2014: The Year of the Patient

As we reach the end of another year, we once again look back at recent advancements and milestones in the field of personalized medicine. As we celebrated 10 years of progress, we also looked toward the future, identifying changes needed to ensure another decade of discovery. Reflecting upon the highlights of 2014, it is clear that this truly was the year of the patient. A renewed sense of urgency to shift towards a more patient-centered approach to care has been created across the healthcare system.

The following captures highlights from The Age of Personalized Medicine Blog for 2014.

Michael Kolodziej, M.D., National Medical Director for Oncology, Office of the Chief Medical Officer, Aetna, kicked off the year with reflections on the challenges facing the adoption of personalized medicine.

So what are the practical challenges? There are many. And many share the underlying theme that the old paradigms do not work so well. … Perhaps the biggest challenges lie in the area of clinical utility, which impacts providers, payers and regulatory agencies. Patients are impacted in a huge way. Most people have an idea of where we need to go, but we have a shortage of ideas about how to get there. Finally, all of this occurs in the setting of unsustainable growth in health care spending, and the near uniform agreement that we need to spend our money in a more intelligent, impactful way. … We have a lot of work to do together.

In March, we were honored to share the personal and candid story of Stephanie Dunn Haney, a lung cancer survivor, and her experience with molecular testing and targeted therapies. Stephanie’s story continues to remind us of the hope personalized medicine offers to so many.

Molecular testing and personalized medicine gave me my life back, and my sense of a future back. While I’m realistic enough to know that my daughters are fairly certain to lose their mother before they are grown, I also know I have tools to fight with, and a responsibility to share my story.

As we talk about the need to keep the patient at the center of all that we do, we at the Personalized Medicine Coalition (PMC) saw a need to establish a baseline of consumer awareness, knowledge and attitudes about personalized medicine. In July, PMC released a national survey, U.S. Public Opinion About Personalized Medicine, with key findings that will guide future outreach and education efforts.

We’re at the beginning of the golden age of personalized medicine. Armed now with a clear picture of the public’s opinion, we have an opportunity to raise awareness and increase understanding of what personalized medicine is, and how it can transform approaches to healthcare delivery.

Of course, in order to bring molecular tests and targeted therapies to patients, key regulatory and reimbursement areas must be addressed. PMC also published The Future of Coverage and Payment for Personalized Medicine Diagnostics in July, which took a critical look at CMS policies, highlighting specific challenges to the further implementation of personalized medicine diagnostics.  Later that month, the U.S. Food and Drug Administration’s (FDA) released its long-awaited final guidance on the regulation of companion diagnostic devices, as well as proposed framework for regulating laboratory developed tests (LDTs).

Investors have long argued that clarity is necessary in both regulation and reimbursement for continued advancement of personalized medicine. We now have clarity on FDA’s current thinking although many issues remain unresolved. The community has time to consider this framework and may soon have a chance to provide public comments. And finally, the pharmaceutical industry has the FDA’s assurance that targeted treatments will not be held up by co-development challenges.

In October 2014, the PMC, the American Association for Cancer Research (AACR), and Feinstein Kean Healthcare (FKH) convened the second national Turning the Tide Against Cancer national conference, which brought together leaders throughout the healthcare and policy communities for a passionate and engaging discussion on the importance of moving towards a more high-value, patient-centric system of cancer care.

Keynote speaker, cancer survivor, and The New York Times Emmy® Award winning columnist of “Life, Interrupted,” Suleika Jaouad, shared insights into communication challenges patients face during a Q&A session. Suleika’s words serve as a reminder that if we are to increase adoption of personalized healthcare, we must ensure patients are given the tools and education needed to properly understand their treatment options.

Communication is the golden ticket. We live in the WebMD age where patients often consult Google before they consult a doctor. This can be dangerous and can lead to misinformation and misunderstandings. Creating an environment where the patient feels comfortable asking questions and talking to their medical team is crucial.

Following the conference, FKH Chairman, Marcia A. Kean, M.B.A., proposed next steps:

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
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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.

We encourage you to learn more about the Turning the Tide Against Cancer initiative, and the important work we are doing to make a difference for cancer patients.

As an appropriate end to the year, we celebrated the 10th Anniversary Personalized Medicine Conference in November, and conference organizer Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics, Harvard Medical School, reflected on a decade of developments in personalized medicine.

The past decade has witnessed many exciting new developments in personalized medicine: the significant reduction in the cost of DNA sequencing and related technologies; the use of these technologies for an unprecedented rate of discovery of human disease genes; a near universal acceptance of the importance of genetics and genomics in drug development, especially for cancer; the levels of investment in personalized medicine companies; recognition of the importance of personalized medicine by professional societies; and the deep involvement by the administrative and legislative bodies in the U.S. and throughout the world.

2014 was a milestone year. We look forward to the year ahead, and the continued opportunity to engage with leaders throughout the personalized medicine community, and across the healthcare system, to discuss the future of personalized healthcare and how we can provide the best value to patients.

Special Edition Required Reading: Turning the Tide Against Cancer 2014 National Conference

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 a special installment of Required Reading reporting on coverage of the Turning the Tide Against Cancer 2014 national conference, which was held on October 9 in Washington, D.C. The following articles focus on the passionate and engaging discussion that took place at the conference, delving into the importance of moving towards a more high-value, patient-centric system of cancer care that helps to improve patient outcomes and represents each individual’s unique needs and definition of “value.”

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Through Len’s Lens: Putting a Price on Value by J. Leonard Lichtenfeld, M.D., MACP, MedPage Today

Cancer Community Turns Focus to ‘Value’ by Alicia Ault, OncologyPractice.com

‘Turning the Tide’ Working Group Issues Recommendations on Patient-Centered, Value-Based Cancer Care  by Peggy Eastman, Oncology Times

Turning The Tide Against Cancer: A Discussion on Value by Amy O’Connor, PACE USA Blog

ASCO’s Tool for Scoring Cancer Drug Value to be Released in Early 2015 by Cathy Kelly, The Pink Sheet Daily (Subscription Required)

The Pharmaceutical Research and Manufacturers of America’s (PhRMA) Conversations blog also featured a video series with several speakers from the Turning the Tide Against Cancer 2014 national conference to get their thoughts on scientific advances in cancer treatments. The full set of responses can be viewed below.

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

Linda House, R.N., B.S.N., M.S.M., Executive Vice President, External Affairs, Cancer Support Community

J. Leonard Lichtenfeld, M.D., MACP, Deputy Chief Medical Officer, American Cancer Society

Stephen L. Eck, M.D., Ph.D., Vice President, Global Head of Oncology Medical Sciences, Astellas Pharma Global Development

Roy S. Herbst, M.D., Ph.D., Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Thoracic Oncology Research Program, and Associate Director for Translational Research, Yale Comprehensive Cancer Center and Yale School of Medicine

To follow the news on the Turning the Tide Against Cancer initiative, visit the News page.

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.

Q&A with Suleika Jaouad, The New York Times Emmy® Award Winning Columnist, “Life, Interrupted,” and Cancer Survivor

In advance of the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed questions to Suleika Jaouad, The New York Times Emmy® Award winning columnist of “Life, Interrupted,” and cancer survivor, who will be speaking at the event on October 9 in Washington, D.C. Below, Suleika shares insights from the patient perspective on the need for a patient-centered approach to cancer care.

QUESTION: As a cancer patient, would you describe your health care experience as “patient-centered”? Why or why not?

Suleika Jaouad: Yes and no. I feel deeply grateful and indebted to my doctors who have always gone above and beyond to provide me with the very best care, but the lack of patient-clinician communication has been an ongoing struggle and source of frustration for me. For example, just a few days after my diagnosis, I learned via Google search that the chemotherapy treatments I was scheduled to undergo in less than a week would most likely leave me infertile. It was only after I initiated a conversation about fertility that my doctors told me about the available options. This felt like a major breach of trust early on in my treatment and I couldn’t help but wonder what else my doctors weren’t telling me. At 22, I hadn’t had the chance to start a family yet. Preserving my ability to be a mother one day felt like a lifeline to an already uncertain future. After explaining this to my medical team, they agreed to delay chemotherapy so that I could undergo fertility preservation treatments. This experience was the first of many that made me realize I needed to take an active role in my medical care in order to better advocate for myself.

QUESTION: In your opinion, how can we create a more patient-centered approach to cancer research and care?

Suleika Jaouad: Communication is the golden ticket. We live in the WebMD age where patients often consult Google before they consult a doctor. This can be dangerous and can lead to misinformation and misunderstandings. Creating an environment where the patient feels comfortable asking questions and talking to their medical team is crucial. It’s also very important for clinicians to educate their patients and to take the time to explain things more than once in clear, simple language. My doctors are some of the smartest people I’ve ever met. This made me feel safe and like I was in good hands, but half of the time I felt lost in the conversation. A lot of the terminology and medical jargon they used sounded like a foreign language to me. I wanted to understand and learn more about my disease but I often felt overwhelmed and didn’t know where to start.

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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.

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 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:

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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.

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.