Simplifying and Accelerating the Complex Cell and Gene Therapy Insights Ecosystem with a Purpose-Built Integrated PaaS Platform

Cell and Gene Therapy platforms involve the most complex production and delivery requirements in the history of biologics; their sophistication is beyond what can be achieved with generic technologies. Cell and Gene Therapy (CAGT) ecosystem is at an inflection point due to innovation and development. Still, they introduce a new level of complexity in research and development (R&D), manufacturing, supply chain, logistics, tracking, and commercialization requirements. These are quite different from traditional therapies, especially with the introduction of Good Manufacturing Practices (GMPs) into the point of care. Thus, biopharma companies entering this space are racing the clock with this intricacy and will face different challenges than those that take therapies to market. 

Many key providers are involved in site identification and long-term patient monitoring while delivering the product to the patient. With Cell and Gene Therapy insights, we can solve deficiencies at the base level – requiring a solution centered around patient journeys and product workflows. 

Challenges in Streamlining the Stages of Cell and Gene Therapy 

Orchestration platforms fostering (personalized) CAGT are highly complex, integrated computer systems that help therapy by maintaining the product’s chain of identity throughout the supply chain. 

Life Sciences and Biopharma companies face exponential challenges, including enabling site identification, patient access, managing supply chain operations, and establishing a network of providers. These companies seeking to integrate their processes into their SAP/ERP platform demand a robust solution capable of servicing these requirements. Hexaware provides that solution by combining deep Life Sciences Industry and Customer Relationship Management (CRM) expertise. 

As various functions use the CAGT orchestration platforms in different locations, platform integration with existing IT infrastructure is challenging for design and implementation. Integration with internal systems used by the client, e.g., Manufacturing Enterprise Systems (MES), Customer Relationship Management (CRM) systems, Enterprise Resource Planning (ERP), as well as external systems owned by logistics providers, need to be considered and managed as per customers’ expectations. 

Cell and Gene Therapy needs the most elaborate supply chain and logistics requirements, introducing visibility into the pharma supply chain. This requires transparency in the process, allowing all key stakeholders to get a single source of truth to support CAGTs. Cell and Gene Therapies must address these challenges along with a compliant, scalable, and connected value chain and align the point of care with the manufacturing facility, ensuring precision and coordination in a unified orchestration platform. 

How Does an Orchestrated and Integrated CAGT Platform Drive Clinical and Commercial Excellence? 

Having an orchestrated and well-integrated CAGT platform leveraging the new-age technology can deliver the following benefits to life sciences organizations: 

• Streamlines patient enrollment by using AI/ML-based algorithms created for individual patients and therapies and connected with external hubs and patient support systems. 
• Reduces the complexity of the identification process, maintaining the essential regulatory documentation to avoid costly delays in activation. 
• Maintains the chain of identity and chain of custody for all the system of records from Cell/Tissue collection to product delivery. 
• Transparent data flow with compliant data flow to other external vital systems, such as EHRs/LIMS, ERPs/MES, logistics systems, and many others—underpinning production and delivery systems. 
• Real-time logistics and manufacturing slots capacity. 
• Order-to-Cash: Manages cash flow and financial risk for Cell and Gene Therapies and provides real-time data to internal and external key providers for the order-to-cash process, including product status, patient data, logistics documents, and related data. 
• Integrates mission-critical players in the Cell and Gene Therapy ecosystem for customized reports, with or without PHI, on a complete historical audit trail. 
• Real-world data: data capturing and leveraging. 

Conclusion 

Advanced therapies and increasing adoption require a rigorous integrated approach. This approach incorporates technology learnings from other industries and advanced therapy best practices. These learnings can be incorporated into a foundational solution for the industry. Hexaware aims to deliver results with minimal disruption to its customers’ existing landscape. In addition, we aim to ensure patient safety throughout the patient’s journey by maintaining a chain of identity and a chain of custody.