Scaled Agile implementation to drive cell and gene therapy customisation programme

A major pharmaceutical company working in cell and gene therapy (CGT) wished to transition an existing industrialisation programme (CGTi) to the Scaled Agile Framework® (SAFe®) to support a more patient-centric value stream. PM-Partners came on board to stand up SAFe and guide its implementation across multiple, geographically dispersed teams.


  • A leading pharmaceutical client is working to transform the value stream for its cell and gene therapies to a more effective, individualised approach.
  • With Agile being the preferred delivery method and multiple teams to co-ordinate, PM-Partners was brought in to support the division as it transitioned to the Scaled Agile Framework (SAFe).
  • The client is on track with their complex solutions build and teams have uplifted their SAFe capabilities and confidence to continue delivering successful increments of work.

Customer background

The client is a leading international pharmaceutical in terms of science and patient/customer experience with a portfolio of cell and/or gene therapies. Its goal is to transform the value stream for the provision of these therapies from a ‘one batch – many patients’ approach to an individualised ‘one batch – one patient’ solution that results in a higher effectiveness level and faster recovery time for the patient.

The challenge

CGT is an evolving treatment area and there is high uncertainty about which therapy will be ready and authorised when. Each therapy is different and requires customisation of the IT solution(s). The integration landscape is highly complex and continuously changing.

In this environment, Lean and Agile methodologies are best practice and preferred delivery methods and systems thinking is essential to success. With multiple teams to co-ordinate, the customer needed an Agile-based method that could scale to better support its goal. As the leading industry standard, SAFe was identified as the Scaled Agile framework of choice and the client sought an expert partner to guide the implementation.

How PM-Partners helped

PM-Partners has excellent SAFe resources and is part of the wider client community within the enterprise. As one of several partners who blended into a single high-performing team of teams, PM-Partners supported the client on their Scaled Agile journey through a combination of targeted training and expert consultancy. This included:

  • Standing up of SAFe structurally, including designing the Agile Release Train (ART) and team structure and creating a pragmatic implementation roadmap.
  • Supporting teams as they transitioned from their existing waterfall programme structure to new ways of working.
  • Preparing for and facilitating PI planning events to align all teams on the ART to a shared mission and vision.
  • Delivering targeted training across Leading SAFe, Agile Release Trains and SAFe for teams, and coaching and preparation of teams for initial PI planning events.

Outcomes delivered

  • Initial SAFe transition successfully implemented over four to six weeks.
  • Client teams made significant progress in their complex solution build in Program Increments 1, 2 and 3.
  • Internal teams have grown their SAFe capabilities and confidence to support self-sufficiency moving forward.
  • Client on track to have in place an orchestration platform to support the value stream transformation in time for new modalities being available and obtaining regulatory approval.

What’s next?

Next steps for the client’s new way of working, include:

  • Optimise team and ART structure.
  • Promote experimentation as an element of continuous learning.
  • Transition from Dev to DevOpsVal (Development, Operations and Validation).
  • Optimise PI Planning format based on retrospective.
  • Consistent tool usage across teams and supporting DevOpsVal.
  • Experiment with PPM tools for product, portfolio, roadmap and backlog management.

Do you need support with your Scaled Agile implementation? PM-Partners has significant expertise guiding clients on their Scaled Agile journey and uplifting the capabilities of their delivery teams. Complete our enquiry form or call us on 1300 70 13 14 to find out how we can help your business transition to new ways of working to better achieve your goals.

SAFe and Scaled Agile Framework are registered trademarks of Scaled Agile, Inc.

  • CLIENT Major pharmaceutical company
  • WE DID Scaled Agile, Agile upskill & coaching, capability uplift

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