Guest Blog
by Paul Hudson

Paul Hudson, President, AstraZeneca U.S. and Executive Vice President, North America

I’ve had the privilege of working in biopharmaceuticals for more than 25 years, and over that period of time I’ve witnessed remarkable progress and breakthroughs in science and the development of innovative medicines. From HIV/AIDS to cancer to heart disease, new therapies have improved health outcomes, extended life expectancy and enabled a better quality of life for patients. For example, since peaking in the 1990s, cancer death rates have declined nearly 22 percent,¹ and today, two out of three people diagnosed with cancer survive at least five years. In lung cancer specifically, in the last four decades, the survival rate is up by 54 percent.

Despite the great progress, however, there are still only 500 treatments available for roughly 7,000 known diseases. To close that gap we must work toward new and innovative ways to engage with patients more effectively. With personalized medicine we have the exciting opportunity to identify, target and engage with patients more effectively. An even greater opportunity for individualized treatment exists when we look beyond disease states and see patients as partners, not as data points.

For example, we now know that cancer is not a single disease, but rather more than 200 unique diseases, many of which are caused by genetic mutations. As the biopharmaceutical industry investigates and earns FDA approval for more targeted therapies in oncology and other disease states, the benefits are clear: better diagnoses, fewer adverse drug reactions, increased patient adherence, improved quality of life and, ultimately, significant savings in overall U.S. health care costs.

Scientific advances, healthy market competition and better information-sharing — and the potential benefits for every stakeholder in our health care system — are all driving the industry toward increasingly personalized health care solutions. Last year alone, 20 percent of FDA approvals were for targeted therapies. At AstraZeneca, more than 80 percent of our pipeline has a personalized medicine approach, and the FDA has approved two new AstraZeneca medicines in just the past 12 months that align with an FDA-approved diagnostic to detect specific mutations.

As remarkable as recent progress has been, in the next quarter century we have the opportunity to produce even more astounding medical breakthroughs, including treatments that transform our current perception of cancer to no longer be a death sentence, but rather a chronic condition. However, realizing the promise of personalized medicines, for patients in need of innovative treatments right now and for future generations, requires more than great science. Our nation’s regulatory framework, clinical trial designs and traditional approaches to insurance coverage and reimbursement haven’t kept up with the pace of advancing medical science.

Initiatives proposed over the past year by the Administration and both houses of Congress are promising in that they address some areas where modernization is desperately needed. Progress also requires exceptional collaboration by health care providers, payers, the government, researchers and even patients. Biopharmaceutical companies share that accountability, too, especially in articulating the value of targeted therapies to payers and providers.

We have some competing interests, to be sure — competition is good business, and in our business, healthy competition inspires the development of new, innovative medicines that address unmet patient needs or improve the current standard of care. Yet everyone with a stake in health care has common interests as well — most notably the heath and well-being of patients, who are also our friends, families and often ourselves.

The bar has never been set higher for the health care industry as a whole to pursue innovation collaboratively. We’re moving faster than ever before and change is rarely easy, but I’m confident in a bright future ahead, for the health care industry and the millions of patients counting on us.

I look forward to discussing these immense opportunities before us, and hearing others’ views on how we can progress personalized health care solutions, at the Personalized Medicine Conference in Boston next month.

1 National Cancer Institute, Surveillance, Epidemiology and End Results Program

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Paul Hudson
President, AstraZeneca U.S.
Executive Vice President, North America

Guest Blog
by Katherine Johansen Taber, Ph.D.

American Medical Association Director of Personalized Medicine Katherine Johansen Taber, Ph.D.

Great excitement accompanied President Obama’s announcement early this year about the Precision Medicine Initiative’s (PMI) aim to “bring us closer to curing diseases like cancer and diabetes and give all of us access to the personalized information we need to keep ourselves and our families healthier.” Indeed, the hallmark projects of the PMI — the establishment of a large national research cohort and an emphasis on better molecular characterization and targeted treatment of cancers — are essential and promising steps for the widespread adoption of clinical care that is informed by patients’ unique genetic, environmental and lifestyle factors. In the immediate future, the PMI is an ambitious research initiative with the goal of improving the nation’s health. However, it is not clear how physicians, along with the patients they care for, will be affected by the PMI in the long term or how they can contribute to its goals.

To date, many in the health care community have only heard of the PMI but do not know how they can become involved, how it will impact their daily routine or how they might prepare themselves for its impact. Most physicians likely believe that they have already been practicing “precision medicine” (i.e., they manage each patient according to his or her unique symptoms, medical and family history and preferences). A number of articles in prestigious medical journals have introduced the PMI, but as the initiative progresses, continued outreach to improve awareness among the health professional community is needed.

The involvement of more than 1 million participants in the national cohort means that it’s quite likely that physicians will have clinical encounters with participants and could view and use their patients’ genetic and other health data to inform the patient’s ongoing care. They also could have the opportunity to recruit patients to become part of the cohort. Successful PMI research projects that are translated into the clinic will result in additional genetic and digital data that could influence patient management. But for these data to have a positive clinical impact, physicians need the skills and tools to use them in a meaningful way.

An important opportunity now exists to engage practicing physicians in unlocking the promise of precision medicine. The pace of genomic discoveries and subsequent clinical implementation has been so rapid that even those beginning practice just 10 years ago missed out on contemporary genomics training in medical school. In addition to this educational demand, the majority of physicians in practice have other competing demands on their time, including implementing new delivery models, participating in quality reporting initiatives, fulfilling meaningful use requirements and utilizing new digital medicine technologies. Consequently, as the PMI begins, initiatives are urgently needed to create genomics resources and tools that are integrated into clinical practice, enabling non-geneticist physicians to become proficient in practicing precision medicine. As newer generations of physicians are trained, they too need enhanced skills for practicing precision medicine.

The American Medical Association (AMA)’s Accelerating Change in Medical Education initiative is working with medical schools toward that goal by equipping students with skills that will foster lifelong learning and the ability to anticipate and adapt to future change.

The health data collected as part of the PMI’s national cohort has the potential to significantly impact clinical care — if it is accessible and meaningful to physicians. Robust and interoperable electronic health record (EHR) systems must be able to access and display longitudinal health data from each patient, no matter where that data is stored or whether it has been collected as part of the cohort project or by another health professional. Similarly, clinical decision support that will enable application of the data to care management is an essential component. However, many EHR systems in use today do not have such capabilities.

Further, physicians are frustrated with the usability of EHR systems and report that they sometimes hamper safe and effective care. The PMI has tasked the Office of the National Coordinator with the development of interoperability standards, yet it allocated only a small amount of money for this work. A much larger investment is needed, along with the collaboration and commitment of industry, research and clinical stakeholders to work toward EHRs that facilitate care based on promising outcomes from PMI and other research projects. Related to that goal, the AMA has identified eight usability priorities that are needed to ensure that EHRs contribute to improved clinical care.

The physician and health professional workforce will be on the front lines of delivering care informed by the PMI. The importance of ensuring that they have the educational and health IT resources needed for such an endeavor cannot be overstated. The PMI should make it a priority to gather input from the health professional workforce throughout the initiative, both to assist in the planning stages and to drive excitement and willingness to participate and adopt promising findings. The AMA believes precision medicine holds great promise for addressing some of the most vexing medical problems and looks forward to working with PMI toward the success of the initiative.

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Katherine Johansen Taber, Ph.D.
Director, Personalized Medicine
American Medical Association