Cell and gene therapies (CGTs) are transforming not only the way in which we treat genetic and intractable diseases, but also the entire pharmaceutical ecosystem as we know it.
Suffice to say, the next generation of CGTs holds tremendous potential for therapeutic benefits. To realise this promise, however, stakeholders across the value chain – including but not limited to pharmaceutical companies, health care providers, health care payers, and patients – will need to come together to fundamentally recalibrate their commercial delivery modus operandi.
Central to this challenge is the high level of personalisation involved in the end-to-end production and delivery of CGTs, which means that current processes being deployed for traditional biopharma products cannot be easily adapted for use. Rather, what is needed is a multidisciplinary approach to designing a new operating model – one centred around complex, patient-centric journeys – and a holistic understanding of the stakeholder ecosystem.
Suffice to say, the next generation of CGTs holds tremendous potential for therapeutic benefits. To realise this promise, however, stakeholders across the value chain – including but not limited to pharmaceutical companies, health care providers, health care payers, and patients – will need to come together to fundamentally recalibrate their commercial delivery modus operandi.
Central to this challenge is the high level of personalisation involved in the end-to-end production and delivery of CGTs, which means that current processes being deployed for traditional biopharma products cannot be easily adapted for use. Rather, what is needed is a multidisciplinary approach to designing a new operating model – one centred around complex, patient-centric journeys – and a holistic understanding of the stakeholder ecosystem.
Deloitte’s five-step methodology to achieve commercial readiness for a CGT product
Deloitte’s experience has revealed that several common approaches can be deployed to help pharmaceutical companies orchestrate streamlined end-to-end commercial delivery processes for CGTs. Based on our experience, we have developed – and subsequently refined – a five-step methodology to move a CGT product from clinical to commercial readiness.