Capitalizing on the Promise of Precision Medicine

The Personalized Medicine Coalition (PMC) is pleased that the President has announced the launch of a new Precision Medicine Initiative during his State of the Union Address. Personalized medicine exemplifies the potential of emerging science to improve patient outcomes and support efficient health delivery. We hope that this new effort will renew focus on policies that can help accelerate advances in targeted treatment, all the way from discovery though delivery.

As President Obama said during Tuesday night’s address, personalized medicine has reversed diseases once thought to be unstoppable and as a nation, we need to do more to harness the benefits of such innovative treatment advances.  The President stated, “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time.”

In order to reap the rewards of our federal investment in the human genome, innovative reforms will be necessary throughout the development process – all the way from discovery through delivery and payment for health care. Focusing on any one aspect of this complicated continuum is not enough. We have worked with stakeholders to identify policies that will accelerate these advances such as increased coordination across FDA in the review of personalized medicine products, appropriate reimbursement for the diagnostic tests that enable the use of targeted therapies and incentives for their development.

PMC has been working to secure these reforms and more in Congress through the bi-partisan 21st Century Cures Initiative and with the broader personalized medicine community to educate key stakeholders about the advances in science that are leading us to this new era in medicine. We look forward to working with both the Administration and Congress to accelerate innovation in support of better patient care, and deliver on the promise of personalized medicine.

Next Steps To Turn the Tide Against Cancer

Three weeks ago, 200+ health care leaders representing a broad spectrum of stakeholders convened in Washington, D.C., for the second conference of the Turning the Tide Against Cancer Through Sustained Medical Innovation initiative. There were intense discussions — among panelists and in the hallways between sessions — on the challenges facing cancer research and care.

Now back at our desks, the question arises, what do we want to do next — as individuals, as a community, and as a nation? And, critically, what must we do next to enable and encourage innovation in cancer research?

In 2011, Feinstein Kean Healthcare joined forces with the Personalized Medicine Coalition (PMC) and the American Association for Cancer Research (AACR) to create the Turning the Tide Against Cancer initiative, in response to disconnects within the health care system that threatened to stifle advances, ironically at an unprecedented moment of scientific progress.

We saw disconnects between patients and the health care system…disconnects between the accelerating pace of science and the slowness of change in our policy environment…and disconnects between the exigencies of driving innovation and the sober realities of a cost-contained era.

As we observed these disconnects, we also noted that as a nation we were attempting to solve complex problems while operating within traditional vertical silos (e.g., patients in patient advocacy organizations; physicians in physician professional societies; researchers in scientific societies) rather than cross-sector collaborations.

And so, we sought to catalyze the entire cancer and health policy community towards action by connecting all stakeholders through the Turning the Tide Against Cancer initiative. Uniquely, stakeholders from across the cancer ecosystem have been represented in all events and deliberations of the initiative.

Now, building upon several years of intellectual exploration, research, dialogue, debate and the deliberations of the broad range of experts that produced the Issue Brief, “A Pathway for Change: Supporting the Shift to Patient-Centered Cancer Research and Care and Addressing Value and Cost of Cancer Care” released at the conference, we ask again, what’s next?

I propose that every individual touched by cancer, and every organization concerned about the nation’s cancer burden, take responsibility for three actions.

1. Review the Issue Brief, and share your thoughts/ideas about the policy options and/or propose other options.
2. Involve your organization in the Turning the Tide Against Cancer Through Sustained Medical Innovation initiative, by participating in our activities and events.
3. Join our partners PMC and AACR and advocate for those options that you agree with, integrating them into your own policy platforms and your communications with policymakers in order to drive momentum and catalyze change.

In the past, individual champions such as the renowned Mary Lasker were a driving force to advance and change our approach to cancer research and care. As Dr. Len Lichtenfeld of the American Cancer Society asked following the first Turning the Tide Against Cancer conference, “Where is our Mary Lasker going to come from? …Who is going to guide this revolution?”

I believe that in this era, we are all destined and empowered to be leaders. And as I looked out at the attendees of the Turning the Tide Against Cancer conference, I saw Mary Lasker in the face of each participant. We are all Mary Lasker. We must all be Mary Lasker.

Please join us as we take the next step.

Reflections from the Turning the Tide Against Cancer Conference

Following the Turning the Tide Against Cancer national conference last Thursday, I’ve had time to reflect on what we must do next to improve how patients experience cancer care.

To make that change we must acknowledge key truths.

Science is driving us towards more targeted solutions and novel approaches to treatment. The clinical trials and regulations necessary to get new products to market must change with the science. They must be nimble to keep pace with the extraordinary advances we are seeing.

Coverage and payment decisions must also allow patients access to advanced treatments and not disincentivize innovations in health care. While new products sometimes seem expensive, we must remember that costs are saved by getting the right treatment to the right patient at the outset of care.

We must educate. Each of us has a responsibility and a role to play in educating all participants in health care about the changes we are seeing in cancer. We must educate patients and their families about the complexity of decision-making and share information with them so that each patient can make informed choices. We must provide resources so health care providers are able to stay current with the latest developments in care. We also must educate policy makers to ensure that negative unintended consequences of policies are avoided.

Everyone working in health care wants to provide patients with the absolute best treatments imaginable – and those we have not yet even begun to imagine. Sometimes that will require addressing very tough questions in order for personalized medicine to be fully integrated into the health system.

Finally, we should celebrate the improvements made in cancer care from innovations in clinical trial design, to imaginative diagnostic testing of solid tumors that allow for better targeting of treatments, and tests that help physicians and patients make the best treatment choices. Advances are being made in science that are extending and improving lives. This is no small feat, and while our goals are great, we must celebrate the achievements that have taken us this far, and acknowledge the policies and pathways that made those discoveries possible.

We have an opportunity and responsibility to change the future of cancer care through continued education and advocacy. I invite you to help be a part of this change by sharing your thoughts and joining us on this journey to turn the tide against cancer.

A Patient-Centered Perspective on Cancer Research and Care

Shelley Fuld Nasso, M.P.P., CEO, National Coalition for Cancer Survivorship, addressing the role of payment reforms in supporting innovative cancer care at the Turning the Tide Against Cancer 2014 national conference (Photo: Liz Roll)

A key theme at the Turning the Tide Against Cancer national conference was the need for a patient-centered approach to cancer care. Shelley Fuld Nasso, M.P.P., CEO, National Coalition for Cancer Survivorship (NCCS), shared her thoughts on the importance of patient education, shared decision-making, and aligning a treatment plan with the goals and priorities of the patient.

Read more about Shelley’s thoughts on incentive structures that encourage innovation, as well her personal experience with cancer, and the urgent need to push discovery to help save lives on the NCCS blog.

Turning the Tide Against Cancer: Collaboration to Improve Outcomes

Over the past few weeks, the Age of Personalized Medicine editorial team has been talking to leaders from the co-convening organizations of the second Turning the Tide Against Cancer Through Sustain Medical Innovation national conference, which will be held on October 9, 2014, in Washington, D.C.

Our conversation with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research, on the need for continued collaboration across the diverse spectrum of stakeholders in the cancer community, can be viewed below.

We also heard from Edward Abrahams Ph.D., president of the Personalized Medicine Coalition and Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare, on the need for policies that encourage and keep pace with innovation in cancer research and personalized medicine.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. If you are unable to attend the conference in person, please join us via webcast on October 9 by visiting the Turning the Tide Against Cancer homepage. The Age of Personalized Medicine will also be tweeting live from the conference using #T3cancer.

Turning the Tide Against Cancer: Policies to Sustain Innovation

Leading up to the second Turning the Tide Against Cancer Through Sustain Medical Innovation national conference on October 9, 2014, in Washington, D.C., the Age of Personalized Medicine editorial team had the chance to sit down with leaders from the initiative’s co-convening organizations to talk about the current cancer research and care landscape, what progress has been made since the start of the initiative, and the upcoming conference.

Last week, we heard from Edward Abrahams Ph.D., president of the Personalized Medicine Coalition on the importance of patient-centered care and value, and the need for policies that encourage innovation in cancer research and personalized medicine in order to improve patient outcomes.

Our conversation with Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare, on the importance of enacting policies that keep pace with the rapid development of innovative cancer treatments, can be viewed below. Stay tuned for our video interview with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9 using #T3cancer.

A Preview of the Turning the Tide Against Cancer National Conference – Part 2

Leading up to the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed two questions to leaders in the cancer community who will be speaking at the event on October 9 in Washington, D.C. In part one, we asked speakers to share their insights on the role of innovation in advancing cancer research and care. The second question focused on the shift to patient-centered research and care, and how patient-centric approaches can improve healthcare.

QUESTION: What does having a patient-centered healthcare system mean, and why it is important for the healthcare system as a whole?

Here’s what some of the conference speakers had to say:

 

Patricia J. Goldsmith, CEO, CancerCare

“Consistent with the IOM definition, patient-centered care is respectful of and responsive to the individual patient’s preferences, needs and values. The days when clinicians make all of the decisions are over. Now that the consumer movement has reached healthcare, patients are becoming empowered to partner with their physicians to get the treatment they believe is best for them. The balance of power is shifting so that decision-making is shared. Within this environment, patients can fully engage in the process of developing and managing their own treatment. This is important because we know that engaged patients have better outcomes, higher levels of satisfaction with their health care, and consume fewer clinical resources.”

 

Tanisha V. Carino, Ph.D., Executive Vice President, Avalere Health

“In order to strive for a more patient-centered approach to cancer care, it is important to consider how patients are engaged in defining healthcare priorities, including identifying areas of unmet need and the types of study designs that best reflect the risks and tradeoffs they experience in care practice. Sustained medical innovation plays a central role in meeting these constantly evolving patient needs, which are particularly complex for cancer patients. Moreover, patients are now bearing much more financial responsibility for their care than in the past. The majority of exchange enrollees chose plans in the Silver metal level, which come with average deductibles up to $2,260 and maximum out-of-pocket costs reaching up to $6,350 for in-network care, according to Avalere PlanScape™ analysis. With increased financial accountability, patients, along with their caregivers, are increasingly engaged in making choices regarding the most appropriate treatment. Payment mechanisms for cancer care and new insurance products will need to keep pace with both medical advances and the financial realities facing patients and their caregivers.”

 

Amy P. Abernethy, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine; Chief Medical Officer and Senior Vice President of Oncology, Flatiron Health, Inc.

“Cancer care isn’t about cancer and cancer care isn’t about health systems.  Nor is it about research or researchers. It’s about real people who are touched by, afflicted with, and hopefully live way beyond the experience of cancer.  So fundamentally, we need to build our medical innovations with the patient in mind.  For this reason, I’ve always thought we have to have the patient at the center of our data story – where data from one patient tells a longitudinal story across a life and then it’s the data of many patients that are aggregated together to form our foundational data set to support innovation.  Similarly, patients need to be the cornerstones of our clinical trials and basic research – our muse.”

 

Newton F. Crenshaw, Vice President, North American Oncology Commercial Operations, Global Business Development and Advocacy, Eli Lilly and Company

“Patient-centered care means exactly that: treatment choices and care that reflect the preferences, needs, and values of someone with cancer, for whom each treatment decision has a profound implication on health and quality of life. Every patient’s experience is unique: for some people, progress means a better prognosis and more time spent with their families; others prioritize treatment that has fewer side effects or is easier to administer. Ultimately, patient-centered care respects these differences and prioritizes the values of each individual person.”

 

Tony Coelho, Former Member, U.S. House of Representatives; Chairman, Partnership to Improve Patient Care

“Personalized and patient-centered cancer care will improve health outcomes by identifying the treatments that work best for individual patients, improving outcomes by avoiding trial and error medicine. To further support patient-centered care, policies must not limit access or push ‘one-size-fits-all’ treatment solutions. Patient-centeredness consists of a series of principles focused on patient engagement, patient activation, access to a range of treatments, and shared decision-making. Patient-centered principles must be incorporated into the early phases of evidence development, translation and implementation, as well as in the design and implementation of new payment and delivery reform models for cancer care.”

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Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9. Join the conversation with #T3cancer.

A Preview of the Turning the Tide Against Cancer National Conference – Part 1

Leading up to the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed two questions to leaders in the cancer community who will be speaking at the event on October 9 in Washington, D.C. In part one, we asked speakers to share their insights on the role of innovation in advancing cancer research and care. Check back for part two where we ask leaders to define patient-centered and explain how patient-centric approaches can improve healthcare.

QUESTION: What role does medical innovation play in paving the pathway to progress towards a sustainable and high-value, patient-centric cancer care system?

Here’s what some of the conference speakers had to say:

………………

Amy P. Abernethy, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine; Chief Medical Officer and Senior Vice President of Oncology, Flatiron Health, Inc.

“One area of important medical innovation is the generation and use of data. This is not just hype around ‘big data’ but the recognition that we need amalgamation of data streams that tell the whole person’s story. This includes information about the cancer itself, and also the individual’s personal life: their values and needs, their personal experiences, as well as biometric monitoring. The longitudinal story expressed through data can then be used to support many innovations in cancer care. It can act as a clinical annotation stream to inform biological research such as annotation of biospecimens, biomarkers and basic discovery. It can be used to optimize cancer care delivery, or used for quality monitoring and to highlight gaps in care to be resolved. It can be used to compare differing interventions to figure out what works for whom and when. Advancing high quality and sustainable medical care is dependent on innovations around the generation and use of data.”

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Newton F. Crenshaw, Vice President, North American Oncology Commercial Operations, Global Business Development and Advocacy, Eli Lilly and Company

“Medical innovation is absolutely central to advancing the fight against the over 200 types of cancer. Each new advance, no matter how small, contributes to our scientific understanding of this collection of diseases, and provides new hope and cures to people with cancer. This cycle of continuous innovation has had impressive results and generated savings throughout the health care system: since 1975, the 5-year survival rate for cancer patients has increased by about 40%. To sustain–and accelerate–this progress, our society must continue to foster and reward innovation.”

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Tony Coelho, Former Member, U.S. House of Representatives; Chairman, Partnership to Improve Patient Care

“The rapid pace of medical innovation in oncology is increasing our ability to provide more personalized, patient-centered care (based on their biomarkers, quality of life considerations, etc.). Achieving more efficient delivery of high quality care will require continued medical innovation, including development of new treatments, improvements to existing treatments, and increasing efficiencies in the delivery system that support higher quality care and an overall a reduction in the economic and health burden of disease. But innovation is worthless without access to it.”

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Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9. Join the conversation with #T3cancer.

Required Reading: September 2014

Great stories are published daily about the impact personalized medicine is having on individual patients, and the medical community as a whole, but it can be a challenge to stay on top of the news. With that in mind, we bring to you a monthly roundup of the three to five most thought-provoking articles we are reading, sharing and discussing with our colleagues.

This is the September 2014 installment of Required Reading.

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Medical Calculators Use Big Data to Help Patients Make Choices by Laura Landro, The Wall Street Journal

Michael Kattan, chairman of the department of quantitative health sciences at Cleveland Clinic’s Lerner Research Institute, discusses sophisticated risk calculators, or “nomograms,” that can combine a patient’s unique characteristics, such as age, gender, race, extent and type of disease and other health factors; compare them with the vast databases of similar cases and studies; and use them to predict probable outcomes depending on the treatment a patient chooses.

FDA’s Shuren Defends Plan to Issue Guidance for LDTs at House Hearing by Michael D. Williamson, Bloomberg BNA

On September 9, the House Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine the regulation of laboratory developed tests (LDTs) as a continuation of the committee’s 21st Century Cures initiative. Members heard testimonies from various witnesses on recently released guidance from the U.S. Food and Drug Administration (FDA) and its impact on innovation and the practice of precision medicine. Read more about the FDA’s proposed framework for regulating LDTs.

Experts Warn US in Danger of Losing Biotechnology Edge by Chris Casey, Medical Xpress

The United States is in potential danger of losing its biomedical edge to countries that are aggressively funding research into personalized medicine, according to discussion that emerged at the 21st Century Cures Roundtable on September 5. Roundtable panelists noted that biotechnology is at a crossroads in America, and that funding levels for research have flattened in recent years.

Researcher Urges Wider Genetic Screening for Breast Cancer by Rob Stein, NPR Shots Blog

Mary-Claire King, the geneticist who identified the first breast cancer gene, is recommending that all women get tested for genetic mutations that can cause breast cancer, regardless of their personal or family history. According to a paper she recently published in Proceedings of the National Academy of Science, women who carry mutations in BRCA1 or BRCA2, but have no family history of breast or ovarian cancer, have the same high risks of developing either cancer as those who are identified to be at-risk by virtue of their family history.

Turning the Tide Against Cancer: Patient-Centered Care and Value

On October 9, the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare will be convening the second Turning the Tide Against Cancer Through Sustained Medical Innovation national conference in Washington, D.C., to continue the ongoing dialogue which began at the initiative’s inaugural conference in June 2012.

This year’s conference will bring together leaders from across the cancer community to help identify specific policy solutions to the challenges of supporting the shift to patient-centered research and care and addressing the value and cost of cancer care — two key themes that have emerged through the initiative’s ongoing work.

The Age of Personalized Medicine editorial team sat down with each of the initiative co-conveners to talk about the current cancer research and care landscape,  the upcoming conference, and what progress has been made since the start of the Turning the Tide Against Cancer initiative in 2011.

Our conversation with Edward Abrahams Ph.D., president of the Personalized Medicine Coalition can be viewed below. Stay tuned for additional video interviews with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research and Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9.