How collaboration will strengthen the future of cell and gene therapies

As clinical science continues to deliver on the promise of CGT, how can the industry make them available and affordable at scale?

Recently, COVID-19 shined a light on the existing frailties and resilience of the cell and gene therapy (CGT) ecosystem. Shifting priorities, delayed clinical trials, lab closures and heightened risks for immunocompromised patients threatened the research, development, manufacturing and delivery of CGTs. As we explore in our report, How collaboration will strengthen the future of cell and gene therapies (pdf), we invite the CGT industry to look at collaboration and data sharing in unprecedented and forward-leaning ways.

As clinical science continues to deliver on the promise of CGTs, how can therapies be made available and affordable at scale? If the pandemic has taught us anything, it is that this can only be accomplished through an ecosystem of stakeholders working together – patients, health care providers, health services companies, insurers, payers and the biopharmaceutical industry.

As Orlando Serani, Program Lead, Advanced Cellular Therapies Supply Chain at Johnson & Johnson, put it during a recent OCTS Cell Therapy Summit panel discussion hosted by EY, “We need to collaborate at the speed of science.” For CGT, this translates into using the power of data and technology to enable an unprecedented level of cooperation, a willingness to share information and a high degree of trust – in other words, a recipe for resiliency that will serve patients and the industry now, next and beyond.

EY expects the CGT global market to grow exponentially faster than the total pharmaceutical global market, from an estimated US$3 billion annually in 2021 to an estimated US$50 billion annually in 2027. The more than 2,600 CGT clinical trials signal a wave of potential product approvals between 2022 and 2027.

To date, CGT companies have continued to raise significant financing. The Alliance for Regenerative Medicine (ARM) Global Regenerative Medicine & Advanced Therapy Sector Report states that between January and June 2020, these companies raised an estimated US$10.7 billion globally, which is a 120% increase over last year, per Biomedtracker.

While transformative, these highly specific therapies also come with challenges. They are difficult and expensive to manufacture and administer, leaving zero room for error. And they are marked by short-term treatment and curative-intended outcomes, which mean higher-than-average prices.

During an EY-hosted panel discussion on scaling CGTs at the recent OCTS Cell Therapy Summit, Sarah Dye, Senior Vice President of Oncology at Optum (part of UnitedHealth Group), stressed the need to establish new models of reimbursement for cell and gene therapies. “Improved reimbursement models should be tied to patient outcomes, align incentives across the value chain and help spread the significant costs of these treatments across multiple years. This type of payment innovation is a significant shift from today’s payment models and will take time to develop.” 

Can a more collaborative environment help the CGT industry reach its potential?

A cross-functional EY team studied each step and the connectivity points along the CGT value chain and asked:

• How can we help scale the delivery of these life-saving therapies?
• How can we work to ensure every player in the value chain knows where a therapy is at any given moment, safely and securely?
• How can we get the CGT industry to think about collaboration in ways they never before considered?

And EY worked with Microsoft to address the critical technology challenges. “Data and technology can help deliver personalized, life-altering therapies at scale and with security, accessibility, and reliability,” said David Rhew, M.D., Microsoft Chief Medical Officer & Vice President of Healthcare, Worldwide Commercial Business (WCB).  “We are working to solve the challenge of seamlessly ingesting and enriching any volume, variety, or velocity of healthcare data from one system to another to ensure that patients receive the right treatment, at the right place, at the right time.”

What the CGT industry needs is an open trust data exchange, such as Pointellis™, that links all the key players in the CGT ecosystem that have a stake in patient outcomes. Pointellis™ serves to speed up the delivery of vital, potential life-saving therapies, minimize costly errors and makes cutting edge treatments more widely available to everyone who can benefit from them.

What can we achieve by combining and sharing data in ways we never before considered?

“The global disruption caused by the pandemic has demonstrated that resiliency, agility and innovation are more possible with digitally enabled business models that have data at their core,” said Pamela Spence, EY Global Health Sciences and Wellness Industry Leader and Life Sciences Industry Leader. “It has also served as a ‘hinge moment,’ by transforming the focus to be more patient-centric, with a growing understanding that patients expect to own their own data and access it through secure platforms.”

In CGT that translates into a digital ecosystem that will be connected and open, traditional distinctions will be blurred among the players in the CGT value chain. The result will be a more responsive value chain, with reduced turnaround times and enhanced efficiency, enabling delivery of on-demand, individualized and, eventually, lower-cost therapies with high levels of control and traceability to a wider audience.

Apart from addressing the challenges and needs of the complicated CGT value chain, an open digital platform, such as Pointellis™, provides an opportunity to create a more highly personalized, patient-centric experience, now and in the future. Shared information, trust and an unprecedented level of collaboration among the players will not only mean faster, more efficient and accessible treatments, as organizations dramatically increase success rates and lower costs, but more successes will also lead to different treatment options that will offer patients more choices specific to their needs, both medically and financially.

The mission

At EY, we want to help make cell and gene therapies available to every person and family that can benefit. By harnessing the transforming power of data, technology and stewardship of information, solutions such as Pointellis™, allow everyone else in the ecosystem to focus on what they do best – from developing new science, to delivering outstanding logistics, to giving patients the best medical care possible.