’ve made it simple for teams to set up KPI, data, and decision trackers that capture information automatically. This setup not only eases the load on BD teams but also provides a clear record of progress that’s accessible to both partners. Legal teams see this as risk mitigation. Alliance management views it as partnership insurance. BD departments recognize it as deal protection. Systematic documentation isn’t bureaucratic overhead – it’s strategic infrastructure.

Every partnership should be built to last, not just through the excitement of early wins but through the inevitable turbulence of long-term growth. And that longevity comes down to one thing: a documented track record that keeps everyone accountable. Because, at the end of the day, the most valuable tenet of partnerships is the trust that you did exactly what you both agreed needed to be done –  and, as the saying goes, "if it’s not written down, it didn’t happen!"

If you want to chat more about anything we wrote, or you’re interested in finding a way to work together, let us know!