How can you create one language for a patient with multiple digital IDs?

By Adlai Goldberg

EY Global Digital, Social and Commercial Innovation Life Sciences Leader

Keenly focused on capturing opportunities and managing impacts created by the digital megatrend for the life sciences clients.

7 minute read 20 Jul 2021

The cell and gene therapy industry can be strengthened by bridging the gaps in its complicated supply chain.

In brief
  • Cell and gene therapies (CGT) offer a beacon of hope to people with chronic illnesses.
  • The successful scaling of CGTs requires the right digital solutions to overcome the challenges of a complex treatment ecosystem.

A mother in her early 60s is free of non-Hodgkin lymphoma after participating in a clinical trial for the breakthrough CAR T-cell therapy (chimeric antigen receptor), a customized treatment made from her own white blood cells. 

A father in his late 20s is free of sickle cell disease after receiving a novel gene replacement therapy as part of a National Institutes of Health clinical trial.

A young boy can see after receiving a newly approved U.S. gene replacement therapy for retinitis pigmentosa, a rare form of genetic retinal degeneration that leads to blindness. 

For patients with difficult-to-treat diseases, such as relentless cancers and inherited genetic disorders, the cell and gene therapy (CGT) industry represents a real beacon of hope. With the growing number of successful product launches, strong financial backing and favorable regulatory environments, EY believes the global CGT market will experience dramatic growth in the next few years. The company predicts revenues will multiply from an estimated US$3b annually in 2021 to an estimated US$50b annually in 2027. With that, the hundreds of CGT patients today will turn into hundreds of thousands by decade’s end.

But is the industry ready?

CGTs have complex manufacturing and supply chain processes that can impact their ability to reach all the people who can benefit. Unlike conventional “1 for many” therapies that are mass produced, CGTs are tailormade “N of 1” treatments requiring the patient to be part of the supply chain. Multiple, flawless handoffs of time-sensitive, unique treatment data and biological materials (human blood or tissue) must occur securely across a diverse set of disparate organizations and information systems, each using their own digital treatment identifiers. While patient outcomes depend on getting these digital handoffs right the first time, they are subject to human error, travel delays, lab closures and even pandemics.

Closing gaps, opening doors for cell and gene therapies

To successfully scale cell and gene therapies, real-time signaling among the players in this 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 – including health care providers, drug companies and manufacturers, lab supply and equipment providers, health services companies and insurers or payers – must be able to securely communicate and share information they trust.

“When you consider all the steps and variables along the cell and gene therapy supply chain and multiply that by the anticipated growth of products and patients, you realize that unless we do something now, there could be a tsunami in store for us,” said Sean Harapko, EY Americas Supply Chain & Operations Solutions Leader.

EY teams’ research, powered by input from more than 450 professionals across multiple geographies, including practicing oncologists, oncology thought leaders, health care providers and payers, showed that what the industry needed was a cloud-based, digital platform – an open but private, secure data exchange and the digital backbone connecting each participant along the CGT supply chain. This kind of tool, such as the Pointellis™ platform created through an EY teams and Microsoft alliance, can form a secure and trusted collaborative arena that expedites the timely and transparent flow of data and materials and minimizes dangerous and costly errors. It can provide each of the participants in the CGT ecosystem with the capabilities and information they need to do their job to the best of their ability and help ensure the right treatment at the right time and right place, every time. 

“With our understanding of processes, technologies and information flow, we realized that where cell and gene therapy was concerned, science had outpaced information technology. The digital infrastructure needed to support this nascent industry was missing,” said Adlai Goldberg, EY Global Digital, Social and Commercial Innovation Health Sciences and Wellness Leader. “It’s like trying to get cash out of an ATM in any country, in any currency, without the data exchange platform that’s behind the ATM network,” he added.

Where cell and gene therapy were concerned, science had outpaced information technology. The digital infrastructure needed to support this nascent industry was missing.
Adlai Goldberg
EY Global Digital, Social and Commercial Innovation Life Sciences Leader

As the EY organization identified the specific pain points in the treatment journey, it was clear that there was a consensus within the industry that a solution was needed  to capture, govern and standardize data by decoding each unique digital ID from each stakeholder in the value chain.

Who faces the gaps in CGT?

EY organization research identified three important areas within the CGT ecosphere in which gaps could be managed with the right technology:

  1. Manufacturing
  2. Patient operations
  3. CGT logistics

Three fictional personas represent a composite of the main players, core challenges, and potential solutions for these areas.

Manufacturing managers need constant visibility across multiple orders

Alfie Ray is a manufacturing manager for a biopharma company and must optimize treatment manufacturing capacity so that more patients can benefit from potentially life-saving therapies. He must also meticulously plan to ensure all patients receive their treatments at exactly the right time. But filled manufacturing slots can free up at a moment’s notice, due to changing patient or logistical circumstances. Alfie needs constant visibility into the status of scheduled manufacturing, including the ability to analyze inbound orders and track 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 maximize manufacturing capacity?

A slot scheduling app can bridge the gap between manufacturing and health care providers, offering a new level of transparency that allows for the optimal use of manufacturing slots. A tool like this would provide Alfie with:

  • The ability to anticipate treatment journey progress
  • At-a-glance views into manufacturing status and capacity
  • Centralized management of treatment scheduling, sequencing and rescheduling

See how collaboration in the CGT supply chain works 

Explore how digital solutions can bridge the gaps in the CGT supply chain.

Read more

Patient operations case workers need to manager multiple patient treatments

Jenny Chen is a patient operations case worker for a drug manufacturer, responsible for managing the treatment journey for her patient caseload. As cell and gene therapy production involves many steps, it’s her job to resolve multiple challenges, including logistics, scheduling and human error, so that every order makes it where it needs to be, every time. Navigating multiple internal and external digital information systems, as well as manual spreadsheets and databases, increases her chances for error. If Jenny is missing information from any step in the process, she needs to search long and hard for it. This may delay a delivery, or worse, create a mix up in therapies, which could be fatal.

How can Jenny better track these revolutionary therapies if there are gaps in the process and interactions she cannot see?

A case assist app would provide up-to-date information when Jenny needed it, allowing her to address important issues between providers, transporters and manufacturers in real time. With this app, she could

  • Quickly respond to status changes, notifications and pending requests
  • Eliminate the need to manually track down information

CGT logistics managers need a central point to manage all shipments

Lucy Cordova is a CGT logistics manager. It’s her job to ensure that shipments are maintained at precise temperatures and delivered to correct destinations at the right time. Most of her deliveries have multi-stop journeys involving different vendors. With shipments in various stages and multiple vendor websites to check, it’s difficult for Lucy to get a full, precise picture of what’s happening with each life-saving delivery.

How can Lucy easily access and assess all her time- and temperature-sensitive shipments from end-to-end?

A logistics integrating app would provide holistic, real-time status of all of Lucy’s shipments across the end-to-end journey. She could review package-specific details, such as temperature, origin and destination. If there are any unusual temperature changes or delays, the shipment would be flagged — creating a “to do” list so Lucy can address issues immediately and keep life-saving treatments on track.

And that’s just the beginning. The right data platform can become the industry utility, helping every player in the CGT ecosystem do their job better via the power of data they trust and the speed of secure, up-to-date information. The power of this platform will be measured by the end result – better outcomes, no matter how large the patient population – helping to ensure that the therapies of last resort become the treatments of first choice.

Summary

As the cell and gene therapy industry grows, a successful scale and real-time signaling among the players in this extraordinarily complex supply chain will be essential. 

About this article

By Adlai Goldberg

EY Global Digital, Social and Commercial Innovation Life Sciences Leader

Keenly focused on capturing opportunities and managing impacts created by the digital megatrend for the life sciences clients.