Cell and Gene Therapy (CGT) Supply Chain Automation FAQs

In this article we address some of the common questions that we hear around supply chain automation within the CGT sector. These include: why automate your supply chain, how early you should consider it, how long it typically takes and the cost.

Contents:

• What is Supply Chain Automation?
• Why Automate the CGT Supply Chain?
• Patient Safety
• Expansion and Scale-up
• Digital Supply Chain Management Options
• When Invest in CGT Supply Chain Automation?
• Which supply chain element should be automated first
• How long does it take to digitalize your supply chain?
• Costs of Supply Chain Automation

What is Supply Chain Automation?

Simply put, supply chain automation means using digital technology, such as partner integrations, to send or receive information and notify stakeholders. A digital supply chain will often involve a cell orchestration platform to automate the flow of data and trigger notifications.

An automated digital supply chain replaces traditional and manual processes of using pen and paper, or locally saved spreadsheets. Instead, it stores the data within the cloud, which can then be accessed by the verified users across the world.

Tracking individual patients from enrollment to treatment administration is important for advanced therapies, making non-automated methods complex.

Why Automate the CGT Supply Chain? 

Many early-clinical CGT trials involve small patient groups, so why automate the supply chain at all? Manual methods like spreadsheets, are still common but more developers are opting to automate early:

Patient Safety

The first and foremost is generally around patient safety. For personalized medicines, managing the COI (Chain of Identity) is critical, so automating the compilation of the COI is key. An automated, integrated system will create COI records in a reportable format, which is incredibly valuable.

However, a well configured cell orchestration system can go beyond this, by utilizing integrations, workflows and notifications. For example, integrations with key supply chain partners can send and receive data in real time. Automated workflows will help to drive the process forward by flagging changes and prompting users for action.  

This combination of automating information flow, and prompting actions, can significantly reduce the administrative resource needed to manage a therapy. This not only speeds up the process, whilst reducing costs and errors, but resource can be redirected into patient care.

Expansion and Scale-up

Another common reason for CGT supply chain automation is preparation for scale up or wider portfolio management. Within CGT supply chain management, each patient represents a batch that requires individual tracking. As a result, the administrative support required for supply chain management in advanced therapy grows with each patient added.

In addition, cell and gene therapies often have complex supply chains with many steps spread over multiple stakeholders. Adding healthcare sites or users can therefore magnify the training burden of non-digital supply chain. Automated systems prompt users as to what is coming next and can help prevent parts of the process being missed.

Adding new geographies with varying languages and time zones is one of these complexities. Additionally, adding new partners and dealing with new shipping routes and sites can be challenging, not to mention regulatory requirements. However, specialist CGT supply chain software will apply these ‘rules’ automatically, without placing additional demand on users.

We’re seeing more and more developers facing the challenge of commercializing cell and gene therapies. And the speed of these scale-up demands is increasing. Therefore, early preparation for this is becoming increasingly attractive.

Digital Supply Chain Management Options

There are various options available when it comes to CGT supply chain automation. The two main solutions are: custom built solutions (commissioned by your business), or cell orchestration platforms (customizable software solutions). Both of which will vary in price, capabilities, and time to deliver.

TrakCel have been designing, building, and supporting orchestration platforms for CGT for over 10 years. Our flagship system, OCELLOS deploys in months and has an existing network of integrated CGT supply chain partners. OCELLOS configures specifically to match your advanced therapy supply chain. Users simply log-in to the cloud-based system and manage patients within a simple interface.

It is important to identify current and future requirements before beginning supply chain digital transformation to ensure a long-term solution. (To learn more about supply chain management approaches, read our blog: What is Supply Chain Management and Why is It Important?)

When Invest in CGT Supply Chain Automation? 

There are many viewpoints, but much depends on the therapy, indication, organizational structure, timelines and process complexity within the supply chain. Any one of these factors could be the driving force behind building an automates supply chain eco-system.

However, customer feedback suggests that orchestrating early when things are less complex is easier and quicker, and can then scaled up. Process errors, or near misses, resulting from implementing new processes and systems are easier to spot and correct at smaller scale. 

Most users also find it easier to manage upscaling changes via familiar system than to learn an entirely new system. Early adoption also means all records are in one place, rather than managing multiple systems during a critical phase of growth. 

At TrakCel, we are seeing more pre-clinical developers reviewing supply chain orchestration to support their IND (investigational new drug) application. But depending on the driving factors for orchestration, some chose a phased deployment above a fully integrated eco-system initially.

Having asked customers what internal factors aid digital supply chain transformation, involving cross-functional teams from the scoping point is key. As with any project, it is critical that the key drivers for the project are clear and remain in focus. It is also critical to engage end users throughout the project. 

Which Elements Should you Automate First? 

As each therapy process has unique elements, the risks and weaknesses within supporting processes will also differ.  

Here at TrakCel, we start client projects with a discovery phase that moves beyond the initial quote scope. This aims to map all processes in detail and identify weak spots that orchestration could help to address. This is limited to the function that the client has deemed critical, e.g., patient scheduling or COI. 

Workflows to safeguard these key processes are then configured in OCELLOS to fit the client needs and therapy journey. High risk areas can be prioritized, with the ‘nice to haves’ as a secondary focus that can follow in the timescale. 

In early-clinical deployments, labelling and courier integrations are common, with manufacturing often next on the roadmap. As a result, there are a number of partners offering these services who are already part of the OCELLOS eco-system.

This leads some clients to prioritize pre-existing integrations as they tend to be quicker and more cost effective to deploy. However, if preferred, we do have capability of integrating with your chosen existing or new partners.

How Long Does it Take to Digitalize a CGT Supply Chain?

The timeframe for deployment depends on the type of solution you have chosen. However, custom builds tend to take longer because they must be fully scoped and developed from scratch.

Cellular orchestration platforms can be quicker, however, it depends on scope. The more existing infrastructure and configuration you are able to adopt, the faster deployment will be. Understanding realistic timeframes should be addressed within the scoping stage. Any key dependencies that impact timescales can then be identified, and priorities agreed.

What Does Supply Chain Automation Cost?

Costs for software deployment are generally built around the hours needed to deliver the scoped solution. Tips to keep costs down include:

• Focus on critical elements and avoid changing your scope as you go.
• Utilize the existing infrastructure and eco-system of your chosen supplier.
• Avoid unnecessary customization.

Where this can be managed, a system like OCELLOS Lite with a couple of key integrations could deploy from around $300k. It is important to look at full cost of ownership carefully, including support, upgrades or alterations or licensing. e.g. With a custom solution you bear the full cost of basic maintenance, but this is shared with a multi-tenant platform.

Interested in how supply chain automation could benefit you? Complete our contact form and one of our team will arrange a free demonstration of OCELLOS.

Want to keep up to date with TrakCel news? Follow us on LinkedIn.