Case Study: Critical Comparator Rescue: Supplying 1,000 Packs of EU-Origin PD-1 Immune Checkpoint Inhibitor for Phase 3 Oncology Trial
A US-based clinical-stage biotechnology company, actively engaged in the development of next-generation immuno-oncology therapies, was preparing for a multisite Phase 3 interventional clinical trial across several European Union member states. The trial involved a therapeutic regimen where a PD-1 immune checkpoint inhibitor widely used in oncology was utilized as a comparator in one of the key arms of the study.
The biotech sponsor had a clear regulatory directive to use EU-origin product with full documentation, including a Certificate of Analysis (CoA) and consistency in batch identification, in line with EMA and local regulatory expectations. With only a few weeks remaining before first patient administration, the sponsor faced a rapidly deteriorating sourcing situation after their initial supplier failed to deliver.
The Situation: Compressed Timelines, Missed Promises, and Sourcing Breakdown
The client was referred back to AvanSource by their Clinical Trial Manager, with whom preliminary conversations had occurred months prior. Our initial dialogue had focused on future possibilities and regulatory alignment regarding EU comparator sourcing. However, in this re-engagement, the tone was very different: urgency, concern, and uncertainty.
Initially hesitant to disclose full study details, the Clinical Trial Manager asked broadly about our sourcing capacity. At AvanSource, we’ve learned that strategic clarity from the outset is non-negotiable. We emphasized that understanding the exact quantity, documentation requirements, timeline expectations, and batch constraints was essential—particularly in a volatile market with limited high-demand oncology comparators.
After aligning on a confidential discussion, we were briefed on the true scope:
- 1,000 packs of a 240mg PD-1 immune checkpoint inhibitor
- Single-batch requirement
- Certificate of Analysis mandatory
- Delivery required within 5 weeks
- No flexibility on timeline due to enrolled and scheduled patients
From this profile, it was immediately evident that something had gone critically wrong in the sponsor’s sourcing strategy. Based on industry norms, comparator procurement typically occurs before or early in the patient recruitment phase, often several months in advance. Securing supply this late into the timeline—with patients already enrolled and drug administration scheduled—introduced unacceptable clinical risk.
Further probing revealed that the sponsor had originally contracted another supplier, who initially committed to delivery within the required timeframe. However, after accepting the purchase order, the supplier issued multiple postponements, citing minor logistical delays. Eventually, mere days before the expected shipment date, they withdrew entirely, admitting they could not fulfill the order.
This caused a substantial loss of time, erosion of internal confidence, and a cascading risk to the trial’s dosing schedule.
Layered Challenges: Technical, Logistical, and Regulatory
High Quantity from a Single Batch
Most commercial releases of this PD-1 inhibitor include ~2,000–2,500 packs per batch. Acquiring 1,000 packs from a single lot narrows availability dramatically, especially for EU-marked stock with CoA.
Documentation Constraints
Several potential sourcing countries were ruled out due to lack of accompanying documentation, even though larger volumes were potentially available. The sponsor’s regulatory and QA teams were firm: CoA was non-negotiable, and study details could not be shared with intermediaries.
Market Scarcity & Internal Approval Loops
Oncology comparators like this PD-1 inhibitor are often constrained by limited allocations, batch expiry dynamics, and tight upstream release schedules. The sponsor’s internal systems also required reconciliation of cost, expiry date suitability, and parallel import risks.
The AvanSource Approach: Precision, Persistence, and Partnership
Unlike large-scale distributors or wholesalers with broad portfolios and rigid internal structures, AvanSource operates as a specialized, agile comparator partner. Our team focuses exclusively on hard-to-source, high-stakes medicines in therapeutic areas where failure to deliver has real clinical and financial consequences.
Within hours of confirming project feasibility, we initiated a full-scale market activation:
- Analyzed available sourcing routes to determine the most viable and compliant supply path
- Initiated negotiations with key supplier partners with access to the relevant product batch
- After several rounds of discussion, secured preliminary confirmation that fulfilling the 1,000-pack request was feasible
- Rather than stopping there, we continued close collaboration to reinforce commitment and ensure availability
This effort led to securing batch exclusivity, which was critical to protect against market competition or partial depletion of the batch that could jeopardize the single-batch requirement.
This result was only possible thanks to longstanding supplier relationships, built over years through consistent collaboration, successful project execution, and a deeply personal approach.
In this case, personal trust and reputation played a decisive role—our supplier network chose to prioritize our request because of our track record, responsiveness, and credibility in the comparator space.
Our ability to mobilize fast was rooted in:
- Long-standing relationships with reliable EU supply partners
- Real-time tracking of batch releases and expiry risks
- Established internal systems for batch-level traceability and regulatory alignment
Crucially, we maintained daily communication with the sponsor’s Clinical Trial Manager. Even on days where the update was “no major movement yet,” we proactively shared that update—never leaving them in the dark, and reinforcing our role as a trusted operational ally.
The Outcome: A High-Risk Supply Project Delivered Early
Despite the highly compressed timeline and narrow supply conditions, AvanSource successfully:
- Delivered 1,000 packs of a 240mg EU-origin PD-1 immune checkpoint inhibitor
- All from a single validated batch
- With CoA and required supporting documentation
- Delivered one week ahead of the five-week deadline
- With expiry and pricing aligned to sponsor expectations
This allowed the sponsor to complete labelling and internal QP release with time to spare—effectively preventing clinical risk and avoiding potential delays to first patient dosing.
The Outcome: A High-Risk Supply Project Delivered Early
This project underscores several core differentiators that enabled success:
- Specialization over scale: Unlike general wholesalers, we invest deeply into select medicines we know we can deliver.
- Trust-based relationships: Our suppliers moved quickly because they know we only bring high-urgency, high-integrity projects.
- Total availability: We were accessible via phone, email, and messaging at any hour—because comparator failure doesn’t happen on a schedule.
- Honest communication: Even when it was uncomfortable, we told the truth—no false assurances, no delay denial.
- End-to-end consistency: From first contact to final delivery, the project was handled by one team, one voice, one mission.
Strategic Takeaways
This project underscores several core differentiators that enabled success:
- Specialization over scale: Unlike general wholesalers, we invest deeply into select medicines we know we can deliver.
- Trust-based relationships: Our suppliers moved quickly because they know we only bring high-urgency, high-integrity projects.
- Total availability: We were accessible via phone, email, and messaging at any hour—because comparator failure doesn’t happen on a schedule.
- Honest communication: Even when it was uncomfortable, we told the truth—no false assurances, no delay denial.
- End-to-end consistency: From first contact to final delivery, the project was handled by one team, one voice, one mission.
Final Reflection
In a high-stakes clinical environment, where a single comparator delay can derail an entire trial arm, the value of an experienced, honest, and focused sourcing partner cannot be overstated.
By operating with clarity, courage, and competence, AvanSource turned a near-miss into a quiet success—ensuring that no patient was put at risk, and a global sponsor learned what true operational partnership looks like.
