Building Service Infrastructure for “Made-To-Order” Therapies – MedCity News

Advanced cell and gene treatments and radioligand therapies represent the cutting edge of modern medicine. Unlike conventional pharmaceuticals, these next-generation therapies are not produced in bulk. Because they are made to order, individually crafted to meet a specific patient’s needs or generated in small, precisely timed batches, they demand fundamentally different logistical frameworks. This personalized paradigm offers immense promise for more effective care for serious illnesses while simultaneously introducing intricate operational challenges that traditional clinical trial infrastructure was never designed to accommodate.

The most critical challenge stems from the exceptionally time-sensitive nature of these therapies. For cell and gene treatments, even a single customs delay can compromise the entire “vein-to-vein” process — where a patient’s cells are harvested, engineered in a specialized facility, and then re-infused. Radioligand therapies present even more stringent timing constraints, as their radioactive isotopes steadily decay and can effectively “die on the shelf” if not delivered and administered according to precise schedules. When unpredictable delays occur in either scenario, an entire dose may become unusable, compelling sponsors and clinical sites to restart the entire process, an extraordinarily costly setback, particularly in late-stage clinical trials.

Because these “made-to-order” treatments merge clinical delivery with manufacturing, they also demand unusually tight cross-functional coordination. Sponsors, contract development and manufacturing organizations (CDMOs), and clinical sites must share real-time data, everything from courier tracking to patient scheduling, to avert failure points. As Phase 3 trials expand, site readiness becomes another bottleneck: staff often require specialized training in handling radioactive or cryopreserved products, while facilities may need upgrades to meet regulatory standards for safe delivery. These layered complexities can strain even the most experienced research centers if no overarching system ensures each step flows seamlessly into the next.

Forward-thinking organizations are addressing these multifaceted challenges through service design principles — an approach that reconceptualizes the entire clinical trial as a high-touch, integrated service ecosystem rather than a collection of disconnected tasks. This paradigm shift enables companies to develop reliable, dynamic, and scalable service infrastructure that simultaneously enhances customer trust, operational efficiency, and sustained competitive differentiation. For successful implementation and seamless transition to commercialization, organizations must meticulously develop two foundational elements:

• Designing a cohesive service vision and experience – Creating a clear illustration of the target state for the service makes your intended ambition tangible and helps align all stakeholders. This vision serves as a focal point to define and coordinate action across teams, ensuring everyone understands not just what they’re building, but why it matters for patients, clinicians, and the organization. The service vision should incorporate patient journeys, site workflows, and data integration points to create a holistic picture of how the therapy delivery process should function ideally.

• Defining the operationalization plan and building a roadmap – Working backward from the service vision, organizations must identify priorities and define specific steps and initiatives to fully operationalize the experiences and platforms that achieve their service vision. This includes determining technology requirements, training needs, process documentation, and change management approaches. The roadmap should include both quick wins to build momentum and longer-term structural changes needed for sustainable success.

In practice, this service-oriented approach manifests in several tangible implementations. Real-time scheduling platforms can match production slots with patient appointments, ensuring that manufacturing capacity aligns perfectly with clinical needs. Patient concierge programs handle travel and lodging details, recognizing that patients may need to travel significant distances to specialized treatment centers. Dedicated site enablement teams provide hands-on training to clinical staff and preempt regulatory complications by ensuring sites meet all requirements before therapy delivery begins. By viewing the trial through the lens of patient and site experience, sponsors can reduce attrition, minimize scheduling complications, and capture more consistent data — ultimately laying the groundwork for smoother commercialization once the therapy wins approval.

What’s at stake is more than operational efficiency; it’s the ability to deliver cutting-edge treatments to patients who often have no other options. When delays or logistical failures jeopardize a dose, a patient’s window of opportunity may vanish. Success in this environment hinges on reimagining clinical trial infrastructure as an adaptable, full-service ecosystem — one that anticipates the unpredictability of “made-to-order” production and turns potential bottlenecks into sources of competitive strength.

As personalized therapies continue to evolve, the organizations that will lead this field will be those that recognize that excellence in manufacturing must be matched by excellence in service delivery. By building robust service infrastructure from clinical trials through commercialization, companies can ensure that these revolutionary treatments fulfill their life-changing potential for patients worldwide.

Photo: CASEZY, Getty Images

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