In this exclusive BioPharma APAC Q&A, Dr. Matthew Lakelin, Co-Founder and Head of Consultancy Services at TrakCel, and Antonios Spanos, Industry Advisor for TrakCel Consulting Services, discuss the growing challenge of "portal fatigue" within the cell and gene therapy (CGT) sector. They explore the inefficiencies caused by fragmented digital platforms and highlight TrakCel’s efforts to streamline workflows, enhance patient safety, and drive industry-wide standardization.

Portal fatigue challenges:

Q: How would you describe the impact of "portal fatigue" on healthcare professionals, especially within the cell and gene therapy sector? What specific aspects of the digital platforms contribute most to this issue?

Matthew: Portal fatigue significantly challenges healthcare professionals working with cell and gene therapies (CGTs), decreasing efficiency, increasing frustration, and potentially leading to burnout. It's important to remember that approved treatment center (ATC) staff derive little direct benefit from using a portal, aside from ordering a specific therapy and knowing the software helps ensure patient safety. Therefore, portals should not create additional work or become burdensome.

As highlighted in a recent industry whitepaper, "To date, each commercial [Immune Effector Cell] product manufacturer has invested in a different, proprietary computer application/portal or even multiple portals to facilitate patient enrolment, manufacturing dates, and shipping expectations. This was identified as a major area of concern by both clinical and manufacturing stakeholders. As more products are approved, the sheer number of unique IT platforms and variety of communication pathways will eventually overwhelm clinical site staff and can be extremely expensive for each manufacturer to support. This will limit both access to therapy at the site level and patient safety from all angles.” ^[1]

This proliferation of proprietary systems contributes to portal fatigue. ATC staff must learn and adapt to different platforms with inconsistent user interfaces and workflows. Remembering numerous usernames and passwords is cumbersome and can lead to security risks. Furthermore, entering the same information into multiple systems is time-consuming and inefficient. This lack of interoperability hinders collaboration and can lead to data silos.

Time poverty and safety risks:

Q: With healthcare professionals already facing significant time constraints, how does the lack of standardization across cell and gene therapy platforms affect both efficiency and patient safety? Could you provide examples of critical information being missed or delayed due to these fragmented systems?

Antonios: Time is a precious commodity in healthcare, and CGTs are no exception. The lack of standardization across CGT platforms further compounds this challenge, increasing the risk of errors and impacting patient safety. Inconsistent terminology and processes can lead to confusion, missed information, and treatment delays.

For instance, consider the complexities of onboarding new software at an ATC. Each new platform requires significant effort for security audits and user training, consuming valuable time and resources. Furthermore, every subsequent upgrade necessitates further training, adding to the burden on healthcare providers. This lack of standardization can also lead to user confusion and increase the risk of errors, particularly with varying data entry processes. Imagine the potential consequences of discrepancies in how patient information or treatment details are recorded. Such inconsistencies could lead to delays in treatment, incorrect orders, or even administration of the wrong therapy, jeopardizing patient safety.

Security and password management also become more challenging when each system has its own unique requirements. Healthcare providers are forced to remember multiple passwords, which can encourage poor security practices and increase the risk of data breaches.

Integration and standardization:

Q: What steps are being taken at Trakcel to standardize or integrate digital platforms to streamline the workflow for healthcare professionals? Do you foresee industry-wide collaborations to address this growing challenge?

Matthew: At TrakCel we are committed to driving standardization and integration to alleviate the burden on healthcare professionals. A collaborative approach, combining technology solutions with practical guidance and industry partnerships, is key to achieving this goal.

For example, a 'Global Gateway' is under development to allow ATCs access to all OCELLOS-supported therapies through a single login. Clients are also guided toward standardized processes and terminology based on TrakCel's extensive experience. The aim is to leverage the collective experience of clients to inform best practices. For instance, if a client requests custom functionality that adds no value, this is challenged to avoid encouraging unnecessary portal fatigue. It takes time to develop the experience and confidence to do this.

To further promote standardization, best practice guides are being developed, informed by the outputs of the Industry Advancement Board (IAB) forums. These forums bring together stakeholders to identify challenges and develop solutions. Active engagement with ATC staff through IAB forums and participation in industry initiatives further drives standardization. Industry-wide collaboration is essential for developing and adopting standardized practices.

Beyond logistics:

Q: Cell and gene technology platforms are more than just logistics tools; they manage patient identity, data security, and compliance. How do you envision these platforms evolving to support the chain of custody and ensure the integrity of therapies from development to delivery?

Matthew: Cell and gene therapy platforms are evolving into comprehensive solutions that go beyond logistics. These platforms play a crucial role in supporting the chain of custody and ensuring the integrity of therapies throughout the entire process, from ordering/patient enrolment to treatment.

Currently, platforms capture detailed chain of custody information, creating audit-ready reports that track every handover and change in custody across the supply chain. They also integrate with other stakeholders who, while they may not handle the therapy directly, are critical to the smooth operation of the supply chain. For example, integrations with patient hub providers (e.g. Cencora) automate information flow for benefits approval by payers. Integration with commercial 3PLs supports order-to-cash processes.

Looking ahead, we envision these platforms evolving to further simplify the user experience for healthcare professionals. For example, integration with electronic health records (EHRs) such as EPIC will reduce duplication of data entry between the EHR and the orchestration platform.

Given the high cost of treatment with CGTs, and while feedback from the market indicates there has been limited adoption of these so far, there could be a rise in the use of outcome-based payment models. A key barrier to adopting these models is the difficulty in managing these approaches. We believe that integrating outcomes-capturing platforms — such as registries and ePRO systems — could help simplify the management of innovative payment models, improving patient access to these high-value therapies.

Orchestration platforms capture a wide array of data across the supply chain, which will only continue to expand. Mining and analyzing data across multiple therapies to identify potential points of failure in the supply chain is an onerous task — the introduction of AI into orchestration platforms can help alleviate this and maximize the value of data captured in these systems.

Adaptation to evolving regulations:

Q: As cell and gene therapy technologies advance and regulations evolve, what strategies do you think are crucial for ensuring that platforms remain flexible and scalable to meet new scientific discoveries and regulatory demands?

Antonios: Adaptability and scalability are essential for CGT platforms to keep pace with the rapid advancements and evolving regulatory landscape. This goes beyond just cell and gene therapies and applies to any therapy where close orchestration and scheduling of activities across complex or time-critical supply chains is beneficial.

Our quality and regulatory team constantly monitors the countries in which our platform is used to ensure our software continues to support our clients' compliance with regulations. This is not limited to the functionality of our software, but also practical considerations that could impede the use of our platform. For example, the State of Texas recently introduced a requirement for central security assessment and monitoring of cloud-based technologies used by State agencies (TX-RAMP). By proactively working with the authorities, we ensured our platform was approved for use in Texas, removing a potential barrier to adoption for our clients. This is also reflected in our forward-facing approach to monitoring the development of a nationwide regulation along similar lines, FedRAMP, to ensure compliance and ease of access for our customers.

In addition to monitoring regulations, it is essential to review other emerging therapeutic modalities where close orchestration and scheduling of activities across complex or time-critical supply chains would be beneficial. For example, personalized vaccines have highly complex supply chains, and we have already developed our platform to support these. Radiopharmaceuticals have time-critical supply chains (short manufacturing to treatment timeframes based on short half-lives of products), and we have had preliminary discussions with developers of these emerging therapies to evaluate the application of orchestration technologies to their supply chains. While our orchestration platform was originally developed to support autologous cell therapies, we strongly believe that as therapies become increasingly personalized, we will continue to identify new applications for our technology.

Future-proofing the system:

Q: Looking ahead, how can the industry design platforms that are future-proofed for the rapid developments in cell and gene therapies? What role do you believe Trakcel will play in supporting the next generation of advanced therapies?

Matthew: Future-proofing CGT platforms requires a forward-thinking approach. Early platforms were developed in a very product/customer-specific manner and struggled to adapt to changing needs. Platforms should be highly configurable to adapt to new therapies, technologies, and regulations without requiring extensive recoding. They should also prioritize the needs of ATC staff, minimizing their workload and streamlining their workflows. Active participation in industry initiatives and standardization efforts is crucial for ensuring platforms remain aligned with best practices.

TrakCel is committed to supporting the next generation of advanced therapies. Our configurable OCELLOS platform, built on proven technology (Salesforce), allows us to adapt quickly to changing requirements and provide a user-friendly experience for ATC staff. This has allowed us to develop a ‘clicks-not-code’ approach to adapting our system, reducing the time required to make changes and simplifying testing requirements. Moving to a configurable platform also enables the outsourcing of some of our configuration and testing work to approved third parties rather than insisting all change requests must be managed by TrakCel. This gives us agility and the ability to quickly scale our capacity to make changes during peak demand.

As an industry, we need to get better at steering companies down the right path. For example, suppose a client asks us to build custom functionality that adds no value but creates more work for their ATC users, it is our role as experts in the field to challenge this to avoid creating unnecessary portal fatigue among healthcare professionals. It takes time to develop the experience and confidence to do this. We are the first to admit that in our early years when the market was small and we/our clients’ were still learning what we needed to support the supply chain, we said ‘yes’ a little too readily.

Of course, our product needs to evolve with the industry, and we have a detailed product roadmap covering the next two years and beyond. As we work with more therapies, support a growing number of companies, and work with an increasing number of healthcare providers and partners our knowledge of the industry increases we can use this to inform our product roadmap.

So where do we see ourselves in the future? We will champion standardization where possible and continue to ensure that orchestration platforms create as little burden as possible on healthcare professionals, helping improve the adoption of life-saving advanced therapies. We’d like OCELLOS to be the platform of choice for ATCs. While it sounds ambitious, if the industry were to consolidate into a single ordering portal used by clinicians, we’d like OCELLOS to be that portal.

Dr Matthew Lakelin

Head of Consultancy Services & Co-Founder of TrakCel

Matthew holds a PhD in Pharmacology and has over 20 years’ experience working in the pharmaceutical and biotechnology industry. Matthew has led the deployment of TrakCel’s software to a wide range of advanced therapies (including CAR-T, TILs, personalized immunotherapies, neoantigen cancer vaccines) and in his role as Head of Consultancy Services is a key spokesperson and responsible for ensuring that TrakCel solutions continue to evolve to meet industry needs.

Antonios Spanos

Industry Advisor for TrakCel Consulting Services

Antonios Spanos has over 10 years of experience within the healthcare, pharma and biotech industries. Antonios has supported cell therapy products from preclinical right through to commercialization, as well as expansions of multiple indications, numerous territories, manufacturing network, and implementation of several IT solutions. He uses his deep understanding of Cell and Gene Therapy supply chains and experience of vein-to-vein systems to give guidance on overcoming challenges and improving efficiency.

^[1] https://www.sciencedirect.com/science/article/pii/S2666636723000453