Coordination Is Not Coherence: Why the IEGP Needs a Spine

Section 1 — The Vertical Gap

Integrated evidence planning has matured. Over the past decade, pharmaceutical organizations have invested substantially in bringing Medical Affairs, HEOR, Clinical Development, Market Access, and Commercial into a shared conversation about evidence. Cross-functional Integrated Evidence Generation Plans (IEGPs) start earlier in development than they used to. Regional and global teams are more often aligned. The range of study designs considered has broadened, and the governance of evidence planning has become more disciplined. In the language of business strategy, this is horizontal integration. The benefits are familiar — synergies across functional plans, more holistic gap identification, less duplication, better use of evidence-generation budgets. It is genuine progress, and well covered in the existing literature.[1][2][3]

There is another axis, though, and it has received much less attention. A value chain is not only a set of activities to be coordinated; it is a sequence of stages through which value flows. For evidence planning, that cascade runs from vision and strategy, through evidence generation and synthesis, to publication and external communication. Vertical integration, in its business-strategy sense, refers to the linkage across those stages, and is building coherence (Figure 1).

The two axes can cause challenges for organizations for different reasons. Horizontal integration is a coordination problem: who does what, when, with whose input. Vertical integration is an architectural problem: does what happens at each stage actually derive from, and feed into, what happens at the stages above and below it. An IEGP can be well-coordinated across functions and still fragment vertically, producing evidence that does not trace back to a clear strategic question, or generating data that the eventual communications plan cannot support.[4]

The vertical perspective is useful especially for organizations still working through horizontal integration, because it clarifies what the horizontal work is for. Coordinating functions around a plan is easier when the plan has an organizing logic that runs through it.

When vertical integration is missing, the resulting IEGP is a plan that everyone has signed off on without it being clearly tied to the overarching vision or the subsequent communication strategy. This shows up in several persistent ways. We focus on four, each mapping onto a different transition along the evidence cascade (Figure 2).

These are symptoms of the same underlying absence: a missing organizing structure that runs vertically through the plan and gives each stage a clear line to the stages above and below it.

This paper argues that the medical and scientific narrative, properly conceived, is that structural answer.

Section 2 — What We Mean by “Narrative”

The medical and scientific narrative is the structured articulation of the scientific case for a product, organized around persistent thematic pillars that together capture why the product matters, what it does, how it differs, and how it fits into patient care. Here, the pillars are framed as questions the evidence must answer; the narrative itself is the team’s shared, evolving view of what those answers are for this product.

The narrative begins tied to the target product profile (TPP). The TPP defines what the product is intended to be; the narrative defines what the evidence needs to show in order for that intention to hold. Early in development, the narrative is necessarily aspirational, built on disease understanding, mechanism, early clinical signal, and a hypothesis about where the product will fit. As evidence accumulates, the narrative becomes progressively more specific. By launch and beyond, it is largely factual. The structure remains stable while the content within it matures.1

The five building blocks of the narrative

Narrative structure varies across organizations in how the different pillars or pieces are specified, but they tend to cover similar ground. For the purpose of this paper, we will discuss the narrative building blocks shown in the figure below. Each part is framed as a question the evidence must be able to answer. Sub-questions and specific evidence needs live underneath the narrative components; the building blocks themselves are the stable layer. The blocks extend beyond the product to the broader system, especially blocks 1, 4, and 5. Not all of them carry equal weight for every product, but all five require active consideration.

Section 3 — Narrative as Architecture

If the four challenges in Section 1 are breaks at specific points along the evidence cascade, a properly conceived narrative is what repairs them. When the narrative is treated as the organizing architecture of evidence planning rather than as a downstream output, each break is addressed by a corresponding property of the structure itself.

a. Completeness in gap identification (addresses the vision → evidence break)

The first break occurs because gap identification surfaces what is locally visible. The narrative addresses this by giving the team a comprehensive view of the product’s vision and of what the total evidence package eventually needs to be able to communicate. Working through the five narrative building blocks forces the team to make that vision concrete at the level evidence planning requires: not only “what is the strategy” but “what are we going to need to be able to say, to whom, and on the basis of what evidence.”

This matters most for evidence needs that do not announce themselves. Consider Pillar 5, optimizing the patient journey. Evidence about diagnostic pathways, screening, and patient finding tends to fall between the scopes of clinical development, HEOR, and Medical. In a stakeholder-by-evidence-type matrix, these needs rarely surface as priorities because no single stakeholder owns them. Organized against a narrative pillar, they become visible as a structural requirement: the product’s evidence case is incomplete without them, regardless of who generates them.

b. Structural stability (addresses the strategy → evidence break)

Strategy is dynamic. Strategic objectives and imperatives evolve over time as the competitive landscape shifts, as program data read out, and as organizational priorities are reset between cycles. This is normal and necessary; strategy should respond to new information. The challenge is what that responsiveness costs when the IEGP itself is organized around the current cycle’s strategic imperatives.

Mapping against the narrative provides a stable backbone. The pillars are anchored in the scientific and clinical reality of the product and its disease area; they do not depend on which strategic imperatives are prioritized in a given planning cycle. Unmet need is a question the evidence must address regardless of whether the current cycle’s emphasis is on launch readiness, scientific platform-building, or evidence supporting label expansion. Strategic imperatives, in this view, do not organize the IEGP; they are prioritization signals applied within it. Gap identification maps against the narrative blocks; gap prioritization layers in imperatives. Evidence items linked to current imperatives get higher priority; evidence items that are not urgent in this cycle, but remain necessary to complete the narrative, retain their place in the structure.

The result is an IEGP that can be re-prioritized without being re-built. Strategy continues to evolve, but the narrative structure holds. Imperatives shift within it, evidence accumulates against it, and prior work remains legible across cycles instead of being orphaned by each shift.

A second benefit of the same stability is that it makes scenario planning practical. Because the pillars are anchored in the product’s scientific case, alternative strategic scenarios can be mapped against the same backbone: how would gap priorities reorder if the competitive landscape shifted in a particular direction; if a key trial readout were ambiguous; if regulatory expectations moved on biomarker validation. Each scenario produces a different prioritization within the same pillar structure, which makes the comparisons cleaner and the trade-offs more legible. Without the stable backbone, scenario planning has to re-build the IEGP for each scenario, which is expensive enough that it usually doesn’t happen.

c. End-to-end coherence (addresses the evidence → communication break)

The break between evidence generation and external communication is repaired by organizing both against the same logic from the start.

When the narrative is the organizing structure, the team is forced to think through, early, what it ultimately wants to be able to communicate, to which audience, and to plan evidence generation backwards from that. Each evidence-generation activity has a place: which pillar does it serve, which stakeholder, which specific question does it answer? Publication planning is not a parallel stream but a downstream expression of the same pillars that structured evidence generation. The SCP, in this view, is the eventual factual narrative in the specific form required for external scientific communication.

d. Cumulative memory (addresses the across-cycles break)

With evidence organized against persistent narrative building blocks, each block becomes a cumulative knowledge asset over time: what has been generated, what has been published, what gaps remain and why, which trade-offs were made and on what reasoning. The structure provides continuity that the current-cycle imperatives cannot, because the blocks are the same in the next cycle.

This is what reframes the narrative from periodic deliverable to living document. A static IEGP gets signed off, referenced, and superseded. A living narrative can be maintained without needing to be rewritten: updated as evidence lands, revised as the product’s position in its landscape evolves, extended as new questions emerge. The governance cost of a living document is real, and we address it directly in Section 4. The benefit is that insight compounds across cycles rather than resetting at each one.

Taken together, the four properties — completeness, stability, end-to-end coherence, and cumulative memory — describe a structure that does vertical work. It runs through the plan from vision to communication. It holds its shape when the surrounding context moves. It gives each stage of the evidence cascade a clear line to the stage above and below.

Section 4 — Trade-offs

The framework proposed in this paper does not come without costs. Three trade-offs are worth naming explicitly, because they are created by the approach itself rather than inherited from existing IEGP practice.

The first is a timing paradox. The narrative is most needed early, yet early is also when the narrative is least factual, and many teams hesitate to commit to too much specificity at this stage. However, the aspirational narrative is useful precisely because it forces a team to articulate what it is hoping to be able to demonstrate, and the gap between the aspirational and the factual then becomes the agenda for evidence generation. The aspirational narrative does not need to be correct early in order to be useful; it needs to be specific enough that subsequent evidence can sharpen, revise, or refute it, and to allow open discussion of data scenarios.

The second is premature crystallization. A narrative drafted early and treated as architecture risks calcifying. Evidence that contradicts the initial hypothesis can be quietly de-prioritized because it does not fit the pillars as drafted; teams can become attached to the version of the story they wrote first. The mitigation lies in treating the aspirational narrative as a living document and a tool, not as an all-or-nothing outcome.

The third is the governance cost of a living document. A static IEGP is signed off, referenced, and superseded by the next cycle’s version. A living narrative needs to be maintained: updated with new evidence, or if the product’s position meaningfully shifts, kept current across cycles. That is a real cost, in time and in clear ownership. We do not believe this paper is the place to specify what that governance should look like in detail. The right answer depends on organizational structure, on how Medical Affairs is positioned relative to other functions, and on the maturity of the asset. The principle worth flagging is that the process and document should be kept as lean as possible while capturing the required detail — updates should be triggered by genuinely new insight, not by routine cycles such as budget requests or leadership reviews. If the narrative is current, those moments draw on it rather than re-open it.

Section 5 — What This Means for Medical Affairs Leaders

Medical Affairs sits across all five narrative blocks, which makes this function well-placed to steward the narrative and IEGP as a living document — not because Medical necessarily owns evidence planning, but because it has line of sight across the pillars and across the full evidence cascade.

Three implications follow.

Engage earlier. Narrative-as-architecture works best if the narrative is in place before evidence-generation decisions are made. Medical Affairs leaders brought into IEGP development late are asked to optimize a structure they did not help shape; the framework asks for involvement at the stage where the narrative hypothesis is being formed.

Drive the medical vision for the product. Many product visions originate from commercial work and are framed around market positioning. The medical vision is often somewhat different, a view of what the product needs to mean clinically and scientifically. Where this is left implicit, the IEGP defaults to evidence in support of the commercial vision, and pillars without an obvious commercial use case get under-resourced. Driving the medical vision means owning that articulation explicitly, in a form the rest of the cross-functional team can plan against.

Convene across functions. The narrative is a cross-functional deliverable, drawing on clinical development, Medical Affairs, HEOR, Commercial, Market Access, and external clinical and patient voices. Medical Affairs is positioned to steward the structure precisely because it sits between these functions, not above them. Where the narrative becomes a Medical product rather than a cross-functional one, it loses both its authority and its accuracy.

Section 6 — Conclusions

Horizontal integration delivers coordination. Vertical integration delivers coherence. The two are not interchangeable. A well-coordinated IEGP that lacks vertical coherence will produce activities that everyone has agreed to without anyone being able to say what the plan is, collectively, trying to demonstrate. A vertically coherent IEGP that lacks horizontal coordination will be intellectually clean but operationally fragile. The work of the past decade has built the coordination layer. The work this paper argues for is the coherence layer that runs through it.

No platform, process redesign, or governance reform substitutes for the absence of an organizing logic. The question is not how the IEGP gets built; it is what the IEGP is built around. Treating the narrative as architecture rather than as output reorders the question: first the team aligns on what the evidence eventually needs to demonstrate, then the plan is derived from that, moving from coordination of activities to building a vertical spine running through the evidence cascade.

About the Author

Friederike Winter is Managing Partner and co-founder of Consilience. She has experience in life-science strategy and medical advisory, previously at EY-Parthenon, stradoo, and Prescient Healthcare Group. Her work focuses on evidence strategy, narrative development, medical strategy and launch excellence, across oncology, hematology, rare disease, and other specialty areas. She holds a DPhil in Neuroscience from the University of Oxford.

friederike.winter@consiliencestrategy.com

Consilience is a boutique Life Science consultancy linking together science, strategy, and organizational context.

Our therapeutic area experience extends across oncology, hematology, rare disease, neurology, cardiovascular, metabolic disorders, and more. Technologies we’re familiar with include (multi-specific) antibodies, allogeneic and autologous cellular therapies, antibody-drug conjugates, peptide-receptor-radionuclide-therapy and -diagnostics, protein degraders, and gene therapies.

The companies we work with range from Biotechs planning for first commercial launch to global Pharma companies. We typically work with Medical Affairs, Commercial, NPP, and Clinical function leads focused on an asset, technology, therapeutic area pipeline, or portfolio.