3 reasons advanced therapies require a dedicated IT strategy

Advanced / cell and gene therapies have specific technological requirements that don’t apply to traditional pharma and biotech sectors. In this post, we outline why advanced therapies require a dedicated IT strategy and highlight 3 main take aways from our recent white paper in which we outlined the challenges and lessons learned by leading experts.

The advanced therapies sector is rapidly growing:

• The FDA expects to approve 10-20 Biologics License Applications (BLA) annually;
• 40 cell and gene therapies are expected to be commercially available in the next 2 years;
• By 2030, it’s projected that more than 340,000 US patients will have been treated with CGT products.

Development, manufacturing, and treatment facilities are expanding to keep pace with this anticipated growth. In order to meet the increasing volume of demand and to accommodate highly specialized sectoral requirements, the digital infrastructure that underpins this highly complex ecosystem also needs to expand.

Due to the nature of advanced therapies, where living tissue is collected from specific individuals for the manufacture of personalized treatments, cell and gene therapy developers typically work much more closely with the end patient than in traditional biopharma manufacturing, and with much tighter manufacturing lead times.

This places even greater importance on both data management and effective integrations between the different software systems that support the personalized supply chain. As a result, the cell and gene therapy industry has many unique requirements of its IT landscape that are simply not shared by other types of drug development.

In November 2022, we organized a roundtable webinar with a fantastic panel of industry specialists to discuss IT strategies for supporting CGT companies as they move towards commercialization. We have just published a white paper outlining this discussion in detail and invite you to download it here!

Not sure? Get a taster with this quick overview of our top 3 take aways:

• Foundational IT systems can be used for basic data management but important information about customers (i.e. healthcare providers) cannot be readily purchased, it must be collected in the field and updated in a shared system
• Compared with traditional small molecule treatments, the logistics of CGT treatment are significantly more complex, meaning that solutions that work for biotech companies may simply not be suitable
• Apheresis and treatment dates can suddenly change, requiring a whole production plan to be rescheduled at a moment’s notice
• The transition from Phase I/II to Commercialization can be as short as 5-6 years, dramatically faster than with traditional pharma, leaving less time to develop an effective data strategy

• It’s never too early to start planning an integrated data strategy – there are many moving parts in CGT treatment and these need to be mapped-out in advance
• However, invest in your IT solutions too early and there is no guarantee that the therapy will move beyond clinical phase, resulting in lost time and money
• On the other hand, leave implementation until too late in the process and there may not be enough time to do the job properly
• Appointing a dedicated Strategy Lead for digital system implementation can be a serious boon but the end-to-end ecosystem can still take years to setup

• If implementing an in-house system that is hosted in the cloud, then the relationship with the software (PaaS) provider is largely transactional – but when working with third party solutions (SaaS) vendors, it’s important to develop a meaningful partnership
• The sector is relatively new and therefore clear collaboration means that guidance needs to be provided in both directions
• Third party vendors don’t necessarily know the exact requirements and blockers that CGT companies face, so clear communication is crucial as very few (if any) solutions will be fit-for-purpose out of the box
• That’s why it’s important for therapy developers and CDMOs to understand what the vendor needs to facilitate implementation and have the relevant data ready for sharing

Want to learn more? Download our white paper now!