Accelerating Cell & Gene Therapy Commercialization with Hexaware

Client

Pioneering Biotech on a Mission

Our client, a forward-thinking biotech firm, was preparing to launch the world’s first autologous T-cell therapy for solid tumors—a truly groundbreaking scientific achievement. Speed to market was critical to deliver life-changing care to patients who couldn’t wait. The vision was bold, but success required more than scientific and technological innovation—it demanded an agile, compliant, and patient-centric supply chain capable of matching the therapy’s complexity.

Challenge

Navigating Complexity at Speed

Bringing personalized medicine to market is never simple. Every patient represents a unique treatment journey, with data flowing between hospitals, labs, CROs, and manufacturing facilities.

The client faced a high-stakes challenge: design and deploy a fully operational supply chain solution in under six months. On top of this aggressive timeline, they needed:

• Real-time visibility across manufacturing and hospital networks.
• Tight regulatory compliance, especially for FDA-approved labeling.
• Accurate logistics tracking, from courier records to barcode scans.
• A seamless experience for stakeholders—from physicians to manufacturing partners—without compromising security.

Failure to get it right could lead to delays, rework, and patients waiting longer for critical treatments. Even minor lapses in regulatory compliance (such as with FDA standards) risked derailing the biotech firm’s broader vision for personalized medicine.

Solution

Building a Patient-Centric Supply Chain

Hexaware partnered closely with the biotech team to design a solution that was fast, flexible, and future-ready.

Within six months, we:

• Built distinct hospital and manufacturing communities with custom workflows to streamline collaboration.
• Deployed Salesforce Health Cloud to manage patient registration, QA, scheduling, and logistics.
• Integrated Electronic Data Capture, CRM systems, and courier services to create a connected data ecosystem.
• Strengthened the user experience with Single Sign-On (SSO) for secure, effortless access.
• Introduced barcode-enabled lot creation with auto-populated details, ensuring accuracy at every stage.
• Enhanced compliance by modifying product labels to align with FDA guidelines.

From handling Out-of-Specification (OOS) lot retirements to supporting second manufacturing cycles, every capability, workflow, and system was designed with patients, regulators, and partners in mind.

Benefits

Faster Commercialization, Stronger Collaboration

The impact was transformative:

• The solution adapted seamlessly to trial demands, supporting repeat manufacturing cycles when required.
• Cross-functional collaboration improved between HCPs, CROs, and manufacturing teams
• Visibility and control expanded across scheduling, patient management, and manufacturing milestones.
• Real-time barcode updates boosted logistics accuracy and reduced delays.
• A secure, intuitive platform improved the end-user experience across the ecosystem.
• Commercialization accelerated without compromising quality or compliance.

Ultimately, Hexaware gave the client what they needed most: confidence that their therapy could reach patients quickly, compliantly, and reliably.

Summary

Closing the Gap Between Innovation and Patients

Hexaware enabled a pioneering biotech to overcome the complex hurdles of cell & gene therapy commercialization. In just six months, we delivered an integrated, compliant, and patient-focused supply chain solution—accelerating market readiness, enhancing collaboration, and ensuring accuracy at every stage. Together, we helped bring breakthrough therapy closer to the patients who need it most.

Discover how Hexaware empowers life sciences and healthcare organizations to accelerate innovation, enhance compliance, and deliver better outcomes for patients worldwide. Explore our life sciences and healthcare solutions now.