Operating partner to biopharma, contract research, contract manufacturing, medtech, and diagnostics organizations applying AI across discovery, development, and commercial.
Intelligine Group works with sponsors, CROs, CDMOs, medtech, and diagnostics organizations on the engagements where AI is being applied against research productivity, clinical operations, manufacturing and quality, regulatory, and commercial. The firm brings biomedical training, McKinsey life sciences experience, and a delivery cadence calibrated to the regulated environment in which the work is executed.
Advisory across discovery, development, manufacturing, and commercial.
<p>Engagements in biopharma and life sciences divide across four planes. Discovery, where AI is being applied against target identification, lead optimization, and translational research. Development, where the application surface includes clinical operations, site identification, patient recruitment, regulatory submission, and the data integrity posture against which the submissions are made. Manufacturing and quality, where the application surface includes batch release, deviation investigation, and the quality systems infrastructure that the regulated environment requires. Commercial, where the application surface includes market access, medical affairs, and the field-force operating model. The firm runs engagements at all four planes, and the diagnostic that opens each engagement identifies which plane is the binding constraint in the organization at hand.</p>
An assessment scoped against the regulated lifecycle.
<p>The two-week assessment is scoped against six named workstreams. Pipeline economics, examined at the asset level, with explicit attention to the cost trajectory across the program lifecycle. Operational throughput, measured against site activation cycle time, screen failure rate, deviation closure cycle, and the named cycle metrics the organization uses to govern the development plane. Technology estate, with a written inventory of the AI workloads in production, in pilot, and approved but not started, and an explicit accounting of the validated systems in which the workloads sit. Talent posture, with a written assessment of the organization's capacity to absorb the operating model the AI estate requires inside the validated environment. Regulatory and quality posture, including the computer system validation practice, the data integrity controls, and the audit history with the relevant regulatory bodies. Partnership posture, including the CRO, CDMO, and academic relationships through which a meaningful share of the AI exposure flows.</p>
A readiness instrument written for the validated environment.
<p>AI readiness in biopharma is structurally different from readiness in unregulated sectors because the validated environment imposes a discipline on the data layer, the model layer, and the operating layer that has no analogue in commercial software. The readiness instrument has seven dimensions: data fitness for the regulated workload, computer system validation capability, data integrity controls posture, model risk management practice, operating model maturity at the executive sponsor level, partner readiness across the CRO and CDMO surface, and change management bandwidth at the functional level.</p><p>Organizations that score below the threshold on dimensions two and three are advised, in writing, that the architectural decisions they are contemplating cannot be deployed inside the validated environment until the readiness gap is closed, and that the gap closure is a separately scoped engagement that should be completed before the AI workload is approved.</p>
A roadmap built against the asset and the lifecycle.
<p>The roadmap in biopharma is structurally different from the roadmap in operating businesses because the unit of economic accountability is the asset, not the operating period. The roadmap names the assets to which the AI workloads attach, the lifecycle stage at which the workload is intended to influence the asset, the architectural commitments required at each stage, and the kill criteria the operating model adopts at each stage. The financial trajectory is expressed at the program level rather than the operating-period level, and the rewrite trigger is calibrated against the program economics rather than against the quarterly P&L.</p>
Prototypes that respect the validated environment from the first call.
<p>The architectural prototype in biopharma is built against the validated environment from the first commit. The prototype is delivered inside 72 hours of kickoff, on the organization's own validated infrastructure, against a representative slice of the organization's data. The wedge architecture is modified for the regulated environment in three ways. The audit trail is generated at the per-call level, retained inside the validated environment, and reconcilable to the computer system validation artifact. The routing layer is constrained to providers whose contractual posture supports the relevant regulatory framework. The orchestration layer is explicitly written to surface decisions in a form the licensed function (clinical, quality, regulatory) can validate, modify, or override.</p>
Production stand-up calibrated to the validated lifecycle.
<p>Production stand-up runs from the close of the prototype through day 30 for unregulated workloads, and through the validated lifecycle for workloads that touch the regulated surface. The validated stand-up follows the organization's own computer system validation practice and is co-executed by the firm's architect and the organization's quality function. The asset is owned by the organization on its balance sheet at close, with the operating mandate retained by the firm under the commission-and-operate structure for a defined period.</p>
Examples of where the firm engages, and the kind of operating result the work targets.
Illustrative examples drawn from the firm’s engagement patterns. Figures shown are representative of the operating outcomes the firm targets within the engagement model. Tap a card to read the engagement.