• The cell and gene therapy market is expanding rapidly, with the FDA anticipating the approval of 10 to 20 new products per year by 2025
• The development, manufacturing, and delivery of allogenic and autologous therapies are uniquely complex and require both flexibility and precision within the supply chain
• Creating a connected clinical and commercial ecosystem is crucial for the timely delivery of the right treatment to the right patient
• To ensure on-time and high-quality performance, manufacturers should leverage advanced digital technology to simplify the complex cell and gene therapy journey

• Sites of care. Channel strategy impacts the patient journey, logistical needs, and any wraparound services, such as patient support programs. Knowing the number of the clinical sites, their locations, the type of provider – inpatient vs. outpatient, for example – and how these sites compare to where patients are currently receiving treatment will help determine the optimal channel strategy.
• Provider education. While most cell and gene therapies are provided in an inpatient setting due to the adverse event profile, there has been a recent shift to outpatient settings for some. As a result, broader sites of care, such as community hospitals and physician practices, are administering these advanced therapies and may need more extensive on-boarding, education, and support. In addition, the broader physician community treating these patients need to be educated about the therapy, which patients are most likely to benefit, how to refer these patients to a treating facility if necessary, and also if there is anything they can do to support follow-up care.
• Logistical needs. Delivering a cell and gene therapy product to a specific patient within a specific time frame involves the tight coordination of a lot of moving parts. From order management to invoicing to payment, order to cash services must be flexible and align with the therapy process. Due to the patient-specific nature of autologous cell therapies, stringent chain of identity and chain of custody management are paramount throughout the entire supply chain. In addition, most cell-based therapy products require cryogenic storage to avoid cell degradation. Reliable, accurate, and efficient temperature-controlled storage and transportation – preferably on a global scale – are critical to safely connect these advanced therapies to patients.
• Scalability. With many cell and gene therapies in the pipeline and the potential to treat larger patient populations, manufacturers should plan for future growth. Ensuring that clinical facilities and partners have the capacity to scale data management, storage, shipping, and administration will facilitate smooth, uninterrupted operations.

Navigating seamlessly from the clinical journey to commercial journey in an inherently complex cell and gene therapy space is possible through an integrated ecosystem

The treatment journey begins with patient enrollment, which involves initial screening for coverage and patient education. Next comes the in-depth process of coverage research: working through prior authorization requirements, obtaining pre-certifications, assessing affordability needs, taking care of clinical appeals, and accessing available sources of patient financial assistance. The subsequent ordering and credit check process can be a challenge with these high-cost therapies. To avoid the delay of cell collection, it’s important to establish proper limits or set up an exception process. During the cell collection phase, the patient appointment, any pre-collection education, and pick-up and shipment of the cells require tight coordination.

The live cells are transported to the manufacturer where they are manipulated. The completed therapy is then transported to a treatment center in coordination with the scheduled administration. Prior to administration, the patient may undergo a pre-conditioning process. After the treatment administration, there’s a need for posttreatment engagement. The FDA requires long-term follow-up, and many payers require outcomes data.

Orchestrating this series of interdependent clinical and business processes must be underpinned by comprehensive patient operations, support, and coordination along with an advanced digital technology platform to ensure a smooth treatment journey.

“Within the cell and gene world, clinical and commercial processes definitely collide, so having a partner that supports both of these areas integrated with a connectivity platform really makes a lot of sense moving forward.”
Albert Cooksey, ICS

Six strategies for optimizing the commercial supply chain in the complex and variable cell and gene therapy market

1. Establish meaningful partnerships early. Aligning with partners to bridge anticipated supply chain capability gaps – such as global couriers, third-party logistics, patient support services, and technology solutions – will mitigate issues as early as possible in the process.
2. Take a “business process first” approach. Coordinate with internal SME’s and external stakeholders to tap into their respective business expertise to provide a truly comprehensive value chain.
3. Obtain cross-functional leadership. There are many functional areas and teams that might have a say in how this process works. It’s important to have a cross-functional team of leaders both within the organization and across partners and to establish clear roles, responsibilities, and accountability for value streams.
4. Expand on journey mapping to more detailed end-to-end value mapping. Dig deeper than the high-level scenario plan. Really think through how all the touchpoints are going to work and how everything will flow through the process and be sure to map out a variety of potential scenarios.
5. Spend extra time on exception management and master data. Given the nature of cell and gene therapy, exceptions are more the norm, so it pays off in the short- and long-term to highlight them during the value stream mapping process.
6. Prioritize eSystems for foundational capabilities as early as possible. Build a strong foundation in the clinical environment, then layer commercial processes and services on top.

“AmerisourceBergen has incredible strength in supply chain solutions and patient and clinical support services. TrakCel is a leader in cellular orchestration technology. There’s a natural collaboration and partnership that leverages clinical and commercial best practices to design an end-to-end service offering.”