By Adlai Goldberg, EY Global Digital, Social and Commercial Innovation Health Sciences and Wellness Leader
The volume of patients treated with cell and gene therapies (CGTs) is expected to increase dramatically, from the hundreds today, to hundreds of thousands by decade’s end. EY predicts the global CGT market will experience a meteoric rise, from an estimated US$3b annually in 2021 to an estimated US$50b annually in 2027. This growth, which far surpasses global pharmaceutical market expectations, can be attributed to strong financing and a prolific pipeline. There are more than 2,600 CGT clinical trials in different modalities at different stages of maturity worldwide signaling a potential wave of 300 to 400 product approvals between 2022 and 2027.1
But making these revolutionary treatments available at scale will be challenging. Unlike chemotherapy, another form of cancer treatment, their development and delivery rely on multiple handoffs of time-sensitive information and materials across a diverse set of organizations and systems. Patient outcomes depend on getting these transactions right the first time, but they are subject to human error, travel delays, lab closures and even pandemics. To successfully scale cell and gene therapies, real-time signaling across an extraordinarily complex supply chain will be essential, so that problems can be detected early and speedy course corrections made. All the members of the supply chain must be able to securely communicate and share information they trust.
CAR-T vs. Chemo: An Incredibly More Complex Treatment Journey
CAR-T therapy, where the patient’s own T cells are extracted, modified, activated, expanded, purified and returned to the patient, requires nearly triple the number of supply chain steps as chemotherapy — from doctor to leukapheresis center to shipping company to drug manufacturer to shipping company to hospital to treatment center. In addition, as the therapy moves from “vein to vein,” a multitude of analog and digital handoffs occur among the players in this supply chain — with each player having their own individual systems and digital identifiers describing their steps in the journey for the therapy being produced.
Two Examples of Gaps in the CGT Supply Chain
Jenny Chen is a case worker within a drug manufacturer’s patient operations function, responsible for managing the treatment journey for her patients. These therapies involve many steps, and it’s her job to resolve multiple challenges, including logistics, scheduling and human error, so that every order makes it to where it needs to be, every time. Working with multiple systems, both internal and external, as well as navigating manual spreadsheets and databases, increases her chances for error. If Jenny is missing information from any step in the process, she needs to search for it. This takes time that may delay a delivery, or worse, create a mix-up in therapies, which could be fatal.
How can Jenny best track these revolutionary therapies if there are gaps in the process and interactions she cannot see?
Alfie Ray is a manufacturing manager for a biopharma company and must optimize the utilization of manufacturing capacity for treatments. It is mission-critical for him to manufacture as many therapies as possible to give more patients access to potentially life-saving treatments. He needs to do a lot of planning to ensure patients receive their treatments at exactly the right time. Despite having slots filled, however, manufacturing capacity can free up due to changing patient or logistical circumstances. Alfie needs visibility into the right information to continually monitor the status of scheduled manufacturing, including analyzing inbound orders and tracking new ones. At the same time, he must optimize availability and manage the overall schedule on the manufacturing floor.
How can Alfie gain better transparency in real time to help him do his job?
The Challenges: Connectivity and Transparency
Supply chain connectivity and transparency, as well as concerns around patient safety, will intensify as more CGTs, both autologous and allogenic, enter the market and cross international borders. Current mechanisms used to communicate and coordinate with different stakeholders are inadequate for this anticipated flood of products and patients. Complicating matters is that patients and caregivers are now embedded in the supply chain, with many managing their own treatments.
The CGT manufacturing community, including drug manufacturers, contract development and manufacturing organizations (CDMOs), and lab supply and equipment providers, are independently exploring strategies to improve supply chain resilience and address bottlenecks in the current processes. These strategies include: advancements in next generation engineering and manufacturing technologies; acquisitions and collaborations to expand manufacturing capacity; and enabling de-centralized or bedside manufacturing when possible.
But improvements in manufacturing procedures alone are not enough to solve the complex challenges in successfully delivering these therapies at scale. To fully ensure the right patient gets the right treatment at the right time, the industry needs a proven mechanism to integrate and share information and data across the CGT supply chain.
Closing the Gaps, Connecting the Dots
Nearly four years ago, EY studied the connectivity points along the CGT supply chain to identify issues and how they can be addressed. The analysis explored key obstacles at every step of the CGT process, including: how to conduct genetic sampling and sequencing to serve a global market; how to transport patient samples and data across national borders with different legal and regulatory guidelines; and how to handle receipt, storage and administration of individualized therapies for every patient. This market research encompassed more than 450 professionals across multiple geographies, including practicing oncologists, oncology thought leaders, health care providers and payers.
The conclusion? Truly individualized treatment requires an error-free outcome from beginning to end. It means creating a fail-safe value chain with far better transparency and a real-time understanding of what is going on with every patient throughout the course of their therapy at any point in time.
This translates into an interoperable system connecting each participant along the value chain and forming a collaborative arena, one that minimizes dangerous and costly errors and accelerates access to vital, potentially life-saving therapies to everyone who can benefit from them. Rather than building duplicative data systems that create more siloes, the CGT ecosystem stakeholders can focus on what they do best: developing and delivering much needed therapies and keeping patients and health care providers informed and engaged.
For Jenny the case worker, this translates into up-to-date information when she needs it, allowing her to address important issues between providers, transporters and manufacturers in order to deliver the best experience for her patients. For Alfie the manufacturing manager, this means bridging the gap between manufacturing and health care providers, allowing for centralized management of treatment scheduling, sequencing and rescheduling, as well as the optimal use of manufacturing slots.
And that’s just the beginning.
Note: The case worker and manufacturing manager are fictional characters.
The views reflected in this article are the views of the author and do not necessarily reflect the views of the global EY organization or its member firms.
1Adlai Goldberg. 2020. Life Sciences. December 8. Accessed 10 March 2021. https://www.ey.com/en_gl/life-sciences/pointellis/how-collaboration-will-strengthen-the-future-of-cell-and-gene-therapies