Why Medical Affairs, Clinical, Regulatory, and Commercial still can't align and what infrastructure actually solves it.
Pharmaceutical leaders universally recognize that Medical Affairs, Clinical, Regulatory, and Commercial need to align early in drug development. Yet this "simple" coordination consistently fails across the industry. The problem isn't awareness or culture. It's the absence of systems that make collaboration the path of least resistance.
The pharmaceutical industry rightfully focuses enormous attention on the latest advances in AI, breakthrough scientific research, and cutting-edge therapeutic modalities. These innovations deserve the spotlight. But while we apply rigorous scientific methods to drug discovery and sophisticated technology to clinical trial management, we often overlook a time-tested imperative that can make or break a development program: cross-functional collaboration.
We need to apply the same level of rigor to how we coordinate across Medical Affairs, Clinical Development, Regulatory Affairs, and Commercial teams as we do to our science and technology. Because no amount of AI sophistication or scientific brilliance compensates when a drug gets approved but can't launch for two years because the reimbursement strategy wasn't built during development.
There's a moment I've experienced repeatedly in conversations with pharmaceutical leaders: a knowing nod when you mention cross-functional collaboration. Everyone agrees it's essential. Everyone can describe what it should look like. Many have even experienced it working well at a previous company.
Yet when our Life Sciences Strategic Advisory Board convenes, bringing together leaders like Dr. Jethro Ekuta (Chief Regulatory & Safety Officer at Ascendis Pharma, with 30+ years across FDA and major pharmaceutical companies including AstraZeneca, Johnson & Johnson, Sanofi, Bristol Myers Squibb, and Pfizer) and Dr. Rob Kaper (a Medical Affairs leader at various pharmaceutical companies, most recently as Head of Global Medical Affairs at Otsuka Pharmaceuticals), they independently describe the same challenge. The infrastructure for doing what everyone knows should be done simply doesn't exist.
We created our Life Sciences Strategic Advisory Board to understand not just what pharma does, but what it struggles to do despite knowing better. Members provide strategic input across our product and customer engagement initiatives, helping us tailor our workflow automation solutions to evolving industry needs. More importantly, they help us see the patterns. These are the recurring gaps that persist across companies regardless of talent or leadership commitment.
The solution isn't just another working session on teamwork or a cultural initiative. It's building infrastructure that makes early, cross-functional alignment inevitable rather than aspirational.
Medical affairs once sat too close to marketing, creating compliance risks the industry couldn't ignore. As Dr. Kaper recalls, "When I joined Medical Affairs, I was hired by somebody in marketing. Nowadays, we frown upon that very much." Following massive off-label promotion violations resulting in billion-dollar settlements, Corporate Integrity Agreements were created to establish strict functional separation.
This separation was necessary. But the industry overcorrected. Functions stopped talking entirely, developing separate systems, vocabulary, and planning cycles. What began as compliance guardrails became barriers to strategic coordination.
Today, everyone recognizes the overcorrection. Yet consistent cross-functional alignment still doesn't happen. Why? Because the systems pharma runs on were literally designed to keep functions apart. And those systems remain in place.
Here's what actually happens when pharmaceutical teams attempt coordination.
A critical decision needs to be made: protocol design, evidence planning, or label strategy. Well-meaning professionals go function by function. Regulatory provides approval requirements. Clinical Development adds trial design constraints. Supply Chain flags manufacturing considerations. Commercial surfaces positioning needs. Market Access identifies reimbursement evidence requirements.
Each function provides input in isolation. Requirements conflict, but no one discovers this until later.
As Dr. Ekuta observes, "When those different groups finally come together, you'll find that there are new issues you now have to deal with." These are issues that could have been resolved if everyone had been at the table from the start.
The predictable consequences:
This isn't a failure of individual professionals. It's a predictable outcome when infrastructure doesn't support real-time, multi-stakeholder coordination.
Dr. Kaper articulates the solution simply: "Just sit together and talk to each other. Don't present it as a fact when it's too late. Do it together." Then he adds the critical observation: "And it sounds very straightforward and simple. It's still not happening to the full extent."
Why the simple solution consistently fails:
Consider the real cost. Clinical development focuses solely on regulatory approval, missing outcomes data needed for reimbursement. The drug gets approved on schedule but can't launch because payers won't reimburse. Two additional years are spent on post-approval studies that should have been embedded in Phase 3. Patients wait. Revenue is delayed.
All because a conversation didn't happen during Phase 2 protocol design.
As a technology CEO serving pharmaceutical companies, I've learned that pharma is incredibly sophisticated at managing complex chemistry and clinical trial logistics. But organizations often run cross-functional collaboration on Post-It notes and email. The infrastructure doesn't match the coordination challenge.
Not everyone needs to be in every meeting, but everyone needs to see the same information. When Dr. Ekuta describes "a central dashboard where all stakeholders can access information in real time," he's articulating the prerequisite for effective collaboration.
Imagine a Target Product Profile that lives in one place accessible to all stakeholders. When it's updated based on Phase 2 learnings, Regulatory flags in real-time: "This efficacy claim will require additional Phase 3 endpoints." Market Access notes: "European reimbursement needs quality-of-life outcomes." Medical Affairs adds: "KOLs are asking about duration of response that current design won't answer."
These conversations happen asynchronously, in context, before protocol finalization.
Instead of ad hoc conversations, require stakeholder input at specific gates:
This prevents scenarios where Clinical designs Phase 3 trials lacking reimbursement data, or Regulatory arrives at label negotiations without supporting evidence for desired claims.
Cross-functional alignment fails when critical requirements exist only in meeting notes, email threads, and individual memories. Evidence gaps, reimbursement requirements, regulatory label strategies, and Medical Affairs insights must be systematically documented where they can inform planning, not discovered during submission preparation.
Consider the typical scenario: Medical Affairs has captured valuable insights from KOL interactions and MSL field intelligence. Regulatory Affairs has developed a clear label strategy. Market Access has identified the specific evidence payers will require. But these requirements live in separate functional documents or, worse, in individual inboxes. Clinical Development designs Phase 3 protocols without visibility into what evidence the label negotiation will need or what outcomes data payers require.
Effective infrastructure creates:
When requirements are documented centrally, misalignment becomes visible before it becomes expensive. The conversation shifts from "we wish we'd known that" to "here's what we need to address."
Collaboration cannot depend on individual initiative or cultural aspiration. Someone must own cross-functional coordination at each development phase, with explicit accountability for ensuring stakeholder input happens.
As Dr. Ekuta notes, the manual coordination work (tracking down documents, reformatting data, synthesizing insights) remains "invisible in formal tracking systems" despite being critical to project success. When no one is specifically responsible for ensuring cross-functional input, it doesn't reliably occur.
Effective infrastructure requires:
Process gates that require documented input from all relevant functions aren't bureaucracy. They're strategic guardrails. Protocols can't advance without Medical Affairs evidence review. Regulatory submissions require documented Market Access strategies. Phase 3 can't initiate without an updated TPP signed off by all functions.
The ultimate measure of collaboration infrastructure is whether it prevents expensive late-stage rework. Protocol revisions due to late stakeholder input, evidence gaps discovered during submission preparation, post-approval Phase 4 studies addressing reimbursement needs that should have been captured in Phase 3: these are symptoms of infrastructure failure.
Two-year reimbursement delays aren't an anomaly. It's the predictable outcome when cross-functional alignment happens too late. Every protocol amendment has a cost: not just the direct expense, but timeline delays, opportunity costs, and patients waiting longer for treatments.
Infrastructure that works creates measurable outcomes:
When you track amendment reasons, calculate rework costs, and measure how often late discoveries delay timelines, you transform collaboration from an abstract cultural value into an operational metric you can manage and improve.
This is what workflow automation platforms like our Approvia solution enable. Rather than replacing strategic thinking, these systems ensure it happens at the right time. They create a single source of truth where Target Product Profiles, evidence plans, and stakeholder requirements live together. They build workflows that make collaboration structurally inevitable rather than dependent on individual initiative.
When proper infrastructure exists, several shifts occur:
As Dr. Kaper notes, "These discussions should happen early (Phase 2, Phase 3, and ongoing). But you need systems that make them happen reliably."
The knowing-doing gap persists not because of ignorance or insufficient commitment. It persists because the infrastructure to enable consistent cross-functional collaboration doesn't exist in most pharmaceutical organizations. Cultural change without infrastructure change is just wishful thinking.
The stakes are real: patients waiting two-plus years for treatments while companies develop reimbursement strategies that should have been built during development. Rare disease patient advocacy groups eager to inform protocol design while companies lack systems to capture their insights systematically. Billion-dollar R&D investments undermined by million-dollar infrastructure gaps.
The pharmaceutical industry has proven it can coordinate incredibly complex challenges: Phase 3 trials across hundreds of sites, biologics supply chains, regulatory submissions across global agencies.
Cross-functional collaboration in drug development should be solvable. But it requires acknowledging that the knowing-doing gap won't close through exhortation. It closes through infrastructure that makes early alignment the path of least resistance.
The industry will continue advancing AI capabilities, pursuing breakthrough science, and developing innovative therapies. Those efforts deserve continued investment and attention. But they deserve to be matched with equal rigor applied to the fundamental challenge of cross-functional coordination. The science is too important, and patients are waiting too long, for collaboration to remain the thing everyone agrees should happen but somehow never does.
The assessment takes 10 minutes and provides specific guidance based on your collaboration maturity profile.