SPEAKERS:
- Denis Peeters, Global Head of Go-to-Market Capabilities (GTMC), Sanofi
- Andrey Shutov, Launch Scientific Communications Director and Medical Hub Lead, Novartis
- Susana Gómez-Lus Centelles, President, AMIFE (former Medical and Market Access Director, Iberia, Lundbeck)
- Moderator: Gaetano Pellitteri, VP Field Medical Affairs Europe, Syneos Health
KEY TAKEAWAYS:
- Alignment failures are measurement failures first; incompatible KPIs precede every cross-functional communication breakdown
- Sanofi replaced NPV with "time to peak patients", a metric that gives every function permission to negotiate in the same language
- US-first clinical design is economically rational and produces European launches that arrive sounding like relaunches
- EMA approval is a regulatory ceiling, not an access guarantee; country-level payer rejection is where launches actually fail
- Field insights that cross four geographies simultaneously can reverse an entire drug's positioning, if anyone is structured to catch them
The industry has spent a decade diagnosing its alignment problem. The diagnosis is correct. The treatments haven't worked.
At Pharma 2026, moderator Gaetano Pellitteri, VP Field Medical Affairs Europe at Syneos Health, opened by separating two categories of failure that organizations routinely conflate: "We have all seen fantastic drugs with fantastic science behind them failing when we are launching them... the issue is that the internal engines, medical and commercial, were probably not working through the same track." Leaders from Sanofi, Novartis, and AMIFE discussed why those engines keep diverging and what, structurally, would actually stop them.
The answer that emerged is uncomfortable. Pharma has been applying communication remedies to a design problem. Functions are built to diverge. Medical optimizes for caution, commercial for growth, regulatory for compliance, market access for reimbursement thresholds. No volume of collaboration workshops repairs this if each function is still evaluated against a different definition of what a successful launch looks like. The misalignment isn't interpersonal. It's architectural.
The Measurement Problem Inside the Alignment Problem
The most durable insight from the session had nothing to do with organizational structure charts or governance models. It was about the unit of measurement.
Denis Peeters described the specific intervention Sanofi made to address what he called the "single currency" gap: "What we decided to do at Sanofi is to define a single currency that everybody uses... It's not about dollar figures. It's about time to peak patients, to measure our impact on patients. How fast do we treat the maximum number of patients with our therapy, and every function across the value chain measures their decision across this." The elegance of the metric is that it converts an essentially commercial urgency into a language medical affairs can embrace without feeling co-opted. When R&D argues for a longer trial to secure a broader label, the question is no longer "what does that cost?" but "does it treat more patients faster?" That framing gives medical and commercial a shared mechanism rather than competing claims on the same decision.
Why do the functions diverge in the first place? Andrey Shutov located the root not in organizational politics but in professional formation: "Medical people are usually trained to play on the safe side. Commercial people are specifically trained not to under-tell the story. And this definitely brings some collision." Both instincts are rational responses to how each function is evaluated. The collision is structural, not accidental, and it persists regardless of how frequently teams meet or how earnest those meetings are.
The external consequences of unresolved internal misalignment are direct. "If this single currency is not well established internally," Shutov argued, "it definitely reflects in the external image of the product, of the brand and definitely can ruin the scientific credibility." Susana Gómez-Lus Centelles grounded this in regulatory outcomes: without medical, commercial, and regulatory teams aligned from the very beginning, even the best drug can fail to secure price and reimbursement. The cost of a currency gap is not theoretical but measurable in lost patient access.
The implication for any leadership team is a simple self-test. Ask your medical lead, your commercial lead, and your market access lead independently: what single metric defines launch success? If the answers differ, and in most organizations they will, the alignment program is managing perceptions.
Why US-First Is Rational and Costly at the Same Time
The US-first problem is not a failure of global ambition. It is a rational response to economic structure that produces predictable downstream damage, most visible when European launches arrive carrying evidence packages optimized for conversations that payers in Berlin, Madrid, or Rome never asked to have.
Peeters stated the structural reality without evasion: "When you have between 60 and 80% of the value that comes from a single market, you just can't have something that is not fit for purpose for the US. And that creates a lot of healthy tension internally because – and rightly so – other markets could ask: what about us?" The question isn't whether to design for the US. It's whether designing for the US exclusively has become too expensive a default to maintain.
Shutov described what that expense looks like in practice: "If your communication strategy is built around US launch and then you're trying to reshape and reshuffle the whole sequence of the evidence for the European key markets, sometimes it sounds like a second launch or relaunch which is not that powerful." The narrative authority that drives prescriber and payer confidence is spent in the first market. Europe inherits the derivative version, and payers recognize it as such.
Pellitteri condensed the mechanism to six words: "Science does not always guarantee access."
Gómez-Lus Centelles described how the gap opens at the country level. A company designs a clinical package, secures EMA approval, then goes country by country only to discover that payers see no unmet need. The fourth-in-class problem is real: payers ask why they should pay for a drug when they already have treatments for the disease. The answer requires listening to payer needs before designing the trial, not after receiving the rejection. Peeters named the underlying cause of the evidence mismatch: "Too often we come with our own perception of the world which does not necessarily resonate with payers and then we get sort of stuck with a science story that doesn't really talk to them because it doesn't address their problem." By the time European reimbursement negotiations begin, the data set is fixed.
He extended the diagnosis to the industry level: "I think collectively as an industry we all bear responsibility for creating this dragon of MFN because we've been collectively accepting to have prices that are probably a factor 1 to 15 or even 1 to 20 between the US and some countries." The pricing asymmetry that makes US-first rational is itself an industry artifact. MFN is the policy consequence of allowing it to compound.
Discover more on this topic at Pharma Commercial Data & Tech Europe 2026 (4-5 November, London) Europe’s collaborative home for data and tech pioneers. Visit the website here.
The Doctor's Office Is Where Alignment Becomes Visible
Pellitteri reframed the conversation with the question every field operations leader should be able to answer: when MSLs and reps are visiting the same doctors, are they delivering the same message, and are they taking the right insights back to the right stakeholders? The doctor's office is not just where alignment is tested. It is where misalignment accumulates undetected until a launch trajectory has already been set on the wrong path.
Gómez-Lus Centelles offered the session's most concrete illustration of what proper insight capture enables. Her team launched an antidepressant positioned around cognitive symptoms. One year in, prescribers had stopped using that frame: "People, doctors, were not talking about cognitive symptoms, they were talking about another kind of symptoms... And this changed all the strategy of the positioning of the drug." The signal appeared simultaneously in Spain, Colombia, Brazil, and the United States. It didn't emerge from formal market research. It came from field teams close enough to notice that the market had replaced the company's premise with its own, and from an organization structured to act on that observation rather than file it in a CRM free-text field.
Peeters described Sanofi's current operational approach: an AI-enabled system in which field teams dictate interaction summaries to an agent that pressure-tests for compliance, structures the data, and feeds pattern recognition across the field force, connecting what is happening in physician conversations to training programs, market research priorities, and objection handling. The speed at which field intelligence reaches strategic decision-makers is itself a competitive variable. Most organizations are still operating on a cycle that converts field observations into strategy adjustments over months. That lag is where launches lose momentum they never recover.
Shutov added a geographic dimension worth noting. Alignment failures tend to be governance failures rather than regional ones. Within a region, communication is generally functional. The breakdown happens at the interface between regional teams and global strategy, where insights that should feed upward into evidence generation plans instead stall in reporting structures that weren't designed to receive them.
Timing Is the Variable That Determines Whether Any of This Works
Pellitteri described the structural challenge in terms of a triangle: payers on one side, regulatory and patients at the other two. The challenge is identifying early where to concentrate energy to succeed on all three directions simultaneously. The triangle is always present. The question is which vertex gets attention first and how late the others are brought in.
Shutov identified the single variable that determines whether the triangle holds: "If you're able to align early between all the functions before you start communicating externally, it's a critical success factor just to avoid any gaps and credibility issues later on." Early alignment is not a process discipline. It is the condition under which every subsequent decision, evidence generation, label strategy, payer messaging, field deployment, remains recoverable rather than path-dependent.
Peeters extended this to clinical design itself: "100% of our clinical trials. That's the target. We're not there yet. 100% of every trial is validated by a patient board. And we make sure that we're measuring what matters to them, not to us." The patient voice, brought in early enough, changes what gets measured. That changes what the data set can answer. That changes what conversations are available with payers at the country level years later. The causal chain runs from trial design to reimbursement outcome, and the leverage point is at the beginning.
Gómez-Lus Centelles distilled the organizational prescription: "I will go for a real cross functional way of working and I will throw away the silos, the functional way of working." Peeters added the discipline required to make it stick — define the North Star metric and cascade it with enough rigor that functions can resolve trade-offs without escalation.
The panel identified something most alignment programs don't address directly: functions are not just misaligned on priorities, they are misaligned on what success looks like after the launch is declared complete. Medical defines success by label quality. Commercial defines it by revenue ramp. Market access defines it by reimbursement breadth. Each definition is internally coherent and collectively incoherent. "Time to peak patients" works not because it is elegant but because it makes those three definitions temporarily commensurable. When the question becomes how fast do we treat the maximum number of patients, label quality, revenue ramp, and reimbursement breadth all become instrumental to the same answer. Trade-offs that previously required escalation can be resolved at the function level.
Ask your three leads for one metric. If the room produces three different answers, the next launch is already carrying structural risk, and the collaboration workshops scheduled to address it are treating a consequence rather than the cause.
To get you highlights of Pharma 2026 faster, we are using generative AI technology to summarise the transcripts of the sessions. If you have any feedback about the summary, please contact lucy.fisher@thomsonreuters.com.
Discover more on this topic at Pharma Commercial Data & Tech Europe 2026 (4-5 November, London) Europe’s collaborative home for data and tech pioneers. Visit the website here.
