Implementation of Cell & Gene Therapy Platforms

Kristina Halbleib

May 6, 2021

Design, development and implementation of complex orchestration platforms enabling (personalized) Cell & Gene Therapies (CGT), by maintaining the Chain of Identity of the product throughout the End-to-End Supply Chain.

Challenge

Orchestration platforms enabling (personalized) Cell & Gene Therapies are highly complex, integrated computer systems, which enable a Therapy by maintaining the Chain of Identity of the product throughout the End-to-End Supply Chain.

The supply chain processes to support personalized CGT are very complex and differ dramatically from those of standard pharmaceutical products and the regular channels through which these products are distributed. For CGT products, depending on the nature of the product itself, it´s logistic and storage requirements, as well as required turnaround times to patients, bring unprecedented challenges to those in charge of designing, implementing and operating CGT orchestration platforms.

These orchestration platforms are used by a great variety of external (nurses, doctors and pharmacists at hospitals) and internal (supply chain professionals, customer service, personnel at manufacturing plant etc.) users, which all carry out different activities in the system and have different needs and expectations. Creating one integrated system that enables all of these functions is very challenging, as user requirements for these functions can be very different given the different tasks carried out by the respective functions. Hence, the creation of one product that takes into consideration all user requirements from the various functions is very challenging and requires a lot of due diligence, as implementation of constantly changing business requirements and a great user experience do not always go hand-in-hand, which results in a balancing act.

As these CGT orchestration platforms are used by various functions in different locations, platform integration with existing IT-Infrastructure is a challenging aspect of the 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 to customers expectations.

What KVALITO did

  • Provided consultants responsible to build and lead teams/workstreams as part of the organizational governance driving the platform design and implementation
  • Design of business processes and data flows, use cases and definition of user requirements
  • Creating traceability of requirements, processes, as well as their documentation and training materials, to enable effective and efficient change management by utilizing TIBCO NIMBUS
  • Execution of risk and data integrity assessments
  • Creation of training material
  • Project planning and management of platform releases
  • Validation of CGT orchestration platforms incl. All relevant CSV deliverables
  • Led Change Management activities for CGT orchestration platform, including impact assessment on end-user, system training and procedural documentation, along with creation and update of respective documentation and communication of changes to end-users
  • Business process definition and improvement
  • Business relationship management
  • Scoping and enablement of manufacturing plant (CMO) and country launches including the roll-out of the platform
  • Master data setup enabling the set up of users, hospital sites and manufacturing plants for CGT orchestration platforms
  • Preparation of audit packages, preparation for health authorities as well as supporting health authority inspections

People, Processes and Tools

People / Roles

  • Business Process Excellence
  • Governance & Organizational Change Management Lead
  • Change Management Lead
  • Change and Communications Manager
  • Enablement Lead
  • IT Project Manager
  • Master Data Manager
  • QA/eCompliance / Validation Subject Matter Expert / CSV QA
  • (Project)Quality Manager
  • Training Manager

Tools and Technologies

  • Salesforce.com
  • SAP ECC
  • SAP S4/HANA
  • Dell Boomi
  • Airtable
  • Vineti
  • Clarity PPM
  • TrackWise
  • Oracle Agile PLM
  • TIBCO NIMBUS
  • Jira
  • HP ALM

Processes

  • End-to-End supply chain process

Value Delivered

  • Enabling personalized medicines by implementing a Chain of Identity application (individualized medicines, treatments, products)​
  • Enabling product launches globally
  • Enabling Manufacturing site launches, incl. contract manufacturers (CMO)
  • Increasing productivity and user experience​
  • Leverage knowledge and resources​
  • Saving time and costs​
  • Increasing GxP compliance​
  • Improving business experience

Clients / References

  • Novartis
  • Genentech / Roche

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