The anticipated rise in cancer cases can be attributed to people living longer; growing exposure to risk factors, especially in low- and middle-income countries; and an expected increased incidence among younger people.

While we haven’t yet won the war on cancer, we are winning some battles. Over the past 30-plus years, survival rates have doubled, and people are living longer with cancer than ever before. Novel treatments are helping patients delay the worsening of their disease or lower the chance of recurrence, while improving their overall quality of life.

On the scientific front, we are witnessing what experts are calling a “golden age” of cancer research and discovery. We know that cancer is not one, but many diseases – more than 200 in fact. And our knowledge and management of those diseases is increasing at a rapid pace.

Some of the most exciting, life-changing possibilities for patients with cancer and other serious illnesses are in cell and gene therapies (CGT). Cell therapy aims to treat disease by restoring or altering certain sets of cells or by using cells to carry a therapy through the body. Gene therapy replaces, inactivates or introduces genes into cells. Therapies that are considered both cell and gene therapies alter genes in specific types of cells and insert them into the body.

In addition to being difficult to create and administer, cell and gene therapies are also very expensive and only available to a handful of people. EY examined how it could help transform the treatment of oncology and other serious diseases by enabling highly effective and efficient delivery of individualized therapies at commercial scale.

The EY team leveraged its strengths with data, technology and trust to develop a fully connected data infrastructure — Pointellis™ — with associated capabilities and services. This digital backbone expedites a flow of information along the end-to-end value chain, helping patients to receive the care they need while revolutionizing patient outcomes.

This data infrastructure will speed up the delivery of these life-saving therapies, minimize costly errors, avoid duplicative systems costs and make them available to everyone who can benefit from them.

Health outcomes that were once unimaginable are now within reach.

“Individualized therapies can dramatically improve outcomes in cancer and alleviate the burden of these catastrophic diseases,” says Pamela Spence, EY Global Health Sciences and Wellness Industry Leader. “This is not just a game changer for cancer care but has the potential for application in a number of other very debilitating diseases.”

Gene therapy has been a work in progress for almost 40 years, but it is now experiencing an acceleration. In 2017, the U.S. Food and Drug Administration (FDA) approved the first gene therapy treatments. While 2019 only saw one approval, the agency expects to see a doubling of new gene therapy applications every year. Scott Gottlieb, the former FDA Commissioner, predicted that by the year 2025, the US will be approving between 10 and 20 different gene therapies every year.

However, the evolving cancer treatment paradigm from a mass market (1-for-Many) to an individualized (N of 1) poses significant challenges that will multiply as CGT options and their usage increase.

“These treatments use the patient’s own blood or tissue, which is transformed into a personalized therapy and then reinfused. There is no room for error – the system must deliver the right drug for the right patient at the right time and right place, every time,” says Adlai Goldberg, EY Global Digital, Social and Commercial Innovation Life Sciences Leader.

The operational requirements for individualized care

The only way to make cell and gene therapies a reality at scale is to create an ecosystem of different stakeholders working together and sharing data and information they all trust. This includes patients, health care providers, health services companies, insurers, payers, and the biopharmaceutical industry. No single player – regardless of how smart or well-funded – can do this alone.

Truly individualized care requires an error-free outcome from beginning to end. It means creating a  value chain with far better transparency and a real-time understanding of what's going on with every individual patient throughout the course of their therapy at any point in time. How did EY approach this challenge? By asking the right questions.

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.