Arevolution is coming – one that will forever change the ways that we treat some of the world's most pressing health care problems, such as inherited genetic disorders and cancers.  But is the world ready? The cell and gene therapy (CGT) industry, which has been evolving for more than four decades, is finally gaining speed. The more than 2,600 cell and gene therapy clinical trials1 in progress worldwide signal a strong wave of product approvals between 2022 and 2027.²

But these highly specific therapies come with challenges that threaten their ability to serve all the patients who need them. Unlike traditional therapies, they are not mass manufactured but tailor-made for small numbers of people or a specific individual as part of a complex process. They are difficult and expensive to administer, limiting their current availability to a small population. And their manufacture and delivery offer zero room for error.

Central to the problem is a complex supply chain that involves the seamless orchestration of time-sensitive, biological materials and information across a diverse set of disparate organizations and systems. Currently, most of this work is done manually. Making these life-saving therapies available at scale will require digital processes that operate at speed and minimize the possibility of human error.

Three years ago, when cell and gene therapies were largely in clinical trials and only a handful of patients were being treated, EY anticipated these issues and asked a fundamental question: as the speed of science outpaces digital technology, how can we help move these promising treatments into the mainstream effectively, efficiently and safely?

We brought in industry leaders to identify the pain points within the growing field and collaborate on how EY could help.

They helped to confirm EY’s vision that making lifesaving cell and gene therapies widely available required speeding up the delivery of vital, potentially life-saving therapies; minimizing costly errors; and making cutting-edge treatments more widely available to everyone who can benefit from them.

How does a big idea become reality? With an industry as diverse as the cell and gene therapy – including patients, healthcare providers that administer treatments, biopharma companies that manufacture the treatment, logistics companies that transport biological samples and vaccines, payers that fund it and regulators that oversee it – how do you ensure that each voice is heard?

The first challenge EY tackled was to bring together a wide range of players in the cell and gene therapy ecosystem and unite them with an ambitious task of defining the vision for how the new ecosystem would look and operate. What were the critical elements needed to make these therapies available to as many patients as possible? What did each player need to operate effectively?

Using EY wavespace^TM to bring the parties together resulted in EY Pointellis^TM – an open, trusted data exchange and the digital backbone that links all the key players in the cell and gene therapy ecosystem. 

The EY team responsible for Pointellis^TM used the collaborative technology and mindset of wavespace in multiple ways to make this happen, starting with a collaborative session inviting industry players to detail the walls they need help scaling to save lives through cell and gene therapies.

What that first session revealed is that a whole new level of collaboration and data sharing would be needed between patients, hospitals, logistics companies and biopharma companies. Every process needed to be tracked precisely with zero room for error. The common denominator, the missing piece of the puzzle that would enable every player of the ecosystem to perform their roles better, was a data platform that could provide secure, real-time data accessible to all, every step of the way.

In order to build this platform, the EY team drew on disciplines from across the organization in IT, data, cybersecurity, tax, legal and transactions and collaborated with alliance partner Microsoft as well as specialists in cell and gene therapies.

“EY wavespace was integral to our ability to come up with a solution for delivering cell and gene therapies at scale. It allowed us to have the people, processes and technologies ‘in the room’ to tackle this complex problem efficiently. Without wavespace, there would be no Pointellis^TM,” said Adlai Goldberg, EY Global Digital, Social and Commercial Innovation Life Sciences Leader.

After that initial meeting in 2017, the team continued to use wavespace at regular intervals to move from concept to creating a roadmap that helped to create a much-needed piece of infrastructure that will benefit the entire cell and gene therapies industry.

For example, one issue biopharma companies raised with the EY team was the desire to treat as many patients as possible through  manufacturing as many of individualized treatments as possible each day. To do this, a timely, precise turnaround is needed. However, requirements and schedules change all the time.

The wavespace team worked with Pointellis^TM to develop a scheduling app for the platform that helps manufacturers plan better and make scheduling switches promptly and easily. The tool includes visibility into patient data and the ability to trace the location of biological materials (e.g., blood, tissue) and treatments and to verify treatment outcomes.

Industry leaders also identified another key point of friction that CGT therapies must overcome: how to enable case workers to manage increasing numbers of patients. In the shift from clinical trials to mainstream usage, the volume of cell and gene therapy patients will rise from a hundred, to thousands, to tens of thousands.  Many of the current processes to handle cases are manual or require case workers to access different IT systems.

A case management app was developed to digitize the capabilities, data and analytics needed to track caseloads and manage status changes, notifications and pending requests. This will enable case workers to deliver treatments safely and on time, every time and set a benchmark for the industry in going forward.

Bringing new products to market in a digital world requires collaboration with a range of disciplines, including software sales, product development, branding and pricing, coding, data engineering, scientific research, tax, transaction and legal. It also requires agile new product development through rapid prototyping, creating minimum viable products (MVPs), testing and refinement. 

These stages are no longer linear processes – they must happen concurrently, something wavespace supported in this process by aligning teams, creating a structured way to collaborate across scrums, build out MVPs and launch products into the marketplace.

“We brought different parties together in wavespace to come up with business solutions, and Pointellis^TM offered a collaborative digital solution for the cell and gene therapy ecosystem,” said Goldberg.

As the EY Pointellis^TM team worked to equip the cell and gene therapy industry with the tools for reaching a wider swath of patients, the vision for the platform has been refined as an industry utility, helping every player in the cell and gene therapy ecosystem do their jobs better through the power of data and the speed of real-time information. In short, Pointellis^TM is about putting life-saving treatment into the hands of every person who could benefit.

For EY, Pointellis^TM represents the opportunity to contribute something of value to an emerging industry that could alter the lives of millions – for the better. For wavespace, Pointellis^TM is confirmation of the value of “the sky’s the limit” thinking, anticipating issues and needs before they arise, and working nimbly and quickly with clients to achieve success in a world of technological advancement. As Pointellis^TM shifts to market testing, wavespace is switching to helping respond to market feedback and refine the product.

The purpose of Pointellis^TM is to liberate everyone in the cell and gene therapy ecosystem to focus on what they do best – from developing new science, to delivering outstanding logistics, to keeping patients and their health providers connected and engaged.