How should Americans receive their health care?

It’s a question hotly debated by doctors, patients and policymakers alike. And while the solution is certainly complex, it’s hard to argue against the idea that personalized health care must be key to the equation. Personalized health care goes beyond the one-size-fits-all approach to treating patients by considering each individual’s unique clinical history, genetics, and biological makeup to determine the best path of treatment. The results lead to better patient outcomes with fewer negative side effects.

But personalized health care is not just the treatment of the future, it’s the treatment of today thanks to the efforts of biopharmaceutical leaders like Genentech working on scientific discovery and policy reform to transform the ways we practice heath care.

“The spirit of personalized health care is about improving the lives of every type of patient, delivering solutions that benefit patients and the health care system as a whole,” says Alexander Hardy, chief executive officer of Genentech, a company that has helped lay the scientific groundwork for personalized health care.

Since the introduction of targeted therapies, new technologies for mapping the genome and interrogating disease biology have opened the way for safer, more effective medical treatments. As new types of data emerge, digital health tools and sophisticated analytics approaches are paving the way for unprecedented advances in science and technology. But we still have a long way to go. Today, only 15 percent of cancer patients are currently being comprehensively profiled – and more than 50 percent aren’t getting any testing related to their disease. Companies like Genentech hope to drastically increase access to life-altering, biomarker-driven therapies.

“There’s an evolution happening within our industry related to data and technology,” Hardy says. “We have an opportunity to extend this approach to help people by accelerating the discovery of new treatments, achieving earlier diagnoses and allowing for easier access to medicines – resulting in improved outcomes across the board.”

Dr. Mark Lee is global head of Personalized Health Care, Product Development at Roche and Genentech. He leads one of the teams in the company working to understand how to leverage vast amounts of data from multiple sources and incorporate it into the discovery and development of new potential treatments. We sat down with Dr. Lee to find out how Roche and Genentech are working to deliver this next generation of the best possible care for patients today, and for many decades to come.

How have recent scientific and technological advancements disrupted the delivery of health care?

Scientific and technological advancements are allowing us to leverage the vast amounts of data that we can access to help patients receive the right treatment at the right time. Not every patient responds the same way, and it is incredibly challenging to predict who’s going to benefit from which medicine and how. But there is now more data per patient than ever before, allowing us to hone-in on the subtle differences that make each of us unique to deliver more personalized treatments that can yield better outcomes.

The technologies around DNA sequencing – such as “next generation sequencing,” which uncovers the molecular make-up of our genes in normal and diseased cells in the body – provide tremendous insight into the genetics of each individual’s disease. To this end, we have partnered with Foundation Medicine to help physicians discover targeted therapy, immunotherapy or clinical trial options for patients facing advanced cancers. This work has led to the launch of multiple clinical trials, like CUPISCO, to test the safety and efficacy of genomically-driven therapies, potentially revealing new treatment options that these patients may not have even previously considered.

The emergence of machine learning approaches has also opened up tremendous opportunities to gain new insights from the vast troves of medical imaging data collected every day. While human interpretation of imaging studies like retinal scans, CT scans, MRI and tissue pathology are critical to current delivery of quality care, the application of advanced analytics methods to imaging data has huge implications for patients. It can help us learn how best to treat individuals by predicting how aggressive a disease or how effective a treatment is likely to be.

And then another opportunity is, of course, the use of digital tools like smartphone apps and wearables which allow us to paint a much richer picture of each individual and reveal how these pictures vary over time. Floodlight is a smartphone-based sensor that we are developing to detect changes in neurologic function in multiple sclerosis (MS) patients. When we couple that with patient outcomes captured across large populations, we are able to understand differences in a person’s biology and likelihood of disease progression and response to treatment.

THE PROMISE OF PERSONALIZED HEALTH CARE

Personalized health care can transform patients’ lives by delivering care tailored to the individual. It enables us to prevent, diagnose and treat patients more effectively and quickly.

PAST

It used to be that patients who suffered from a broad category of disease were treated with the same medicines, leaving physicians to puzzle over why they worked for some people and not others.

PRESENT

Now, scientists have begun to understand, target and diagnose illnesses on a molecular level and our approach to treatment has fundamentally changed. However, our understanding of medicine continues to grow every day.

FUTURE

In an era of digital technology, we will be able to increasingly tailor medical treatment to the needs of individuals and small groups of patients. Far more information will be captured, stored and analyzed to learn how diseases manifest themselves and how patients experience them day-to-day. Combined with a deeper understanding of molecular science and new methods for diagnostics, this development will change how we research and develop medicines.

How does a robust digital health platform help to put patients first?

Roche and Genentech are uniquely positioned within the pharmaceutical industry with our long history of expertise in personalized health care, the scale of our R&D efforts, and the diversity of companies across the Roche Group. These teams include experts in discovering and developing diagnostics and medicines, as well as in genomic profiling, imaging analytics, real-world data and software tools. As such, we are involved across the health care spectrum, from prevention to disease monitoring and potential treatments.

Parts of the company are working to develop digital technologies, including software as a medical device. We don’t want these devices to only provide interesting information, but instead to provide actionable information for every person that uses them. We want these tools to meet a high bar for validation and supporting clinical evidence for utility, such that patients and health care providers can integrate all of these tools as part of their routine care. That’s really where we need to go if we want patients to benefit from these technologies.

How are you leveraging the power of data to revolutionize and improve care?

We’ve made investments and established great collaborations to try to understand how best to tap into the expertise that’s out there. One of our approaches to personalized health care is informed by data that we collect from multiple sources, including clinical trials as well as real-world data sources such as electronic medical records. This allows us to look at patients who receive care in all different contexts – patients of different ages with different chronic conditions, patients with different genetic backgrounds, races and ethnicities, and patients with varying experiences and lifestyles. We want to bring all of that information to bear as a complement to what we’re doing with our own trials.

Through real-world data in oncology, patients and doctors can now examine medicines for their efficacy across patient populations that are more fully representative of the general population. Our acquisition of Flatiron Health has helped to facilitate this. We began collaborating several years ago and have learned together how to get this data to the point where we could draw some really powerful conclusions that enable medicines to be proven for their efficacy and then made accessible to patients not only in the U.S., but also around the world.

What is unique about personalized health care in the U.S. compared to other developed countries and what impact does that have on how Genentech approaches personalized health care?

The U.S. is a leader in scientific and technological innovation and has an amazing track record in introducing data analytics and digital technologies across a number of industries. We do have a complex health care system with private and public payers—a system where a lot of the information on patients in the real world is fragmented.

As a global company, Roche and Genentech are able to work across borders to learn quickly with our partners in the U.S. and abroad about which approaches work best and what needs to be put in place to ensure that our science, data and digital health technologies are fully brought to bear to serve patients. We see an increasing appetite across health care ecosystems to learn from this data together to allow our strategies to work across developed countries and eventually globally.

A PERSONALIZED APPROACH TO ONCOLOGY

Genentech partner organization, Foundation Medicine, is a molecular insights company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.

Through comprehensive genomic profiling and molecular insights, Foundation Medicine is able to identify the genomic makeup of a patient’s tumor and then match him or her with relevant treatments such as targeted therapies, immunotherapies or clinical trials.

This conversation with Cindy Perettie, CEO of Foundation Medicine, explores the impact that genomic testing and molecular insights can have for patients and examines how cross-sector collaboration is transforming the future of personalized health care.

Where do you see personalized health care working best today? And in what ways is personalized health care pivotal to the future of medicine in delivering better, long-term patient outcomes?

The field of oncology has had a head start in personalized health care because of the great work, including that from our research and early development groups, to elucidate tumor biology and accelerate biomarker development. Our partnership with Foundation Medicine has allowed us to understand an individual’s specific disease and how best to treat it. In some powerful examples, that allows us to bring novel, highly effective targeted therapy to patients.

One example of this is a specific gene called ALK-1. Research into this specific gene has spurred broader use of deep tumor molecular profiling and is leading personalized approaches based on the individual biology of each person’s cancer and much better patient outcomes as a result.

Ophthalmology is another area where we’re seeing great potential for improved patient outcomes through personalized health care. When we apply artificial intelligence and deep learning approaches to images of the eye, we are gaining insights into whether a given patient with a retinal disease, such as that resulting from diabetes, will progress. For two patients who look similar to the conventional assessment by the ophthalmologist, we are finding that the AI-based algorithms can pick up additional information that tells us a different story: We are learning how to tell if one patient is going to lose their vision in the next two years and the other will not, or if one patient will require intensive treatment for a whole year while another may only need a few doses. This potentially allows us to tailor therapeutic strategies—intensifying treatment for the more aggressive disease and maybe taking a less aggressive approach for the other.

What barriers still exist that prevent companies like Genentech from realizing the full potential of personalized health care?

A critical element to these approaches is the availability of “meaningful data at scale” — data that’s going to be fit for the purpose of answering these scientific and clinical questions. The data has to have the right depth (the types of data and amount of data per patient) and the right breadth (the number of patients with such data) across the population. And most importantly, it has to have the right level of quality, which has been a major challenge.

Much of the real-world data generated today is done in different ways, in different parts of world, and in different centers. Without having the depth, breadth and quality, we can’t draw the necessary robust scientific conclusions. We know that there is a requirement for data of this type at very large scale in order to develop these algorithms and ultimately validate them to the appropriate standards. The algorithms need to have that kind of validation in order for doctors to apply them in everyday practice and deliver the right kind of care to patients.

What is the best approach to achieving this level of credibility with the data?

It’s impossible for any one entity to do this alone. You really need to bring in partnerships, not only with other companies, but also with the other important health care partners, including doctors, patients, academic institutions, regulators, payers and governments. These innovations aren’t going to be integrated unless we address the whole ecosystem.

Our partnerships with Foundation Medicine and Flatiron Health, for example, have helped accelerate the creation of a real world, de-identified clinico-genomic database linking the genomic data from Foundation Medicine to the clinical outcomes data from Flatiron Health that provides scientifically and clinically meaningful real-world longitudinal insights. We also work with other key stakeholders in the health care ecosystem, including regulators and policymakers; as an example, we partner with the Duke-Margolis Center for Health Policy Real-World Evidence Collaborative, which is helping to accelerate the use of real-world evidence for regulatory decision-making.

Lastly, Roche and Genentech are committed to Advancing Inclusive Research™. We developed an external council of leaders from various organizations focused on inclusive research, including the LUNGevity Foundation, a nonprofit dedicated to improving patient outcomes via research, patient support and education. The council advises our efforts and are collaborating with these thought leaders to explore solutions that enrich data heterogeneity by broadening inclusion of ethnic and racially diverse patient communities in our clinical research programs.

What excites you the most about the future of health care?

For physicians and patients to know that they have the best knowledge and information available to provide and receive the best possible care. Historically, doctors didn’t have as much information on the patients as they would have liked, and didn’t have the tools to rapidly synthesize all of a patient’s data and integrate with the exponentially growing, real-time medical knowledge. Now, we have tools to help oncology care transform large data sets into actionable insights that support individualized treatment decisions. Technology is taking the burden off physicians and off the health care system by making it much more streamlined, while allowing us to push the frontiers of personalizing patient care and optimized individual outcomes.

I think about my own time in the clinic; the most important time that you have is being able to interact with the person in front of you – examine, listen to and converse with your patient. If we can make more of that time meaningful, we will have done a huge amount to address the challenges in care that exist today.

I think it is incredibly exciting to be able to have greater confidence that you’re doing the absolute best by your patients, and for patients to know that they’re getting the most sophisticated care possible no matter where they are.

Profound advances in science, data and technology – and a new, holistic approach – are allowing us to deliver the benefits of personalized health care to every part of the health care ecosystem.

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