Posted: 21 Oct. 2021 5 min. read

Orchestrating a patient-centric cell/gene ecosystem

By Rajesh Singh, managing director, Deloitte Consulting LLP

Cell and gene therapies (CGTs) have shown promise in their ability to cure disease rather than merely treat symptoms. CGT, however, is still in its infancy and biopharma companies typically need to synchronize multiple stakeholders and processes to ensure the therapies deliver on their clinical promises and meet patient expectations.

I recently participated in a digital workshop—in collaboration with London-based Hanson Wade—that looked at the steps involved in designing a patient-centric digital ecosystem for CGT. These living therapies are customized for each patient, and the ability to create a new therapy is dependent upon that patient. Moreover, the nature of a CGT product requires biopharma companies to collaborate with a variety of stakeholders including hospitals, contract manufacturing organizations, and couriers. CGT also involves multiple hand-off points, all of which need to be tracked.

John Lally, senior director of Commercial Innovation and Digital Strategy at Vertex Pharmaceuticals, was my co-presenter during this session. He drew a parallel between an orchestra and the many players involved in CGT. Each player in an orchestra, he explained, has a piece of sheet music to follow. The conductor of this orchestra (like the biopharma company) controls the score and is responsible for ensuring that individual players work together to achieve harmony. The score shows the conductor how all the pieces of music need to fit together to make music. This analogy helps to explain the different types of deliverables we create when planning for CGT.

Deloitte's 2020 report on CGT explains why developing a patient-centered value chain is a new competency that requires a whole new way of organizing and operating. Here are a few key considerations for the successful orchestration of cell and gene therapies:

  • Site certification: Identifying and certifying the CGT site can be an intensive process. The site needs to be able to keep up with demand as more patients are referred and enrolled in the therapy. It’s also important that the site ensures equitable and fair access to patients.
  • Collaboration: Cell collection and infusion relies on clinical institutions and hospital networks. Biopharma companies should work closely with hospital staff to schedule cell collections and the therapy infusion. Hospitals also have to ensure the manufacturing facility’s capacity is in sync with the collection of the patient’s cells. John noted that this level of collaboration with hospitals is new for many biopharma companies.
  • Exception handling: Every patient is different, which means each therapy is unique. As a result, biopharma companies should expect exceptions. The majority of CGT patients do not precisely follow the anticipated care path. Apheresis reschedules happen in 40% to 60% of all orders. Some of the most frequent causes are patient availability, health conditions, and approval from the health plan. An order could also be delayed for a variety of issues ranging from manufacturing problems to weather. A snowstorm, for example, might delay the courier assigned to pick up material from the hospital. Such exceptions will lead to additional work, but they should be built into the process.
  • Real-time tracking: John noted that biopharma companies typically have less than 48 hours from the time cells are collected to the time the cells reach the manufacturing site. This extraordinarily tight timeline creates new challenges for biopharma companies. They should determine how they will work with couriers to track products being transported from the hospital to the manufacturing site. I heard a nurse say that she can use her phone to track a pizza from the time it’s ordered to the second it is delivered. But it is still difficult to track a cell-therapy product in real time. Clinical staff should be notified about any delays so that patients aren’t left waiting in expensive ICU beds.
  • Customer-engagement platforms: A customer-engagement platform is typically used to help CGT sites enroll the patient, schedule the aphesis appointment, educate the patient and care team, and even research the patient’s health benefits. These are expensive therapies and patients typically expect white-glove service.
  • Chain of custody and identity: The ability to track and trace helps ensure that the intended patient receives the right therapy. The materials involved in CGT need to be tracked as they move from the patient to the manufacturing site, back to the infusion center and finally to the patient. Each time the product changes hands needs to be recorded (also known as the chain of identity and chain of custody). Labeling is also critical for tracking. Deloitte’s 2020 report on optimizing the CGT business model identified labeling as a time-consuming task with significant implications for operations and patient safety. In an April 22 blog, my colleague Jennifer Rabin detailed the role she played in a working group that recently finalized CGT labeling standards.                                                     

The effectiveness of CGT might depend on how well biopharma companies collaborate with stakeholders to enable the patient journey. Using the components above to create a blueprint that is centered around the patient can help biopharma companies anticipate and overcome challenges.

Acknowledgement: Josh Fyffe, senior consultant, Deloitte Consulting LLP

This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor.

Deloitte shall not be responsible for any loss sustained by any person who relies on this publication.

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