Harnessing the power of cell and gene therapies will require a next-generation level of collaboration not seen before the COVID-19 pandemic.

In brief

• Before cell and gene therapies can meet increasing demand at the necessary speed and scale, the industry must address key challenges.
• A fractured supply chain, complicated manufacturing and unprecedented pricing are among the barriers that threaten cell and gene therapy (CGT) universal accessibility.
• With human lives at stake and little time to lose, the CGT industry must evolve into an interoperable ecosystem with collaboration at its core.

The pandemic showed us that when the world needed it most, the biopharma industry delivered, relinquishing silos and producing rapid vaccines, diagnostic tools and therapeutics to fight a common enemy. Corporate individualism gave way to teamwork, altruism replaced egoism and collaboration trumped competitiveness. But can the industry build on this momentum to scale transformative CGTs for cancers, inherited genetic disorders, autoimmune diseases, and chronic illnesses? 

In our report, Industrialized collaboration: the key to scaling advanced therapies (pdf), we explore the challenges to making the expected profusion of CGTs universally accessible, and why an industrialized level of collaboration – one that is woven into the fabric of the CGT industry – is needed.1

Chapter 1

Challenges to universal accessibility

CGT therapies are complex with many steps resulting in many hurdles for the CGT industry.

Unlike “1 for Many” treatments that have a one-directional supply chain – from manufacturer to distributor to medical facility to patient, “N of 1” CGTs are more difficult and expensive to produce, with a bidirectional supply chain involving nearly triple the number of steps. Autologous CGTs, where a patient’s own blood or tissue is transformed into a therapy, are especially complicated and present the most risk if there is a single misstep. They depend on upwards of 40 coordinated digital and analog handoffs between disparate teams of health care providers, manufacturers, third-party logistics companies (3PLs) and insurers and payers.

When steps, stakeholders, and systems multiply, there are bound to be issues and delays. Today, patients must wait an average of six to eight weeks for treatments, and 90% of therapies may not be delivered as originally planned. Imagine what will happen when the thousands of CGT patients today evolve into hundreds of thousands by decade’s end. In addition, CGTs come with high price tags, testing the limits of current reimbursement strategies.

For several years, as part of its purpose of “building a better working world,” EY has been studying the CGT landscape and collaborating with private and public sector stakeholders worldwide to identify and manage issues that threaten CGT scalability. Acting as both a convener and advisor, EY has embarked on what it now calls the “industrialized collaboration movement to advance CGTs.”

EY identifies three key hurdles for the CGT field:

• Eliminating supply chain friction points
• Streamlining bespoke manufacturing
• Making therapies affordable

Eliminating supply chain friction points

A recent EY qualitative survey of CGT supply chain representatives from leading manufacturers, hospitals, 3PLs and payers identified specific supply chain pain points. The majority of interviewees agreed that the CGT supply chain is fragmented, labor-intensive and lacking in standardization, with 75% citing too many different software systems that don’t “talk” to each other as a significant problem. As such, the absence of real-time visibility along the patient and therapy journey is a significant threat, especially as therapies scale. In order to ensure that the right patients receive the right treatments at the right time and place, hospitals, manufacturers, logistics providers and payers must integrate and accommodate each other’s workflows while maintaining a secure chain of identity and chain of custody. Most survey participants called for better collaboration and industry standards – including a unified digital platform – to cost-effectively and safely facilitate the anticipated high-volume distribution of the near future.

Streamlining bespoke manufacturing

Now that patient numbers are small, CGT manufacturing processes are highly manual and require numerous skilled operators. With the expected increase in patients, the industry is focused on solutions that scale at 1,000 times the current rate. Automation and technology are going to be key to streamlining processes and reducing manpower and risk. Moreover, more and more manufacturers are realizing the power of collaboration in keeping up with the continued influx of new therapies, material demands and processes.

Making therapies affordable

While CGTs can deliver tremendous value, they typically come with high price tags, coupled with uncertainty around response durability. Current models of drug pricing, which are based on utilization, don’t work. CGT companies and payers are considering new payment models, such as: outcomes- or value-based contracts (OBCs/VBCs); “drug mortgages”; and subscription-based models.2

Chapter 2

Industrializing collaboration

The cell and gene therapy industry recognizes the need to embrace a culture of collaboration.

In the latest of its ongoing discussions with advanced therapy stakeholders, the EY organization hosted a June 2021 Reuter’s webinar titled, “Develop a Collaborative Delivery Network for Cell and Gene Therapies.” A panel of four professionals from the CGT supply chain – representing biopharma, manufacturing, logistics and technology – shared their thoughts with the moderator, Adlai Goldberg, EY Global Digital, Social and Commercial Innovation Life Sciences Leader.

A good part of the conversation centered on the need to embrace and instill a culture of collaboration. An audience poll revealed that 97% of attendees agree that greater levels of collaboration in an industry that is inherently competitive are essential to successfully scaling CGTs, and nearly a third cited industry culture as the biggest barrier.  

Panelists stressed the importance of building it together, with “functioning interoperability” as its goal and digitization at its core. Said Goldberg, “Scaling next generation therapies requires a next generation effort, something we call Industrialized Collaboration. Where collaboration is woven into and through the fabric of the CGT industry.”

To help facilitate a collaborative CGT ecosystem, EY, with input from global biopharmaceutical companies and other CGT supply chain members, 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. Such a platform can give these stakeholders the ability to bring more life-saving therapies to those who will benefit in a more rapid and efficient manner.

Chapter 3

The future: a vision of an interoperable ecosystem

EY’s industrialized collaboration movement has a single purpose: help CGT universal accessibility.

Evolving from the popularized “co-opetition,” which combines competition and collaboration, to “co-opportunity,” which focuses on doing the right thing to create opportunities for all involved, the “industrialized collaboration” movement has a single purpose: to help ensure CGT universal accessibility. Its vision is one of an interoperable CGT ecosystem, including:

• Increased supply chain robustness through digitization and connectivity
• COVID-19-level collaboration, trust and information/resource sharing
• A smooth patient journey for all who can benefit

The COVID-19 pandemic brought out the best in the biotechnology field, and now the CGT ecosystem has an opportunity to industrialize collaboration to match their transformational innovations, including:

• Driving standards and efficiencies in a value chain that decreases the probability of issues, errors, and delays, and lessens time-to-therapy delivery
• Building out digital capabilities that are not duplicative and allow for an interoperable digital ecosystem
• Designing optimal manufacturing and delivery processes through consortia composed of industry and regulatory representatives
• Experimenting with new payment models and finding ways that both incentivize innovation and help ensure equitable distribution of therapies
• Deciphering how to monitor patients long term
• Seeking the input of all stakeholders, including patients and patient advocates

Chapter 4

Join the movement

Leaders who actively collaborate for progress in CGTs will make a positive and lasting impact.

How EY can help

Pointellis™

Pointellis™ is an open, trusted data exchange platform and suite of applications that links all the key players in the cell and gene therapy (CGT) ecosystem involved in the patient’s treatment journey.Read more

CGTs have shown tremendous promise for fighting serious diseases and the industry is in its infancy. Leaders who not only embrace the full potential of CGTs, but actively collaborate for progress, will make a positive and lasting impact on the lives of people with serious diseases and inferior lifestyle conditions. In doing so, they will put their organizations at the forefront of next generation health and change the course of medical history.

At EY, we want to help the cell and gene industry make these 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.

Connecting participants in the CGT supply chain

Pointellis™ is an open, trusted data exchange platform and suite of applications that links all the key players in the cell and gene therapy (CGT) ecosystem involved in the patient’s treatment journey.