EY approach

A cross-functional, multidisciplinary EY team that included EY wavespace™, an EY growth and innovation center connecting people, solutions and technology to tackle complex challenges, studied each step and connectivity along the CGT value chain. It asked: what issues could arise? What changes are required to address them? The team leveraged EY’s multidisciplinary capabilities and diverse geographies and experiences to further define and solve this complex problem.

Identifying challenges at every step of the CGT process – for example:

• Genetic sampling and sequencing: core to an individualized treatment may be the collection of a patient’s blood and tumor biopsy, analysis of their genetic makeup, identification of genetic mutations in the tumor and development of a therapy that targets those genetic mutations. How does the industry conduct genetic sequencing at the required level of specificity and commercial scale to serve a global market?

The question was: how do we create an environment where that could exist?

• Transportation logistics: Moving not just patient samples but very large amounts of patient data safely and securely is a central challenge to implementing individualized therapies. For instance, crossing national borders means crossing different jurisdictions, which may have different regulations pertaining to the movement of data, tissue and therapeutic products. 

The question was: how do we allow end-to-end operations to exist across different legal entities and regulatory guidelines? 

• Administration of therapies: Traditionally, the same cancer drugs were administered to thousands of people, with treatments being manufactured and then distributed to the medical centers for mass distribution. But when treatments are created for a specific individual, the timely flow of information becomes far more complex with the involvement of many more stakeholders. 

The question was: how can health systems and oncologists handle receiving, storing and administering individualized therapies for every patient?

• Care management: As life expectancy after cancer diagnosis and treatment continues to improve, there is growing recognition of the need to address patients’ health and wellness, emotional and psychosocial needs from the time of diagnosis through treatment and survivorship. 

The question was: how can we leverage the large body of patient data to create an end-to-end care management system that engages and empowers patients and improves their overall health and quality of life? 

The EY team also conducted market research of more than 450 professionals (practicing oncologists, oncology thought leaders, health care providers, payers and other stakeholders) across multiple geographies (the US, France, Germany and Spain), to better understand the current care management paradigm and determine needed behavioral and process change from patient, health care, manufacturing, intermediary and reimbursement standpoints. 

Building a fully connected infrastructure of data, capabilities and services with Microsoft

Working with Microsoft, EY LLP developed a private, secure broad services information platform to help enable the reliable delivery of individualized therapies for cancer and other chronic diseases. 

We call it Pointellis™.

Pointellis™ introduces new industry data capabilities focused on enabling six core functional areas of the digital ecosphere:

1. Biometric chain of identity and custody, to track and trace biopsy tissue and blood samples from point of care when the patient first enters the system, all the way through medicine administration;
2. Supply chain, to allow for enrolment, scheduling, demand and capacity planning as well as coordination of logistics and delivery;
3. Patient engagement, to share appropriate information and keep the patient engaged through the waiting process as well as provide disease management information;
4. Care management, to provide oncologists and health care providers who treat and support these critically ill patients with up-to-date information and decision support based on the wealth of data captured through the platform;
5. Health outcomes, to measure more accurately and allow providers, health systems, payers and manufacturers to adapt treatment and maximize clinical benefit; and,
6. Funds allotment, to manage the complexities of paying all who are involved with the successful treatment of a patient.

“Combining EY and Microsoft’s experience was fundamental to developing Pointellis™, which connects the many stakeholders involved in providing individualized treatments,” says Goldberg, “Pointellis™ enables a supply chain as individual as the treatment itself, one for each patient. It safeguards the chain of custody and identity, validating every handoff from patient through to manufacturer and back again, and ensuring patients are treated safely and securely.”

EY teams are working with organizations across health, life sciences and other sectors to make cell and gene therapies available at scale. We’re helping them understand the role they play in this new era of health care and what it takes to get there. We’re using our expertise in business model design, information flow and data analytics to help them develop and shape the ecosystems that CGT requires. And we’re continuing to build the information platform needed to make these ecosystems work for patients: Pointellis™.

Our hope is that by providing this trusted platform, we’re liberating everyone else in the 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.

“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 and 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 health care data from one system to another to ensure that patients receive the right treatment, at the right place, at the right time.”

Leaders who embrace this potential now and actively come together won’t just change the lives of people with cancer and other serious diseases. They will put their organizations at the forefront of next generation health.

By providing a digital backbone, Pointellis™ is facilitating the transformation of the cell and gene therapy industry and allowing stakeholders to collaborate in unprecedented ways. These connections will promote the continued growth and success of the industry as it moves to greater level of commercialization, with the EY organization playing a central role.

Please visit Pointellis^TM  to learn more.