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December 22, 2021

Why CGT 3.0 success depends on interoperability

Posted in Commercial Scale by Ankur Garg

The cutting edge therapies of CGT 3.0 require modern operations. That means far more than just stand-alone digital systems and select integrations — it means digitized production and workflows across a digitally connected ecosystem. Interoperability across the CGT ecosystem will support the multi-dimensional growth of CGT 3.0. It accelerates development and clinical trials, increases patient access, and keeps patients safe.

Title: Patients are central to the CGT ecosystem
Subtitle: CGT 3.0 requires a digitally connected, interoperable ecosystem.

The patient-centric, complex, and time sensitive nature of the CGT value chain requires true interoperability to provide a holistic view across the ecosystem — in real time — for every individual patient and product journey. More than simple data-sharing integrations, interoperability is the ability of different digital systems and equipment to exchange, interpret and act on the data and present data as information that can be easily understood by users. When the ecosystem is interoperable, human resources, data, and physical machines are all connected and working in concert to deliver CGTs to the right patient at the right time.

(For more on why integrations and interoperability are important for CGTs, see How integrated digital systems solve key challenges with cell and gene therapies (CGTs).)

The way systems are integrated drives interoperability and generates real value for the CGT ecosystem. There are three basic ingredients for successful interoperability in CGTs:

  1. Modern Application Programming Interfaces (APIs) that can share information with any system or device capable of receiving web-based requests.
  2. APIs purpose-built for CGT-specific use cases such as patient services, manufacturing, and specialty logistics. 
  3. Secure, compliant systems that safeguard patient safety and data privacy. 

Modern, best-in-class open APIs allow systems to quickly and easily integrate and create a seamless user experience. The ideal integration approach is system-agnostic and enables the creation of flexible, bi-directional, customizable exchanges that are simple to create and update as user needs change. They put the power in the hands of the customer, especially key in a space that is evolving and growing. Interactions with other systems are efficient, minimizing the number of required data requests back and forth, and precise in the data and information exchanged.

(For more on the characteristics of integration solutions for CGT, see How integrated digital systems solve key challenges with cell and gene therapies (CGTs).)

Each CGT therapy, stakeholder, and patient is unique, yet similar throughlines underlie many of the activities in the CGT patient and product journeys. These similarities make up a set of foundational use cases that exist across the ecosystem at care sites, manufacturers, and third party providers. The creation of APIs for CGT-specific use cases unifies the ecosystem by linking disparate, heterogeneous digital systems and devices, making them interoperable to provide the greatest benefit to CGT stakeholders. This increases transparency and the availability and quality of information — ultimately delivering higher-quality patient experiences.   

Title: Traceability across over 100 touchpoints ensures patient safety
Subtitle: Every data point for COI and COC must be captured and stored in a safe and secure way for use at any time now, or up to 15 years in the future.

Patient safety and data privacy must be safeguarded at all times and at all points in the CGT value chain. A single therapy — for a single patient — has more than 100 touchpoints, is processed by more than 10 digital systems, and travels through 5-10 physical locations from collection to treatment. Tracking  of every data point and building an immutable single source of truth for Chain of Identity (COI) and Chain of Custody (COC) are critical, required activities for patient safety with no room for error.1,2 

Connected digital systems provide COI/COC traceability and  increase data security by reducing manual errors and protecting access and exchanges.  Every digital system and integration must comply with regulatory requirements for data integrity and data privacy and be validated. COI and COC must be tracked and, ideally, digitally orchestrated across an integrated ecosystem, to give  stakeholders and regulators precise, real-time COI and COC, now and for 10 to 15 years into the future.3

Title: Traceability is required for patient safety
Subtitle: Both the FDA and EMA require traceability of patient and donor materials and drug product to ensure that patients are treated with the drug product meant specifically for them.
Title: Traceability is required for patient safety
Subtitle: Both the FDA and EMA require traceability of patient and donor materials and drug product to ensure that patients are treated with the drug product meant specifically for them.

(For more on the regulatory landscape and standards, see Key industry and government regulations provide a cybersecurity foundation in advanced therapies and for specifics on data and COI/COC, see Patient Data and Integrations – the unique role in CGTs )

The digital maturity needed for success in CGT 3.0 is found in a secure, interoperable CGT value chain that provides the most comprehensive and reliable information in real time. This solution elevates healthcare, making it more efficient, transparent, collaborative, and information driven, enabling healthcare providers to focus on patients, not paperwork. It brings cohesion to a set of heterogeneous, disparate systems and provides the automation, efficiency, and cost-effectiveness the industry needs to grow and scale. Ultimately, interoperability increases patient access and safety.

(For additional insight, see last week’s blog How integrated digital systems solve key challenges with cell and gene therapies (CGTs))

References

  1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry. Silver Spring, MD. The FDA. January 2020.: https://www.fda.gov/media/113760/download
  2. European Commission, EudraLex. The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products. London, UK. The European Commission. November 2017.: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
  3. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Long Term Follow-Up After Administration of Human Gene Therapy Products: Guidance for Industry. Silver Spring, MD. The FDA. January 2020.: https://www.fda.gov/media/113768/download