Cross-Pillar

The Standardization Gap: 1967 to 2026 and Still No Playbook

By MSL Blueprint · 12 min read · May 2026

In 1967, the Upjohn Company created a new role. They called it the Medical Science Liaison.

The original liaisons weren't what we'd recognize as MSLs today. They were promoted sales representatives with strong physician relationships and institutional access — not scientifically credentialed, not engaging as peers. But the core idea held: place someone at the boundary between the company and the academic medical community whose job is scientific exchange rather than product promotion.

The role spread. Over the next two decades, other companies created their own versions — sometimes called MSLs, sometimes regional medical scientists, sometimes clinical liaisons. They typically reported through commercial organizations and operated without a shared definition, common competency expectations, or any industry body to coordinate. Every company figured it out on its own.

Then, in 1989, Bristol-Myers Squibb fielded the first MSL team requiring advanced scientific degrees — PharmD, MD, PhD. This is the model that defines the modern MSL function. Everything before it was a precursor. Yet even after BMS established the modern archetype, commercial reporting structures persisted at many companies well into the late 1990s and early 2000s. The function as we know it is younger than it appears.

That modern function is now nearly 40 years old. In the time since, the pharmaceutical industry has standardized clinical trial design, harmonized global regulatory submissions, codified commercial compliance, and built multi-billion-dollar technology platforms for every function from sales operations to pharmacovigilance. The MSL function — which now exists at virtually every major biopharma company, employing thousands of advanced-degree professionals worldwide — still doesn't have a strategic playbook.

Not a compliance framework. It has one. Not an activity taxonomy. It has one of those too. What it doesn't have — what nobody has built — is the strategic architecture layer: the frameworks that tell field medical leadership how to plan, deploy, and measure what their teams achieve. How many MSLs do you need? Where should you put them? What should they be working toward? How do you know if it's working?

Every MSL leader answers these questions. Every one of them answers them alone.

Six Inflection Points

The history of MSL standardization isn't a blank page. It's a story of incremental formalization — each step valuable, each step incomplete. The gaps between the dates tell the story as clearly as the dates themselves.

1967: The Role

Upjohn creates the Medical Science Liaison. The original purpose is peer-to-peer scientific exchange with academic physicians — a function that sits explicitly outside the commercial structure. Other companies adopt the concept over the following decades, but there is no shared definition of what the role entails, no common competency expectations, and no industry body to coordinate.

The key insight is that Upjohn's original liaisons were promoted sales representatives — not the scientifically credentialed professionals the title describes today. Even as the role spread, it remained embedded in commercial organizations. These were nominally "non-promotional" positions that still reported through sales and marketing leadership, often with commercial KPIs like reach, frequency, and touchpoint volume. For its first two decades, the MSL is a role, not a function. Every company invents its own version from scratch.

1989: The Modern MSL

Bristol-Myers Squibb fields the first MSL team requiring advanced scientific degrees — PharmD, MD, PhD. This is the model that defines the modern MSL function. Everything before it was a precursor.

The distinction matters. Before 1989, "MSL" described a commercial employee with physician access. After 1989, it begins to describe a scientifically credentialed professional hired for scientific expertise. The BMS model is the one that scales across the industry over the next decade — and the one that every subsequent standardization effort addresses. Yet even after BMS established the archetype, commercial reporting structures persisted at many companies well into the late 1990s and early 2000s. The organizational separation — MSLs reporting through medical affairs rather than commercial — came later, driven by the compliance framework that arrives in 2002.

2002–2003: The Firewall: PhRMA Code & OIG Compliance

The regulatory architecture that defines what MSLs can and cannot do arrives in rapid succession. The PhRMA Code on Interactions with Healthcare Professionals is published in 2002. The Office of Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers follows in 2003, establishing the medical/commercial firewall that structurally separates field medical from commercial operations. Enforcement actions in the same era — including a $430 million settlement involving a medical liaison as a whistleblower — reinforce that these boundaries have teeth.

This is the moment the MSL function gets its legal identity. The firewall creates a protected space for scientific exchange, separated from promotional activity by regulatory force. It tells MSLs what they are not: they are not sales. It tells organizations what MSLs cannot do: they cannot promote.

What happened next is where the structural gap originates. The firewall required companies to separate field medical from commercial — but it didn't tell them what to build in its place. MSL teams were pulled out of sales organizations and dropped into a newly created "Medical Affairs" that was typically a sub-function of clinical development. These departments were often led by medical director MDs whose experience was in clinical trials and publication support, not in managing a geographically dispersed field force. The MSL leader — often a former MSL or first-line manager — was left to negotiate the function's purpose with legal and regulatory leadership, negotiate the plan of action with VP-level commercial stakeholders who still expected "buy-in," and advocate for independence and budget from clinical development leadership who would often rather fund another clinical trial.

The result, at most companies, was a function defined almost entirely by what it couldn't do. After the prohibited activities were stripped away, whatever remained became the MSL role — and the metrics that tracked it were inherited from commercial: reach, frequency, touchpoints, territory coverage. Worst case, the function became purely reactive field medical information — MSLs waiting by the phone. The separation from commercial gave the function its own organizational legs, but it largely skipped the step of defining the function's strategic purpose. A few MSL programs found the sweet spot. Many didn't.

What the firewall doesn't do is tell leaders what MSLs should do. It creates the room. It doesn't furnish it. For the next fifteen years, every MSL team will operate inside these legal boundaries with no industry-level guidance on how to plan, deploy, or measure the function they're now required to keep separate from commercial.

2018: The Guidelines

The MSL Society publishes the first-ever non-regulatory industry guidelines for MSL activities — over 50 years after the role was created and almost 30 years after establishing the modern MSL function. Developed over 24 months with input from more than 1,500 MSLs and leaders across the global industry, the guidelines represent the first systematic attempt to define what MSLs do at an industry level.

The timeline is itself the story. For half a century, the MSL function operated without agreed-upon activity definitions. Every company, every leader, every MSL was working from locally developed expectations.

The guidelines are an important milestone. They codify what MSLs actually do — KOL relationship management, scientific exchange, congress support, insight gathering, medical information response, adverse event reporting. A 2019 implementation survey of 275 MSLs across 29 countries confirmed the reality: 98% report KOL relationship management as their primary activity. The guidelines accurately captured what was already happening in the field.

But they're an activity taxonomy, not a strategic framework. They tell you what an MSL does during a KOL interaction. They don't tell a leader how many MSLs they need, where to place them, what objectives to set, or how to measure whether the function is creating strategic value. Twenty-three pages of activity guidance. Two paragraphs on planning.

2021: The Position Statement

Four professional societies — the Alliance for Patient Access, the International Federation of Associations of Pharmaceutical Physicians, the Medical Affairs Professional Society, and the MSL Society — publish a joint best practices position statement. For the first time, standards are codified across organizations, not just within a single professional body.

That four organizations needed a joint statement to align on MSL best practices in 2021 — 54 years after the role was created and 32 years after the modern MSL function was established — underscores how fragmented the function has been. The position statement is progress. It creates cross-organizational consensus on what good MSL practice looks like.

But again, it standardizes on practice, not planning. It answers the question "what does excellent MSL execution look like?" It does not answer the question "how do you build a strategically excellent field medical organization?"

2026: The Missing Layer

This is where MSL Blueprint enters the timeline. Not as a criticism of what came before — every milestone on this timeline represents real, important work by organizations and professionals who care about the function. MSL Blueprint occupies a different layer entirely.

The analogy is straightforward. The professional societies — the MSL Society, MAPS, the MSL Institute, the DIA Medical Affairs and Scientific Communications Forum, and others — tell MSLs what they do and how to do it well. MSL Blueprint tells leaders how to plan, deploy, and measure what field medical teams achieve. Bottom-up versus top-down. Practitioner-facing versus leadership-facing. Both are needed. Until now, only one existed.

The Four Layers

Stand back from the timeline and a structural pattern becomes visible. The MSL function has been formalized in three layers. A fourth has never been built.

Layer 1: Compliance. What MSLs can't do. Established by OIG guidance, reinforced by corporate SOPs, enforced by legal departments. This layer is well-defined and legally binding. Every MSL organization has it because the law requires it.

Layer 2: Activities. What MSLs do. Standardized by professional society guidelines and refined by cross-organizational best practices. KOL engagement, scientific exchange, congress support, insight gathering, medical information, adverse event reporting. This layer is well-developed and broadly adopted — though it's worth noting that for many organizations, the activity list was originally defined less by strategic intent than by what remained after compliance carved out the prohibited activities. The guidelines formalized what the function had organically become, which is valuable, but the starting point was "what's left" rather than "what should this function accomplish."

Layer 3: Competencies. What MSLs need to know and do well. Defined by professional society competency surveys, elaborated by individual company training programs. Scientific knowledge, communication skills, relationship management, business acumen. This layer is actively maintained and continuously updated.

Layer 4: Strategic Architecture. How leaders plan, deploy, and measure. This layer answers: How many MSLs do we need? Where do we put them? What should they be working toward? How do we know if it's working? How do we connect field medical activity to medical affairs strategy? How do we build a career architecture that retains top talent and develops organizational maturity?

This layer is empty.

The pattern is revealing. Layers 1 through 3 are all practitioner-facing. They tell the individual MSL what to do, what not to do, and what to be good at. Layer 4 is leadership-facing. It tells the people who run field medical teams how to think about the function strategically. The industry built the practitioner layers first. The leadership layer was left to individual leaders to figure out on their own — and many of them did, building impressive programs through experience, judgment, and sheer effort. But their solutions were universally ad hoc, with enormous variance from company to company and leader to leader. When those leaders moved on, their strategic architecture often left with them. No shared framework was ever built.

Why the Gap Persists

If this gap is so structural, why hasn't anyone filled it? The question is fair. Four forces explain the persistence.

First, the function grew organically. MSL teams started small — three to five people covering a product launch. The leader was usually a former MSL or medical director who figured it out as they went. Planning was informal because the scale didn't demand formality. But field medical teams are now twenty, thirty, fifty people. Some organizations have over a hundred MSLs across multiple therapeutic areas. The informal approach that worked for a five-person launch team does not scale to a cross-therapeutic-area field medical organization. Yet the frameworks never evolved with the headcount.

Second, the industry's attention went to compliance first. After OIG, the primary organizational concern was making sure MSLs didn't cross the medical/commercial firewall. Risk management consumed the oxygen that strategic planning might have used. Compliance is necessary. But it became the ceiling rather than the floor.

Third, there was no natural owner for this work. The professional societies — the MSL Society, MSL Institute, MAPS, and others — are practitioner-focused, as they should be. CRM vendors optimize for their platforms. Consulting firms sell bespoke engagements, not shared frameworks. Nobody's business model was "build the strategic infrastructure for field medical leadership."

Fourth, and perhaps most fundamentally, the data gap. Strategic planning requires frameworks, but it also requires benchmarks. What does mature look like? How do you compare? Commercial benchmarking reports have existed — annual surveys from firms like PharmaForce have been available for years at significant cost, and many MSL leaders used them. But those reports focused on structural and activity metrics: team size, reporting structure, titles, activity types, and call frequency. They told you how many MSLs your competitors had and what activities they tracked. They didn't tell you whether those teams were strategically mature, whether their planning was effective, or whether their outcomes justified their investment. Every MSL leader who wanted to benchmark their organization's strategic effectiveness had exactly one data set to work from: wherever they worked last.

What Comes Next

You need Layers 1 through 3 to run a field medical team. You need Layer 4 to run a strategically mature field medical function. MSL Blueprint's framework gives Layer 4 three concrete pillars — Organizational Maturity, Planning Optimization, and Outcomes & Metrics — each explored in depth on the framework page and in the pieces linked below.

The Standardization Timeline shows an industry that has been formalizing a function for six decades — and accelerating. It took 51 years to get the first activity guidelines. Only three more years for a cross-organizational best practices statement. The strategic planning layer is the next step. Start with the framework, or take the assessment and find where your organization stands.

[Explore the Framework →](/framework)

[Take the Maturity Assessment →](/assess)

The author is the founder of MSL Blueprint and has spent the last 20 years building, leading, and scaling field medical teams at several biopharmaceutical companies — from team design and territory optimization through scientific platform strategy, KOL engagement frameworks, and qualitative outcome measurement. MSL Blueprint is building the strategic planning and measurement layer that the field medical function has been missing since 1967.