December 16, 2021

How integrated digital systems solve key challenges with cell and gene therapies (CGTs)

Title: The patient-centric autologous CGT process
Subtitle: Patient data is generated at every step of the complex process. 

One patient. One cell therapy. Ten or more distinct digital systems.

That’s often the number of heterogeneous digital systems across care sites, manufacturers, and third-party providers (such as ERP, CRM, CTMS, MES, and HUB) that are involved in the production and delivery of a single batch of patient-specific cell therapy. For it all to work, it all has to work together — and that means integrations.

Cell and gene therapy (CGT) manufacturing and delivery are streamlined by the use of digital systems at any single step, improving efficiency, data capture, and data quality. Until these systems are connected, the potential gains remain unrealized. Manufacturers must orchestrate these systems in concert to ensure that the right patient gets the right therapy at the right time. 

Why is so much interoperability required? The answer lies in the patient-centric nature of CGT workflows. The patient is at the center of every cell and gene therapy. This patient focus demonstrates both the most unique and beneficial aspect of CGTs — and the fundamental challenge in making and delivering advanced therapies. The personalized, patient-centric value chain is complex, involving many participants, business systems, and activities that must all be carefully coordinated and tracked to ensure patient safety and on-time treatment.

(For more on the importance of patient data in the unique CGT value chain, see Patient Data — the Unique Role in Cell and Gene Therapies.)

Title: Digital systems and data in the CGT value chain
Subtitle: Each patient and product journey touches more than 10 digital systems that are only efficient when connected.

Integrations supporting CGTs must be as modern and technology-forward as the ground-breaking therapies to address the central challenges of the CGT value chain:

  • Patient safety is number one and patient data is mission-critical.
  • Patient and provider experiences must be outstanding.
  • Time and access to information are critical in the short and long terms. 
  • Digital systems are diverse and specialized.
  • Data access, quality, and regulatory compliance are paramount. 
  • Science and therapy technologies are evolving. 
  • Manual and inefficient processes are an obstacle to scaling. 

(To understand the challenges of data management in advanced therapies, see From Complex to Controlled: Proven data management strategies for greater speed and simplicity in cell and gene therapy operations and filings.

For more on the regulatory landscape and standards, see Key industry and government regulations provide a cybersecurity foundation in advanced therapies.)

Title: Digital systems and patient data are subject to multiple regulations and standards
Subtitle: A variety of regulatory agencies play a role in the protection of patient data and the standards for building secure digital systems.

The solution is a purpose-built, enterprise-grade cloud platform that bi-directionally integrates the CGT value chain’s many specialized systems. Based on open Application Programming Interfaces (APIs) and a “Secure by Design” (SbD) approach to the software development life cycle, the integration-first platform will provide the bridges needed to connect the value chain systems. A connected value chain is more secure and compliant — protecting patients, their data, and therapy processing.

(To learn more about SbD and cybersecurity, see Cybersecurity success in advanced therapies starts by prioritizing security as a “Way of working”)

A true solution for CGT addresses the challenges of the CGT value chain, and most importantly, creates a cohesive, reliable value chain that protects patient safety. The right digital solutions for CGT will have the following characteristics:

  • Flexible and configurable platforms support the “one size does not fit all” paradigm in CGT. In a space that is still evolving, ideal integrations allow the system owner to control the shape of the data and form-fit the solution to their needs.
  • Simple and fast to implement purpose-built solutions with plug-and-play API and out-of-the-box functionality for real-world use cases require less time and resources.
  • Scalable digital systems meet customers where they are today, in clinical trials or nearing commercialization, while supporting their growth and expansion by automating workflows and eliminating manual processes and cross-system data entry.
  • Real-time access to accurate data and information about patient and product journeys provides transparency to stakeholders and helps ensure on-time delivery.
  • Interoperable applications and devices supporting the variety of activities involved in producing CGTs reduce friction and increase efficiency.
  • Compliant and secure is a non-negotiable baseline in CGT. Globally compliant, pre-validated systems avoid guesswork and code changes for meeting pharmaceutical regulations and data protection standards.

Connecting CGT stakeholders requires integrations with everything from business systems to manufacturing and payer systems. These systems can become interoperable through a modern, flexible integration layer that is agnostic to specific system connection points. A seamless end-to-end integration of the value chain improves ease of use and performance, freeing providers to focus on the patients, creating enhanced patient and provider experiences. It also ties hundreds of required data points together across the broader ecosystem for the initial patient and product journeys and into long-term follow-up.